chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: F
Vaccine: UNK
Symptoms: Rash
Clinical narrative: Severe 4? x 2? rash about 2? from injection site.  GP sent me to medi clinic to see if it was cellulitis.  That Dr said it appeared to be  severe injection  reaction, even though it was 2? lower on arm than injection spot.  It turnd into bruising, and is still slightly visible 18 days later.  The rash was very painful and i did het a headache and not feel well for 3 days after shot.  I will not do the 2nd shot
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Aura, Headache, Vision blurred
Clinical narrative: Right eye blurry vision and headache after. Next day 1 hour into school started with blurry vision in right eye with aura.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Urticaria
Clinical narrative: Light hives on both forearms approximately 2 hours after Shingrix vaccination. To treat the hives, patient received Solu-medrol 125mg IM at 12:52pm in the left gluteal, and Diphenhydramine 25mg orally at 12:49pm. Patient was contacted at 2:09pm on June 25 after he had been drive home, and patient stated the hives have improved to light pink and barely elevated, and he was instructed to continue diphenhydramine 25mg one every 4-6 hours as needed.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Abdominal pain upper, Alopecia, Anxiety, Asthenia, Dysmenorrhoea
Clinical narrative: Stomach pain, headache, nose bleed, hair loss, nail picking, anxiety, Raynards phenomenon, painful periods, body pain, left eye droop, lack of energy
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Epistaxis, Eyelid ptosis, Headache, Laboratory test, Nail picking
Clinical narrative: Stomach pain, headache, nose bleed, hair loss, nail picking, anxiety, Raynards phenomenon, painful periods, body pain, left eye droop, lack of energy
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Pain, Raynaud's phenomenon
Clinical narrative: Stomach pain, headache, nose bleed, hair loss, nail picking, anxiety, Raynards phenomenon, painful periods, body pain, left eye droop, lack of energy
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood test, Computerised tomogram, Haematoma, Pain, Swelling
Clinical narrative: Severe swelling, hematoma, severe pain, went to ER
Age: 70.0
Sex: F
Vaccine: UNK
Symptoms: Chills, Dehydration, Fatigue, Hypersensitivity, Injection site pain
Clinical narrative: 6/26/2019   Dear Dr.,   I hope all is well with you. As suggested in the literature accompanying the vaccine, this is to report on my allergic reactions to my prescribed shingles vaccine (Shingrix) which I received this past Monday, 6/24/2019 around 3pm. The site was increasingly painful and I grew tired.  By late night through early morning, I had high fever and shivers, and such dehydration that I had to continually drink water. The fever abated toward the morning (6/25 )and I slept until 10am, unusually late for me.  I functioned at a slow pace, with a needed nap around 5pm, again unusual for me. I am almost back to normal today(6/26/2019.)  I have never had such a reaction to any other vaccine. Please file this report to the Vaccine Adverse Event Reporting System (www.vaers.hhs.gov.) as suggested.  Thank you for your attention and care.  Respectfully,
Age: 70.0
Sex: F
Vaccine: UNK
Symptoms: Pyrexia, Somnolence
Clinical narrative: 6/26/2019   Dear Dr.,   I hope all is well with you. As suggested in the literature accompanying the vaccine, this is to report on my allergic reactions to my prescribed shingles vaccine (Shingrix) which I received this past Monday, 6/24/2019 around 3pm. The site was increasingly painful and I grew tired.  By late night through early morning, I had high fever and shivers, and such dehydration that I had to continually drink water. The fever abated toward the morning (6/25 )and I slept until 10am, unusually late for me.  I functioned at a slow pace, with a needed nap around 5pm, again unusual for me. I am almost back to normal today(6/26/2019.)  I have never had such a reaction to any other vaccine. Please file this report to the Vaccine Adverse Event Reporting System (www.vaers.hhs.gov.) as suggested.  Thank you for your attention and care.  Respectfully,
Age: 18.0
Sex: F
Vaccine: HEP, HEPA, HPV9, MNQ
Symptoms: Syncope
Clinical narrative: patient who had syncope after received first dose of HPV series, GARDASIL 9; This spontaneous report was received from a registered nurse via a company representative and refers to an 18-year-old non-pregnant female patient. The patient had history of syncope after she received other vaccines (unspecified). No information regarding the patient's drug reactions or allergies and concomitant therapies was provided.  On an unknown date, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (exact dose, site and route of administration, lot # and expiration date were not reported). On the same day, she was also vaccinated with meningococcal acyw conj vaccine (crm197) (MENVEO), hepatitis B vaccine (manufacturer unknown) and hepatitis A vaccine (manufacturer unknown) (exact doses, sites and routes of administration, lot # and expiration dates were not reported), all for prophylaxis.  On an unknown date, after receiving the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), the patient had syncope. Laboratory diagnostics were not performed and she did not receive any treatment for the event. The patient recovered on an unspecified day, after lying down and resting.   The relatedness between the event and the suspect therapies was not reported.  Upon internal review, the event of syncope was determined to be medically significant.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; Multiple patients were vaccinated with improperly stored ROTATEQ on multiple dates; Information has been received from a medical assistant concerning a patient of unknown age, gender and race. The patient's medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medications were not reported.  On 17-OCT-2018, the patient was vaccinated with an improperly stored dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) orally for prophylaxis (lot number N034400 with expiration date in 10-MAY-2019) (strength and anatomical location were not provided).  The Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) was stored at an unknown temperature for an unknown time frame. There was a previous temperature excursion and the call was because of a data logger.  No adverse effects reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1907USA001848: US-009507513-1907USA001849: US-009507513-1907USA001847: US-009507513-1907USA001793: US-009507513-1907USA001794: US-009507513-1907USA001795: US-009507513-1907USA001796: US-009507513-1907USA001797: US-009507513-1907USA001798: US-009507513-1907USA001799: US-009507513-1907USA001800: US-009507513-1907USA001801: US-009507513-1907USA001802: US-009507513-1907USA001803: US-009507513-1907USA001804: US-009507513-1907USA001805: US-009507513-1907USA001806: US-009507513-1907USA001807: US-009507513-1907USA001808: US-009507513-1907USA001809: US-009507513-1907USA001810: US-009507513-1907USA001811: US-009507513-1907USA001812: US-009507513-1907USA001813: US-009507513-1907USA001814: US-009507513-1907USA001815: US-009507513-1907USA001816: US-009507513-1907USA001817: US-009507513-1907USA001818: US-009507513-1907USA001819: US-009507513-1907USA001820: US-009507513-1907USA001821: US-009507513-1907USA001822: US-009507513-1907USA001823: US-009507513-1907USA001824: US-009507513-1907USA001825: US-009507513-1907USA001826: US-009507513-1907USA001827: US-009507513-1907USA001828: US-009507513-1907USA001829: US-009507513-1907USA001830: US-009507513-1907USA001831: US-009507513-1907USA001832: US-009507513-1907USA001833: US-009507513-1907USA001834: US-009507513-1907USA001835: US-009507513-1907USA001836: US-009507513-1907USA001837: US-009507513-1907USA001838: US-009507513-1907USA001839: US-009507513-1907USA001840: US-009507513-1907USA001841: US-009507513-1907USA001842: US-009507513-1907USA001843: US-009507513-1907USA001844: US-009507513-1907USA001845: US-009507513-1907USA001846: US-009507513-1907USA000952: US-009507513-1907USA000953: US-009507513-1907USA000954: US-009507513-1907USA000959: US-009507513-1907USA000962: US-009507513-1907USA000963: US-009507513-1907USA000964: US-009507513-1907USA000965: US-009507513-1907USA000966: US-009507513-1907USA000967: US-009507513-1907USA000968: US-009507513-1907USA000969: US-009507513-1907USA000970: US-009507513-1907USA000988: US-009507513-1907USA000989:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; multiple patients were vaccinated with an improperly stored vaccine; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported.  On 04-JUN-2019 00:00, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), 2 ml, orally, LOT# R034700, expiry date 16-JUN-2020 for prophylaxis. The vaccine was exposed to a temperature of 34.2 F for 4 hours and 54 minutes. This call was made because of a digital data logger. There were no previous temperature excursions. No adverse effects were reported.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-1906USA011674: US-009507513-1907USA000882: US-009507513-1907USA000883: US-009507513-1907USA000884: US-009507513-1907USA000885: US-009507513-1907USA000886: US-009507513-1907USA000887: US-009507513-1907USA000888: US-009507513-1907USA000889: US-009507513-1907USA000890: US-009507513-1907USA000891: US-009507513-1907USA000892: US-009507513-1907USA000893: US-009507513-1907USA000894: US-009507513-1907USA000895: US-009507513-1907USA000896: US-009507513-1907USA000897: US-009507513-1907USA000898: US-009507513-1907USA000899: US-009507513-1907USA000900: US-009507513-1907USA000901: US-009507513-1907USA000902: US-009507513-1907USA000903: US-009507513-1907USA000904: US-009507513-1907USA000905: US-009507513-1907USA000906: US-009507513-1907USA000907: US-009507513-1907USA000908: US-009507513-1907USA000909: US-009507513-1907USA000910: US-009507513-1907USA000911: US-009507513-1907USA000912: US-009507513-1907USA000913: US-009507513-1907USA000914: US-009507513-1907USA000915: US-009507513-1907USA000916: US-009507513-1907USA000917: US-009507513-1907USA000918: US-009507513-1907USA000919: US-009507513-1907USA000920: US-009507513-1907USA000921: US-009507513-1907USA000922: US-009507513-1907USA000923: US-009507513-1907USA000924: US-009507513-1907USA000925: US-009507513-1907USA000926: US-009507513-1907USA000927: US-009507513-1907USA000928: US-009507513-1907USA000929: US-009507513-1907USA000930: US-009507513-1907USA000931: US-009507513-1907USA000932: US-009507513-1907USA000933: US-009507513-1907USA000934: US-009507513-1907USA000935: US-009507513-1907USA000936: US-009507513-1907USA000937: US-009507513-1907USA000938: US-009507513-1907USA000885:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; Multiple patients were vaccinated with improperly stored ROTATEQ on multiple dates; Information has been received from a medical assistant concerning a patient of unknown age, gender and race. The patient's medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medications were not reported.  On 16-NOV-2018, the patient was vaccinated with an improperly stored dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) orally for prophylaxis (lot number N034400 with expiration date in 10-MAY-2019) (strength and anatomical location were not provided).  The Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) was stored at an unknown temperature for an unknown time frame. There was a previous temperature excursion and the call was because of a data logger.  No adverse effects reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA011434: US-009507513-1907USA001849: US-009507513-1907USA001847: US-009507513-1907USA001848: US-009507513-1907USA001794: US-009507513-1907USA001795: US-009507513-1907USA001796: US-009507513-1907USA001797: US-009507513-1907USA001798: US-009507513-1907USA001799: US-009507513-1907USA001800: US-009507513-1907USA001801: US-009507513-1907USA001802: US-009507513-1907USA001803: US-009507513-1907USA001804: US-009507513-1907USA001805: US-009507513-1907USA001806: US-009507513-1907USA001807: US-009507513-1907USA001808: US-009507513-1907USA001809: US-009507513-1907USA001810: US-009507513-1907USA001811: US-009507513-1907USA001812: US-009507513-1907USA001813: US-009507513-1907USA001814: US-009507513-1907USA001815: US-009507513-1907USA001816: US-009507513-1907USA001817: US-009507513-1907USA001818: US-009507513-1907USA001819: US-009507513-1907USA001820: US-009507513-1907USA001821: US-009507513-1907USA001822: US-009507513-1907USA001823: US-009507513-1907USA001824: US-009507513-1907USA001825: US-009507513-1907USA001826: US-009507513-1907USA001827: US-009507513-1907USA001828: US-009507513-1907USA001829: US-009507513-1907USA001830: US-009507513-1907USA001831: US-009507513-1907USA001832: US-009507513-1907USA001833: US-009507513-1907USA001834: US-009507513-1907USA001835: US-009507513-1907USA001836: US-009507513-1907USA001837: US-009507513-1907USA001838: US-009507513-1907USA001839: US-009507513-1907USA001840: US-009507513-1907USA001841: US-009507513-1907USA001842: US-009507513-1907USA001843: US-009507513-1907USA001844: US-009507513-1907USA001845: US-009507513-1907USA001846: US-009507513-1907USA000952: US-009507513-1907USA000953: US-009507513-1907USA000954: US-009507513-1907USA000959: US-009507513-1907USA000962: US-009507513-1907USA000963: US-009507513-1907USA000964: US-009507513-1907USA000965: US-009507513-1907USA000966: US-009507513-1907USA000967: US-009507513-1907USA000968: US-009507513-1907USA000969: US-009507513-1907USA000970: US-009507513-1907USA000988: US-009507513-1907USA000989:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; Multiple patients were vaccinated with improperly stored ROTATEQ on multiple dates; Information has been received from a medical assistant concerning a patient of unknown age, gender and race. The patient's medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medications were not reported.  On 12-DEC-2018, the patient was vaccinated with an improperly stored dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) orally for prophylaxis (lot number N034400 with expiration date in 10-MAY-2019) (strength and anatomical location were not provided).  The Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) was stored at an unknown temperature for an unknown time frame. There was a previous temperature excursion and the call was because of a data logger.  No adverse effects reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA011434: US-009507513-1907USA001848: US-009507513-1907USA001847: US-009507513-1907USA001849: US-009507513-1907USA001793: US-009507513-1907USA001795: US-009507513-1907USA001796: US-009507513-1907USA001797: US-009507513-1907USA001798: US-009507513-1907USA001799: US-009507513-1907USA001800: US-009507513-1907USA001801: US-009507513-1907USA001802: US-009507513-1907USA001803: US-009507513-1907USA001804: US-009507513-1907USA001805: US-009507513-1907USA001806: US-009507513-1907USA001807: US-009507513-1907USA001808: US-009507513-1907USA001809: US-009507513-1907USA001810: US-009507513-1907USA001811: US-009507513-1907USA001812: US-009507513-1907USA001813: US-009507513-1907USA001814: US-009507513-1907USA001815: US-009507513-1907USA001816: US-009507513-1907USA001817: US-009507513-1907USA001818: US-009507513-1907USA001819: US-009507513-1907USA001820: US-009507513-1907USA001821: US-009507513-1907USA001822: US-009507513-1907USA001823: US-009507513-1907USA001824: US-009507513-1907USA001825: US-009507513-1907USA001826: US-009507513-1907USA001827: US-009507513-1907USA001828: US-009507513-1907USA001829: US-009507513-1907USA001830: US-009507513-1907USA001831: US-009507513-1907USA001832: US-009507513-1907USA001833: US-009507513-1907USA001834: US-009507513-1907USA001835: US-009507513-1907USA001836: US-009507513-1907USA001837: US-009507513-1907USA001838: US-009507513-1907USA001839: US-009507513-1907USA001840: US-009507513-1907USA001841: US-009507513-1907USA001842: US-009507513-1907USA001843: US-009507513-1907USA001844: US-009507513-1907USA001845: US-009507513-1907USA001846: US-009507513-1907USA000952: US-009507513-1907USA000953: US-009507513-1907USA000954: US-009507513-1907USA000959: US-009507513-1907USA000962: US-009507513-1907USA000963: US-009507513-1907USA000964: US-009507513-1907USA000965: US-009507513-1907USA000966: US-009507513-1907USA000967: US-009507513-1907USA000968: US-009507513-1907USA000969: US-009507513-1907USA000970: US-009507513-1907USA000988: US-009507513-1907USA000989:
Sex: F
Vaccine: MMR
Symptoms: Drug ineffective, Seroconversion test negative
Clinical narrative: did not show any efficacy on her immunity response, hense she did not seroconvert to either the first two doses of MMR II due to the vaccine being ineffective; did not show any efficacy on her immunity response, hense she did not seroconvert to either the first two doses of MMR II due to the vaccine being ineffective; This spontaneous report was received from a female patient of unknown age referring to herself. Information about pertinent medical history, drug reactions/allergies and concomitant medication was not reported.  On unknown dates, the patient was vaccinated with two doses of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (dose detail, route, lot # and expiration date were not reported) for prophylaxis.   On an unknown date, the patient was vaccinated with the third dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (dose detail, route, lot # and expiration date were not reported) for prophylaxis because she explained it did not show any efficacy on her immunity response, hence she did not seroconvert to either the first two doses of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) due to the vaccine being ineffective (vaccination failure and seroconversion test negative)  The patient also commented that other unspecified vaccines did not have any efficacy on her immunity, so she did not seroconvert to other unknown vaccinations she had previously received as well.  The outcome of  both events was not reported. The causality assessment between both events and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was not reported either.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effects were reported; one dose of expired VARIVAX (lot N012487 exp 4/20/2019) was administered; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, current conditions, concomitant medications, drug reactions and allergies.  On 05-JUL-2019, the patient was vaccinated with an expired dose of varicella virus vaccine live (oka/merck) (VARIVAX) with lot number N012487 and expiration date on 20-APR-2019, 1 dose for prophylaxis (frequency, route of administration and anatomical injection site were not reported) (expired product administered). The suspect vaccine was stored properly through the date of administration and the sterile diluent used was not expired and it was stored properly. No adverse effects were reported.
Sex: U
Vaccine: MENB
Symptoms: Pain in extremity
Clinical narrative: sore arm; This case was reported by a physician via sales rep and described the occurrence of pain in arm in an unspecified number of  patients who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received Bexsero at an unknown dose. On an unknown date, unknown after receiving Bexsero, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Bexsero.  Additional details were provided as follows: The age at vaccination was not reported. The physician made a general statement regarding his clinical experience with Bexsero. The physician stated patients experienced a sore arm.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site warmth
Clinical narrative: injection site itching; injection site redness; injection site hot to touch; injection site hardness; This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 73-year-old female patient who received Herpes zoster (Shingrix) (batch number GX25K, expiry date 30th November 2021) for prophylaxis.   On 28th June 2019, the patient received the 1st dose of Shingrix (intramuscular). On 29th June 2019, 1 days after receiving Shingrix, the patient experienced injection site erythema, injection site warmth and injection site induration. On 1st July 2019, the patient experienced injection site itching. On 1st July 2019, the outcome of the injection site induration was recovered/resolved. On an unknown date, the outcome of the injection site erythema, injection site warmth and injection site itching were not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema, injection site warmth, injection site induration and injection site itching to be related to Shingrix.  Additional details were received as follows: The patient received Shingrix on the left deltoid. Mention descipency regarding outcome.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity
Clinical narrative: body aches all over; arm pain; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th May 2019, the patient received the 1st dose of Shingrix. On 7th May 2019, less than a day after receiving Shingrix, the patient experienced pain in arm. On 8th May 2019, the patient experienced general body pain. On an unknown date, the outcome of the pain in arm and general body pain were recovered/resolved.   It was unknown if the reporter considered the pain in arm and general body pain to be related to Shingrix.  Additional details were provided as follows: The patient experienced arm pain the day of the injection that got worse over the next few days and then resolved. The patient also noted extreme body aches all over that last a few days and resolved. This was 1 of 3 cases reported by same reporter.  There is a discrepancy between the outcome reported in the structured field (recovered/resolved with sequel, unknown for food poisoning) and the outcome reported in the source document (recovered, and recovering).
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Rash; This case was reported by a pharmacist via call center representative and described the occurrence of rash in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 6 days after receiving Shingrix, the patient experienced rash. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the rash was recovered/resolved.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported, but it could be 64 or 65 years. The health care professional stated that a patient experienced a rash 6 days after receiving a dose of Shingrix. The rash was not at the injection site and was not a shingles-type rash. The rash cleared up on it's own with the use of Benadryl.
Age: 86.0
Sex: F
Vaccine: VARZOS
Symptoms: Balance disorder, Feeling abnormal, Syncope, Tremor
Clinical narrative: Shaky balance Fainted next morning Felt bad rest of the day Fully recovered
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Blood glucose normal, Dyskinesia, Immediate post-injection reaction, Posture abnormal, Syncope
Clinical narrative: Immediately after HPV vaccine was given while pt is in sitting position-- > pt fainted per LVN and "entire body jerked for a few seconds"  per older sister who witness episode.  Pt remembers the vaccination but does not remember slumping over.  Pt reports feeling normal  and had reassuring exam when I returned to room with blood glucouse 94.  BP96/61.  HR 80.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Asthenia, Back pain, Influenza like illness
Clinical narrative: 12 hours after having the shot, I had flu-like symptoms.  I took ibuprofen and they went away.  See more details in an earlier field of this application.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Dyspepsia, Fatigue
Clinical narrative: Chills, arthralgia, dyspepsia, headache, fatigue
Age: 78.0
Sex: F
Vaccine: PPV
Symptoms: Injection site cellulitis, Injection site reaction, Injection site swelling, Injection site warmth, Skin lesion
Clinical narrative: Swollen lesion around left deltoid that looks similar to cellulitis. Pt reports feeling of warmth around the swollen areas
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Neuralgia, Rash
Clinical narrative: Patient contracted Shingles. Rash, nerve pain. Treatment was with Valacyclovir 1 gram with instructions of 1 tab by mouth three times daily for 7 days and Gabapentin 300 mg with instructions of 1 cap by mouth three times daily for 30 days.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Injection site erythema, Injection site vesicles, Injection site warmth
Clinical narrative: Redness and warmth all R upper arm. Has concentrated vesicles
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Fatigue, Injection site pain, Injection site rash, Injection site reaction
Clinical narrative: Tiredness, Itching, Injection site pain. Rash hives Below injection site. hives on LFT calf, Both elbows & hands near thumb Joints! Elbow & Knee Joint Pain 1.) Below injection site red rash & Red dots. 2.) tiredness and rash on arm lasted for a week and gradualy went Away. 3.) short term Memory was effected. 4.) After About 2 weeks most of the hives are gone. the reminded me of mosquito Bites. Because of the Locations I felt is was a Reaction. 6. P.S. I know the shingle shot is important. If you need to contact me, I can talk with you on the phone.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site urticaria, Memory impairment, Pruritus, Rash, Rash erythematous
Clinical narrative: Tiredness, Itching, Injection site pain. Rash hives Below injection site. hives on LFT calf, Both elbows & hands near thumb Joints! Elbow & Knee Joint Pain 1.) Below injection site red rash & Red dots. 2.) tiredness and rash on arm lasted for a week and gradualy went Away. 3.) short term Memory was effected. 4.) After About 2 weeks most of the hives are gone. the reminded me of mosquito Bites. Because of the Locations I felt is was a Reaction. 6. P.S. I know the shingle shot is important. If you need to contact me, I can talk with you on the phone.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Tiredness, Itching, Injection site pain. Rash hives Below injection site. hives on LFT calf, Both elbows & hands near thumb Joints! Elbow & Knee Joint Pain 1.) Below injection site red rash & Red dots. 2.) tiredness and rash on arm lasted for a week and gradualy went Away. 3.) short term Memory was effected. 4.) After About 2 weeks most of the hives are gone. the reminded me of mosquito Bites. Because of the Locations I felt is was a Reaction. 6. P.S. I know the shingle shot is important. If you need to contact me, I can talk with you on the phone.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Abdominal discomfort, Headache, Pyrexia
Clinical narrative: Patient developed a bad headache, fever (101 degrees), and upset stomach. Tylenol helped.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: The patient reports having soreness in the arm/injection site as well as redness. Recommended the patient use cold compresses as well as tylenol for the pain.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Hyperhidrosis, Lethargy, Migraine
Clinical narrative: I received the Shingrix vaccine in my upper left arm around 11.30am on Tuesday July 9, 2019. Around 5:30 that evening I became very lethargic and began experiencing pain in my joints. I had pain in both ankles (like they were sprained) and in my knees. I also experienced pain in my left wrist. I slept until about 2am when I woke up shivering and bathed in sweat. I had a severe migraine and was congested. I also urinated about 10 times that evening.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Pollakiuria, Respiratory tract congestion
Clinical narrative: I received the Shingrix vaccine in my upper left arm around 11.30am on Tuesday July 9, 2019. Around 5:30 that evening I became very lethargic and began experiencing pain in my joints. I had pain in both ankles (like they were sprained) and in my knees. I also experienced pain in my left wrist. I slept until about 2am when I woke up shivering and bathed in sweat. I had a severe migraine and was congested. I also urinated about 10 times that evening.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Extra dose administered
Clinical narrative: Patient came in and asked for meningitis vaccination to be administered for college age patient. We administered Menactra. Patient's mother later reported that the patient had already completed combination meningitis vaccine and was looking to get meningitis B only.  As a result patient received an additional dose of Menactra.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Dizziness, Headache, Myalgia
Clinical narrative: Muscle pain, joint pain, chills, headache, nausea, Sharp shooting pain in rt. knee, dizziness
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pain
Clinical narrative: Muscle pain, joint pain, chills, headache, nausea, Sharp shooting pain in rt. knee, dizziness
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Fatigue, Myalgia
Clinical narrative: Adverse symptoms: fatigue, muscle and joint pain, fever Treatment: ibuprophen Symptoms began upon waking the following morning and lasted approximately 24 hours
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; The patient was administered the 1st dose of GARDASIL 9 on 18-JUN-2018. the 2nd dose on 03-JAN-2019 and the 3rd dose on 27-JUN-2019; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medications, drug reactions or allergies were not reported.  On 18-JUN-2018, the patient was vaccinated with the first dose of  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # N028092, expiration date: 28-MAY-2020; on 03-JAN-2019, with the second dose of  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # R008163 expiration date: 18-NOV-2020; and on 27-JUN-2019, with the third dose of  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # 1602283, expiration date: 18-AUG-2021 (reported as 16-AUG-2021) (route of administration and anatomical location not provided for any dose) all for prophylaxis (inappropriate schedule of product administration). No adverse effects reported.
Sex: M
Vaccine: PPV
Symptoms: Urticaria
Clinical narrative: The patient "broke out in hives the day after he was administered PNEUMOVAX 23"; This spontaneous report was received from a physician, via company representative, regarding a male patient of unknown age. Information about his pertinent medical history, drug reactions or allergies, and concomitant medications were unknown by the reporter.   On an unspecified date, the patient was vaccinated with 1 dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), injection for prophylaxis (strength was not provided; route, lot number and expiration date were unknown by the reporter).   On an unspecified date (reported as the day after he was administered pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23)), the patient broke out in hives. The patient did not seek medical attention nor diagnostic laboratories, or studies were performed. It was unknown by the reporter if he received treatment for the event. It was reported that the event of hives was no a cancer or an overdose event. On an unspecified date (reported as within 24 hours), the patient recovered from hives.  The reporter did not provide causality assessment between the aforementioned event and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23).
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 75-year-old male patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 10-DEC-2013, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route of administration not specified) by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced shingles and was treated by a healthcare provider. The outcome of shingles was unknown. The reporter considered shingles to be related to Zoster Vaccine Live ( ZOSTAVAX).     Additional information has been requested.
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Dizziness
Clinical narrative: Since getting the vaccines she has been dizzy; This is a spontaneous report from a non-contactable consumer. A female patient of an unspecified age received pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein) (PREVNAR 13) and varicella zoster vaccine rge (cho) (SHINGRIX), both via an unspecified route of administration on Jun2019 at a single dose for an immunization. The patient's medical history and concomitant medications were not reported. It was reported that since getting the vaccines she had been dizzy. She did not know if they were bringing her potassium down. When she eats a banana, she feels a little better but this morning when she woke up she was dizzy again. The outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: MENB
Symptoms: Injection site erythema
Clinical narrative: Redness more than 1-2 inches around the injection site on the arm; This is a spontaneous report from a contactable physician (pediatrician) via a Pfizer sales representative. This physician reported similar event for 4 patients. This is the first of 4 reports.  A patient of an unspecified age and gender received the first dose of meningococcal group b rlp2086 (TRUMENBA, lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date on the patient's arm at single dose for routine vaccination.  The patient's medical history and concomitant medications were not reported.  It was reported on an unspecified date that the patient experienced redness more than 1-2 inches around the injection site on the arm. The outcome of the event was recovered on an unspecified date.   Information on the batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2019291991 same reporter/drug/event, different patient.;US-PFIZER INC-2019291989 same reporter/drug/event, different patient;US-PFIZER INC-2019292015 same reporter/drug/event, different patient
Sex: U
Vaccine: MENB
Symptoms: Injection site erythema
Clinical narrative: Redness more than 1-2 inches around the injection site on the arm; This is a spontaneous report from a contactable physician (pediatrician) via a Pfizer sales representative. This physician reported similar events for four patients. This is the second of four reports.  A 16-year-old patient of an unspecified gender received the first dose of meningococcal group b rlp2086 (TRUMENBA, lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date on the patient's arm at a single dose for routine vaccination. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced redness more than 1-2 inches around the injection site on the arm. The outcome of the event was recovered on an unspecified date (subsided after a few days).  Information on the batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2019291868 same reporter/drug/event, different patient
Sex: U
Vaccine: MENB
Symptoms: Injection site erythema
Clinical narrative: Redness more than 1-2 inches around the injection site on the arm; This is a spontaneous report from a contactable physician (pediatrician) via a Pfizer sales representative. This physician reported similar event for 4 patients. This is the third of 4 reports.  A 16-year-old patient of an unspecified gender received first dose of meningococcal group b rlp2086 (TRUMENBA, lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date on the patient's arm at single dose for routine vaccination.  The patient medical history and concomitant medications were not reported.  It was reported on an unspecified date that the patient experienced redness more than 1-2 inches around the injection site on the arm. The outcome of the event was recovered on an unspecified date.   Information on the batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2019291868 Same reporter/drug/event, different patient.
Sex: U
Vaccine: MENB
Symptoms: Injection site erythema
Clinical narrative: Redness more than 1-2 inches around the injection site on the arm; This is a spontaneous report from a contactable physician (pediatrician) via a Pfizer sales representative. This physician reported similar event for 4 patients. This is the fourth of 4 reports. A patient of unspecified age and gender received the first dose of meningococcal group b rlp2086 (TRUMENBA, lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date on the patient's arm at single dose for routine vaccination. The patient's medical history and concomitant medications were not reported. It was reported on an unspecified date that the patient experienced redness more than 1-2 inches around the injection site on the arm. The outcome of the event was recovered on an unspecified date.   Information on the batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2019291868 Same reporter/drug/event, different patient
Age: 22.0
Sex: F
Vaccine: MNQ, VARCEL
Symptoms: Burning sensation, Pruritus, Rash, Varicella post vaccine
Clinical narrative: Dx: Varicella infection after vaccination Adverse: Rash, itching, burning Treat: Isolation, OTC Benadryl, rest, oral hydration
Age: 29.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Pruritus, Skin warm
Clinical narrative: Varicella vaccine given at 11:30am on 7/10/2019. Patient waited 15 minutes after injection so we could monitor for adverse reactions. At 11:45am she stated her arm was really itchy. Upon evaluation her arm was red and hot to touch. She was given Benadryl 25mg & a ice pack. By 12:00pm she felt relief.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site pain, Pain in extremity
Clinical narrative: Started with intense soreness in left deltoid progressing to  increased pain in left arm with flu like symptoms
Age: 1.25
Sex: F
Vaccine: DTAP, HEPA, VARCEL
Symptoms: Cough, Dyspnoea, Rash
Clinical narrative: Rash, cough, and shortness of breath reported by mother.
Age: 26.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain
Clinical narrative: Lt arm inj site with a  8cm cellulitis area, painful, red to touch
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Screaming
Clinical narrative: Patient came in about 5 weeks after the vaccine and described to pharmacist her reaction. Patient states she had a "screaming" headache that started at midnight after her vaccine. The headache lasted for two days.
Age: 0.17
Sex: M
Vaccine: DTAP, HEP, HIBV
Symptoms: Food refusal, Pyrexia, Screaming
Clinical narrative: High fever, high pitched screaming for 4+ hours, refusal to eat for 7+ hours, no wet/dirty diapers
Age: 1.75
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: Client was given DTaP that expired on 07/07/2019, no adverse events. Client's mother notified.
Age: 3.0
Sex: M
Vaccine: DTAP
Symptoms: Gait disturbance, Injection site erythema, Injection site induration, Injection site mass, Injection site movement impairment
Clinical narrative: His leg swelled. Quickly after vaccine he had a red ring around the injection sight that over the course of a few days grew over four inches and had a hard lump. My child wouldn?t walk for over 24 hours, limped for two days. The redness didn?t go away for over a week and now he has a hard nodule over two weeks after vaccine.
Age: 3.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site nodule, Injection site swelling
Clinical narrative: His leg swelled. Quickly after vaccine he had a red ring around the injection sight that over the course of a few days grew over four inches and had a hard lump. My child wouldn?t walk for over 24 hours, limped for two days. The redness didn?t go away for over a week and now he has a hard nodule over two weeks after vaccine.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site erythema, Injection site swelling, Nausea, Pyrexia
Clinical narrative: redness at injection site; swelling at injection site; flu-like symptoms; nausea; fever; This case was reported by a other health professional via sales rep and described the occurrence of injection site erythema in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced injection site erythema, injection site swelling, influenza-like symptoms, nausea and fever. On an unknown date, the outcome of the injection site erythema, injection site swelling, influenza-like symptoms, nausea and fever were recovered/resolved.   It was unknown if the reporter considered the injection site erythema, injection site swelling, influenza-like symptoms, nausea and fever to be related to Shingrix.  Additional details were provided as follows: The GlaxoSmithKline Field representative called in to report this adverse event narrated to her by a scheduling agent at the doctor's office.  At around the end of 2018, the patient received the 2nd dose of the Shingrix in her right arm. The patient's age at event onset was not reported but it could be 55 years or 56 years. The patient had swelling at the injection site (right arm) which resolved within 24 hours, redness at the injection site (right arm) which resolved within 24 hrs, flu like symptoms with fever of 101 degree F which resolved in 24 hours and nausea which also resolved within 24 hours.  No hospitalizations was reported.  Additional information was not provided as this was second hand information. The reporter consented to follow up.      Lab Comments: On an unknown date, body temperature was checked
Sex: F
Vaccine: PNC13
Symptoms: Product contamination physical
Clinical narrative: Prevnar 13 with particulates was given to some of the patients; Prevnar 13 with particulates was given to some of the patients; This is a spontaneous report from a contactable pharmacist. This pharmacist reported similar events for three patients. This is the third of three reports.   An 80-year-old female patient received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date at single dose for immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) with particulates was given to the patient. Pharmacist reported that they have a box of pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) shot and they have already given it to some of the patient. At the time of the reporting (11Jun2019), when the pharmacist was about to give one to a patient, it looked like there was a very big particulate and when the pharmacist look through the box, about 5 of the shots have that in there so the pharmacist took it out completely. Also stated that it was white and it was pretty big. It was like sand so the pharmacist left it out in the fridge and it kind of dissolve on the top of the shot. It looked like a big patch of knock on the side. It was also reported that the pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) was in the fridge and was monitored 24/7. Clarified that the product was not frozen at any time. Pharmacist reported lot number: X70865, Expiration date: Dec 2020, and NDC# 00005197102 but was not sure to which patient it was administered.  Information on lot number, batch number and expiration date has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2019256007 Same reporter, event, product/ different patient;US-PFIZER INC-2019255933 Same reporter, event, product/ different patient
Age: 0.08
Sex: F
Vaccine: DTAPIPV, HIBV, PNC13, RV1
Symptoms: Dermatitis diaper, Eczema, Inflammation, Skin exfoliation
Clinical narrative: Severe, persistent eczema-like rash to diaper area that appeared first on 5/21/19. Rash has peeled, improved, and reinflamed multiple times and continues to be ongoing. Rash is not fungal or bacterial per pediatrician. Moisturizers, barrier creams are ineffective. Changed diaper/wipe type, soaps, and cannot find an allergen that could be the cause.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Chills, Heart rate increased, Insomnia, Pyrexia
Clinical narrative: PATIENT RECEIVED SECOND DOSE OF SHINGRIX ON 2/8/2019 AND CAME INTO THE PHARMACY TODAY, 07/10/2019, REORTING SHE HAD AN ADVERSE REACTION TO THE VACCINATION. SHE DID NOT HAVE ANY ADVERSE REACTIONS TO THE FIRST DOSE, BUT 12 HOURS AFTER RECEIVING THE SECOND DOSE THE PATIENT STARTED HAVING CHILLS, FEVER, STOMACHE, AND AN ELEVATED HEART RATE OF 122 BPM. SHE SAID IT HIT HER ALL AT ONCE AND MADE IT SO SHE WAS UNABLE TO SLEEP. SHE WAS VERY WORRIED ABOUT HER HEART RATE. SHE STATED AT 9:00AM THE NEXT MORNING (2/9/2019) EVERYTHING STOPPED AND SHE WAS FINE.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness, swelling, and warmth on L arm near shot started next morning; treating with cephalexin 500 mg QID x 10 days
Age: 4.0
Sex: F
Vaccine: UNK
Symptoms: Peripheral swelling
Clinical narrative: Swollen arm
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Develop rash that appears to be shingles on her abdomen and upper thigh
Age: 75.0
Sex: M
Vaccine: PNC13
Symptoms: Asthenia, Gait inability, Weight decreased
Clinical narrative: pt complains of weight loss and feeling weak not being able to walk
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Musculoskeletal pain
Clinical narrative: A week after the injection, started having pain in left upper back, shoulder blade area.  The pain increased over the next two days, which were a weekend. Saw Dr. Monday morning and he thought the vaccination had activated the virus in by body.  He prescribed Valacyclovir.  Pain continued moving around upper back for 10 days. I had shingles about 15 years ago, and this was worse pain and lasted longer.