chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site hypersensitivity, Malaise, Swelling
Clinical narrative: Swelling; Sensitive; Headache; general malaise; chills; This case was reported by a consumer via call center representative and described the occurrence of headache in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th June 2019, the patient received the 2nd dose of Shingrix. On 9th June 2019, less than an hour after receiving Shingrix, the patient experienced swelling. In June 2019, the patient experienced headache, general malaise, chills and injection site hypersensitivity. On an unknown date, the outcome of the headache, general malaise and chills were recovered/resolved and the outcome of the swelling was unknown and the outcome of the injection site hypersensitivity was not recovered/not resolved.   It was unknown if the reporter considered the headache, general malaise, chills, swelling and injection site hypersensitivity to be related to Shingrix.  Additional details were provided as follows: The reporter indicated that she received Shingrix vaccine and developed a headache, experienced general malaise, and chills on and off through and then these symptoms resolved.   She also had swelling below the injection site that started within an hour of receiving the vaccination.   At the time of reporting, the injection site was sensitive. The reporter consented to follow up. This case has been linked with case US2019106971, reported by same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Pain, Swelling
Clinical narrative: Soreness; Swelling; Fatigue; This case was reported by a pharmacist via call center representative and described the occurrence of pain in an unspecified number of adult patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced pain, swelling and fatigue. On an unknown date, the outcome of the pain, swelling and fatigue were unknown.   It was unknown if the reporter considered the pain, swelling and fatigue to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not applicable for this report. An unspecified number of patients received Shingrix and experienced soreness, swelling and fatigue. The reporter mentioned that just normal side effects found in product insert. The reporter could not have thought specific patient to report on, just patients in general that have received the vaccine. No patient identifiers, lot numbers, or expiry dates to provide.
Age: 72.0
Sex: F
Vaccine: PPV, TTOX, VARZOS
Symptoms: Product administered at inappropriate site, Rash
Clinical narrative: Vaccine administered at inappropriate site; Rash; This case was reported by a consumer via call center representative and described the occurrence of rash in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included PNEUMOCOCCAL VACCINE (PNEUMONIA VACCINE) for prophylaxis and TETANUS TOXOID (TETANUS VACCINE) for prophylaxis.   Previously administered products included Zostavax.   On 15th May 2019, the patient received the 1st dose of Shingrix, PNEUMONIA VACCINE and TETANUS VACCINE. In May 2019, 4 days after receiving Shingrix and an unknown time after receiving TETANUS VACCINE, the patient experienced rash. On 15th May 2019, the patient experienced vaccine administered at inappropriate site. The patient was treated with corticosteroids, dermatological preparations (nos) (Corticosteroid Cream). On an unknown date, the outcome of the rash and vaccine administered at inappropriate site were unknown.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional information was provided as follows: The patient received her Shingrix vaccine on the muscle area on left side of the body below the waist, which led to .. On the same day, she received Pneumonia and Tetanus vaccine. About 4 days later, she developed a rash on the top of her foot. She visited her dermatologist on 25th May 2019 and was prescribed a corticosteroid cream. Her dermatologist was not able to figure out what kind of rash it was. The reporter consented for follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of product administration, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: inappropriate route of vaccination; Swelling at the injection site; Warmth at the injection site; Redness at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a female patient who received Herpes zoster (Shingrix) (batch number 3P25J, expiry date 21st September 2021) for prophylaxis.   On 11th June 2019, the patient received the 1st dose of Shingrix (subcutaneous) .5 ml. On 11th June 2019, unknown after receiving Shingrix, the patient experienced intramuscular formulation administered by other route. In June 2019, the patient experienced injection site swelling, injection site warmth and injection site erythema. On an unknown date, the outcome of the injection site swelling, injection site warmth, injection site erythema and intramuscular formulation administered by other route were unknown.   It was unknown if the reporter considered the injection site swelling, injection site warmth and injection site erythema to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix in left arm. The Shingrix vaccine was administered to the patient subcutaneously under the skin, this led to inappropriate route of administration.  The patient was experiencing redness, warmth and swelling at the site of injection which was 3 and half inches in diameter.  The patient was recommended to take Benadryl. The patient consented to follow up and provided her physician's details but she did not feel comfortable to provide her address. No further details were provided.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Breast enlargement, Erythema, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: enlarged breasts; red area below injection site; raised area below injection site; pain below injection site; This case was reported by a consumer via call center representative and described the occurrence of pain localized in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles. Previously administered products included Zostavax. Concomitant products included cortisone (non-proprietary) (Cortizone Injection).   On 15th May 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In May 2019, 1 day after receiving Shingrix, the patient experienced pain localized, breast enlargement, localized erythema and swelling. On an unknown date, the outcome of the pain localized, localized erythema and swelling were recovered/resolved and the outcome of the breast enlargement was not recovered/not resolved.   It was unknown if the reporter considered the pain localized, breast enlargement, localized erythema and swelling to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix in the left arm 24 to 36 hours after vaccination with Shingrix, the patient developed a painful, red, raised area on her left bicep, several inches below the injection site, this reaction lasted 3 weeks and had resolved. The patient also developed breast enlargement 3 to 4 days after her first dose, and this had not resolved at this time of reporting. The reporter did not have all the details of this case. The patient consented to follow up.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Swelling
Clinical narrative: enlarged breasts; red area below injection site; raised area below injection site; pain below injection site; This case was reported by a consumer via call center representative and described the occurrence of pain localized in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles. Previously administered products included Zostavax. Concomitant products included cortisone (non-proprietary) (Cortizone Injection).   On 15th May 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In May 2019, 1 day after receiving Shingrix, the patient experienced pain localized, breast enlargement, localized erythema and swelling. On an unknown date, the outcome of the pain localized, localized erythema and swelling were recovered/resolved and the outcome of the breast enlargement was not recovered/not resolved.   It was unknown if the reporter considered the pain localized, breast enlargement, localized erythema and swelling to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix in the left arm 24 to 36 hours after vaccination with Shingrix, the patient developed a painful, red, raised area on her left bicep, several inches below the injection site, this reaction lasted 3 weeks and had resolved. The patient also developed breast enlargement 3 to 4 days after her first dose, and this had not resolved at this time of reporting. The reporter did not have all the details of this case. The patient consented to follow up.
Sex: F
Vaccine: PPV
Symptoms: Allergy to vaccine
Clinical narrative: Allergies as per medication list: Pneumococcal Vaccines/ Severe; This is a spontaneous report from a contactable nurse. A 68-year-old female patient received pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein), via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced allergies as per medication list with pneumococcal vaccines/ severe on an unspecified date. The outcome of the event was unknown.  Pfizer is a marketing authorization holder of pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) has submitted the same report to the regulatory authorities.
Sex: F
Vaccine: PNC13, UNK, UNK
Symptoms: Allergy to vaccine, Drug hypersensitivity
Clinical narrative: Allergies: Prevnar [pneumococcal 7-val conj vacc]; Sulfamethoxazole; Penicillins; and Trimethoprim; This is a spontaneous report from a Pfizer sponsored program. A contactable physician reported that a 64-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; sulfamethoxazole and trimethoprim, both via an unspecified routes of administration from unspecified dates at unspecified doses for unspecified indications. The patient's medical history included penicillin allergy. Concomitant medications were not reported. The patient experienced allergies with Prevnar [pneumococcal 7-val conj vacc]; sulfamethoxazole; and trimethoprim on an unspecified date. Outcome of the event was unknown.   Information on lot number, batch number and expiration date has been requested.
Sex: F
Vaccine: MENB
Symptoms: Urticaria
Clinical narrative: Hives; This is a spontaneous report from contactable nurse via a Pfizer sales representative. A 17 1/2-year-old female patient received the first dose of meningococcal group b rlp2086 (TRUMENBA), via an unspecified route of administration on an unspecified date at single dose for immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced hives on an unspecified date. Event took place after use of product. The outcome of the event was unknown.   No follow-up attempts are possible. No further information is expected.
Age: 81.0
Sex: M
Vaccine: VARZOS
Symptoms: Fall, Mobility decreased, Muscular weakness, Musculoskeletal disorder, Sleep disorder
Clinical narrative: During the early morning hours I woke up after a fretful sleep. I got out  of bed and I fell to the floor. Strength in my muscles was reduced to the extent that I could not move and I spent the remainder of the night on the floor unable to rise up from th e floor or to operate my limbs. By the time I got up in the morning  the morning the symptoms were gone.
Age: 1.0
Sex: F
Vaccine: HEPA, MMRV
Symptoms: Decreased appetite, Feeling abnormal, Poor quality sleep, Pyrexia, Urticaria
Clinical narrative: Two weeks after getting the MMR. Patient came down with a sudden fever. Ranging 102-104 degree F.  Had a fever and was throwing up for 2 days straight. Then broke out in hives all over her entire body.  She?s been miserable and feeling awful since. Struggling to eat and nurse. Not sleeping well.
Age: 1.0
Sex: F
Vaccine: HEPA, MMRV
Symptoms: Vomiting
Clinical narrative: Two weeks after getting the MMR. Patient came down with a sudden fever. Ranging 102-104 degree F.  Had a fever and was throwing up for 2 days straight. Then broke out in hives all over her entire body.  She?s been miserable and feeling awful since. Struggling to eat and nurse. Not sleeping well.
Age: 44.0
Sex: M
Vaccine: MNQ, PNC13
Symptoms: Malaise, Pyrexia
Clinical narrative: Fever of 103 degrees Fahrenheit, malaise. Tylenol/ibuprofen for fever.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site rash
Clinical narrative: Rash on left leg
Sex: F
Vaccine: HPV9
Symptoms: Loss of consciousness
Clinical narrative: Patient passed out 3 minutes after administration of gardasil 9; This spontaneous report was received from a physician via company representative refers to a 12 year old female patient. The patient's pertinent medical history, concomitant medications, and drug reactions/allergies were unknown. On approximately 27-MAY-2019 (reported as about 3 weeks ago), the patient was vaccinated with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (unspecified lot number, expiry date and dosing details) for prevention of human papilloma virus infection (prophylaxis). On the same date, patient passed out 3 minutes after administration of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (loss of consciousness). The patient sought medical attention and was instructed to lay down for several minutes and was given water to drink. It was unknown that whether lab diagnostics/studies were performed. On 27-MAY-2019, the patient recovered with no further intervention. The reporter's causality assessment between the drug and the event was unknown.  Upon internal review, the event was considered to be medically significant.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 68-year-old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In 2012 the patient was vaccinated by a pharmacist with zoster vaccine live (ZOSTAVAX) (dose, route of administration, lot # and expiration date were not specified) for the long-term prevention of shingles and zoster-related conditions prescribed by a health professional. On an unspecified date, patient was treated by a physician for herpes zoster. The outcome of herpes zoster was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Age: 17.0
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: no adverse event; the patient received one dose of Gardasil 9 on 13-JUN-2019 and a second dose on 14-JUN-2019; This spontaneous report was received from a nurse and refers to a 17-year-old male patient. No information regarding the patient's pertinent medical history, concomitant medications and drug reactions or allergies was provided.    On 13-JUN-2019, 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 # R021636, expiration date 12-MAY-2021, intramuscularly for human papillomavirus (HPV) prevention. On 14-JUN-2019, the patient received a second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). No adverse events were reported.     The outcome of an inappropriate schedule of product administration was unknown.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, Influenza like illness
Clinical narrative: I feel like I have the flu; Inappropriate schedule of vaccine; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received up to 1 year before the 2nd dose).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced influenza-like symptoms and drug dose administration interval too long. On an unknown date, the outcome of the influenza-like symptoms and drug dose administration interval too long were unknown.   It was unknown if the reporter considered the influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient herself. The age at vaccination was not reported. The patient was not at all sick from the 1st dose. The patient received 2nd dose delayed than the recommended schedule, up to 1 year from the 1st dose, which led to lengthening of vaccination schedule. The patient had a lot of side effects after the 2nd dose of Shingrix, she felt like she had the flu. The patient thought the symptoms might be due to delayed schedule of 2nd dose.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Rash
Clinical narrative: rash; blister; This case was reported by a nurse via sales rep and described the occurrence of rash peripheral in a 60-year-old female patient who received Herpes zoster (Shingrix) (batch number TT9BR, expiry date unknown) and (batch number 44N5L, expiry date unknown) for prophylaxis.   Co-suspect products included bupropion hydrochloride (Wellbutrin) unknown for prophylaxis.   On 4th June 2019, the patient received the 1st dose of Shingrix. On an unknown date, the dose was an unknown dose. On 4th June 2019, the patient started Wellbutrin at an unknown dose and frequency. On 6th June 2019, 2 days after receiving Shingrix and Wellbutrin, the patient experienced rash peripheral and blister. The patient was treated with steroids nos (Steroid Injection) and steroids nos (Oral Steroids). Wellbutrin was discontinued. On an unknown date, the outcome of the rash peripheral and blister were unknown.   It was unknown if the reporter considered the rash peripheral and blister to be related to Shingrix and Wellbutrin.  Additional details were provided as follows: After vaccination with Shingrix, the patient experienced rash and blisters on trunk and extremities. The clinic advised to the patient to discontinue in case reaction to that medicine. On 12th June 2019, the patient came back to office with complaint of rash worsening. The patient refered to dermatologist. The patient appointment was on 13th June 2019.
Age: 51.0
Sex: U
Vaccine: VARZOS
Symptoms: Influenza like illness, Pain in extremity
Clinical narrative: flu like symptoms; left arm very sore; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 51-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11th June 2019, the patient received the 1st dose of Shingrix. In June 2019, less than a week after receiving Shingrix, the patient experienced influenza-like symptoms and pain in arm. The patient was treated with ibuprofen (Advil). On an unknown date, the outcome of the influenza-like symptoms and pain in arm were not recovered/not resolved.   It was unknown if the reporter considered the influenza-like symptoms and pain in arm to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient. The patient had received the 1st dose of Shingrix this past Tuesday, before reporting date. Less than a week after receiving Shingrix, the patient experienced flu like symptoms and left arm very was sore. The patient was taking Advil for the events and inquiring if anything else could be taken to help with the symptoms.
Sex: U
Vaccine: VARZOS
Symptoms: Abdominal pain, Asthenia, Blood test, Chills, Cold sweat
Clinical narrative: Fever; soreness at the injection site; chills; nausea; vomiting; abdominal cramping; Urinary tract infection; feeling unwell/felt so bad; kidney problems; sore arm; cold sweat; viral infection; feeling weak; This case was reported by a consumer via call center representative and described the occurrence of fever in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th June 2019, the patient received the 2nd dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced fever, injection site pain, chills, nausea, vomiting, abdominal cramp, urinary tract infection, feeling unwell, renal disorder, pain in arm, cold sweat, viral infection and feelings of weakness. The patient was treated with macrobid (nos) (Macrobid) and ceftriaxone. On an unknown date, the outcome of the fever, injection site pain, chills, nausea, vomiting, abdominal cramp, urinary tract infection, feeling unwell, renal disorder, pain in arm, cold sweat, viral infection and feelings of weakness were unknown.   It was unknown if the reporter considered the fever, injection site pain, chills, nausea, vomiting, abdominal cramp, urinary tract infection, feeling unwell, renal disorder, pain in arm, cold sweat, viral infection and feelings of weakness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix vaccine just had soreness at the injection site, but last night I did not feel well and woke up with a temp of 102.1, chills, nausea and vomiting. The patient went to the emergency room because the patient was having kidney problems, I went to emergency room and was treated for urinary tract infection. Also the patient was having abdominal cramping. In emergency room the patient was given fluids and a dose of ceftriaxone and the temperature came down so they released the patient. They said the patient's bloodwork was fine and the patient could have a virus.The patient did tell them that the patient got the shot but they did not seem concerned with it.  Over the weekend, the patient was feeling slightly better, occasional nausea and cold sweats. The patient arms were sore initially but that has resolved.  At the time of reporting, the patient spiked a temp again, had Nausea and vomiting.  The patient asked how long do these side effects last. The patient already missed 2 days of work.      Lab Comments: On unknown date the labs test were performed.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain, Loss of personal independence in daily activities, Malaise, Nausea, Pain in extremity
Clinical narrative: Fever; soreness at the injection site; chills; nausea; vomiting; abdominal cramping; Urinary tract infection; feeling unwell/felt so bad; kidney problems; sore arm; cold sweat; viral infection; feeling weak; This case was reported by a consumer via call center representative and described the occurrence of fever in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th June 2019, the patient received the 2nd dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced fever, injection site pain, chills, nausea, vomiting, abdominal cramp, urinary tract infection, feeling unwell, renal disorder, pain in arm, cold sweat, viral infection and feelings of weakness. The patient was treated with macrobid (nos) (Macrobid) and ceftriaxone. On an unknown date, the outcome of the fever, injection site pain, chills, nausea, vomiting, abdominal cramp, urinary tract infection, feeling unwell, renal disorder, pain in arm, cold sweat, viral infection and feelings of weakness were unknown.   It was unknown if the reporter considered the fever, injection site pain, chills, nausea, vomiting, abdominal cramp, urinary tract infection, feeling unwell, renal disorder, pain in arm, cold sweat, viral infection and feelings of weakness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix vaccine just had soreness at the injection site, but last night I did not feel well and woke up with a temp of 102.1, chills, nausea and vomiting. The patient went to the emergency room because the patient was having kidney problems, I went to emergency room and was treated for urinary tract infection. Also the patient was having abdominal cramping. In emergency room the patient was given fluids and a dose of ceftriaxone and the temperature came down so they released the patient. They said the patient's bloodwork was fine and the patient could have a virus.The patient did tell them that the patient got the shot but they did not seem concerned with it.  Over the weekend, the patient was feeling slightly better, occasional nausea and cold sweats. The patient arms were sore initially but that has resolved.  At the time of reporting, the patient spiked a temp again, had Nausea and vomiting.  The patient asked how long do these side effects last. The patient already missed 2 days of work.      Lab Comments: On unknown date the labs test were performed.
Sex: U
Vaccine: VARZOS
Symptoms: Pyrexia, Renal disorder, Urinary tract infection, Viral infection, Vomiting
Clinical narrative: Fever; soreness at the injection site; chills; nausea; vomiting; abdominal cramping; Urinary tract infection; feeling unwell/felt so bad; kidney problems; sore arm; cold sweat; viral infection; feeling weak; This case was reported by a consumer via call center representative and described the occurrence of fever in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th June 2019, the patient received the 2nd dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced fever, injection site pain, chills, nausea, vomiting, abdominal cramp, urinary tract infection, feeling unwell, renal disorder, pain in arm, cold sweat, viral infection and feelings of weakness. The patient was treated with macrobid (nos) (Macrobid) and ceftriaxone. On an unknown date, the outcome of the fever, injection site pain, chills, nausea, vomiting, abdominal cramp, urinary tract infection, feeling unwell, renal disorder, pain in arm, cold sweat, viral infection and feelings of weakness were unknown.   It was unknown if the reporter considered the fever, injection site pain, chills, nausea, vomiting, abdominal cramp, urinary tract infection, feeling unwell, renal disorder, pain in arm, cold sweat, viral infection and feelings of weakness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix vaccine just had soreness at the injection site, but last night I did not feel well and woke up with a temp of 102.1, chills, nausea and vomiting. The patient went to the emergency room because the patient was having kidney problems, I went to emergency room and was treated for urinary tract infection. Also the patient was having abdominal cramping. In emergency room the patient was given fluids and a dose of ceftriaxone and the temperature came down so they released the patient. They said the patient's bloodwork was fine and the patient could have a virus.The patient did tell them that the patient got the shot but they did not seem concerned with it.  Over the weekend, the patient was feeling slightly better, occasional nausea and cold sweats. The patient arms were sore initially but that has resolved.  At the time of reporting, the patient spiked a temp again, had Nausea and vomiting.  The patient asked how long do these side effects last. The patient already missed 2 days of work.      Lab Comments: On unknown date the labs test were performed.
Sex: F
Vaccine: MENB
Symptoms: Pain in extremity
Clinical narrative: Significant arm pain; This case was reported by a physician via sales rep and described the occurrence of pain in arm in a 17-year-old female patient 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 recovered/resolved.   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 patient had significant arm pain and was lasted for several days.
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Accidental underdose, Exposure via skin contact, Immediate post-injection reaction, Injection site haemorrhage
Clinical narrative: bled profusely; exposure via skin contact; underdose; This case was reported by a pharmacist via call center representative and described the occurrence of injection site hemorrhage in a 67-year-old female patient who received Herpes zoster (Shingrix) (batch number MT2A4, expiry date 11th September 2021) and (batch number 497D9, expiry date 11th September 2021) for prophylaxis.   The patient's past medical history included motor vehicle accident (several weeks prior to vaccination).   On 13th June 2019, the patient received Shingrix. On an unknown date, the dose was an unknown dose. On 13th June 2019, immediately after receiving Shingrix, the patient experienced injection site hemorrhage, exposure via skin contact and accidental underdose. On an unknown date, the outcome of the injection site hemorrhage, exposure via skin contact and accidental underdose were unknown.   It was unknown if the reporter considered the injection site hemorrhage to be related to Shingrix.  Additional details were provided as follows: The pharmacist reported that blood shot from the injection site upon administration of Shingrix, after removing the needle blood and clear fluid leaked from the site, which led to injection site hemorrhage, exposure via skin contact and accidental underdose.  The reporter denied signs of a hematoma at the injection site.  No additional details provided.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: sore at the injection site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 67-year-old female patient who received Herpes zoster (Shingrix) (batch number G2ZF2, expiry date unknown) for prophylaxis.   On 8th October 2018, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: The patient received 1st dose of Shingrix on left arm. The patient experienced injection site reaction, the injection was sore. Consent to follow up was provided.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Lymphatic disorder, Musculoskeletal pain, Neck pain, Pain
Clinical narrative: lymph system overwhelmed; swollen injection site; pain in upper body; Shoulder pain; Neck pain; This case was reported by a consumer via call center representative and described the occurrence of lymphatic disorder in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included lymphadenectomy (8 years ago on left arm prior to the vaccination). Concurrent medical conditions included lymphedema.   On 2nd February 2019, the patient received the 1st dose of Shingrix (intramuscular). In February 2019, 12 hrs after receiving Shingrix, the patient experienced lymphatic disorder, injection site swelling, general body pain, shoulder pain and neck pain. The patient was treated with ibuprofen (Advil). On an unknown date, the outcome of the lymphatic disorder was not recovered/not resolved and the outcome of the injection site swelling was recovered/resolved and the outcome of the general body pain, shoulder pain and neck pain were recovering/resolving.   The reporter considered the lymphatic disorder to be related to Shingrix. It was unknown if the reporter considered the injection site swelling, general body pain, shoulder pain and neck pain to be related to Shingrix.  Additional information was provided as follows: The patient received Shingrix injection and experienced side effects were worse than she expected and that the injection seemed to overwhelm her lymph system. She received the injection was given on her right deltoid due to removal of lymph node surgery in her left arm 8 years ago. About 12 hours after the injection, the patient started to experience swelling of the injection area, pain in her upper body from her Teres major and minor on her left side across her shoulders and into her neck. It took several weeks for the symptoms to resolve with the exception of upper body pain which has lessened but still continues. Her physician and pharmacist told her they do not know if she should get a second injection or if they could give the injection in her thigh.  The physician was treating her symptoms with Advil, compression garments, and massage therapy for lymphedema once per month. The reporter consented for follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Swelling
Clinical narrative: Swelling; This case was reported by a nurse via call center representative and described the occurrence of swelling in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced swelling. On an unknown date, the outcome of the swelling was unknown.   It was unknown if the reporter considered the swelling to be related to Shingrix.  Additional details were provided as follows: This case was reported via chat. The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The reporter asked, if Shingrix was a live vaccine. The reporter stated, her friend was swelling as she reported and they just went to the emergency room. After being provided information that the vaccine was not live, reporter ended chat. No further information was provided.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: left arm swollen; left arm redness; left arm hot to the touch; This case was reported by a pharmacist via call center representative and described the occurrence of swelling arm in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th June 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In June 2019, less than a week after receiving Shingrix, the patient experienced swelling arm, erythema of extremities and skin warm. On an unknown date, the outcome of the swelling arm, erythema of extremities and skin warm were not recovered/not resolved.   It was unknown if the reporter considered the swelling arm, erythema of extremities and skin warm to be related to Shingrix.  Additional details were provided as follows: The patient received the 1st dose of Shingrix in left deltoid. The patient's left arm was swollen, red, and hot to the touch.  The reporter did not provide any additional details.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthritis, Injection site pain
Clinical narrative: I have arthritis in a joint in my left thumb.  The morning after the injection I could hardly move my thumb.  I took a Naproxen 500 mg tablet after breakfast and the pain started to lessen in about 30 minutes.  I had all the other symptoms described with the second dose but felt better by the second morning after the injection.  I still have slight soreness at the injection sight on the third day.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Joint range of motion decreased
Clinical narrative: I have arthritis in a joint in my left thumb.  The morning after the injection I could hardly move my thumb.  I took a Naproxen 500 mg tablet after breakfast and the pain started to lessen in about 30 minutes.  I had all the other symptoms described with the second dose but felt better by the second morning after the injection.  I still have slight soreness at the injection sight on the third day.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Nausea, Pain in extremity, Peripheral swelling
Clinical narrative: PT STATED THAT SHE HAD A SORE AND SWOLLEN ARM, NAUSEA, CHILLS, SHE DID TAKE TYLENOL
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Asthenia, Fatigue, Headache, Pain in extremity
Clinical narrative: Sore arm, major body pain in all joints (required oxycodone), headache, weakness, extreme fatigue and couldn't get out of bed for 48 hours
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Influenza like illness, Injection site pain
Clinical narrative: About  8 hours after receiving my second shingrix shot, I had extreme chills and skin hurt all over from 6:30pm-12:30am ... it felt like a bad case of the flu ... these symptoms stopped abruptly and then I felt fairly normal the rest of the night into the morning, just a little tired and a slight headache also, had a sore arm at injection site ... nothing out of the normal for  an intramuscular shot I had the exact same reaction with my first shingrix shot that was given on 03/14/2019 at the same pharmacy so glad to be finished with these shots!
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: About  8 hours after receiving my second shingrix shot, I had extreme chills and skin hurt all over from 6:30pm-12:30am ... it felt like a bad case of the flu ... these symptoms stopped abruptly and then I felt fairly normal the rest of the night into the morning, just a little tired and a slight headache also, had a sore arm at injection site ... nothing out of the normal for  an intramuscular shot I had the exact same reaction with my first shingrix shot that was given on 03/14/2019 at the same pharmacy so glad to be finished with these shots!
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Wrong product administered
Clinical narrative: pt was in for a nurse visit. when checking the schedule to see what vaccine he was to get it stated MEN #2 (this is all that showed on the schedule). this normally means Menningitis or Menactra. It did not stated Menningitis B. pt was given Menactra. Provider received notification the next day that the patient was given this and noticed he should have received Bexero. When I went back with the provider to see what happened the only way you can see he was to get Bexero is if you hoover over the comment section of the schedule or open the appointment desk up.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Pt reported to pharmacy today. Said starting the next day, redness, swelling, itching around injection site, (about 5 inches square around arm). Said she is taking ibuprofen, I recommended topical Benadryl, or can also use oral, but cautioned drowsiness. Told her she should see improvement within 2-3 days. Also told her if it continues to worsen or swelling goes to head or neck to go to clinic right away.
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Blood test normal, Computerised tomogram abnormal, Diarrhoea, Fatigue, Feeling hot
Clinical narrative: Within 24 hours of the Bexsero (given concurrently with 2nd dose of Menactra) on 6/6/19 diarrhea (which subsided fairly soon), significant headache front of head to over the top of the head to the back of the neck, constant feeling of being hot, and extreme fatigue sleeping 3 hours at a time over the first 3 days after the immunization. At the time was on an antibiotic and had just finished a 6-day course of prednisone for sinusitis. Also received the second dose of Menactra the same day. Headache, feeling hot and fatigue worsened over the course of the next few days prior to seeing nurse over the weekend were told to alternative Motrin and Tylenol every 3 hours and apply ice packs to patient's neck  (saw nurse practitioner on 6/9/19-was told not a reaction to the immunization that is was stress over exams which had ended 2 weeks prior or a tension headache). Symptoms worsened over the week which resulted in ER visit on 6/14/19. Treated headache as if it were a migraine. Findings on Catscan did note sinusitis (already under treatment as per above at time of vaccine) and a mucocele but have had several consultations regarding the mucocele and symptoms post the vaccine do not correlate with a mucocele and it appears that patient has probably had this for years and we did not know. To date it is now 6/21/19, headache has improved--some days better than others but longstanding symptom is extreme fatigue which has never subsided since the initial alleged reaction on 6/7/19. To date, wondering if this is all still related to the vaccine/the perfect storm given was being treated for an illness at the time or whether that is something else but the timing correlates with the immunization. Still following up with pediatrician as well as ENT as still under the care of the ENT for long term 3-week course of antibiotics which ended today 6/21/19 and follow-up regarding the mucocele.
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Headache, Nuclear magnetic resonance imaging normal, Paranasal cyst
Clinical narrative: Within 24 hours of the Bexsero (given concurrently with 2nd dose of Menactra) on 6/6/19 diarrhea (which subsided fairly soon), significant headache front of head to over the top of the head to the back of the neck, constant feeling of being hot, and extreme fatigue sleeping 3 hours at a time over the first 3 days after the immunization. At the time was on an antibiotic and had just finished a 6-day course of prednisone for sinusitis. Also received the second dose of Menactra the same day. Headache, feeling hot and fatigue worsened over the course of the next few days prior to seeing nurse over the weekend were told to alternative Motrin and Tylenol every 3 hours and apply ice packs to patient's neck  (saw nurse practitioner on 6/9/19-was told not a reaction to the immunization that is was stress over exams which had ended 2 weeks prior or a tension headache). Symptoms worsened over the week which resulted in ER visit on 6/14/19. Treated headache as if it were a migraine. Findings on Catscan did note sinusitis (already under treatment as per above at time of vaccine) and a mucocele but have had several consultations regarding the mucocele and symptoms post the vaccine do not correlate with a mucocele and it appears that patient has probably had this for years and we did not know. To date it is now 6/21/19, headache has improved--some days better than others but longstanding symptom is extreme fatigue which has never subsided since the initial alleged reaction on 6/7/19. To date, wondering if this is all still related to the vaccine/the perfect storm given was being treated for an illness at the time or whether that is something else but the timing correlates with the immunization. Still following up with pediatrician as well as ENT as still under the care of the ENT for long term 3-week course of antibiotics which ended today 6/21/19 and follow-up regarding the mucocele.
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Swelling, erythema, and warmth at injection site
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth, Local reaction
Clinical narrative: Patient was given the vaccines at another facility on 6/18/19. Pt presents to this clinic on 6/20/19 with a localized reaction to the administration site on the Left thigh (Kinrix). It is flat, red, warm to touch, measuring 7cm x 7cm. Pt denies pain but states it is itchy.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site warmth, Pyrexia
Clinical narrative: Presented with fever @ 7:30 AM on 6/19/2019. Later had large area at injection site, red and warm to touch. Was seen in ED and it was decided the cause was an immunization site reaction and not cellulitis.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site warmth, Lethargy, Nausea
Clinical narrative: Fever, body aches, nausea, headache, lethargy, swelling, heat & redness at site of immunization.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia, Swelling
Clinical narrative: Fever, body aches, nausea, headache, lethargy, swelling, heat & redness at site of immunization.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Headache, Nausea, Pyrexia
Clinical narrative: chills, nausea, fever, headache, joint aches, neck and shoulders
Age: 17.0
Sex: F
Vaccine: HEP, HEPA, MNQ
Symptoms: Blood pressure decreased, Dizziness, Hyperhidrosis, Loss of consciousness, Malaise
Clinical narrative: one minute after 3rd im given, patient reported "not feeling well". she was pale, diaphoretic and dizzy. She lost consciousness for about 15 seconds. Patient was assisted from chair to a mat on the floor and placed on her side. She was able to communicate appropiatley. B/P was 80/40 and had a weak pulse.  Paramedics were called, but did not treat. B/P remained low, 90/50 with weak pulse. Patient refused medical transport and/or fluids. She drank 20 ounces of water and was released to her parent. No further complications noted with follow up phone to mother.
Age: 17.0
Sex: F
Vaccine: HEP, HEPA, MNQ
Symptoms: Pallor, Pulse abnormal
Clinical narrative: one minute after 3rd im given, patient reported "not feeling well". she was pale, diaphoretic and dizzy. She lost consciousness for about 15 seconds. Patient was assisted from chair to a mat on the floor and placed on her side. She was able to communicate appropiatley. B/P was 80/40 and had a weak pulse.  Paramedics were called, but did not treat. B/P remained low, 90/50 with weak pulse. Patient refused medical transport and/or fluids. She drank 20 ounces of water and was released to her parent. No further complications noted with follow up phone to mother.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Back pain, Fatigue, Headache, Loss of personal independence in daily activities, Malaise
Clinical narrative: Back and body aches. Next day: back and body aches, groggy, headache, tired -- didn't feel well enough to go out as I had planned.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Somnolence, X-ray of pelvis and hip
Clinical narrative: Back and body aches. Next day: back and body aches, groggy, headache, tired -- didn't feel well enough to go out as I had planned.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Pain, Pyrexia
Clinical narrative: Total body aches, headache, fatigue, low grade fever 100.6
Age: 1.0
Sex: F
Vaccine: MMRV, VARCEL
Symptoms: Pyrexia, Rash, Rash papular
Clinical narrative: fever of 104 F on 6/19.  papular diffuse rash on abdomen and upper back since 6/19 evening
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash, Injection site swelling, Pruritus
Clinical narrative: Redness, swelling, and rash surrounding injection site. Area was size of baseball. Patient noted itching.