chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pyrexia
Clinical narrative: Rigors and chills; Headache; Dizziness; Nausea; Fever; Injection site redness; Injection site swelling; This case was reported by a physician via call center representative and described the occurrence of fever in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix (intramuscular). On an unknown date, 8 hrs after receiving Shingrix, the patient experienced fever, chills, headache, dizziness, injection site erythema, injection site swelling and nausea. The patient was treated with ondansetron. On an unknown date, the outcome of the fever, injection site erythema and injection site swelling were recovered/resolved and the outcome of the chills, headache, dizziness and nausea were unknown.   It was unknown if the reporter considered the fever, chills, headache, dizziness, injection site erythema, injection site swelling and nausea to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not provided. The patient who was also a physician reported the following adverse reactions to Shingrix The patient was vaccinated on an unknown deltoid and awakened with rigors, chills and a fever of over 101 degree F. The patient also reported severe nausea which was treated with ondansetron. headache, dizziness, and swelling and redness of her entire deltoid region. The event fever and swelling and redness resolved by the next day. No additional details were provided      Lab Comments: On an unknown date lab test was performed.
Age: 60.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Blood disorder, Blood immunoglobulin M decreased, CD4 lymphocytes normal
Clinical narrative: low IgM; blood dyscrasia; This case was reported by a other health professional via call center representative and described the occurrence of decreased igm in a 61-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 6th March 2019, the patient received the 1st dose of Shingrix. On 6th May 2019, the patient received the 2nd dose of Shingrix. On an unknown date, less than a year after receiving Shingrix and Shingrix, the patient experienced decreased igm and blood dyscrasia. On an unknown date, the outcome of the decreased igm and blood dyscrasia were unknown.   The reporter considered the decreased igm and blood dyscrasia to be unrelated to Shingrix and Shingrix.  Additional details were provided as follows: It was reported that the previously healthy patient developed low IgM and blood dyscrasia after receiving a full series of Shingrix. The patient's CD4 counts were normal. The reporter was calling from a different state from the patient, and was calling to help rule the Shingrix out as a cause. The reporter stated she does not believe the Shingrix caused this. The reporter did not consent to follow-up. Additional information was not known.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Pain, Pyrexia
Clinical narrative: fever; tired; feeling achey; This case was reported by a consumer via call center representative and described the occurrence of fever in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   On 14th June 2019, the patient received the 2nd dose of Shingrix (intramuscular). In June 2019, less than a week after receiving Shingrix, the patient experienced fever, tiredness and pain. On an unknown date, the outcome of the fever, tiredness and pain were recovered/resolved.   It was unknown if the reporter considered the fever, tiredness and pain to be related to Shingrix.  Additional details were provided as follows: The patient had second dose of Shingrix and he experienced fever, feeling tired and achey for about 10 hours after that dose and it resolved.   The reporter did not consent to follow-up. This case has been linked with the case US2019AMR116518, reported by same reporter for same patient.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Glossodynia, Malaise, Myalgia, Pain in extremity
Clinical narrative: Tip of her tongue of very red and sore; Painful, nasty blister in the same spot on the tip of her; Tounge redness; Feeling unwell; muscle ache; sore arm; tired; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (was presented inside her mouth on the roof of her mouth and on her tongue. and on side of her face.), general body pain and pain. Previously administered products included Shingles with an associated reaction of herpes zoster (received 7 to 8 years ago). Concurrent medical conditions included post polio syndrome.   On 16th June 2019, the patient received the 1st dose of Shingrix. On 16th June 2019, less than a day after receiving Shingrix, the patient experienced pain in arm and tiredness. On 17th June 2019, the patient experienced feeling unwell and muscle pain. On 19th June 2019, the patient experienced sore tongue, tongue blistering and tongue redness. On an unknown date, the outcome of the pain in arm and tongue blistering were recovering/resolving and the outcome of the feeling unwell, sore tongue and tongue redness were unknown and the outcome of the tiredness was not recovered/not resolved and the outcome of the muscle pain was recovered/resolved.   It was unknown if the reporter considered the pain in arm, feeling unwell, tiredness, muscle pain, sore tongue, tongue blistering and tongue redness to be related to Shingrix.  Additional details were provided as follows: The patient had shingles shot 7 to 8 years ago from the date of reporting. In November 2018, the patient presented shingles inside her mouth on the roof of her mouth and on her tongue. It also presented on the side of her face.  The patient received vaccine on her right arm and on the same night her arm was sore. The next day the patient's both arms ached and she was not feeling well. The patient was really tired and on Sunday she felt the worse regarding the tiredness. The muscle soreness improved but the right arm still hurts as of the day of reporting. The morning, on the day of reporting, while brushing her teeth, she noticed that the tip of her tongue of very red and sore and a couple of hours ago she noticed a painful, nasty blister in the same spot on the tip of her tongue. The reporter consented to follow up.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Tongue blistering, Tongue erythema
Clinical narrative: Tip of her tongue of very red and sore; Painful, nasty blister in the same spot on the tip of her; Tounge redness; Feeling unwell; muscle ache; sore arm; tired; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (was presented inside her mouth on the roof of her mouth and on her tongue. and on side of her face.), general body pain and pain. Previously administered products included Shingles with an associated reaction of herpes zoster (received 7 to 8 years ago). Concurrent medical conditions included post polio syndrome.   On 16th June 2019, the patient received the 1st dose of Shingrix. On 16th June 2019, less than a day after receiving Shingrix, the patient experienced pain in arm and tiredness. On 17th June 2019, the patient experienced feeling unwell and muscle pain. On 19th June 2019, the patient experienced sore tongue, tongue blistering and tongue redness. On an unknown date, the outcome of the pain in arm and tongue blistering were recovering/resolving and the outcome of the feeling unwell, sore tongue and tongue redness were unknown and the outcome of the tiredness was not recovered/not resolved and the outcome of the muscle pain was recovered/resolved.   It was unknown if the reporter considered the pain in arm, feeling unwell, tiredness, muscle pain, sore tongue, tongue blistering and tongue redness to be related to Shingrix.  Additional details were provided as follows: The patient had shingles shot 7 to 8 years ago from the date of reporting. In November 2018, the patient presented shingles inside her mouth on the roof of her mouth and on her tongue. It also presented on the side of her face.  The patient received vaccine on her right arm and on the same night her arm was sore. The next day the patient's both arms ached and she was not feeling well. The patient was really tired and on Sunday she felt the worse regarding the tiredness. The muscle soreness improved but the right arm still hurts as of the day of reporting. The morning, on the day of reporting, while brushing her teeth, she noticed that the tip of her tongue of very red and sore and a couple of hours ago she noticed a painful, nasty blister in the same spot on the tip of her tongue. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Accidental underdose, Exposure via skin contact, Pain in extremity
Clinical narrative: Underdose; exposure via skin contact; Inadvertent exposure to vaccine; sore arm; This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (received 1st dose on an unknown date).   On 12th June 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 12th June 2019, unknown after receiving Shingrix, the patient experienced accidental underdose, exposure via skin contact and inadvertent exposure to vaccine. In June 2019, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm, accidental underdose, exposure via skin contact and inadvertent exposure to vaccine were unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that a fellow pharmacist administered dose 2 of Shingrix to a male patient and some of the vaccine leaked down the patient's arm  which led to accidental underdose, exposure via skin contact and inadvertent exposure to vaccine. The patient noted that the arm was not sore as it had been after dose one. The patient was concerned they may not have received the full dose. This case has been linked with case US2019AMR116516, reported for the dose 1 of the same patient.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Limb injury, Pain in extremity, Product administered at inappropriate site
Clinical narrative: severe arm pain; Possible arm injury; Vaccine administered at inappropriate site; This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm, arm injury and vaccine administered at inappropriate site. The patient was treated with narcotics, nos (Narcotics (Unspecified)). On an unknown date, the outcome of the pain in arm, arm injury and vaccine administered at inappropriate site were unknown.   It was unknown if the reporter considered the pain in arm and arm injury to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient presented at the facility's emergency department with severe arm pain and she was treated with narcotics.  The reporter stated that, the patient had reported possible arm injury in their chat and the Shingrix vaccine might had been administered in a patient's joint or synovial fluid in the right arm, which led to intramuscular formulation administered by other route.  The vaccine was administered at a different facility.  The reporter declined and did not gave consent to follow-up. Additional information was unknown.
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Herpes zoster, Malaise, Rash, Rash vesicular
Clinical narrative: Weakness; not feeling well; Shingles outbreak; rash on back/ rash that looks like; This case was reported by a other health professional via call center representative and described the occurrence of shingles in a 87-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In June 2019, the patient received the 1st dose of Shingrix. In June 2019, 5 days after receiving Shingrix, the patient experienced shingles and varicella-like rash. On 15th June 2019, the patient experienced weakness and feeling unwell. The patient was treated with valaciclovir hydrochloride (Valtrex). On an unknown date, the outcome of the shingles, varicella-like rash, weakness and feeling unwell were unknown.   It was unknown if the reporter considered the shingles, varicella-like rash, weakness and feeling unwell to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported, but it could be 86 or 87 years. The patient got 1st dose Shingrix and the patient was feeling weak and not feeling well.   On 20th June 2019, the patient experienced rash that looks like shingles on his back. The physician diagnosed patient with shingles and prescribed Valtrex. The reporter did not consent to follow-up.
Sex: F
Vaccine: FLU3
Symptoms: Limb discomfort, Musculoskeletal discomfort, Musculoskeletal pain
Clinical narrative: arm and shoulder discomfort; shoulder pain; Initial information received on 21-Jun-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 74 years old female patient who experienced arm and shoulder discomfort and shoulder pain, while she received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  In January 2019, the patient received a dose of suspect 0.5 ml INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number not reported via unknown route in the left deltoid.  On an unknown date, following the vaccination the patient experienced limb discomfort and shoulder pain (musculoskeletal pain).  (Other relevant tests included no lab data.)  Final diagnosis was limb discomfort and shoulder pain.  The patient was treated with IBUPROFEN (IBUPROFEN), CORTISONE (CORTISONE) and arthritis cream.  The outcome of the events was reported as unknown at the time of reporting.  Information on the batch number was requested.  Documents held by sender: none.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect route of product administration
Clinical narrative: 18 year old male consumer received the Menactra via subcutaneous (SQ) route; Initial information received on 25-Jun-2019 regarding an unsolicited valid non-serious case received from a non-healthcare professional via phone.  This case involves a 18 years old male patient who was vaccinated with 0.5 ml second booster dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (batch number: U6346AA and expiry date: 30-Aug-2020) via subcutaneous route in right arm on 03-Jun-2019.  The patient's past medical history, medical treatment(s), vaccination(s), family history and concomitant medications were not provided.   It was a case of actual medication error due to inappropriate route of vaccination.  It was unknown if any adverse event occurred or not following the vaccination.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.   Documents held by the sender: none.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, MNQ
Symptoms: Product storage error
Clinical narrative: they had a temperature excursion for the vaccines Menactra, Pentacel asshipment of vaccine that was too long in transit; Initial information received on 25-Jun-2019 regarding an unsolicited valid non-serious case received from a consumer (Office Staff).  This case involves a two months old male patient who received vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot UJ065AA and Exp. Date 16-Oct-2020) via unknown route in the left thigh, on 25-Jun-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error case due to incorrect product storage. Menactra also had a temperature excursion but was not administered to the patient.  It was reported that they had a temperature excursion for the following vaccines Menactra, Pentacel. Caller stated she did not check the temp because she thought it was delivered at a normal delivery time. Caller stater Pentacel was administered this morning.  It was unknown whether the patient had any adverse reactions.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested for Menactra.  List of documents held by sender: none.
Sex: U
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: an expired dose of Daptacel administered to 18 month old; Initial information received on 25-Jun-2019 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 18 months old patient (gender not reported) who was vaccinated with a dose of expired vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (Exp. Date 15-May-2019) via unknown route and administration site on 30-May-2019.  The patient's medical history and concomitant medications were not reported.  It was an actual medication error case due to expired vaccine used.  It was unknown whether the patient experienced any adverse event post vaccination.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested.  List of documents held by sender: none.
Age: 0.17
Sex: M
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: received a dose of expired Daptacel; Initial information received on 25-Jun-2019 regarding an unsolicited valid non-serious case received from a consumer.  This case involves a 2 months and 17 days old male patient who was vaccinated with a 0.5 ml dose of expired vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] VACCINE lot C5202AA via intramuscular route in the left thigh on 24-Jun-2019.  The patient's medical history not reported and concomitant medications included ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) via oral route for unknown indication.  It was an actual medication error case due to expired vaccine used.  It was unknown whether the patient experienced any adverse event post vaccination.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Age: 6.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: gave an expired dose of Quadracel, no adverse event; Initial information received on 25-Jun-2019 regarding an unsolicited valid non-serious case received from a nurse by phone.  This case involves a 6 years old female patient who was vaccinated with an expired 0.5 ml dose of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] (batch number: C5222AA and expiry date: 20-Jun-2019) via intramuscular route in the left deltoid on 25-Jun-2019.  The patient's past medical history, medical treatment(s), vaccination(s), family history and no other medications or vaccinations were given.   It was a case of actual medication error due to expired vaccine used.  No adverse event reported following vaccination.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.   Documents held by the sender: none.
Age: 2.0
Sex: U
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Quadracel was inadvertently given to 2 year old; Initial information received on 25-Jun-2019 regarding an unsolicited valid non-serious case received from a nurse by phone.  This case involves a 2 years old patient (gender not reported) who was vaccinated with a dose of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] (Batch number, expiry date, dose, dose in series, route and site of administration were not reported) on an unknown date.  The patient's past medical history, medical treatment(s), vaccination(s), family history and concomitant medications were not provided.   It was a case of actual medication error due to inappropriate age at vaccine administered.  It was unknown if any adverse event occurred or not following the vaccination.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.   Information on the batch number was requested.  Documents held by the sender: none
Age: 12.0
Sex: M
Vaccine: HPV4
Symptoms: Injection site pain, Injection site swelling, Musculoskeletal stiffness, Pain
Clinical narrative: aching pain and stiffness.  Tender swollen spot in mid left deltoid.
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: She has MCV4 on Tuesday 6-25-19. Developed Redness & swelling that evening on left Deltoid. Today seen in office 6-27-19. Fainter redness, Puffy. Not tender. Will Take Claritin. Area 6x9cm.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: MOM REPORTED 6/21/19 THAT INFANT'S RIGHT LEG WAS RED AND SLIGHTLY HARD UNDER AREA OF INJECTION THAT WAS GIVEN ON 6/19/19 AND THAT THE AREA WAS FADING WITHOUT ANY OTHER SYMPTOMS. IT APPEARED TO BE THE AREA WHERE THE PEDAVAX HIB WAS GIVEN  SHE CALLED PCP DR. AND HE TOLD HER THAT IT WAS NORMAL. TOLD HER TO FOLLOW UP WITH PCP OR ER IF REDNESS SPREADS OR BECOMES WORENED. FOLLOWED UP  WITH MOM AGAIN  ON 6/24/19 AND SHE RELATES NO FURTHER REDNESS OR HARDNESS.
Age: 1.08
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Extreme swelling, hot to touch, very painful for infant. (For at least 2 weeks after) Seemingly itchy. It has been nearly 2 months since the vaccine was given, the redness and swelling has subsided but there is still a hard lump under the skin where she got her vaccine.
Age: 1.08
Sex: F
Vaccine: DTAP
Symptoms: Injection site warmth
Clinical narrative: Extreme swelling, hot to touch, very painful for infant. (For at least 2 weeks after) Seemingly itchy. It has been nearly 2 months since the vaccine was given, the redness and swelling has subsided but there is still a hard lump under the skin where she got her vaccine.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Antibody test, Arthralgia, Chills, Erythema, Full blood count
Clinical narrative: Day of injection a left arm very sore. began at 11:45 pmChills, Feverish body warm, Headache,Ached all over especially hands and feet joints nausea  second day eruption to Right inner mid thigh, red ring and pustuale painful and itchy found the area because I wnet to scratch it I have pictures tylenol then pharmacist recommended ibuprophrn,  Third day  headaches still achy no fever pus broke on eruption very red I have picture . Painful arm and site of eruption and itchy all over Painful and itchy Saw Dr did blood work Took ibuprophen and antihistamine.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Nausea, Pain, Pain in extremity, Pruritus
Clinical narrative: Day of injection a left arm very sore. began at 11:45 pmChills, Feverish body warm, Headache,Ached all over especially hands and feet joints nausea  second day eruption to Right inner mid thigh, red ring and pustuale painful and itchy found the area because I wnet to scratch it I have pictures tylenol then pharmacist recommended ibuprophrn,  Third day  headaches still achy no fever pus broke on eruption very red I have picture . Painful arm and site of eruption and itchy all over Painful and itchy Saw Dr did blood work Took ibuprophen and antihistamine.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus generalised, Pyrexia, Rash pustular, Skin warm
Clinical narrative: Day of injection a left arm very sore. began at 11:45 pmChills, Feverish body warm, Headache,Ached all over especially hands and feet joints nausea  second day eruption to Right inner mid thigh, red ring and pustuale painful and itchy found the area because I wnet to scratch it I have pictures tylenol then pharmacist recommended ibuprophrn,  Third day  headaches still achy no fever pus broke on eruption very red I have picture . Painful arm and site of eruption and itchy all over Painful and itchy Saw Dr did blood work Took ibuprophen and antihistamine.
Age: 55.0
Sex: F
Vaccine: HEP
Symptoms: Contusion, Musculoskeletal pain, Neck pain
Clinical narrative: All I know is that patient called the pharmacy Friday(06/28/2019) and spoke with the overnight RPh.  She stated that she was having a bad reaction to the engerix b and that she had bruising and pain radiating from the shoulder to the neck.   Several attempts were made to speak with the patient later on Friday, but I was unable to reach her.  I called the Doctor and they were closed today for training but would reopen on Saturday and we will try to contact them at that time.  She was told to contact her doctor, but I am unable to confirm that the patient was seen by a health care professional after reporting the effects.
Age: 86.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: patient had a rash that developped 5 inches below injection site.  recommended the patient to use hydrocortisone and cold compresses. patient is debating seeing her physician for an antibiotic
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Dysphonia
Clinical narrative: change in voice. Patient does not have new pets. Patient does not have a history of asthma. Patient does have a history of environmental allergens. Patient did not have recent travel. Patient does not have a history of smoking. Patient  did not have previous Chest X-ray. Patient did not have had a PPD done. Ambulatory referral to ENT.  Treated with Prilosec 20 mg 20 mg 1 tab bid, Dymista 137-50 mcg/spray 1 spray by Nasal rout BID.
Age: 1.08
Sex: F
Vaccine: VARCEL
Symptoms: Blister, Injection site vesicles, Irritability, Pruritus, Pyrexia
Clinical narrative: One day after vaccine was given developed fever broke out with vessicals at injection site and developed vessicals on knees legs back and forehead.  Motjher states has been very fussy and itching.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Angioedema, Fatigue, Lip swelling, Pain, Peripheral swelling
Clinical narrative: Fatigue and body aches throughout entire body for the first 20 hours.  Angioedema reaction started 48 hours after the injection including swelling of both hands, left foot, and top lip.
Age: 35.0
Sex: F
Vaccine: HEP
Symptoms: Fatigue, Pyrexia
Clinical narrative: FATIGUE, MILD FEVER FOR 2 DAYS POST-IMMUNIZATION; TREATED W/ IBUPROFEN AT HOME
Age: 22.0
Sex: F
Vaccine: TYP
Symptoms: Disturbance in attention, Fatigue, Feeling abnormal, Flushing, Hyperhidrosis
Clinical narrative: Hours after the client received the vaccine she said her "face felt flushed," and she was "sweaty."  This morning (day after vaccine administration) ,  her eyes were "glassy and dilated," she felt fatigued, and her face is itchy. She says she "feels off," and unable to focus, and  "out of it." She went to work today but "is dragging." She denies nausea and diarrhea. She said her throat never "closed up." She said her arms are sore because she received a Tdap vaccine at a different clinic on 6/26/2019 , the day before she received the Typhoid vaccine.  She has taken ibuprofen. She has not taken her temperature to determine if she has a fever.
Age: 22.0
Sex: F
Vaccine: TYP
Symptoms: Mydriasis, Pain in extremity, Pruritus
Clinical narrative: Hours after the client received the vaccine she said her "face felt flushed," and she was "sweaty."  This morning (day after vaccine administration) ,  her eyes were "glassy and dilated," she felt fatigued, and her face is itchy. She says she "feels off," and unable to focus, and  "out of it." She went to work today but "is dragging." She denies nausea and diarrhea. She said her throat never "closed up." She said her arms are sore because she received a Tdap vaccine at a different clinic on 6/26/2019 , the day before she received the Typhoid vaccine.  She has taken ibuprofen. She has not taken her temperature to determine if she has a fever.
Age: 75.0
Sex: M
Vaccine: TDAP
Symptoms: Pain of skin
Clinical narrative: Patient stated "skin was sore" for several days after the vaccine, stated contact was painful, resolved after several days
Age: 15.0
Sex: F
Vaccine: HEPA
Symptoms: Eye movement disorder, Fall, Loss of consciousness, Pallor, Presyncope
Clinical narrative: Client had a vasovagal response approx. 10minutes after receiving the vaccine.  Client's mother reported that the client was in the standing position when she became pale, eyes rolled back and she fell to the floor and lost consciousness for a few seconds.
Sex: M
Vaccine: MENB
Symptoms: Product dose omission
Clinical narrative: Missed dose; This is a spontaneous report from a contactable consumer (mother). This consumer (mother) reported similar event for 2 patients (twins). This is 2nd of 2 reports. A 19-year-old male patient received first dose of meningococcal group b rlp2086 (TRUMENBA), via an unspecified route of administration on Aug2018 at a single dose for an immunization. Medical history included none. Concomitant medication was not reported. The reporter stated that they were on the 2 dose schedule with meningococcal group b rlp2086. First dose was in Aug2018 and their second was supposed to be in Jan2019, so her doctor recommended one thing and pharmacy recommended another so she called first. The second dose was supposed to be 6 months after the first one but the second one was a missed dose now. They forgot about it. She went to see doctor and doctor recommended in getting the second dose, but the pharmacy recommended something different to administer it. The doctor recommended going ahead and getting the second dose but the pharmacy recommended to start the cycle over again. So she called and got an answer. They did live in the dorm, and lived in it in Jan2019 when the missed dose occurred.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2019265453 same reporter/drug/event, different patients
Sex: M
Vaccine: MENB
Symptoms: Cerebrovascular accident, Meningitis
Clinical narrative: Drug ineffective; Patient developed meningitis after having been vaccinated with Trumenba; Couple of strokes; This is a spontaneous report from a contactable consumer via a Pfizer sales representative.  A 19-year-old male patient received the 2nd dose of meningococcal group b rlp2086 (TRUMENBA), via an unspecified route of administration, on 07Oct2017, at single dose, for immunization and the 1st dose via an unspecified route of administration, on 10Mar2017, at single dose, for immunization. Medical history included meningitis (before any vaccination with Trumenba). Concomitant medications were none. The patient experienced meningitis in May2019 with outcome of unknown and couple of strokes on an unspecified date with outcome of unknown.  The information on the lot number has been requested.
Sex: U
Vaccine: MENB
Symptoms: Myalgia, Nausea
Clinical narrative: Nausea; Muscle pain; This is a spontaneous report from a contactable nurse received via a Pfizer sales representative. A patient of unspecified age and gender received meningococcal group b rlp2086 (TRUMENBA, lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date at a single dose for an immunization. The patient's medical history and concomitant medications were not reported. The patient experienced nausea and muscle pain after meningococcal group b rlp2086 was administered. The physician prescribed ondansetron hydrochloride (ZOFRAN) after meningococcal group b rlp2086 was administered to prevent adverse events. The outcome of the events was unknown.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: PNC13
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: pain at site along with major swelling around injection site "golf ball sized egg at injection site"/Swelling did not show up until later in the week after the shot was given; pain at site along with major swelling around injection site "golf ball sized egg at injection site"/Swelling did not show up until later in the week after the shot was given; This is a spontaneous report from a contactable other health professional via Pfizer Sales Representative.  A 72-year-old female patient received pneumococcal 13-val conj vac (dipht 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.  The patient experienced pain at site along with major swelling around injection site "golf ball sized egg at injection site"/swelling did not show up until later in the week after the shot was given on an unspecified date with outcome of unknown.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Confusional state, Disorientation, Fatigue, Headache, Injection site pain
Clinical narrative: Severe fatigue, minimally  abated after 24 hours; Severe headache, minimally abated after 24 hours; Acute muscle aches over much of body, most pronounced across entire back, unabated after 24 hours; Acute muscle pain at sight of injection; Complete confusion and disorientation  in bed late at night; Physical inability to carry out normal activities, still continuing after 24 hours
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Loss of personal independence in daily activities, Myalgia
Clinical narrative: Severe fatigue, minimally  abated after 24 hours; Severe headache, minimally abated after 24 hours; Acute muscle aches over much of body, most pronounced across entire back, unabated after 24 hours; Acute muscle pain at sight of injection; Complete confusion and disorientation  in bed late at night; Physical inability to carry out normal activities, still continuing after 24 hours
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site swelling
Clinical narrative: had immediate redness and swelling around injection site of the MMR vaccine  about 3x3 inches; otherwise appeared well
Age: 40.0
Sex: F
Vaccine: UNK
Symptoms: Abortion incomplete, Abortion spontaneous, Full blood count, Haemorrhage
Clinical narrative: I received the flu vaccine after a normal prenatal appointment in the office. Later that evening, I laid down, to be awakened by the sensation of needing to make a bowel movement. I went to the bathroom and bared down as if to pass stool and expelled my 14 week -4 day fetus, which began the spontaneous incomplete abortion, requiring hospitalization. I nearly lost uterus due to uncontrolled bleeding. At admission, my H&H was 12 and 35%, but decreased to 9.25 and 28%, due to hemorrhage.  Pregnancy history: 4 pregnancies with 3 deliberate abortions. EDT: April 4, 2017
Age: 12.0
Sex: F
Vaccine: HEPA, HPV9
Symptoms: Dizziness, Eye movement disorder, Headache, Immediate post-injection reaction, Lethargy
Clinical narrative: Seconds after both vaccines had been given patient turned pale, felt dizzy, and her eyes rolled back. She never lost consciousness, but was pale and lethargic for about 15 minutes. She also complained of headache which we treated with Tylenol once she was alert and interactive. On further history, she had not eaten much lunch or drank much fluids throughout the day. She was monitored for about 45 minutes following vaccination. During that time she drank 2 juice boxes and a bottle of water, ate an ice pop and a few cookies. She slowly improved and was back to baseline and able to walk out of our office without assistance by 4:13pm. I spoke with her mother at 5:30pm that evening and she reported patient active, back to her usual self.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV9
Symptoms: Pallor
Clinical narrative: Seconds after both vaccines had been given patient turned pale, felt dizzy, and her eyes rolled back. She never lost consciousness, but was pale and lethargic for about 15 minutes. She also complained of headache which we treated with Tylenol once she was alert and interactive. On further history, she had not eaten much lunch or drank much fluids throughout the day. She was monitored for about 45 minutes following vaccination. During that time she drank 2 juice boxes and a bottle of water, ate an ice pop and a few cookies. She slowly improved and was back to baseline and able to walk out of our office without assistance by 4:13pm. I spoke with her mother at 5:30pm that evening and she reported patient active, back to her usual self.
Age: 24.0
Sex: M
Vaccine: HPV9
Symptoms: Injection site urticaria, Urticaria
Clinical narrative: 11 hours after the HPV vaccine was given, started to break out in hives on injection site and torso. Went to emergency room and was treated with Benadryl.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: 4" area of redness, swelling, warmth, itching at site of vaccine.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Asthenia, Fatigue, Headache, Influenza like illness
Clinical narrative: flu-like symptoms - muscle joint aches, pain at the injection site,  nausea, headache, fatigue-lack of energy.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Myalgia, Nausea
Clinical narrative: flu-like symptoms - muscle joint aches, pain at the injection site,  nausea, headache, fatigue-lack of energy.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Pyrexia
Clinical narrative: fever
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Gait disturbance, Headache, Myalgia, Pyrexia
Clinical narrative: CHILLS , FEVER, MUSCLE ACHES, SEVERE HEADACHE BEGINNING IN THE MIDDLE OF THE NIGHT AFTER THE VACCINE AND ONGOING THE ENTIRE NEXT DAY.  I COULD NOT GET OUT OF BED ALL DAY  HARD TO WALK.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Differential white blood cell count normal, Full blood count normal, Haemoglobin decreased, Hypotonia, Unresponsive to stimuli
Clinical narrative: About 8 &1/2 hrs. after the baby had been given the Vaccine, the baby seemed 'floppy' and unresponsive per mom. No suggestion of any seizures. Baby was taken to the
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Immunisation, Product preparation issue
Clinical narrative: Patient was given adjuvant without antigen. Pharmacist readministered full vaccine on the opposite (left) arm on the same day.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood glucose increased, Diarrhoea, Headache, Hypertension, Pain
Clinical narrative: Adverse events; Rash on the right arm about 6 inches diameter, fever, body ache, headache, diarrhea,  high blood pressure, high blood sugar. Treatment; 1-Acetaminophen (OTC) 2-Diphenhydramine (OTC) 3-Cephalexine 500mg  Outcome; On 6/28/2019 patient stated that her symptoms are improving .
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Rash
Clinical narrative: Adverse events; Rash on the right arm about 6 inches diameter, fever, body ache, headache, diarrhea,  high blood pressure, high blood sugar. Treatment; 1-Acetaminophen (OTC) 2-Diphenhydramine (OTC) 3-Cephalexine 500mg  Outcome; On 6/28/2019 patient stated that her symptoms are improving .
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Contusion, Erythema, Vaccination site discolouration
Clinical narrative: At the time of vaccination, patient had a drop  that was visible.  Then, then next day, patient start seeing bruises. Then patient came in with the site of vaccination and around it  being black, blue and Yellowish. Patient says that it is not painful or bothersome. It looks as if he got burned.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Immediate post-injection reaction, Malaise, Vomiting
Clinical narrative: 11 Y/O female normal growth and development, immediately after receive immunizations, PT felt sick, sat down and vomited. PT was taken to the acute care room and VS taken and VS were in the normal range. PT was alert and oriented with time and place, PT after rest with feet elevated felt better. PT rested about 30 minutes and PT was released with mother under own ambulation.
Age: 70.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Left upper arm soreness and redness
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity, Paraesthesia
Clinical narrative: Patient called in to pharmacy stating that a few days after his arm pain from the vaccine subsided he started to experience sharp shooting pain in his left arm (the injection had been in his right arm) and a tingling sensation on the left ear that slowly started to get better by the time of his call. The patient was told that this was not likely due to the vaccine and sounded like a medical emergency. He was told to go to the ER immediately.
Age: 12.0
Sex: M
Vaccine: PPV
Symptoms: Wrong product administered
Clinical narrative: Patient should have been administered Prevnar 13 and was given Pneumo23
Age: 0.58
Sex: F
Vaccine: PNC13
Symptoms: Face oedema, Rash, Rash maculo-papular
Clinical narrative: Reports onset of rash approx 3.5 hours after 3rd dose in series, no problems prior.   Went to urgent care, then ER.  Described by ER as maculopapular rash at 1500; facial edema onset at 2100.  Prescribed benadryl, prednisolone, and Epi injection.  Was told by urgent care and ER that it was likely related to component of Prevnar vaccine.   Prevnar was given 3/15/19 alone without other routine 6 month vaccines, which were given on 3/1/19.  This was due to Prevnar being out of stock in our office at the time.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site haemorrhage, Injection site induration, Injection site swelling
Clinical narrative: BLEED, SWOLLEN  AND HARD BUMP  APPEARRED   AT THE SITE OF INJECTION. NO OTHER SYMPTOMS. PATIENT WAS FINE AFTER 15 MINS SITTING ON THE BENCH EXCEPT THE SWELLING ON THE ARM.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema
Clinical narrative: erythema of the upper arm
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Headache, Nausea, Spinal pain
Clinical narrative: Per Dr. who saw the patient,  severe diffused arthralgia in the hips and spine, headache and nauseated. Dr. advised patient to go to ER
Age: 40.0
Sex: M
Vaccine: TDAP
Symptoms: Axillary pain, Blood test abnormal, Headache, Infection, Injection site pain
Clinical narrative: PT RECEIVED VACCINE ON SATURDAY, THE FOLLOWING TUESDAY HE BEGAN EXPERIENCING PAIN IN HIS LEFT ARM PIT, FELT HIS LYMPH NODES WERE SWOLLEN.  THEN WEDNESDAY HE STARTED EXPERIENCING PAIN IN HIS LEFT SHOULDER AND STARTED INCREASING IN SEVERITY.  PAIN WAS SIGNIFICANT ENOUGH TO DISTRUPT HIS SLEEP,  HASNT HAD RELIEF AND NOW THE LEFT SIDE OF HIS HEAD IS BEGINNING TO HURT.  PT WAS SEEN BY AN URGENT CARE DR.  AND WAS EVALUATED.  DR. COMPLETED BLOOD WORK PANEL AND SHOWED PT HAS INFECTION.  GAVE HIM ANTIBIOTIC SHOT AND CAPSULES.  SCHEDULED FOLLOW UP VISIT WITH PRIMARY CARE PHYSICIAN.  URGENT CARE PHYSICIAN NOT SURE IF THE SHOULDER PAIN COULD BE DUE TO THE VACCINE OR JUST COINSIDENCE
Age: 40.0
Sex: M
Vaccine: TDAP
Symptoms: Lymphadenopathy, Sleep disorder
Clinical narrative: PT RECEIVED VACCINE ON SATURDAY, THE FOLLOWING TUESDAY HE BEGAN EXPERIENCING PAIN IN HIS LEFT ARM PIT, FELT HIS LYMPH NODES WERE SWOLLEN.  THEN WEDNESDAY HE STARTED EXPERIENCING PAIN IN HIS LEFT SHOULDER AND STARTED INCREASING IN SEVERITY.  PAIN WAS SIGNIFICANT ENOUGH TO DISTRUPT HIS SLEEP,  HASNT HAD RELIEF AND NOW THE LEFT SIDE OF HIS HEAD IS BEGINNING TO HURT.  PT WAS SEEN BY AN URGENT CARE DR.  AND WAS EVALUATED.  DR. COMPLETED BLOOD WORK PANEL AND SHOWED PT HAS INFECTION.  GAVE HIM ANTIBIOTIC SHOT AND CAPSULES.  SCHEDULED FOLLOW UP VISIT WITH PRIMARY CARE PHYSICIAN.  URGENT CARE PHYSICIAN NOT SURE IF THE SHOULDER PAIN COULD BE DUE TO THE VACCINE OR JUST COINSIDENCE
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Pain
Clinical narrative: Per pt the area is red, painful area circular in shape.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain
Clinical narrative: Per pt the area is red, painful area circular in shape
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site mass, Pruritus generalised, Tinnitus
Clinical narrative: PER PATIENT: PT STATES SHE HAD ITCHING ALL OVER HER BODY, RINGING IN EARS, AND A LUMP THAT FORMED AT THE INJECTION SITE. PT TOOK BENADRYL AND ICED THE AREA OF THE INJECTION. BY THE NEXT DAY, REACTION HAS IMPROVED.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Peripheral swelling
Clinical narrative: Patient presented to the pharmacy 3 days after immunization with left arm red and swollen. Patient stated that the swelling and pain has subsided some since previous day.
Age: 63.0
Sex: F
Vaccine: RAB, RAB
Symptoms: Tinnitus
Clinical narrative: mild tinnitus right ear began 6 days post first dose, continuous sx for 3 hours, then intermittent for next week, including post 2nd dose