chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 86-year-old female patient who received INFANRIX (batch number N5339, expiry date March 2016). Concurrent medical conditions included food allergy, peanut allergy and penicillin allergy. Concomitant products included lisinopril, metoprolol ER and raloxifene. On 3rd April 2015, the patient received the 1st dose of INFANRIX .5 ml. On 3rd April 2015, immediately after receiving INFANRIX, the patient experienced injection site pain. On 10th April 2015, the patient experienced injection site erythema, injection site swelling and injection site itching. On an unknown date, the patient experienced inappropriate age at vaccination administration. The action taken with INFANRIX was unknown. On an unknown date, the outcome of the injection site pain was unchanged and the outcome of the inappropriate age at vaccine administration was unknown and the outcome of the injection site erythema, injection site swelling and injection site itching were not recovered/not resolved. It was unknown if the reporter considered the injection site pain, injection site erythema, injection site swelling and injection site itching to be related to INFANRIX. Additional details were reported as follows: Pharmacist reported that she gave an INFANRIX by mistake to an adult patient. The patient experienced soreness at the injection site immediately but then it went away. However about a week later, on 10 April 2015, the patient started experiencing other symptoms at the injection site (erythema, swelling and pruritus) and the soreness at the injection site also came back.
This spontaneous report as received from a pharmacist via a company representative refers to three patient of unknown age. On an unknown date each of the patients was vaccinated with a dose of ZOSTAVAX (lot #, expiration date, dose not reported, injection) for prevention of shingles. On an unknown date, within a day of receiving ZOSTAVAX, each patient experienced injection site redness, warmth to touch and swelling. The patient sought medical attention. The outcome of the events was reported as resolved. The pharmacist noted that he had not come across similar cases of injection site reactions "for some time". Additional information has been requested.
30 minutes after 2nd dose 2/20/23 major muscles, arms, thighs back flared as though on fire. Muscle pain continues.
Hematochezia (7 days), pancytopenia, and transaminitis with now new diagnosis of autoimmune hepatitis.
Narrative:  COVID infection following COVID vaccine series 02/19, Pfizer, dose #1 03/12, Pfizer, dose #2 08/31 COVID swab, result: detected 08/31 SARS- COV-2 Variant Sequencing result: pending 09/14 COVID swab, result: detected 08/27 pt cc: cough, diarrhea, fatigue, fever, exposure: unknown
Patient got Infanrix instead of Boostrix; 13 YO patient was given Infanrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 13-year-old male patient who received DTPa (Infanrix) (batch number 9hp92, expiry date 21-APR-2024) for prophylaxis.   On 24-APR-2023, the patient received Infanrix. On 24-APR-2023, an unknown time after receiving Infanrix, the patient experienced wrong vaccine administered (Verbatim: Patient got Infanrix instead of Boostrix) and inappropriate age at vaccine administration (Verbatim: 13 YO patient was given Infanrix). The outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 26-APR-2023 The reporter was medical assistant. The reporter reported that a 13 year old patient was given Infanrix instead of Boostrix. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up. The reporter reported that a 13 year old patient was given Infanrix instead of Boostrix, which led to wrong vaccine administered and inappropriate age at vaccine administration.
This spontaneous report as received from a Healthcare worker refers to a 2 years old female patient with allergies and eczema. The patients medical history included urinary tract infection. The patient was allergic to penicillin and amoxicillin. On 14-JAN-2013, the patient was vaccinated with a first dose of 0.5 milliliter (ml) VAQTA(lot number was reported as H010106 and expiry date was 21-FEB-2015) intramuscularly. Other suspect therapies included M-M-R II, (Merck) VARIVAX, influenza virus vaccine (manufacturer unknown) on 14-JAN-2013. On 21-JAN-2013, the patient had visited another clinic for another visit and received ACTHIB and PREVNAR(Lot number, expiry date, route and dose were not reported for all) but inadvertently received the second dose of VAQTA (lot number was reported as H010106 and expiry date was 21-FEB-215)that had the same lot and expiration date as that of the one which was administered on 14-JAN-2013. No concomitant medications were reported. On 21-JAN-2013, the patients parents contacted the clinic stating that the patient had swelling, redness on right leg and fever. The patient sought medical attention for the same and on 22-JAN-2013, the patient was seen in the emergency department of hospital for swelling , redness on right leg and fever. The patient was prescribed BACTRIM and BENADRYL. Approximately on an unknown date in January 2013, the event were recovered and the patient was doing well. Additional information has been requested.
Pt recvd 3 doses of Engerix-B & was recognized as a nonresponder;
Patient received both vaccines and sat in the immunization both for a few minutes with me discussing new medication he was starting and made no statement about change in feeling. After the consultation, he then proceeded to self check out to pay for his items while I returned to the pharmacy to start the next immunization. Assistant manager came and told me someone fainted. I then proceeded with the emergency kit to check on the patient. Patient was sitting in a chair sweating profusely when I arrived but was awake. Patient said he didn't recall fainting but just woke up with everyone standing above him checking on him. COS stated he was watching Patient at check out and then watched Patient slowly slump over and faint.  Patient declined any treatment at the time. His wife came to pick him up where I walked him out to the car in case of a second instance but stated he felt fine at the time he and his wife left for the evening.
1 year old white female had shots on 6/18/01. On 6/21/01, mom says she broke out all over, especially on face, by 6/19/01. On 6/23/01, she was asleep, became clammy, face and eyes swelled, had shallow breathing, had large welts on face and was unresponsive. Was taken by EMS from home to hospital and still in hospital on 6/25/01. Released from hospital on 6/25/01 and is improving.
Initial report was received 21 April 2010 from a health care professional. An 18-month-old male patient had received an intramuscular right thigh injection of PENTACEL, lot number C3533AA and an intramuscular left thigh injection of HAVRIX (manufacturer GlaxoSmithKline), lot number AHADB359 on 21 April 2010, and an unspecified amount of time later that same day, the patient's temperature went up to 104 degrees and he experienced a febrile seizure which lasted five to ten minutes. It was reported that the patient had a temperature prior to vaccination; however this was not reported to the physician. The patient had no known illnesses or pre-existing medical conditions at the time of vaccination, and he had not been taking any concomitant medications. According to the reporter, the patient recovered.
Patient was to receive the Bivalent COVID 12 years and up. Patient received the Monovalent COVID 12 years and up in error.
Painful, hard and swollen knot at injection site, very red and hot to the touch.  Lymph nodes are also inflamed under arm on same arm as injection site.
The pt became unsociable, decreased eating habits, cranky/fussy, stopped cooing and making sounds, flat affect personality, non-responsive to attempts to get him to react with smiles or cooing. Sx lasted 3-4 weeks.
Complaints of rash to injection site of the PNEUMOVAX injection, went to urgent care 09/30/2018, given Cephalexin 500mg QID and started it 10/01/2018, did not improve, went to the ER 10/02/2018, given IV Clindamycin 600mg and discharged with Clindamycin 300m gq 6 hours for 10 days. Evaluated at PCP office on 10/08/2018, reports symptoms improving but not gone and will finish Clindamycin course.
This case was reported by a nurse via sales rep and described the occurrence of seborrheic dermatitis in a 80-year-old female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced seborrheic dermatitis. On an unknown date, the outcome of the seborrheic dermatitis was unknown. It was unknown if the reporter considered the seborrheic dermatitis to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported, but the patient was 80 years old at the time of reporting. The patient experienced seborrheic dermatitis. The reporter was agreed to follow up from GlaxoSmithKline (GSK).
Severe pain in multiple joints (hands, shoulders, back, SI joints, knees, feet) the morning after the bivalent booster. I had trouble getting out of bed. Symptoms improved in 2 hours after taking Aleve. Only my feet (1st MTP joints) were involved by gout previously.  Since starting COVID vaccinations in 2021, I have developed some type of inflammatory arthritis, which was intermittent and milder before this last booster. I have seen a rheumatologist for work-up. My hands continue to be painful.
Excessive vaginal bleeding 2 weeks after missed menstrual cycle. Severe abdominal cramping, intermittent, contraction-like. Pain lasted around 2 hours then stopped, bleeding also stopped completely. Went to doctor and was told it was a miscarriage.
My daughter has cardiac syncope that she never had before. Now she's on disability and can't do anything by herself.
This spontaneous report was received from a pharmacist who was reporting on an unspecified number of patients of unknown age and gender. No information regarding the patients' pertinent medical history, concurrent conditions, concomitant medications, drug reactions or allergies was provided. On unknown dates, starting on or after 19-MAY-2017, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 injection (dose and route of administration were not reported; lot # M042324, expiration date on 10-JUN-2018), for prophylaxis. Administered doses of vaccine experienced the temperature excursion of 31 degrees Fahrenheit or below for 59 hours. The excursion was detected by a Digital Data Logger. There was no previous excursion reported. No adverse effects were reported. Additional information has been requested.
Approximately 3 hours after receiving the vaccine, patient developed slight soreness at injection site (noticeably less than following dose 1 of this vaccine). Then, at approximately 12 hours post-dose, developed the following symptoms lasting the entirety of the night: generalized/dull headache, photosensitivity, generalized myalgias/arthralgias, subjective fever/chills alternating with cold sensitivity. All symptoms except headache resolved by the next morning, but at approximately 24 hours post-dose, all symptoms returned and lasted for the remainder of that day. By the next day, all symptoms had completely resolved and have since not recurred.
The complained of swelling and heat to the left side of neck to the injection site. The pt went to the  ER. Pt was treated with antibiotics. Dx was lymphadenitis.
Since 21 February she has complained of recurrent episodes of generalized itching and rashes described as raised, red, itchy whelts which can occur anywhere on her body, especially at sites of pressure or where her skin is scraped or scratched. Lesions last less than 24 hours, spares her palms and soles, and resolve without post-inflammatory changes. She denies laryngeal, pulmonary, GI, neurologic, and cardiovascular symptoms with these episodes except as noted above. Episodes worsened with heat but not associated with exercise, sweating, cold, foods, medications, NSAIDs, IV contrast, latex exposure, infections, or insect bites/stings. She received her Moderna COVID-19 vaccine booster dose on 17 February, 4 days prior to onset of symptoms. She has used oral antihistamines with benefit. She denies constitutional symptoms. UCT score today is 21 (2, 3, 3, 3, 3, 2, 3, 2). No history of adverse reactions to prior vaccines.
1550 - shortly after receiving the HPV after Hep A IM, the patient slump over on the exam table after passing out. Patient had a 5 second upper body twitching and was not responding to name. Within 5 seconds later, patient came to.
Cellulitis, we did not observe it here in the pharmacy. Pt was seen at a walk-in clinic and received clindamycin.
(1) Neuropathy starting in legs and progressing upwards. (2) Lower extremity weakness that progressed upwards. (3) Loss of dexterity. (4) Slurred speech.
This description was reported to this writer. The patient had just arrived and sat down in the post vaccination area. He was sweating profusely on his head. The patient was assisted to the floor by the nurse. The patient did say to the nurse that he was "feeling lightheaded". He stated that he had a needle phobia. Patient denied a history of fainting and of diabetes. Vital signs were taken. EMTs were notified to attend to patient. Patient was assisted to a chair. Encouraged to drink fluids . Patient was released by EMTs after 30 minutes.
This spontaneous case reported by a consumer, describes the occurrence of vaccination site pain (arm soreness), headache, fatigue (intense fatigue) and pyrexia (fever) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 025L20A and 031M20A) for COVID-19 immunization. The patient's past medical history included cardiopulmonary arrest (2 years ago). On Jan 11, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Feb 10, 2021, received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; unspecified dosage form. On Jan 11, 2021, patient experienced vaccination site pain (arm soreness) and fatigue (intense fatigue). On Feb 11, 2021, patient experienced headache and pyrexia (fever). At the time of the report, vaccination site pain (arm soreness), headache, fatigue (intense fatigue) and pyrexia (fever) outcome: unknown/not provided. Treatment details included Tylenol yesterday twice. No concomitant medications reported.
Injection site with red swelling or bump - hard and hot to touch = about the size of my palm.
Patient said got pimples on back of neck, not itching. Got pimples within 20 minutes of vaccination, it's still there today (11/1/13).
2-5mm papules and pustules on Right side of nose, head, chin, and occiputal x 2-3 days.  Pt. treated with Motrin 800mg, T3's, Azithromax, and Predisone cream.
Severe headache, sore throat, low grade fever, felt terrible for around 24 hours. I called clinic because my throat felt like there was a big lump in it but I could still swallow.
A legal complaint was received from an attorney regarding an adult male. The decedent's history includes exposure to asbestos and asbestos-containing products. According to the legal complaint, sometime in the 1960's or 1970's, decedent was administered OPV or IPV. On or about 2002, the decedent was reportedly diagnosed with mesothelioma. The legal complaint states that the decedent's exposure to asbestos, asbestos-containing products, and the SV40 virus caused severe and permanent injury to the plaintiff, including, but not limited to breathing difficulties, asbestosis, lung and/or other cancer, mesothelioma, and/or other lung damage. On 10/11/02, he died. The death certificate lists the immediate cause of death as respiratory arrest due to mesothelioma.
No other AE.; GARDASIL on 9/19/2012 at the age of 12. The patient received the second dose of GARDASIL on 5/13/14 at the age of 13; This spontaneous report was received from a pharmacist and refers to a 13-year-old patient of unknown gender.There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 19-SEP-2012, the patient was vaccinated with the first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (exact dose, route of administration, anatomical location, lot # and expiration date were not reported). On 13-MAY-2014, the patient received second dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (exact dose, route of administration, anatomical location, lot # and expiration date were not reported) (inappropriate schedule of vaccine administered). Both doses were administered for prophylaxis. The reporter stated that the patient only received 2 doses of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL). No additional adverse event was reported.
Fever, chills, elevated blood pressure, elevated pulse, fatigue, muscle pain, headache. Bad night sweating. First two shots, I had no side effects. The side effects were with the booster.
12/3/21 ID note: "The patient  is a 50 y.o. Hispanic female with history as noted below who was admitted for 5 days of generalized body malaise alongside headaches, dizziness, nausea, vomiting, shortness of breath, difficulty breathing, and decreased appetite, as well as loss of sense of taste and smell. Her first symptoms where nausea and vomiting, and she later developed a dry cough and shortness of breath. She was hypoxic on presentation to the ED, and was started on 6 LPM.  Today she reports she feels a lot better, with some appetite and able to eat, sitting up at the side of the bed with energy.  She still has a cough.  Denies shortness of breath on 6 LPM.  She feels like her legs are a little "inflamed" but not swollen.  She reports generalized pain in body, noting her whole back and upper legs especially. Also with slight headache, but improved.  She reports being vaccinated against COVID-19 with the Johnson and Johnson vaccine 8 or 9 months ago.  She was not aware that she should get a booster now, and said that she thought the vaccine lasted for a year. Of note, her daughter started to present with just loss of taste this past Friday, but she tested negative for COVID.Multifocal pneumonia due to COVID-19 virus with hypoxia, was saturating in the 80's on RA on admission, put onto 6 LPM, currently stable; Onset 5 days PTA, on 11/27. Low fever, saturating at 80's on RA, admitted on 6 LPM NC. Covid + on 12/2 by flu panel.  Cxray 12/2:  Lower lung predominant multifocal opacities are concerning for viral pneumonia.  Interleukin-6, continue dexamethasone , continue remdesevir day 2/5, prophylactic anticoagulation, monitor O2 needs closely"
pt admitted to hosp with hypoxic respiratory failure and sepsis due to positive for COVID 19; treated with antibiotics, steroids, breathing treatments; remdesivir, Baracitinib; overall condition and oxygenation worsened; pt experienced respiratory arrest in the hospital
Meningitis, fever 101, headache, chest pain, elevated heart rate (resting is 61, heart rate while laying flat was 92. Sleeping heart rate is 52, woken up with heart rate exceeding 104), fluctuating heart rate while inactive.
Pt got redness at injection site increasing in size every 2 days. So far about 50 cent piece size.
Started with dizziness in the morning around 7 AM when woke-up and then nausea and vomiting till approx. 4 PM. No other medicines were taken to treat these symptoms. Due to minor to moderate to headache, took extra strength Tylenol around 4 PM.  After 7 PM, felt better and no signs of these symptoms.
his son was born in several airway birth defects; his son was born in several airway birth defects; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the parent.  A neonate male patient was exposed to BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), transplacental, administration details for the mother: as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The mother's relevant medical history and concomitant medications were not reported. The following information was reported: EXPOSURE DURING PREGNANCY (congenital anomaly), CONGENITAL ANOMALY (congenital anomaly), outcome "unknown" and all described as "his son was born in several airway birth defects".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300274748 same reporter/drug, different patient/event;
Initial report received from a health care provider on 27/Mar/2006. A five-year-old patient (gender not reported) had received an intramuscular, right arm injection of Daptacel, lot number C2405AA, on 22/Mar/2006. Two days later, the patient experienced "redness and swelling of the entire arm after vaccination". The patient had received four previous doses. At the time of this report, the patient had recovered from the event. The reporter in this case is the same as for cases 2006-00694, 2006-00695, 2006-00697, 2006-00698, 2006-00699, and 2006-00700.
Breakthrough case admission after 5 vaccines Pfizer 1/25/21  Lot# El9261;  Pfizer 2/15/21 Lot# Em9810;  Pfizer 9/21/21 LOt# FD8448;  Pfizer 3/26/22 Lot# FJ9943;  fizer 9/12/22 GJ5342
Injection given at 3:30pm. At approximately 8pm, I began having an intense headache with dizziness, muscle aches, and low grade fever. At approximately 1:30am, fever spiked to 103 despite taking Tylenol and ibuprofen alternating, still having headache and dizziness and then I began full body shaking. Not chills but uncontrolled shaking and muscle spasms throughout body.  This continued for 5 hours with Intense body shaking, muscle spasms, fever, headache, dizziness, exhaustion and sore arm. The shaking and muscle spasms stopped but the other symptoms continued. Fever fluctuated between 101-103. I went to the doctor Friday morning at 11am to report this. As the time of filling this out, it is Saturday at 4pm and I still have headache, dizziness, fever between 99-101 while taking OTC meds, sore arm,  and fatigue.
Dizziness, sleepiness, fatigue, blurred vision on 4/21/10. Fever 100.8. 4/23/10 pain to left arm and arm pit. Swelling to left axilla, started today.
Patient started having a rash on stomach and arms.  Patient went to a dermatologist who told him it was probably a reaction to the Spikevax immunization.  The rash started about 4 to 7 days after the immunization - patient could not give exact information on when rash started.  He still currently has a rash.