chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Two days post vax, the pt experienced joint pain. On 5/11/99, the pt's feet were swollen bilaterally; severe hip, knee, and ankle pain. Not good since then. The follow up received on 1/31/01 states concurrent medical conditions included severe premenstrual syndrome, a penicillin allergy, a family history of rheumatoid arthritis, a history of fluid retention, arthritic pain in fingers and knee caps (1987) when taking megastrol and aldactaside, and the feeling of flu-like symptoms while on aldactaside. Aldactaside was discontinued on 6/4/97. Medical records from the pt's cynacologist and gynecoendocrinologist indicated pt was complaining of multiple arthralgias at 5/6/99 visit. Lab tests revealed negative lab tests for antinuclear antibody and rheumatoid factor on 5/17/99. The pt had elevated eosinoophils 7.4%, elevated monocytes 0.4 thousand/cubic millimeter, and elevated globulins 3.4cm/dl. The information received on 1/31/01 did not provide an outcome. The adverse events of reactive arthritis and joint pain do not meet serious criteria, but are being submitted as an expedited report by special FDA request per the 6/28/00 letter.  A follow up report received 10/10/2002 adds: (in May 1999) The symptoms were treated with an anti-inflammatory, steroids, celecoxib (Celebrex) 100 mg twice daily for 1.5 weeks and nabumotone (Relafen) 750 mg every 12 hours. The info received on 06/09/1999 reported the pain was less severe, but the swelling persisted. The info received on 01/31/2001 did not provide an outcome. In a news article published 06/25/2001, a reporter stated, "The stiffness and swelling has become so severe that she is dependent on anti-inflammatory drugs to keep her mobile". The pt stated, "I just keep moving. It doesn't get rid of the pain, but it keeps me from stiffening." The outcomes of the flu-like symptoms and viral syndrome were not provided. The most recent info, received on 02/11/2002, did not provide the outcome of the reported events. The adverse event of "reactive arthritis" does not meet ICH serious criteria, but is being submitted as an expedited report by special FDA request per the 06/28/2000 letter.
Gave an Expired Dose of Heplisav-B; Initial Report Received on 20-Oct-2021  A certified medical assistant in the US (IA) reported that a 33 year-old female (race and ethnicity not provided) received an expired dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.  Medical history was reported as anxiety mood disorder, obesity and "Toprimax" allergy.  No relevant concomitant medications were reported.    On 20-Oct-2021, the patient received an expired dose of HEPLISAV-B (Lot # 934259, expiration date 25-Sep-2021 and NDC # 43528-003-05) in the right deltoid from a certified medical assistant.   The patient had not reported any adverse reactions at the time of the report. No additional information was reported.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Woke up in AM of 02/16/2005 with rash (red, raised, non-vesicular) to trunk which then spread to arms, legs, face.  Seen by physician on 02/17/2005 - unsure whether chicken pox or reaction to vaccines.  Spoke to patient's Mom on 02/18/2005 rash was improving and no other symptoms.
pt recv vax;exp itch,pain,swelling & inflam at inject site;inflamed area as large as dollar coin;this is one of 11 patients who exp the above rxn p/vax
Administered only the liquid conjugate portion; Administered only the liquid conjugate portion; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 12-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA713A, expiry date 30th June 2023) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 16-AUG-2022 Reporter's Comment: The reporter was a medical assistant. The reporter reported that the patient received only the liquid conjugate portion of the Menveo vaccine. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up. Additional Supportive Information: The patient administered only the liquid conjugate portion of the Menveo vaccine, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered
Polymyalgia Rheumatica; This case was reported by a lawyer and described the occurrence of polymyalgia rheumatica in a 70-year-old female patient who received Herpes zoster (Shingrix) (batch number unk, expiry date unknown) for prophylaxis.   On 1st October 2018, the patient received the 1st dose of Shingrix (intramuscular). On 1st February 2019, the dose was an unknown dose. On 20th October 2018, 19 days after receiving Shingrix, the patient experienced polymyalgia rheumatica (serious criteria GSK medically significant). The action taken with Shingrix was unknown. On an unknown date, the outcome of the polymyalgia rheumatica was unknown.   It was unknown if the reporter considered the polymyalgia rheumatica to be related to Shingrix.  The initial information was received on 27 May 2021 via medical record (case is medically confirmed). The patient received Shingrix on 01 October 2018 and 01 February 2019. The patient experienced Polymyalgia Rheumatica on 20 October 2018.
Patient passed out 5 minutes after all injections were completed. Regained consciousness immediately and was alert and oriented x5. Paramedics called and came to evaluate the patient.  Patient declined ambulance ride or hospital visit, and attained a ride home.
Allergic type response laryngeal construction 9/21/10 at 1600-2200, relieved with BENADRYL and Albuterol. Blurred vision continued for 1 week following - seen 10/1/10 by Dr - Diagnosed with central serous retinopathy.
3/14/03 10:09am 15 month B/B mom c/o swelling and redness to L thigh after immunixzation yesterday of DTaP. No fever. Benadryl 12.5/5yo 2cc po q 6. Cold packs wrosened s/s of infection or spreading.
Extra dose of IPV given; Got Kinrix at two months of age; Got Kinrix, months later got complete series of Pediarix; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 2-month-old male patient who received DTPa-IPV (Kinrix) (batch number HN7L7, expiry date 31st August 2021) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa-HBV-IPV (Pediarix) (batch number J7X44, expiry date 11th May 2023) for prophylaxis and dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included DIPHTHERIA TOXOID + HEPATITIS B VACCINE + PERTUSSIS TOXOID + POLIOMYELITIS VACCINE + TETANUS TOXOID (PEDIARIX) and DIPHTHERIA TOXOID + HEPATITIS B VACCINE + PERTUSSIS TOXOID + POLIOMYELITIS VACCINE + TETANUS TOXOID (PEDIARIX).   On 18th February 2021, the patient received the 1st dose of Kinrix and Kinrix Pre-Filled Syringe Device. On 30th December 2021, the patient received the 3rd dose of Pediarix and Pediarix Pre-Filled Syringe Device. On 18th February 2021, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device and not applicable after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and inappropriate schedule of vaccine administered. On 30th December 2021, the patient experienced extra dose administered. On an unknown date, the outcome of the inappropriate age at vaccine administration, inappropriate schedule of vaccine administered and extra dose administered 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 details were provided as follows: Clinical Supervisor reported that, the patient received a dose of Kinrix at two months of age, which led to inappropriate age at vaccine administration. Several months later, the patient received a complete series of Pediarix. The 1st dose of Pediarix was given on 19th April 2021 (batch number 4977T, expiry date 5th September 2022) and 2nd dose on 21st June 2021 (Batch number 4977T, expiry date 28th November 2021) The patient received 3rd dose of Pediarix leaving him with an extra dose of IPV given which led to inappropriate schedule of vaccine administered and extra dose administered. Pediarix was given on the correct schedule, but started at the incorrect age. The reporter consented to follow up.
Possible vaccination induced rubella. Diffuse, macular rash over face, trunk, and back.
This spontaneous report was received from a certified medical assistant and refers to an unspecified number of patients of unknown age and gender. Information on the patients' concurrent conditions, medical history or concomitant medications was not reported. On an unknown date, the patients were vaccinated with improperly stored (temperature: 31 F for 16 hours) doses of PNEUMOVAX 23 (lot # L013428, expiration date: 13-FEB-2017), dose and route were not provided. No adverse symptoms reported. This is one of two reports received from the same source. Additional information has been requested.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old male patient received BNT162b2 (BNT162B2 NOS), on 01Nov2022 at 12:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 63 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2023) Positive, notes: COVID 19 Treatment. The patient was treated with Paxlovid (lot1921151A) from 01Mar2023 to 06Mar2023. The information on the batch/lot number for BNT162B2 has been requested and will be submitted if and when received.
Patient received first dose of Pfizer BioNTech COVID19 Vaccine on 3/6/21 at vaccine clinic.   Patient admitted to hospital when second dose was due and given Janssen COVID19 vaccine on 3/29/21 while admitted.
This spontaneous report as received from a pharmacist via company representative refer to a non pregnant female patient of unknown age. Patient's medical history and concurrent conditions were unknown. On 08-SEP-2016 the patient was vaccinated with ZOSTAVAX (dose, frequency and route of administration were not reported in unspecified arm). Concomitant therapies were unknown. On 09-SEP-2016, patient came back into pharmacy with complaint of injection site: entire backside of her arm was red and painful. Pharmacist did not state that redness was a rash, therefore breakthrough varicella, could not be ruled out. No treatment was given for adverse events. The outcome of events was unknown. Causality assessment was not reported. Additional information has been requested.
When she got the shot at abt 9:15am, she complained about her leg, but I knew she had gotten a shot, so I figured it was typical. Then about 2:30pm when I got her out of the car she acted like she couldn't walk on her right leg, and was crying. We came in and she ate some yogurt, then, she was so fussy, I felt her head and decided she felt a little warm, and with her leg being sore, it wouldn't hurt to give her some ibuprofen. I gave that to her at about 3:15pm. In about 45 minutes she was running around and playing and laughing with me. About 30-45 minutes after that, all the sudden, she started SCREAMING and crying and wouldn't stop. I tried to take her, temp but she was fighting me hard and I couldn't get her to stay still to get it. Then I called her ped. and they suggested I giver her Tylenol, since she had JUST had ibuprofen less than 2 hrs prior. While on the phone she started acting lethargic, droopy eyed, and she was BURNING UP. I got scared, because the lethargy reminded me of when she had gotten the peanut butter. I tried giving her the Tylenol and she threw it right up, so I gave her a rectal Tylenol. The Dr said I should take her to the ER, and I called my neighbor to come and help me since no one wasn home yet. She started getting chills and any time I tried to move her she screamed like she was in pain. Her tongue looked swollen and she was drooling some. She kept trying to pass out in the car and I tried to keep her awake. When we got to the ER, after her Motrin and Ibuprofen her temp was like 102.9. I would definitely say before all that it must have been like 105 or 106. The nurse & Dr at the ER ended up giving her a bunch of meds, including epinephrine, Benadryl, a steriod shot, and  think the other was Zantac.  They had to monitor her overnight and gave her more Ibuprofen and Tylenol.
Died after booster shot; she had something in the brain; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Died after booster shot) and CEREBRAL DISORDER (she had something in the brain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DEATH (Died after booster shot) (seriousness criteria death, hospitalization and medically significant) and CEREBRAL DISORDER (she had something in the brain) (seriousness criterion hospitalization). The patient died on an unknown date. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, CEREBRAL DISORDER (she had something in the brain) outcome was unknown.            Company comment: This is a spontaneous case concerning a female patient of an unknown age with no reported medical history, who experienced the serious  unexpected event cerebral disorder and death. The events occurred on an unknown date after the booster dose of mRNA-1273.  It is not clear if cerebral disorder (she had something in the brain) refers to a previous medical history or is an event. No information was provided regarding medical history and events. Further information has been requested.The benefit-risk relationship of mRNA-1273 is not affected by this report.  It was stated that the reporter don't know if Patient had underlying health conditions. Reporter was not certain if the booster dose was a Moderna shot. No concomitant medications were mentioned. No treatment details were reported.   This case was linked to MOD-2022-452712, MOD-2022-452729 (Patient Link).; Sender's Comments: Company comment: This is a spontaneous case concerning a female patient of an unknown age with no reported medical history, who experienced the serious  unexpected event cerebral disorder and death. The events occurred on an unknown date after the booster dose of mRNA-1273.  It is not clear if cerebral disorder (she had something in the brain) refers to a previous medical history or is an event. No information was provided regarding medical history and events. Further information has been requested.The benefit-risk relationship of mRNA-1273 is not affected by this report.; Reported Cause(s) of Death: Unknown cause of death
pain in arms; Fever; Fatigue; Headache; Weakness; arm was red from shoulder to wrist; This is a spontaneous report received from a contactable reporter(s) (Other HCP: dentist) from medical information team. The reporter is the patient.  A 68 year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), administered in arm left, administration date 2015 (Batch/Lot number: unknown) for immunisation. Relevant medical history included: "asthma" (not ongoing); "high blood pressure" (unspecified if ongoing); "She has an allergy to pollen" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Asmanex for asthma, reaction(s): "affecting her vocal cords". The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 2015, outcome "recovered" (2015), described as "pain in arms"; PYREXIA (non-serious) with onset 2015, outcome "recovered" (2015), described as "Fever"; FATIGUE (non-serious) with onset 2015, outcome "recovered" (2015), described as "Fatigue"; HEADACHE (non-serious) with onset 2015, outcome "recovered" (2015), described as "Headache"; ASTHENIA (non-serious) with onset 2015, outcome "recovered" (2015), described as "Weakness"; VACCINATION SITE ERYTHEMA (non-serious) with onset 2015, outcome "recovered" (2015), described as "arm was red from shoulder to wrist".  Additional information: She is 74 years old. She did not get her covid vaccine yet. Her husband did he is 80 years old and he is ok. In 2015 she got a flu shot (unspecified) and Prevnar 13 vaccines together. Her reaction was so bad that she spent three days in bed. Right when she got home she got so weak and had pain in her arms and everything. She was bedridden for 3 days. She had fever, fatigue, headache, weakness, and her arm was red from shoulder to wrist. Her husband had to take her to the bathroom. She was a dentist. She is a non smoker and non drinker. Her doctor passed away, she will go to another doctor in two weeks. She does not know the name of the flu shot. This was the first time she had the flu shot and Prevnar 13 and never got them again. She recovered three days after the shots by a Sunday or Monday she felt better. She does not recall the exact dates. She had the shots on Friday. She did not call doctor or do anything. She just stayed in bed waiting. She is going to cardiologist tomorrow. She used to have asthma and was taking asmanex, a corticosteroid, and the inhaler was affecting her vocal cords and she does not have any anymore. She is not taking it anymore. She also used to have high blood pressure and took medications, then she decided to not watch tv and have less stress and does not need blood pressure medication anymore and she is ok. She has an allergy to pollen and things like that which was diagnosed when she was 40 or 50 years old.  No follow-up attempts are needed. No further information is expected.
Patient was administered the pneumovax 23 this past Monday and after about 24 hours was having pain in her upper left ar and then the pain spreed down her arm to her lower back.  She went to her physican and he told her that she had cellulitus and was given Keflex 500mg 1bid for 10 days
The first dose of FLUMIST nasal spray was given to a 11 month old patient. It is not recommended to administer FLUMIST to children under the age of 2 due to increased incidence of wheezing and hospitalization.
PATIENT STATES HE EXPERIENCED FEVER, SORENESS IN ARMS, CHILLS, AND ACHES ALL OVER BODY.
Information has been received from a physician concerning an 88 year old male who on an unknown date, was vaccinated with the first dose of VARIVAX (Oka/Merck) (lot# not provided). The patient received a titer test which showed that had never had chickenpox. Within a week after vaccination the patient developed full blown chickenpox. He did not have a fever or any other major health risks, but had lesions all over his body and face.  A skin biopsy was performed (result unknown). Subsequently, the patient recovered from full blown chickenpox. Unspecified medical attention was sought. Follow-up information from the physician indicated that the 89 year old (previously reported by the same reporter as 88 year old) patient received his first dose of VARIVAX (Oka/Merck) (lot# 661868/1009X) SQ on 15-DEC-2008. On -05-JAN-2009, the patient developed rash secondary to chickenpox. The skin biopsy was positive for chickenpox. On 14-JAN-2009, the patient recovered from chickenpox. The reporting physician did not consider the chickenpox to be serious. Additional information is not expected.
On second dose: fever, headache, body aches, dizziness, sore arm In first dose just sore arm for 1 day; On second dose: fever, headache, body aches, dizziness, sore arm In first dose just sore arm for 1 day; On second dose: fever, headache, body aches, dizziness, sore arm In first dose just sore arm for 1 day; On second dose: fever, headache, body aches, dizziness, sore arm In first dose just sore arm for 1 day; On second dose: fever, headache, body aches, dizziness, sore arm In first dose just sore arm for 1 day; This is a spontaneous report from a contactable consumer or other non hcp.   A 60-years-old male patient received BNT162B2 (BNT162B2, solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration, administered in Arm Left on 26Mar2021 14:15 (at the age of 60-year-old) as dose 2, single for covid-19 immunisation.  The patient previously took BNT162B2 (BNT162B2, solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration, on 05Mar2021 (at the age of 60-year-old) as dose 1, single for covid-19 immunisation and experienced sore arm. The patient medical history was not reported. Concomitant medications included escitalopram oxalate (LEXAPRO) taken for an unspecified indication, start and stop date were not reported; rosuvastatin taken for an unspecified indication, start and stop date were not reported; ezetimibe taken for an unspecified indication, start and stop date were not reported. The patient had no allergies to medications, food, or other products. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 26Mar2021, the patient experienced fever, headache, body aches, dizziness, sore arm. No treatment was taken for the events. The outcome of the events were recovering.  No follow-up attempts are needed. No further information is expected.
Information has been received for the pregnancy registry for GARDASIL from a registered nurse concerning a 15 year old female with no pertinent medical history and no drug reactions/allergies, who on 14-JAN-2008 was vaccinated with the first dose of GARDASIL 0.5 mL, IM. On 26-MAR-2008, the patient received the second dose of GARDASIL 0.5 mL, IM. There was no concomitant therapy. The patient is pregnant (positive pregnancy test). At the time of report, the patient was 31 weeks gestation (last menstrual period approximately 20-DEC-2007, estimated delivery date 25-SEP-2008). The patient did not seek medical attention. No other symptoms were noted. Follow-up information was received from the nurse who reported that the patient had a history of asthma and positive PPD. The nurse reported that the patient delivered a normal healthy female baby on 19-SEP-2008 with no congenital anomalies and there were no other complications. The Baby weighed 2810 grams, and APGAR score was 9/9. There were no birth defects and no complications with the infant. There were no infections or illness during the pregnancy. The nurse reported that during the pregnancy on 18-JUL-2008, the patient's ultrasound test resulted normal for fetal anatomy. During the pregnancy, the patient took prenatal vitamins for pregnancy and ferrous sulfate for anemia. The patient had not had any previous pregnancies. Additional information has been requested.
Rash, similiar to hives on face primarily, a few on legs and arms.  Used Steriod creme on  sites to reduce the pain and inflamation.   There are still some eruptions, with the skin peeling and leaving open spots, especially on lips.