chrisvoncsefalvay/vaers-outcomes huggingface dataset:
1st dose- had a sore arm after the shot; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 57 year-old male patient received bnt162b2 (BNT162B2), administration date 16Apr2021 (Lot number: EW0164) at the age of 57 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "HIV", start date: 1991 (ongoing), notes: Verbatim: HIV; "Vertigo", start date: 2018 (unspecified if ongoing), notes: he had bout of vertigo 3 years ago, gave him some type of IV medication and as been gone since then; "lightheaded", start date: 2018 (unspecified if ongoing), notes: A week after he had gotten lightheaded. Concomitant medication(s) included: TIVICAY taken for hiv infection, start date: 2013 (ongoing); DESCOVY taken for hiv infection, start date: 2013 (ongoing). Past drug history included: Lexiva, start date: 1998, stop date: 2013, for HIV; Epivir, start date: 1998, stop date: 2013, for HIV; Zerit, start date: 1998, stop date: 2013, for HIV. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 16Apr2021, outcome "recovered" (16Apr2021), described as "1st dose- had a sore arm after the shot". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Concomitant medicinal Tivicay and Descovy  Dosage text: one pill every day at night before bed. 1st dose- had a sore arm after the shot. Sore Arm: Originally he states that this had began within the first two weeks of his COVID vaccine but he would have to look at his COVID vaccine card for that date. He clarifies and confirms that he only had the sore arm after his 1st dose and that had only started probably about an hour or so after that dose and it was very mild and only lasted a couple of hours. He wouldn't of even called it a 1 on a 1 to 10 scale, it was just more annoying. He did not have the sore arm after the 2nd dose. He did take his HIV medication 2 weeks prior to his COVID vaccine because he take them once every day. He did take his HIV medication 2 weeks prior to his COVID vaccine because he take them once every day. He takes Tivicay and Descovy and for both he takes one pill every day at night before bed. He says he doesn't know the exact dosage because it doesn't come in dosages like normal medications like 10 mg or 40 mg, there's a standard dosing for it and that's what he takes. There is no lower or higher dose and he started those two in 2013. Before that was on Lexiva, Epivir and Zerit and took those from 1998 until 2013. He was diagnosed in 1991 but he didn't seek treatment until 1998. He had an MRI when he got there and then another when he was discharged. At first they did a CAT scan and then an MRI, both on 24Aug2021, Tuesday, and then before he left the hospital they gave him a second MRI which was on Wednesday, 25Aug2021. They also did a clotting test before the left the hospital and from what he heard it had came back fine. They took 15 vials of blood and did that clotting test.  No follow-up attempts are possible. No further information is expected.
After receiving the vaccine, I felt very fatigued, chills, my tongue felt tingling, and my throat felt like it could be swelling for 24 hours. On 12/07/2022 I tested positive COVID-19. I felt like was getting a cold. My neck on the left side and my shoulder hurt really bad. I contacted my doctor and was given the prescription PAXLOVID. As of today, my neck and shoulder still hurts.
Patient developed multiple vaginal aphthous ulcers. Painful. Lesions appeared 24hrs after dose.
This spontaneous report as received from a registered nurse refers to several unspecified patients of unknown age. The patients may have been vaccinated with RECOMBIVAX HB (date, route and lot number unknown). No other co-suspects were reported. No concomitant medications were reported. It was reported that the vaccine was improperly stored. No treatment information was reported. No adverse effect was reported. Same reporter linked for case 1212USA004414 (GARDASIL) and case 1212USA005071 (VAQTA). Additional information has been requested.
Left arm has a red rash at injection site as of this morning, 2/4/21,
Day after the injection I experienced a red rash about the size of a tennis ball at the injection site.  There was no pain or problems swallowing, no hives or headaches, just the rash.  It  lasted for two full days and was warm to the touch.
Headache, Myalgia, Fever & NauseaVomiting Narrative:  Received 1st dose on 12/31/20. Approximately 2 weeks after injection, noted redness and warmth at injection site. Seen at ED and treated with a course of cephalexin with improvement. Received 2nd dose on 1/26/21. Noted sore arm day of and day after dose. Approximately 48 hours after administration noted onset of nausea, myalgias, fever and headache. All symptoms resolved 72 hours after administration. No known prior COVID infection  Other Relevant History:
Smallpox vaccine 07/10/02. Cellulitus left deltoid 07/19/02. Celulitis resolved 07/22/02.
Case number PHHY2015US158435 is an initial spontaneous report received from a consumer (patient's daughter) on 23 Nov 2015. This report refers to a female patient whose age was not reported. Her medical history and concomitant medications were not reported. The patient was vaccinated with influenza vaccine (manufacturer and batch number: not reported) on an unknown date. On an unspecified date, she passed away from heart failure. The reporter stated that she did not think having the influenza vaccine over the years was related to the event. No further information was provided.
5 pm on Sunday, I started getting pains on my lower leg. Not like an ache. All up and down the inside of the leg (the pain was). There was a pressure point where I found a point where if I pressed it, it was really painful. My skin - the inner leg towards the back - it was really really sensitive. If you touched it lightly it felt painful - not a searing pain. If I massaged it, it would go away but in a few minutes it would come back. I took an aspirin in case of a clot. At this time, I was thinking of deep vein thrombosis. Gradually, it went away. It lasted quite awhile - it lasted between 2 or three hours like this. Even now, the skin isn't sensitive, but I can still press that one point and it hurts. (That pressure point.) I went to the Doctor on the 13th, he sent me to an Ultrasound there wasn't a clot in the leg. That came out fine. When I had the IBS for four months (with a lot of diarrhea). I just found out yesterday that my magnesium was low and they gave me a drip for that. My potassium was a little low also. I had the magnesium drip last night - it was an Hospital ER visit - but it was for bloodwork that had been done yesterday to check me after IBS symptoms.
Information has been received concerning an approx. 12 month old male who in 1998 was vaccinated with MMRII. In approx. 1998, "soon after" vaccination, the pt developed autism. Unspecified medical attention was sought. Upon internal review, autism was determined to be an "Other Important Medical Event". Additional information has been requested. F/U: This is an amended report. The narrative has been changed to indicate that the information was received from the pt's mother and the pt's age was changed to approx. 12 months old.
5 CM erythema, satellite lesions, catter pustules,c/w erythema multiforme
dizziness/dizzy spell; swelling in the right hand; weakness; vertigo; congestion; rapid heartbeat; very sensitive rash on certain areas but that stays on the upper legs; Exhaustion; joint pain; Chills; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness/dizzy spell), PERIPHERAL SWELLING (swelling in the right hand), ASTHENIA (weakness), VERTIGO (vertigo) and NASAL CONGESTION (congestion) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021321A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Tunnel vision in November 2020. Concurrent medical conditions included Hypothyroidism.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (dizziness/dizzy spell), PERIPHERAL SWELLING (swelling in the right hand), ASTHENIA (weakness), VERTIGO (vertigo), NASAL CONGESTION (congestion), HEART RATE INCREASED (rapid heartbeat), RASH (very sensitive rash on certain areas but that stays on the upper legs), FATIGUE (Exhaustion ), ARTHRALGIA (joint pain) and CHILLS (Chills). At the time of the report, DIZZINESS (dizziness/dizzy spell) and CHILLS (Chills) had not resolved and PERIPHERAL SWELLING (swelling in the right hand), ASTHENIA (weakness), VERTIGO (vertigo), NASAL CONGESTION (congestion), HEART RATE INCREASED (rapid heartbeat), RASH (very sensitive rash on certain areas but that stays on the upper legs), FATIGUE (Exhaustion ) and ARTHRALGIA (joint pain) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient reported other symptoms that it said "come and go on a daily basis". The patient said that she had the possibility of having COVID, tested negative, and then scheduled the vaccine. Patient says until she has the test she wouldn't want to get the vaccine until having the test back.   Concomitant medication included Thyroid glandular bovine peroxide-free formula 200mg/day for hypothyroidism. Treatment medication included Tylenol Extra strength.   The patient also said that on 1st of November driving went completely blind. The vision came back but tunneled. Run a battery of test for thyroid, could not find anything.  Company Comment: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
Tingling from elbow radiating to hands and burning both feet. Weakness in upper extremities.  Possible Guillian Barre Syndrome.
Body aches; low grade fever; chills, shivering; headache; nausea; stiff/sore arm; stiff/sore arm; This is a spontaneous report from a contactable Other Health Professional for herself. A 30-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EJ1685) dose number 1, intramuscularly on 26Dec2020 15:30 at single dose on arm Left for COVID-19 immunization. Medical history included irritable bowel syndrome, chicken allergy and COVID-19.  Concomitant medications received within 2 weeks of vaccination included clonazepam, spironolactone and melatonin, all from unknown date for unknown indication.  Onset of symptoms began roughly 9hrs post vaccine. Lasted roughly 24 hours (28Dec2020). Body aches, low grade fever, chills, shivering, headache, nausea, stiff/sore arm. Adverse event start date: 27Dec2020 00:00. No treatment was received for the events. The action taken in response to the events for BNT162B2 was not applicable. Outcome of the events was resolved on 28Dec2020.
Patient had a reaction to first vaccine of Pfizer with complaints of tingling in throat.  Patient spoke with physician prior to second administration and was recommended to get Moderna as second vaccine.  Patient premedicated with Benadryl, famotidine, and prednisone at home prior to vaccine administration.  Approximately 20 minutes after vaccine administration patient complaints of feeling like her throat was "thick" and that she needed "to use my EpiPen"  EpiPen administered. VS O2 sat 99% HR 130's.  Rapid response called as per hospital protocol and patient was transferred to ED.
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 36-year-old male patient received BNT162b2 (BNT162B2), on 19May2022 as dose 1, single (Lot number: FM9992) and on 09Jun2022 as dose 2, single (Lot number: FM7553) at the age of 36 years for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported.  The following information was reported: VACCINATION FAILURE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown Results; (20Jul2022) positive, notes: positive COVID test 20Jul2022. Therapeutic measures were taken as a result of vaccination failure, suspected covid-19.  Additional information: The patient received other medication in 2 weeks. The antiviral treatment was started on 08Jul2022 and stop treatment on 12Jul2022. The patient received Ibuprofen medication started on 08Jul2022 and stop treatment on 08Jul2022. The patient had cough and tested positive COVID on 20Jul2022.   No follow-up attempts are needed. No further information is expected.
Patient states excruciating arm pain unrelieved by heat or ibuprofen. Pain continued and grew steadily worse. Area was red and swollen. Swelling grew worse to below elbow and patient could not straighten arm. Pt. went to MD and was given steroids and antihistamines. Pt much better and feels she got a bad vial.
This spontaneous report was received from a registered pharmacist and refers to a 66 year old patient of unknown gender. Information regarding pertinent medical history, drug reactions or allergies and concomitant therapy was not reported. On 03-AUG-2017, the patient was vaccinated with an improperly stored ZOSTAVAX, lot number M041087 with expiration date 03-JAN-2018 (dosage schedule, anatomical location and route of administration not provided) for prophylaxis, reconstituted with properly stored diluent (MRK INJ). The administered vaccine was exposed to a temperature of 6 degree Fahrenheit to 14 degree Fahrenheit for 1 hour. Previous temperature excursion was reported as 6 degree Fahrenheit to 14 degree Fahrenheit for 45 minutes. The call was because of a data logger. No adverse effects were reported. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1708USA010696: US-009507513-1708USA010732: US-009507513-1709USA014569: US-009507513-1709USA014570: US-009507513-1709USA014571: US-009507513-1709USA014572: US-009507513-1709USA014573: US-009507513-1709USA014575: US-009507513-1709USA014576: US-009507513-1709USA014577.
920 H/A feels dizzy, B/P 80/60. No breakfast, 945 B/P 110/80 feeling much better. 10:00 B/P 118/80 - P 84. Mom was called by the school nurse.
Dime-sized lump on (L) deltoid w/2" redness surrounding. Not painful. Using ice pack.
This spontaneous report as received from a treating pharmacist via company representative refers to multiple, unspecified patients, during the past three days, had received ZOSTAVAX (Lot# unspecified) single dose injection (dose and location unspecified), and returned to the pharmacy within three days post-vaccination, with symptoms of "cellulitis" at the injection site and surrounding areas. The patient did not reintroduce the therapy, the patient had sought medical attention via contacted pharmacist. At the time of report, the outcome of the event was unknown. Additional information has been requested.
Extreme Jumpiness, Anxiety, Restlessness, Insomnia, Continual crying for 3 hours and Fussiness for 24 hours, and seemed to have abdominal pain.
Information has been received from a nurse practitioner concerning a female patient who was vaccinated with a dose of VAQT.  The patient showed a false positive for HEPATITIS A after receiving the vaccine.  Laboratory test included "blood work".  Unspecified medical attention was sought.  No product quality complaint involved.  Follow-up information received on 21-JAN-2009 from an unspecified reporter who reported that they had no patient with known adverse reactions.  Additional information is not expected.
Phizer-BioNTech COVID-19 Vaccine EUA Injection site pain, tiredness, headache, chills, fever, nausea, feeling unwell, dizziness & weakness
Rash; they thought maybe it was yeast, looked yeasty to them they said; This is a spontaneous report from a contactable consumer or other non hcp. A 43-years-old female patient received BNT162B2 (BNT162B2, solution for injection, Batch/Lot Number: ER8736), via intramuscular, administered in Arm Right on 02Jun2021 (at the age of 43-year-old) as dose 1, single and dose 2 via intramuscular, administered in Arm Right on 24Jun2021 (Batch/Lot Number: EW0168) (at the age of 43-year-old) as dose 2, single for covid-19 immunisation. Medical history included vaginal herpes from an unknown date and unknown if ongoing, depression from an unknown date and unknown if ongoing. Concomitant medications included fluoxetine hydrochloride (FLUOXIBENE) taken for depression, start and stop date were not reported; acyclovir taken for genital herpes, start and stop date were not reported. Patient did not took any other vaccines within for weeks prior to vaccination. On 05Jun2021, the patient experienced rash. After the second dose patient got more of a rash. On an unknown date in Jun2021, Patient went to her husband's clinic for his job and they prescribed, a cream because they thought maybe it was yeast, looked yeasty to them they said. Patient stated that "so they gave me that and then they gave me Diflucan which just did nothing". The events resulted in health care professional visit. Therapeutic measures were taken as a result of events. Patient considered the event rash as non serious. The outcome of the events were not recovered.   Information on Lot/Batch number was available. Additional information has been requested.
GENERAL ACHES/FEELS GENERALLY ACHY ALL OVER; TROUBLE GETTING OUT OF BED; YAWNING A LOT; FATIGUE; This spontaneous report received from a patient concerned a 63 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: normal allergies, sinus, non alcohol user, non-smoker, and arthritis, and other pre-existing medical conditions included: The patient had high blood and that doesn't have anything to do with the shot and had no history of drug abuse or illicit drug use. The patient received COVID-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, and batch number: 206A21A expiry: UNKNOWN) dose was not reported, administered on 16-AUG-2021 for prophylactic vaccination. Concomitant medications included cetirizine hydrochloride for sinus, and allergies. On 17-AUG-2021, the patient experienced general aches/feels generally achy all over. On 17-AUG-2021, the patient experienced trouble getting out of bed. On 17-AUG-2021, the patient experienced yawning a lot. On 17-AUG-2021, the patient experienced fatigue. The action taken with COVID-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from general aches/feels generally achy all over, fatigue, trouble getting out of bed, and yawning a lot. This report was non-serious.
body pain; headache; This case was reported by a consumer via call center representative and described the occurrence of general body pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced general body pain and headache. On an unknown date, the outcome of the general body pain and headache were not recovered/not resolved.   It was unknown if the reporter considered the general body pain and headache to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported.  The age group was not reported but it was selected as adult as per the vaccine indication. The patient experienced general body pain and headache after receiving Shingrix. The reporter wanted to know what could he/she take to relieve the body pain and headache.
I received a call from the daycare indicating that my son had a rash larger than a 3x5 card on his arm. I picked him up and he had a hot, red rash from his elbow up to his shoulder. His arm was also swollen. The next day his rash had grown more and was still very hot. His arm was 2x the size. I took him by the hospital and they said that it was a reaction to his vaccine and I should report it.
still having pain in my arm; have pain; it's shooting up to my elbow; it's shooting up in my shoulder; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received rsv vaccine prot.subunit pref 2v (RSV VACCINE PROT.SUBUNIT PREF 2V), on 13Sep2023 as dose number unknown, single (Batch/Lot number: unknown) for for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN (non-serious) with onset 2023, outcome "not recovered", described as "have pain"; ARTHRALGIA (non-serious) with onset 2023, outcome "not recovered", described as "it's shooting up in my shoulder"; ARTHRALGIA (non-serious) with onset 2023, outcome "not recovered", described as "it's shooting up to my elbow"; PAIN IN EXTREMITY (non-serious) with onset 2023, outcome "not recovered", described as "still having pain in my arm". Additional information: The patient stated "I am still having pain in my arm and it's shooting up to my elbow. It's going on 6 weeks now and it's not getting any better sometimes when I lift up my arm. I have pain and it's shooting up in my shoulder and it hurts. "  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v, rsv vaccine prot.subunit pref 2v  has been requested and will be submitted if and when received.
Information has been received from a consumer concerning her approximately 12 month old male with food allergies and no pertinent medical history who in approximately 2005 was vaccinated with a dose of RECOMBIVAX HB (manufacturer unknown).  Secondary suspect therapy included a dose of PEDVAXHIB (OMPC) (manufacturer unknown).  Concomitant therapy included a dose of INFLUENZA virus vaccine (unspecified) (manufacturer unknown), a dose of DTAP+HEPB+IPV (manufacturer unknown) and a dose of PREVNAR.  All the vaccines were given in his first year of birth.  After receiving the vaccines the patient did not respond to his name, stared at the fan, delayed speech and flapping.  Unspecified medical attention was sought and unspecified lab work was performed but no results provided.  The consumer reported that at 26 months of age the patient was diagnosed in the autism spectrum, but the patient had improved.  Follow up information was received from a receptionist who indicated that the responsible physician retired about 6 years ago.  Upon internal review, autism spectrum was determined to be an other important medical event.  Additional information has been requested.