chrisvoncsefalvay/vaers-outcomes huggingface dataset:
After the second injection, I was experiencing what I thought was a lupus flare up. I needed to get into a new rheumatologist so that took some time getting into with my current insurance. I was experiencing a tremendous amount of joint and muscle pain. I have a Low grade fever off and on as well as my lupus butterfly rash on my face and a few sores in my nose. All symptoms I have had when dealing with a lupus flare. One thing that was different was muscles being pulled for doing very little. My back and neck muscles kept getting pulled often. Extreme dry eyes/nose- all which was similar autoimmune symptoms I have had in the past. Extreme periods of nausea, but I have been unable to take certain medications I use to be able to take. I can not take any nausea medications because it now will give me a horrible migraine that last for days. My primary doctor gave me a steroid dose pack to help me until I could get into my rheumatologist and I had a horrible reaction to them with extreme diarrhea, nausea, vomiting, and migraines. None of those symptoms to medications has happened in my past. My symptoms started was a gradual increase over the time period after getting my vaccine. Not all at once. But after about a week after getting the vaccine it started to happen slowly to the point where I am today. The doctors ran various test for my lupus and all of my inflammation lab markers came back extremely high. But none of my lupus/autoimmune markers came back as active. I also ended up going to the ER concerned with chest pain- but after many test nothing was conclusive or found. I have a follow up with a cardiologist  pending
When the vaccine was administered only the solution containing IPV and DTaP was given, not the powder for the Hib.
Rash on inject site arm, warm to the touch, itchy at times, grew larger very quickly
My son got sick from the 1st vaccine; This is a spontaneous report from a Pfizer Sponsored Program via a non-contactable consumer (patient's mother) reported for patient (reporter's son).   A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date, as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that her son got sick from the 1st vaccine on an unspecified date. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
dose drawn from current mixed solution from 11/08/2021 and administered on 11/09/2021
12 a few minutes past vaccines patient complained to parent that her stomach "hurt". 400 spoke with parent-she states she is fine.
Pruritic rash L arm, that extended to abdomen and back. Rash started the day after receiving injections. Did not report to provider at the time. Resolved at f/u visit 7/3/07
This spontaneous report was received from a Registered Nurse and refers to a multiple unspecified patients of unknown age and gender. On an unknown dates, the patients were vaccinated with improperly stored GARDASIL 9 lot # L019286, expiration date: 14-SEP-2015 (dose, route and anatomical location were not reported). There were no adverse effects reported. This is one of the several reports received from the same reporter. Additional information has been requested.
This spontaneous report was received from a pharmacist via Pfizer refers to a 54 year old male patient. The patient's medical history, current conditions and concomitant medications were not reported. On an unknown date, approximately in 2013 (reported as "3 years ago"), the patient was vaccinated with PNEUMOVAX 23 (dose, frequency, route, lot number and expiry date were not reported). On an unknown date, the patient experienced pneumonia and it was reported that he gets it a lot. His last episode was in March 2016. It was enquired if he should be given PREVNAR 13. The outcome of pneumonia was unknown. The reporter did not provide the relatedness for the event with PNEUMOVAX 23. Upon internal review, "pneumonia" was determined to be medically significant. Additional information has been requested.
I63.9 - Stroke (CMS/HCC) R53.1 - Acute left-sided weakness
This initial spontaneous case, was received from other health professional (pharmacist) on 22-Nov-2017, concerns a patient of unspecified age and gender. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient was administered with FLUCELVAX QUADRIVALENT (batch number: 195211, expiry date: Mar-2018, dose, route of administration and anatomical location: not reported). It was reported that, the refrigerator reached a temperature of 47F-56F for 456 hours in which the flu vaccine was stored. The reporter stated that the patient received flu vaccine which was stored outside the recommended range. The reporter stated that it was the first-time excursion and there was no adverse event (reported as no AE) to report. The reporter assessed the case as non-serious.
Lot of stomach cramps; had a lot of diarrhea; This is a spontaneous report from a contactable consumer (patient).  A 76-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), (batch/lot number: EL8982, expiry: 30May2021) via an unspecified route of administration, on 31Jan2021 at a single dose, for covid-19 immunization. Medical history included neoplasm malignant (cancer), blood cholesterol ("cholesterol") and "blood pressure".  Patient's concomitant medications were unspecified. On 01Feb2021, patient had a lot of diarrhea and a lot of stomach cramps for a week. He got it from a week ago today and he has been experiencing this and couldn't go to work. The outcome of events was unknown.  Follow-up attempts are completed. Information about batch/lot number has been obtained.
Information has been received from  76 year old female patient without drug reactions/allergies. The patient's medical history included recurring shingles. In approximately December 2014 (reported as "at least 2 or 3 months ago"), the patient was vaccinated with a dose of ZOSTAVAX, injection, one shot, (lot #, expiration dated and strength were not reported). Concomitant medications included unspecified blood pressure medicine and cholesterol medicine. The patient reported that she had recurring shingles prior to being prescribed and receiving ZOSTAVAX. She stated that she was told that ZOSTAVAX would keep her shingles from coming back anymore. She received ZOSTAVAX after one of her shingles cases had cleared up. she stated that, "about 4 or 5 weeks after" receiving ZOSTAVAX in approximately January 2015, she developed the shingles again. The patient sought medical attention by seeing her doctor. No lab diagnostics studies were performed. The physician prescribed unspecified "pills". The unspecified pills (manufacturer unspecified) cleared up the case of ZOSTAVAX on an unspecified date which was "3 weeks to a month after" this shingles outbreak began in 2015. The patient recovered from the events. Additional information has been requested.
Approx 3-4 days after his vaccines client noticed rash on right chest. Superior to armpit. Slightly down arm. It began as red bumps. Now there are many vesicular rash on the area. Some spots have opened. Client expresses it is itchy. He was going to contact his physician.
Persistent Dry Mouth after dose 1 Oral Candidiasis (yeast tongue) after dose 2  (02/21/2021) Took Clotrimazole lozenges 5 per day for 2 weeks Needed refill  prescription of Clotrimazole still on it .  Some relief but not gone. Gastric reflux-
Patient had ED visit with leg swelling and pain that resulted in right mid femoral DVT discharged home from ED with apixaban.
Patient had checked "yes" to the question about fainting, light-headedness, dizziness from previous immunizations so healthcare worker was aware of the situation. Healthcare worker told her to remain seated in her chair and to wave if she felt any issues arise. Right after the immunization she was fine, able to walk to the chair directly outside of pharmacy for observation. Approximately 5 minutes into observation, she waved healthcare worker down, healthcare worker immediately went to talk to her about her symptoms, healthcare worker grabbed an ice pack, while breaking the ice pack, patient fainted while she was sitting in the chair, healthcare worker held her head up to ensure proper breathing and spoke to patient, she came back after about 30 seconds, which is when healthcare worker assisted the patient in moving to the ground and putting her feet up. Healthcare worker or a pharmacy technician remained with the patient until her husband arrived. It took her husband approximately 25 minutes to get to the pharmacy, during that time healthcare worker did ask the patient if she wanted medical attention and she declined, knowing the feeling would subside. It did take her approximately 30 minutes to feel comfortable enough to sit up. Her husband took her out in a wheel chair.
Information was received from a health professional regarding a patient (demographics unknown), who on an unknown date, was vaccinated with VARIVAX (Merck) lot # J003221, expiration 15-MAR-2015, that had been improperly stored. The outcome of improperly stored vaccination is unknown. This is a corrected report. On 30-OCT-2013, information has been received from the registered nurse, who stated that the doses of VARIVAX (Merck), Lot # J003221, expiration date on 15-MAR-2015 were exposed to unknown temperatures for 5 hours during interoffice transport. All vaccines were unsupported and were possibly administered to patients. No adverse symptoms reported. Nurse was unable to provide further temperature excursion details or dates of administration. All patients were revaccinated. No symptoms were reported. This is one of several reports received from the same source. Additional information is not expected.
4pm injection, 4:03pm reaction tickle in throat, tingle in throat, then up to roof of mouth and tongue. No  swelling. 30 min later changed to a sensation of scalding in her mouth. Lasted  3.5 hrs. 1 hr after symptoms took famotidine and cetirizine (5pm) symptoms resolved at 7pm
Covid symptoms since I got my second shot; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (Covid symptoms since I got my second shot) in a patient of an unknown age and gender 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INFLUENZA (Covid symptoms since I got my second shot). At the time of the report, INFLUENZA (Covid symptoms since I got my second shot) outcome was unknown.            Concomitant medications were not provided.  No treatment information was provided.   Reporter did not allow further contact
On 25JUN91 pt started fever up to 102.0F R; that night pt had 105.0 R temp came down some w/APAP, swollen glands behind ear & sl ear infect; pt put on ATB; MD stated the ear infect was sl & this should not have caused that high fever;
This spontaneous report as received from a healthcare worker refers to an 11 year old patient on unknown gender. On 10-NOV-2004 the patient was vaccinated with the first dose VAQTA (dose 0.5 ml, lot# and expiration date were unknown) intramuscular. On 23-JUN-2014, the patient was vaccinated with the second dose of VAQTA (dose 0.5 ml, lot# and expiration date were unknown) intramuscular. No adverse effects were reported. The physician would contact CDC (regarding dosage interval) so no patient details or lot information offered. The reporter stated first dose VAQTA administered at another unspecified facility. Additional information has been requested.
Patient received 2 dose series of Pfizer covid vaccine with no adverse events, however, did not meet age eligibility requirements.
Fevered 100f hit at midnight. Joints and muscle aches. Upset stomach. Very tired. Headache.
SIDS Category II, undetermined 8/29/06 Received autopsy report which stated COD as Category II SIDS & manner of death as undetermined.  Patient was cosleeping with parent in adult bed lying on belly & suffocation caused by overlay could not be excluded.
Patient received vaccines 9/14/17, on 9/15/17 she states she became ill, with nausea and fever. By 9/17 her arm where she received immunizations where red, painful and warm to the touch. Pt states she couldn't move her arm without pain. She was seen by her gynecologist on 9/19/17 and showed provider her arm. GYN provider directed patient to go to her primary care provider. She was seen by primary care office and was diagnosed with cellulitis and started on antibiotics. Pt then called office to let us know what had happened.
room seemed to be spinning; elevations in blood pressure; felt extremely dizzy; This is a spontaneous report from a contactable Pharmacist. A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date unknown) via unspecified route of administration on unspecified date at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was a resident of a long-term care facility. The patient, within a few minutes of receiving first dose of vaccine (unspecified date), experienced elevations in blood pressure and felt extremely dizzy and described that the room seemed to be spinning. The outcome of the events elevations in blood pressure, felt extremely dizzy and room seemed to be spinning was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
This spontaneous report as received from a pharmacist refers to multiple unspecified patients of unknown age and gender. The patients' concurrent conditions and medical history were not provided. On unknown dates, the patients were vaccinated with improperly stored (Oka/Merck) VARIVAX lot # L004654 (expiry date: 11-FEB-2017) (route and site of administration not reported). Concomitant medication was not mentioned by the reporter. The vaccine was stored at 42F for a time frame of 10.5 hours and administered to the patients. Previous temperature excursion was reported to be 40F for 9 hours. It was also mentioned that the call was not a result of "data logger". No adverse effects reported. No further information was provided. Product quality complaint was not filed. Additional information has been requested. This is one of the two reports received from the same reporter. d
My menstrual cycle began after receiving the shot, prior to the shot I did not have a menstrual cycle. I begin to have regular menstrual cycles for 5 months.
very tired, very sleepy; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (very tired, very sleepy) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (very tired, very sleepy). At the time of the report, FATIGUE (very tired, very sleepy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.; Sender's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) 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 May2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included treatment with Paxlovid from 20May2023 to 24May2023.  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-202300204050 same reporter/patient, different drug/event;
This is a spontaneous report received from a contactable consumer (parent reporting for son) via Medical Information Team. A 28-year-old male patient received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration on an unspecified date in May 2021 as 1st dose, single dose for COVID-19 immunization. Patient medical history and concomitant medications were not reported. Son got the first dose Pfizer vaccine in early May 2021. On an unspecified date in 2021, he developed Bell's Palsy after getting the vaccine. Looking for any medical expert for someone who has had this happened to them after getting the first dose and should he get the second dose. She was asking if this will happen again if he gets the second dose. Reporter seriousness for he had a bells palsy reaction after the first dose was unspecified. The outcome of the event was unknown. Information on the lot/batch number has been requested
Burning/ Scratchy throat that progressed to a feeling of throat swelling, rash on throat, tongue edema, ears "clogged". She was taken via ambulance to hospital.  Received epi/ benadryl/ steroids and was released a short time later.
I caught COVID-19 three days later after my vaccination. I went to the ED at night after burning my hand and there was a little room, I sat in for two hours and I came down with COVID-19. I had scratchy throat, and I was leaving for a trip, so I took a test and, I was positive. I called my doctor, and he gave me PAXLOVID on around the 13th of April 2022. I felt like taking a nap and the symptoms in about 4 to 5 hours. I didn't take my temperature. I was negative 5 days later. Not to belittle it but it wasn't that bad.
Provider summary "Patient is a pleasant 79 yo M with a PMH of Chronic respiratory failure due to COPD on 4L NC at home, pulmonary fibrosis, RA, DMII who presented to SHL with shortness of breath and weakness. He was recently admitted and discharged for community acquired pneumonia from 6/25 - 6/30. He was discharged on antibiotics but they were sent to his home delivery service and there was a delay in treatment. He has had worsening shortness of breath and fatigue in the meantime. He was found to be in respiratory distress and significantly hypoxic on admission requiring BiPap support. He was found to be COVID + and was placed on dexamethasone. Presuming, he may have had COVID when he was here in June but was not tested at that time. He was out of the "therapeutic window" for remdesevir. He was weaned off of Bipap to his home 4L NC in a day or so. He participated with PT/OT and was cleared to go home with home therapy/homecare. He will continue 6 more days of PO dexamethasone and then resume home medrol. He will hold his home MTX until completing therapy for COVID. He will complete another 3 days of PO augmentin. He was discharged home in stable condition with strict return precautions."
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 71-year-old male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "History of colon cancer" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Client was in clinic for Pfizer vaccine over 12 years and was administered the 5-11 years vaccine.  No treatments needed and no symptoms show after dose.
The patient developed a rash on her neck a week after receiving the vaccine and it has not gone away. She has treated with benadryl cream and calamine lotion and it is still red and itchy
The pt experienced a fever of 101, chills, night sweats, headache occurring 2 days post vax.  Follow up on 12/11/2001: "Please not vaccination administered at different location."
Fever( 101.8 F) inflammed, hot to the touch, painful, red and hard around the injection site, headaches continuing for 48 hours, then still painful
Itching; Hands had become red; Hands became swollen to the point where couldn't make a fist; Swelling on face; Swelling on back; Swelling on legs; Swelling on chest; Swelling on mouth; Swelling on stomach; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Hands had become red), PERIPHERAL SWELLING (Hands became swollen to the point where couldn't make a fist), SWELLING FACE (Swelling on face), SWELLING (Swelling on back) and PERIPHERAL SWELLING (Swelling on legs) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Feb-2021, the patient experienced ERYTHEMA (Hands had become red), PERIPHERAL SWELLING (Hands became swollen to the point where couldn't make a fist), SWELLING FACE (Swelling on face), SWELLING (Swelling on back), PERIPHERAL SWELLING (Swelling on legs), SWELLING (Swelling on chest), MOUTH SWELLING (Swelling on mouth) and ABDOMINAL DISTENSION (Swelling on stomach). On 06-Feb-2021, the patient experienced PRURITUS (Itching). At the time of the report, ERYTHEMA (Hands had become red), PERIPHERAL SWELLING (Hands became swollen to the point where couldn't make a fist), SWELLING FACE (Swelling on face), SWELLING (Swelling on back), PERIPHERAL SWELLING (Swelling on legs), SWELLING (Swelling on chest), MOUTH SWELLING (Swelling on mouth), ABDOMINAL DISTENSION (Swelling on stomach) and PRURITUS (Itching) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment was provided. No concomitants were provided.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: Follow up received on 14 JULY 2021 and added patient demography. added 2nd dose details. added new event.
Diarrhea, tired, some cramping, low fever, swollen throat, fast heart rate at times