chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fever 101 degrees Fahrenheit; chills; muscle aches; This is a spontaneous report from a contactable other Health Professional (patient). A 27 years old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142) at his 26 years old, via an unspecified route of administration at left arm on 08Jan2021 19:15 at single dose for COVID-19 immunization. Medical history included depression, bipolar, dental implants, sinus surgery. No known allergies. Concomitant medication included vortioxetine hydrobromide (TRINTELLIX), bupropion (BUPROPION), acetylsalicylic acid, caffeine, salicylamide (EXCEDRIN). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced fever 101 degrees fahrenheit, chills, muscle aches on 09Jan2021 09:00 with outcome of not recovered. No treatment received for the adverse events. No COVID prior vaccination, since the vaccination the patient hadn't been tested for COVID-19.
back pain; arm pain; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (back pain) and PAIN IN EXTREMITY (arm pain) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, the patient experienced BACK PAIN (back pain) and PAIN IN EXTREMITY (arm pain). At the time of the report, BACK PAIN (back pain) and PAIN IN EXTREMITY (arm pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Rec'd Anthrax vax in rt upper arm on 12/13/99. Now has 17cm x 17cm red, indurated patch of skin surrounding injection site; very itchy.
This case was reported by a pharmacist via call center representative and described the occurrence of rheumatoid arthritis flare up in a 52-year-old female patient who received SHINGRIX (batch number 27J4P, expiry date unknown) for prophylaxis. Concurrent medical conditions included rheumatoid arthritis. On 7th December 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 7th December 2018, several hours after receiving SHINGRIX, the patient experienced rheumatoid arthritis flare up (serious criteria GSK medically significant). On an unknown date, the outcome of the rheumatoid arthritis flare up was recovering/resolving. It was unknown if the reporter considered the rheumatoid arthritis flare up to be related to SHINGRIX. Additional details were provided as follows: At 2:50 pm, the patient received SHINGRIX vaccine. The reporter was not certain about the lot number because it was difficult to read the paperwork. The pharmacist reported that one of their patients told them on the day before reporting that she had an rheumatoid arthritis flare up the same night she received a dose of SHINGRIX. The patient felt better.
headache; This is a spontaneous report from a contactable consumer. A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6204, Expiry date, NDC number: not provided), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The reporter reporting adverse event for Pfizer Covid 19 vaccine and states the person that administered the shot, it was the same gal. The patient said had a headache first time on an unspecified date and nothing the second time. The patient confirms she received the Pfizer Covid 19 Vaccine. Outcome of the event was unknown.  The lot number for the vaccine, was not provided and will be requested during follow up.
Patient reported to the pharmacy on the morning of 7/25/20 to ask the pharmacist why she was still experiencing pain "all up and down" her right arm after receiving her pneumonia shot on 7/3/20.  She stated that she was not experiencing any swelling, redness, or signs of infection, but still had an "aching" pain weeks after.  She was told to follow up with her doctor for an assessment, although she has not been seen yet for this complaint.
"Chickenpox" looking rash on back, mainly under right scapula. 7 or 8 pox on left side of back. No cold symptoms, fever or pain. Very itchy. Treat with Aveeno bath and Benadryl.
Severe nausea 12 hours after receiving shot.  Severe headache and body aches.  Could not eat or drink anything for 4 days and then nausea for 2 months after.  Cold, wet feeling on top left side of my head like I was bleeding or my hair was wet.  This symptom lasted for 2 days and then it moved to the back of my left leg, below my butt, off and on for 4 days.  Still comes back on occasion, but only stays for a few hours.
Severe arm pain (left arm where in injection was) for the first 72 hours. Couldn?t move my arm. Couldn?t sleep from pain level. Severe pain. Pain is moderate now. Can lift my arm over my head now, but with pain.
pt had near-syncopal episode x 2 accompanied by diaphoresis; no other etiology elucidated p/tx in hosp;
GOT REAL, REAL SICK; This spontaneous report received from a consumer via social media via a company representative concerned a patient of unspecified age, sex, race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was previously treated with covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: Unknown, expiry: Unknown) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination.  It was unknown whether patient had any adverse events following vaccination with covid-19 vaccine ad26.cov2.s (dose number in series 1).  The patient additionally received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, batch number: Unknown, expiry: Unknown) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  Reporter stated, on an unspecified date "the only person that got real, real sick had all the jabs" (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of got real, real sick was not reported (dose number in series 2). This report was non-serious.
Patient received PNEUMOVAX 10-31-17 at approx. 10:30 AM. At approx. 2 AM she passed out in her kitchen and hit head on floor.
Fatigue and mild dizziness 3 hours after vaccination. Extreme neck, back and lymph node pain the day after vaccination.
8cm red area surrounding DTaP site, swollen, warm. (Pt had 6cm red after last Dtap 12/21/00).
p/vax pt exp lt central visual scotomata w/grey spots & dec color vision; Dx by ophthalmologists as Multiple Evanescent White Dot syndrome=MEWDS
fever; chills; ache; Nausea; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), CHILLS (chills), PAIN (ache), NAUSEA (Nausea) and FATIGUE (fatigue) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.  On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose.   On an unknown date, the patient experienced PYREXIA (fever), CHILLS (chills), PAIN (ache), NAUSEA (Nausea) and FATIGUE (fatigue).   At the time of the report, PYREXIA (fever), CHILLS (chills), NAUSEA (Nausea) and FATIGUE (fatigue) outcome was unknown. Not Provided    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   This case was linked to US-MODERNATX, INC.-MOD-2021-047767 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-047767:2nd dose
Chronic graft versus host disease; This is a literature report.  A patient (no qualifiers provided) received BNT162b2 (COMIRNATY), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history included: "allogeneic haematopoietic stem cell transplantation (HSCT)" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Comirnaty (Dose 1, single), for COVID-19 immunization. The following information was reported: CHRONIC GRAFT VERSUS HOST DISEASE (medically significant), outcome "unknown".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information currently available,The casual association between the reported event and suspected vaccine BNT162B2 cannot be completely excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202200611693 Same reporter/product/event, different patient
It appears this patient may of received a booster of Moderna as a 4th dose. Per the database, patient received a 1st dose of Moderna on1/7/21, 2nd on 2/8/21, and 3rd dose on 4/16/21, and then a booster dose on 12/2/21.
Vaccinations adminstered Friday morning at approx. 10:30am.  For the following 12 hours, patient experienced discomfort and moderately high temperatures (100 - 101 deg.).  However throughout the weekend and into Monday morning, patient had crying fits for 1.5 - 2 hours at a time, high fevers, generally 101-102 deg (high of 103.5 at one point), and he began vomitting his bottle after each feeding.  We have remianed in contact with a Nurse, as well as a physician from the pediatricians office.
This spontaneous report was received from a physician via company representatives referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 23-JAN-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 0.5 mL (Vls 10 SDV) (Lot # K007822, expiration date 15-AUG-2015) dose, route and anatomical location were not provided. There was no concomitant medication provided. On an unknown date, the PNEUMOVAX 23 had a temperature excursion for 24 hours, the highest recorded temperature was 47.5 F (8.6 Celsius). The vaccine status was reported as "in excursion", and was storage in a Refrigerator(R). There was no product quality complaint involved and no adverse effects were reported. This is one of several cases received from the same reporter. Additional information has been requested.
An expired booster dose was given to a patient; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (An expired booster dose was given to a patient) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (An expired booster dose was given to a patient). On 28-Oct-2021, EXPIRED PRODUCT ADMINISTERED (An expired booster dose was given to a patient) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product use was provided by the reporter. No treatment medication was provided.
L facial numbness for several hours,  Started after  1/2 hour waiting time after vaccination
Appendix ruptured, after second vaccine.; Pain in her side, diagnosed as infected Gall Bladder, after second vaccine.; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in the upper left arm on 08Apr2021 at around 11:30 AM (Batch/Lot number was not reported) (at the age of 66-year-old) as dose 2, single for COVID-19 immunization. The vaccine was administered at a hospital. The patient did not receive additional vaccines on the same date of the Pfizer vaccine. The patient's medical history was not reported. There were no concomitant medications. The patient previously received the first dose of BNT162B2 on 12Mar2021 at around 11:30 AM (Batch/Lot number was not reported) (at the age of 66-year-old) administered in the upper left arm for COVID-19 immunization. The patient was taking the Pfizer vaccine for COVID because she did not want to get sick and wanted to be around her family. The patient did not receive any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. The patient experienced appendix ruptured, after second vaccine on 28Apr2021 and at about 5AM, she went to the emergency room. She was admitted to the hospital. She has heard that other people have had ruptured appendix, after the vaccine. The patient experienced pain in her side, diagnosed as infected gall bladder, after second vaccine on 05May2021 05:00 AM. The patient reported that after she was released from the hospital, 2 days later, she was with pain in her side, diagnosed with an infected gall bladder, which was not removed. The patient reported that the pain in her side diagnosed as infected gall bladder occurred early in the morning maybe 5 AM. She was hospitalized for one night. She was admitted to the same hospital, both times. The events required a visit to emergency room and to physician office (after discharge from the hospital). The patient reported that there were no relevant tests. The outcome of appendix ruptured was recovered completely on 02May2021. The outcome of pain in her side diagnosed as infected gall bladder was recovered completely on 06May2021.   Information on the batch/lot number has been requested.
Allergic reaction, the symptoms have been debilitating; This is a spontaneous report from a regulatory authority. A contactable consumer (reporter daughter)  reported for an unspecified age female patient received bnt162b2, (Formulation: Solution for injection, Batch/Lot Number: Unknown; Expiration Date: Unknown), dose 1 Single, via an unspecified route of administration on unknown date or covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications was not reported. On an unknown date,patient experienced allergic reaction and on four weeks there was no improvement. Reporter stated that  we were on four weeks and she  not improved. The symptoms have been debilitating. if there was any information could you  guide us with, so far all of what the doctors have been prescribed has not helped her improve. The outcome of event was not recovered.  No follow-up attempts was needed
Patient came in for a COVID vaccine appointment.  She mentioned to me she had her period and was cramping.  She said this is her third time and that each time she got the vaccine she was having her period and that even when she caught COVID she had her period.  After proper screening and confirmation she was here to get the Moderna booster, I told her to stay in the store for 15 minutes after getting the vaccine.  Immediately after I gave her the vaccine she told me she felt heavy and she seemed to faint or lose consciousness over the next minute.   She slumped backward and I caught her with her upper arm and slowly let her lie down on the ground.  I called over to my coworker to call emergency as I tried to wake her and find her pulse and take her blood pressure.  She then woke up within 2 minutes and I took her pulse which was 54beats per minute and her blood pressure 115/80.  She told me she felt heavy and had a metallic feeling.  She said when she woke up she felt like she was sleeping and confused as to why she woke up in the area she was in but then quickly oriented her self and knew she had come in for a vaccine.  At 3:25pm she said she doesn't want us to call paramedics and she is starting to feel better.  She mentioned she also biked here.  She also said her period was giving her cramps and a nausea feeling.  She mentioned afterward that she has had a fear of needles in the past and has fainted from blood draws but that was over 10 years ago.  We recommended she follow up and report to her doctor.
allergic reaction; really itchy from her knees up to her neck; rash; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (allergic reaction), PRURITUS (really itchy from her knees up to her neck) and RASH (rash) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HYPERSENSITIVITY (allergic reaction), PRURITUS (really itchy from her knees up to her neck) and RASH (rash). At the time of the report, HYPERSENSITIVITY (allergic reaction), PRURITUS (really itchy from her knees up to her neck) and RASH (rash) outcome was unknown.            No concomitant medication use was provided by the reporter.  No treatment of events was reported. Action taken with mRNA-1273 in response to the event was not applicable.
Information has been received from a RN concerning a 3rd grade student who on 10/24/1996 was vaccinated with a dose of varicella virus vaccine live. In mid December 2004 the student developed Chickenpox in mid December of 2004. According to the school nurse 58 other elementary school students who developed chicken pox and 34 of them had previously been vaccinated with a dose of varicella virus vaccine live. Unspecified medical attention was sought. There was no information regarding the present status of the student. No product quality complaint was involved.  Addition information    has been requested.
at 0830 as I was driving home, I had throat tightening and sweating - this lasted approx 30 minuites
Pain in left breast, and underarm so intense I cannot sleep on my left side. First reported to primary care doctor April 26, 2021. It is getting worse and it's been 6 months.
Severe Chest pain 10/10 that occured while lying down and last for 30-45 minutes. MIdsternal, Pressure.  Was not relieved with antacid, Peptobismal.  Severe pressure in Midsternal area especially when lying flat.  Eventually resolved but occured 2 evening in a row.  Also have fever > 102, chills, malaise, Headache.
difficulty breathing; racing heart; Dizzy; nauseated; headache; heart attack; fingers started tingling and going numb; fingers started tingling and going numb; arms became heavy; lethargic; feeling exhausted; Arms are still weak; This is a spontaneous report from a contactable consumer (patient). A 35-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), at same age, via an unspecified route of administration, administered in arm left on 23Apr2021 09:00 (Batch/Lot Number: EW0169) as single dose for covid-19 immunisation. Medical history included scoliosis. The patient's concomitant medications were not reported. Patient was received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: CR8733), at age of 35 years old, administered in arm left on 02Apr2021 05:00 PM, for covid-19 immunisation. The patient experienced dizzy and nauseated with a headache at 3:00am 26Apr2021. At 7:00am patient woke up again with the same symptoms but strong nausea, difficulty breathing and racing heart. Her fingers started tingling and going numb once she was up (on 26Apr2021). Her arms became heavy and she started feeling lethargic (on 26Apr2021). Patient thought she was having a heart attack on 26Apr2021. Blood pressure was normal and pulse ox was normal. Most symptoms subsided by 11:00am. Arms are still weak at 7:47pm. Still feeling exhausted. Events resulted in doctor or other healthcare professional office/clinic visit. No other vaccine administered in four weeks. No other medications in two weeks. No treatment was received. No covid prior vaccination. No covid tested post vaccination. No known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcomes of events were recovering.
Erythematous macular rash on trunk, neck, and groin.  Not on extremities.
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 46-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. 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 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. COVID-19 Treatment included Paxlovid from 28Jul2023 to 02Aug2023.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
pt recvd vax & devel flu like symp for 2 days; redness; warmth; swelling & induration of approx 10cm in diam at inj site;
Uncomfortable progressed to febrile (103F) with extreme pain, lethargy/unresponsive and rapid HR.  Seen in ER on 11/8/2014.
sick; This is a spontaneous report received from a contactable consumer via Pfizer-sponsored program. A 20-year-old female patient received BNT162b2 (Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number and Expiration date was not reported) via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunisation. Medical history included COVID-19 from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. Historical vaccine included patient received BNT162b2 (Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number and Expiration date was not reported) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation and was fine. On an unspecified date, after their second dose, patient felt as sick as they did when they had Covid (prior to vaccination).  The outcome of the event was recovered on an unspecified date. Patient asked if there had been any data collected on how long the antibodies hang around in a person body and asked if they can mix the Moderna and the Pfizer doses, patient stated that she had heard of people that mix the series if one or the other was not available. Patient also asked that if Pfizer can explain why they were that sick, and if they get the booster dose, will they get as sick again. The outcome of the event was recovered on an unspecified date.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101229081 same reporter/drug/AE, different patients