chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a contactable consumer (patient). A 47-year-old female patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# not reported), via an unspecified route of administration, on Aug 30, 2021, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. On Aug 30, 2021, patient experienced some arm soreness, some joint pain only in her legs, weakness in her legs, a feeling like there was a pinch nerve but only one spot at a time. It was like it would be at her thigh and 15 to 20 minutes later it goes to her calf and then her feet. According to the caller, the pinch nerve feeling was all over her legs, but it was not happening constantly. This never happened to her before. She wants to know if these kinds of side effects have been reported previously. The outcome of the events: unknown. Follow-up activities closed. Batch/lot number not available for vaccine/BNT162B2.
tinge of a fever; Felt warm in face and on forehead; Extreme arm(shoulder) pain/soreness; Extreme arm(shoulder) pain/soreness; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 38 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 27Oct2021 12:00 (Lot number: FE3590) at the age of 38 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Anxiety" (unspecified if ongoing), notes: other medical history: Anxiety; "known allergies: Penicillin" (unspecified if ongoing), notes: known allergies: Cephalosporins, Penicillin. Concomitant medication(s) included: FLU, start date: 22Oct2021, stop date: 22Oct2021. Past drug history included: Cephalosporins, reaction(s): "known allergies: Cephalosporins", notes: known allergies: Cephalosporins, Penicillin. The following information was reported: PAIN IN EXTREMITY (non-serious), ARTHRALGIA (non-serious) all with onset 27Oct2021, outcome "recovered" (2021) and all described as "Extreme arm(shoulder) pain/soreness"; PYREXIA (non-serious) with onset 03Nov2021, outcome "recovered" (2021), described as "tinge of a fever"; FEELING HOT (non-serious) with onset 27Oct2021, outcome "recovered" (2021), described as "Felt warm in face and on forehead". Therapeutic measures were not taken as a result of pain in extremity, arthralgia, pyrexia, feeling hot.  Additional information: facility type vaccine Doctor's office/urgent care. If other vaccine in four weeks: Yes. Other medications in two weeks: No. Extreme arm(shoulder) pain/soreness for at least 2 days (but that's normal, I think); unable to lift arm fully due to extreme soreness. A tinge of a fever on Weds, 03Nov in the evening but no other symptoms. No chills, no muscle aches or pains, no malaise. Felt warm in face and on forehead, but otherwise fine. If covid prior vaccination: No. If covid tested post vaccination: No  No follow-up attempts are possible. No further information is expected.
4 days p/vax pt devel an inj site rxn characterized by redness & swelling @ the site of vax;tx w/hot & cold compresses, DPH & advil;
When I got the shot, the muscle in my left upper arm got very hard. Harder than any vaccine I've gotten, but reasonable. I am diabetic and I wear a continuous glucose monitor.  Instructions are are to switch arms I use the monitor on. The glucose disk injects a small short needle into the skin that stays in for two weeks. After the second Pfizer shot in April, the muscle got harder. I got a third shot (same arm), and I started getting bad muscle pain when I stuck the glucose disk in the left arm.  Muscle was harder. Pain was so bad I had to remove the disk and put another on the right arm.  Right arm was fine. So far I'm on my 5th shot. Only last shot was bivalent Pfizer. By this time I figured out to do the last shot in the right arm. I started putting anti-inflammatory gel on the arm every day (Arnicare gel with Arnica as active ingredient) The muscle hardness went down a lot but still not completely gone.
Patient became short of breath.  Patient used her inhaler Symbicort and was given 50 mg of oral Benadryl.
Started having abdominal pain and constipation.  CT revealed rectal Mass. Dx with rectal ca with mets. Had to have major surgery. Chemo and radiation
Chest pain, tightness. Comes and goes away daily for like 2 weeks.
At 13:10 the patient complained of sudden nausea while walking from injection room to seating area at vaccine clinic. States she did not eat lunch today, declined offer of snack or water. States she premedicated herself with 25 mg Benadryl 30 minutes before today's vaccine - as she does for all vaccines she gets.
headaches; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID:.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for COVID-19 immunization. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "headaches".  Additional information: The reporter said he talked to 200 people who have a headaches from that booster shot.  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-PV202300034302 Same reporter/ drug/ event for different patients;
General malaise; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MALAISE (non-serious), outcome "unknown", described as "General malaise". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Vaccine had a low temp excursion. Revaccinated 10/26/2022
headache; This is a spontaneous report from a Pfizer-sponsored program, reported by a contactable consumer (patients wife). A male patient (reporter's husband) received his first dose of BNT162B2 (PFIZER-BIOTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: not reported), unspecified route of administration on 25Apr2021 as 1st dose, single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter and her husband got the first dose last 25Apr2021 and second dose was scheduled on 16May2021. On an unspecified date after the first dose, they took the rapid test and results came back negative. On an unspecified date for a week, the patient had a headache. The reporter was asking if the patient should hold the second dose until the symptoms disappear. The outcome of the event was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Pt recvd vax 9APR93 915AM pt was screened for immun; no contraindications were found; reported no hx of convuls allergies to med or eggs; Td was given IM on the rt deltoid, MMR was given SQ on lt arm; pt felt ill; lips full;
had a flare up of his RA, his joints hurt more in his fingers and his feet; This is a solicited report from a non-Pfizer sponsored program (marketing program name not available) received from a contactable consumer, based on information received by Pfizer from (manufacturer control number US-AMGEN-USASL2021096112), license party for Manufacturer.  This serious solicited report (SL2021096112) was reported to Manufacturer on 21/JUN/2021 by a consumer from a commercial program (PSP00180) and involves a 67 years old male patient who experienced had a flare up of his ra, his joints hurt more in his fingers and his feet [rheumatoid arthritis] while receiving Enbrel. No historical medical condition was reported. The patient's current medical condition included rheumatoid arthritis. No concomitant medications were provided.The patient's co-suspect medication included Covid-19 Vaccine. The patient began Enbrel on an unknown date. On an unknown date, the patient received the COVID-19 (Coronavirus disease 2019) vaccine and had a flare up of his Rheumatoid Arthritis (RA). His joints hurt more in his fingers and his feet. No treatment information was received. The outcome of the event rheumatoid arthritis was reported as unknown. Action taken with Enbrel was reported as unknown for the event rheumatoid arthritis. The causal relationship between the event rheumatoid arthritis and Enbrel was not provided by the consumer. Follow up has been requested for lot number.  Manufacturer Comment: This individual case report does not change the safety profile of the product.  The reporter's assessment of the causal relationship of the events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  Manufacturer Causality Assessment: The event Rheumatoid arthritis flare up was unrelated to etanercept.  Pfizer is a marketing authorization holder of Covid-19 Vaccine in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of Covid-19 Vaccine has submitted the same report to the regulatory authorities.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported event rheumatoid arthritis flare up and the vaccination with BNT162B2, based on the temporal association. The reported rheumatoid arthritis flare up is considered unrelated to the administration of suspect drug etanercept based on the available information.  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.
This spontaneous case was reported by a consumer and describes the occurrence of PHARYNGEAL SWELLING (throat is swelling a bit), HYPOPNEA (shallow breathing), SOMNOLENCE (unusually very sleepy), RHINORRHEA (nose was clogged a few minutes ago and now he feels some nasal drip) and NAUSEA (Slightly nauseated) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 062D21A) for COVID-19 vaccination. The patient's past medical history included Stroke in 2015 and Atrial fibrillation. Concomitant products included BUSPIRONE, ATORVASTATIN, METOPROLOL and APIXABAN for an unknown indication. On 05-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Sep-2021, the patient experienced PHARYNGEAL SWELLING (throat is swelling a bit), HYPOPNEA (shallow breathing), SOMNOLENCE (unusually very sleepy), RHINORRHEA (nose was clogged a few minutes ago and now he feels some nasal drip) and NAUSEA (Slightly nauseated). At the time of the report, PHARYNGEAL SWELLING (throat is swelling a bit), HYPOPNEA (shallow breathing), SOMNOLENCE (unusually very sleepy), RHINORRHEA (nose was clogged a few minutes ago and now he feels some nasal drip) and NAUSEA (Slightly nauseated) was resolving. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No treatment medication use was reported.
Initial difficulty breathing and altered mental status, with hypertension 152/98 at 15 minutes (no other vitals available), gradually improving over about 30 minutes, followed by severe fatigue
Left lower lip became swollen 1.5 days after second Moderna vacination. Pt placed on 5 day course of 40mg prednisone, benedryl 50mg q6h prn and famotidne 20mg po bid rpn.
pt received #1 Moderna vaccine yesterday, pain on left arm, shoulder started around 3 pm, c/o dizziness and nausea*1, denies any blood in the emesis, denies any traumatic injury, last OTC Tyrenol 2 tabs taken at 2200 last night without any relief,
On 10/26/2021 at 6 month well child visit patient was given a Pentacel  that contains DTAP, HIB, IPV, and a single dose of HIB resulting in a double dose of HIB. Mother was notified when error was discover of vaccine error. Mother stated patient had no adverse reactions.  Dr. and clinic supervisor was made aware.
12/5/21 local reaction which increased in size- red, warm, firm and painful.
The pt experienced a pale pink rash on his trunk, frequent and long lasting temper tantrums, crying over an hour, low grade fever, high fever of 103 with an onset of 8 days post vax, dark pink uneven rash on whole body with a duration of 4 days. Treated with Benadryl and Tylenol.
Chest pain; Uncontrollable shaking; Chills which lasted for 3 hours; Fever 102.9 F; This spontaneous case was reported by a nurse and describes the occurrence of CHEST PAIN (Chest pain), TREMOR (Uncontrollable shaking), CHILLS (Chills which lasted for 3 hours) and PYREXIA (Fever 102.9 F) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced CHEST PAIN (Chest pain), TREMOR (Uncontrollable shaking), CHILLS (Chills which lasted for 3 hours) and PYREXIA (Fever 102.9 F). At the time of the report, CHEST PAIN (Chest pain), TREMOR (Uncontrollable shaking), CHILLS (Chills which lasted for 3 hours) and PYREXIA (Fever 102.9 F) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
1st day after vaccination, had typical malaise, body aches, fevers x full day and then recovered.  Felt normal self x 5 days 7th day after vaccination while sitting at table with sudden onset facial flushing.  Cheeks, forehead, anterior neck and chest, upper arms with flat, warm erythematous patches covering large areas. Non-tender, non-pruritic.  Also with  headache
This was the booster vaccine. I didn't really have any reaction to the 1st and 2nd dose. I woke up the following morning, and couldn't move fingers, eyelids etc, because I felt so incredible weak. I had to get help to drink a glass of water. It got better as the day went on, and I felt normal the next day. There was no body ache, headache or fever.
After receiving the vaccine the patient got off the exam table and walked to a chair. He put his coat on while standing.   He became pale and fell face forward onto the floor.  He remained motionless for under a minute.  His mom and I lifted him to the exam table and he began to cry and ask what happened.  He had an approximately 1 inch laceration on his chin that was gaping. I covered that with tissue at first and placed an icepack on the lac.  He continued to cry and settle intermittently.  he was upset again at the thought of stitches.  I gave him 2 tsp of acetaminophen.  I dripped betadine into the lac and secured the margins with steri-strips. After 15 mins and 1/4th of a freeze pop he was calm enough for mom to carry him to the car.  Mom called shortly thereafter saying he felt like he was going to vomit but hadn't at that point.  They were close to home. I advised mom to put him on the couch with some cool packs on the chin and let him rest. I will be calling them back in 45 mins or so.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 21-AUG-2014 the patient was vaccinated with an improperly stored dose of ZOSTAVAX (dose, lot# and route administration were not reported). No adverse effects were reported. Additional information is not expected due to the reporter did not want to be contacted again.
For 14 days, I was extremely sick. I had flu-like symptoms and I was unable to function. I was knocked down flat and I could barely move. I had body aches, muscle aches, headache, sweats, chills, fatigue, left facial dysphagia, and lethargy. I felt absolutely terrible. I went to the doctor on 04/28/2021 and I received 40mg of Depo-Medrol steroid.
2-3 days p/vax devel h/a, sore throat, muscle soreness-edema of feet w/tenderness, rash on feet & ankles, noc sweat;
lymph nodes in arm pit swollen (about half the size of a softball); Fatigue/tired; Slight fever; heavy legs; achy, sore; Flu-like symptoms; he was warm and flushed; feeling bad; This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient).     A 52-year-old male patient received BNT162B2 (PFIZER-BIOTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: ER8733) via an unspecified route of administration, administered in arm left on 24Mar2021 at 11:00 (at the age of 52 years old) as dose 1, single for COVID-19 immunisation. Medical history included surgery (also reported as the patient had 4-and-a-half-hour surgery and gave blood thinners), prostate cancer, prostatectomy (recovering, 03Mar2021, also reported as 4 weeks ago), incontinence and erectile dysfunction. Concomitant medication included tadalafil (CIALIS, taking a low dose) taken for prostatectomy from 13Mar2021 and ongoing. On 25Mar2021, the patient experienced lymph nodes in arm pit swollen (about half the size of a softball, discovered the node when he went to take a shower), fatigue, slight fever, heavy legs, achy, sore, and tired, flu-like symptoms, warm and flushed, feeling bad (about 24 hours later). The patient stated that he hasn't done anything today because movement makes it worse. Patient prior vaccinations within 4 weeks were reported as none and adverse events following prior vaccination reported also as none. The adverse events did not result to emergency room or physician office visit. The outcome of the events lymph nodes in arm pit swollen and fatigue was recovering; outcome of warm and flushed, feeling bad was unknown; outcome of all the other events was recovered on 26Mar2021.   No follow-up attempts are possible. No further information is expected.
Twelve hours after receiving the vaccine, I began to shake uncontrollably with severe chills and fever of 102.  I did take Ibuprofen, which helped with the fever.  But I had a headache, pretty severe, for 48 hours which Ibuprofen did not help.  I was very weak and spent the better part of two days in bed.  Now, even on day 3, I still do not feel very good.  After rising this morning, I became very short of breath and shaky and had to lie down for 30 minutes.  I also had bad heart palpitations.  I have also had stomach pains off and on.  I have also had sharp pains in my head and neck.  Very fatigued.
Started with a fever of 101 F and a severe headache (4 days).  The next day had blurry vision, the fever increased to 102 F and it would not break, also started to experience muscle and joint pain as well as back spasms  (9 days).  Started to also experience chills.   Had a fever for  9 days along with abdominal pain and shortness of breath.  Skin turned an orangish color on the 5th day and lasted for 4 days.  Also experienced extreme leg pain (in the bones).  Then she started to experience nausea.  Eventually, by day 10 she had extreme shortness of breath and this is when we took her to the ER.  She was diagnosed with pneumonia and was hospitalized where she is today.
Pt. was 13 months old and here for 12 mo WCC on 4-30-15. KINRIX was given. CDC states that the DTaP can count as 4th dose if minimal interval had passed and there was 6 months between 3rd and 4th DTaP (KINRIX).
On 11/3/05 I was given the Influenza and pneumococcal vaccine. On 9/26/09 I was diagnosed with pneumonia on my left side of my lung. I was discharged on Oct. 1, 2009. Hospital gave me another influenza and pneumococcal vaccine. I was re-admitted on Oct 5, 2009 until Oct. 12, 2009 with double pneumonia. I do not understand why if vaccinated in 2005 and 2009 why I got pneumonia much less double pneumonia.
Redness, swelling, induration and itch at site of injection (4 x 4 cm).
Stillbirth 12/3/09 Medical records received for dates 6/11/09 to 11/9/09. OB records. DX: fetal demise 28wks. Pt was high risk pregnancy. (+)clomid pregnancy. Normal IUP documented from 6/11/09 to 10/5/0, OV pt unsure about feeling FM, (+)FHR. Received H1N1 vax 11/3/09, FHR(+), on 11/9/09 pt. c/o no fetal movement. Notation on amniocentesis procedure, 1/2cc hemosiderin colored old blood consistent with long standing FD US consistent with 22wk gestation. Pt by date was 28wks.
Started nausea and upset stomach. 24 hours later, woke up unable to breathe and semi-consciousness. Went to the ER. Sent home with 3l of oxygen. On 24 oxygen for 3 days until saturation level were back to normal.
mom says about 5 hrs p/vax pt devel high fever x 3 days (104 R); fever would stop for 1 1/2d then return for about 2 wks @ a time; would stare off in space, listless, spit up;
The one and only time I got the shot I got the flu; Initial information received on 17-Oct-2020 regarding an unsolicited valid non-serious case from a non-healthcare professional via social media.  This case involves a patient of unknown demographics who stated that the one and only time patient got the shot and got the flu (influenza), after receiving INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s), concurrent condition and family history were not provided.  Concomitant medication was not reported.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiration date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, (latency unknown) the patient received one and only time patient got the shot and got the flu (influenza) following the administration of INFLUENZA VACCINE..  No laboratory data reported.  Action taken with INFLUENZA VACCINE was unknown.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome was unknown for the flu.  There will be no information on the batch number for this case.
Patient received vaccines and was instructed to remain seated for 15 minutes after administration. Approx. 3 minutes after vaccines were given, patient became very pale and faint, followed by vomiting. A cool compress was placed on her neck and she was laid flat. Dr. was notified and she checked her immediately after this episode began. Patient remained lying flat for approx. 20 minutes and then was given a Coke to sip on. She was able to leave the office without difficulty.
pt recvd vax;lab eval revealed rubella antibody 2.12 & rubeola IGG 0.27;20dec93 vaccinated w/ dose of measles;titer checked on 11apr95 was neg;
1200 extreme fatigue, 1300 diarrhea, nausea, stiff neck, hypotensive-lightheaded, paliptations;