chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Severe body aches like the flu; This is a spontaneous report from a contactable other healthcare professional, the patient. A 46-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration on 08Mar2021 (at the age of 46-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not receive any other medications within 2 weeks of vaccination.  Prior to the vaccination, it was unknown if the patient was diagnosed with COVID-19. Since the vaccination, the patient had not tested positive for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced severe body aches like the flu on 09Mar2021. No therapeutic measures were taken as result of the event. The clinical outcome of the event severe body aches like the flu was resolved (which lasted for one and half days) on 11Mar2021.   Information about lot/batch number cannot be obtained. No further information is expected.
Received dose on 1/13. On 1/22, Upon getting out of a hot shower, noted large area of redness near site of injection on left deltoid. It measures 12cm in length by 6 cm at it's widest point. Looks a little like a teardrop. Does not itch, is not painful or swollen.
Lethargy; Swollen face; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 10-Mar-2021 and was forwarded to Moderna on 11-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (Lethargy) and SWELLING FACE (Swollen face) 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 LETHARGY (Lethargy) and SWELLING FACE (Swollen face). The patient was treated with PREDNISONE at a dose of 1 dosage form and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form. At the time of the report, LETHARGY (Lethargy) and SWELLING FACE (Swollen face) had resolved. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication use was provided by the reporter.  Additional treatment of events was reported with antibiotics.
Large (2 inch x 2 inch), raised and red rash at injection site that started a eight days after first vaccination and so far has remained for a day. Slightly itchy and warm. No treatment needed.
April 15-shot. April 16-50 cent size warm red hard spot. Softball size pink skin around red spots. April 18 Pink skin gone - red spot still warm. April 19 Red spot lighten. April 21 all spot gone.
exposed to COVID-19; This is a spontaneous report from a contactable consumer (Patient's daughter) reported for her mother. A 94-year-old female patient (reporter's mother) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: ER8733 and expiry date: not provided), first dose via an unspecified route of administration, in arm left, on 27Mar2021, 10:30 (age at the time of vaccination 94 years-old), as a single dose for COVID-19 immunisation at college campus. Patient's medical history included heart problems, defibrillator, pacemaker, Arthritis, Fibromyalgia, Neuropathy, early stages of dementia. Concomitant medications were not provided. Patient did not receive other vaccine in four weeks of vaccination. It was reported that patient takes the medications at 9 in the morning and 4 at night. Patient received her first dose of Pfizer COVID-19 vaccine on 27Mar2021 and she supposed to get second dose on 17Apr2021. On 08Apr2021 the patient was exposed to COVID-19 by her son's girlfriend who she lives with their family. The patient is currently isolating. Patient's daughter asked if the patient can get the second dose on 17Apr2021 because she was told it was up to 23 days. Outcome of event was unknown.  No follow-up attempts are needed. No further information is expected.
Last night, several hours after I received this vaccine,  I laid down in bed to sleep at approx 12:30am. I then became freezing cold; to the point bordering on chills. When I couldn't warm up and get to sleep, I added a heavy blanket to the bed (in August-!) Finally I was able to get to sleep once I warmed up and the chills subsided. Today I feel mostly back to normal...but shaken-up that I had that adverse event...which isn't even listed as a side-effect.
booster; fainted; fever; chills; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A 17 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 17 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 immunization; Bnt162b2 (DOSE 2, SINGLE), for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "booster"; SYNCOPE (medically significant), outcome "unknown", described as "fainted"; PYREXIA (non-serious), outcome "unknown", described as "fever"; CHILLS (non-serious), outcome "unknown", described as "chills". The events "booster", "fainted", "fever" and "chills" were evaluated at the emergency room visit. Clinical course: The reporter (Pharmacist) stated that her son got Pfizer Biontech COVID-19 Booster dose and had fever and chills but subsequently he fainted. The patient was then taken to ER. The reporter said, had read all the information regarding myocarditis in the PI and asks if information from the trials regarding within how many days after the vaccine dose did myocarditis happened. The reporter asked if encountered this problem with a particular lot of Pfizer Biontech COVID-19 vaccines.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the events immunization and syncope and the suspect drug BNT162B2 cannot be 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.
Night after vaccines, right thigh grossly swollen, indurated, red lacey rash over anterior thigh. Pt with decreased range of knee motion. Received DECADRON & ZYRTEC at an urgent care. Next AM - still indurated, decreased redness slightly.
I had the first of two injections yesterday. Overnight I developed a bad headache and all of my skin is ultra sensitive, and my arm is very sore. (to be expected). I got the injection at pharmacy, not by my physician. I don't know that I need anything addressed medically, but I just ache all over. I had shingles 2 years ago, and I will go thru this again to prevent it. It is a lot better than shingles.
About 5-10 minutes after receiving the dose, a headache instantly appeared and throughout the day became a severe migraine that lasted up to two days. I had itching and redness at the injection site about 30 minutes after. I woke up in the middle of the night to hardness and sore, aching pain at the injection site.  I did experience extreme exhaustion about an hour after injection and that lasted for about 24-36 hours.   A weird bump has also formed spontaneously on the inside of my arm, opposite of the injection site at the same time the hardness and sore, aching pain arrived. The bump is slightly raised and a pink oval has formed around it with what appears to be blue and purple bruising.  I have had this bump since Friday night and it just looks like it is becoming slowly, more bruised. However nothing is forming at the center of the red bump.   I am unsure if the bump is related to receiving the vaccine or not, but did appear at the same time as other side effects.
Within 1 month of receiving the vaccination, a varicose vein began to form on my left leg. Within weeks of it first appearing, the vein spread in a spiderweb-like fashion, surrounding my shin region. Within another month, the pain and sensation caused by the varicose vein was severe to the point that everyday functioning was not possible without use of a compression stocking. After doctor consultation, surgery was recommended to remove the vein. A pre-surgery sonogram of my legs determined that other varicose veins have started to form internally throughout my lower body, and will need to be monitored. Surgery was performed on Nov. 11th.   My family does have a history of varicose veins, and I have had one removed in the past. But unlike the previous surgery, I'm suffering from regular headaches, dizziness and lethargy post-surgery. Pre-surgical testing from the previous procedure also did not show other internal varicose veins forming.
Patient receive Flu shot in September 2023 - reported for RSV vaccine and received second Flu shot on 11/13.
About two weeks following my second dose of the Pfizer vaccine I developed extremely inflamed pea size hives covering my back and extending around the upper part of my body.  I received medical treatment with a steroid shot, Medrol 4 mg prednisone dose pack, and clobetasol topical lotion.  The inflammation diminished significantly over ten days or so.
Spotting/early menstration (about 4 days early). Tracking cycle for fertility.
4/02/2021 10AM got vaccine, 1:00 pm headache, following tiredness,  4/03/2021.  2:00 am horrible shakes that I could not control for about 3 hours. After that had chills for about an hour, after the chills began having severe abdominal pain down into the legs could not walk abdomen pains hurt so bad. Started throwing up around 5:00pm. Still horrible abdomen pains. 4/04/2021  around 4am pains in abdominal area starting to get better, as day progressed leg pains going away not as severe abdominal pains. Pain is working into lower back now. Beginning to have an appetite again. 8:00pm lower back beginning to have severe pain . 4/05/2021 . 2:00 am awaken by back pain. Could not get out of bed without help. This will be 3rd day hoping pain will go away by end of day. I have a high pain tolerance and these pains have been just as bad as child birth pains. I will never do this vaccine again.
Transverse myelitis with bilateral leg weakness. Developed 12 hrs after vax.
Received 1st dose of Pfizer vaccine on 8/12/2021.  Pt states she noted increasing tachycardia since first injection that has gotten progressively worse over time.  Pt now c/o syncope daily, is noted be orthostatic with tachycardia of 140-150bpm with simple ambulation.  Pt has been evaluated by cardiology with no significant findings as of this time.  Pt is now hospitalized on floor for further evaluation
Muscle pain at injection site (can't raise arm), fever (101.5 F), fatigue, chills, restlessness.
Patient noticed a mildly painful red rash down her arm beginning the day after vaccination that resolved after 4 days.
SIDS 2 mos of age 1 day p/vax; no known relationship, but timing of sids death warranted report;
pt was dizzy - after 15 minutes of watching her she complained of a headache she could answer questions but not with any enthusiasm.  she was groggy - I got a blood pressure cuff and took three readings and they continued to increase the last reading was 148/120 I suggested to mom we need medical care and offered to call an ambulance - mom said she would take her to the er across the street
This case was reported by a physicians assistant and described an adult subject of unspecified gender who was vaccinated with hepatitis B vaccine recombinant Engerix B and subsequently tested positive for the hepatitis B antigen. The physicians assistant reported that there were four cases of antigenemia detected following the administration of Engerix B, however subject identifiers were not provided. Medical history included renal failure (cause not specified) requiring hemodialysis. On an unspecified date before July 14 2005, the subject received a dose of Engerix B. The physicians assisted reported that the subject received, either the second, third or booster dose of Engerix B. At an unspecified time after vaccination with Engerix B on or before July 14 2005, the subject tested positive for hepatitis B antigen. The outcome of the event was not reported.
Thyroiditis subacute; Arthralgia; Headache; Lymphadenopathy; Pyrexia; This is a spontaneous report from a non-contactable consumer or other non hcp. This is 24 of 29 reports. A 43-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch Number/Lot Number: Not reported), dose 2 via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. Medical history included allergies to shellfish, mite and grasses from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch Number/Lot Number: Not reported) dose 1 via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. The patient experienced thyroiditis subacute, arthralgia, lymphadenopathy and pyrexia on an unspecified date. Serious criteria considered as medically significant, intervention required and the patient's hospitalization was prolonged as a result of thyroiditis subacute. The outcome of the events were reported as not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
20 minutes after shot while passenger in vehicle I passed out and went into convulsions for 2 minutes   The next day after shot at 7am I passed out again and went into convulsions while blacked out  The next few days I did not feel right
8JAN92 pt recvd Engerix-B vax & 9JAN92 rt eye sclera became red & inflamed, devel minor sore throat & fever; pt seen by MD to treat events; 10JAN92 tx x 2 days w/Sulfacetamide drops; 12JAN92 Tobrex instituted;
27JUL95 pt recv vax 31JUL95 tc fr mom rt side of face, neck swollen, lt side less swollen;c/o pain in testicles-very swollen testicles;referred to ER:water buildup by testicles;referred to urologist; leg ache, abd pain, h/a, sore throat
Chills; Slight temperature; Feeling very wiped out tired; feeling not well; This is a spontaneous report from a contactable healthcare professional, the patient. A 56-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP7534), via an unspecified route of administration in the right arm on 18Mar2021 at 16:00 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure and the patient was on medication for it. The patient did not have any allergies to medications, food or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medication included unspecified medication for high blood pressure from an unknown date. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 21Mar2021 at 22:00, approximately three days after the vaccination, the patient started feeling not well. On 25Mar2021, seven days after the dose, the patient woke up to chills, slight temperature and feeling very wiped out tired. The adverse events did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events feeling not well, chills, slight temperature and feeling very wiped out tired. The clinical outcomes of the events feeling not well, chills, slight temperature and feeling very wiped out tired were not recovered at the time of the report.   No follow-up attempts are needed. No further information is expected.
I had ?normal? side effects from vaccine starting 20 hours after shot. I would say it was on the severe side. 40 hours after the shot the maxillary zone of the left trigeminal nerve turned exactly that portion of my face numb. I?ve had trigeminal neuralgia for 22 months but never this symptom. I am convinced there is a correlation here. I didn?t go for any treatment. The numbness went away after 10 hours. Just thought someone should know.
Patient states that after first dose of moderna she felt swelling in left arm.  The second day was ok and the third day she was extremely exhausted.  She was tired for 3 days but swelling in arm lasted 2 weeks.  She had second dose of moderna in 3 weeks.  Her arm felt like it was "on fire" and felt very tired 3 hours later.  Approx. 3 am woke up with fever, all over body muscle aches and vomiting which lasted for 24 hours and then felt ok.  One month after injection patient had swelling of body which was worse on face, hands and feet.  She was seen in this office 2/23/21 and prescribed medrol dose pack.  Today 2/25/21 she has less swelling of hands and feet and face has returned to normal.  She states fatigue has not changed.
Information has been received from a registered nurse referring to a 14 years old patient of unknown gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 22-SEP-2016, the patient was given a dose of PROQUAD (lot # L051098, expiration date 17-JUN-2017, rHA (recombinant human albumin); dose and route were unknown). No adverse effect was reported. Additional information has been requested.
Administration of an expired vaccine; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 04-Nov-2021 and was forwarded to Moderna on 04-Nov-2021.    This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of an expired vaccine) in a 61-year-old female patient 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration of an expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administration of an expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications provided. No treatment medications provided.
fever; muscular pain; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), MYALGIA (muscular pain) and FATIGUE (fatigue) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 26-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-May-2021, the patient experienced PYREXIA (fever), MYALGIA (muscular pain) and FATIGUE (fatigue). At the time of the report, PYREXIA (fever), MYALGIA (muscular pain) and FATIGUE (fatigue) outcome was unknown.            Concomitant product use included blood pressure medications.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not applicable.
Pt. experienced rash around injection sites. Itchiness, burning, and area felt warm. Mother states pt. was fussy and complaining of chills the night after the vaccines but no fever. Medical Staff Advised Mother to give pt. BENADRYL. Mother of child states child is doing better. Is still using BENADRYL.
States redness and induration at site of injection.  Severe migraine, body aches day after vaccination.  No temp noted 3 days after vaccination.
Patient inadvertently received pediatric formulation of Pfizer-BioNTech COVID-19 vaccine. Patient is twelve years old and should have received adult (12 and up) formulation of Pfizer-BioNTech. Mother was contacted by Manager and informed of adverse event on 11/8/2021. Patient's mom did not note any adverse reactions from the vaccine. Mother agreed to bring her son in 21 days from the event to restart the series with the correct dosage per CDC/ACIP recommendations.
Just now testing positive for COVID and am finding weird effects.; Just now testing positive for COVID and am finding weird effects; 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 BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), 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. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "Just now testing positive for COVID and am finding weird effects."; COVID-19 (medically significant), outcome "unknown", described as "Just now testing positive for COVID and am finding weird effects". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Just now testing positive for COVID.  The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received.
COVID-19 INFECTION; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported 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.  On an unspecified date, the subject experienced covid-19 infection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid-19 infection was not reported. This report was non-serious.