chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The initial safety information received was reporting only non-serious adverse drug reactions, Upon receipt of follow-up information on 05Aug2021, this case now contains serious adverse reactions. Information processed together.  This is a spontaneous report from a contactable nurse (patient). A 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 1 via an unspecified route of administration, administered in arm left on 28Jul2021 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. There were no medical history and concomitant medications. No investigation assessment. Two days after her first injection (as reported) her left arm and fingers started going numb from the elbows down on 28Jul2021. She did not have strength used to have in her left hand and fingers. As a result that she was unable to button clips on bra, cannot open bottles or containers, cannot hold onto or grip things like steering wheel can hold wheel straight but if turn cannot use left hand safely enough. It comes and goes and is not constant. Today it hurts really bad. She cannot use her fingers to type correctly today. Seriousness of the events is medically significant and at times disabling. Her strength was affecting her daily living. She had not had a stroke but feels that way on that side. Treatment included she was taking prescription steroids. The outcome of events was not recovered.  The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.; Sender's Comments: A causal relationship between BNT162B2 and the reported events cannot be excluded based on temporal association.  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 RAs, Ethics Committees, and Investigators, as appropriate .
Developed generalized urticaria, 6 days, post vax. Large urticarial wheal over left thigh injection site with central clearing. Resolved with Benadryl. Incidentally has been  complaining of ear pain prior to reaction.
COVID 19 Treatment; COVID 19 Treatment; Dose 1 and 2: Moderna and Dose 3= Pfizer / BioNTech; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 76-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Sep2022 as dose 3 (booster), single (Lot number: GH9703) at the age of 75 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 19Feb2021 as dose 1, single (Lot number: 006m204), in left arm and on 19Mar2021 as dose 2, single (Lot number: 00182119), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Type 2 DM" (unspecified if ongoing); "Hyperlipidemia" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing); "IBS" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 28Sep2022, outcome "unknown", described as "Dose 1 and 2: Moderna and Dose 3= Pfizer / BioNTech"; 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, patient took Paxlovid from 25Sep2023 to 30Sep2023.
pain in his leg, the pain was in the middle part of the back of the lower part of his leg, the fibula; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in his leg, the pain was in the middle part of the back of the lower part of his leg, the fibula) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (pain in his leg, the pain was in the middle part of the back of the lower part of his leg, the fibula). At the time of the report, PAIN IN EXTREMITY (pain in his leg, the pain was in the middle part of the back of the lower part of his leg, the fibula) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided.  Treatment information was not provided.   This case was linked to MOD-2021-399933 (Patient Link).
Fatigue, headache, muscle pain, chills, fever, weakness, unable to participate in daily activities for one week
Uncontrollable crying lasting 4-6 hours after injection.  No crying next day.
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): NVSC2022US189517_OS (Novartis). A 61-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, 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: CARDIAC FAILURE (medically significant), outcome "unknown", described as "heart failure". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
aches in right hand; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 86 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 19Jan2021 (Batch/Lot number: unknown) at the age of 86 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LIPITOR [ATORVASTATIN]; METOPROLOL; SYNTHROID; SPIRONOLACTONE; ALLEGRA. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 20Jan2021, outcome "recovered" (2021), described as "aches in right hand". Therapeutic measures were not taken as a result of pain in extremity.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Developed myalgias and joint pains approximately 48 hours after the injection, then improved. Then about a week after the injection, developed severe myalgias and joint pains. Treated with Medrol dose pack (6 days) with improvement. 3 days later developed pleuritic chest pain as well as shortness of breath. Presented 48 hours after this started for medical care and was diagnosed with acute pericarditis. Started on ibuprofen 600 mg TID and colchicine 0.6 mg BID with significant improvement in discomfort. Discharged from the hospital after 48 hours of observation.  Did develop paroxysmal SVT which was felt to be 2/2 to the acute pericarditis. Started on metoprolol tartrate 50 mg BID to help with rate control and sent home with zio patch for additional cardiac monitoring.
Pt exp maculopapular rash over the buttocks & lower back w/in 24 hrs p/receiving HIBTITER/DTP; immun administered in the buttocks; Seen in office; tx included hydrocortisone cream;
PATIENT LOST CONSCIOUSNESS FOR 20-30 SECONDS. HER BODY WAS JERKING AND THEN SHE CAME BACK TO CONSCIOUS WITH CONFUSION OF WHAT HAPPENED. PATIENT WAS PALE.  SHE WAS GIVEN WATER/JUICE AND CHECKED OUT BY PARAMEDICS.
COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in a male patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Hidradenitis suppurativa and Crohn's disease.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) had resolved.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       No concomitant medications were reported.  It was unknown if patient was enrolled in COVID-19 vaccine clinical trial.  The reporter causality for events of COVID-19 with Humira was no reasonable possibility.  No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked in.
Patient received first dose of Shingrix in October 2020 and failed to get the second dose; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 52-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in October 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The case was reported by patient herself. The age at vaccination was not applicable for this report. The patient failed to receive the second dose till the time of reporting, which led to incomplete course of vaccination. The reporter consented to follow-up.
febrile seizure the evening the vax was given w/t104.4; pt was seen in ER; by next morning t99 & no further problems;
This spontaneous report as received from a registered nurse refers to a 15 year old patient (unspecified gender). On 15-JUN-2015, the patient was vaccinated with an improperly stored dose of GARDASIL (dose and route were not provided) (lot # K008931 exp. 04-MAR-2017; lot # K009482 exp. 06-MAR-2017) which was exposed to below 36F for 361.81 hours. The nurse was requesting assistance in determining revaccination. In addition, excursion below 32F (31.2F) started on 13-JUL-2015. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested. This is a corrected report. The AE term of "medication error" was changed to "incorrect product storage" which is more specific.
Redness and swelling, pain from injection site to within 1-2" of elbow. Pt used cold packs and Tylenol, lasted up to 1 week.
35 y/o reservist on drill weekend presents to ED 40 mins after receiving 2nd dose of moderna SARS-CoV-2 vaccination with c/o redness of upper r forehead and mild sensation of tightness in her throat, face and tongue itchy and tingly. No prior vax reactions or h/o anaphylaxis.  Pt was given 50mg benadryl which resolved her Sx within 20 min. No e/o anaphylaxis was noted but given pt's complaints of tightening throat she was observed for 4 hrs in ED. She had no worsening of sx over this time.
Extreme tiredness, followed by light cold like symtoms.  Headache and being out of it.  Day 3 started having left back paid and not being able to take a deep breath, on day two of this pain now.  Treating with Ibuprofin and Tylenol.
I had a fever starting 2 am tuesday morning until thursday morning. My fever went up as high as 103.9 F and my resting heart rate was consistently 123-125 (monitored by apple watch).
Pt in week of training when he received the vaccinations. 35 days later, pt developed weakness and decreased range of motion in the feet and legs and feet were "slapping the ground" when walking. On day of evaluation (10 Mar 2010) he also was diagnosed with pneumonia with a RML infiltrate. Service member was hospitalized at hospital on 10-16 Mar 10 for pneumonia and suspected Guillain Barre. In ER had 1+ reflexes in LE. Had IVIG while hospitalized and began to improve. Symptoms: muscle weakness, abnormality, gait, malaise and fatigue.
lymph nodes in the groin area are uncomfortable; sore arm; lump at the injection site; low grade fever of 99.8F; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL DISCOMFORT (lymph nodes in the groin area are uncomfortable), VACCINATION SITE PAIN (sore arm), VACCINATION SITE SWELLING (lump at the injection site) and PYREXIA (low grade fever of 99.8F) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in March 2020.    On 21-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On an unknown date, the patient experienced MUSCULOSKELETAL DISCOMFORT (lymph nodes in the groin area are uncomfortable), VACCINATION SITE PAIN (sore arm), VACCINATION SITE SWELLING (lump at the injection site) and PYREXIA (low grade fever of 99.8F). The patient was treated with IBUPROFEN (ADVIL 12 HOUR) ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, MUSCULOSKELETAL DISCOMFORT (lymph nodes in the groin area are uncomfortable), VACCINATION SITE PAIN (sore arm), VACCINATION SITE SWELLING (lump at the injection site) and PYREXIA (low grade fever of 99.8F) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication were not reported by the reporter.
Flu like symptoms:  chills, muscle ache, headache, low grade fever,  for 2 days.
A nurse reported that an expired FluMist vaccine was administered to a 39 year old male patient on Oct 19 2005. There was no adverse event reported following vaccine administration, No other information is available. The reporter causality is not provided.
24 hours after injection pt reported fatigue, soreness, blotchy areas at/near site of injection, also malaise, after 48 hours she feels a lot better, still a little fatigue and splotches are still visible on are
Started with the worst sore throat ever. Then headaches, dry itchy eyes. 3/29 moved to chest, bad dry cough, cloudy head
Fever,headache, chest pressure, low back weakness, sore throat, lymphadenopathy left armpit, vesicular rash starting 8 days after vaccination.  Treated with motrin.
Temp 102.5(R) w/in 8 hrs of immun, high pitched, unconsolable crying throughout the night; (about 8 hrs)
Rash on back, shoulders, abdomen mainly on right side. Slightly itchy "pimple looking".  No treatment at this time but has a follow up appt with doc on 1/23/2011.
from shoulder to shoulder (back only) sunburn-like sensation at level 4 pain. extreme muscle pain and piercing sensation in the muscles behind both the shoulders and the neck. pain level would increase from a stalemate position (pain level 5) to pain level 7-8 while simply moving  to escalate to a pain level 9-10 when sneezing, looking right / left or down, or even being in a driving car the pain would occasionally shift from one area to another, but would always remain between the shoulders and neck pain still persists after 6 days and causes simple tasks as easy as getting out of bed exhausting and excruciating
Headache, Myalgia, Fever, sore arm, fatigue. Same symptoms after 1st dose; worse after 2nd dose Narrative:  Other Relevant History:
Elevated temp day following shot of Hep B. Diarrhea and vomiting second day after shot. Taken to ER due to dehydration and elevated temperature. Was to be released that evening but was kept until Friday, at patient's request for flucuating temp. Medical record states dysuria, sweat, syncope. msv
received an extra dose of IPOL, no AE; Initial information received on 30-Mar-2021 regarding an unsolicited valid non-serious case from a physician.  This case involves a 19 months old male patient who received an extra dose of IPV (VERO) [IPOL] (Dose 3: lot number and expiration date not reported,via unknown route in unknown administration site and Dose 4: lot T1D481M and expiration date: 25-Jul-2022, via intramuscular route in the left thigh) for prophylactic vaccination on 17-Mar-2020 and 30-Mar-2021 respectively (extra dose administered).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP) ; HIB VACCINE (HIB) and HEPATITIS A VACCINE (HEPATITIS A).  It was a case of actual medication error due to extra dose administered (same day latency).  It was reported that the caller was with questions on expected adverse effects.  At the time of reporting, It was not reported whether the patient had any adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
He got his vaccine, 48 hours later almost to the dot he said that he was getting a reaction, looked and he had red dots on his arms.  His wife went to look at his body and under his breast area, mid chest and noticed the rash starting, red, and across his back.  It goes from spots to blotches to it's almost one solid red color.  The wife waited to get the flu vaccine to give his body time to recover from the other vaccines.  She gave him 50 mg of Benadryl as it keeps coming out and this has been going on for 3 days.  The initial area where he had the breakout has lessened and then it spreads.  He had no difficulty breathing, did not have a fever, did not have any itching.  He is tired, but perhaps from the Benadryl.  The rash has faded away now to where it is more of a tannish area than the pink.  The pharmacist said that since he has had reactions to the last flu vaccines that it has to be some inert ingredient that he is allergic to.    He went in for his wellness appointment to his PCP, and was told that he needed a shingles shot.  He had a very severe allergic reaction to that that he got at the doctors office.  This was on 8/11/22.  This reaction was paint all over his body, big blotches and no elevation to the spots, just red dots everywhere like he was pocked with pins.   He then had the COVID booster on 9/12/22 with 0 reaction, Pfizer vaccine.  He has not had any reactions to any of the COVID vaccines.    He has had a reaction to a previous flu vaccine 2 years ago that started after 24 hours of getting the vaccine.
Arm goes numb for approximately 30 minutes after receiving Anthrax vaccine, event has happened for the past 2 doses
Information has been received from a registered nurse concerning a male, who on 10Jan2001 was vaccinated with a first dose of Hepatitis B vaccine recombinant (yeast) (6307005/1566K). Immediately after vaccination on 10JAN2001, the patient complained of feeling, "unfocused, dizzy, hot, sweaty, like something in the chest- a tightness that lasted only seconds". The patient also reported "weakness and tinnitus". The nurse stated she would like the lot checked. Unspecified medical attention was sought. Another patient (WAES01011045) had a similar experience after vaccination with the same lot.  The records of testing prior to the release of this lot has been checked by Biological Quality Assurances and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released.  Additonal information has been reported.
Resident with acute onset of SOA this AM with Sao2 of 65%. Transfered to ER with diagnosis of bilateral pulmonary embolism
Information has been received from a RN concerning a 67 year old white female with no allergies or medical history who on 18May04 at 14:30PM was vaccinated IM in the left deltoid with a first dose of hep b virus vaccine rHBsAg (yeast) (lot 647547/0031P). Concomitant vaccination on the same day at 14:30PM included an IM first dose in the right deltoid of hep A vaccine (inactive) (lot 647701/1165N). There was no illness at the time of vaccination. Two weeks after vaccination, on approx 01Jun04, the pt experienced systemic itching of her skin, interrupting her sleep. There was no rash. The nurse reported that the symptoms had resolved. Unspecified medical attention was sought and no treatment required. A product quality complaint was not involved. Follow up was received from the RN who indicated that the pt came into the office on 18Jun04 to received her second dose of hep B virus vaccine rHBsAg (yeast) (manf unk). After questioning the pt, she stated that two weeks after her first doses of hep B virus vaccine rHBsAg (yeast) and hep A vaccine (inactive), on 27May04 at 20:30PM, she began to itch all over. No rash appeared but the itching kept her awake and she did not take any medication. The itching lasted two days only and she was okay. Subsequently, the pt recovered. No further information is expected.
Left shoulder was red, warm and taught, probable MMR and DTP; same site. Rash developed from shoulder to elbow. Pt was given Tylenol 5cc q 4 hours, Benadryl 1/2 tsp q 4 hours and ice to area.
individual symptoms of adverse events began at 6AM 10.12.2023, symptoms to include dull headache, slight sore throat, dizzy and nausea, injection site right deltoid muscle sore. Individual will be resting at home, self care.
Patient was provided second covid vaccination. After administration, patient began bleeding. Pressure was applied but blood filled the inject-safe bandage. Pharmacist was able to use cotton to absorb blood and re-bandaged injection site. Before re-applying a bandage, the bleeding had stopped. Parent was instructed to use cool compress if swelling occurred. After 15 minutes, patient was fine.
ABOUT 3 MINUTES AFTER GIVING THE SHOT, SHE THREW UP AND FELT LIKE SHE WAS GOING TO PASS OUT. HER MOTHER TOLD ME BEFORE GIVING THE SHOT THAT SHE PASSES OUT AND THROWS UP AFTER GETTING SHOTS. SHE DID NOT PASS OUT BUT DID FEEL AS IS SHE WOULD. I APPLIED AN ICE PACK TO THE BACK OF HER NECK, GAVE HER WET PAPER TOWELS TO USE TO HELP COOL OFF HER FACE, CUP OF WATER TO SIP ON.  HER MOTHER AND I FANNED HER TO HELP COOL HER OFF. SHE THREW UP A FEW TIMES. WE CONTINUED TO FAN HER AND GIVE HER SIPS OF WATER. AFTER ABOUT 15 MINUTES SHE SAID SHE FELT BETTER. HER COLOR WAS GOOD AND SHE SAID SHE FELT FINE. SHE TOLD ME THIS HAS HAPPENED TO HER SEVERAL TIMES AFTER RECEIVING A SHOT. SHE AND HER MOM WERE EXPECTING THIS TO HAPPEN. I HAD HER WAIT ABOUT 15 MORE MINUTES AFTER SHE SAID SHE WAS OK TO MAKE SURE I FELT SHE WAS ACTUALLY OK TO GET UP. SHE GOT UP FINE AND SAID SHE FELT NORMAL AGAIN.
Chronic pain, headaches, rash, bowel problem, muscle pain, depression, lose of function, blurred vision, tremors, fibromyalgia like symptoms.
Day 1 (10/22): Chills, fever, muscle pain, injection site pain, fatigue, headache Day 2-3: muscle pain, injection site pain, fatigue, headache Days 4-5: muscle pain, fatigue Days 6-7: fatigue Day 8: fatigue, runny nose, mild cough, sensation of swollen lymph nodes at throat Day 9: fatigue, runny nose, mild cough, sensation of swollen lymph nodes at throat, visibly swollen eyelids