chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient taken to ER 36 hrs after varicella vaccination; reported 1.5 inch area of redness,edema around injection site of (L) ant/lat upper arm. No fever, rash, itching or s/s of allergic reaction. Given Septra for poss. cellulitis. Contacted MOP on 16 Jul 07, states s/s are "much better" but not completely resolved.
p/vax pt exp swelling/4cmx4cm area of erythema rt arm;
27 y/o service member reports feeling tingling in his throat within 10 minutes after receiving his first dose of COVID-19 vaccine. Patient denies swelling or difficulty breathing. His VS remained stabled throughout the event which lasted 20 minutes, then spontaneously resolved. However, staff states that his throat tingled just before he experienced anaphylaxis to dogs in the past which resulted in stabilization in the ED at that time. SM denies any adverse reaction to vaccines received in the past.
24 hours after vaccine (L) bicep developed whelps, then stomach and leg. Several hours later whelps developed on (R) bicep. Patient used hydrocortisone cream and symptoms improved.
FOLLOWING THE INJECTION THE PATIENT FAINTED MOMENTARILY. UPON AWAKENING HE WAS DIAPHORETIC AND BREATHING RAPIDLY. HE  THEN VOMITED. PHARMACIST CHECKED BP AND IT WAS WITHIN RANGE,. 911 WAS CALLED AND UPON ARRIVING THE PARAMEDICS CHECKED VITALS AND CONCLUDED PATIENT WAS OKAY. PATIENT WAS NOT TRANSPORTED.
few hives; nausea; sick; don't feel well; Severe muscle aches; back spasms; severe fatigue; headache; no energy; itchy; This case was reported by a consumer via call center representative and described the occurrence of sickness in a 55-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of no adverse event (received 1st dose on an unknown date).   On 24th September 2021, the patient received Shingrix. In September 2021, less than a week after receiving Shingrix, the patient experienced muscle pain, spasms, fatigue, headache, loss of energy and pruritus. On 24th September 2021, the patient experienced sickness and unwell. On 28th September 2021, the patient experienced hives and nausea. On an unknown date, the outcome of the sickness, unwell, muscle pain, spasms, fatigue, headache, hives, nausea, loss of energy and pruritus were not recovered/not resolved.   It was unknown if the reporter considered the sickness, unwell, muscle pain, spasms, fatigue, headache, hives, nausea, loss of energy and pruritus to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient herself The patient received 2nd dose of Shingrix shot on Friday in the right arm and was sick and still did not feel well. The patient enquired how long would it last. The patient had side effects few hours after shot but still didn't felt well 4 days later. The patient was aware about the side effects and they were still lingering. The had triggered severe muscle aches to the point that he/she had back spasms, severe fatigue, headache, back spasms, a few hives on the day of reporting and nausea.  The patient had no health problems and did not take medication. The patient reported that he/she had contacted doctor and she said it was his/her body building up immunity and patient felt awful. The patient had no energy and was active and owned a horse but did not able to ride because he/she did not feel well. The patient was itchy.
1st dose of Pfizer was given on 12/12/21. On 12/13/21 patient came back from school and asked 'is it normal that my heart feels that someone is stabbing it all the time?' Increased pain during 'walking between classrooms at school' and 'when I was at recess'. PCP was called and next day appointment was scheduled. 10 days later, still c/o sharp pain and SOB with increased activity.
breast cancer; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:.  A female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, 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: BREAST CANCER (medically significant), outcome "unknown". Therapeutic measures were taken as a result of breast cancer. Additional information:The Covid vaccine Before Covid your product gave my mother breast cancer. Luckily it was caught early but she had to have a mastectomy. The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
13 yo female came in for 2nd dose of pfizer. received the pediatric dose erroneously.
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. No information about the patient's pertinent medical history, concomitant medications and drug reactions or allergies was reported. On 04-NOV-2016, the patient was vaccinated with a dose of ZOSTAVAX 19400 plaque-forming units (PFU) injection, lot # reported as M026878, expiry date 27-JUL-2017 (dose, route of administration and anatomical location were not specified), in error. No adverse effects were reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
Rash; This case was reported by a consumer and described the occurrence of rash in a 89-year-old male patient who received Herpes zoster (Shingrix) for an unknown indication.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, unknown after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was recovered/resolved.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were provided as follows: Age at vaccination was not reported. The patient experienced a rash after the first dose of Shingrix, but did not believe it was related to the vaccine at the time. The reporter did not consent to follow-up. For tolerance of 2nd dose refer case US2020243348.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020243348:Same reporter
chills; body ache; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills) and MYALGIA (body ache) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026B21A and 001B21A) for COVID-19 vaccination.     Concurrent medical conditions included Breast cancer (remission at this stage) since 2013. Concomitant products included ANASTROZOLE for Cancer, ATORVASTATIN for Cholesterolosis NOS.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Apr-2021, the patient experienced CHILLS (chills) and MYALGIA (body ache). On 07-Apr-2021, CHILLS (chills) had resolved. On 08-Apr-2021, MYALGIA (body ache) had resolved.            The patient reported symptoms of chills started about half an hour after the Covid 19 vaccine second dose. The chills were violent, and I could not control them, but the duration was only 15-20 minutes and they did not reoccur.  The body ache was normal to a flu and lasted into the evening, all symptoms were gone by morning. I was not alarmed as I knew of the reported side effects.   No information regarding corrective treatment was reported by the patient.   This case was linked to MOD-2021-155044 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: Significant FU received contains updated information about patient demographics and her medical condition and concomitant medication and event outcome were updated.
syringe broke, so the nurse readministered another entire dose; syringe broke, so the nurse readministered another entire dose; dry mouth; arm extremely sore; A spontaneous report was received from a from a consumer and concerning a 36 Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced dry mouth and her arm extremely sore.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 21 Jan 2021 prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 lot: 012L20A  intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 9 Feb 2021 prior to the onset of the events, the patient received their second dose of mRNA-1273 lot: D32L20A  intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 19 Feb 2021, The patient experienced the events as dry mouth and her arm extremely sore  Before taking the second dose the syringe broke, so the nurse readministered another entire dose in the same arm (left arm). and she doesn't know if it belongs to both doses or to which dose it belongs to.  Laboratory details not provided.  Treatment details not provided.   Action taken with mRNA-1273 in response to the events was not applicable.  The outcome of events dry mouth and her arm extremely sore was unknown and for syringe issue and extra dose administered was considered as recovered.; Reporter's Comments: This case concerns a 36 Y/O F with NS unexpected events of syringe broken and extra dose administered for mRNA-1273 lot # D32L20A, with associated adverse events of NS unexpected dry mouth and NS expected vaccination site pain. Events occurred the same day as second dose mRNA-1273. Treatment not reported. Event outcomes unknown. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.
My left hand turned blue and the veins in that hand looked very dark (almost purple) seconds after I received the Pfizer-BioNTech vaccine for COVID-19 in my left arm.  My left hand turned blue like it was cold, but I was not cold anywhere on my body.  My left hand's veins were also mostly purple in the fingertips.  This side effect was not painful and lasted about 30 minutes.  Other symptoms I've experienced because of the Pfizer-BioNTech vaccine for COVID-19 in my left arm: - soreness across entire arm, especially at injection site - occurred upon injection and is slowly getting better. I took two 200mg of ibuprofen two days after the injection because the pain randomly got worse without any outward cause - swollen injection site - occurred upon injection and is the same at this time - tingling across entire arm - occurred upon injection and stopped seven hours later at 11pm
Arm itchy and bumpy. Scratched area.  Silver dollar size.    Zyrtec taken and sx 90 % subsided.  Plan to follow-up with PCP.
Fever, shaking chills, headache, body aches, nausea.  Episode of dizziness/syncope once overnight.
NEGATIVE FOR COVID 19 ANTIBODIES 2  WEEKS AFTER VACCINATION; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose was not reported, administered on 09-MAR-2021 in the left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced negative for covid-19 antibodies 2 weeks after vaccination. Laboratory data included: Antibody test (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of negative for covid-19 antibodies 2 weeks after vaccination was not reported. This report was non-serious.
pt recv vax 9APR96 & had episodes of crying, irritability & vomiting w/in 24hr of vax;sx persisted another day, parents brought to ER;MD thought pt had a gastrointestinal illness & was released;
Information has been received from a doctor of pharmacy concerning an 8 year old male patient who in 2003 was vaccinated subcutaneously with the first dose 0.5 ml dose of MMR II and the second dose in 2006. Secondary suspect vaccine included varicella received on 04-AUG-2009. The pharmacist reported that the patient who inadvertently received a third dose of MMR II, developed redness, swelling and warmth on the left arm at the injection site on 05-AUG-2009. The affected area was about 2 inches in diameter. At the time of reporting the patient had not recovered. The patient sought unspecified medical attention. Additional information has been requested.
Pt reported having chest pain and labored breathing 10mins after the vaccine. PT was nauseous and also felt faint. PT was also very sweaty. EMS to scene. Pt BP was 189/99. Pt was advised he needs to go to the ER. Pt refused transport and signed documents by ems.  No Epi pen was given. Pt had a coworker take him to ED where he had an ACS workup. No findings. Discharged from ED
on 4-23-19 child returned to clinic and was administered: TD IPV, MMR, and HeP B. 2 to 3 minutes later, child complained of dizziness and nausea, then a minute or 2 after he had < 10 second seizure: Blank stare, left arm was straight forward and rigid with mild jerking. Child was pale and clammy  with some  confusion after seizure episode. BP 117/70 Hr 61.EMS called and child assessment preformed. Mom was told by EMS team that the child was stable and no emergency room visit was need it at the time. Mom refused to visit emergency room because she had other children with her at the time.Additional information for Item 18:  on 4-26-19 @10: 20am I called parents and spoke to mom and patient is well with no signs of seizures. Mom was advised to seek a pediatrician to monitor patient's health and inform MD of the episodes. Mom stated that she has no health insurance at this time ,but she will try to apply for Charity care.  Before the episode on 4-23-19 ,patient visit the clinic on 3-19-19 for the first time.  Mom reported that she lost her child's vaccine records during the migration from another country. Mom was made aware that child need it to restart all vaccines.   On 3-19-19 I administered:  1. tdap: Sanofi, lot# C5566AA, IM, Right  Arm.  2.  Menactra:  SANOFI, LOT # U6152AA, IM, RIGHT ARM.  3.  IPV: SANOFI, LOT # P1A432M, IM, LEFT ARM.  4. PROQUAD: MERCK, LOT # RO18779, SUBQ, RIGHT ARM. 5. Hep A:  MERCK, LOT # R027431, IM, RIGHT ARM  6. Hep B: MERCK ,LOT # R021372 IM, LEFT ARM 7. HPV:MERCK, LOT # R023608 IM, LEFT ARM.  Immediately after last vaccine (HPV )child had a brief syncope episode and he complained of headache and dizziness. At that time he was cold, pale, and clammy, B/P 107/74, HR 63. He recovered quickly and went home.
Hot Flashes, usually daily. Random Goose bumps on different parts of the body.  Can feel them coming on and they go away after a minute.   Not related to the hot flashes.  These arent as frequent, but still happen from time to time.  Originally for the first 3 week, occurred several times a day.
pt recv vax 25OCT96 & pt devel vomiting & diarrhea w/o fever 48hr p/vax;pharmacist related there were other pt that exp v,d who did not recv vax;this is one of 25 cases reported by pharmacist;
Chills; fluctuating temperature 0.5 -1 degree  changes; Localized pain; Slightly burning sensation in the right thigh; This is a spontaneous report from a contactable consumer (patient). This 69-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration on an unspecified date, reported as about 19 days ago (as of 22Mar2021), as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (lot number unknown) on an unspecified date for COVID-19 immunisation. The patient reported he received the second dose about 19 days ago and still had on and off side effects like minor chills, fluctuating temperature 0.5 -1-degree changes, localized pain that went away and slightly burning sensation in the right thigh. The clinical outcomes of minor chills, fluctuating temperature 0.5 - 1-degree changes, and slightly burning sensation in the right thigh were unknown. The clinical outcome of localized pain was recovered on an unspecified date.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Began experiencing heavy heart arrythmia within hours of receiving the 2nd vaccine.  Went to urgent care, and was confirmed by EKG. Followed up with Cardiologist, had stress test and Echo cardiogram, confirmed arrythmia and enlarged left ventricle.  The arrythmia was heavy for first 2-3 weeks, gradually began to dissipate after 4-6 weeks.  No prior history of heart trouble.
She was give TDAP on 7/9/14. On 7/11/14 she developed a painful, red, swollen arm. She also had chills. Dr advised MOTRIN, BENADRYL and was given dicloxacillin for possible cellulitis. She also had itching.
Patient were administered from a vaccine that experienced a temperature excursion; Patient were administered from a vaccine that experienced a temperature excursion; This spontaneous case was reported by a physician and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patient were administered from a vaccine that experienced a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patient were administered from a vaccine that experienced a temperature excursion) in a 48-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Mar-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 28-Mar-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient were administered from a vaccine that experienced a temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient were administered from a vaccine that experienced a temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patient were administered from a vaccine that experienced a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patient were administered from a vaccine that experienced a temperature excursion) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  The health care professional (HCP) reported a temperature excursion, the reporter believed that the vaccines were okay, but the department of health instructed to call Moderna. HCP stated that the vaccines went from frozen to refrigeration temperature, so HCP believed they were okay to use. Four patients had been administered from these vaccines.  No treatment information was provided.   This case was linked to MOD-2022-541803 (Patient Link).
4/10 - 2nd COVID vaccine  4/12-  nausea, diarrhea, vomiting, body aches, chills, lack of energy, dehydrated, followed by internal head and body tremors, internal vibration feeling  had severe insomnia, loss of appetite  Went to ED twice - flu, covid negative, got some benadryl for sleep, seems to make her delirious. Leukopenia noted. Later tried valium, helped with sleep, still with vibration sensation.   Tried Weaned off valium but still struggled with insomnia  4/19  - started on ambien  4/20 - trazodone helped, slept well afterwards  last night, again still had difficulty sleeping  She continues to have internal tremor/head vibration, almost wavy. No visible tremors  Also has noted b/l facial twitching, heart palpitations, jittery and tingly in the head.  She does wake up with headaches at times, this is intermittent.  Nausea resolved. Continues with abd pain and diarrhea, lost 5 lbs  vision - no changes  no light or sound sensitivity  no fevers  no focal paresthesias, weakness has had ongoing tremors, shaking in her body, sensation of brain vibrations/tremors, insomnia seen by neurology; all repeat labs normal awaiting brain MRI
Pt give injection 2 minutes later asked to sit felt lightheaded. Pt given cold rags with head between legs and started seizing. For approx 2 min talk pt through it and eventually came around. Pt very sweaty and no color.
1. Electric shocks up back of neck into head an hour after (with all three).  2. Lymphatic fluid swelling in left armpit within 12 hours, after 24  hours the swelling was huge and watery and had moved down. After 36 hours it looked like a large implant on the side of his torso.  3. Main event was upon waking on May 1st: woke up with the swollen area being sore and stretched it out. Got up to start the day and got lightheaded, sudden heart palpitations, seeing spots, so he got on his knees then passed out and fell to floor. Spouse then witnessed a full TONIC seizure, starting with his pupils dilating then rolling backwards into his head, entire body went rigid for 25-30 seconds while letting out a loud scream/howl, then going limp and breathing stopped for about three seconds. He then started panting and sweating profusely. He was non-responsive and could not move or speak. Was gaining more speech by the time paramedics arrived but was very confused and tired. Could not stand or walk on his own. Was transported by ambulance to nearest hospital emergency room.
SUSPECTED COVID-19 INFECTION; ANGIOEDEMA; VACCINE EXPOSURE BEFORE PREGNANCY; This spontaneous pregnancy report received from a physician via another pharmaceutical company (Pfizer) concerned a 40 year old pregnant female. The patient's height, and weight were not reported. The patient's concurrent conditions included: wheat allergy (rash). The patient was pregnant at the time of event reporting with Gravida 1. The patient received first dose of covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1805018 expiry: unknown) dose was not reported, 1 total administered on 19-MAR-2021 for covid-19 prophylaxis. Age at time of vaccination 38 years old. On 19-MAR-2021, the patient experienced vaccine exposure before pregnancy (Dose number in series 1). The patient received second dose of non-company suspect vaccine elasomeran (Moderna covid-19 vaccine) (Dose number in series 2) (form of admin, and route of admin were not reported, batch number: 006D21A expiry: unknown) dose was not reported, administered on 10-NOV-2021 for covid-19 prophylaxis. Concomitant medications included dextromethorphan hydrobromide/doxylamine succinate/ephedrine sulfate/ethanol/paracetamol, and guaifenesin/pseudoephedrine hydrochloride. It was reported that patient's last menstrual period was on 25-NOV-2021 and expected delivery date was on 01-SEP-2022. On an unspecified date, the patient experienced suspected covid-19 infection (Dose number in series 2). The patient received non-company co-suspect drug Paxlovid (form of administration not reported, oral, batch number, and expiry date were not reported) dose was not reported, administered from 22-JUL-2022 to 24-JUL-2022 for treatment of COVID-19. On 24-JUL-2022 (on day 3 of Paxlovid treatment course) the patient experienced angioedema (tongue swelling, skin erythema, and muscle heaviness) (Dose number in series 2). The outcome of pregnancy was not reported. The action taken with covid-19 vaccine ad26.cov2.s, and elasomeran was not applicable and with Paxlovid was not reported. The patient had not recovered from angioedema, and the outcome of suspected covid-19 infection and vaccine exposure before pregnancy was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20220804040- covid-19 vaccine ad26.cov2.s-Angioedema.  The event(s) shows an incompatible temporal relationship. Therefore, this event(s) is considered not related(Latency between event occurrence and vaccination was more than 16 months, also event occurrence was more related with administration of co-suspect drug - Paxlovid )