chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient went to ER 11-12-08 at approximately 11 pm. She was complaining of itching & had hives from her shoulders, down both arms to the elbows, and across her chest area.  Hives did not extend down onto her breasts.  She was treated with 125mg injection of Solu-Medrol & sent home with 2 additional 20mg tablets & a script (RN was unable to recall dosages written on script).  She was also advised to purchase some Benadryl over the counter and take as directed.  We saw her back in Employee Health around 0800 on Wednesday, 11-13-08, for new employee orientation.  RN reports patient showed no evidence of hives at that time.
She got a warm feeling after getting the shot about 5-10 min after getting it.  It came in waves. She felt lightheaded. She drank water there. Did not faint. Lightheaded for about 1.5 hours.   Stayed at the vaccine site. Stayed there for 1.5 hours. They did not take her vitals.   Felt OK after that for a while. She went home and did gardening.   . Then went to bed. 1 AM, had severe pain in the left arm. Chills, at 5 AM took Aleve, then fell back to sleep. Later in the day took Advil. With Advil had 101 F.   Took about 48 hours to feel back to normal, except daily panic attacks.   10 yrs ago had panic attacks. Since vaccine she has had panic attacks every day.  During panic attacks she is scared she will pass out, lightheaded, warm feeling, then heart races. It resolves if she jumps around or exercises. The panic attacks have lasted a few min.
4 y.o. female developed generalized urticaria several days later after immunization. Given diphenhydramine 6.25 mg 1mx1, ZANTAC 40/5 2.5 ml PO BID, and OTC BENADRYL PRN.
pt states started w/sx the morning p/vax c/o edema @ site, under lt arm & a nodule @ the base of neck;c/o h/a, fatigue, fever 99.5;c/o soreness from mid lt arm up to neck;saw PMD & was referred to MD;MD felt is was a brachial plexus rxn;
within about 30seconds to 1min after administering Pfizer covid vaccine, 12 year old patient passed out....went from talking, laughing to sagging off his chair, I grabbed him and slowly lowered him to the floor....he was having difficulty breathing, focusing , etc.....talked to him, focus him on breathing, gave him water to drink, wet cloth to forehead, face and neck...he came out of it and said he felt ok....he got up and walked to the waiting area with his mom...appeared to be fine, was talking and laughing again, when all of a sudden he was just sitting there, eyes wide open, but not aware. Another customer was there and she noticed him and immediately got him to focus, breathe, popped an ammonia inhalant, applied instant ice pack to his back and neck which brought him out of it.....asked mom and we called 911, EMT's  responded and transported Patient to the hospital to be checked.
Headache; dizziness; foggy; heavy feeling in chest; heavy feeling in shoulders, and arm; This is a spontaneous report from a contactable consumer (patient). A 54-year-old male patient received the first dose of BNT162B2 (PFIZER COVID-19 VACCINE, lot number: unknown), at the age of 54 years old, in left arm on 06May2021 15:30 at single dose for covid-19 immunisation. The patient medical history was reported as none. The patient had no known allergies. The patient was not diagnosed with covid-19 prior to vaccination. The patient didn't receive any other vaccines within 4 weeks and any other medications within 2 weeks prior to vaccination. The patient experienced headache, dizziness, foggy, heavy feeling in chest, shoulders, and arm on 14May2021 05:00. The patient had not been tested for covid-19 since the vaccination. No treatment was received. The outcome of events was not recovered.  Information on the lot/batch number has been requested.
pt recvd vax on 29SEP95 & exp fever on 30SEP95 of 100 ax & on 1OCT95 99ax; mom states that also on 1OCT95 pt was sleepy & had welts; dx urticaria w/some features resembling erythema multiforme;tx DPH
FLU-LIKE SYMPTOMS; LETHARGIC; NIGHTMARES; CHILLS; BUMP ON FOREHEAD; This spontaneous report received from a consumer concerned a 5 decade old male. 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, intramuscular, batch number was not reported) dose was not reported, administered on OCT-2021 for prophylactic vaccination. The batch number was not reported. The Company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On OCT-2021, the patient experienced lethargic. On OCT-2021, the patient experienced nightmares. On OCT-2021, the patient experienced chills. On OCT-2021, the patient experienced bump on forehead. On an unspecified date, the patient experienced flu-like symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from flu-like symptoms, chills, lethargic, bump on forehead, and nightmares. This report was non-serious.
Losing hair; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (Losing hair) in a  patient of an unknown age and gender 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 ALOPECIA (Losing hair). At the time of the report, ALOPECIA (Losing hair) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment and concomitant medications were reported.
Systemic rash, primarily focused on upper thighs; This spontaneous case was received on 02-Mar-2021 from other non-health professional (consumer) via Communication (reference number: SEQW21-00859) and concerned a patient of an unknown age and gender.  The patient's medical history and concomitant medications were not reported.  On 18-Oct-2018, the patient was vaccinated with Afluria Quadrivalent (influenza vaccine, anatomical location, route of administration, indication and dose: not reported). The batch number was not reported.  On an unspecified day, an unknown amount of time after receiving influenza virus vaccine polyvalent, the patient had a reaction which included systemic rash, primarily focused on the patient's upper thighs.   The outcome of the event was not reported.  The reporter did not provide a causality assessment.  The case was assessed as non-serious.  Company comment: The event of 'generalized rash' is considered to be unassesseable to influenza virus vaccine polyvalent.; Sender's Comments: The event of 'generalized rash' is considered to be unassassable to influenza virus vaccine polyvalent.
The patient had nausea and sweaty palms shortly after the vaccine.  Later on she said she had fatigue and shortness of breath.
Patient lost consciousness, slumped forward and fell out of his chair onto the ground, convulsing and spitting/foaming somewhat at the mouth. He regained consciousness shortly thereafter. His blood pressure was deemed "low" by the attending nurse (but I don't know the exact measurement).
Severe body aches, fever, skin felt on fire, headache, leg pain, continued nerve type pain on injection arm and should blade for over two weeks.
p/vax pt exp 2 episodes of seizure activity 06/21/2000 1331 spoke to parent. Child has completly recovered- had a total of 5 seizures after vaccine. He is not on any seizure control meds. Correction to VAERS form 0.8 yrs. Consent sent in order to get hospital DC summary.
Right arm red, hot and hard to touch - "itchy", where given very swollen and large area of redness around where shot given at least 100mm Benadryl oral and cream, ice, Motrin.
vaccine that was drawn up in syringe past the 6 hour window was inadvertently mixed with newly drawn up vaccine. Patient may have rec'd expired vaccine or non-expired vaccine.  We contacted Pfizer, CDC and our Facility vaccine experts and the conclusion made was that microbiological contamination was the primary concern and patient was advised to watch for signs of infection at site or fever and report to us if any other symptoms occur. We were advised revaccination is not required.
Patient had some itching in the left arm and mild rash 5 minutes after the immunization . Gave 25 ml of benadryl. The benadryl relieved the rash and itch. Patient sat and was observed for another 45 minutes and rash/itch went away.
Tinnitus in left ear, not resolved as of 4/7/2021. Very distressing and unable to sleep, not improving on N-Acetyl Cysteine or Nortriptyline
Onset of low-grade fever, chills, muscle aches and headache within ~6 hours of injection, and continuing throughout night until about 11:00 the next day (~21 hours duration, but with mild headache still present as I'm typing this report). Also had imbalance issues when I got up at night. I took two (2) Aleve at night ~2:00 AM to help with the headache.
pt recvd vax in the pM of 17NOV92; exp tingling & swollen lips & rash on arms; pt was referred to an internist who confirmed that had definitely had allerg react;
22 minutes after vaccine was administered pt stated that she could not swallow and a red rash was noted to her neck and chest.  Throat was red and swollen.  Administered IM diphenhydramine and immediately took pt to ER.
Lymphadenopathy concerns, swelling in neck, tenderness/tightness. Diarrhea, difficulty swallowing, sore throat, soreness in abdomen.
Initial report was received 28 September 2011 via a search of the scientific literature. This article describes 5 children who presented for epilepsy care with presumed parental diagnosis of alleged vaccine encephalopathy caused by pertussis vaccinations in infancy. Their conditions were all rediagnosed years later, with the support of genetic testing, as Dravet syndrome (a rare epileptic encephalopathy characterized by an onset in infancy with polymorphous seizure types and developmental decline). All five children had normal development initially. The authors concluded that vaccination acted as a trigger for seizures in these patients who already had a genetic susceptibility to epileptic seizures. They found no evidence that the outcomes, in terms of subsequent seizure types or intellect, were any different between those patients with Dravet syndrome whose symptoms started within two days of vaccination and those whose symptom onset was not related to vaccination. This case captures information for one of the five patients. The other four patients have been captured in case numbers 2011-09348, -09597, -09598, and -09600. A 6-month-old patient received a pertussis vaccine (manufacturer unknown, lot number, route, site and date of administration not reported) and less than 24 hours after vaccination, developed an afebrile unilateral clonic seizure. After 1 year of age, the patient developed other seizure types including generalized tonic-clonic, myoclonic and hemiconvulsions, which were intractable to multiple medication trials. Cognitive development was described as slowing. Initial brain MRI results were normal. At 4 years of age, patient was diagnosed with Dravet syndrome based on positive SCN1A (neuronal sodium channel alpha-1 subunit) testing results which showed nonsense mutation (C5734T, Arg1912Stop) and were proved de novo through parental testing. Electroencephalogram findings at diagnosis showed generalized discharged and slowing. Outcome was not recovered. Documents held by sender: None.
cannot lay down on this arm; felt something under her sleeve; red, hot, and was scratchy from the injection site; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (cannot lay down on this arm), FEELING ABNORMAL (felt something under her sleeve) and VACCINATION SITE ERYTHEMA (red, hot, and was scratchy from the injection site) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No medical history information provided.  Concomitant products included LAMOTRIGINE and CLONAZEPAM (KLONOPIN) for an unknown indication.   On 31-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 05-Apr-2021, the patient experienced MUSCULAR WEAKNESS (cannot lay down on this arm), FEELING ABNORMAL (felt something under her sleeve) and VACCINATION SITE ERYTHEMA (red, hot, and was scratchy from the injection site). At the time of the report, MUSCULAR WEAKNESS (cannot lay down on this arm), FEELING ABNORMAL (felt something under her sleeve) and VACCINATION SITE ERYTHEMA (red, hot, and was scratchy from the injection site) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable. No treatment information provided.
The shot was given to the patient around 8:30 A.M. After she was finished she waited in the room about 5 minutes and than walked to the waiting room.  She was standing up in the front about to leave but she passed out and her head hit the floor. She lost concussion and was shaking according to witnesses in the front. Doctor gave the patient .half cc of benadryl and her temperature  dropped to 94.5 ,911 was called and the ambulance arrived around 8:50 A.M.
slight hardness over a five inch area of upper arm with constant itchiness; slight hardness over a five inch area of upper arm with constant itchiness; Warmth at injection site; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (slight hardness over a five inch area of upper arm with constant itchiness), INDURATION (slight hardness over a five inch area of upper arm with constant itchiness) and VACCINATION SITE WARMTH (Warmth at injection site) in a male patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. AV3832B) for COVID-19, SARS-CoV-2 infection, Coronavirus disease 2019, 2019-nCoV infection and 2019 novel coronavirus infection.     Previously administered products included for Product used for unknown indication: Flu shot on 16-Nov-2023. Past adverse reactions to the above products included No adverse event with Flu shot. Concurrent medical conditions included HIV disease.    On 16-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. On 16-Nov-2023, the patient experienced PRURITUS (slight hardness over a five inch area of upper arm with constant itchiness), INDURATION (slight hardness over a five inch area of upper arm with constant itchiness) and VACCINATION SITE WARMTH (Warmth at injection site). At the time of the report, PRURITUS (slight hardness over a five inch area of upper arm with constant itchiness), INDURATION (slight hardness over a five inch area of upper arm with constant itchiness) and VACCINATION SITE WARMTH (Warmth at injection site) had not resolved.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Patient have not had any adverse reactions to previous Moderna vaccines for Covid 19. No treatment medication reported.
This patient was given 0.2 ML of adult dose Pfizer instead of 0.2 of pediatric formulation. No reaction noted
Patient passed out/fainted after giving 2nd vaccine. He came to a few seconds later and had pale and clammy skin for a few minutes. He sat there until he was failing better and then eventually left with his mother. I called a few hours later and patient was feeling better.
This spontaneous report was received from a 74 year old female patient. The patient's pertinent medical history, drug reactions allergies, concurrent conditions and concomitant medications were not reported. The patient reported a previous adverse event with ZOSTAVAX on a different country (1703CAN011148). On an unspecified date in 2007 (reported as "ten years ago"), the patient was vaccinated with a dose of ZOSTAVAX for prophylaxis (dose, route, lot # and expiration date were not reported).  In December 2016, the patient experienced shingles. The patient went to the physician and received unspecified pills and unspecified eye drops. At the time of reporting the patient stated she was a healthy lady (outcome: recovered). A product quality complaint was not involved. The causality assessment between the event and ZOSTAVAX was not provided. Additional information is not expected because the reporter refused additional contact.; Sender's Comments: US-009507513-1703CAN011148:
Blurred vision; Complete loss vision; Hearing impairment Whoosh; spike in blood sugar; Fatigue; A spontaneous report was received from a consumer who was a 41-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced complete loss of vision (blindness), fatigue, blurred vision, spike in blood sugar (blood sugar increased), and hearing impairment "whoosh" (hearing impaired).  The patient's medical history, as provided by the reporter, included diabetes. Concomitant medications were insulin glargine and insulin lispro.  The patient said he was compliant with his insulin injections.  On 29 Dec 2020 , prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection.   On 29 Dec 2020, the patient experienced a spike in blood sugar.  He tested his blood sugar immediately following the vaccination and it was in the 280-380 range.  Prior to the vaccine, it was 100 to 150.  On an unspecified date, his hemoglobin A1C was below 7.  On 05 Jan 2021, he experienced hearing impairment "whoosh".  On 09 Jan 2021, the patient experienced complete vision loss.    On 11 Jan 2021, he experienced blurred vision.     Action taken with mRNA-1273 in response to the events was not reported.   The event of complete vision loss resolved on 11 Jan 2021.  The outcomes of the events of fatigue, blurred vision, hearing impairment "whoosh", and blood sugar spike were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.  The patient's medical history of diabetes remains a confounding factor. Further information has been requested.
This spontaneous report was received from a medical assistant who refers to multiple unspecified patients of unknown age and gender. The patients' pertinent medical history, allergic reactions and concomitant medications were unspecified. On unspecified dates, the patients were vaccinated with improperly stored VARIVAX (lot # M025870, expiry date 24-MAY-2018, dose, strength, vaccination site, route unspecified) for prophylaxis. The vaccines were exposed to a temperature of 11 Fahrenheit (F) for 24 hours. Stability questions were asked about M-M-R II during the call, however no doses of improperly stored MMRII doses were administered to patients. Digital data logger was not involved. There were no previous temperature excursions. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of two reports received from the same reporter. Follow-up information was received on 30-NOV-2016 from a telephone call to the reporter. A message was left on voice mail for a return phone call for patient identifiers and dates of vaccinations. No other information was reported. All telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested. Sender's Comments: US-009507513-1610USA007027: MERCK 1610USA005924: Mfr number.
Post menopausal bleeding.  Two years after my last menstrual cycle. Bleeding began less than two weeks after booster.
Patient, a 51 yo Female born 04/27/1969, sitting in the observation area complaining of dizziness status post first vaccine of Pfizer.  Client stated symptoms began 5 minutes post vaccination, she denied headache, nausea, vomiting, diarrhea and any other symptoms. Client was alert and oriented to time, situation, place and person (CAOx4). Client was able to stand and walk on her own to the zero gravity chair for evaluation with a steady gait. At 0915 baseline vitals while sitting : Blood pressure (BP) 118/78, Respiratory Rate (RR) 12, heartrate (HR) 78, pupils were equal, accommodating, round and reactive to light (PEARRL), skins were normal color for ethnicity, warm and dry. EMT reassessed compliant of dizziness and client stated the symptom had subsided. Client stated she had not had anything to eat and had minimal fluid intake. Client denied history of dizziness following injections or vaccines and reported she takes aspirin daily. At 0925 second set of vitals while standing taken: BP 118/78, RR 12, HR 62, PEARRL, CAOx4, skin warm and dry. Client negative for orthostatic pressures. Client stated dizziness was fully resolved, she accepted a bottle of water and was advised to stay an additional 15 minutes for a total of 30 minutes observation. At 0942 client stated she had fully recovered from complaint of dizziness. She left observation site by self ambulation and had a steady gait.
Raised, red, feverish, 2 inch area at injection site followed with sinus drainage, sneezing 20 hr after injection lasting for 2 day period. (Right arm).
24 HRS PAST GETTING FLU SHOT PATIENT C/O BEING DIZZY, HAD LOW GRADE FEVER & RUNNY NOSE X 1 DAY.  DIARRHEA X 6-8 HOURS.
Left arm still sore off and on after 4 weeks from 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Left arm still sore off and on after 4 weeks from 1st dose) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included TAMSULOSIN for an unknown indication.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Left arm still sore off and on after 4 weeks from 1st dose). At the time of the report, VACCINATION SITE PAIN (Left arm still sore off and on after 4 weeks from 1st dose) outcome was unknown. Not Provided      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.   Concomitant product included eye drops (unspecified).  No treatment information was provided.   This case was linked to MOD-2021-148079 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 17-May-2021: The follow up received on 17-May-2021, contains information: added primary reporter details, additional reporter, date of administration of first dose and concomitant medications were added.