chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Painful injection spot for about 5 days after; This is a spontaneous report from a contactable consumer, the patient. A 66-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 30Aug2021 (at the age of 66-years-old) as a single dose for COVID-19 immunisation. Medical history included rheumatoid arthritis (RA) and cancer. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received unspecified concomitant medications. The patient previously received sulfur (MANUFACTURER UNKNOWN) for an unknown indication on an unknown date and experienced drug allergy. On 30Aug2021, the patient experienced painful injection spot for about 5 days after. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event painful injection spot for about 5 days after was recovered on an unknown date in Sep2021.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Mild, Systemic: Visual Changes/Disturbances-Mild, Additional Details: gave patient hepatitis a shot and afterward pt felt dizzy. He sat on chair and mom call nurse. After few minutes, he said felt better
Extremely painful thigh muscles/bones; achy all over; low grade fever (99.8); general malaise. Lasted until Sunday (10/16/22) morning.Still felt very tired and achy  much of the day.
Pain in arm, then for next 2 days fever and chills (continued pain in arm- redness, burning, streaking raised patches until emergency room treatment on 10/22/2012 (cellulitis was confirmed).
Localized erythema, swelling, pruritus and urticaria of left lateral thigh started 24 hours post injection. Increased in size 48 hours post injection. Increase in size and pain 70 hours post injection. Topical triamcinolone at 48 hours prescribed, Cephalexin 250 mg/5 ml take 8 ml BID prescribed as 70 hours.
I felt awful like never before in my life.  This lasted 3 1/2  days.  Joint pain, aches, fever, nausea, vomiting and extreme fatigue.  My family thought I had actually gotten COVID.  Still having reflux issues and not at 100% strength.
ACUTE HYPOXEMIC RESPIRATORY FAILURE 2/5/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Since 7/3/21 patient complains of fever 104.5F,  malaise, weakness, rigors, also developed cough and shortness of breath on 7/6/21
swelling, itching & induration devel about inject site w/in 1 hrs of inject; swelling cont to inc to 12cm x 10cm area w/in 48 hrs;
No additional adverse reactions reported; Patient inadvertently given PROQUAD and V ARlV AX on the same day; PROQUAD 0.5ml IM; This spontaneous report was received from a registered nurse referring to a 1-year-old  unreported gender patient. The patient's pertinent medical history, concomitant therapies, drug reactions, or allergies were not reported.     On 19-JUL-2021, "about a half hour ago", the patient was inadvertently given Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live recombinant Human albumin (rHA) (PROQUAD) 0.5 milliliters (ml)  intramuscular (lot number T036565 with expiration date 26-APR-2022) (incorrect route of product administration) and varicella virus vaccine live (Oka/Merck) (VARIVAX) 0.5 ml subcutaneous (lot number T036561 with expiration date 28-OCT-2022) as prophylaxis (incorrect route of administration and inappropriate schedule of product administration) (doses number, vaccination scheme frequencies and anatomical locations of administration were not reported).  No additional adverse reactions were reported.
Itchy upper thighs and underside of arms after 2nd shot; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Itchy upper thighs and underside of arms after 2nd shot) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A and 011J20A) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Feb-2021, the patient experienced RASH PRURITIC (Itchy upper thighs and underside of arms after 2nd shot). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Itchy rash, at an unspecified dose and frequency and HYDROCORTISONE (HYDROCORTISONE 1% IN ABSORBASE) for Itchy rash, at an unspecified dose and frequency. On 16-Feb-2021, RASH PRURITIC (Itchy upper thighs and underside of arms after 2nd shot) had resolved.            No concomitant medications were reported.   This case was linked to MOD-2021-395833 (Patient Link).
When I woke up this morning I could feel my throat was swollen and I had slight difficulty ingesting saliva. But I was able to drink water without too much problem. After a while when I was brushing my teeth I realized I could not gargle. I did not pay much attention. When I tried to eat breakfast I realized that I was not able to ingest any solid food at all. Then I realized my voice had become very hoarse. When I told my wife about it (she is a pediatrician) she looked into my mouth to check uvula but could not see it. She pointed out it could be an allergic reaction but was not sure of the reason. I took liquid Benadryl which we had at home and she also gave me a table of famotidine. I also had prednisone but did not take that as as I did not want anything to hurt vaccine's immunity effect. However, out of caution we drove to an ER and waited in its parking lot for an hour. Slowly I noticed that my swelling had reduced and I was able to see a little bit of uvula. So we decided to come back home. I am feeling much better now though not fully normal.
Nausea, Fever (up to 101.6), chills, rash developing next day over neck, arms, back
Pain at injection site. Difficulty moving arm X 24 hours; malaise; body ache; exhaustion; belly pain; nausea; anorexia all X 24-30 hours.
01/07/2021 7pm staff was shivering, chill, 100.2, body ache, joint pain, upset stomach. Following day fatigue, did not eat. Saturday, Sunday, still having upset stomach. Feel like having cold sore in mouth but could not see the cold sore.  Spoke with PCP.  PCP said could be something else.
Patient reported that she had redness and warmth at the injection site. After 24 hours the redness seemed to spread lower on arm.
pt recv vax 5/7/99 & 5//12/99 mom noticed a rash @ site;it cont to get more pronounced;5/13/99 so red raised area size & shape of lime bean;no itching or pain;warm to touch;
Patient developed symptoms of COVID 19 on 4/12/2021 Headache and cough.
Report 2001027578-1 describes soft tissue swelling at the dorsum of each wrist in a 9-year-old female who received hepatitis a vaccine inactivated (Havrix) and hepatitis B vaccine recombinant (Engerix-B).  (Please see 2001027578-2 for the Engerix-B report.)  Medical history, concurrent conditions, and concurrent medications were not specified. On 07 November 2001, the vaccinee received an injection of havrix into one deltoid and an ingection of Engerix-B into the other deltoid. It was not known if she had received previous injections of Havrix or Engerix-B. Approximately one hour post-immunization, the vaccinee experienced soft tissue swelling at the dorsum of each wrist. The vaccinee was sent to a clinic for evaluation. There was no redness, pain, or fever. The vaccinee was seen again in the clinic on 15 November 2001. There was no change, and swelling was still present
feel weird, objects looked distorted,; could not sleep; felt hyperactive with her eyes popping out of her head; bone pain; muscle soreness; Headache; hallucinations; This spontaneous case was reported by a consumer and describes the occurrence of HALLUCINATION (hallucinations) in a 54-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included GABAPENTIN for Peripheral neuropathy, CLONAZEPAM (CLONAZEPAM AUDEN) for Seizures, METOPROLOL, DROXIDOPA and MONTELUKAST SODIUM (SINGULAIR) for an unknown indication.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, the patient experienced HALLUCINATION (hallucinations) (seriousness criterion medically significant) and HEADACHE (Headache). On an unknown date, the patient experienced FEELING ABNORMAL (feel weird, objects looked distorted,), SLEEP DISORDER (could not sleep), EUPHORIC MOOD (felt hyperactive with her eyes popping out of her head), BONE PAIN (bone pain) and MYALGIA (muscle soreness). On 11-Apr-2021, HALLUCINATION (hallucinations) had resolved. At the time of the report, FEELING ABNORMAL (feel weird, objects looked distorted,), SLEEP DISORDER (could not sleep), EUPHORIC MOOD (felt hyperactive with her eyes popping out of her head), BONE PAIN (bone pain), MYALGIA (muscle soreness) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment given included Naproxen.  Company comment: Based on the information provided which includes a temporal association between the use of mRNA-1273 vaccine and onset of the reported events, a causal relationship cannot be excluded.  Headache and myalgia are consistent with the product safety profile.; Sender's Comments: Based on the information provided which includes a temporal association between the use of mRNA-1273 vaccine and onset of the reported events, a causal relationship cannot be excluded.  Headache and myalgia are consistent with the product safety profile.
Patient fainted directly after administration of HPV. Mom and nurse slid her to floor where she regained consciousness. (This was 3rd of 4th shots given)
Patient was given 3rd dose of COVID vaccine at park. Patient was bring down by staff to get COVID vaccine. Patient already received 2 doses of Moderna COVID vaccine but due to improper organization at facility and record keeping; pharmacist didn't realize patient was receiving third dose. Upon further evaluation we figured out that patient got third dose. We immediately informed facility staff and patient is monitored for vitals every 2 hours. No adverse event reported until now.
Adverse reactions or side effects experienced: N/A; The patient was vaccinated in 19-NOV-2016, 31-OCT-2017 and latest in 2019; This spontaneous report has been received from a lawyer, via a Plaintiff Fact Sheet and Medical Record from a case in litigation for Zoster Vaccine Live (ZOSTAVAX) (MARRS# 1907USA012323 original legal case), concerning a 69-year-old female patient. The patient's medical history, previous drug reactions or allergies and concomitant medications were not reported.  On 19-NOV-2016, the patient was vaccinated with Pneumococcal Vaccine, Polyvalent (23-valent) (manufacturer unknown), on 31-OCT-2017, she received a second dose of Pneumococcal Vaccine, Polyvalent (23-valent) (manufacturer unknown) and on an unspecified date in 2019 (reported as latest in 2019) she was vaccinated with a third dose of Pneumococcal Vaccine, Polyvalent (23-valent) (manufacturer unknown) (Inappropriate schedule of product administration), all administered as prophylaxis (strength, dosage schedule, route of administration, anatomical site of vaccination, vaccination scheme frequency, lot number, and expiration date were not reported for all doses). No adverse effects were reported.; Sender's Comments:  US-009507513-1907USA012323:
I was my everyday usual "feeling ill but somewhat functional" until I got the 2nd dose of Covid vaccination, since that night (4/14/21)  I've had a headache every day, nauseous, vomiting, sweats and chills, extreme body pain, dizzy, short of breath, I've had irregular ecg readings, and extremely tired, it has not gone away even now 5/23/21). I am also letting all of my physicians be aware.  I?d also like to note that the volunteers filling syringes were all at a round table eating and drinking with masks off, no gloves, socializing while filling the Covid vaccination syringes to be given to people with underlying illnesses and weakened immune systems.
pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (pain at the injection site) 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 No adverse event.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Mar-2021, the patient experienced VACCINATION SITE PAIN (pain at the injection site). At the time of the report, VACCINATION SITE PAIN (pain at the injection site) outcome was unknown. Not Provided          Action taken with mRNA-1273 in response to the events was not Applicable.  Concomitant product use was not provided by the reporter. Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-074957 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-074957:
As stated earlier, I have had HSV since 1984 and have consistently had 2-3 outbreaks per year treated only with Valtrex during the outbreak. Since having my 3rd Moderna Vaccine, I have noted monthly outbreaks requiring daily Valtrex and have even broken through that once since starting daily dosing of it. No other changes have happened in my life and I have not been sexually active since 2009.
Was administered a flu shot at my workplace by a pharmacy employee. Two days later my left arm began to hurt. On the third day the pain extended to the shoulder and the left side of neck. I lost strength in arm and was unable to lift heavy objects as well as lift arm. Tried to alleviate the pain with ICYHOT patches but they did not work. I then visited my physician and was prescribed BEVODINIX 1 capsule every 12 hours. To date the pain has not gone away. Can lift arm and strength is back but arm still in pain when I try to lift it and cannot lift past shoulder without pain.
Vertigo-like imbalance; Walking like a drunk without the booze; It isn't quite debilitating, but I have had to sit or lie down to help navigate the day; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administered in arm left, administration date 07Mar2021 11:00 (Lot number: EN6206) as dose 1, single for COVID-19 immunisation. Relevant medical history included: "Chronic bronchitis" (unspecified if ongoing); "seasonal asthma" (unspecified if ongoing); "known allergies: curry spice" (unspecified if ongoing); "have had vertigo" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Codeine, reaction(s): "allergies".  The following information was reported: BALANCE DISORDER (non-serious) with onset 10Mar2021 22:00, outcome "not recovered", described as "Vertigo-like imbalance"; GAIT DISTURBANCE (non-serious) with onset 10Mar2021 22:00, outcome "not recovered", described as "Walking like a drunk without the booze"; ASTHENIA (non-serious) with onset 10Mar2021 22:00, outcome "not recovered", described as "It isn't quite debilitating, but I have had to sit or lie down to help navigate the day". Therapeutic measures were not taken as a result of balance disorder, gait disturbance, asthenia.  Additional information: The patient experienced vertigo-like imbalance and walking like a drunk without the booze. The patient informed that she had vertigo and it was not vertigo. The patient did not receive other vaccine in four weeks. The patient did not receive other medications in two weeks.  The patient did not have COVID prior to vaccination. The patient had not been tested for COVID post- vaccination.   No follow-up attempts are possible. No further information is expected.
Numbness starting in left forearm, 50% of hand strength in lt hand loss, achy injection site, numbness rt forearm, bottom 2 digits of hand, neve ailment
This spontaneous report as received from a nurse refers to unspecified patients of unknown age and gender. Medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patients were vaccinated with ZOSTAVAX (dose, route and lot number were not provided). On an unknown date, the nurse reported that since unspecified date, improperly stored ZOSTAVAX administered to patients and no adverse effects were noted. Follow up information was received from the registered nurse. The registered nurse stated that she did not have patient identifiers or dates of vaccine administration available at that time. On an unknown date unspecified number of patients were vaccinated with ZOSTAVAX (lot#J014811, expiration validated as 21-FEB-2015). This is one of several reports received from the same reporter. Additional information has been requested.
BILATERAL FOOT SWELLING; BILATERAL FOOT REDNESS; This spontaneous report received from a patient concerned a 68 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non smoker, and non alcohol user, and other pre-existing medical conditions included the patient have no health conditions/medications. the patient had no known allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, expiry: 09-JUL-2021) dose was not reported, administered on 06-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 22-JUN-2021, treatment medications included: ibuprofen. On an unspecified date, the subject experienced bilateral foot swelling, and bilateral foot redness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from bilateral foot swelling, and bilateral foot redness. This report was non-serious.
Client was administered incorrect dose of vaccine based on age.  Client should have received Pfizer dose authorized for age 12+, client was in error administered pediatric dose
Outbreak of Herpes Simplex 1 on face. Approximately 30 hours post injection. Increased swelling in affected area. Went to ER to receive anti viral medications.
Only symptom was painful left arm when moved. Onset approx 45 minutes after immunization. Tx: Tylenol and cold compresses. As of 11/12, left arm remains painful to move.
Pt woke up with left knee pain during the night. The pain is on the side of the knee and it hurts when moves, not swollen. Does not hurt when touched.
Patient broke out in a severe rash with itching on right arm, left elbow and private area about 5 hours after administration. Rash has resulting in oozing wounds with scratching as well.
Pediatric vaccine was diluted with 0.13 ml instead of 1.3 ml so the patient got a more concentrated dosage than recommended. Patient presented mild pain at injection site the first 24 hours
Bloody diarrhea  x2 resolved same day Painful mouth ulcers resolved after 72 hours
Short of breath/SOB; It hurt really bad going in, like she hit a nerve; I was exhausted; I had a big knot on my arm where the shot was given; my arm was sore; This is a spontaneous report from a contactable consumer via a sales representative. A patient of an unspecified age received first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, solution for injection, Lot number unknown) intramuscular on 26Jan2021 as a single dose for COVID-19 Immunization.  The patient relevant medical history and concomitant medication were unknown. It was reported that after the first dose of vaccine on an unspecified date, the patient had experienced hurt really bad going in, like hit a nerve. Patient was exhausted went to bed from noon until about 5pm, arm was sore but not bad when went to sleep and then when woke up, patient had a big knot on arm where the shot was given. Patient rubbed it out and it lasted for 2 days. Then, 3-4 days after the shot, patient was taking the garbage can to the curb, it is on wheels, and had to stop twice in the driveway because was so short of breath.  It got better and then it happened again the next day walking into another room and was very SOB. Patient asked if this was normal. The outcome of the events was unknown.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
SOB, chest tightness, throat closing took 3 BENADRYL and 20mg Prednisone.
was diagnosed with epilepsy; grand mal seizure took patient's life; This case was reported by a consumer via interactive digital media and described the occurrence of grand mal seizure in a female patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received Bexsero. On 6th November 2018, unknown after receiving Bexsero, the patient experienced grand mal seizure (serious criteria death and GSK medically significant). On an unknown date, the patient experienced epilepsy (serious criteria GSK medically significant). On an unknown date, the outcome of the grand mal seizure was fatal and the outcome of the epilepsy was unknown. The patient died on 6th November 2018. The reported cause of death was grand mal seizure.   The reporter considered the grand mal seizure and epilepsy to be possibly related to Bexsero.  Additional details were provided as follows: The age at vaccination was not reported. The patient was healthy her whole life until her physician recommended she get the meningitis shot. Shortly after the vaccination, the patient was diagnosed with epilepsy.  On 6th November, 2018, a grand mal seizure took patient's life. It was reported that young woman was killed by the meningococcal vaccine. The case was linked with the case US2020AMR069851 reported by same reporter; Reported Cause(s) of Death: Grand mal seizure
1/18/23 Client reports that she is not pregnant and is currently on period. Varicella vaccine (and others as listed above) administered on 1/18/23. UPT obtained on 1/18/23 resulted as positive. Pt. reports last normal menstrual period on 12/9/22. Reports light bleeding/spotting on 1/6/23 and then bleeding became heavier by 1/15/23. MD impression on that day was concern for threatened abortion and plan was to return to clinic on 1/26/23 for repeat UPT. Pt. was seen on 1/26/23 for repeat UPT which resulted positive. Pt. was sent to ED for further evaluation of state of pregnancy.
Swelling of face and throat, did not require epinephrine. Treated with steroids and allergy medications.