chrisvoncsefalvay/vaers-outcomes huggingface dataset:
headache; chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 15-year-old female patient received BNT162b2 (BNT162B2), on 26Jan2022 as dose 3 (booster), single (Lot number: FH8027) at the age of 14 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot#EW0164), administration date: 19May2021, when the patient was 14-year-old, for Covid-19 immunization, reaction(s): "headache", "chills"; BNT162b2 (DOSE 2, SINGLE, Lot#EW0172), administration date: 09Jun2021, when the patient was 14-year-old, for Covid-19 immunization, reaction(s): "headache", "chills". The following information was reported: HEADACHE (non-serious), outcome "unknown"; CHILLS (non-serious), outcome "unknown".   Additional information: The mother calling on behalf of her daughter (patient) who received Pfizer covid-19 vaccines; the mother stated that after the first three Pfizer doses everything was ok, aside from headache and chills. Fourth dose on 24Jan2023 Lot#GK1337: Pfizer bivalent.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300039503 same product, event and patient, different dose;
Woke up with 100 degree fever around 5:00am, 1 day post-vaccination.  Fever persisted 24 hours, with intense night sweats. Other flu-like symptoms included headache and eye pain. Eye pain persisting until time of this report. Eye movement is painful, but no blurred vision. Sore arm persists.
woke up next morning w/moderate-severe muscle pain (hard to walk) and feeling very Weak and fatigued.  Stayed in bed all day and about half of the next day. Pain in arm lasted 3 more days
Staying seated after the shot - 3 minutes after she became antsy 4 minutes after she became nauseous and sweaty 5 minutes after she was very thirsty wanted a drink  6 minutes after she took a drink, she lost all color in her face and lips and then passed out. (She had a few convulsions so to me it seemed like a seizure) I asked the pharmacy tech to call ambulance and she did She came to and was still very pale and sweaty, confused, scared, she was happy to be alive 20 minutes after - the ambulance showed up and checked her vitals. They were back to normal so we went home.
Got a 0.5 ml dose instead of a 0.25 ml dose for their booster.; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL OVERDOSE (Got a 0.5 ml dose instead of a 0.25 ml dose for their booster.) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 071F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, the patient experienced ACCIDENTAL OVERDOSE (Got a 0.5 ml dose instead of a 0.25 ml dose for their booster.). On 25-Oct-2021, ACCIDENTAL OVERDOSE (Got a 0.5 ml dose instead of a 0.25 ml dose for their booster.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported. Treatment information was not reported.   This case was linked to MOD-2021-363330 (Patient Link).
This case was reported by a consumer via call center representative and described the occurrence of sweating in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, 3 hrs after receiving SHINGRIX, the patient experienced sweating, chills, pain in arm, fever, cough and headache. On an unknown date, the outcome of the sweating, chills, pain in arm, fever, cough and headache were recovered/resolved. It was unknown if the reporter considered the sweating, chills, pain in arm, fever, cough and headache to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. About 3 hours post vaccination the patient experienced sweating and chills which lasted for 1 day and pain in the arm which lasted for 5 days. Next day the patient experienced low fever of 100.4 degrees which lasted for 1 day, along with cough and headache which lasted for 3 days. The caller did not want to provide any additional information. Lab Comments: lab test performed on an unknown date.
Nausea, feel bad within 5 minutes resolved with cold compress papertowel.  No local reaction at sites.  Mother called back reports  rash on stomach, neck and face. Red and eyes puffy about an hour later.  TX at local doctor with epi shot of benedryl, Rx for steroids, take at home, no SOB per mother.
Initial information received on 10-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to cases 2018SA284722, 2018SA284723, 2018SA284724, 2018SA284725, 2018SA284726, 2018SA284727, 2018SA284728, 2018SA284729, 2018SA284730, 2018SA284731, 2018SA284733, 2018SA284732, 2018SA284734, 2018SA284735, 2018SA284736, 2018SA277767, 2018SA284721, 2018SA284751, 2018SA284752, 2018SA284746, 2018SA284747, 2018SA284748, 2018SA284749, 2018SA284753, 2018SA284754, 2018SA284750 (same reporter). This case involves a six-year-old patient (gender not reported) who was vaccinated with a dose of FLUZONE QUADRIVALENT (lot number- U1997AA and Exp. date 30-Jun-2019) via intramuscular route in the left deltoid on 03-Oct-2018, which was outside of the recommended temp range (below 32F). The patient's medical history and concomitant medications were not reported. It was an actual medication error due to incorrect product storage. No information about any adverse event reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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. List of documents held by sender: none.
The day I received my first vaccine dose, my period started that night.  Cramps, clots, massive blood loss for 10 days.  My normal period is not like this at all.  My normal period lasts 3-4 days, heavy on the first day, then gradually lessens and is over by the 4th day.  on 9/18/21,  I was tired and felt ill all day.  At  3am on 9/19/21, I woke up with the worst stomach pain, fever, nausea.  It was gone in four hours.
Pt. stated that his arm started swelling within the hour, felt like he had been stung by a bee, then hand swelled, left his hand and calf swelled and pt says there was a knot at his knee, then his buttocks got welts that were extremely itchy and pt scratched them and he still has marks from that. Afterwards  went back to legs and arm swelled quite severely like he had been stung by a wasp. This lasted about two weeks. Pt did not seek treatment and reported to me today on 9/12/2017.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 45-year-old male patient received BNT162b2 (BNT162B2), on 07Apr2021 as dose 1, single (Batch/Lot number: unknown) and on 26Apr2021 as dose 2, single (Batch/Lot number: unknown) at the age of 44 years for covid-19 immunisation. The patient's relevant medical history included: "tension HA" (unspecified if ongoing), notes: tension HA; "plantar fasciitis" (unspecified if ongoing); "varicose veins" (unspecified if ongoing); "hx elevated BP reading" (unspecified if ongoing), notes: hx elevated BP reading. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (22Jul2022) Negative; (23Jul2022) Negative; (24Jul2022) Negative; (25Jul2022) Positive, notes: awoke symptomatic today 25Jul2022 and was positive on recheck. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Other medication in 2weeks was reported as no. Known allergies was reported as NKDA.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect drug to  l the reported events vaccination failure , covid 19   cannot be completely excluded based on temporal association and known drug safety profile
COVID; This spontaneous report received from a consumer via a company representative 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, and batch number were not reported) dose was not reported, administered on MAR-2021 for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On DEC-2021, the patient experienced covid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from covid. This report was non-serious. This report was associated with a product quality complaint: 90000262891. This case, from the same reporter is linked to 20221225992.
Information has been received from a 72 year old female consumer, with no known allergies, and a history of chicken pox as a child, who on 20-FEB-2007 was vaccinated with a single dose of ZOSTAVAX (lot#652947/1411F). On 12-JUL-2007 the patient developed a sharp pain in her front and back. Medical attention was sought and shingles was diagnosed on 14-JUL-2007 by an emergency care physician. At the time of this report the patient had not recovered. There was no product quality complaint involved. Follow up information has been received from the physician. on 14-JUL-2007 the patient went to the emergency room for a rash on her left thorax. It was noted that this was a papular rash without vesicles. the rash was painful and in a distribution commonly seen with herpes zoster. The patient was diagnosed with herpes zoster. The patient was diagnosed with herpes zoster. The patient was prescribed FAMVIR 500mg two tablets a day and the rash subsequently resolved completely. She did not have any sequelae from this rash and was otherwise doing well. No further information is expected.
I tested positive for Covid on 17Mar; I tested positive for Covid on 17Mar; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Sep2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 17Mar2023, outcome "unknown" and all described as "I tested positive for Covid on 17Mar". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (17Mar2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient stated, "I had all my boosters including the bivalent one in Sep2022. I begged and pleaded to get another the beginning of Mar2023 because I was going. I was denied. I tested positive for Covid on 17Mar, got Paxlovid on 19Mar".  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
SIDS death; pt had cold sx a/death; no treatment; mom stated mucus was coming out of nose & mouth when awoke & saw pt was dead; 16FEB92 had URI;
After the injection at 4:00 p.m. on December 13, I started to have a slight pain in my arm that night. On the morning of December 14, I started to have chills and a temperature of 37.5 degrees until 3:00 p.m. After 3:00 p.m., I started to have a very bad headache, muscle pain in my upper body, a bit of nasal congestion, a temperature of 37.8 degrees, a heartbeat of 100 beats per minute, I could feel my heart beating, a bit of vomiting, and a poor appetite. By 4:00-7:00 p.m., the fingers and palms start to feel numb, with some pins and needles sensation in my fingers, hands and arms, while the calves have a muscle jumping and numbing sensation. After 8:00 p.m., my whole body started to feel weak and my lower back was sore, while the numbness was reduced. On December 15, I woke up and my fever was gone and my arms were almost pain-free, and all my symptoms improved.
Day one joint pain, sore throat, hard to breathe. Day two congestion and fever. Day three headache and cough. Symptoms continued for 20 days.
Fatigue,  significant muscle soreness throughout body, but especially in legs, soreness at injection site
Tiredness, sore arm,  bad torso rash, general feeling of unwell.
pt devel maculopapular lesions on 7APR97 w/sl edema of rt ear & ankles;number of lesions about 30;mild area of rash/hives noted;8APR97 sx were increasing & mod to severe case of hives reported;saw MD 9APR97 dx as allergic rxn to vax;
-Very sore arm. Constant issues -Keeps me from sleeping (no sleep on left side) -Wakes me up -Cannot extend arm overhead as usual
I was itching at first and then started breaking out. I thought I had food poisoning or something from eating. I went to urgent care, and they gave me a steroid shot. It went away and then came back again. I went back to the ER, and they gave me another steroid shot and it went away but came back again. I am having to take BENADYRL constantly. They told me I need to see a specialist, but the appointments are like 3 months out.
Observation volunteer called clinic rapid response team.  This RN assessed the client; VSS, no dificulty breathing.  Client states bilateral upper extremities felt 'tingly'.  Sensation resolved within 5 minutes of oberservation, but began to feel nauseious.  Requested that client move to vaccination area for closer observation for a longer observation period.  Client cooperative.  After about 15 minutes client vomitted small amount.  No other symptoms.  Client monitored for additional 30 minutes.  Nausea resolved.  Advised client she should call 911 if any s/s return. Client verbalizes understanding.
Information has been received from a licensed practical nurse concerning a 38 year old female patient who on an unspecified date was vaccinated with a dose of MMR II. The nurse reported that the patient had a negative measles titer. The patient did not have any information about previous immunization, but knew she had previously, at "some time", received MMR II vaccination. The patient's outcome was unknown. Additional information has been requested.
After receiving the COVID-19 vaccine, patient fainted, his head hit the wall, felt very hot, nauseous and dizziness. @1050 patient was evaluated by Dr. BP was taken every 10 minutes.
This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 76-year-old female patient who received SHINGRIX (batch number C523T, expiry date 4th July 2020) for prophylaxis. On 27th April 2018, the patient received the 1st dose of SHINGRIX. In June 2018, several weeks after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were provided as follows: In first week of June 2018, the health care professional reported that the patient experienced shingles a few weeks after receiving the dose of the SHINGRIX series. The health care professional was not sure of lot number either it was C523T or Cs23T.  The health care professional could not read the writing.
Left leg red swollen warm to touch. No fever reported. Mother administered Tylenol. No reports of pain in the leg. Walking on the leg without difficulty.
Muscle Aches & pains, low grade fever, headaches has continued for past 7 days, soreness at injection site
ITCHINESS; This spontaneous report received from a patient concerned a female 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, and batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 18:01 for prophylactic vaccination on left arm. No concomitant medications were reported. On 04-APR-2021, the subject experienced itchiness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of itchiness was not reported. This report was non-serious.
Information has been received from a physician regarding a male patient of unknown age with no pertinent medical history, drug reactions or allergies. On 12-MAR-2014, the patient was vaccinated with a first dose of M-M-R II (route and lot number were not provided). On 24-MAR-2014, the patient developed a spotted rash that waxed and waned and was not getting worse. Physician mentioned that rash now looks like dark spots on the patient's had and torso. A blood work (CBC) was performed and results were unspecified. The patient did not receive treatment for the adverse event. The patient sought medical attention, at office visit. At the time of the report, the patient had not recovered from the adverse event. Additional information has been requested.
Upper left arm, tingling, super sensitive to touch, Day 2:  shoulder and chest pain. Day 4:  shingles rash. Day 5:  shingles Dx, Valtrex Rx.
feels like someone is pushing on side of ears; car sickness; joint pain; nausea; headache; fatigue for 8 hours of day & at night; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of EAR DISCOMFORT (feels like someone is pushing on side of ears), MOTION SICKNESS (car sickness), ARTHRALGIA (joint pain), NAUSEA (nausea) and HEADACHE (headache) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History Information was reported.     In February 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EAR DISCOMFORT (feels like someone is pushing on side of ears), MOTION SICKNESS (car sickness), ARTHRALGIA (joint pain), NAUSEA (nausea), HEADACHE (headache) and FATIGUE (fatigue for 8 hours of day & at night). At the time of the report, EAR DISCOMFORT (feels like someone is pushing on side of ears), MOTION SICKNESS (car sickness), ARTHRALGIA (joint pain), NAUSEA (nausea), HEADACHE (headache) and FATIGUE (fatigue for 8 hours of day & at night) outcome was unknown.            Symptoms: Patient reported that side effects includes congestion.  No concomitant medications were reported. Treatment medication includes: Antibiotics.  Action taken with mRNA-1273 in response to the event was not applicable.   Reporter did not allow further contact
Started with nausea and headache (within a couple of hours of shot). Woke at 12:20 am with high temperature, severe shakes, extreme weakness and inability to walk without assistance due to shaking and weakness. Had extreme body aches and full blown migraine. Was too weak to call for help. Had Advil in nightstand and took several to help. Called doctor in the morning and was advised to rotate Advil and Tylenol. Was too weak to get out of bed all next day (Friday) and half of Saturday. Also experienced tightness in chest to where I had to start taking Albuterol (haven't taken that in years). Bad side effects and extreme weakness and total loss of energy lasted 3 days.  Persistent headache and tightness in chest lasted up to 7 days.. Horrible experience. I felt like I was poisoned.
Fibromyalgia, migraines, eye pain, 24/7 pain, nausea, constant fatigue, circulation issues - blood pooling in hands and feet, ovarian cysts, multiple strep throat and tonsillectomy.
Information has been received from a physician concerning a female patient who on an unspecified date was vaccinated with GARDASIL. Subsequently, the patient experienced dizziness and nausea within a few minutes post-vaccination. Unspecified medical attention was sought. It was reported that the symptoms lasted only a few minutes. Additional information has been requested.
Patient reported via phone erythema, and hives at site of vaccine one hour later post second dose of Hepatitis B vaccine, stated on 7/22/16 that she had mild erythema after dose one.
This case was reported by a consumer via call center representative and described the occurrence of disorientation in a female patient who received SHINGRIX for prophylaxis. On 31st August 2018, the patient received the 1st dose of SHINGRIX. On 31st August 2018, less than a day after receiving SHINGRIX, the patient experienced disorientation, lightheadedness, injection site pain, pain in arm, pruritus and weird feeling. The patient was treated with Cortisone Cream. On an unknown date, the outcome of the disorientation, lightheadedness, injection site pain, pain in arm, pruritus and weird feeling were unknown. It was unknown if the reporter considered the disorientation, lightheadedness, injection site pain, pain in arm, pruritus and weird feeling to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient felt very odd (lightheaded, disoriented and extreme pain at the injection site for the entire day). The patient's arms were very sore much longer. However, since then, the patient had been itching constantly mostly on stomach but it had moved to her lower extremities at the time of reporting. The patient received Cortisone Cream which did help but the patient was not sure how long this was suppose to last and asked would the side effects be as severe with the second dose. This case has been linked with US2018GSK175246, reported by the same reporter.