chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a registered nurse and refers to an unspecified number of patients of unknown age and gender. There was no information about patients' pertinent medical histories, concomitant medications, drug reactions or allergies reported. On an unknown dates in 2016, the patients were vaccinated with an improperly stored doses of ROTATEQ (lot #L008057, expiration date 01-DEC-2016; lot# reported as L023870, expiration date 20-APR-2017, dose was not reported; orally). No adverse events were reported. The reporting nurse suspected, that some doses were administered as excursion, which occurred on 29-JAN-2016. Time frame 2 hours and 4 minutes, temperature 10.3 Celsius degree. This is one of several reports received from the same reporter. Additional information has been requested.
Rash CETIRIZINE 10 MG EVERY  DAY, METHYLPREDNISOLONE 4 MG Other as directed
3 cm round area on upper L arm. There is a nodular sense to the lesion. Painful to touch. No induration or surrounding erythema.  Does not represent an allergy, rather a response to vaccine.  Treated with Loratadine 10  mg tab, ice to area, and follow if not improving or worsening.
Red spots that looked like pimples on arm and thigh after first dose. One spot on under side of my arm kept getting bigger and led to a staph infection.
Five hours after the high-dose flu shot, I developed shaking chills and a fever. This has been followed by a flu-like illness that is still active 10 days later.
Chills, body aches, headache, stomach ache, fever 102. Lasted over 24 hours
Flushed skin, red veins, began within four hours of injection.  Nausea, Vomiting and dizziness after twelve hours.  Administered Benadryl to counteract reaction.  Flushed skin and nausea reduced after 16 hours.  Dizziness persisting into next day.
Panic attack; Fast hear beat; This spontaneous case was reported by a consumer and describes the occurrence of PANIC ATTACK (Panic attack) and HEART RATE INCREASED (Fast hear beat) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, the patient experienced PANIC ATTACK (Panic attack) and HEART RATE INCREASED (Fast hear beat). On 27-Mar-2021, PANIC ATTACK (Panic attack) and HEART RATE INCREASED (Fast hear beat) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Transient ischemic event with mental status changes, gait instability, diplopia, and speech slurring. Symptoms started 11/21/22. Patient reported she had COVID19 vaccine 11/10/2022  with influenza vaccine and attributes the TIA to COVID19 vaccine. Symptoms resolved. Had chronic small vessel  ischemic changes on MRI, but no evidence of acute infarct.
Patient received a dose that had expired; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a patient who received HAV (Havrix) (batch number unknown, expiry date 30th June 2022) for prophylaxis.   On 17th August 2022, the patient received Havrix. On 17th August 2022, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date:17-AUG-2022 Reporter's comment: The  pharmacist reported that on 17th August 2022 a patient received a dose of Havrix that had expired on June 2022. The reporter consented to follow up. The vaccine administration facility was the same as primary reporter. Additional supportive information: The patient had received an expired dose of Havrix, which led to expired vaccine used. Call center's email attached confirming that the formulation was not confirmed by reporter and neither by their system. Therefore conservatively it was coded as Solution for Injection.
Back pain, joint pain, stiff fingers and toes, jaw twitch, eye soreness, sleepiness
On 3/27/21 at around 9pm He felt tightness in chest which lead to heart attack and death
Informatino has been received from a pharmacist referring to a newborns (numbered 113). Background: Since June 2015, there had been 1645 times (30 minutes each time = 822.5 hours) that the temperature dropped below 36F. Of course, there was 144 times (30 minutes each time = 72 hours) that temperature was below 32F, the lowest being 29.7F. On 04-JUL-2015, there was a low temperature of 30.2F. On 20-AUG-2015 the patients were vaccinated with the improperly stored RECOMBIVAX HB strength 2.5/0.5 (units not provided) (lot number K020216 and expiration date of 17-SEP-2016) (dose and route of administration were not reported) (incorrect product storage). There was no product quality complaint (PQC). This is one of several reports received from the same reporter. Additional information has been requested.
Information has been received from a company representative concerning her 12 month old son who on 03-MAR-2007 was vaccinated with a first dose of varicella virus vaccine live (Oka/Merck) (lot number not provided). On 05-APR-2007, the patient developed oval shaped blisters on his leg, trunk and arms (30 in total). The blisters cleared off after 24 hours. Prescribing physician's information was not provided. Unspecified medical attention was sought. The outcome is reported as recovered. There was no product quality complaint. Additional information has been requested.
absence seizure-like loss of cognition extending from 10 hours after booster vaccine to 28 hours.  Uncomfortable, disconcerting loss of awareness then subsided, but I have been experiencing pre-ventricular contractions with an alarming frequency, and far beyond historical limits.
About 1 week after the 1st dose, beginning on 4/20/21, I started experiencing a significant increase in my tinnitus condition in my right ear. 2 wks later, it also started in my left ear. The ringing, buzzing and whistling sounds have become louder and very difficult to tolerate affecting my sleep and some other daily  resting activities. I informed my doctor and was advise to do Audiology test and discuss with ENT specialist.
A large erythematous mass with streaking was noted surrounding the small pox vaccination site.  Physician diagnosed as dermatitis.
2nd day swollen red lumps , very itchy all over body from the neck down, chest, stomach, arm thighs, calf for 5 days, with mild itching lingering and redness after 5 days,  swelling went down after 5 days
Tingling/itching in mouth and throat, no difficulty breathing at time of patient interview. Antihistimines prescribed.
The vial was initially stored in the refrigerator on 4-JUN-2023 and expired on 30-MAY-2023.; No adverse event; doses to patients on 5JUN2023 from vials of the Moderna COVID-19 bivalent vaccine that had expired.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses to patients on 5JUN2023 from vials of the Moderna COVID-19 bivalent vaccine that had expired.), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 4-JUN-2023 and expired on 30-MAY-2023.) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 019H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 05-Jun-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 05-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses to patients on 5JUN2023 from vials of the Moderna COVID-19 bivalent vaccine that had expired.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 4-JUN-2023 and expired on 30-MAY-2023.) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (doses to patients on 5JUN2023 from vials of the Moderna COVID-19 bivalent vaccine that had expired.), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 4-JUN-2023 and expired on 30-MAY-2023.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (doses to patients on 5JUN2023 from vials of the Moderna COVID-19 bivalent vaccine that had expired.) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 4-JUN-2023 and expired on 30-MAY-2023.).    No concomitant medication was reported.  Suspect product dosage text was reported as unknown. It was reported that no adverse reactions have been reported by any patients. The vial was initially stored in the refrigerator on 4-JUN-2023 and did not underwent any temperature excursions. No treatment medication was reported. This case is reported for patient 41 out of 50 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-735331 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-735331:Patient 1 out of 50 (Lot AS7143C was administered on 5Jun2023)
Severe myalgias x 24 hrs 3 days after nasal H1N1 FLUMIST & fever to 101 F, pt could not walk within 24 hrs.
tested positive for covid-19 in July; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (tested positive for covid-19 in July) in a female patient of an unknown age 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SARS-COV-2 TEST POSITIVE (tested positive for covid-19 in July). At the time of the report, SARS-COV-2 TEST POSITIVE (tested positive for covid-19 in July) outcome was unknown.            No concomitant medications were provided by the reporter.  No treatment information was provided by the reporter.  Company Comment: Based on the mechanism of action of mRNA-1273 causal association between the event of COVID virus test positive and mRNA-1273 is assessed as not applicable. The date of vaccination was not recorded, hence could not establish a temporal association or a causal relationship between the mRNA-1273 vaccine and the event reported. further FU is required to clarify the AE.; Sender's Comments: Based on the mechanism of action of mRNA-1273 causal association between the event of COVID virus test positive and mRNA-1273 is assessed as not applicable. The date of vaccination was not recorded, hence could not establish a temporal association or a causal relationship between the mRNA-1273 vaccine and the event reported. further FU is required to clarify the AE..
Had rash described as hives on abdomen, thighs that had onset 10-28-09. Had slight nasal congestion and red throat on exam. Diagnosed pharyngitis. No urticaria on exam. 10-29-09 beet red flush to upper chest. Rest of exam normal. Treated with initially Benadryl then Zyrtec. Had previous FluMist no problems.
Injection arm going to sleep; Itchiness at the injection site; redness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Injection arm going to sleep), VACCINATION SITE PRURITUS (Itchiness at the injection site) and VACCINATION SITE ERYTHEMA (redness at the injection site) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Itchiness at the injection site) and VACCINATION SITE ERYTHEMA (redness at the injection site). On 01-Mar-2021, the patient experienced VACCINATION COMPLICATION (Injection arm going to sleep). In February 2021, VACCINATION SITE PRURITUS (Itchiness at the injection site) and VACCINATION SITE ERYTHEMA (redness at the injection site) had resolved. At the time of the report, VACCINATION COMPLICATION (Injection arm going to sleep) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported.  Treatment medications was not provided by the reporter
Child c/o painful arm shortly after vaccination. Evening of 1/14/10 arm was noticeably swollen, red, warm to touch. Site of injection was raised- right arm. Dad is elevating arm, applying ice, giving Benadryl and Tylenol. Redness, swelling lasted 48hrs. All symptoms resolved in 3-4 days. Did not take to provider or ER.
After second dose close to 6 hrs but could be 4 hrs. patient developed very itchy hives on both arms, and pain at site of injection, increase over 2 days though remained on both arms, maybe a lesion on chest wall. No respiratory symptoms, no facial swelling, no GI symptoms, no sore throat. Noticed also small lymph nodes cervical at left side of neck, slightly tender. was prescribed H1 blocker cetirizine and Benadryl as needed .
Fever, Chills, headache, body aches. Severely Stiff neck Severe Headache Locked Jaw-unable to open and close Vomitting
Narrative:  complains of having narcolepsy while he was driving. He is drifted road several times. He is been fine until he received the SARS -CoV-2 injections for experimental gene therapy. He would like to make a case reporting of his event Additionally, he is no longer using CPAP because he is out of supplies. His last sleep study was done in 2015 at hospital.
On 10/15/2022 headache, congestion in head and lungs, upper respiratory, tired, and a cough. On 10/15/2022 and 10/16/2022 I took a COVID-19 home test, they were both negative. My symptoms stayed the same for another day. I tested positive on Monday, 10/17/2022. The symptoms were all the same except I had more congestion in the lungs. I called my doctor on 10/17/2022, he prescribed PAXLOVID. I started the PAXLOVID on the 10/18/2022. I tested negative on 10/23 and 10/25, but I still have respiratory congestion. It went deep into my lungs when I was on the PAXLOVID. It was worse than a cold.
Fever 101.9, Body aches, chills, headache, feeling slightly disoriented  Started at 4pm, approx 7 hours after injection  Treated with Tylenol, 3 extra strength tablets, every 4 hours Fever is down to 99.9 as of 5p 4/8 or 25 hours from symptoms onset
stomach ache; yucky; This is a spontaneous report from a contactable consumer (parent) reported for a patient (her kid) that: A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), dose 2 via an unspecified route of administration on 2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. Consumer stated, he was calling about some questions regarding, if you can tell me about the side effects of the Pfizer vaccine how long it last for his kids all have their second dose on the same day, 3 of his kid. His 3 children have vaccination, second dose at the same time at same day. One kid has stomachache and was yucky for couple of days on an unspecified date in 2021. Another child has continued to have headache since during the second shot migraine headaches since the second vaccine. He personally had his second shot. There is, last Saturday and he has having headache so, like bad headache, may get headache all days. So, He take two Ibuprofen (Hence, captured as suspect) it is (headache) not going away so, he just wants to know. He wants to know, his son is Type-1 diabetic, and it is not little managed, and he had his first vaccination try to figure out to his second and he did not tried Ketone and BKA since he got his first vaccination, his first shot. He is not feeling good at all, he is been sick, he had no energy and he just feel yucky. So, how long last for how long before we are ok, just wanted to know about headache and stuff. When probed for the confirmation vaccine name as Pfizer COVID 19 vaccine, Consumer stated, he got his second shot since he got his first shot, yes. The event outcome was Recovered on unspecified date in 2021.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Patient presented for second dose of the Pfizer vaccine, but given the incorrect formulation for patient age (patient received formulation intended for 12 and older). Error was realized on day of vaccination. Contacted patient's parent and explained error and possible adverse reactions that could be experienced. Parent reported no significant reaction. Follow-up call placed 2 days later, with no significant reactions noted.
One week following injection of Prevnar, mother noticed small dimple. No redness swelling or pain (Right thigh). Over the next several weeks, area became bigger. Mother brought child in 12/18/02 to have indentation in right thigh checked (3cmx1.5cm area of fat necrosis on right anterior thigh. Referred to plastic surgery. Appointment with doctor on 1/29/03.
I'm not sure if this related to the vaccine, but I suspect it is. Starting about 10-14 days after receiving the vaccine (IM into my deltoid), I have been experiencing a regional (almost dermatomal) distribution itchiness and hypersensitivity in my left infrascapular and upper lateral back region. It's a superficial (dermal/epidermal) discomfort, not deep. I have observed NO associated rash or hives; nothing is visually evident. I am still experiencing this at day 19 post vaccine. I've not taken any medication, have not applied any topicals, etc.
developed a severe rash after getting the second shot of the Pfizer COVID-19 vaccine. The rash was on my back. It goes away and comes back. From yesterday it spread to my entire body.; fever; nausea; couldn't sleep; shingles; This is a spontaneous report from a contactable consumer (patient). A female patient of unspecified age received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date (at an unspecified age) at 2nd dose, single for COVID-19 immunization. Medical history included shingles, breast cancer in 2009 followed by lumpectomy with radiation treatment (during radiation treatment, she developed shingles, was sent by doctor to dermatology for treatment). The patient was not pregnant at the time of vaccination. The patient's concomitant medications were not reported. Historical vaccine included BNT162B2 (dose: 1) for COVID-19 immunization. It was reported that after getting the second shot of Pfizer COVID-19 vaccine, the patient developed a severe rash. The rash was on the patient's back. It goes away and comes back. From yesterday (as reported), the rash spread to the patient's entire body. The patient also had fever with nausea and could not sleep. The patient asked if she could take diphenhydramine hydrochloride (BENADRYL). The patient noticed that after the second shot of Pfizer vaccine on the third (as reported), the patient's rash got worst, it looked like shingles. Outcome of the events was unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
9:59 AM - Vaccine  2:39 PM - Stinging pain in left arm which slowly radiates out from the vaccine site over the next several hours  7:25 PM - Pain reaches base of neck  7:29 PM - Nausea  7:30 PM - Lightheadedness  8:09 PM - Pain reaches tailbone  8:13 PM - Entire back and both shoulders begin throbbing  11:25 PM - nasal congestion  12:15 AM - body temperature drops to 97.9  12:20 AM - shortness of breath, blood oxygen drops to 95%  12:32 AM - blood oxygen drops to 92%.  12:34 AM - blood oxygen rebounds to 95%  12:35 AM - blood oxygen stabilizes at 96%. I am usually at 97-98 while resting.  1:31 AM - one of the worst sore throats I've had in my life begins  2:05 AM - low grade fever 99.1, chills, severe shivering even when under three blankets with heater on full blast, uncontrollable muscle spasms in face, arms, fingers, and legs  7:32 AM - woke up with severe muscle and joint pain. Too bad to sleep through. Can't even walk from my bed to my bedroom door without collapsing. High grade fever 101.7.
09/01/2022 While taking my shower, I noticed more hair loss. It continued until all my hair was gone. I talked to my PCP, and she added a new medication, it did not help so she topped the medication. I then went to a Dermatologist. He said it was probably connected to stress. He diagnosed me with. Lately I have heard about hair loss with COVID. As far as I know, I have never had COVID.
Patient with acute onset of severe vertigo and disequilibrium, also with redness, pain and swelling at injection site. Patient had unstable gait on neurologic exam and positive Dix Hallpike. She had an urgent MRI brain that was negative. She was treated with antibiotics for cellulitis at injection site.
Pt recvd hep B vax on 29NOV89,08JAN90 & 11JUN90.Test results neg for HBSAB.Addt'l dose given 18SEP90 & test results were weakly pos for HBSAB.