chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Morning after 1st dose of Pfizer vaccine for COVID-19 had itching on ankles, later that day itching on wrists, followed by hives on arms and legs. I called PCP, spoke with NP who advised Claritin in morning and Benadryl at night. I don't tolerate Benadryl, so advised Claritin twice a day was ok and to resume Claritin 1 day after 2nd vaccination.  Stopped Claritin after hives resolved, 3 days before second vaccination was scheduled. The day before second vaccination scheduled I developed watery blisters on the outside of right thigh. I kept appointment for 2nd Pfizer but advised at that time may have worse reaction after 2nd Pfizer and that I had up to 3 weeks more to get 2nd Pfizer if I chose to do so. I called PCP after returning home. Got callback from NP next morning. Advised not to take 2nd Pfizer and to wait before trying any other vaccine. I mentioned increase number of watery blisters and beginning of pain in thigh but this was not addressed.  I checked internet for symptoms and suspected Shingles, even though I had been vaccinated some years prior. The next day pain was worse. I called again and insisted on talking directly to PCP. Over the phone diagnosed as Shingles and confirmed via photos.
Not get to sleep last night; Knot on the area of the injection; Pain on left arm where the vaccine was administered; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Not get to sleep last night), VACCINATION SITE MASS (Knot on the area of the injection) and VACCINATION SITE PAIN (Pain on left arm where the vaccine was administered) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039A21A and 027A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INSOMNIA (Not get to sleep last night), VACCINATION SITE MASS (Knot on the area of the injection) and VACCINATION SITE PAIN (Pain on left arm where the vaccine was administered). At the time of the report, INSOMNIA (Not get to sleep last night), VACCINATION SITE MASS (Knot on the area of the injection) and VACCINATION SITE PAIN (Pain on left arm where the vaccine was administered) outcome was unknown.            No concomitant medication were reported. No treatment medication was reported.
Patient was given a 3rd Hep A.   She had received the 1st one on 09.20.2012 and the 2nd on 04.16.2013.  She was given a 3rd one on 04.12.2019- there was no adverse reaction noted .
Feeling awful; This case was reported by a consumer and described the occurrence of feeling unwell in a 57-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th October 2019, the patient received the 1st dose of Shingrix. On 11th October 2019, 1 days after receiving Shingrix, the patient experienced feeling unwell. On an unknown date, the outcome of the feeling unwell was unknown.   It was unknown if the reporter considered the feeling unwell to be related to Shingrix.  Additional case details were reported as follows: The patient had first Shingles vaccine the day before reporting. The patient had shingles vaccine and felt awful on day of reporting. The reporter requesting consent to follow up.
This spontaneous report was received from a nurse practitioner who referred to an unspecified number of patients of unknown demographics. No information regarding the patients' pertinent medical history, concomitant medications and drug reactions or allergies was provided. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX (lot# M039317 and expiration date: 20-SEP-2018 and lot# M033904 and expiration date: 20-JUL-2018; dose and route of administration were not reported) as prophylaxis. The vaccines were stored in the temperature between 6 degrees Fahrenheit (F) to 14F (9.1F) for 2 hours, with a previous temperature excursion of more than 6F and less than 14F (9.9F) for 15 hours. Data logger was not involved. It was reported that sterile diluent (manufacturer unknown) used to reconstitute the vaccines was properly stored. No adverse effects were reported. No product quality complaint was involved. This is one of three reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1707USA000248: US-009507513-1707USA001314.
vaccine does appear to have highly elevated the ringing. The second dose seemed to elevate it; my face and neck felt slightly inflamed, almost "puffy"; my face and neck felt slightly inflamed, almost "puffy"; This is a spontaneous report from a contactable consumer or other non hcp (patient) .  A 33-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date (Age at vaccination was 33 years) as dose 2, single for covid-19 immunisation. Medical history included alcoholism from an unknown date and unknown if ongoing. The patient did not have covid-19 prior to vaccination. The patient did not have any known allergy. The patient took Selective serotonin reuptake inhibitors (SSRI) in two weeks. The patient did not take other vaccine within four weeks. Previously patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number was ER8734 and expiration date were not reported), via an unspecified route of administration, administered in left arm, on 31Mar2021 at 16:30 hours (Age at vaccination was 33 years) as dose 1, single for COVID-19 immunization and few hours later he got a headache and some queasiness, the typical side effects. His ears began loudly ringing, which he attributed to the headache and immune response. The headache and nausea quickly faded, but his tinnitus remained highly elevated for weeks. His GP cleaned out his ears, which were heavily impacted with earwax, and that definitely helped. The patient experienced vaccine does appear to have highly elevated the ringing. the second dose seemed to elevate it, his face and neck felt slightly inflamed, almost puffy. The patient Seeing similar reports in group that does not appear to be populated by conspiracy theorists, anti-vaxxers or hypochondriancs. Patient think this was a real side effect and some guidance from Pfizer/CDC would be appreciated. The patient did not tested covid-19 post vaccination. The outcome of the events was unknown.  No follow up attempts are possible. No further information is expected.
This case was reported by a pharmacist via sales rep and described the occurrence of cold symptoms in a 60-year-old female patient who received SHINGRIX. Concomitant products included SHINGRIX. On 3rd April 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. In April 2018, less than a month after receiving SHINGRIX and SHINGRIX, the patient experienced cold symptoms and muscle pain. On an unknown date, the outcome of the cold symptoms and muscle pain were recovered/resolved. The reporter considered the cold symptoms and muscle pain to be related to SHINGRIX. Additional details were provided as follows: For tolerability after receiving 1st dose of SHINGRIX, refer case US2018077610. The patient received SHINGRIX in an unknown deltoid. The patient experienced cold like symptoms and muscle aches. The reporter stated that the symptoms during the 2nd dose were even more intensified. The symptoms lasted for approximately about 2 weeks. All questions were asked but the reporter provided limited information.
Before shot, pt. may have been anxious. About 15-20 minutes after shot given, pt. started to feel dizzy & nauseous. Pt. stated her vision was blurry & felt hot. She had slight difficulty breathing. She was told to rest for a while but she thought she could walk it off. She came back & felt worse. She wanted to call ambulance. Paramedics did not determine allergy response but gave pt. breathing treatment & brought her to hospital.
52f for 1 hour and 37 minutes with no adverse event reported; administered the ipol (opened) after the excursion with no adverse event reported; Initial information received on 20-Dec-2022 regarding an unsolicited valid  non-serious case received  from  a other health professional.  This case is linked to case 2022SA515962.  This case involves temperature excursion in which a 14 years old male patient who experienced 52f for 1 hour and 37 minutes with no adverse event reported and was administered the ipol (opened) after the excursion with no adverse event reported.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included meningococcal vaccine a/c/y/w conj (tet tox) (menquadfi) hepatitis b vaccine rhbsag (yeast) (engerix) and hepatitis a vaccine inact (havrix), Verivax for Immunization  On 19-Dec-2022, the patient received a (series: N/A) suspect IPV (VERO)(Dose- 0.5mL)(Frequency-Total/once) (Batch/lot number -V1A021M)( Strength = Standard)(Formulation- Suspension for injection) (Expiry date-17-Feb-2024) via intramuscular route in the right deltoid for Immunization.    On an unknown date the patient developed a non-serious events 52f for 1 hour and 37 minutes with no adverse event reported (product storage error), administered the ipol (opened) after the excursion with no adverse event reported (poor quality product administered)  (Latency- Same day) following the administration of IPV (VERO).  It was reported IPOL(opened) was involved in a temperature excursion. She asks if it is safe to use. She adds that 3 different patient's were administered the IPOL (opened) after the excursion. She adds that none of the patient's experienced any additional AE's as a result of this. Products involved? IPOL (opened).  Action taken : Not applicable.  At time of reporting, the outcome was Unknown for the events  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. 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.
I had not been menstruating at all for 6 months prior to the vaccination then I started getting periods that went on for three weeks straight. It took about two months for it to settle down. I was menstruating on and off for those two months. I tested positive for COVID-19 on 03/28/2022 and then my period started again and it's still ongoing.
Brief generalized sz (2), lasting under 1min each; Fever 102-103, crying over 3hrs;
ash under arms and armpits, with whelps took took 9 days to resolve, tx w/Benadryl, Campho-Phenique,compresses called PCP not available.  Pharmacist recommended OTC meds for pt.
Hives all over body (arms and face). Hives began on left arm and she had swelling and redness at the injection site. Hives came and went for 3 days.
TONGUE ITCHY, SWOLLEN.  LIPS SWELLING.  SOB.
Fever, swollen, warm thigh (anteriorly) with blotchy red macular rash-significant increase in size of thigh; No systemic rash.
Pt recvd MMR vax as a child & pt currently exhibited a lack of response to mumps; no further details were provided;
Sore arm; Swollen arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and PERIPHERAL SWELLING (Swollen arm) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm) and PERIPHERAL SWELLING (Swollen arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) and PERIPHERAL SWELLING (Swollen arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.; Sender'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.
severe pain in vaccinated arm requiring evaluation by health care professional, arm is swollen, no lymphadenopathy, no sign of infection, Rx provided for meloxicam
Red, itchy, painful patch about the size of a tennis ball at injection site. Appeared about 36 hours after vaccination and has lasted over 3 days so far.
Myocarditis diagnosed  ~6.5 weeks  after vaccine, but he reports mild symptoms of  intermittent chest pain, fatigue, and hair loss starting shortly after the Trumenba vaccine.  Cause of myocarditis still undetermined (testing pending).
p/ pt recv vax approx 1yr later devel breakthrough varicella described as mild disease w/less than 50 lesions. m.d. attend sought
TIA  Had my left arm go limp and slurred speech for about three minutes.  Treatment is baby aspirin and Atorvastatin 40mg 1/day Complete recovery
This spontaneous report as received from a other health professional refers to multiple unspecified patients of unknown ages. On 27-JUL-2017 the patient was vaccinated with PROQUAD for prophylaxis. Concomitant therapies included sterile diluent. On 27-JUL-2017, the patients experienced incorrect product storage. On an unknown date the patient experienced no adverse event. The reporter considered incorrect product storage and no adverse event to be not related to PROQUAD. Sender's Comments: US-009507513-1709USA000361: US-009507513-1709USA001607.
Caller states she has had SOB since receiving her vaccine on Sunday.  Able to talk in full sentences during call, denies SOB at this time, however, states that her SOB is constant.  Encouraged to seek care from her MD.
Case number PHEH2014US012647 is an initial spontaneous report received from a physician on 20 Jun 2014: This report refers to a 17-year-old male patient. He was given only MenA component of MENVEO (batch number: M13059) intramuscularly reconstituted with sterile saline instead of MenCYW-135 on 20 Jun 2014. No adverse event was reported following  this administration error.
he has cancer, was in surgery recently; suffered a stroke; amyloidosis diagnosis; his memory has been effected; unable to concentrate on details.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  An 83-year-old male patient received BNT162b2 (BNT162B2 NOS), 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: NEOPLASM MALIGNANT (medically significant), outcome "unknown", described as "he has cancer, was in surgery recently"; CEREBROVASCULAR ACCIDENT (medically significant), outcome "unknown", described as "suffered a stroke"; AMYLOIDOSIS (medically significant), outcome "unknown", described as "amyloidosis diagnosis"; MEMORY IMPAIRMENT (non-serious), outcome "unknown", described as "his memory has been effected"; DISTURBANCE IN ATTENTION (non-serious), outcome "unknown", described as "unable to concentrate on details.". Therapeutic measures were taken as a result of neoplasm malignant. Clinical course, reportedly, the patient had cancer, was in surgery recently and suffered a stroke; also stated his memory had been effected and he was unable to concentrate on details. He stated he had taken all of the Pfizer COVID vaccines and believed they had kept him alive through the cancer and now amyloidosis diagnosis. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300097038 same reporter/patient, different AE/drug;
Site of PNEUMOVAX administration became extremely red, swollen and sore. Redness and induration spread over entire upper arm and pt had knot in armpit. Pt experienced fever and nausea - pt's mother had same rxn.
Patient was in to receive her 2nd Moderna dose and was mistakenly given Janssen/Johnson & Johnson.  Patient was notified about an hour later after error was discovered. She reported no symptoms or side effects at the present time.
Systemic: Dizziness / Lightheadness-Severe, Systemic: patient got dizzy and fell-Medium, Additional Details: 911 was called and ems said his blood pressure was high and sulfur was high
patient a few moments after the administration of shot was pale and lightheaded  and father was calling for help. the intern ran to help the patient and patient was laid on the ground. intern checked for a pulse and tended to the patient and i immediately ran to call 911.  EMS services were here within a few minutes and assessed patient. they determined it was most likely a vaso vagal response to the shot and no other systems. patient was not transported to hospital and no further medical treatment needed.  followed up with dad the next day and patient was still fine and nothing out of the ordinary.
Fever; Chills; Extreme body ache; Tiredness; Injection site pain; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the left arm on 11Apr2021 at 16:15 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 12Apr2021 at 09:30, the patient experienced extreme body ache, fever, chills, tiredness and injection site pain. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events extreme body ache, fever, chills, tiredness and injection site pain was resolved on an unknown date in Apr2021.  No follow-up attempts are needed. No further information is expected.
Patient did not consult until well after the initial reaction occurred but I observed diffuse redness of the left  deltoid area.  Patient stated that that area in days previous was swollen, warm to the touch, and red.  Patient did experience pain possibly due to inflammation.  Patient did not treat herself or seek treatment for reaction.  Reaction was subsiding by the time I was notified
Rash, ErythemaMultiform, 1/17 swollen, erythema, rash, but no itchiness. Narrative: 1/17 swollen, erythema, rash but no itchiness. Resolved 1/18.
Headache, Myalgia, Arthralgia, NauseaVomiting, injection site pain Narrative: Employee reports injection site pain/discomfort, as well as chills, fever, headaches, joint pain, muscle aches, fatigue, and nausea. Reports Dayquil x5-6 doses and Nyquil x3 doses over 3 days for symptoms. Reports symptoms have resolved and is feeling much better as of date of this report. Other Relevant History:
Adverse event: patient received second dose of Moderna COVID-19 vaccine 21 days after the first dose. Outcome: patient experienced low grade fever and body ache at night for a few hours on the same day of the immunization. Patient didn't present any symptom on the following morning.
Shortly after, I began to feel "woozy" and a bit "out of it" mentally. Mostly fatigued but didn't limit my ability to do normal activity things. Around 10:30pm that night, I got a 100.3 degree F fever, aggressive chills, and a headache. Woke up around 11:30 and the fever had broken (due to taking a Tylenol before bed).   Day after vaccine, heaviness in left arm (injection arm). General fatigue and headache. Most prevalent symptom was achy body.
Came to ED with 11/11/2022 Chief Complaint of SOB.  Initial treatment with: Decadron for hypoxia in the setting of COVID infection, ceftriaxone and azithromycin for pneumonia,  IV fluids and insulin. Hospitalized in ICU 11/11/2022 with acute hypoxic respiratory failure, diabetic ketoacidosis, sepsis. Evaluation revealed covid pneumonia, influenza B and superimposed community-acquired pneumonia, bilateral. She required mechanical ventilation on 11/12/2022. Her hospital course was complicated by Non ST elevated myocardial infarction, right perforator pontine stroke and atrial fibrillation with rapid ventricular response. Ultimately, decision was made to extubate 11/21/2022 and transition to hospice 11/22/2022  Patient expired 11/22/2022 @1803. Submitter does not have access to full medical record. If further information is needed, please contact Memorial Hospital  or HOSPICE.
Patient presents with episode of dizziness, lightheadedness, and pallor after receiving booster dose of the Pfizer vaccine.  Patient was placed in antishock position and discharged half and hour later after symptoms subsided.
This case was reported by a nurse via sales rep and described the occurrence of blistery rash in a adult female patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced blistery rash, pain in arm, fatigue and headache. The patient was treated with VALTREX. On an unknown date, the outcome of the blistery rash, pain in arm, fatigue and headache were unknown. It was unknown if the reporter considered the blistery rash, pain in arm, fatigue and headache to be related to SHINGRIX. Additional information was received as follows: The age at vaccination was not reported. The patient experienced sore arm and blistering rash for which the patient was seen for. The reporter gave consent to be followed.
first shingle shot August 2020 or 9 months ago.; This case was reported by a consumer and described the occurrence of incomplete course of vaccination in a 69-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in August 2020 and had prostate surgery and it's been 9 month).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were reported as follows: This case was reported by patient himself. The age at vaccination was not applicable for this report. Till the time of reporting patient did not receive 2nd dose of Shingrix which led to incomplete course of vaccination. The patient received first shingrix dose in August 2020 or 9 months ago and then had prostate surgery and it's been 9 months and patient did not received 2nd dose. The follow up was not asked.