chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Blood pressure went to 185/158. Throat swollen hard to swallow and itchy. Ambulance had to come and assess me.
Noticed some increased redness below injection site (at least 1-2 finger breadth) with itching and some discomfort beginning 12/31, increased on 1/1/21.  Took tylenol 1000 mg and benadryl 25 mg x one dose.  Redness improved over time, still note some slight itching.
Five Day extremely itchy and red eczema-style rash on outside of elbows, almost entirely gone at three weeks.
COUGHING, SNEEZING, WHEEZING, TIGHTNESS IN CHEST, NAUSEA CRAMPING, HIVES CONTINUED TO PROGRESS, WAS GIVEN BENADRYL AND EPI PEN WAS ADMINISTERED.
I felt achy, tired, and slight fever. I tested positive for COVID-19 at home. I spoke with a nurse, and she prescribed PAXLOVID. A week later after taking PAXLOVID my watch went off and said I had a high heartbeat. I went the doctor and the cardiologist said I had A-fib. I had an EKG and my Atrial rate 249. I had to get electrical shock therapy for my heart.
5 minutes after vaccination started to feel "Funny" and "Distant".  Treated with PO juice.  Feeling continued x30 minutes, sent to Urgent Care and diagnosed with anxiety
I've gotten them even with the vaccine/Suspected vaccination failure; got them; awful; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and feels awful. On an unknown date, the outcome of the vaccination failure, shingles and feels awful were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and feels awful to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by patient. The age at vaccination was not reported. The patient experienced shingles event with shingles vaccine. The patient stated that they were awful. The case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation was not reported.
ARM SWELLING; NEXT DAY PROGRESSED TO ERYTHEMA, EDEMA, TIGHTNESS IN ARM PLUS ERYTHEMA TO SHOULDERS & FACE...TIGHTNESS IN FACE; NO RESP DISTRESS-DIRECTED TO ER FOR CARE BY PMD.
Student stated that he received his first Pfizer dose in January and needs 2nd dose. 2nd dose provided and when entering data in database it was noted that student received J&J 4/7/21. Called student and he said he thought it was January but 4/7 was probably correct.
Spontaneous refractory blsiter, resistant to Valcyclovir therapy.  Eventually resolved with aggressive PO Valcyclovir Trmt.
Rash. Looks like bug bites, had lasted over a week and spreading, started on arms and now all over; This is a spontaneous report from a non-contactable consumer, the patient. A 39-year-old, female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date (at the age of 39-year-old) as a single dose for COVID-19 immunisation and received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on left arm an unknown date (at the age of 39-year-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. Concomitant medications include unspecified birth control medications from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date, the patient experienced rash which looked like bug bites, had lasted over a week and spreading, started on arms and now all over. The doctor said it was a reaction to the shots. The event resulted in in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19.  The clinical outcome of the event rash looked like bug bites, had lasted over a week and spreading, started on arms and now all over was unknown at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
dizziness; painful eyes; sore arm; coughing; chills; Fever; nausea; Body aches; fatigue; Headache; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), EYE PAIN (painful eyes), PAIN IN EXTREMITY (sore arm), COUGH (coughing) and CHILLS (chills) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced DIZZINESS (dizziness), EYE PAIN (painful eyes), PAIN IN EXTREMITY (sore arm), COUGH (coughing), CHILLS (chills), PYREXIA (Fever), NAUSEA (nausea), MYALGIA (Body aches), FATIGUE (fatigue) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYNELOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, DIZZINESS (dizziness), EYE PAIN (painful eyes), PAIN IN EXTREMITY (sore arm), COUGH (coughing), CHILLS (chills), PYREXIA (Fever), NAUSEA (nausea), MYALGIA (Body aches) and FATIGUE (fatigue) had resolved and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.
Shot administered. Chills developed 3:00PM, shaking with chills, tired, hot at 8:00PM. Sunday 4:00AM - 9:00AM loose bowels, diarrhea, fever 101.9 degrees, aches, chills, nausea, dry heaves, head and neck soreness. Urgent care visit, sent me to hospital ER for blood work, IV's, CT scan of abdomen. Monday - PCP said probably a flu shot reaction. Urgent care and ER anti nausea med.
Required visit to MD office and MD prescribed antibiotics just in case rash was not due to vaccine injection. Symptoms: 1. Skin rash - 2. Severe local , erythema and pain at site of injection.
Vomiting at night, nausea, inability to sleep, migraine, extreme dizziness and cold sweat immediately following vaccination
pain in injection site left right; fatigue; pain in injection site; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 19-May-2021 and was forwarded to Moderna on 19-May-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (pain in injection site left right), FATIGUE (fatigue) and PAIN (pain in injection site) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high and Fibromyalgia.   On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Apr-2021, the patient experienced VACCINATION SITE PAIN (pain in injection site left right), FATIGUE (fatigue) and PAIN (pain in injection site). On 23-Apr-2021, FATIGUE (fatigue) had resolved. On 04-May-2021, PAIN (pain in injection site) had resolved. At the time of the report, VACCINATION SITE PAIN (pain in injection site left right) outcome was unknown.            Action taken with mRNA-1273 in response to the drug was not applicable. No concomitant medication information was provided. No treatment medication information was provided.    This case was linked to US-MODERNATX, INC.-MOD-2021-148380, US-MODERNATX, INC.-MOD-2021-148880 (E2B Linked Report). This case was linked to MOD-2021-148183 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-148880: US-MODERNATX, INC.-MOD-2021-148380:
serious vision problem; the biggest problem is complete feeling of confusion, which is not normal for him at all. It has been 8 days, and it's not much better.  He had  a CT scan; This is a spontaneous report from a contactable consumer or other non hcp. A 99-years-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 24Feb2021 13:30 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunization. Medical history was none. The patient did not have COVID prior to vaccination. The patient was not tested for COVID post vaccination. The patient did not have any allergies. Concomitant medication(s) included potassium (POTASSIUM) taken for an unspecified indication, start and stop date were not reported; amlodipine (AMLODIPINE) taken for an unspecified indication, start and stop date were not reported; furosemide (FUROSEMIDE) taken for an unspecified indication, start and stop date were not reported; clopidogrel (CLOPIDOGREL) taken for an unspecified indication, start and stop date were not reported. On 25Feb2021, at 02:00, the patient experienced serious vision problem (visual impairment) and the biggest problem is complete feeling of confusion, which is not normal for him at all. it has been 8 days, and it's not much better. he had a ct scan (confusional state). The patient had a CT scan which was normal, but he does not know where anything is and is totally disoriented. He was told this would pass in a week's time, but it hasn't. On an unspecified date, the patient underwent lab tests and procedures which included blood test: unknown result, computerised tomogram: normal, electrocardiogram: unknown result. Therapeutic measures were taken as a result of serious vision problem (visual impairment) and the biggest problem is complete feeling of confusion, which is not normal for him at all. it has been 8 days, and it's not much better. The clinical outcome for the events was not recovered.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Parents awoke to child having a seizure at 0510 AM. Took child to Emergency Room. ER stated unsure that vaccine caused seizure-child going for further testing (EEG) 3/3/10 at Med. Center.
Pt to ED 8/3 for bilateral ankle swelling and pain. 8/4 pt is A&Ox4, cooperative.  Respirations are even, unlabored. 8/5 Pt confused and lethargic. 8/6 pt COVID+. 8/7 Pt more oriented (x4) w/ intermittent confusion and slurred speech. Pt still lethargic, fever of 101.1. 8/11 Pt aox1,confused, on 3L 02 NC not in distress. 8/12 O2 requirements increased; possible component of aspiration pneumonia; remdesivir rx completed. 8/13 pt is aox3-4, with period of confusion. 8/15 Fever (resolved) likely secondary to COVID, now on RA O2 possible component of aspiration pneumonia.8/16 pt alert,orient x3. No distress noted. 8/17 pt is A&OX4, VSS no complaints or discomfort. Pt discharged 8/17.
No adverse reaction seen. Patient was given Pfizer COVID vaccine on 1/28/21 and on 2/18/21 was given Moderna COVID vaccine.
Temp- 101.1.  Sweating with chills.  Flushed.
Soreness in arm; Nausea; This is a spontaneous report from a contactable consumer, the patient. A 29-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration in the left arm on 11Mar2021 at 11:00 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism, hypopituitarism and diabetes insipidus. The patient had no known allergies to medication, food or other products. 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 medication within two weeks of vaccination. On 11Mar2021 at 13:00, the patient experienced soreness in arm and nausea. The events did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of events reported. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events soreness in arm and nausea were recovered on an unknown date in Mar2021.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
A very large, red bump appeard on the leg where the vaccine was administered. It lasted like this for 6 months. The night of the vaccine, he was extremely irritable with a slight fever. Three months later, he was diagnosed with Sensory Processing Dysfunction, apraxia which affected his speech and body coordination, low muscle tone and autism with 60% learning delays. Prior to this vaccine, he had no learning delays and no physical delays. He met every newborn and baby milestone.
3/9 - started low grade fever, loose stools. 3/11 - developed full body papular rash & irritability.
pt recvd MMR vax in 1989 & devel measles; no futher details were provided;
Pt. presented with tiny vesicles center chest 4 days after SHINGRIX #2.
Vaccine recipient reported that they received the vaccine on 12/29/2020. On the same day they developed soreness at the injection site which became better the next day. On 1/2/2021 they reported that their left armpit lymph node became swollen and painful which was very concerning, They made an appointment with their primary care provider. They reported on 1/5/2021 that the left armpit lymph node is slightly better. Moderna COVID- 19 Vaccine EUA
The pt experienced a low grade fever on 1/3/01, up to 99 on 1/4/01, up to 101 - 102 on 1/5/01. The pt still had a temp of 102 and looked ill on 1/6/01 and mom took the pt to the ER and was admitted to the hospital.
Aches all over body, fevers, pain urinating, runny nose, frequent urination.
This spontaneous report as received from a health care worker refers to an unknown number of patients with unknown demographics. Approximately on an unknown date in the year 2014, unknown number of RECOMBIVAX HB vaccines undergone temperature excursion and improperly stored had been administered to an unknown number of patients. No adverse effects were reported. No additional information was provided. No product quality complaint was involved. Additional information has been requested.
diarrhea x 30 hrs, swelling of both eyes and extreme light sensitivity within 8 hrs of receiving injection. light sensitivity lasted for days. 3 days later, patient said it was slowly dissipating.
p/recv vax pt c/o feeling of dizziness, felt hot, perspiring. PE rash
Vaccine administered 2/27/2023 with BUD on vial 2/28/23, however, later we realized the original vial box expiration date was 2/25/23.  Called Moderna to notify and evaluate the case. They sent their email response indicating  "the vaccine administered on February 27, 2023 from lot number AR6965B maintained the activity necessary to protect against the SARS-CoV-2 (covid-19) virus at time of administration". We attempted communication with the patient but the phone number we have is not working. To this moment no adverse effects have been reported.
extreme itching in right arm (not the one injected) from shoulder through hand; lasted about 25 minutes
Post vax the patient experienced arm pain, swelling and redness with localized cellulitis. The patient was treated with Keflex and cool compresses.
Swelling & redness developing about 1 wk p/inject; 10 cm area of induration noted on 22MAY92; no further rx required;
pt recvd vax; exp weakness from waist down, unable to walk w/out assistance; generalized body aches; t 101.1;
Mom called 11/01/02 to inform us that (her son) had an axillary temp of 101.5 with swelling of left arm from shoulder to elbow. Redness @ injection site only. Tender to touch. Mom gave Tylenol. Mom took (her son) to ER on 11/02/02. Dx of shoulder cellulitis ( prob. staph) and put on Keflex. Much improved today 11/04/02.
This is a spontaneous report from a Pfizer-sponsored program. A contactable medical assistant calling on behalf of a physician reported that a 4-month-old male patient received in Apr2017 a single dose of PREVNAR 13, ROTATEQ and PENTACEL, all for immunization. Concomitant medications included nystatin. Medical history was not reported. In Apr2017 the patient had an allergic reaction after receiving pneumococcal 13-val conj vac (dipht crm197 protein). The patient broke out in hives on his legs the next day after receiving the vaccines. The hives progressed to all over his body and his face turned red. Outcome was recovered in Apr2017. The reporter considered the allergic reaction as not serious.
PERIPHERAL NEUROPATHY 12/22/2022 HTN (HYPERTENSION)
Information has been received from a physician for the pregnancy registry for GARDASIL concerning a 26 year old female who on an unspecified date was inadvertently vaccinated with GARDASIL while pregnant. After the patient received GARDASIL, she had a spontaneous termination at 13 weeks from the last menstrual period. The patient had FYA antibodies (noted to be abnormal antibodies indicative of an autoimmune disorder). She was antinuclear antibodies test (ANA) positive with the first termination. The patient was not hospitalized. Subsequently the patient recovered. She had dilation and curettage (D &C) following the spontaneous termination. The reporter didn't necessarily think it was linked but she could not understand the connection to GARDASIL, and she could not find any other reason for the termination. Upon internal review the patient's spontaneous termination was determined to be an other important medical event. The patient also had a second spontaneous termination after the vaccination at 6 weeks and 5 days from the last menstrual period. (WAES# 0810USA02664). Additional information has been requested.
Gave 0.5 mL instead of 0.25 mL/ This was the patient's 3rd dose; Inappropriate schedule of vaccine administered; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL OVERDOSE (Gave 0.5 mL instead of 0.25 mL/ This was the patient's 3rd dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059A22A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Johnson & Johnson vaccine (1st Dose: Johnson & Johnson) on 19-Mar-2021 and Pfizer (2nd Dose: Pfizer) on 27-Dec-2021. Past adverse reactions to the above products included No adverse event with Johnson & Johnson vaccine and Pfizer.    On 14-Jun-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 14-Jun-2022, the patient experienced ACCIDENTAL OVERDOSE (Gave 0.5 mL instead of 0.25 mL/ This was the patient's 3rd dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). At the time of the report, ACCIDENTAL OVERDOSE (Gave 0.5 mL instead of 0.25 mL/ This was the patient's 3rd dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) outcome was unknown.    For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product was provided by the reporter. Patient has not reported any adverse reactions to the dose. No treatment medication was provided.
neck cramps that were severe; This spontaneous case was reported by a patient and describes the occurrence of MUSCLE SPASMS (neck cramps that were severe) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011j20a) for COVID-19 vaccination.     The patient neither had a COVID positive test nor diagnosis. The patient had no acute and chronic illnesses at the time of vaccination.  Previously administered products included for Product used for unknown indication: INFLUENZA VACCINE (flu vaccine in the fall but not too close to the COVID shots). Past adverse reactions to the above products included No adverse event with INFLUENZA VACCINE. Concurrent medical conditions included Drug allergy (codeine, made her heart race), Drug allergy (SUDAFED, made her heart race) and Seasonal allergy.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MUSCLE SPASMS (neck cramps that were severe). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency; PARACETAMOL (TYLENOL) at an unspecified dose and frequency and DICLOFENAC SODIUM (VOLTAREN [DICLOFENAC SODIUM]) at an unspecified dose and frequency. At the time of the report, MUSCLE SPASMS (neck cramps that were severe) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       The patient was not immunocompromised.  Concomitant medication of the patient was not reported.  The patient visited to the doctors for her neck cramps and she was unsure if this was related to the vaccine. The neck cramps had subsided after about a year, it became less and less frequent and rarely occur. The patient did not experience a similar event in the past. Overall status of the patient was improved.  The patient also used CBD cream as corrective treatment.   This case was linked to MOD-2022-609561, MOD-2022-609564 (Patient Link).
extremely tired; hoarse in my speech; A cold sore on my lip; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP 6955) via an unspecified route of administration in the left arm on 24Mar2021 at 15:15 (at the age of 54-years-old), as a single dose for COVID-19 immunisation. Medical history included slightly high Blood Pressure (BP), slightly high low-density lipoprotein (LDL) cholesterol and cigarette smoker. The patient was not allergic to any medications, food, or other products. Concomitant medications included atorvastatin (MANUFACTURER UNKNOWN), lisinopril dihydrate (LISINOPRIL) and zolpidem (MANUFACTURER UNKNOWN), all for an unspecified indications and from an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 30Mar2021 at 07:00, day 6 after the vaccination, the patient felt extremely tired, had hoarse speech and developed a cold sore on lip. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of reported events. The clinical outcomes of the events extremely tired, hoarse speech and cold sore on lip were recovered on 31Mar2021 (day 7.75 after the vaccination).  No follow-up attempts are needed. No further information is expected.