chrisvoncsefalvay/vaers-outcomes huggingface dataset:
@9:30  slipped off her chair. She fainted, no response for less than 1 min. + Loc.  blood pressure 134/44 Pulse 44, blood sugar 114 O2 sats 98% on room air.  @ 9:32 fully responsive, diaphoretic, + nausea, blood pressure 115/77, Pulse 58 O2 sats 98% rrom air. She stated she was fasting. @ 9:45 she was able to tolerate crackers and soda. Decrease nausea no diaphoresis. Blood pressure 120/99, pulse 77, O2 sat 96. @ 10;15  symptoms resolved blood pressure 135/70, pulse 80 O2 sat 99. @ 10:35  She left clinic fully ambulatory. ER precautions discussed.
pain at the site of injection; redness radiating from the injection site; chills; fatigue; difficulty driving; This is a spontaneous report from a contactable consumer, the patient, via a Pfizer sales representative. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot unknown) solution for injection intramuscular (at an unknown age) as a single dose for COVID-19 vaccination. Medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (Pfizer) for COVID-19 vaccination, first dose on an unknown date. The patient recently received both doses of the Pfizer vaccine for Covid. On an unknown date, the patient experienced many side effects with the second dose such as pain at the site of injection, redness radiating from the injection site by about 6 inches, chills, fatigue, and difficulty driving. The outcome of the events pain at the site of injection, redness radiating from the injection site, chills, fatigue, and difficulty driving was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Information has been received from a registered nurse regarding an unknown age and gender patient. On 03-MAR-2012 at 11:30am, ZOSTAVAX, lot # 672477/1604AA was exposed to -12 C for an estimated total time out of range of 4 hours. On 17-APR-2012 at 7:30am, ZOSTAVAX, lot # 672477/1604AA was exposed to -12 C for an estimated total time out of range of 14 hours. On 15-MAY-2012, the patient was administered an out of range dose of ZOSTAVAX, lot# 672477/1604AA expiration date: 13-JAN-2013 (dose and route were not reported). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 58 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient previously received covid-19 vaccine ad26. cov2.s (Janssen, Dose number in series 1) (suspension for injection, route of admin was not reported, batch number: 1805031, expiry: UNKNOWN) dose was not reported, 1 total, administered on 14-MAR-2021 for prophylactic vaccination. It was unknown if patient had adverse event following vaccination with covid-19 vaccine ad26.cov2.s (Dose number in series 1).  The patient received covid-19 vaccine ad26.cov2.s (Janssen, Dose number in series 2) (suspension for injection, route of admin was not reported, batch number: 211A21A, expiry: UNKNOWN) dose was not reported, 1 total, administered on 16-NOV-2021 for prophylactic vaccination. No concomitant medications were reported.  The patient's son was symptomatic and tested positive on 24-DEC-2021. The patient reported exposure from son who was visiting from college.  On 30-DEC-2021, the patient was tested positive for COVID-19 using the home kit test sent by JnJ. He was feeling "a little bit under the weather" and reported symptoms such as a little bit of chills, difficulty breathing, fatigue, cough, and congestion (suspected covid-19 infection and suspected clinical vaccination failure) (Dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from suspected covid-19 infection, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000209617.; Sender's Comments: V0: 20211265893-COVID-19 VACCINE AD26.COV2.S-Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
10 days p/vax rt knee became very swollen; a few day later pain in my rt hip started; pt has devel into fibromyalgia, profound fatigue & a weakened immune system;
patient received a 3rd dose from a vial in which rubber stopper broke and fell into the vial; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTRATION ERROR (patient received a 3rd dose from a vial in which rubber stopper broke and fell into the vial) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 088D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Aug-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (patient received a 3rd dose from a vial in which rubber stopper broke and fell into the vial). At the time of the report, PRODUCT ADMINISTRATION ERROR (patient received a 3rd dose from a vial in which rubber stopper broke and fell into the vial) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant and no treatment medication was provided   Most recent FOLLOW-UP information incorporated above includes: On 07-Sep-2021: non significant follow up appended
DIZZINESS; HEADACHE; WEAKNESS; FEVER; This spontaneous report received from a patient concerned a 39 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included acid reflux, and rheumatoid arthritis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, expiry: UNKNOWN) dose was not reported, administered on 22-JUN-2021 for prophylactic vaccination. Concomitant medications included omeprazole for acid reflux, atorvastatin for drug used for unknown indication, buspirone for drug used for unknown indication, ergocalciferol for drug used for unknown indication, escitalopram oxalate for drug used for unknown indication, folic acid for drug used for unknown indication, and methotrexate for rheumatoid arthritis. On 22-JUN-2021, the subject experienced dizziness. On 22-JUN-2021, the subject experienced headache. On 22-JUN-2021, the subject experienced weakness. On 22-JUN-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 100.4 F. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the dizziness, headache, weakness and fever was not reported. This report was non-serious.
This non-serious medically confirmed report (initial receipt 13-SEP-2014) concerns a 62-year-old female patient. On 13-SEP-2014, the patient received intramuscular AFLURIA (batch number T57305, expiry date AUG-2015) at a dose of 0.5 ml. On 13-SEP-2014, immediately after administering the injection, the patient was scratching her arm in the waiting   area of the pharmacy. The pharmacist discovered that the patient had an itchy red rash and hives on the arm of the injection site. No other adverse reactions like shortness of breath or swelling were noted. The rash and hives were spreading quickly. The patient was treated with Epipen and the rash disappeared 10 minutes after the injection of epinephrine. The outcome was reported as recovered on 12-SEP-2014. Reporter's comments: The reporter assessed the events as non-serious and considered the causality as probably with the use of AFLURIA.
Face rash all over; Headache; Chills; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Face rash all over), HEADACHE (Headache), CHILLS (Chills) and FATIGUE (Fatigue) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in September 2020.    On 06-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2021, the patient experienced HEADACHE (Headache), CHILLS (Chills) and FATIGUE (Fatigue). On 08-Jan-2021, the patient experienced RASH (Face rash all over). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Rash, at an unspecified dose and frequency. On 08-Jan-2021, HEADACHE (Headache), CHILLS (Chills) and FATIGUE (Fatigue) had resolved. At the time of the report, RASH (Face rash all over) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.; Reporter'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
on Thursday 13MAY2021 they start bleeding vaginally, bright red blood till today, it's not a period; cramps; headache; This spontaneous case was reported by a consumer and describes the occurrence of VAGINAL HAEMORRHAGE (on Thursday 13MAY2021 they start bleeding vaginally, bright red blood till today, it's not a period), MUSCLE SPASMS (cramps) and HEADACHE (headache) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039B21A and 037B21A) for COVID-19 vaccination.     Concurrent medical conditions included IUD embedded.   On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form(s). On 12-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-May-2021, the patient experienced VAGINAL HAEMORRHAGE (on Thursday 13MAY2021 they start bleeding vaginally, bright red blood till today, it's not a period), MUSCLE SPASMS (cramps) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at an unspecified dose and frequency. On 17-May-2021, VAGINAL HAEMORRHAGE (on Thursday 13MAY2021 they start bleeding vaginally, bright red blood till today, it's not a period) had resolved. At the time of the report, MUSCLE SPASMS (cramps) and HEADACHE (headache) had not resolved.            No concomitant medications were provided.
On 06/20/2001 the patient complained of pain, hardness and swelling of her arm into the neck and chest area. The patient is unable to sleep.
Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 18-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 20-Mar-2021, PAIN IN EXTREMITY (Sore arm) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, COVID-19: negative (Negative) Tested negative..         This case was linked to MOD-2021-054238 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Non significant follow up received on 10-MAY-2021, dditional information included lab results.
The patient presented with chest pain on 5/15/2021. She had a 9 hour drive on 4/30/2021, and had the J&J vaccine on 4/11/2021.
Headache; restlessness; nausea; brain fog; sore throat; malaise; felt much like the early stages of a cold; Injection site soreness; This is a spontaneous report from a non-contactable consumer, the patient. A 26-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 30Apr2021 at 16:00 (at the age of 26-year-old) as a single dose for COVID-19 immunisation. Medical history included migraine, irritable bowel syndrome, polycystic ovarian syndrome, adenomyosis and allergy to sulfa drugs. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included ondansetron (ZOFRAN), promethazine (MANUFACTURER UNKNOWN), bismuth subsalicylate (PEPTO-BISMOL), paracetamol (TYLENOL) and ibuprofen (ADVIL); all from an unknown date for an unknown indication and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01May2021, the patient experienced headache, restlessness, nausea, brain fog, sore throat, malaise, felt much like the early stages of a cold and injection site soreness, mainly recovered after 24 hours. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events headache, restlessness, nausea, brain fog, sore throat, malaise, felt much like the early stages of a cold and injection site soreness was resolved on an unknown date in May2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pt recv vax & exp a fever of 104 approx 10-12 days p/vax;
Pt was given PPD and HPV vaccine.  Within 15 minutes, she reported some lh.  Pt was observed and then d/ced.  She was waiting in waiting room and 30 minutes after, she complained for feeling flushed, hot, abdominal pain.  Vitals were obtained.  Pt initially with bp of 115/68, HR 93 prior to procedure.  After, it was 88/62, HR 46.  She then began to complain of throat tightness and tingling. Epinephrine administered, with bp 90/59, HR 63 and pt elected to go to ED via private vehicle.
General tonic clonic seizure in patient with no prior seizure history. 11/16/2009 MR and DC summary for 11/7-11/9/2009, patient with tonic-clonic movements, postictal  urinary incontinence and confusion, foaming at the mouth and headache. Neuro consult,  Tx: IVF, Keppra  Dx New onset seizure activity GI consult for patient's recent weight loss, anorexia and constipation, recommended an EGD and Colonoscopy which patient deferred at the time
Patient called 3-2-07 to report "reaction since 2-22-07 with c/o headaches and nausea which subsided 2-24-07. Physician with f/u with phone call if sxs. returned. 3-12/07 pt called with "persistent cough waking her up at night" <mucous, ill from 2/22 - 3/12/07.
Developed arthralgia/myalgias about 6-7 days after injection, fever about the same time, and then rash 10 days after injection.
Incorrect Moderna bivalent formula administered as first dose in the COVID-19 series for an unvaccinated 7 month-old infant.  0.2mL (10micrograms) of Moderna bivalent formula in a marron cap and yellow label administered as a first dose in the COVID-19 series.  Previous to April 18, 2023, this formula was designated as bivalent formula for the age group of 6month - 5 year old child.  However, with the new guidance, dose 1 of the Moderna COVID-19 series for an unvaccinated 7 month old infant, now requires 0.25mL Blue cap and Gray label Bivalent Moderna Formula (that was previously only designated for 6years+).
D-DImer blood test extremely high, was over 1500.; This case was reported by a consumer via call center representative and described the occurrence of fibrin d dimer increased in a 71-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   In June 2022, the patient received the 2nd dose of Shingrix. On 8th June 2022, less than a week after receiving Shingrix, the patient experienced fibrin d dimer increased. On an unknown date, the outcome of the fibrin d dimer increased was unknown.   It was unknown if the reporter considered the fibrin d dimer increased to be related to Shingrix.     Additional Information: GSK Receipt Date: 09-Jun-2022 Reporter's Comments: The patient self-reported this case. The patient had the 2nd dose of Shingrix vaccine shot 6 days before reporting and day before reporting the patient had some blood tests. One such test was called a D-Dimer test. The patient stated that normal results for him/her, that was, his/her age, should be around 710 (unit unspecified), but the results came back over 1500 (unit unspecified).  The patient asked if there was a correlation between D-Dimer results and Shingrix. The patient stated to contact him/her on the day of reporting because he/she was taking a stress test tomorrow afternoon for reporting and would not want anything bad to happen to him/her while doing that test.  The patient wondered if anyone taking the vaccine had taken the D-Dimer blood test and made any connection between the two.
Headache and lightheadedness right after vaccination which disappeared after a day. Headache returned 9 pm on Dec 24  with chills and sore throat. Fever of 100.7 on Dec 25 at around 6 am w/  chills, headache, sore throat and body aches.
Information has been received from a nurse referring to her husband, a 62 year old male patient. Information about concurrent condition, medical history was unknown. The patient had no drug reactions/allergies. On 10-NOV-2016, the patient was vaccinated with a dose of ZOSTAVAX (dose, lot #, expiration date and route were unknown). On 10-NOV-2016 (reported as about 6 hours ago at the reported time), the patient was dripping wet with diaphoresis. He had no chest pains and had a heart attack in the past so he know this was not chest pains. His heart rate and respirations were normal. The patient did not received treatment for the event. The outcome of the event was  unknown. The causality assessment between the event and ZOSTAVAX was not provided. Additional information has been requested.
Systemic: Numbness (specify: facial area, extremities)-Mild, Additional Details: PATIENT ECPEREINCED FACIAL NUMBNESS IN LEFT CHEEK BONE AREA THAT SELF RESOLVED ON 12/16/2022 THEN WOKE UP IN THE MORNING AND NUMBNESS WAS IN ALL OF LEFT CHEEK. NOT PAINFUL BUT JUST SOME SMALL NUMBNESS THAT HAS BEEN SELF RESOLVING THUS FAR
h/a & swollen upper eye lids onset 9DEC h/a 10DEC eye irritation; vax recvd 7DEC92; given rx for Seldane, Motrin 10DEC92;
Hives on my back and left wrist up to elbow . Vaccine on same arm.
Information has been received from a medical assistant concerning 10 children who were vaccinated with a 0.65 ml dose of ZOSTAVAC thinking it as a dose of VARIVAX. No adverse experience were reported. A product quality complaint was not involved. No further information is available.
Patient loss consciousness and was having seizures. called 911, paramedics transported patient to a hospital for observations
Patient reported increased dizziness, vertigo symptoms to her primary care provider on 11/9/2018 then presented to Emergency Room on 12/5/2018 with sudden onset weakness and numbness and hyponatremia. Diagnosed with GBS and treated with IVIG and plasma exchange. As of 12/12/2018 pt remains hospitalized with parasthesia.
10-12 hours of nausea after the third dose; 10-12 hours of headache after the third dose; This spontaneous case was reported by an other health care professional and describes the occurrence of NAUSEA (10-12 hours of nausea after the third dose) and HEADACHE (10-12 hours of headache after the third dose) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022C21A) for COVID-19 vaccination.     The patient's past medical history included Breast cancer. Concurrent medical conditions included Radiation exposure. Concomitant products included LOSARTAN for an unknown indication.  On 07-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Oct-2021, the patient experienced NAUSEA (10-12 hours of nausea after the third dose) and HEADACHE (10-12 hours of headache after the third dose). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 09-Oct-2021, NAUSEA (10-12 hours of nausea after the third dose) and HEADACHE (10-12 hours of headache after the third dose) had resolved.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-348194, MOD-2021-348231 (Patient Link).
Patient reports she began experiencing Heart palpitations, Feelings of of being Jittery, Anxiety, Foggy headed, Headache, Cervical neck pain, Heavy head, Achy Muscles all over body and a cough at 11am the following day.
Large local swelling, redness locally, hot to the touch, pain, unable to move arm, one degree fever, headache for 3 days.
Knot at the injection site; Diarrhea; High fever (104); Vomiting; Headache; Nausea; Joint pain; Muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Knot at the injection site), DIARRHOEA (Diarrhea), PYREXIA (High fever (104)), VOMITING (Vomiting) and HEADACHE (Headache) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006021A, 030L20A and 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Osteoarthritis and Gout.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Nov-2021, the patient experienced VACCINATION SITE MASS (Knot at the injection site), DIARRHOEA (Diarrhea), PYREXIA (High fever (104)), VOMITING (Vomiting), HEADACHE (Headache), NAUSEA (Nausea), ARTHRALGIA (Joint pain) and MYALGIA (Muscle pain). The patient was treated with INDOMETHACIN [INDOMETACIN] for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE MASS (Knot at the injection site), DIARRHOEA (Diarrhea), PYREXIA (High fever (104)), VOMITING (Vomiting), HEADACHE (Headache), NAUSEA (Nausea), ARTHRALGIA (Joint pain) and MYALGIA (Muscle pain) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Nov-2021, Body temperature: 104 (High) high fever 104.No concomitant medications were reported.   This case was linked to MOD-2021-386081 (Patient Link).