chrisvoncsefalvay/vaers-outcomes huggingface dataset:
20SEP95 mom states she was holding pt on 15SEP95 & pt began having a sz; mom took pt to hosp ER; mom states temp 102 & ER MD told her child needed to see a ped neurologist; pt given Motrin & fever came down & no further szs;
Hard red swollen knot at site, warm to the touch, size of quarter. Fussy, poss elevated temp & painfull to touch. Also noted pt is teething.
High Fever, 103, shaking, vomiting, large and extremely painful bump at injection site of polio vaccine (also was vaccinated with yellow fever, flu and meningococol at the same time). Diagnosed with allergic reaction.
Feel tired and worn out.; Head cold; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE BIONTECH, Lot number: EN6297) via an unspecified route of administration in the left arm on 16Mar2021 at 14:00 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. Medical history included generalized anxiety disorder and depression. Concomitant medications included buspirone hydrochloride (BUSPAR), duloxetine (CYMBALTA), clonazepam (KLONOPIN), acetaminophen, dextromethorphan, guaifenesin, phenylephrine (ALKA SELTZER) and fexofenadine hydrochloride (ALLEGRA), for unknown indications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. 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 felt like tired and worn out, like a head cold, on 18Mar2021. The patient did not receive any treatment for the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of feel tired and worn out and  head cold were unknown.   No follow-up attempts are needed. No further information is expected.
Dizziness; Tiredness; This is a spontaneous report from a contactable consumer, the patient. A 72-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6200) via an unspecified route of administration in the arm right on 17Feb2021 (at the age of 72-years-old) as a single dose for COVID-19 immunisation. The medical history was not reported. 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 concomitant medications included folic acid (MANUFACTURER UNKNOWN), lisinopril (MANUFACTURER UNKNOWN), lithium (MANUFACTURER UNKNOWN), methotrexate (MANUFACTURER UNKNOWN), hydrochlorothiazide/triamterene (HYDROCHLOROTHIAZIDE WITH TRIAMTERENE) and rivaroxaban (XARELTO), all from unknown dates for unknown indications and unknown if ongoing. On 01Mar2021, the patient experienced dizziness and tiredness. The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event dizziness and tiredness were recovering at the time of this report.    No follow-up attempts are needed. No further information is expected.
Between first and second dose I did not feel good. Thought it was my thyroid but blood work came back good.   After second dose,  I was thrown into every menopause symptom.  Skipped period, headaches, nausea, dizziness, brain fog, anxiety, hot flashes, night sweats.
Injection site itching; Injection site swelling; Injection site redness; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PRURITUS (Injection site itching), INJECTION SITE SWELLING (Injection site swelling) and INJECTION SITE ERYTHEMA (Injection site redness) in a 40-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect products included non-company products ADALIMUMAB (HUMIRA) solution for injection for an unknown indication and TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form, ADALIMUMAB (HUMIRA) (Subcutaneous) CF,solution for injection in pre-filled pen and dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (Intramuscular) 1 dosage form. On 02-Aug-2022, the patient experienced INJECTION SITE PRURITUS (Injection site itching), INJECTION SITE SWELLING (Injection site swelling) and INJECTION SITE ERYTHEMA (Injection site redness). At the time of the report, INJECTION SITE PRURITUS (Injection site itching), INJECTION SITE SWELLING (Injection site swelling) and INJECTION SITE ERYTHEMA (Injection site redness) had not resolved.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  It was unknown if patient was enrolled in a COVID-19 vaccine trial.  The reporter's causality for all the events with Humira was a reasonable possibility (probable).  The reporter's causality for all the events with Moderna COVID-19 vaccine and Pfizer Biontech COVID-19 vaccine was a reasonable possibility (possible).  Treatment information was not provided.
headache; This is a spontaneous report from a contactable pharmacist. A 58-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number not provided), via an unspecified route of administration on an unspecified date in Apr2021 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the first dose of the Pfizer COVID-19 vaccine 3 weeks ago (Apr2021), and he was supposed to receive the second dose today. The patient stated that ever since the first dose, he had a headache that will not go away. The pharmacist would like to know if there were any recommendations from Pfizer to apply the second dose. The outcome of headache was not recovered.  No follow-up attempts are needed; information about lot number cannot be obtained.
Red annular rash with central clearing, slightly raised borders for some lesions, without pruritus, appearing 6 days after vaccinations on the lower extremities, near where he had his injections.
Within a couple of days my Jaw got tight, my shoulder joints were sore, my arms got so weak, I couldn't lift heavy. Then, it moved to my knees and muscles and was very painful. Then, gradually went away by time 2 weeks were up, no I have nerve and muscle pain in legs. I am better. I visited an immunization specialist and he wouldn't do any tests. He said the reaction would all be at the injection site.
Patient received dose #2 of Pfizer vaccine on 6/7/2021 at vaccination center and was notified by email that vial was left in freezer past recommended time frame. Medication expired beyond its freezer allowable date. Email recommended patient get re-vaccinated with dose again. Clinic re-administered dose on 6/14/2021 as recommended. No adverse reactions identified on site.
This case was reported by a physician via call center representative and described the occurrence of injection site swelling in a 72-year-old female patient who received SHINGRIX for prophylaxis. On 20th May 2018, the patient received the 1st dose of SHINGRIX. In May 2018, less than a day after receiving SHINGRIX, the patient experienced injection site swelling, injection site erythema, injection site blisters and bullae. On an unknown date, the patient experienced scar. On an unknown date, the outcome of the injection site swelling, injection site erythema, injection site blisters and bullae were recovered/resolved and the outcome of the scar was unknown. It was unknown if the reporter considered the injection site swelling, injection site erythema, injection site blisters, bullae and scar to be related to SHINGRIX. Additional details were provided as follows: The patient recently reported swelling, redness and blisters at the injection site within 24 hours after receiving vaccine. It was also reported that patient developed a 3 cm superficial bullae. At the time of reporting, the patient's symptoms had resolved however the patient had scaring on arm (latency was less than a year after receiving vaccination) where blisters were. The healthcare professional reported that, the patient received vaccine at another facility, possibly local pharmacy, however was unsure of the exact location.
Pediatric dose administered to a 19 y/o; Pediatric dose administered to a 19 y/o; This case was reported by a nurse via call center representative and described the occurrence of underdose in a 19-year-old female patient who received HAV (Havrix 720) (batch number F7X23, expiry date 17th May 2023) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 4th November 2022, the patient received Havrix 720 .5 ml and Havrix Pre-Filled Syringe Device. On 4th November 2022, unknown after receiving Havrix 720 and Havrix Pre-Filled Syringe Device, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 04-NOV-2022 Reporter's Comment: The licensed practical nurse reported that they administered a pediatrix dose of Havrix to a 19 year old patient instead of the full adult dose. The LPN confirmed vaccine was administered in their facility. The reporter inquired how to proceed. The reporter did not consent to follow up. Additional Supportive Information: The adult patient received a pediatric dose of Havrix instead of full adult dose, which led to underdose and adult use of a child product.
pt recv vax 29OCT96 & was later hospitalized for GBS;medical director spoke w/PMD who did not report direct correlation between synd & flu vax;
broke out w/red blotches p/6PM on 6AUG92 on both legs; huge welts all over legs & one on abdomen; blotches on face & legs lasted >24 hrs;
soreness at right arm injection site; swelling at right arm injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (soreness at right arm injection site) and VACCINATION SITE SWELLING (swelling at right arm injection site) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017B21A and 04FC21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Jun-2021, the patient experienced VACCINATION SITE PAIN (soreness at right arm injection site) and VACCINATION SITE SWELLING (swelling at right arm injection site). On 04-Jun-2021, VACCINATION SITE PAIN (soreness at right arm injection site) and VACCINATION SITE SWELLING (swelling at right arm injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-260340 (Patient Link).
was feeling sick; temperature start to go up 101.7F; nauseous; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 26-Feb-2021 and was forwarded to Moderna on 28-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (was feeling sick), PYREXIA (temperature start to go up 101.7F) and NAUSEA (nauseous) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced MALAISE (was feeling sick), PYREXIA (temperature start to go up 101.7F) and NAUSEA (nauseous). At the time of the report, MALAISE (was feeling sick), PYREXIA (temperature start to go up 101.7F) and NAUSEA (nauseous) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication were reported No treatment medication were reported. Patient got temperature 101.7F
Within 1-2 minutes after receiving her booster patient had 2-3 seizure activities; Hypertension of 158/108; Hypotension of 95.5F; Moderate agitation; Lethargy; Moderate to severe confusion.  Patient thought she was at the bank; This spontaneous case was reported by an other health care professional and describes the occurrence of SEIZURE (Within 1-2 minutes after receiving her booster patient had 2-3 seizure activities) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 17-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 ml. On 17-Nov-2021, the patient experienced SEIZURE (Within 1-2 minutes after receiving her booster patient had 2-3 seizure activities) (seriousness criterion medically significant), HYPERTENSION (Hypertension of 158/108), HYPOTENSION (Hypotension of 95.5F), AGITATION (Moderate agitation), LETHARGY (Lethargy) and CONFUSIONAL STATE (Moderate to severe confusion.  Patient thought she was at the bank). At the time of the report, SEIZURE (Within 1-2 minutes after receiving her booster patient had 2-3 seizure activities), HYPERTENSION (Hypertension of 158/108), HYPOTENSION (Hypotension of 95.5F), AGITATION (Moderate agitation), LETHARGY (Lethargy) and CONFUSIONAL STATE (Moderate to severe confusion.  Patient thought she was at the bank) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment were reported. No concomitant drugs reported.  Company comment: This case concerns a 64-year-old, female patient with no medical history reported, who experienced the unexpected event of seizure. The event occurred 1-2 minutes after receiving third dose of mRNA-1273. The patient experienced seizure activities. She experienced hypertension of 158/108, moderate agitation, lethargy and moderate to severe confusion. The rechallenge was not applicable as events occurred after third dose and no further dosing was reported or planned, based on information provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This case concerns a 64-year-old, female patient with no medical history reported, who experienced the unexpected event of seizure. The event occurred 1-2 minutes after receiving third dose of mRNA-1273. The patient experienced seizure activities. She experienced hypertension of 158/108, moderate agitation, lethargy and moderate to severe confusion. The rechallenge was not applicable as events occurred after third dose and no further dosing was reported or planned, based on information provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Mild dull continuous headache(6:30am-at least 8:50pm while completing survey) Lethargic/tired (approximately 10 hours so far) Sore arm at injection site. Started about 15-30 minutes after injection.
I woke up on the morning of December 7, 2022, with a sore throat. I tested for COVID-19 at home. The result was positive. I called my doctor and went to get tested for COVID-19. The result was positive as well. They examined me in the car and spoke with me about my symptoms. I asked about the antiviral medication. She told me I was not a good candidate because I take blood thinners. My symptoms were very mild. She recommended taking SUDAFED, continuing my ZYRTEC, taking NYQUIL at bedtime, and taking TYLENOL. I never had a fever. I didn't feel energetic, but I couldn't sleep well. The medications held back all the sinus issues. The sore throat went away. I started feeling better the next Monday. I took another COVID-19 test on Tuesday. The result was positive. By Thursday, I was no longer positive for COVID-19.
This case was reported by a consumer via Interactive Digital Media and described the occurrence of vaccination failure in a male patient who received DTP vaccine (A or W not known). On an unknown date, the patient received DTP vaccine at an unknown dose. On an unknown date, unknown after receiving DTP vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and whooping cough (serious criteria GSK medically significant). On an unknown date, the outcome of the vaccination failure and whooping cough were unknown. The reporter considered the vaccination failure and whooping cough to be possibly related to DTP vaccine. Additional details were provided as follows: This case was reported by the patient's parent. The age at vaccination was not reported. The patient was fully vaccinated and had whooping cough but it was milder than his sister. This case was considered as suspected vaccination failure because the primary vaccination schedule and laboratory confirmation was unknown. The case had been linked with the case US2017GSK139597, reported by the same reporter.
4/27/2023 periodic sharp nerve pain left thigh, lasted 3-4 days 5/4/2023 bilateral shoulder pain (worse at nights), lasted 5 consecutive days,  Advil helps 5/12/2023 started to experience numbness and tingling in bilateral hands and feet, especially  fingers and toes; these symptoms persisted to this day of reporting. Visited primary care physician and a neurologist, and a mild form of Guillain-Barre Syndrome has being considered
Patient's husband called Thursday evening (4/12/18 at 6:50pm) to report that patient has had swelling that is warm to touch and rash at injection site that has spread down to her leg and up to her cheek.
Began with extreme fatigue, some nausea and constipation that persisted and worsened to the point that patient saw PCP on Monday, January 25, 2021.  Abdominal x-ray done on 1-25-21 showed stool in upper colon.  Mag Citrate and Fleet's enema prescribed and administered on 1-25-21.  Extreme fatigue and weakness continued.  Patient called PCP on Tuesday, 1/26/21, but did not receive call back.  Patient called PCP again on 1/27/21.  Patient was told that abdominal x-ray done on 1/25/21, also showed possible left kidney stone on x-ray report that was read by radiologist.  CT scan scheduled and completed on 1/28/21.  PCP called patient and confirmed kidney stone lodged in lobe of left kidney that appeared spiked and possibly unable to pass.  Presently unable to get immediate appointment with urologist, and pain medication prescribed.  Please also not that patient has absolutely no prior history of any type of kidney stone.  Still awaiting relief.
received the 1st dose but not the 2nd dose yet; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received the 1st dose but not the 2nd dose yet) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received the 1st dose but not the 2nd dose yet). On 17-Feb-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received the 1st dose but not the 2nd dose yet) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Initial report received from a healthcare professional on 11 July 2013. A female patient, had received a dose of ADACEL vaccine, batch number: U4667AA (route and anatomical site of administration were not reported) on an unspecified date. The patient was pregnant. The patient's last menstrual period data was 1 December 2012 and the estimated date of delivery was 07 September 2013. The patient's medical history and concomitant medications were not reported. Patient had no risk factors. Laboratory investigations were not reported. At the time of this report, the patient did not experience any adverse event. List of documents held by the sender: none.
Noticed some discomfort the evening of shot called 7/13/15 said she had 6 x 6 spot warm, red to the touch and painful. Was seen at immediate care 7/13 and given antibiotics for cellulitis.
Patient's husband said she developed shingles and started having a painful rash, which is now being treated with valacyclovir.
23 year old white female received first dose of Pfizer vaccination today, March 26, 2021 at 1328.Lot# ER 8732. Vaccine given in left deltoid. She complaints of lightheadedness to RN  @ 1335. She states " I have anxiety when having blood drawn". Denies any past medical history and NKDA. Assisted to floor and legs elevated. Vital signs obtained; blood pressure 120/70, pulse 71, 02 saturation 99% on room air, respirations 18, even and unlabored. After consuming water, stated "I feel better". Assisted off floor into sitting position and another set of vital obtained. Blood pressure 124/74, pulse 76, 02 saturation 97%, respirations 18, even and unlabored. awake, alert, oriented to time, place, and situation. Discharged from facilty at 1400 in stable condition.
Information has been received from a health professional concerning a male who on an unspecified date was vaccinated with one dose of varicella vaccine. "While on vacation" the pt was exposed to chicken pox and subsequently developed an outbreak of the disease. It was also noted htat the pt's sister was also vaccinated  and experienced similar events. Additional info has been requested.
delayed subcutaneous hypersensitivity reaction, otherwise called "COVID arm", which consists of a rash on the arm of the shot that itches; delayed subcutaneous hypersensitivity reaction, otherwise called "COVID arm", which consists of a rash on the arm of the shot that itches; A spontaneous report was received from a healthcare professional concerning a 73 years old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events delayed subcutaneous hypersensitivity reaction, otherwise called covid arm, which consists of a rash on the arm of the shot that itches/ type IV hypersensitivity reaction and rash pruritic  The patient's medical history was not provided. Concomitant medications reported were vitamins, calcium, biotin, levothyroxine, escitalopram, atorvastatin, alendronate sodium, omega 3, antihistamine tablet, probiotic for drug use for unknown indication.  On 9 Feb 2021,approximately 9 days prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 013M20A) intramuscularly for prophylaxis of COVID-19 infection.  On 17 Feb 2021, the patient experienced the event(s) delayed subcutaneous hypersensitivity reaction, otherwise called covid arm, which consists of.a rash on the arm of the shot that itches.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), delayed subcutaneous hypersensitivity reaction, otherwise called covid arm, which consists of was unknown.