chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Drug exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a health care professional and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Drug exposure during pregnancy) in a female patient of an unknown age (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history provided by Reporter.  Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 27-May-2020 and the estimated date of delivery was 03-Mar-2021. On 30-Dec-2020, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Drug exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) during pregnancy.  On 27-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Drug exposure during pregnancy) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Jul-2020, Pregnancy test: positive (Positive) Positive. On an unknown date, Ultrasound scan: normal (normal) normal, normal (normal) normal and normal (normal) normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.
Sore Arm/Swelling Chills Soreness in Armpit Area Headache at base of neck Drowsiness
Child's mother calls health dept. to report local reaction on right arm around site of injection. Child was evaluated in emergency room and given Benadryl and Motrin. Reaction resolved now.
The Patient received a full pediatric dose of the Pfizer orange cap instead of the adult dose of the Pfizer purple cap, recommended for their age.
Patient had sudden onset of aphasia and Right side hemiplegia while  sitting in observation after second COVID-19 vaccine. Patient family with her advised she has PMH of stroke and complex migraines. Patient was assessed by transport team and taken to Emergency Department.
Patient is a 51 year old female who has not completed a 30-minute observation period due to the following signs and symptoms of an adverse reaction starting @ 1054: swelling of tongue and lips, body numbness, clammy skin, syncope, shortness of breath, hypertension, and tachycardia (see VS flowsheet for values). Pfizer-BioNTech COVID-19 vaccine # 1 in series administered @ 1035.  Action(s) taken: @ 1056 Epinephrine administered and Transferred to higher level of care post RRT @ 1105. Allergy to COVID-19 vaccine documented in Allergies activity: Yes Patient and husband advised to discuss second dose considerations with a clinician and obtain refill for Albuterol and Epinephrine.
Pain down arm, radiating to neck, ear and jaw.  Pain in neck continues nearly 3 weeks later, pain in jaw and ear intermittent.
Dizziness throughout morning starting Saturday, July 10. Another episode on Monday.  Mild dizziness each morning, usually resolving midday.  July 20 and 21 dizziness lasting throughout day.
Reactivation of Bell's palsy on L face, with altered sensation, strength, muscle control and muscle twitches on L. Original Bell's dx 3/11/2006, with almost complete recovery within months.
After being administered with the. Vaccine fist it was a little after taste in my mouth.  I felt like I wasn?t toned off of marijuana.  I then became goofy. Started laughing etc. Then in the drive home about 20 minutes later I started to be tired. I was in the phone with a friend and slipped into a deep slumber. The next day Saturday I woke groggy like from a hang over minus the headache. I had a sudden urge to eat , i bacon and egg sandwich with mayo then had a urgency to eat a bowl of cereal. (rice crispies. Then tried to work (remotely from home) but I could not concentrate or focus. Finally I just threw in the towel and went back to sleep. Woke up to send this report.  Good night. I still recommend this inoculation to everyone!
Covid vaccine given one day past use by date (past 72 days in refrigerator) No ill effects.  Physician aware and notified parents.  Not redosing vaccine at present.
Information has been received from a healthcare worker concerning a 7-year-old female who on 06-JUL-2007 was vaccinated subcutaneously with "one vial" of Zostavax (Oka/Merck) (lot# 654604/1406F) instead of Varivax.  Medical attention was not sought.  The outcome was not provided.  No product quality complaint was involved.  Additional information has been requested.
beyond 36 days since first dose; diagnosed with shingles; now plum; bumps; itchy; itchy; bright red; left arm rash; hemorrhage in her right eye after dental work; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of EYE HAEMORRHAGE (hemorrhage in her right eye after dental work) and HERPES ZOSTER (diagnosed with shingles) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Blood pressure high, Shingles (at age 30) and H1N1 influenza in 2009. Previously administered products included for Product used for unknown indication: varicella zoster in November 2020 and varicella zoster on 06-Mar-2021. Past adverse reactions to the above products included No adverse event with varicella zoster and varicella zoster.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, the patient experienced EYE HAEMORRHAGE (hemorrhage in her right eye after dental work) (seriousness criterion medically significant). On 04-May-2021, the patient experienced VACCINATION SITE DISCOLOURATION (now plum), VACCINATION SITE MASS (bumps), PRURITUS (itchy), VACCINATION SITE PRURITUS (itchy), VACCINATION SITE ERYTHEMA (bright red) and VACCINATION SITE RASH (left arm rash). On 06-May-2021, the patient experienced HERPES ZOSTER (diagnosed with shingles) (seriousness criterion medically significant). On 07-May-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (beyond 36 days since first dose). At the time of the report, EYE HAEMORRHAGE (hemorrhage in her right eye after dental work), HERPES ZOSTER (diagnosed with shingles), VACCINATION SITE DISCOLOURATION (now plum), VACCINATION SITE MASS (bumps), PRODUCT DOSE OMISSION ISSUE (beyond 36 days since first dose), PRURITUS (itchy), VACCINATION SITE PRURITUS (itchy), VACCINATION SITE ERYTHEMA (bright red) and VACCINATION SITE RASH (left arm rash) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient was given a "pain medication" from the ER on 04MAY2021 and valacyclovir on 06MAY2021 when she was diagnosed with shingles. Valacyclovir was prescribed as treatment for shingles.    The patient does not want her second dose, which has been postponed from 23APR2021 to 17MAY2021, and instead wants to wait for a "booster shot".  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.; 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.
Patient's mother reports urgent care visit on Saturday, 9/23 due to episodes of crying, fever and rash all over the body. She is seen for follow up in our office today for continued symptoms including nasal congestion, nasal discharge, fever to 102, poor appetite and rash. Patient was started on amoxicillin by urgent care for OM in the left ear. His symptoms are improving since urgent care visit but not yet resolved.
Fall at home.  Admitted for weakness and elevated Lactate.  Found to be covid positive.
Dry, buring, peeling palm of hands Thinning nails,  nails lifting from nail bed Lesions on trunk of the body, Right and Left legs, shoulders, and back
rt arm reported to be red, hot, swollen from shoulder to elbow, itchy & hurts to touch started Wednesday;mom waiting form call from PMD;MD dx allergic rxn;
Next day at 7: 30am woke up like usual and ate breakfast.  Around 8am, took shower and got chills that is out of norm.  Started to get dress, went down, started to vomit, and could not get up.  Tried to crawl but could not get footinglegs felt like spaghetti.  Patient was able to get up and felt supper shaky; laid on bed gradually got better.  Patient started to sweat and it took about 24 hours to stop shaking.  Patient has never had an experience like that so was very surprised. She ate the same dinner as the night before to make sure that it was not food poisoning and was not.  Patient has received vaccines in the past with no problem besides a sore arm.  Patient has taken same medicine for years; there was no change. Patient lives by herself.  Today went for a walk as usual but did not walk as many hours as usual.   Patient did not call doctor because it was the weekend.  Patient has follow-up with doctor on Thursday in preparation for surgery to replace pacemaker. Patient is almost back to normal.
This case was reported by a physician and described the occurrence of injection site pain in a 39 year old female pt who received hep B vaccine recombinant (Engerix B) for prophylaxis. On 8/13/03, the pt received an injection of Engerix B (5386A2). Immediately post-immunization, she experienced "severe stinging and pain" at the injection site, which resolved after two minutes. The reporting physician suspected an "unusual or abnormal vaccine lot"; however, the physician also reported that patients who previously received this lot of vaccine did not experience pain.
Grey dots on legs; This case was reported by a pharmacist and described the occurrence of skin discoloration in a infant patient who received Hib (Hiberix) for prophylaxis.   Previously administered products included Pediarix with an associated reaction of skin discolouration (received 1st dose on 14th June 2022, refer link case US2022AMR171044), Pediarix with an associated reaction of skin discolouration (received 2nd dose on 14th September 2022, refer link case US2022AMR171048), Hiberix (received 1st dose on 14th June 2022, refer link case US2022AMR171044) and Hiberix with an associated reaction of skin discolouration (received 2nd dose on 17th August 2022, refer link case US2022AMR171050).   On 17th October 2022, the patient received the 3rd dose of Hiberix. On an unknown date, less than a month after receiving Hiberix, the patient experienced skin discoloration. On an unknown date, the outcome of the skin discoloration was unknown.   It was unknown if the reporter considered the skin discoloration to be related to Hiberix.     Linked case(s) involving the same patient:  US2022AMR171044, US2022AMR171048, US2022AMR171050   Additional Information: GSK Receipt Date: 16-NOV-2022 Reporter's Comments:  The patient experienced the gray dots on left thigh that have been noted on patient's legs after receiving Hiberix. The reporter consented to follow up. Additional supportive information: This case linked with US2022AMR171048, US2022AMR171050 and US2022AMR171044. This was 1 of 19 linked cases, reported by same reporter; Sender's Comments:  US-GSK-US2022AMR171028:Same reporter US-GSK-US2022AMR171042:Same reporter US-GSK-US2022AMR171039:Same reporter US-GSK-US2022AMR149551:Same reporter US-GSK-US2022AMR171047:Same reporter US-GSK-US2022AMR171034:Same reporter US-GSK-US2022AMR171048:Same reporter US-GSK-US2022AMR171044:Same reporter US-GSK-US2022AMR148962:Same reporter US-GSK-US2022AMR171050:Same reporter US-GSK-US2022AMR149560:Same reporter US-GSK-US2022AMR148961:Same reporter US-GSK-US2022AMR149561:Same reporter US-GSK-US2022AMR148919:Same reporter US-GSK-US2022AMR171056:Same reporter US-GSK-US2022AMR171007:Same reporter US-GSK-US2022AMR171025:Same reporter US-GSK-US2022AMR171062:Same reporter
TIA, orthostatic dizziness, right periophthalmic ICA aneurysm
The patient had no symptoms or adverse effects of administration.; Caller is a nurse who reports an expired dose of VARIVAX was given to a patient.; This spontaneous report was received from a registered nurse regarding a patient of an unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 12-SEP-2022, the patient was vaccinated with an expired dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot #T029537, expiration date: 01-SEP-2022, (strength, dosage regimen, anatomical location, and route of administration were not provided) administered as prophylaxis (Expired product administered); which was reconstituted with an sterile diluent, lot #U027011, expiration date: 02-MAR-2024 (strength, route of administration, anatomical location, and indication were not provided). The patient had no symptoms or adverse effects of administration. No history of temperature excursions for the administered varicella virus vaccine live (oka/merck) (VARIVAX).
This spontaneous report as received from a consumer refers to his 1 year old female daughter. Patient did not had any pertinent medical history drug reactions or allergies. On 22-AUG-2014, the patient was vaccinated with ZOSTAVAX, 0.5 ml/once, in her leg (reported as needle on top of thigh") (strength, route and lot number were not reported). Concomitant therapies included nystatin and cephalexin. The patient's father reported that patient was supposed to received (Oka/Merck) VARIVAX but was given ZOSTAVAX instead. The patient's father confirmed that the patient received 0.5 ml of ZOSTAVAX. Patient's father stated that patient "looked to be normal". Patient did not received treatment for the adverse events. No labs diagnostics studies were performed. The patient did not seek medical attention. Additional information has been requested.
pt recv vax & devel a large area of cellulitis (area of rxn spread 3x the initial size), tx w/Keflex po;rxn resolved p/approx 1wk;this is one of eight patients from this facility who exp the above rxn
pains in her right arm that starts at shoulder and goes to the elbow/ pains were radiating from her shoulder to the back of her head; pain had been waking her up; Developed shoulder and arm pain immediately after the shot; Developed shoulder and arm pain immediately after the shot; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13) via unspecified route of administration in Oct2018 at a single dose for immunization. Medical history included that the patient was diabetic since 2009 (diagnosed 10 years ago). There were no concomitant medications. The patient reported that last year in October she got a pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) vaccination at the prompting of her primary care physician. She developed shoulder and arm pain immediately after the shot and it has continued ever since. Patient stated she was still getting pains in her right arm that starts from the shoulder and goes to the elbow. Lately on unknown date, the pains were radiating from her shoulder to the back of her head. The pain had been waking her up. Patient stated that immediately after the vaccination it improved slightly and then it has gotten worse over time. The vaccine was administered to her by a pharmacist. Her primary care insisted that she get the vaccine. Patient did not know the dose she was given, but stated that she received the standard dosage. She wanted to know how long is this pain supposed to last. The patient was suggested that the patient consult her healthcare provider, as it has been a year that she received the vaccine and was still experiencing the pain. The outcome of the event 'pain had been waking her up' was unknown; while the outcome of the other events was not recovered.  Information on the batch number has been requested.
About 5 days after receiving the vaccine, I noticed itchy red bumps appear on my right calf leg.; After a few days, the bumps became redder and bigger after some itching and more bumps rose on my left thigh; After a few days, the bumps became redder and bigger after some itching and more bumps rose on my left thigh; This is a spontaneous report from a non-contactable consumer, the patient. A 22-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration in the arm right on 08Feb2021 (at the age of 22-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were 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. On 13Feb2021, 5 days after the vaccination, the patient noticed itchy red bumps appear on her right calf leg. After a few days, the bumps became redder and bigger after some itching and more bumps rose on her left thigh. These were initially thought to be caused by bed bugs, so all the linings and blankets of the bed were thoroughly dry cleaned. However, the bumps persisted. It was believed to be an allergic response of some kind; however, causation was unclear. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events itchy red bumps appear on he right calf leg, bumps became redder and bigger after some itching were unknown at the time of this report.  No follow-up attempts are possible. No further information is expected.
No additional AE; the patient received an improperly stored PROQUAD vaccine; This spontaneous report has been received from a licensed practical nurse referring to a patient of unknown gender or age. The patient's pertinent medical history, concurrent conditions, concomitant mediations and drug reactions or allergies were not reported.   On 15-JUN-2023, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (albumin status recombinant human albumin (rHA)) (PROQUAD) injection (product quantity: 1, lot# W039841, expiration date 12-JUN-2024, strength, exact dose, route and anatomical location were unknown) for prophylaxis (product storage error). No additional adverse event was reported.  This is one of the two reports received from the same reporter.; Sender's Comments:  US-009507513-2306USA009052:
Bivalent booster was given yesterday from vials that were put in the fridge and after that refrozen and thawed again; No Adverse Event; Bivalent booster was given yesterday from vials that were put in the fridge and after that refrozen and thawed again; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Bivalent booster was given yesterday from vials that were put in the fridge and after that refrozen and thawed again), PRODUCT STORAGE ERROR (Bivalent booster was given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and NO ADVERSE EVENT (No Adverse Event) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 11-Jan-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Bivalent booster was given yesterday from vials that were put in the fridge and after that refrozen and thawed again). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Bivalent booster was given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Bivalent booster was given yesterday from vials that were put in the fridge and after that refrozen and thawed again), PRODUCT STORAGE ERROR (Bivalent booster was given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Bivalent booster was given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and PRODUCT STORAGE ERROR (Bivalent booster was given yesterday from vials that were put in the fridge and after that refrozen and thawed again).    This case included information of patient 15th out of 100 patients.  No concomitant medication was provided by reporter. Nurse reported an adverse event 100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again 100 adults male patients are involved, date of administration 11 Jan 2023, lot numbers unknown to the HCP.  No treatment medication was provided by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-697752 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-697752:MASTER CASE
Upper extremity dysfunction; felt like it was paralyzed; Left arm hurt; pain in shoulder down to armpit; This spontaneous case was reported by a consumer and describes the occurrence of PARALYSIS (felt like it was paralyzed) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma, Migraine and Sinus disorder. Concomitant products included MONTELUKAST SODIUM (SINGULAIR) and SALBUTAMOL (ALBUTEROL HFA) for Asthma, IBUPROFEN for Migraine.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 06-Jan-2021, the patient experienced PARALYSIS (felt like it was paralyzed) (seriousness criterion medically significant), PAIN IN EXTREMITY (Left arm hurt) and PAIN (pain in shoulder down to armpit). On an unknown date, the patient experienced MUSCULOSKELETAL DISORDER (Upper extremity dysfunction). At the time of the report, PARALYSIS (felt like it was paralyzed) and PAIN IN EXTREMITY (Left arm hurt) had resolved and PAIN (pain in shoulder down to armpit) and MUSCULOSKELETAL DISORDER (Upper extremity dysfunction) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.  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.
The next morning, I started having diarrhea on 09/28/2021, I talked to my doctor on the 30th. She told me to take Pepto-Bismol, I saw her on the 7th of October she recommended I do the BART diet and continue with 2 Pepto-Bismol tablets a day. On October 14th diarrhea cleared up. I lost about 2 lbs. I weigh 107 so I went down to 105.