chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient was administered first dose of SHINGRIX shot. She reported reactions to TDAP in past but no reactions to FLUAD or ZOSTAVAX. Patient tolerated shot in the shot room and was able to put on her coat unassisted and left the room. She was alert and conscious. She sat in front of pharmacy. Another pharmacist rushed to her aid and declared that she was unconscious and turning blue. I called 911. The other pharmacist stayed with the patient. After about a minute the patient was conscious but remained laying on the floor and regained her normal color and was breathing normal. She was wheeled off to the emergency department by paramedics.
Information has been received through the Merck Pregnancy Registry from a physician concerning a 24 year old female who on 17-AUG-2007 (also reported as 07-AUG-2007) was vaccinated with VARIVAX (Oka/Merck) (LOT # 654030/0913F), MMR II and DTaP (manufacturer not reported). The physician reported that the patient learned that she was pregnant after receiving the vaccination with the VARIVAX. Her last menstrual period was 01-AUG-2007. The estimated due date is 07-MAY-2008. Both the vaccination with and pregnancy test were done on 17-AUG-2007. The physician reported that there was no maternal adverse event. The patient contacted the physician. Follow up information has been received from the same physician. The infant was liveborn (weeks gestation not reported). The infant was diagnosed with Triploidy 69 KY (male). It died at 5-6 gestation weeks. Per the physician's discussion with OB there was no evidence it was vaccine related. Additional information has been requested.
Rash on arm and itching approximately 9 days after, rash on wrist approximately 11 days after, skin irritation and itching on both ankles approximately 11 days after
Headache, Fever, SkinRash, Petechiae rash over the trunk on second day of vaccination Narrative:
Unable to walk, stand without assistance. Unable to move feet or toes, unable to void or defecate without assistance. No feelings on toes or feet.
This spontaneous report as received from a pharmacist via a field representative refers to a patient of unknown demographics. No concurrent conditions or medical history were provided. On an unknown dater, the patient received at least 1 dose of M-M-R II, injection (strength, dose, route of administration, lot# and expiry date unspecified) as a child but pharmacist was not sure if M-M-R II series was completed. No concomitant medications were reported. The pharmacist reported that the patient came in for M-M-R II because titer was drawn for school entrance and titer for one of the measles, mumps, and rubella virus vaccine components (type unspecified) was low (dates not provided). The outcome of the event was unknown. The relatedness between the event and M-M-R II was not reported. Additional information has been requested.
patient had fainted about 5 mins after the vaccine but then she woke up in about 2 mins . Her husband had laid  her flat on the ground. She seem to feel better as she was laying on the ground. at that time the ambulance was en route . i had checked on her pulse/bp . the ambulance had arrived but she refuse to go to the hospital . she had felt better . she did walk out of the pharmacy on her own.
Pain in right arm & shoulder, down to her wrist. Unable to lift arm over head. Having difficult time doing daily activities.
pt recvd vax 1PM today this PM-9PM had sudden onset diff & pain swallowing & swelling lt calvicular area & neck; acute adenitis lt supraclavicular & lt ant low cervical areas;
cold sweats, shivering, mild nausea for a few hours. then fever and headache for another several hours. all occurring overnight from 11:30 or so to resolving by noon following day with just a headache and general fatigue remaining
Hepatitis B Vaccine, Dose 2 administered on 5/18/09 @ 3 PM.  On 5/19/09 upon awakening in morning, patient describes itching hives over upper chest, shoulders & upper arms, with edema of lips, and Rt side of face.  Takes Zyrtec for seasonal pollen allergies which he took.  Reported to facility on 5/20/09 at 2:45 PM to report signs & symptoms, which had dimished at this time.  Will continue Zyrtec today and tomorrow and see company M.D. on 5/21/09.
My husband breaks out with them every 4-5 weeks has for two years he's had all the shots nothing helps with pain; My husband breaks out with them every 4-5 weeks has for two years he's had all the shots nothing helps with pain; This social media spontaneous report as received from the wife's patient via another company and refers to a male patient of unknown age.      On an unknown date, the patient was vaccinated with zoster vaccine live (ZOSTAVAX), for prophylaxis (dose, route of administration, lot# and expiration date were not provided).         On an unspecified date, the patient had been breaking out with shingles for two years. Despite of having all the shots, nothing had helped with pain. The outcome of shingles and pain was not recovered.        The causality assessment between the events and vaccine live (ZOSTAVAX) was not provided.
Pt immunized with 3 doses Hep B vaccine and shows acute Hepatitis B
Received the vaccination at 0730 10/31/06.  within 1/2 hour started to feel flu like symptoms.  She continued to feel sick to her stomach, became pale.  She reported her arms and legs felt like cement and she had trouble lifting them.  After one hour she had hives.  She was seen by the Dr. by 1000. Dr. did physical and gave benadryl.  She was seen again on 11/1/06 to clear to return to work.
LUNGS ARE STIFFENING (ACUTE RESPIRATORY DISTRESS SYNDROME); PATIENT PLACED ON VENTILATOR; SUSPECTED COVID-19 INFECTION/BREAKTHROUGH INFECTION; SUSPECTED CLINICAL VACCINATION FAILURE; This spontaneous report received from a consumer concerned a 62 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, Expiry: Unknown) 1 total, dose was not reported, administered on JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On SEP-2021, the patient experienced suspected clinical vaccination failure and suspected covid-19 infection (breakthrough infection, dying in intensive care unit) (ICU). On unspecified date, the patient experienced lungs are stiffening (Acute respiratory distress syndrome) from the ventilator. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection, lungs are stiffening (Acute respiratory distress syndrome) from the ventilator and suspected clinical vaccination failure was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition). This report was associated with product quality complaint: 90000196340.; Sender's Comments: V0: 20211011489-covid-19 vaccine ad26.cov2.s-lungs are stiffening (Acute respiratory distress syndrome), Patient placed on ventilator, suspected covid-19 infection/ breakthrough infection. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).  20211011489-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
This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. Medical history was not reported. The reporting pharmacist informed that on an unknown date, dur to an under filled sterile diluent vial, it caused a patient, did not be able to receive a dose of ZOSTAVAX (lot number, expiration date, strength and route were not reported). Concomitant therapy was not reported. No adverse reactions were reported. Additional information has been requested.
Arm pain, 102.8 fever,  chills, body aches,  loose stools, headache the following day, arm pain continued more than 3 days
severe itching injection site swelling  and hardening in area of injection soreness in upper left arm at injection sitte moderate pain in left upper arm; now only slight pain. slight pain in left upper arm when raising arm up
My child already has seizures.  The evening of the first dosage, she had a seizure, worse than usual.  I thought maybe it was a fluke, however the same thing happened again after the second dose.  THe medicine I'm refering to is Gardasil.
1/23 5:00AM - Woke up with chills, body aches, and a low grade fever. 11:00AM - Fever was at 101. Took Tylenol. 5:15PM - Fever at 103, heart rate 125-145 for about an hour. Took Tylenol and hydrated. 6:15-11:00 - 105-120. 1/24 - heart rate normal, low grade fever, fatigue, and body aches and chills all day. Also noticed pain under my armpit on the side my injection was on. 1/25 - I have had a red bump on my arm since Saturday, but today it is warm and no better than it was on Saturday.
This case was reported by a consumer via sales rep and described the occurrence of Epstein-Barr virus infection in a female patient who received HAVRIX 1440 adult for prophylaxis. In January 2018, the patient received HAVRIX 1440 adult. In January 2018, less than a month after receiving HAVRIX 1440 adult, the patient experienced Epstein-Barr virus infection (serious criteria hospitalization). On an unknown date, the outcome of the Epstein-Barr virus infection was unknown. The reporter considered the Epstein-Barr virus infection to be unrelated to HAVRIX 1440 adult. Additional information was received as follows: The age at vaccination was not reported. The patient developed Epstein Barr virus shortly after receiving HAVRIX vaccine and was hospitalized for one week in January 2018. The physician told the patient that they did not think there was a correlation between getting vaccinated and getting the Epstein Barr virus. The patient had elevated liver enzymes.
Patients started with itching, was given 25 mg diphenhydramine at 12:30 pm. She then developed some wheezing and urticaria. Received one dose of Epi-pen, and then an albuterol treatment.
12/20/21 post travel Day 5 test, and with positive household members/travel companions was POSITIVE. Fully vaccinated and remains asymptomatic.
One of twenty-one cases: A non-serious, spontaneous event of a half dose of FLUMIST administered was received from a registered nurse. The event occurred in an eighth grade adolescent male. No medical or drug history was reported for this adolescent. FLUMIST was inadvertently administered in one nostril to 21 children during a flu clinic at an elementary school. The nurse administered the doses had been trained on administering FLUMIST but forgot to take off the divider clip; 21 children received only half a dose. No adverse effects were reported; the event is considered resolved.
swollen gums, sores in mouth, swollen and sore to touch gland on her right side of her neck
Tired/extreme fatigue for 5 days after vaccine. Taken to Urgent care on 6/23/22 for sore throat, stomach pain and sleepyness.
Since getting the Covid Vaccine, I have had uncontrollable panic attacks. Medication has not helped, therapy has not helped, meditation has not helped. They are so bad that I had to quit nursing school and my job. I can not even leave the house without having a panic attack. This includes grocery shopping, picking my children up off the bus, going out to eat, going to church, even visiting my parents. I have experienced panic attacks before, but they were never this bad, never this frequent and medication always helped curb them. Before the vaccine, I would experience maybe one panic attack every 6 months and could easily walk them off or take medication to curb them. Now, they occur almost every day, I cannot leave the house, no amount of medication has helped, I can not even concentrate and they have become extremely scary. This started approximately 2 weeks after my 2nd covid vaccine.
Vaccine was administered subcutaneously, well below deltoid/shoulder muscle. Following day had 3 inch diameter red, swollen, hot, itchy ,painful area at site.  Today on 6/24/22 I am continuing to have same issues with tingling down  left arm and left side of face. I visited Pharmacist at same location and was told the vaccine was administered in the wrong area and that I should call my primary physician. She was not clear if the vaccine would be effective.
Kept in fridge on 07-Feb-2022 and administered on 08-Apr-2022; expired doses of Moderna COVID-19 were administered beyond the beyond use date; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (Kept in fridge on 07-Feb-2022 and administered on 08-Apr-2022) and EXPIRED PRODUCT ADMINISTERED (expired doses of Moderna COVID-19 were administered beyond the beyond use date) in a 68-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 083J21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired doses of Moderna COVID-19 were administered beyond the beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Kept in fridge on 07-Feb-2022 and administered on 08-Apr-2022). At the time of the report, PRODUCT STORAGE ERROR (Kept in fridge on 07-Feb-2022 and administered on 08-Apr-2022) and EXPIRED PRODUCT ADMINISTERED (expired doses of Moderna COVID-19 were administered beyond the beyond use date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided.  It was reported that the patient received total 4 doses and the dose received on 8-Apr-2022 was the second booster. The vials were kept in refrigerator on 07-Feb-2022 and administered on 8-Apr-2022. The vial did not undergo any temperature excursions No treatment medication information was given.
This vaccine is not indicated for people 17 years-old or less. It was administered to a 12 year-old. No adverse events were observed or expected, but filled out the form because reported vaccine errors is strongly encouraged.
Patient developed severe joint pain approximately 2 weeks after vaccines & was placed on a weaning dose of prednisone by her PCP.  She is on a 10mg dose of prednisone today & joint pain has returned.
3/9 patient began with rash to left side of face, sore throat, left ear pain and productive cough. Was evaluated @ the facility on 3/10 where the vaccine was administered- Johnson and Johnson.  Evaluated @ facility on 3/12/21. Herpes Zoster affecting left side of scalp and face extending to eyelid. Referred to Ophthalmology for evaluation. Zpak discontinued and changed to Amoxil.
Headache, Myalgia, Fever, left arm injection site swollen Narrative:
Received Tdap on June 18th.  Within 2 days she had an area at the injection site approximately 3 inches in diameter.  The site was red, hard & very itchy.  Applied CORTAID.
Patient's mother brought her in as a walk in for the Covid Vaccine. Completed form with incorrect date of birth and wrote age as 12. Both the mother and daughter verbally confirmed age as 12 when asked. The mother signed the form. After vaccination was given and billing was done later in the day the insurance rejected based on age being incorrect. It appears that her actual date of birth is different which makes her 11 years old instead of 12 so her parent gave false information in order to get the shot before it is approved for under 12. We tried calling the mother to see if the insurance has incorrect date of birth but she will not return our call.
R ophthalmic herpes zoster with onset within 24 hrs after administration of influenza vaccine.
Inappropriate schedule of vaccine administered; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On 08-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not applicable.    This case was linked to US-MODERNATX, INC.-MOD-2021-071157 (E2B Linked Report); Sender's Comments:  US-MODERNATX, INC.-MOD-2021-071157:
Patient received  the 1st dose COVID-19 vaccine at 2:47 pm. Advised healthcare professional at 3:15 pm, she felt as if weight on her chest; similar to chest congestion (resolved 5 days ago).  At 3:30 pm patient shared she felt sweaty and still felt as if weight on chest.
Two hours post vax, the pt was irritable, and screamed for nine hours. The injection site was swollen. The next day she was "out of sorts". The most recent information received on 3/27/00 reported the condition of the pt as resolved.
Patient developed fever, starting low and increasing to 102.1, as well as feelings of hypersensitivity in his skin, chills and extreme fatigue about 20 hours after his first dose of Pfizer. Symptoms resolved by the following morning - lasted about 18 hours.
fever to 103,edema, ecchymosis, tenderness at vaccination site and limping on shot-administered leg 48 hours after vaccination with DTaP.
Slept a lot; Dry heaves; Arm was killing; Chills a lot; Nauseous; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSOMNIA (Slept a lot), RETCHING (Dry heaves), VACCINATION SITE PAIN (Arm was killing), CHILLS (Chills a lot) and NAUSEA (Nauseous) in a 102-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HYPERSOMNIA (Slept a lot), RETCHING (Dry heaves), VACCINATION SITE PAIN (Arm was killing), CHILLS (Chills a lot) and NAUSEA (Nauseous). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, HYPERSOMNIA (Slept a lot), RETCHING (Dry heaves), VACCINATION SITE PAIN (Arm was killing), CHILLS (Chills a lot) and NAUSEA (Nauseous) outcome was unknown.            Concomitant medications were not provided. Reporter stated that after booster patient also experienced bile.  Company comment: This spontaneous case concerns a 102-year-old female patient with no details relevant medical history, who experienced the unexpected non serious event/AESI of Sleep excessive (PT: Hypersomnia) after mRNA- 1273 vaccine. The onset of the event occurred on an unknown date after the booster dose of mRNA- 1273 vaccine. It was reported that after the vaccination, the patient slept a lot. The non serious expected events of Vaccination site pain, Chills and Nausea were also reported. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.   This case was linked to MOD-2021-417671 (Patient Link).; Sender's Comments: This spontaneous case concerns a 102-year-old female patient with no details relevant medical history, who experienced the unexpected non serious event/AESI of Sleep excessive (PT: Hypersomnia) after mRNA- 1273 vaccine. The onset of the event occurred on an unknown date after the booster dose of mRNA- 1273 vaccine. It was reported that after the vaccination, the patient slept a lot. The non serious expected events of Vaccination site pain, Chills and Nausea were also reported. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.
Patient hospitalized for peripheral vascular disease on 4/30/2021. Patient hospitalized for wound dehiscence, hypotension on 5/7/2021. These visits are within 6 weeks of receiving COVID vaccination.
Tingling sensation on their lips and tongues; head and room  spinning; seizure; The initial case was missing the following minimum criteria: unspecified suspect product. Upon receipt of follow-up information on 07Jul2021, this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable consumer. A 76-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EN6205) via an unspecified route of administration, on 06Mar2021 (at the age of 76 years old) as dose number unknown, single for COVID-19 immunisation. The patient's medical history included allergy to many antibiotics wherein the patient got hives or intense vomiting, and an ongoing high blood pressure. Concomitant medication included an unknown high blood pressure medication. The healthcare professional also said for her to stop taking it because of that sensation she had on her lips and tongue. On 06Mar2021, immediately after the vaccination, it was reported that the patient experienced tongue and lips were tingling. The nurse had the patient stayed for 30 minutes longer until sensation disappeared. The patient was admitted to the hospital and did not receive any treatment for the event. 7 hours later, the patient experienced that her head and room was spinning so intensely she couldn't function or open her eyes. The patient's husband wanted to take her to the hospital, but due to COVID, the patient was afraid to go. The spinning lasted for 7 hours. The patient did go to a neurologist to be sure that she didn't have a tumor, the doctor said that she was fortunate that she didn't have a stroke. The patient had an MRI brain scan to be sure she didn't have any prior issues that may have caused that seizures. She never experienced the dizziness and intense length of time. The outcome of the event "tingling sensation on their lips and tongues" was recovered on 06May2021, vertigo was recovered on unspecified date in Mar2021, while for the remaining event was unknown.
Pt felt severe pain in arm after shot and could not lift arm that night. He woke next day and felt very ill like the flu. He could not get warm that night or all day today. His body was very sore. No fever.