chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Syncope; This spontaneous report as received from a pharmacist, and refers to a 66 year old female patient with asthma. The patient is allergic to sulfa, novocaine and lidocaine. Information regarding the patient's medical history was not reported.     On 27-DEC-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) lot # T022294 and expiration date on 26-MAR-2022, intramuscular in the left deltoid for pneumococcal prophylaxis. On the same day, she had a syncope. The patient did not seek for medical attention and any treatment was given.   At the reporting time, reported as "this morning", the syncope was improving but ongoing.   The reporter considered syncope to be related to Pneumococcal Vaccine, Polyvalent (23-valent)(PNEUMOVAX23).  Upon internal review, the event of syncope was considered to be medically significant. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T022294; expirationdate: 26-MAR-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
Vaccine given intra articularly in Left Shoulder.  Immediate numbness and severe pain.  Severe pain, loss of range of motion, and intermittent numbness in left upper extremity continue and are still present at the time of this report. Still unclear as to if permanent disability has occurred.
Information has been received from a physician through a pregnancy registry concerning a 33 year old caucasian female with a repaired cleft palate/lip and no previous pregnancies who on 10/1/01 tested negative for varicella antibodies. On 10/10/01, the pt was vaccinated with a dose of varicella virus vaccine live (638902/0468L). Concomitant therapy included azithromycin, erythromycin, albuterol, and fluticasone propionate. The physician reported that the pt was three weeks pregnant at the time of vaccination and did not know. The pt's date of last menstrual period was reported by the physician to be 8/30/01. The pt's estimated delivery date was determined to be 6/24/02 according to her 9 week ultrasound on 11/20/01. On 1/9/02, serum alpha-feto protein screening was normal. On 1/22/02, an ultrasound was normal. On an unspecified date the pt had a fever and cough. On 3/12/02, a chest x-ray reveled pneumonia, and the pt was hospitalized for pneumonia. On 6/6/02, 37 weeks from LMP, the pt delivered a normal baby girl weighing 7 lbs. 4oz. Complications during labor and delivery included inadequate pelvis and signs and symptoms of pregnancy induced hypertension. The pt did not have any varicella or herpes zoster symptoms or local reaction post vaccination with varicella vaccine live. The infant had no symptoms of congenital varicella zoster syndrome. Additional info received via medical records indicate that the infant had congenital ptosis. The pt had mild palpebral fissure asymmetry (the right was a bit smaller than the left). The physician did not see any signs of anisocoria or EOM problems to suggest a neuro-ophthalmic lesion. Funduscopic exam was normal. The physician recommended reassurance. A review of the medical records indicated no other adverse symptoms were noted. No additional info is expected.
Severe L upper arm pain with L trapezius and neck spasm/ pain. L lower back spasm/pain. Low grade fever.
Teeth sensitivity on the side of vaccine injection area; This spontaneous case was reported by a consumer and describes the occurrence of HYPERAESTHESIA TEETH (Teeth sensitivity on the side of vaccine injection area) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HYPERAESTHESIA TEETH (Teeth sensitivity on the side of vaccine injection area). At the time of the report, HYPERAESTHESIA TEETH (Teeth sensitivity on the side of vaccine injection area) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   No treatment information was provided.
Patient said she had swelling in the left arm forming a large, warm knot. The swelling has since gone down and she is not experiencing any symptoms at this time, but will see her doctor if they resume.
Ordered for patient was the pneumococcal 23 vaccine and patient was inadvertently given Meningococcal B instead
pt recv vax 2OCT96 & 16OCT96 pt exp a shingles-type rash on buttocks;
I had a racing heartbeat going up to 148 beats a minute. This was 60 hours after injection. I call 911 and was taken to emergency room/ racing heart rate; Some Dizziness/ Lightheadedness; This is a spontaneous report from a contactable consumer reported herself that a 75-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL0739), via an unspecified route of administration on 02Feb2021 at 09:45 in arm right as a 2nd dose, single for COVID-19 immunization. The patient's medical history included CLL, macular degeneration ongoing, cataracts and I all allergic to Vespids (wasps, yellow jackets and hornets), heartburn and constipation. Historical vaccine included BNT162B2 on 12Jan2021 (administration time: 08:45 AM, vaccine location: right arm, dose number: 1). Concomitant medications included omeprazole DR for heartburn taken orally and ongoing, herbal remedies, ascorbic acid, ergocalciferol, nicotinamide, retinol, riboflavin, thiamine hydrochloride (VITAMINS [ASCORBIC ACID; ERGOCALCIFEROL; NICOTINAMIDE; RETINOL; RIBOFLAVIN; THIAMINE HYDROCHLORIDE]) and miralax (MACROGOL 3350) taken orally for constipation stopped on 01May2021. On 04Feb2021 at 09:30, the patient experienced a racing heartbeat going up to 148 beats a minute. This was 60 hours after injection. The patient called to 911 and was taken to emergency room. The events resulted in emergency room/department or urgent care. It was unknown If patient took treatment for the event. The patient underwent lab test included heart rate irregular resulted as going up 148 beats a minute. Upon follow up on 12Mar2021, it was reported that, 60 hours after receiving the 2nd dose my heart rate started increasing or a very rapid rate despite the fact that I was sitting still the heart rate reaches 148 and then went down to 108. EMT were called and suggested I go to ER. More test were done to eliminate any cardiac Rx. Nothing was found. I also had some dizziness and lightheadedness. No Prior vaccinations with in four weeks. On 04Feb2021, the patient experienced racing heart rate and dizziness. On 05Feb2021, the patient underwent lab tests and procedures included EKG was normal, Blood test was normal, CT of heart was normal, and Chest X-ray was normal. The outcome of the events palpitations was recovered, while with other event was unknown.  Reporter considered the event racing heart rate as serious (Life-threatening, important medical event) and required visit to: Emergency room. The patient was hospitalized for 9 hours.  Follow-up (12Mar2021): New information was received from a contactable consumer included: information on Medical history and lab data.  Information of Lot/Batch number was available. Additional information has been requested.
Narrative: COVID infection following COVID vaccine series 01/20, Pfizer, dose #1 02/09, Pfizer, dose #2 08/27 COVID swab, result: detected 08/27 CXR impression: Probable atelectatic changes in the left base. Otherwise no acute process is seen. 08/26 pt cc: Nausea, vomiting, fatigue exposure: unknown 08/28 pulm v/q impression: No definite perfusion abnormality to suggest significant pulmonary embolus. Small pulmonary emboli cannot be completely excluded. 09/01 CXR impression: New and large-volume parenchymal opacities within both lungs, RIGHT much worse than LEFT, since 5 days ago, most in keeping with ongoing COVID pneumonitis. No large pleural effusion. 09/04 pt deceased
Patient was to receive Jynneos MPX vaccine intradermally. Vaccinator used proper technique, however the needle was too superficial, so when she injected the vaccine content, the content leaked out of the injection site.  Following evaluation, pt was revaccinated via subcutaneous administration.
Chief complaint of increased redness, warmth, and pain with palpation at the site of a shingles vaccine on the left upper arm (at the triceps area).  Patient received the shingles vaccine two days ago.
Very bad diarrhea; Belching with bad taste; Injection site pain to the touch; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Very bad diarrhea), ERUCTATION (Belching with bad taste) and INJECTION SITE PAIN (Injection site pain to the touch) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced DIARRHOEA (Very bad diarrhea), ERUCTATION (Belching with bad taste) and INJECTION SITE PAIN (Injection site pain to the touch). At the time of the report, DIARRHOEA (Very bad diarrhea), ERUCTATION (Belching with bad taste) and INJECTION SITE PAIN (Injection site pain to the touch) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. Patient took Pepcid AC and tums as treatment.   Reporter did not allow further contact
Pt called out 10 minutes after vaccination was given complaining of throat swelling, wheezing, eye's swollen shut, lips swollen, sweating, vomiting, and itching all over. Multiple RNs and Dr. at bedside. IV inserted 50mg Benadryl given, 4mg of Zofran given, IV Decadron given, without improvement, O2 saturation declined to 80%, O2 administered via Non-rebreather at 5Ls. 25mg of Benadryl given. Pt weened off O2 after 20 minutes when O2 saturation was 93-95%. Pt stated she was feeling much better, her throat was just sore. 30 minutes later pt visibly looking so much better, swelling gone, O2 saturation normal, states she feels much better.
Client presented at the vaccination site on 02/06/22. The client reported he received a first dose of Pfizer COVID vaccine on 07/29/21 (lot #: EW0175) and a second dose of Pfizer COVID vaccine on 08/19/21 (lot #: FC3183). Client reported with her first dose on 07/29/21 at 1806, she reported after the vaccination at 2100, she saw a red raised rash on her stomach area after her shower, fever, and she had dizziness, tiredness, and weakness for nine hours the next day from 0600 to 1500. Client?s mother told she gave client Tylenol for the fever with help and the stomach rash disappeared on its own by the next morning. Client reported with her second dose of COVID Pfizer vaccine on 08/19/21, she had dizziness which lasted only two hours after the vaccination, tiredness, and weakness the next day from 0600 to 1800. Client?s mother told she didn?t take client to follow-up with her PCP for both doses. Client?s mother reported client has no chronic illnesses or taking any medications and has no known allergy. Client?s mother is requesting for the booster dose of Pfizer COVID vaccine today for her daughter. PHN submitted a medical consult via text message to clinical project coordinator, requesting to proceed with the booster dose of Pfizer COVID vaccine. Per the doctor, approval to proceed with the booster dose of Pfizer COVID vaccine was obtained via text message from clinical project coordinator. Client received the booster dose of Pfizer COVID vaccine, LOT#: FK9896 on 02/06/22 at 1621 by LVN. The client did not report any symptoms during the 30-minute observation period. PHN educated client?s mother and client on possible adverse reactions and when to seek EMS. Client?s mother and client verbalized understanding. Client left vaccination site at 1651 unassisted and with a steady gait.
Patient started with erythematous papular dry rash to face, neck and chest about 12 hours after receiving COVID pfizer booster and HD Flu vaccine. Rash has persisted x 15 days
had the shot, now has a rash; This case was reported by a consumer via interactive digital media and described the occurrence of rash in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 5th November 2021, the patient received Shingles vaccine. In November 2021, less than a week after receiving Shingles vaccine, the patient experienced rash. On an unknown date, the outcome of the rash was not recovered/not resolved.   It was unknown if the reporter considered the rash to be related to Shingles vaccine.  Additional details provided were as follows: The case was reported by patient's husband. Age at vaccination was not reported. The patient received a dose of Shingrix vaccine yesterday from the day of reporting and experienced rash. Follow-up would not be possible as no contact details updated.
tested positive for Covid after first dose; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (tested positive for Covid after first dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Mar-2021, the patient experienced SARS-COV-2 TEST POSITIVE (tested positive for Covid after first dose). At the time of the report, SARS-COV-2 TEST POSITIVE (tested positive for Covid after first dose) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Mar-2021, SARS-CoV-2 test: positive (Positive) tested positive for Covid.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.    Reporter did not allow further contact
confused/When talking to her she is talking out of her head/hought her condo was turned completely around; She is having headaches; muscle pain; chills; double vision; dizziness; her arm, and joint pain; her arm, and joint pain; extremely exhausted; This is a spontaneous report from a contactable consumer. A 68-year-old female patient (consumer's mother) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration on 08Apr2021 (Batch/Lot number unknown as complainant does not have the product with them at the time of call) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Reporter was calling about her mother. The patient was fine before she got this shot and no one can seem to help her. They had the vaccine on 08Apr2021 and her mom (patient) started having severe reactions to it on 10Apr2021. Patient had the chills, muscle aches, muscle pain, headache, dizziness, her arm, and joint pain. She did not have fever, but had chills. She had double vision now. The symptoms are not going away. They are getting worse. They took her mom to the ER. The patient was confused. When talking to her she was talking out of her head. The severity of confusion is she thought her condo was turned completely around. Patient was not getting better. Went to the doctor and the doctor was at a lost. Patient was extremely exhausted. Caller stated they all took the same shot on the same day and her mom was the only one to have a reaction. Patient was literally out of her mind. Caller's dad had to take patient to the store with him because he didn't want to leave her by herself. They live in a condo on the second floor. Her mom thought the condo was reversed. Her dad was worried to leave her mom by herself because he didn't want her to go out the wrong door and go over the balcony. Her mom was not like that prior to receiving COVID19 Vaccine. Reporter was asked if there was an antidote. They were told patient should see her doctor and that she need treatment but no one could give they something to antidote the vaccine. The outcome of events was not recovered.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
HEADACHE; SORE ARM; FEELING SICK; NAUSEATED; CHILLS; TIRED; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included unspecified allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805029, and batch number: 1805029 expiry: UNKNOWN) .5 ml, administered on 07-MAR-2021 to Left Arm for prophylactic vaccination. No concomitant medications were reported. On 08-MAR-2021, the subject experienced feeling sick. On 08-MAR-2021, the subject experienced nauseated. On 08-MAR-2021, the subject experienced chills. On 08-MAR-2021, the subject experienced tired. On 09-MAR-2021, the subject experienced headache. On 09-MAR-2021, the subject experienced arm sore. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from feeling sick, nauseated, tired, headache, and arm sore, and the outcome of chills was not reported. This report was non-serious.
Information has been received from a physician concerning a 15 year old male who on 06-JUL-1995 and 04-JUN-1998 was vaccinated with the first and second dose of MMR II (HSA) (lot# not reported). On 24-NOV-2009 the patient did the first blood work and the results showed IgM <1:10, IgG 5.73, and serum amylase 150. On 05-DEC-2009 the patient experienced onset of symptoms and on 06-DEC-2009 was diagnosed with mumps. The patient was febrile and had left side parotitis. At the time of the report, the outcome of mumps was unknown. Additional information has been requested..
Pt received vaccine at 13:45 and 20-30 minutes later, experienced hot flush, wheezing, cough, dyspnea, tongue swelling and shortness of breath. Pt returned to BAS. Vital signs at 14:20; BP-143/72; Pulse-72; Respirations-20 and temperature was 97.9F. She was administered 1.0cc Epi and 25mg Benadryl and O2 therapy. Pt's breathing improved and she was sent to NHCP for further treatment.
At around 1500  throat was itching and felt like I was short of breath.   swelling in right arm and hand. severe itching in the right arm and hand. as per patient
No additional AE reported; Nurse reports products that experienced temperature excursion over the weekend were administered to a patient./ Temperature above 9 Celsius degrees (13,25 Celsius degrees); This spontaneous report was received from registered nurse and refers to a patient of unknown age and gender.  The patient medical history, current conditions and concomitant medications were not reported.  On 13-FEB-2023, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # 1879875 and expiration date 19-NOV-2023 (dose, strength and route of administration were not provided) and haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (lot # W015926, expiration date 14-FEB-2025, (dose, strength, anatomical location and route of administration were not provided) for prophylaxis (Product storage error). The suspect vaccines experienced temperature excursion (temperature above 9 degrees Celsius (13.25 degrees Celsius) for 2 hour 32 minutes) on unknown date over the weekend. There was no previous temperature excursion. No additional adverse event was reported.
Inconsolable crying beginning 2 hrs p/receiving immun & lasting 7 hrs;
3/16/06 - From mother of child - Mother saying child got shots on 3/6/06. Now has a rash on her face and bumps on her legs. Child rec. Immun. on 3/6/06. No fever, pain, rash, illness for several days after shots. Then on 3/14/06 mother noticed few bumps on legs. One under R elbow, one on Lt arm, 2 on L hand. Raised - no pustule. No drainage. None on abd, back or elsewhere noted. Child had fever 3/15/06 x 2 "I know because she was hot." Unknown temperature readings, has not had any since. Child has not been ill, has been her "normal self." Rash on face is only on R side of cheek and not spreading. Filled out form VAERS-1 and advised mother to take child to her PMD. She will see MD 3/17/06 at 11:00 am. Reviewed with mother adverse reaction events info, PMD Children's Clinic, asked mother to call if any change in child after seeing PMD.
Patient's arm is red all the way around radiating down to the elbow from the upper arm. She states it's itchy, swelling and getting hard.
Received 2 Doses of Heplisav-B, Had Titers Drawn and Had A Negative Titer; Initial Report Received on 17-Jul-2023  Service Center reported that a female patient (age, race, and ethnicity unknown), received two doses of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and got a negative titer.  Medical history, allergies, and medications at the time of vaccination were not reported.   On an unspecified date, the patient received the first dose of HEPLISAV-B vaccine (Lot #; expiration date, NDC # not reported).  One month later, on an unknown date, the patient received the second dose of HEPLISAV-B vaccine (Lot #; expiration date, NDC # not reported).   On an unspecified date, after receiving 2 doses of the HEPLISAV-B vaccine, the patient got a negative titer. No additional information was reported.  Company Comment:  The company assessed the event as non-serious. The event was not immunologically confirmed as the time to serological marker testing and the serological marker results were not reported.; Sender's Comments: The company assessed the event as non-serious. The event was not immunologically confirmed as the time to serological marker testing and the serological marker results were not reported.
This case was reported by a physician via a sales representative and described the occurrence of yellow skin in a female subject of unspecified age who was vaccinated with Havrix for prophylaxis. On an unspecified date the subject received an unspecified dose of Havrix (unknown). At an unspecified time after vaccination with Havrix, the subject's palm and feet turned yellow. This case was assessed as medically serious. The sales representative reported that the events were "self-limiting". At the time of reporting, the outcome was not specified.
This spontaneous report as received from a health care worker refers to unspecified patients of unknown age and gender. No information about medical history, concurrent conditions were reported for the patients. On an unknown date the patients were vaccinated with improperly stored VAQTA (dose strength, dose number, route unspecified). No adverse events were reported. The outcome of events reported was unknown. No product quality complaint was involved. This case is linked to the cases 1506USA004940, 1506USA004986, 1506USA004985 via same reporter link. Additional information has been requested.