chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Bilateral bicep and thigh muscle weakness, as well as hand and foot cramps.  This has occurred with each covid vaccine with both Pfizer and Moderna.  I am reporting this from the booster since I know these symptoms are directly related to the covid vaccines for me.  I had the first two doses in January 2021, and the symptoms lasted around 4 months.  Symptoms resolved from the summer until my booster on Dec 30, 2021, now all of these symptoms have returned.
Patient was due to receive the Pfizer Bivalent Booster. Instead, the Monovalent was administered in error.
This case was reported by a pharmacist via call center representative and described the occurrence of vesicular rash in a 75-year-old female patient who received SHINGRIX (batch number 49R72, expiry date 13th March 2021) for prophylaxis. Previously administered products included ZOSTAVAX with an associated reaction of rash vesicular (received several years before the date of reporting with a smaller, similar rash, described as looking like shingles). On 14th December 2018, the patient received the 1st dose of SHINGRIX. In December 2018, less than a week after receiving SHINGRIX, the patient experienced vesicular rash, injection site warmth, injection site pain, skin scaly and injection site erythema. On 20th December 2018, the outcome of the injection site warmth was recovered/resolved. On an unknown date, the outcome of the vesicular rash was not recovered/not resolved and the outcome of the injection site pain, skin scaly and injection site erythema were unknown. It was unknown if the reporter considered the vesicular rash, injection site warmth, injection site pain, skin scaly and injection site erythema to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX in the left deltoid. The patient developed a softball-sized area approximately half inch below the injection site. The area was red, very warm to the touch and somewhat painful. The pharmacist saw the patient 6 days after vaccination and stated that, the area looked a little red and a little scaly. The reporter was unable to provide time from vaccination to development of rash. The reporter consented to follow up.
Patient presented with AMS, 5 episodes of emesis. Her ct scan revealed a subarachnoid hemorrhage (possibly an eurismal)
10 minute hypotonic, hyporesponsive episode, Infants vital signs okay, color pale but stable, gradually returned to normal.
COVID; COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID.  An adult patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID". The reporter intended to sue "you" for damages and lost wages that was cause by COVID> The reporter had to quit job to care for wife and raise kids.      The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Swelling left eye. Hives all over face and body swelling in face and body we went to the emergency room where he was given BENADRYL, epinephrine was discussed but due to heart conditions was put on hold as a last resort, he responded well to BENADRYL
Chills; Aches; 100 degree fever; Tired; Headaches; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730), via an unspecified route of administration in the left arm on 24Mar2021 at 09:30 (at an age of 58-years-old), as a single dose for COVID-19 immunisation. The patient had no medical history. Concomitant medication included vitamins (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205), via an unspecified route of administration in the left arm on 03Mar2021 at 17:30 (at an age of 58-years-old), as a single dose for COVID-19 immunisation. The patient had no allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 25Mar2021 at 08:00, the patient experienced chills, aches, 100-degree fever, tired and headaches. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported events. The clinical outcome of chills, aches, 100-degree fever, tired and headaches were not resolved.   No follow-up attempts are needed. No further information is expected.
About 12 hours or so after dose 2, I had headache and body aches and a little upset stomach but then it went to something else, anytime I tried to eat anything it went right through me. I had a few good days and then it started up again (food going right through me) and this continued for a few week. I had not introduced anything new. I had to contact my doctor. It was bad. It was very extreme - it was like how they try to clean your system out before you have a colonoscopy. I couldn't understand what was going on. I had to take medication - I switched out the probiotic I was on temporarily. I had to be extra careful with my diet - not getting gluten etc. But I still had the issue for a few weeks - off and on. They couldn't see what was causing it, but they could just help with the symptoms themselves. I took Tums for the pain and I took anti-diarrheal medication. I did a lot bland food and a liquid diet for a bit to calm the stomach. I am still having at this time is that I am still sticking to my diet (low FODMAP diet) but things I should be able to eat is causing bloating and/or pain. I have been to Urologist, Gastro doctor and Gynecologist. No one knows why I am having the bloating or pain. I have to eat every two or three hours and if I miss that window, I get bloating. That is what is going on still with symptoms. I had the Booster vaccine: October 11, 2021 I saw my primary care doctor - and she ran some blood work and referred me to GI doctor. Did a pelvic exam and put in for me to get an Abdominal CT - and they found out I had a Kidney stone and some more cysts. But nothing that seemed to be wrong with the stomach itself. They thought that switching out the probiotic might help.
This spontaneous report was received from a nurse practitioner refers to a 21-year-old patient of unknown gender. The patient's concurrent conditions, medical history, drug reactions, allergies and concomitant therapy were unknown. On an unknown date, the 21-year-old patient was inadvertently vaccinated with first dose of Oka-Merck) PROQUAD (dose, units, frequency, Lot# and expiry date unknown). It was reported that there were no state records that showed the patient was ever vaccinated with (wistar ra 27-3) M-M-R II or Oka/Merck VARIVAX. No adverse symptoms reported. No product quality complaint was reported.
1hr p/vax t101oral; rt deltoid swollen & painful treatment; DPh, APAP & ice to shoulder fully recovered 3-4 days;
Patient was sitting in a chair when all of a sudden her hands became twisted, her wrists wrapped around each other, and she became unconscious.  Her legs went straight out and body became rigid in a prone position.  Her head went back and her breathing became very deep (rattling sound).  Seizure began and estimated to last between 2.5 to 3 minutes.  Then patient became conscious again and had no recollection of event other than headache (patient unsure if she had headache prior to seizure or not).
This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. Pertinent medical history was unknown. On 16-JAN-2015 the patient was vaccinated with a dose of ZOSTAVAX (lot # K010648, expiry date: 30-OCT-2015, 0.65 ml, subcutaneous, anatomical location was unknown) that underwent an unsupported temperature excursion (Incorrect product storage). Concomitant medications were unspecified by reporter. No adverse event reported. The outcome of the events was unknown. No further information provided. This case# 1501USA008553 is linked to the case# 1501USA008296 via same reporter link. Additional information has been requested.
Mononucleosis; This case was reported by a other health professional via call center representative and described the occurrence of mononucleosis in a 37-year-old female patient who received HBV (Engerix B adult) (batch number FT42N, expiry date 3rd February 2021) for prophylaxis.   On 23rd July 2019, the patient received the 1st dose of Engerix B adult. In August 2019, 30 days after receiving Engerix B adult, the patient experienced mononucleosis. On an unknown date, the outcome of the mononucleosis was unknown.   It was unknown if the reporter considered the mononucleosis to be related to Engerix B adult.  Additional details were provided as follows: The pharmacy technician stated the patient who received Engerix B series and at the time of reporting has mono. No further details provided on the call. The pharmacy technician consents to follow up from safety. Adverse event submitted after call was completed. There was no second suspect vaccine. The reporter clicked on new vaccine rather than save and could not delete the second vaccine. Only the Engerix B was suspect.
gave Fluzone QIV instead of the intended Fluzone HD QIV to patient with no reported adverse event; Initial information received on 21-Aug-2023 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves a 80 years old male patient who received Influenza Quadrival A-B Vaccine [Fluzone Qiv] instead of the intended Influenza Quadrival A-B High Dose Hv Vaccine [Fluzone High-Dose Quadrivalent] with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 19-Aug-2023, the patient received 0.5 ml of suspect Influenza Quadrival A-B Vaccine Suspension for injection (lot number: V80418A; Expiry date:Jun-2024) (Strength-Standard) (Frequency: Once) via intramuscular route in the left arm for immunization.  On 19-Aug-2023, the patient received Influenza Quadrival A-B Vaccine [Fluzone Qiv] instead of the intended Influenza Quadrival A-B High Dose Hv Vaccine [Fluzone High-Dose Quadrivalent] with no adverse event (wrong product administered) (Latency: same day).  It was reported, Pharmacist had an event on Saturday where they were administering flu vaccines. They gave an 80 year old patient and 67 year old patient the FLUZONE QIV instead of the intended FLUZONE HD QIV. Caller would like to know what the recommendation is since a patient that should have received the incorrect flu vaccine? Should they revaccinate? These inquiries are reported as medication errors for the administration of FLUZONE QIV instead of the intended FLUZONE HD QIV.   Action taken: not applicable.  Outcome: Unknown   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
AN IRREGULAR HEART BEAT; LETHARGY; ELEPHANT LEGS; PREMATURE ATRIAL CONTRACTIONS; PREMATURE VENTRICULAR CONTRACTIONS; MUSCLE WEAKNESS; INJECTION SITE PAIN; This spontaneous report received from a consumer concerned a 69 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included mild copd, and aortic aneurysm. The patient experienced drug allergy when treated with prednisone, and pseudoephedrine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022 expiry: UNKNOWN) dose was not reported, administered on 13-MAR-2021 on right arm for prophylactic vaccination. No concomitant medications were reported. On 2020, Laboratory data included: Echocardiogram (NR: not provided) Unremarkable. On 16-MAR-2021, the subject experienced muscle weakness. On 16-MAR-2021, the subject experienced injection site pain. On 17-MAR-2021, the subject experienced premature atrial contractions. On 17-MAR-2021, the subject experienced premature ventricular contractions. On an unspecified date, the subject experienced elephant legs, an irregular heart beat, and lethargy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from elephant legs, and lethargy, and muscle weakness on 22-MAR-2021, was recovering from injection site pain, and had not recovered from premature atrial contractions, premature ventricular contractions, and an irregular heart beat. This report was non-serious.; Sender's Comments: V1: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
a couple of. months after my booster I developed hives, psoriasis along my skalp and a horrible reaction on my eyelids
Vaccine was administered at the age of 14; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine was administered at the age of 14) in a 14-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 21-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-May-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine was administered at the age of 14). On 21-May-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine was administered at the age of 14) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.        Concomitant product use was not provided by the reporter. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 07-Jun-2021: Follow-up received on 07-Jun-2021 and vaccine facility updated.
Abdominal Pain, Nausea/Vomiting, Fever, and Body Aches after receiving 1st dose of COVID-19 vaccine (Pfizer) on Sunday.  Acetaminophen given 1 hour prior to admission
Fatigue; Body aches; Migraine; Vomiting; Chills; Sweats; This is a spontaneous report from a contactable other health professional (patient). A 31-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283), intramuscular on 07Jan2021 09:15 at a single dose on Left arm for COVID-19 immunization. Medical history included Chronic back pain, and latex allergy. Concomitant medication included gabapentin, acetaminophen, tramadol, sulindac, methocarbamol. The patient previously took the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), intramuscular on 17Dec2020 09:30 at a single dose on right arm for COVID-19 immunization. The patient experienced fatigue, body aches, migraine, vomiting, chills, sweats on 07Jan2021 12:30. No treatment received for adverse event. The outcome of the event was recovered on an unspecified date in Jan2021. The events were assessed as non-serious. The patient was not pregnant at time of vaccination. Facility where the most recent COVID-19 vaccine was administered was Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.
Received booster dose on Friday, January 14th. The following day she woke with  neck pain which lasted for several days. Next she developed swollen lymph node?s under both arms and  throat. She complained of extreme fatigue and couldn?t seem to get enough sleep.  On Saturday January 22nd she developed a sore throat that worsened rapidly. On Tuesday January 25th she went to a clinic where she was diagnosed with Mononucleosis.  There have been no sick contacts in our family or with her boyfriend or other friends.  Since Mononucleosis is an infection of the EBV I wanted to let you know. She?s doing fine. Thank you
Caller got the Pfizer Covid 19 vaccine and 2 booster shots. Caller mentioned that she experienced small strokes after taking Paxlovid and could not speak; Caller got the Pfizer Covid 19 vaccine and 2 booster shots. Caller mentioned that she experienced small strokes after taking Paxlovid and could not speak; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team and product quality group, Program ID. The reporter is the patient.  A 77-year-old female patient received bnt162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), in Nov2022 as dose number unknown (booster), single (Batch/Lot number: unknown) and as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Caller got the Pfizer Covid 19 vaccine and 2 booster shots. Caller mentioned that she experienced small strokes after taking Paxlovid and could not speak". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The caller caller got the Pfizer Covid 19 vaccine and 2 booster shots. The caller mentioned that she experienced small strokes after taking Paxlovid and could not speak. The caller was calling about Paxlovid. She last took it back on 08Aug2022. She was 77 years old at the time. She experienced small strokes after taking Paxlovid. She was now 78 years old. She also said the virus wasn't the only monster. the drug Pfizer was calling people and naming them, it was hurting them. The patient had Pfizer Covid 19 vaccine and 2 booster last Nov2022 and got tested positive for covid. Caller mentioned that she got covid again and was prescribed for Paxlovid but when she took the pill she experience small stoke and could not speak. Created Manual AE form because after taking Paxlovid she experience small stoke and could not speak.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Redness, egg size swelling, hotness at injection site 1 week after vaccine. Only initial side effects was soreness on the day of injection.
itchiness; Itchy rash on left arm appeared on 14Mar and slight rash on right arm; This is a spontaneous report from a contactable consumer (Patient) or other non hcp.   A 59-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: ENG205, Expiration date was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 06Mar2021, at 18:15 (at the age of 59-years-old) as dose 1, single for covid-19 immunisation. Medical history included obesity, blood pressure increased from an unknown date and unknown if ongoing. Concomitant medications included losartan, clonazepam, fluoxetine all taken for an unspecified indication, start and stop date were not reported. The patient previously took ampicillin and experienced drug hypersensitivity. The patient was not pregnant in that time. No treatment was received in response to the adverse events. The patient did not received any other vaccines within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 15Mar2021 at 03:00, the patient experienced itchiness, itchy rash on left arm appeared on 14March and slight rash on right arm. The outcome of the events was recovering.   No follow-up attempts are possible. No further information is expected.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. There was no information about the patient's concomitant medications, allergies and pertinent medical history reported. On 19-DEC-2016, the patient was vaccinated with an expired dose of ZOSTAVAX lot # L029485, expiry date 06-NOV-2016 (dose, route and site of administration were not reported).  No adverse effects were reported. Additional information has been requested.
05/21/2005- A few lesions appeared on face, neck, chest, and arms. By 05/23/2005, vesicles on scalp and trunk as well. (30-40 lesions total) DX: Varicella.
Tested and penis swelled and were itchy. The swelling increased knee a period of days and radiated to his thighs and stomach. Swelling abated after 4 days. Then, about 4 weeks later he began to exhibit OCD symptoms and tics.  He started needed to have doors closed, lining up books and DVDs to the edges of furniture, and began to obsessively scrunch and touch his nose.
A 3 yr old was to get the 4th HiB vaccine and a 6 mo old was to get Pentacel #3, Hep B #3 and Prevnar #3. Somehow the ActHib bottle ended up on the tray with the 6 mo old shots and the ActHib component from the Pentacel ended up on the tray for the 3 yr old. The DTaP-IPV component of Pentacel was mixed with the ActHib (vaccine that is mixed with its own diluent). It was given to the 6 mo old but the error was caught before anything was given to the 3 yr old. Both vials have a green top. The 6 mo old got the Acthib but it was not the ActHib that comes in the box with the Pentacel.