chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received first dose of Pfizer COVID vaccine at approximately 3:15pm. Patient reports history of severe reaction to other vaccinations in the past, such as the flu shot (flu shot - anaphylaxis). Also reports history of chest pain, but denies ever having heart attack. Per patient, she had a discussion with her PCP, and that per PCP said that it was ok to receive the COVID vaccine. Right after receiving the shot, patient started feeling dizzy. Asked patient to remain seated in vaccination room with me for a few minutes. Dizziness went away after a few minutes after. Asked patient to have a seat in the waiting area for 30 minutes. Followed up after 30 minutes passed, and patient reported facial itch, chest pain, and generalized joint pain, but denied difficulty breathing. Face appeared flushing, but not blue. Also appeared clammy. Called PCP and PCP requested to call 9-1-1. Referred patient to emergency services. Paramedics arrived at 4pm for transport to emergency services. MD will follow up with patient afterward.
First dose April of 2019, second dose on 19Aug2022.; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 84-year-old male patient who received Herpes zoster (Shingrix) (batch number Z4G59, expiry date 7th July 2023) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in April 2019).   On 19th August 2022, the patient received the 2nd dose of Shingrix. On 19th August 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 22-AUG-2022 Reporter's Comments: The pharmacist had a patient who had first dose of Shingrix in April 2019 and was given a second dose on 19th August 2022.  The reporter did not ask about follow up but email was above. Additional Supportive Information: The patient received the second dose later than the recommended interval, which led to lengthening of vaccine schedule.
This is a side effect that I'm having that Is not listed on the pamphlet that I got and it said gave a number to call to report any side effects that your having or adverse reaction your having so that's what I'm doing, on the 30th when I got the shot about about 6, 7 pm that night I started feeling so sick I threw up I couldn't keep nothing down and I started having really bad diarrhea and stomach pain so bad I couldn't stand it this is like the worst case of the flu I ever had, and I was completely fine before getting the covid19 vaccine, so this is totally from the shot I haven't been able to eat since because my stomach has been so upset...
PATIENT DEVELOPED BLISTERS ON THE INJECT LEFT ARM AND THE SKIN STARTED PEELING
pt recv 9AUG95 & the same day pt hair started to come out in clumps;the nurse reported that the only different product the pt used was crest for sensitive teeth;
Severe muscle aches, extreme fatigue for 4 days, nausea,  second menstral cycle for the month of October began on the 9th and has not ended, and headaches.
gets the flu shot then spreads it to his friends; Initial information was received on 12-Oct-2020 regarding an unsolicited valid non-serious case from a consumer/non-health care professional via social media.  This case is linked to cases 2020SA289370 and 2020SA289513.  This case involves an unknown age patient who had gets the flu shot then spreads it to his friends (Influenza), when received vaccine INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient gets the flu shot then spreads it to his friends (Influenza), (unknown latency, non-serious event) following the administration of INFLUENZA VACCINE. Only time patient friend gets the flu was when he gets the flu shot then spreads it to his friends.   No laboratory data was provided.   It was not reported if the patient received a corrective treatment.  At the time of report, the outcome of event was unknown.  There will be no information available on the batch number for this case.
Symptoms of diarrhea, loss appetite started 36 hours after vaccine lasted for 3 days. Reports stomach ache and loss pf appetite today
Chest pain, projectile vomiting, hives and swelling of the face, mouth and throat. Benedryl, steroids, Nitroglycerin 3 times. I was not aware of any other test or results.
Hypertension; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION  in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood cholesterol increased. Concomitant products included ATORVASTATIN for Cholesterol blood increased.    On 08-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, the patient experienced HYPERTENSION. The patient was treated with AMLODIPINE for Hypertension, at an unspecified dose and frequency. At the time of the report, HYPERTENSION outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Feb-2021, Blood pressure measurement: 200 mmHg (High).         Patient went to Emergency Room and stayed for 2 nights after his BP normalized.    Reporter did not allow further contact.
fatigue; chills; headache; low grade fever; This spontaneous case was reported by a patient and describes the occurrence of FATIGUE (fatigue), CHILLS (chills), HEADACHE (headache) and PYREXIA (low grade fever) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 immunization.     The patient's past medical history included No adverse event (No reported medical history). Concomitant products included MONASCUS PURPUREUS, NICOTINAMIDE, PHYTOSTEROLS NOS (RED YEAST RICE WITH PLANT STEROLS) for Cholesterol.    On 10-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021 at 9:00 AM, the patient experienced FATIGUE (fatigue), CHILLS (chills), HEADACHE (headache) and PYREXIA (low grade fever). In February 2021, FATIGUE (fatigue), CHILLS (chills), HEADACHE (headache) and PYREXIA (low grade fever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient herself took two doses of Tylenol for treating events. The events resolved within 24-hours.
severe body aches; itchy arm; sore arm; awake for 3 nights; This case was reported by a physician via call center representative and described the occurrence of general body pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced general body pain, insomnia, itchy upper limbs and pain in arm. On an unknown date, the outcome of the general body pain, itchy upper limbs and pain in arm were recovering/resolving and the outcome of the insomnia was recovered/resolved.   It was unknown if the reporter considered the general body pain, insomnia, itchy upper limbs and pain in arm to be related to Shingrix.  Additional details were provided as follows:  The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient experienced severe body aches for several days that kept her awake for 3 nights and an itchy sore arm well below the injection site that had lingered for 3 weeks but was very gradually subsiding. The reporter asked If the patient gets the recommended 2nd dose could the reaction be worse. The reporter asked if there was data about 2nd shot symptoms after having symptoms with 1st shot also, asked if there was data about immunity after having Zostavax followed by 1 dose of Shingrix having 2 doses.
No additional AE reported.; MMR II and VARIVAX that had undergone temperature excursion was administered to a patient; This spontaneous report was received from a Certified Medical Assistant concerning a 17-year-old male patient. Their concurrent conditions, medical history, drug reactions/allergies, and concomitant medications were not provided.   On 10-NOV-2022, the patient was vaccinated with an improperly storage dose varicella virus vaccine live (Oka/Merck) (VARIVAX) administered as prophylaxis, lot number U029496 with expiration date 21-SEP-2023 (dosage regimen and route of administration were not reported), and Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live recombinant human albumin (rHA) (M-M-R II) administered as prophylaxis, lot number U013036 with expiration date 23-APR-2023 (dosage regimen and route of administration were not reported). The vaccines underwent a temperature excursion of -10 C up to 8 C (0.1 C) for 444 hours minutes and 0 seconds, with a previous temperature excursion of -10 C up to 8 C (-7.2 C) for 7 hours 54 minutes and 0 seconds (Product storage error). No additional adverse events were reported (No adverse event).
Woke up at approx 1:30 am on the morning after the 2nd Covid vaccination with a fever of 101 degrees. Took one Ibuprophen tablet. Fever subsided by 7:30 am. Felt exhausted and slept off and on for the next 24 hours. All symptoms gone as of today 2/16/2021.
Left arm welts red all the way down to elbow, bumps on left and right arm, pain and rash that itches on left hand, left side of gums are really red and raw like a later peeled off very painful and burning. Fatigue, body aches.
This case was reported by a physician and described the occurrence of hepatitis B core antibody positive in a female subject of unspecified age who was vaccinated with hepatitis B vaccine recombinant (Hepatitis B vaccine, manufacturer unspecified) for prophylaxis.  The subject's medical history included steroid injection treatment.  In 1991, the subject received unspecified dose of Hepatitis B vaccine (unknown).  At an unspecified time after vaccination with Hepatitis B vaccine, the subject experienced jaundice.  The subject had laboratory test performed which showed positive for hepatitis B core antibody.  The subject was previously treated by a physician who gave her steroid injections and used a contaminated needle.  This case was assessed as medically serious by GSK.  Relevant test results included hepatitis B core antibody positive.  At the time of reporting the outcome of the events were unspecified.  The physician considered the events were probably related to vaccination with Hepatitis B vaccine.
At  12:05pm pt. c/o dizziness, feeling nauseated , hyperventilating and diaphoretic . Helped pt. to the floor in a supine position with legs elevated, encouraged slow deep breaths. V/S included; BP=142/90, HR=67,  O2 sat=99%. Pt. A&O X4. Loosened pt.'s clothing,  Applied icepack at the back of her neck, offered RM temp H2O and some animal crackers.( Pt. reported  not having eaten for a long time) .At 12:26pm pt. reported feeling better with no dizziness. Pt. was d/c at 1pm in a stable condition, No ambulation problems noted. Pt. did not incur any injuries, trauma or falls while at the clinic.
Start of swelling, no pain, no erythema. Continue to grow in size at time of evaluation.
Day after the shot my left kidney started twitching about once a hour. next day it was very painful and lasted about a month. A week after is subsided my right kidney started hurting and is still painful when I move around.
generalised tonic clonic seizure for 6 min 11/5/09 Vaccination record received, medical records received for date 10/30/09. DX: febrile seizure.  ER f/u exam from febrile seizure and pharyngitis. Pt. being seen in ofice for ER f/u dx tonic clonic seizure and post ictal sleep. Assessment: PE WNL afebrile. 11/5/09 Vaccination record received, medical records received for date   11/16/09 Medical records recieved for DOS 1/30. Final DX:febrile seizure, pharyngitis. fever, 102.9 r.  Infant w/eyes rolling back, body jerking, warm to touch.  Grabbing head. Tonic clonic seizure. 4-5min long. Post ictal 10-15 min. Back to baseline. D/C to home.  ICD9 Codes: 780.31A
Malaise; Shakiness; Dizziness; Increased blood pressure; Fast heartbeat; Difficulty breathing; Headache; Extreme tiredness; Muscle Pain; Upset stomach; This case was reported by a consumer via call center representative and described the occurrence of tremor in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles last october and november 2019 (last October and November 2019.). Concurrent medical conditions included immune disorder (nos).   On 15th September 2020, the patient received the 1st dose of Shingrix (intramuscular) 50 µg. On 15th September 2020, less than a day after receiving Shingrix, the patient experienced headache, tiredness, muscle pain and upset stomach. On 17th September 2020, the patient experienced tremor, dizziness, increased blood pressure, heartbeats increased and difficulty breathing. On an unknown date, the patient experienced malaise. On 18th September 2020, the outcome of the headache, tiredness, muscle pain and upset stomach were recovered/resolved. On an unknown date, the outcome of the tremor, dizziness, increased blood pressure, heartbeats increased and difficulty breathing were not recovered/not resolved and the outcome of the malaise was unknown.   It was unknown if the reporter considered the tremor, dizziness, increased blood pressure, heartbeats increased, difficulty breathing, malaise, headache, tiredness, muscle pain and upset stomach to be related to Shingrix.  Additional details were as follows: The caller shared the patient received weekly infusions of IgM due to an unspecified immune disorder. On 17th September 2020, the patient underwent fast heartbeat test which result increased and increased blood pressure which results 143/76 and highest blood pressure seen since onset of increase was170/92. On unknown date the patient underwent blood test for varicella zoster antibodies IgG and IgM which results was 4000. After receiving 1st dose of Shingrix, the patient experienced upset stomach, muscle pain, extreme tiredness, headache, difficulty breathing, fast heartbeat, increased blood pressure, dizziness and shakiness. The consumer reports her physician changed blood pressure to see if it helped decrease blood pressure however, blood pressure still varies. The reporter consented to follow up.
Hives and rash under armpits, up neck, and in groin area; Hives and rash under armpits, up neck, and in groin area; This is a spontaneous report from a contactable nurse (patient herself). A 42-Year-old female patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140 and expiration date unknown), via an unspecified route of administration at Left arm on 21Dec2020 07:15 AM at single dose for covid-19 immunisation; levothyroxine sodium (SYNTHROID), via an unspecified route of administration from an unknown date at 125ug daily for hypothyroidism. The patient medical history include hypothyroidism. The patient has no known allergies. The patient experienced hives and rash under armpits, up neck, and in groin area on 23Dec2020 with outcome recovered. Events were considered as non-serious with no treatment. The patient has not tested for COVID-19 before or after the vaccination. The action taken in response to the event for levothyroxine sodium was unknown.
Pt reported severe pain, swelling, redness, and heat in entire upper arm that was vaccinated within 4 hrs of administration. Pt could not lift arm fully due to pain. No rxn in other arm w/ inactivated flu. Pt self-treated with EXCEDRIN and rest and improved over the next few days.
became ill causing severe kidney injury; became ill causing severe kidney injury; Lactic acidosis; Off-label use; Booster; This is a spontaneous report from a contactable Nurse (patient).   A 61-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 3 intramuscular, administered in Arm Left on 29Oct2021 (at the age of 61-years-old), as single dose for covid-19 immunization. The patient had received the first dose of the same vaccine on 25Dec2020, at the Arm Left via Intramuscular route at the age of 61-years-old and the second dose on 29Jan2021, at the Arm right via Intramuscular route at the age of 61-years-old. Medical history included diabetes mellitus, hypertension and thyroid disorder. On 29Oct2021 the patient became ill causing severe kidney injury resulting in a three days hospitalization and a near miss from going on dialysis therapy, with outcome of recovering. The patient was not pregnant. The patient received an aggressive fluid rehydration with sodium bicarbonate due to lactic acidosis. No Covid prior vaccination and the patient was not tested for covid post vaccination.   The lot number for BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events Renal injury, illness and Lactic acidosis and BNT162B2.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
3 May 09-received vaccine. First sx 17 May 09-peripheral nerve tingling. Progressed to weakness. Hospitalized 22 May 09 with Guillain Barre syndrome. Had plasmapheresis treatments. Improved, went to nursing home. Improved-went home. Persistent foot drop and pain.  12/23/09 PCP medical records received. Service date 5/22/09. Assessment: Suspect Guillain-Barre Syndrome. Patient presents with no feeling from knees down, both legs. Decreased deep tendon reflexes, decreased sensation, gait broad based. Admit to hospital.  12/22/09, 12/23/09 and 12/31/09. Hospital records and discharge summaries received. Service dates 5/22/09 to 6/6/09. Assessment: Acute inflammatory demyelinating polyradiculoneuropathy a.k.a. Guillain-Barre syndrome. Diffuse neuropathic pain. Hypertension.  Patient reports upper respiratory syndrome like "the flu" three weeks prior to onset of symptoms. Now reports onset of numbness, paresthesias, and dysthesias feet bilaterally. Pain in calves and feet. Weakness climbing stairs. Numbness, paresthesias, left hand. Severe thoracic, lumbar, and coccygeal pain, unable to sleep. Blood pressure elevated. Irregular heart rhythm, sinus bradycardia, left ventricular hypertrophy. Tendon reflexes absent. Anxiety.
Resting tremor in the vaccinated left arm. Progressed to the left leg in May and the right arm/trunk/neck in November. Diagnosed with resting tremor in November.
Took vaccine on 23rd September around noon. Symptoms started late in evening of 28th September.  - There was general itching but was most uncomfortable on the scalp, skin under the eyebrows, chin and back.  - Hands were slightly swollen and red. There were some red areas on the inside of the left arm. - Slight dizziness; no nausea or headache.  Symptoms persisted on 29th September: - Could see redness on the skin of the face where I had scratched. Ears were itchy: not the inside of the ear canal but the outside part of both ears. - Hives (small red dots concentrated in one area under the skin) were visible on the inside of both arms and around armpits. More concentrated at the wrist.  Self-medication started on 29th: - Took a Claritine tablet (10mg loratadine) at 1:40 pm.  - Symptoms started going away with 2 hours. By 4:00 pm there were no symptoms.  30th September: - Woke up at 2:30 am with itching in hands. They were swollen and red.  - Took another Claritine tablet. - Had hives on inside of arms and tops of feet in the morning with general redness on entire arms but symptoms went away after cold shower.   Today is Oct 3rd: there have not been any symptoms since last recording. Will continue to take 1 Claritine tablet every 24 hours for another week.  All the described symptoms are similar to the reaction I get from Pseudoephedrine (in cold medicine) except that the itching is not this intense and is localized to the hands and feet. I had also expected the skin on my palms and soles of feet to peel, which usually happens at the end of the reaction to pseudoephedrine but this did not happen with the Janssen vaccine.
This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, feeling bad and burning sensation. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles, feeling bad and burning sensation were recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles, feeling bad and burning sensation to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported the case. The age at vaccination was not reported. The patient got a Shingles shot after the first shingles occurrence and experienced shingles second time. They felt like being burned with fire and stabbed with a knife at the same time. Second shingles occurrence was much less severe and did not lasted as long. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Redness, itching and slight swelling at injection site.  Approximately 3 in diameter.
Initial case report received from a nurse on 14 Apr 2010: This patient was inadvertently vaccinated with S-OIV FLUVIRIN (batch no. unknown) 0.5 ml intramuscularly on 13 Apr 2010. According to the reporter, no adverse events were noted after the vaccine administration. The outcome of the event was not reported.
Rash/Hives to neck, back and trunk. Severe nausea/vomiting - received steroids to prevent respiratory complications.
atient is fully vaccinate.  COVID + on 11/28/2021.  Hospitalized for 5 days starting on 11/28/2021. Admission dx:  shortness of breath, hypoxia, NSTEMI, pneumonia due to COVID. CHF.  Patient given Remdesivir and steroids with lovenox with improved symptoms;  Oxygen was weaned and discharged.
On the morning of 12/18/2001, the patient developed bumps on his thigh. By that afternoon, the bumps were all over his torso.