chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Serious itching and huge hive at injection site; Serious itching and huge hive at injection site; This is a spontaneous report received from contactable consumer (patient). This consumer reported events for the first and second dose. This is the second of two reports (dose 2). Only this case is serious. A 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number FC3184 and expiration date Oct2021) administered in right arm on 15Sep2021 16:15 (at the age of 46-year-old) as dose 2, single for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Facility where the most recent COVID-19 vaccine was administered was reported as pharmacy or drug store. The patient's medical history included hypertension, stomach nausea and know allergies to mold, mildew, cats, dogs, and pollen, all from unspecified date. Prior to vaccination the patient was not diagnosed with COVID-19. The patient's concomitant medications taken within two weeks of vaccination included amlodipine from unspecified date at 10 mg, once a day for hypertension, amlodipine/benazepril 10 mg/40 mg from unspecified date and famotidine from unspecified date at 40 mg, once a day for stomach nausea. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number Fa7485), administered in right arm on 20Aug2021 04:15 PM (at the age of 46-year-old) as dose 1, single for COVID-19 immunisation and she experienced soreness in her right arm the day of the vaccination which went away, she had pain in the arm near the site and the neck and the shoulder. On 16Sep2021 the patient experienced serious itching and huge hive at injection site. Patient stated that she was calling to find out if it was normal that after the second vaccine, she had lot of itching and hives at the injection site. Treatment received due to the events was reported as cortisone cream and diphenhydramine (BENADRYL). The events were also reported as non-serious (as reported). The patient underwent to lab test and procedure which included anti-nuclear antibodies test (negative) on 30Aug2021. The outcome of the events was not resolved.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101127602 Same patient/drug, different AE, different dose of vaccine
Rash around her arm; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of RASH (Rash around her arm) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, the patient experienced RASH (Rash around her arm). At the time of the report, RASH (Rash around her arm) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant details provided. Treatment details include antibiotics.   This case was linked to MOD-2021-115468 (Patient Link).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 09-May-2021: Follow up received on 09-May-2021 included event details.
Pain localized; Chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain localized), CHILLS (Chills) and PYREXIA (Fever) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    No Medical History information was reported.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) citrate free. In 2021, the patient experienced CHILLS (Chills) and PYREXIA (Fever). On 11-Mar-2022, the patient experienced PAIN (Pain localized). At the time of the report, PAIN (Pain localized) outcome was unknown and CHILLS (Chills) and PYREXIA (Fever) had resolved.            No concomitant medications were reported.   In 2021, the patient experienced chills and fever. On 11-Mar-2022, the patient experienced twinges on side/pain was quick but sharp enough to pause walking. On unknown dates, chills and fever resolved. Moderna was also considered suspect. It was unknown if patient was enrolled in a COVID-19 vaccine trial.  No treatment medication was provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Cough Fatigue Congestion or runny nose Diarrhea Rash Sore throat Loss of taste  Push fluids Claritin Rest benzonatate (TESSALON) 200 mg capsule
Reporting administration error as per immunization system. We contacted Pfizer for expiration dates, Pfizer vaccine specialist advised expiration dates and deemed vaccine viable at the time of vaccine administration. Pfizer vaccine vials only include manufactuarer dates on the box and vials. Therefore, we contacted Pfizer to attain expiration dates directly from them.  No adverse reaction reported from the patietn at the time of the vaccination and no adverse reaction reported since vaccine.
Ears full like underwater for weeks now no other issues have tried everything  nothing works ent says nothing is wrong- all other doses were Moderna this my first Pfizer I?m so upset can?t live like this! I feel like I?m going deaf!
DTaP vaccine given on 4/2/04. Lot #DTPA592B9 SKB. On 4/4/04-PPD read done. Nurse noticed large warm erythematous area on right deltoid where DTaP given, 40mm in diameter.
This is a spontaneous report from a contactable consumer, the patient. A 36-year-old non pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in the left arm on 09Mar2021 at 11:00 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient was allergic to tetracycline. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 09Mar2021 at 18:00, the patient experienced neck pain, muscle stiffness on back of the head, not able to sleep, fatigue and headache. The therapeutic measure was taken as a result of events and included the treatment with methocarbamol. The clinical outcome for the events neck pain, muscle stiffness on back of the head, not able to sleep, fatigue and headache were not resolved at the time of this report. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Immediately after administration of HPV #2 pt had "seizure like activity" and passed out. Placed patient on floor with elevated legs and came around quickly. Responded to name. Place seen by pediatrician.
Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Chills-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Shakiness-Medium, Additional Details: anxiety  1:56pm - BP(120/70mmHG), HR(88bpm),O2sat(100%)
LIGHTHEADEDNESS; HEADACHE; SORE LEGS; NAUSEA; TIREDNESS; LOW-GRADE FEVER; CHILLS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.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 12-MAR-2021 around15:30 for prophylactic vaccination. Concomitant medications included cetirizine hydrochloride. On MAR-2021 around 9:30-10:00 pm, the subject experienced chills. On 12-MAR-2021 around 9:30-10:00 pm, the subject experienced low-grade fever. Laboratory data included: Body temperature (NR: not provided) Approximately 99 F. On 13-MAR-2021, the subject experienced sore legs. On 13-MAR-2021, the subject experienced nausea. On 13-MAR-2021, the subject experienced tiredness. On 15-MAR-2021, the subject experienced lightheadedness. On 15-MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nausea on MAR-2021, and the outcome of lightheadedness, sore legs, tiredness, headache, low-grade fever and chills was not reported. This report was non-serious.
Administered expired vaccine to patient, after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to patient, after the manufacture date of expiration) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 25-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to patient, after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to patient, after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Date the vial initially stored in the refrigerator was reported as unknown. Vaccine manufacture date of expiry was reported as 24-Oct-2021 with total of 102 doses. The vial did not undergo any temperature excursions.  No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow-up received contains non significant information
Rash started night of 3-26-07. No treatment necessary. Reassurance and explanation to parent by doctor.
Was administered 2nd in series today and second person immediately gave me #3 a few seconds later
Patient reported that she had a seizure within 15 minutes of receiving the flu shot.  She has a history of seizures/epilepsy.
The patient was diagnosed with cellulitis at urgent care on day 2 of 2nd vaccine and was started on an antibiotic. She also had a fever from day 2 through day 4 after vaccine.
Headache, stomach ache, fatigue, eyes rolled back in head. Took to ER.
Spouse awoke 12/20 and found spouse dead. Client was not transferred to hospital.
Presented to ED with altered mental status. He became fatigued and lethargic with a brief period of unresponsiveness. Could not speak and had a gaze to his left. Could not carry on conversation or answer questions appropriately. Stroke team activated and CT completed. CT negative for bleed. Neurology ordered Alteplase to be administered. Patient then transferred for further evaluation and treatment. Patient had left MCA occlusion with TICI IIb achieved. Admitted to neurology stroke service in ICU following procedure. Started on aspirin with plavix. Rehab referral.
MODERATE HEADACHE FEVER 100.8 MODERATE BODY ACHE FATIGUE
Lymph nodes swollen on neck and throat. Had ultra sound of soft tissue and found reactive lymph nodes. Had a cat scan and found nodules on thyroid glads and lymph node on neck.
Pfizer-BioNTech COVID-19 Vaccine  Patient received her COVID vaccine .. During the observation period, the patient reported feeling a lump in her throat, clammy hands, lightheadedness, and tingling of her lips and face. Patient was taken back to an exam room. Orange juice provided, patient laid down. Each time patient would sit up, she would feel jittery and lightheaded. After having the patient stay in the patient exam room for 45 minutes with clinical staff monitoring her status, the patient did not report any improvement in symptoms, therefore, she was transported to the ED
Information as received from a nurse concerning unspecified patients of unknown age and gender. Concurrent condition, concomitant medication and medical history were not provided. On an unknown date, an unspecified number of unspecified patients were administered improperly stored doses of PEDVAXHIB (lot# M007762, expiration date 07-DEC-2018; lot# M020101, expiration date 07-MAR-2019; lot# M025193, expiration date 21-MAR-2019) (strength, dose, frequency and route were not reported). No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Redness Swelling Localize rash with cellulitis at injection site Heat Pain hard to raise the arm Burning sensation  Itching at injection site.
Onset of low grade fever, generalized body rash (itchy, slightly raised, hives, blotchy (red) on 5/7/04 (3 days after immunization). Mom gave Benadryl starting on 5/7/04. Stopped Benadryl on 5/12 as rash was much improved. Rash continued to improve on 5/13 and 5/14 (with Benadryl). On 5/16 Rash came back much worse: increased itching, completely covering body. Seen by private physician who diagnosed likely allergic reaction to vaccine. Treated with Zyrtec liquid. To see physician again 5/19/04 (6/2/04 rash gone after 4 days of Zyrtec. Child fine now. Mom states rash almost gone approximately 4 days after starting Zyrtec. States rash was on trunk (neck to top of legs, few spots back of legs, between fingers, axilla, top of feet. No rash on thighs.
One dose and got shingles; Not planning on getting the 2 dose shot; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine and had not received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and not applicable after receiving Shingles vaccine, the patient experienced shingles and incomplete course of vaccination. On an unknown date, the outcome of the shingles and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 05-Aug-2022 Reporter's comment: This case was reported by a patient via interactive digital media. The patient got one dose shot 5 years ago and got shingles.  Patient was not planning to get the 2 dose shot. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of shingles vaccine, which led to incomplete course of vaccination. The follow-up could not be possible as no contact detail were available.
For about 2.5 hours, I had a very severe episode of arrhythmia and palpitations. I assumed it was A-fib, which I have no history of. I almost passed out several times. I was short of breath and dizzy. After 2.5 hours, it started to subside. For about 2 weeks after, my heartbeat was often irregular.
8 days after the first injection got hives (painful, itchy, and very red) on the trunk, chest, back, and some on arms
Muscle pain, headache, fatigue starting about 24 hours after received on 1-5
cough, sore throat, sinus congestion, headache, mild shortness of breath, body aches, diarrhea. starting 1/1/22
This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. Information on pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On 16-APR-2018, the patient was vaccinated with an expired dose of VARIVAX injection (strength and dose volume were not provided) (lot # M012992, expiry: 14-MAR-2018, subcutaneously) and an expired dose of M-M-R II (strength, dose volume, and route of administration were not provided) (lot # M007277, 09-FEB-2018) for prophylaxis (expired product administered). There was no known adverse effects. There was no product quality complaint (PQC) reported.
Vaccine was accidentally given a week early. Patient began to experience GI discomfort, headaches, and feeling tired.
Pt on 11/11/21 developed tachycardia 120s-150s. Sent to pediatric cardiologist who felt it was not myocarditis. ECHO was normal.
Patient received two vaccines, Shingrix and Pneumovax23 on 4/19/22. The shingles shot was given in the right arm and pneumonia in the left. She presented the day after administration barely able to move her left arm - the arm that the pneumonia vaccine was administered. She was stating that her left arm hurt really bad (in the shoulder joint) and upon checking, the area did look swollen and irritated. The location of the vaccine administration was higher than normal. I advised her to make an appointment with her primary care physician and if safe, take OTC anti-inflammatory medication for the pain. My impression was that the vaccine was administered too high, resulting in SIRVA (shoulder injury related to vaccine administration).
Rash is red; Rash is [red,] raised; Rash of red spots diffusely all over her body; Lethargic; This non-serious spontaneous case, initially received from other health professional on 02-Oct-2018, concerns a female patient of an unspecified age.  On 28-Sep-2018 (reported as Friday), the patient was administered Afluria Quadrivalent (influenza vaccine, dose, route of administration, anatomical location, batch number and expiry date: not reported) for an unknown indication.  Within 24 hours after receiving the vaccination, the patient developed a rash of red spots diffusely all over her body. The rash was red, raised, and in some area rows of 4 or 5 in the shape of a crescent and some of the spots had a white circle around the outside of them. The rash spots were not pustular or vesicular. The patient reported feeling somewhat generally lethargic. The patient sought treatment at an urgent care facility and was given Benadryl injection and a prescription for steroid cream. No other reported systemic reaction was reported.  At the time of this report, the outcome of the events was not reported.; Reporter's Comments: A female patient of unspecified age developed rash all over which was red and raised within 24 hours after vaccination and felt lethargic on an unspecified day after the administration of Afluria Quadrivalent. The company assessed the causality as related due to plausible temporal relationship between the events and suspect vaccine.
Cough, stuffy nose, fatigue, loss of smell and taste, dull headache. Symptoms lasted for 12-14 days.
Stroke affecting right side, 03/30/21, then stroke CVA  affecting left side, 05/01/2021
c/o lt nasal congestion, & yellow nasal discharge; lt ear pulating; pt recvd vax 10FEB92 & 10-15 min later had tightness in chest w/o SOB followed by queasiness & tightness of stomach;also sl numbness, sl tenderness & edema noted;sinusitis;
Swollen area at inj stie, red, hot to touch, sore. Started after shot was given.
Patient Is a 54-year-old female with a past medical history of COPD on 2 L nasal cannula chronically, HFpEF, hypertension, hyperlipidemia, hypothyroidism, GERD, IBS who presents with shortness of breath and wheezing. Patient states that last week her mother was admitted to the hospital with COVID-19.  She picked her mother up from the hospital upon discharge and had to spend some time with her to help care for her.  She received a DuoNeb as well as Decadron in the ED, ultimately able to be weaned down to 2 L however she still had significant wheezing.  She had a CT chest which is negative for PE though she does have right middle lobe attenuation of the bronchial tree consistent with a superimposed pneumonia.  Lab work in ED is otherwise unremarkable.  She did test positive for COVID-19.  Patient states she is vaccinated and has received 2/3 boosters.  Patient is admitted to surgical unit for acute on chronic hypoxia, COPD exacerbation and COVID-19 infection.     Clinical Summary Patient was treated with decadron and remdesivir for COVID-19 as well as Azithro.  Patient's breathing improved to where she no longer needed oxygen and wasn't wheezing.    I discussed with the patient, she should receive 3 doses of Remdesivir to prevent progression of COVID since she is at high risk.  Patient states though she has to get home to take care of her husband.   Will DC with short decadron taper and 2 more days of Azythromycin.  Patient has inhalers at home.  Patient instructed to return if she wheezes and to isolate for 10 days.   Discharge diagnosis COVID-19 Infection
vial was first punctured: 24-May-2022 10:00 AM to 10:30 AM and administered on 25-May-2022 09:52 AM; Received expired vaccine more than 12 hours post puncture; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired vaccine more than 12 hours post puncture) and PRODUCT STORAGE ERROR (vial was first punctured: 24-May-2022 10:00 AM to 10:30 AM and administered on 25-May-2022 09:52 AM) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 054A22A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-May-2022 at 9:52 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-May-2022 at 9:52 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired vaccine more than 12 hours post puncture). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vial was first punctured: 24-May-2022 10:00 AM to 10:30 AM and administered on 25-May-2022 09:52 AM). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received expired vaccine more than 12 hours post puncture) and PRODUCT STORAGE ERROR (vial was first punctured: 24-May-2022 10:00 AM to 10:30 AM and administered on 25-May-2022 09:52 AM) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information provided.  Number of doses/vials: 1 Dose / 1 vial Date the vial was initially stored in the refrigerator: 24-May-2022 10:00 AM. The vial was first punctured: 24-May-2022 10AM to 10:30AM The vial did not undergo any temperature excursions. Total amount of time the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F): Approximately 24 hours. The vial exposed to room temperature for more than 24 hours: Approximately 24 hours. No treatment information provided.
First dose: Headache for 1 week   Second dose: headache, body aches, diarrhea, lethargy
Pt became pale with rigid jerking arms & legs, eyes rolled back. Pt unaware surroundings - lasted < 20 secs. No postictal phase. VS stable.
Sudden loss of consciousness while driving motor vehicle.      Transport by ambulance to emergency room.   Hospitalized for 36 hours and released.
Bad headache for 36 hours until I gave in and took 1 Tylenol.  Felt exhausted for 48 hours and slept much more than usual.