chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Feeling unwell; Muscle pain; Joint pain; Nausea; Headache; This is a spontaneous report from a contactable consumer (patient) via a program and the Regulatory Authority. A female patient of an unknown age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: unknown, expiry date: unknown) via an unspecified route of administration, administered on an unknown date as DOSE 1, SINGLE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unknown date, the patient experienced muscle pain, feeling unwell, joint pain, nausea, and headache. Patient reported that she was afraid to take the second dose of the vaccine since she had these terrible side effects. The outcome of the events was unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Began coughing in bed, thinking it was GERD.  Took antacids. Headache, fever and bodily muscular pain.  Frequent urination.  Dizziness.  Inability to sleep.  At 5am, planned to go to hospital.  Pain in left arm reminded me of the flu shot.  At 8am, I was able to take benadryl and aspirin.  Symptoms diminished within 30 minutes.
Bumps with liquid in them within one week after first shot,Sores on my head within one week after first shot; Very bad rash within one week after first shot; This spontaneous case was reported by a consumer and describes the occurrence of BLISTER (Bumps with liquid in them within one week after first shot,Sores on my head within one week after first shot) and RASH (Very bad rash within one week after first shot) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, the patient experienced BLISTER (Bumps with liquid in them within one week after first shot,Sores on my head within one week after first shot) and RASH (Very bad rash within one week after first shot). At the time of the report, BLISTER (Bumps with liquid in them within one week after first shot,Sores on my head within one week after first shot) had not resolved and RASH (Very bad rash within one week after first shot) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication information was not reported  Treatment information was not reported
Approximately a week to 10 days after the second dose (Feb. 23, 2021), I began experiencing severe tendon pain in my legs, resulting in difficulty walking.  The tendon issues have continued and I am treating them with physical therapy, ice, Tylenol, rest and massage.  The condition is improving - after 4 months.
One day post vax, the pt awoke with pain at the injection site. She also had edema and a hard knot at the injection site. She reported pain and numbness in her left forearm and first two fingers. A doctor visit was required and she was treated with Advil. Engerix B was discontinued. Subsequently the numbness resolved and the edema was decreased by 50%. The most recent information received, reports the condition of the pt as unresolved.
Case number PHEH2013US017313, is an initial spontaneous report received from a medical assistant on 13 AUG 2013. This report refers to a 15 year old male patient. His medical history and concomitant medications was not reported. Medical assistant reported that the patient received Men A component of MENVEO (batch number: M12092) intramuscular that was reconstituted with Merck diluent reported as sterile water on 13 AUG 2013. No adverse event was reported. No further information was provided.
Swelling in her (R) UE x 2 weeks Pt's arm still hurts swelling down to her hand
Day after vaccine arm became red and swollen then subsided over a few days 3x5 inches in size (Lt arm) 8 days later the redness, with itchiness, and very hot. Today arm is warm, very red and itchy. Denies fever, skin intact,   Used caladryl, Tylenol with some improvement
Immunocompromised received half dose as third dose; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Immunocompromised received half dose as third dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 ml. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (Immunocompromised received half dose as third dose). At the time of the report, ACCIDENTAL UNDERDOSE (Immunocompromised received half dose as third dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication list was not provided.  Treatment information was not provided.
Scared and not comfortable to go back for the second shot; Did not feel good after first vaccine; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 17-May-2021 and was forwarded to Moderna on 17-May-2021.    This spontaneous case was reported by a patient and describes the occurrence of MALAISE (Did not feel good after first vaccine) and PRODUCT DOSE OMISSION ISSUE (Scared and not comfortable to go back for the second shot) in an 87-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K202A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Dec-2020, the patient experienced MALAISE (Did not feel good after first vaccine). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Scared and not comfortable to go back for the second shot). On 31-Dec-2020, MALAISE (Did not feel good after first vaccine) had resolved. At the time of the report, PRODUCT DOSE OMISSION ISSUE (Scared and not comfortable to go back for the second shot) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing was delayed on an unknown date.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   no treatment information was provided no concomitant medication were reported   Most recent FOLLOW-UP information incorporated above includes: On 17-May-2021: Follow Up information was received on 17-May-2021 and contains No new information.
Information has been received from a registered nurse referring to 2 patients of unknown age and gender. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions reported. On 27-AUG-2015, the patients were vaccinated with ZOSTAVAX (0.65 ml, Lot #L016284, expiration date: 07-OCT-2016), which were improperly stored for 14 days. The outcome was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
13:24-2nd Inj received.  When EE started to leave the clinic she stood up and was dizzy.  EE got light headed.  EE last ate 0600.  At 1400 EE moved to evaluation area VS 148/93 HR 76 O2 97%RA.  EE given applesauce and beginning feeling much better.  EE left evaluation area at 1412, took another applesauce with her.
FEVER; 5 HOURS AFTER SHE GOT THE SHOT, SHE WAS SHIVERING UNCONTROLLABLY; 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: 1808609 expiry: UNKNOWN) dose was not reported, administered on 27-MAR-2021 11:00 on left arm for prophylactic vaccination. No concomitant medications were reported.  On 27-MAR-2021, the subject experienced 5 hours after she got the shot, she was shivering uncontrollably. Laboratory data included: Body temperature (NR: not provided) 102 F, 103 F. On 27-MAR-2021 17:00, the subject experienced fever. On 28-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 101 F. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from 5 hours after she got the shot, she was shivering uncontrollably, and fever on 28-MAR-2021. This report was non-serious.
fever onset 15NOV96 temp max @ 101.0 po w/cough, runny nose,water eyes & conjunctivitis, upper eyelid swelling;rash onset 18NOV;macular different size lesion size lesions sl confluence noted-reddish in color;spread to rest of body 19NOV;
4-28-2009  1150/AM.- MMR #2 given.  730/PM.  Pt had seizure taken to ER s+s unknown.
Patient erroneously administered additional booster dose. Primary series received 4/2/2021, 4/23/2021 Booster received 1/3/2022 at pharmacy. Patient presented for nurse visit for HPV vaccination. LIP did not reconcile outside immunizations and thought patient due for COVID-19 booster. Patient agreed to get COVID-19 booster, then RN realized was a duplication when documented on CDC vaccine record card.
Chronic achy pain, sometimes local, sometimes from top shoulder to elbow; sharp pain when moving certain ways; difficult to get comfortable in bed; dressing is sometimes problematic.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Sep2022 as dose 4 (booster), single (Lot number: GH9694) at the age of 76 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 25Jan2021 as dose 1, single (Lot number: EL1283), in left arm, on 06Oct2021 as dose 2, single (Lot number: FE3590), in left arm and on 03May2022 as dose 3 (booster), single (Lot number: FM9992), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: The patient has no known allergies.
headache; experienced tiredness; This is a spontaneous report from a contactable consumer (patient) via Pfizer-sponsored program. A male patient of unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as 1st dose, single for covid-19 immunization. The patient's medical history included swollen lymph nodes. The patient's concomitant medications were not reported. On an unknown date, the patient experienced headache and tiredness. The reporter wanted to know if Ibuprofen can be taken to relieve symptoms. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
2/4 Headache, dizziness, neck and shoulder aches, left hand and foot numbness which continued into 2/5.
1st dose 2 years ago, 2nd not received; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose 2 years ago into unknown arm).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 29-NOV-2022  Reporter's comment: The reporter reported that his nephew received only one single dose of Shingrix and they were never informed that Shingrix was given as two doses series, hence they never received a second dose of Shingrix.  No additional information provided. The reporter declined consent for safety follow up with his healthcare professional. The reporter declined providing his relatives information and age. The reporter could not provide Shingrix lot, expiration date information, dosage or route of administration. The reporter reported that they all received the shot in the arm. The reporter did not consent to follow up. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. This was one of five cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2022AMR179084:Same reporter US-GSK-US2022178660:Same reporter US-GSK-US2022AMR179085:Same reporter US-GSK-US2022AMR179087:Same reporter
Immediate sensation of slight mental status change which resolved but within 2 minutes started to feel slightly woozy and pre-syncopal, as if anaphylaxis starting. Informed staff. Put on stretcher. Vital signs obtained. O2Sat upper 90s. BP elevated with diastolic in low 100s with sensation of pre-syncope and very slight confusion. Resolved slowly over 30 minutes to about 90% of prior mental status. Continued to feel somewhat dizzy for several hours. Went to bed early. Had very intense disturbing dreams. Very sore vaccine site. Resolved by morning. Arm soreness about 50% of day prior.
moderate chest pressure and pain. Neck and should pressure/pain, too. Left armpit and breast pain and discomfort plus swelling for 5 days
Body aches that I  usually associate with the flu were occurring in the evening but ok in the morning for three weeks following the shot. Then they increased and I have gotten 2 bouts of pneumonia since then and I still have ongoing issues when I have never had anything like this before
Clinical Summary Patient is a 65 y.o. female with a history of sarcoidosis, HTN and COPD with recent RMH Observation stay 9/8/22-9/9/22 for pneumonia who presented to RMH 9/19/2022 with 2 weeks of continued cough despite PO abx, and 2 days of fever, myalgias and headache. On admit, COVID positive. EKG nonacute. CTPA showed BL pneumonia, no PE.   1. COVID Pneumonia: symptom onset 9/17/22 (son had symptoms first) with fever, myalgias and headache. Tested positive 9/19/22 (had negative test on 9/8/22). Vaccinated with booster ~ 3/0222. CTPA on admit showed BL infiltrates, R>L. Not hypoxic on admit. With copd and sarcoidosis history pulmonary did start 10 days dexamethasone. Sputum cultures no growth to date.  2. Bacterial Pneumonia: by history, hospitalized 9/8/22-9/9/22 when COVID was negative. She was sent home on PO Omnicef and Zithromax which she completed for total 5 day course of abx. Had continued cough and then worsened 2 days prior to admit as above. Given IV levaquin and ceftriaxone in ER. Held off on further abx for now. Sputum cx as above.  3. Sarcoidosis: by history, reportedly in remission. Not on long term steroids. 4. HTN: home meds continued. 5. COPD: by history, not on home O2 or inhalers. Not in exacerbation on admit.
Dizziness light headed, itchiness on head, ears felt hot and red,  elevated BP and elevated HR Narrative: Tool Prednisone, Hydroxazine, and Zyrtec- all previously prescribed medications for general allergies.
Patient tested positive for Covid on or around 7/25/21.  Received monoclonal Antibodies on 7/26/21 casirivimab/imdevimab.  Patient brought to the ER and admitted for Covid and hypoxemia on 7/28/21.  Low SPO2.
Shortly after administration patient fainted to the floor.  She reported feeling warm.  We sat her down and gave her water.  Minutes later she left.
Was sick with vomiting and diarrhea. Entire body hurt and fever of 102
PAIN IN RIGHT EYE COMING FROM BACK OF HEAD  STOPS FOR A WHILE AND THEN REPEATS; EYE ITCHING; TIREDNESS; PAIN AT INJECTION SITE; STOMACH PAIN; This spontaneous report received from a patient concerned a 64 year old female. 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: Unknown) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch number. No concomitant medications were reported.  On 05-APR-2021, the subject experienced stomach pain. On 05-APR-2021, the subject experienced tiredness. On 05-APR-2021, the subject experienced pain at injection site. On 15-APR-2021, the subject experienced pain in right eye coming from back of head stops for a while and then repeats. On 15-APR-2021, the subject experienced eye itching. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from stomach pain, and pain at injection site, and tiredness on 07-APR-2021, had not recovered from pain in right eye coming from back of head stops for a while and then repeats, and the outcome of eye itching was not reported. This report was non-serious.
I was swelling; My tongue started to feel heavy and my lips were swelling; My tongue started to feel heavy and my lips were swelling; I started to feel itchy towards the end of that time; I was getting hot; my face started to have a tingling sensation; This is a spontaneous report from a contactable consumer (patient). A 36-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number: EM9809, expiration date was not reported) via an unspecified route of administration, in left arm, on 05Feb2021 11:15 (at the age of 36-years-old), at dose 1, single for covid-19 immunization from school or student health clinic. Medical history included asthma, high blood pressure and known allergies to penicillin, ciprofloxacin, and hydrocodone. Concomitant medications included nifedipine, omeprazole and hydro (as reported). Prior to vaccination the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the covid-19 vaccine. The patient has not been tested with covid-19 after the vaccination. The patient started to feel itchy, getting hot, her face started to have a tingling sensation, tongue started to feel heavy and lips were swelling on 05Feb2021. On 05Feb2021 12:40, she was swelling. The events resulted in resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient visited the nurse station and therapeutic measures were taken; took Benadryl, also received EpiPen and then sent to the hospital to be evaluated. The outcome of the events was recovered with sequelae on an unspecified date in 2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered the vaccine after the 30 day by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered the vaccine to the patient after the 30 days by used date) and NO ADVERSE EVENT (No adverse event) in a 66-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22-2A) for COVID-19 prophylaxis. No Medical History information was reported. On 09-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 09-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered the vaccine after the 30 day by used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered the vaccine to the patient after the 30 days by used date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient administered the vaccine after the 30 day by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered the vaccine to the patient after the 30 days by used date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient administered the vaccine after the 30 day by used) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered the vaccine to the patient after the 30 days by used date). No concomitant medications were reported. The patient received half dose of Moderna vaccine. The vial had not undergone any temperature excursions. The vial was initially stored in the refrigerator on 04-Jun-2022 and 35 vials were affected. No treatment medications were reported.
A non-serious, spontaneous report of administration of expired product was received from a health professional concerning an 11-year-old male patient. Neither medical history nor concomitant medications were reported. The product expired on 22-Nov-2010. On 10-Dec-2010, the patient received expired product. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Additional information was received on 24-Mar-2011 and incorporated into the narrative: no late occurring adverse event was reported.
Patient presented to clinic with mild redness localized to left deltoid area to vaccination site from 3 days ago, improving per patient. Soreness to left axillae area for 3 days, improving per patient. No swelling, rash, difficulty breathing or any other symptoms reported by patient. Patient advised to go to ER for further evaluation and treatment if symptoms worsen or if no improvement in the next 24-48 hours. Patient verbalized understanding.
anterior uveitis  with blurry vision, requiring prednisolone 1% eye drops hourly and dilator drops for 3 weeks.  Dr. does NOT think this is related to vaccine due to timing (6 months later) and association with prodromal viral illness just prior to uveitis symptoms. In his opinion, this could have been COVID despite negative antigen testing (PCR test not performed)