chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sore arm; This is a spontaneous report from a contactable consumer (patient's husband). This reporter reported similar events for two patients. This is 2nd of 2 reports. A 77-year-old female patient received bnt162b2 (PFIZER- BIONTECH COVID-19 VACCINE) via an unspecified route of administration at left arm on 11Jan2021 12:00 PM at single dose for covid-19 immunisation. Patient's medical History and family medical history was none. No additional vaccines administered on same date of COVID vaccine. No other vaccines were received within 4 weeks prior to the first administration date of COVID vaccine. The patient's concomitant medications were none.The patient got the Pfizer Covid-19 vaccine yesterday and had sore arm on12Jan2021. The patient's soreness in arm didn't start until this morning, 24 hours later. It's not a real big problem for her and it's getting better and almost gone. The outcome of the event was recovering.  Information on the Batch/Lot number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021026388 same reporter/product/Event, different patient.
When the client was uploaded to the Immunization Connection it was discovered that the date of birth that was entered in scheduling system did not match the DOB . Parent was notified and while minor was registered as eligible at 16 years old they were only 15 years old during the time Pfizer was authorized to 16.
woke up with pain under left arm and felt a lump by left breast, mammogram and ultrasound was done and the doctor does not know what it is. there is now an biopsy scheduled because the doctor does not know what the lump is.
Swollen lymph nodes in her arm pit area on the left side.  Noticed it last night in her sleep.
States that approx. 2 hours after receiving H1N1 vaccine she developed "little bumps" on tongue. States tongue also swollen. Denied any drainage, shortness of breath, fever, etc. States didn't eat anything unusual.
Felt tired; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 23-Apr-2021 and was forwarded to Moderna on 23-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Felt tired) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (Felt tired). At the time of the report, FATIGUE (Felt tired) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided. No treatment medication was provided.
Next day post vax, the pt was brought to clinic with possible history of seizure. On 6/2/00, he was brought to clinic with actual witnessed seizure and temperature of 100.1. Taken to hospital where it was presumed to be seizure activity secondary to vax. Treated briefly with Phenobarbital.
Tinnitus has been pronounced and continuous form 4-28-21 to present. Have also noticed "eye floaters" for the last two weeks also Have had some mild vertigo sporadically in the last two weeks blood pressure checked at doctor's office today;  134/86.  Normal for me is about 130/74
On 03/01/2021 - A red rash began- redness and swelling nearby the injection site. On 03/02/201 I went to see the Nurse Practitioner- I just inquired does it need treatment or let it be or what have you? She told me if it got any worse to come back and she would prescribe a steroid like Prednisone. She told me to use a cool compress and topical Benadryl if it becomes itchy. It lasted a few or more days and resolved slowly on its own.
My right arm had a tingling/numbness feeling from the elbow to the outside two fingers.  That went away after a week.  My legs and abdomen started jerking and still continue to jerk.
Redness at and around injection site continuing at least 4 days (observed at time of report). Fever, chills body aches, appetite loss, tiredness continuing at least 4 days at time of reported reaction.
Injection site was hot to touch; Left arm swollen; rash 2.5 inches in diameter; Injection site stung; Left arm sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Left arm sore), PERIPHERAL SWELLING (Left arm swollen), INJECTION SITE RASH (rash 2.5 inches in diameter), VACCINATION SITE WARMTH (Injection site was hot to touch) and VACCINATION SITE PAIN (Injection site stung) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041C20A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced PAIN (Left arm sore). On 26-Jan-2021, the patient experienced PERIPHERAL SWELLING (Left arm swollen), INJECTION SITE RASH (rash 2.5 inches in diameter), VACCINATION SITE WARMTH (Injection site was hot to touch) and VACCINATION SITE PAIN (Injection site stung). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 21-Jan-2021, PAIN (Left arm sore) had resolved. At the time of the report, PERIPHERAL SWELLING (Left arm swollen), INJECTION SITE RASH (rash 2.5 inches in diameter), VACCINATION SITE WARMTH (Injection site was hot to touch) and VACCINATION SITE PAIN (Injection site stung) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: TCR: Pt feels better, requesting no more follow ups
Severe migranous headache starting 4/15 and fever starting 4/19.
no known side effects; an expired dose of VARIVAX was accidently administered to a patient; This spontaneous report as received from a medical assistant refers to a 4-year-old female patient. Pertinent medical history, drug reactions, allergies and concomitant medications were not reported.  On 26-JAN-2022, the patient was accidently vaccinated with an expired dose of varicella virus vaccine live (oka/merck)(VARIVAX) (lot number: S038701, expiration date: 01-DEC-2021) 0.5 mL subcutaneously (also reported as intramuscularly, conflicting information) in the private doctor's office/hospital. No temperature excursion occurred. No adverse event was reported. No treatment was given.
Fever,  chills, nausea,  severe headache (still on-going), severe lower back pain (still on-going)
Patient developed a red, itchy rash on lower arms, upper leg and groin area and sides of abdomen.  He states his internist prescribed him a medrol dosepak and antibiotic and he he seems to be getting better.
Information has been received from the mother of an 18 year old female consumer with a history of "reaction to dioxycycline" who in March 2007, was vaccinated with the first dose of Gardasil.  On May 2007 the patient was vaccinated with the second dose of Gardasil.  Subsequently the patient experienced itching on the injection site and headache after receiving the first and second dose of Gardasil.  The patient's mother reported the patient's status as "patient is fine."  Additional information has been requested.
pt recv vax; following a blood donation, lab eval was positive for anti-HBc;f/u from MD revealed, did not have an adverse rxn;
318 patients received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date). On 09-Jun-2021, EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was reported. The date of refrigeration was 07-May-2021.
Patient tested positive for COVID-19 on  AUG2022; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Patient tested positive for COVID-19 on  AUG2022) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 083J21A, 011M20A, 012L20A and 064FC21A) for COVID-19 vaccination.     The patient's past medical history included Asthma. Concurrent medical conditions included Dust allergy and Allergy.   On 18-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Mar-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. In August 2022, the patient experienced COVID-19 (Patient tested positive for COVID-19 on  AUG2022). At the time of the report, COVID-19 (Patient tested positive for COVID-19 on  AUG2022) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In August 2022, SARS-CoV-2 test: (Positive) Positive.         No other vaccines were given within 1 month prior to Moderna COVID-19 vaccine. No concomitant medications were provided. Patient had received all Moderna doses in the past and never had any issues Patient said that she had a history of asthma, but she has never had a reaction like this to anything. No treatment medications were reported.   This case was linked to MOD-2022-669812 (Patient Link).
Throat hurting , really hot Neck Swollen , back of Neck hurt really bad  Joint Pains  Headache
patient contacted me and indicated she had been having soreness and inability to raise arm without pain, she indicated using otc pain meds and without any success.  I told her I would submit the information and get back to her if there were any recommendations given. I contacted her doctor gave the information and they said she had an appointment to come in on 2/16/22.
Received shot in afternoon of Monday Aug 9th, felt fine, perhaps a little dizzy and uncoordinated later that night. Woke up the next morning with sore arm and tingling/numb fingertip in left middle finger, and parts of the peripheral fingers. Paresthesia has lasted for one week now. No weakness, but numbness and tingling have continued.
patient says they were experiencing hives after showering 9recommended taking Benadryl before and after showering to prevent that), patient currently does not have trouble breathing , patient is also experiencing dark urine but that is probably more due to the actual hep a infections
The pt developed severe erythema multiforme, requiring hospitalization, given varicella vaccine, 10/24/01. Pt seen again 11/5/01 with a bacterial upper respiratory and pulmonary infection.  Started on Ceclor. On 11/13/01 developed extremely severe erythema multiforme, requiring approximately 5 hospitalization, recovery was complete.
11:25 - Client received GARDASIL #2 IM. Immediately c/o seeing spots, dizziness, diaphoretic. Head lowered between knees. Unresponsive. Lowered to floor. Placed in supine, Trendelenburg position. Regained consciousness about one minute. Wet cloth to forehead. Crackers and fluids given. Full recovery noted.
tender, firm, enlarged area upper lt arm- 6 /12cm x 4cm (site of varicella vaccine);viral synd @ time of rxn;
pt recvd vax 3NOV94,5NOV94 sl throat irritation;6NOV94 react worse felt like flu, bones hurt, high fever & finally almost comatose-didn't know what day, or what time it was x 3 days; lung congestion, chills, burning up,lasted 1 wk;
Caused an exacerbation and increase in autoimmune disease she has suffered since that time.  Chronic fatigue syndrome; hepatic steatosis; coronary artery spasms; systolic dysfunction; cardiomyopathyviral induced; pulmonary hypertension; fibrocystic breast disease with negative breast biopsy; pre-diabetes; osteoarthritis; GERD; IBS; mitochondrial disorder; Graves' disease; endometriosis; recurrent mild cervical lymphadenopathy with benign workup; depression.  Causality assessment shows temporal relationship only. She was hospitalized 10 days following immunizations for 3 days with an acute respiratory infection. Intermittient fevers followed and developed hepatitis A in June 2076.
Information has been received from a vaccine coordinator concerning a 73 year old female who on an unspecified date in February 2007, was vaccinated with a single first dose of Zostavax (Oka/Merck).  On 12-JUL-2007 the patient developed "pain in her back and chest".  On 14-JUL-2007 the patient developed a "rash".  Unspecified medical attention was sought at a different facility from where the vaccine was administered.  At the time of this report the patient was recovering.  No further information was provided.  There was no product quality complaint involved.  Additional information has been requested. 12/21/07 This is in follow-up to report(s) previously submitted on 9/24/2007. Follow-up information was received concerning a 72-year-old (previously reported as 73) with allergies to sulfa, amoxicillin, LEVAQUIN, "robasise" and "biaxcin", who developed a case of shingles in June of 2007. She was treated with FAMVIR. On an unspecified date, the patient recovered. Additional information is not expected.
52 year old female who has completed 30-minute observation period with signs and symptoms of adverse reaction.Vital signs taken, patient took own benadryl 25 mg orally.  Still feeling itchy throat but stated feeling better.  Took to Emergency room for further assessment. The vaccine was received at 11:00 a.m., patient is post vaccine more than 2 hours and is feeling improved after Decadron and albuterol.  She is advised to monitor symptoms at home.  Stable for discharge.
I woke up with excruciating pain heat and redness in my right toe, which did have what I assume is a fungal infection of the nail, however it had felt fine until it woke me up in the night.  I thought I had developed cellulitis.  However by the next morning it was completely gone back to how it was which is a little painful and irritated but not bad at all.
Symptoms took place all day 8/28/2021: Fever of 102 degrees Fahrenheit, chills (feeling hot and cold off and on all day), left arm and left shoulder very sore (could not extend arm beyond shoulder without pain), light sensitivity (felt like I was hungover although I was sober), extreme fatigue, headache felt like I had a bowling ball for a head (felt better to lay down in bed than it was to stand up and walk around).
Chills, temperature 100.4, fatigue and weakness, nausea for 3 days, extreme diarrhea for 3 days
Woke up 2/3 and felt severe headache, body aches, sore throat, nausea and shortness of breath. Symptoms became more pronounced and went to ER on 2/5; Sent home from ER stating she had panic attack related to vaccine. She went to PCP office and saw the doctor and they ruling out bronchitis or possible blood clot. Doctor informed patient to report the adverse event to pharmacy. Still do not know the official outcome.
73yr old patient presented to PCP on 9/20/18. Patient ordered and administered influenza vaccine-high dose (Trivalent) IM in patient's right deltoid by CMA. CMA noted "shot tolerated, no reaction".  On 12/1/18, patient contacted provider complaining of right arm pain since flu shot administration on 9/20. Endorsed immediate pain, especially with movement, unable to lift right arm or perform upper body exercises. Patient seen by provider on 12/14 for follow up. Patient denied numbness or weakness. Patient endorsed resting arm and using heat for pain. Unknown of other treatments attempted. No prior issues with vaccines noted, but history of rotator cuff surgery on left shoulder. MD requested patient come in for follow up visit. Patient presented on 12/14 for evaluation. MD ordered rest, continued heat, MRI and PT ordered. Patient instructed to use aspercreme or topical lidocaine OTC as needed.
Information has been received from a registered nurse and the parent of an 8 year old healthy male with no allergies and no medical history who on 3/7/97 was vaccinated SC in the left arm with a first dose of varicella virus vaccine live (lot # 619271/1338D). On 3/7/97, the patient was also vaccinated IM in the right thigh with a fourth dose of HIB conjugate vaccine (batch # 6K81443), a fourth dose given IM in the left thigh of diphtheria toxoid (+) pertussis vaccine (+) tetanus toxoid (batch # 6K71127), and a first dose given SC in the right arm of MMR. There was no illness at the time of vaccination. There were no adverse events following prior vaccinations. On 5/12/04 the patient developed 10-15 itchy lesions, 5 of which were vesicular, a very few of which contained fluid. They were on his trunk, behind his ears and on his neck. It was also noted that the patient's parent just wanted to let you know that the patient did get a mild case of chicken pox. On 5/19/04, the patient recovered. The patient was not seen by a doctor and no treatment or diagnostic tests were required. No product quality complaint was involved. It was also reported that on 9/21/95, 1/12/95, and 5/24/96, the patient was vaccinated with a first, second, and third dose of hepatitis B virus vaccine. On 1/12/96, 3/8/96, and 5/24/96, the patient was vaccinated with a dose of diphtheria toxoid (+) pertussis vaccine (+) tetanus toxoid (+) HIB conjugate vaccine, and a dose of hepatitis A virus vaccine inactivated (lot # FVHA523A4). On 6/16/00, the patient was vaccinated with a dose of MMR (lot # 631639/0109K), a dose of poliovirus vaccine inactivated (lot # FR02352) and a dose of diphtheria toxoid (+) pertussis vaccine (+) tetanus toxoid (lot # FDTPA939A2). No further information is expected.
patient died after the second dose of the Moderna vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of DEATH (patient died after the second dose of the Moderna vaccine) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided. Company Comment: Very limited information regarding the events has been provided at this time.; Sender's Comments: Very limited information regarding the events has been provided at this time.; Reported Cause(s) of Death: patient died after the second dose of the Moderna vaccine
Severely delusional, elevated high BP, vertigo, chills,  moderate  fatigue,  swollen  ankles,
This spontaneous report as received from a registered nurse refers to a 70 year old female patient with prednisone allergy, codeine allergy and morphine allergy. The patient's medical history included breast cancer of left side and nodes removed. On 23-AUG-2012 the patient was vaccinated with a first dose of PNEUMOVAX23 (lot number, dose and route of administration were not reported) in the right arm. On 03-OCT-2013 the patient was vaccinated with the second dose of PNEUMOVAX23 (lot number, dose and route of administration were not reported) in the right arm. On 04-OCT-2013 the patient was presented at the Emergency Room (ER) injection site reactions of right arm. Redness, hot, swelling tracking up to the right axilla down to the right forearm. The patient sought medical attention via Emergency Room (ER) visit. The patient did not recover from adverse events. The relatedness between vaccination with PNEUMOVAX23 and adverse events was not reported. Additional information has been requested.
Coughing up a little blood; This is a spontaneous report from a contactable consumer (patient) via Pfizer sponsored program Support. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/lot number and expiration date were not reported), via an unspecified route of administration on 02Mar2021 as dose 1, single for COVID-19 immunization. Medical history included emphysema from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient experienced that she was coughing up a little blood since the beginning of Apr2021. The patient underwent lab tests and procedures which included xray: unknown result on an unspecified date. The outcome of the event was unknown. It was reported that the patient was scheduled supposedly on 30Mar2021 for the second dose, but it was cancelled because she underwent X-ray procedure prior to 2nd dose schedule. The patient was querying if she could get the second dose despite of the event.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
11;45 a.m. blurred vision, dizziness, vertigo. 11:46 am black out
Have a bump/ tender spot on collarbone; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: unknown) via an unspecified route of administration in the right arm on 17Apr2021 at 09:00 (at the age of 37-year-old) as a single dose for COVID-19 immunisation. Medical history included heart condition supraventricular tachycardia, allergy to latex and penicillin. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included unspecified prescription medication for unknown indication on unknown date and unknown if ongoing. On 19Apr2021 at 09:00, 2 days after getting the second shot of vaccine, the patient noticed a bump/ tender spot on collarbone. The event did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event bump/ tender spot-on collarbone was not recovered at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
improperly stored dose of VARIVAX was administered; no additional adverse effects; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender.  No information was provided regarding the patient's historical conditions, previous drug reactions, allergies, concurrent conditions or concomitant medications.  On 17-AUG-2020, the patient was vaccinated an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot # S020158 and expiration date 30-JUN-2021, for prophylaxis (dose, strength and frequency).         It was reported that varicella virus vaccine live (oka/merck)(VARIVAX) was stored at a temperature of (15°F to 46°F): 19.2F durinf 1 hour and 46 minutes. No previous temperature excursions were reported. Digital data logger was involved.