chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is one case out of a cumulative total of 223 cases solicited from the EDSS database during the surveillance period from 01 January 2010 to 24 January 2014. These 223 cases represent children who received 3 or more doses of sanofi pasteur vaccine; cases of pertussis disease in children who received DTaP combination vaccines from other manufacturers are not reported as per study protocol. Initial report received on 24 January 2014 from the Investigator participating in a study under reference number M5A16. A case of pertussis disease in a seven-month-old female subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received three doses of PENTACEL on 16 July 2013 (lot number C4487AA), 16 September 2013 (lot number C4486AA), and 22 November 2013 (lot number C4559AA) (routes and site of administration not reported). The subject developed catarrhal illness and cough on 21 December 2013, 29 days after the last dose, and on 28 January 2014 developed a paroxysmal cough without a whoop. She also experienced post-tussive vomiting, apnea and sleep disturbance. Laboratory testing included a positive PCR on 31 December 2013; a chest X-ray was negative. Corrective treatment included azithromycin for 5 days beginning 04 January 2014. The subject was not hospitalized. At the time of final contact on 06 January 2014 the subject's cough was still ongoing. The duration of the cough was reported at that time as 16 days. Investigator causality assessment is not required as per the protocol. Documents held by sender: None.
I felt fine after vaccine because I went for a walk that day. On the 22nd I was very tired and by the 23rd I had fatigue and a mild headache. By the 25th I had chills and fatigue. I took temperature and it was 97.5 and stayed that way for several days. I was sleeping 10-12 hours a night. I sat in a chair wearing a sweater and a sweatshirt wrapped in blankets and that's where I spent most of my time through the first of March. The 2nd part of March I was starting to feel better but I still had a headache for a few days. I was able to do some walking and then the fatigue came back with a lot of tinnitus and I started sleeping a lot and my balance became poor around beginning of April. I then started having vertigo in April occasionally and by the middle of May I was feeling sick all the time and I was walking with a cane outdoors, which I still do. I had a mental fog and I couldn't walk even two blocks without someone with me. The first time I felt like my head wasn't foggy was 06/27/2021 because I had a couple hours of my head feeling normal. I was able to walk four blocks that day with my husband and now the fogginess just gradually clears up a couple hours most days. Now I don't often feel foggy but I stumble quite a lot and I'm not tired as I had been in the past 4-5 weeks. I am doing physical therapy and I can stand with my feet together and I can close my eyes and don't fall over but I did fall over two weeks ago. I do still have trouble with bending over and I lose my balance and if I'm tired I stagger like a drunk person would. I have a lot of tinnitus and some headaches and still balance issues. Doctors do think it was triggered by virus. I've had an MRI with contrast and it was fine. My hearing has been affected which may or may not be triggered by the immunization. Doctor thought my immune system overreacted to something and possibly immunizations and she told me to wait and see how I do before I get the shingles vaccine. She's trying to figure out what's going on. I had been really healthy and I walk, bike, and yoga. It has just progressed and it's not getting worse its getting better but still ongoing.
SHORTNESS OF BREATH; MUSCLE PAIN IN THE BACK AND THIGH; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (SHORTNESS OF BREATH) and MYALGIA (MUSCLE PAIN IN THE BACK AND THIGH) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included AMOXICILLIN for an unknown indication.    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (SHORTNESS OF BREATH) and MYALGIA (MUSCLE PAIN IN THE BACK AND THIGH). At the time of the report, DYSPNOEA (SHORTNESS OF BREATH) and MYALGIA (MUSCLE PAIN IN THE BACK AND THIGH) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
pt recvd vax; sensation dec & spreading in extremities; heaviness of limbs;PC f/u 26may93: seen x 3 in last wk; no progression noted; just sensation changes;
having slight discomfort at the site of injection; cancer; This is a spontaneous report from a contactable physician (patient) from a Pfizer-sponsored program. This male patient of unspecified age reported that he received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: Unknown) via an unspecified route in Mar2021 as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: Unknown) via unspecified route in Mar2021 as a single dose for COVID-19 immunization and experienced slight discomfort at the site of injection. The patient was diagnosed with cancer in May2021. He was treated with chemo and radiation. Today (13Aug2021) was the last dose of both chemo and radiation. He stated he will go to his oncologist Monday. Patient reported that he received both doses of the Pfizer Covid-19 vaccine in Mar2021, reports having no side effects other than having slight discomfort at the site of injection. The patient reported that his cancer was not related to the vaccine itself. It was HPV related. The patient inquired about the timing of the booster after chemo being given. He just finished treatment (chemotherapy and radiation) today (13Aug2021) and his oncologist suggested he wait a couple weeks to "perk up". He saw his oncologist for a consult in terms of the vaccine. His doctor said they could wait two weeks and reassess and see if he has any antibodies. He did get the vaccine in Mar2021. He just doesn't know if he has antibodies from Mar2021. So his doctor said to wait a couple of weeks before getting any vaccine. The outcome of the events was unknown.  The lot/batch number for the vaccine, BNT162b2, was not provided and will be requested during follow-up.; Sender's Comments: There is no reasonable possibility of causal association between the event of Neoplasm malignant and BNT162b2. The case will be reassessed if additional information becomes available.,Linked Report(s) : US-PFIZER INC-202101048314 same patient, same drug, different AE, different dose of vaccine
Pt developed chicken pox and was admitted to hospital after vaccination d/t syncope, dizziness, and disorientation. Pt also received transfusion and chemo d/t decreased RBC, Hgb, and LDH.
Pt recvd vax in 1987 & in 1988 following vax pt devel erythema multiforme primarily of hands & feet; No further details were provided;
About 1 to 3 min. after administration of vaccines chills seizured. Her eyes rolled back and skin was cold and clammy. Child feel and hit her head. Used ammonia inhalant and she was awake and responsive when ambulance to her to hospital.
This is a spontaneous report from a pharmacist via a non-clinical-study program. An approximately 92 years old female patient received first dose of PREVNAR13; NDC number 000051974 05) on 22OCT2014, in her deltoid, at 0.5 ml single. No other medication was given on that day. Medical history was not reported. Concomitant medication included atenolol at 50 mg twice daily. The reporter stated that soreness of the arm is a possible side effect but the patient's arm had been swollen for about six days and she said it was getting worse. The patient was advised to see her physician, but the reporter was not aware if she followed through. Events were not resolved at the time of the report. Follow-up (19DEC2014): Follow-up attempts completed. No further information expected.
High Fever (102+); chills; body aches; headache; congestion; fatigue; This is a spontaneous report from a contactable Other HCP (patient). A 32-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: ER8729), via an unspecified route of administration, administered in arm left on 16Jun2021 03:30 PM (at the age of 32-year-old) at a dose 2, single for COVID-19 immunization. The patient's medical history was not reported. Patient did not take concomitant medications (The patient did not receive any other medications within 2 weeks of vaccination). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: ER8729), via an unspecified route of administration, administered in arm left on 26May2021 03:30 PM (at the age of 32-year-old) at a dose 1, single for COVID-19 immunization and no reaction on previous exposure to vaccine. The patient experienced high fever (102+), chills, body aches, headache, congestion, fatigue on 17Jun2021 08:30 AM. The patient underwent lab tests and procedures which included high fever was 102+ Fahrenheit on 17Jun2021, nasal swab was negative on 19Jun2021. The patient did not receive any treatment medication for the events. Patient reported no for seriousness criteria-Results in death, seriousness criteria-life threatening, seriousness criteria-caused/prolonged hospitalization, seriousness criteria-disabling/incapacitating and seriousness criteria-congenital anomaly/birth defect. Device Date was 20Jun2021. Outcome of the events was recovering.   No follow-up attempts are possible. No further information is expected.
Shot around 430pm. Pain in hand around 8pm. 1130AM next day -aching in hand (left) but pain is less than night before.
1/16/2023  I had light cold symptoms. I had a positive At Home COVID Test.  A week after that, I had severe chest pains. I saw my doctor and they said it could have been an infection. I was prescribed an antibiotic, can?t remember the name.  The pains went away, slightly. I began getting severe pains again about 3 days later. I went to Urgent Care. I had an x-ray of chest and bloodwork done. My chest was clear. Bloodwork showed a high WBC.   I was prescribed a stronger antibiotic, Doxycycline. Two or three days after that, I had strong pains again. My PCP sent me for a CT to rule out pulmonary embolism sometime in February 2023, unsure of date. The result was negative. I then had an echocardiogram which showed nothing to support my chest pains.  I am having a heart stress test at the end of April.   I still have chest pains all the time, just not severe all the time. I have good and bad days.
swelling on her arm and her hands; swollen hand; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swelling on her arm and her hands) and PERIPHERAL SWELLING (swollen hand) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014m20a) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced PERIPHERAL SWELLING (swelling on her arm and her hands) and PERIPHERAL SWELLING (swollen hand). At the time of the report, PERIPHERAL SWELLING (swelling on her arm and her hands) had resolved and PERIPHERAL SWELLING (swollen hand) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient stated that she would be receiving her second dose of vaccine (30-Mar-2021). Follow-Up: Patient stated that her hand is still swollen and has visited the doctor to find out the reason, she had undergone a blood test and an ultrasound of her hand, results are yet to be known.  The doctor has said that the patient's swollen hand had nothing to do with vaccine and would be able to know the cause once the test results are known.    Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: Report  follow-up: Updated event swollen arm to recovered/resolved.Added lab data.
Mom noticed rash on trunk, diaper area, neck adn on left side of body  10-25-05 a.m. Described as red, smaller then a dime, no pus.  Took to clinic on 10/26/06.  Dr. Advised they were hives possibly from MMR/V.
headache; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 49-years-old female patient received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine, administered at Public Health Clinic/Military facility, via an unspecified route in left arm on 18Aug2021 14:45 (Batch/Lot Number: EW0164) as single dose for COVID-19 immunization. Medical history was none. There were no concomitant medications. The patient didn't receive any other vaccine in the 4 weeks prior to vaccination. She was not diagnosed with COVID-19 before vaccination and was not tested for COVID-19 post vaccination. The patient reported that, after the first vaccine dose, in Aug2021, she experienced a terrible headache for 3 days. The event outcome was unknown at the time of the report.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101198197 Same reporter/vaccine, different dose/event
Information has been received from a physician and the pt's mother concerning a 5 year old male with no known allergies and no illness at the time of administration and no medical history who on 09/09/1996 was vaccinated with first dose of varicella vaccine in his left arm and second dose of MMR vaccine in his right arm. There was no illness at the time of vaccination. On 06/16/2001, the pt had an exposure to varicella. On 22 and 06/23/2001, he had sun exposure at a lake. On 06/28/2001, the child developed severe varicella and on 06/29/2001, medical attention was sought. The child had chicken pox and a fever of 102 deg. F. His varicella was worse on sun exposed areas. Subsequently, the child recovered.
Red swollen lump where injection given. 2 cm in size. Antibiotic given to Tx area. EES given for 10 days. Spot clearing as of 7/23/03.
Initial and follow up information has been received from a medical assistant referring to a patient of unknown age and gender. On 02-JUL-2015, the patient was vaccinated with a dose of GARDASIL, lot # K006960, (expiration date, dose and site of administrations were not reported) that was exposed to temperatures outside of the recommended range. No adverse effects had been observed or reported. This is one of several reports from the same reporter. Additional information is not expected as all the follow ups requested to complete the case were received.
Severe pain in arm that was injected, it started 3 hours after vaccine and progressively got worse to the point where it hurts to use the arm.
This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration) in a 47-year-old male 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 (administer expired vaccine to patients, after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, 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 medication was reported. Date the vial was initially stored in the refrigerator reported as unknown. Number of doses/vials was reported as 102 doses from LOT 026C21A. Expiration date was reported as 24-Oct-2021. The vial did not undergo any temperature excursions. No treatment information was provided. Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow up contains non significant information.
Swelling at injection site.  Fever of 101.7, nausea, body aches, headache within 24 hours of administered dose. Fever continued for 36 hours. Lingering body aches and headache.
Patient developed nausea, vomiting, and diarrhea 6 hours after his vaccination. He was seen at the emergency department at 06:00am on 1/18/2022 due to dehydration. He was treated with Zofran for nausea and was given oral fluids which he tolerated. Advised to follow up with his primary care provider.
Shot on Monday.  Tuesday night developed body soreness and fever between 100-101.  Overnight Tuesday woke up shaking with fever over 102.  Wed had a fever over 103 all day/night taking advil every 4 hours.  Late Wed night, early Thursday morning, woke up shaking again with fever of 105.2.  Could not function enough to go to doctor.  Fever finally broke Thursday morning waking up soaking wet.  Ran a temp of about 100-101 for the next few days after that but felt much better.
Thyroiditis subacute; Neck pain; Odynophagia; Pyrexia; This is a spontaneous report from a non-contactable consumer. A 39-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for covid-19 immunization. A safety signal of subacute thyroiditis following vaccination with the novel mRNA- and vector-based COVID-19 vaccines was found during a screening of the database of individual case safety reports. There were 29 ICSRs reporting SAT following the immunization with COVID-19 vaccines entered in the database. Most of the reports contained Pfizer/BioNTech's and Moderna's mRNA-based vaccines as suspected. This is case one of 29 reports.  The patient medical history and concomitant medications were not reported. The patient previously took first dose of historical vaccine, bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunization. On an unspecified date, (Calculated Time-to-onset (TTO): 2 days), the patient experienced thyroiditis subacute, neck pain, odynophagia and pyrexia. The events were reported as non-serious. The outcome of events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202100974884 ;US-PFIZER INC-202100974885 ;US-PFIZER INC-202100974886 ;US-PFIZER INC-202100974887 ;US-PFIZER INC-202100974888 ;US-PFIZER INC-202100974889 ;US-PFIZER INC-202100974890 ;US-PFIZER INC-202100974891 ;US-PFIZER INC-202100974892
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Patient medical history and known allergies were reported as No. Other medication in 2 weeks was reported as No.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient received the vaccine. Patient received Paxlovid treatment (Lot number- GE1613) from 14Sep2022 to 18Sep2022 for treatment of COVID-19.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Extremely sore arm (not injection site) my whole bicep is sore and some days I cannot lift my arm further than my waist! Could use it to drive (couldnt hold steering wheel). Feels very stiff and painful to use. It has been over one month since the TDAP was given to me. My life is much more difficult to manage 3 kids and everyday life with this side effect. I have trouble sweeping the floor even! Feels like there is a heavy weight on my arm pushing against me.
ELEVATED BLOOD PRESSURE; HEART PALPITATIONS; SHAKINESS; DROWSINESS; This spontaneous report received from a health care professional concerned a 29 years old of unspecified sex. 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: 042A21A, expiry: UNKNOWN) dose was not reported, 1 total administered on 06-APR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, five minutes after vaccination the patient experienced elevated blood pressure, heart palpitations, shakiness and drowsiness. On 06-APR-2021, Laboratory data included: Blood pressure (NR: not provided) 230/116 mmHg, Oxygen saturation (NR: not provided) Normal, and Pulse rate (NR: not provided) Normal. Blood pressure did go down eventually. Patient was rushed to the hospital/Emergency room on 06-APR-2021. The action taken with COVID-19 VACCINE AD26.COV2.S was not applicable. The patient was recovering from elevated blood pressure and heart palpitations, and the outcome of shakiness and drowsiness was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: COVID-19 VACCINE AD26.COV2.S -elevated blood pressure, heart palpitations, shakiness and drowsiness. These events are considered unassessable. The events have a compatible/suggestive temporal relationship, are unlabeled, and have unknown scientific plausibility. There is no information on any other factors potentially associated with the events.
Patient received  a flu vaccine on 10/15/2008.  That evening she felt ill and went to sleep.  She awoke in the middle of the night to drink water and fainted. When she came to, she began to vomit.  The following day, the patient stated she was fine.  She did not seek medical attention for her symptoms.
Pt presented on 9/24/01 with erythema multiforme. He was admitted to the hospital on 9/25/01 and placed on IV Solu-Medrol. He was discharged home on 9/27/01 with no rash.