chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a healthcare worker, refers to a patient of unknown age and gender. No pertinent medical history, concurrent conditions or drug reactions/allergies were reported. On 01-MAR-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9, which had a lot # of L016428 and an expiration date of 30-AUG-2017 (dose, dosage number, route of administration and anatomical location were not reported). It was stated that the temperature excursion was 28.9 F for a time frame of 7 hours. This excursion was found due to a data logger. Additionally, it was stated that no previous temperature excursions had occurred. This is one of the several reports received from the same reporter. Additional information has been requested.
On 2/3/00, the pt developed approximately 80 skin lesions. It was reported that the pt is now doing well, but that he has well over 100 skin lesions. Additionally, it was noted that the lesions are starting to scab.
swelling, redness, and pain L deltoid immediately after injection back spasms and pain in vertebrae 5/01/2021 unilateral lip swelling 5/02/2021
LOW ANTIBODIES IN BLOOD WORK TESTED; MEDICATION ERROR; PSORIATIC ARTHRITIS FLARE UP; This spontaneous report received from a patient concerned a 58 year old male of an unspecified race and ethnic origin. The patient's height, and weight were not reported. The patient's concurrent condition included: psoriatic arthritis. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number, and expiry date: unknown) dose was not reported, with frequency time 1 total administered on 08-MAR-2021 for Covid-19 vaccination. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number, and expiry date: unknown) dose and frequency were not reported from an unspecified date to 08-MAR-2021 for psoriatic arthritis. The batch number was not reported. The Company was unable to perform follow-up to request batch/lot numbers. Concomitant medications included MRNA 1273 for Covid-19 vaccination (medication error).  On an unspecified date in 2021, the patient had low antibodies in blood work tested. Laboratory data included: Covid-19 antibody test (NR: not provided) Positive (low). On an unspecified date in OCT-2021, the patient experienced psoriatic arthritis flare up. It was reported that it was unknown if the patient was enrolled in Covid-19 vaccine trial.  The action taken with Covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab was not reported. The patient had not recovered from low antibodies in blood work tested, and psoriatic arthritis flare up, and the outcome of medication error was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000197405.; Sender's Comments: V0: 20211023652-COVID-19 VACCINE AD26.COV2.S-psoriatic arthritis flare up. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY
This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer (patient) reported for herself. A 30-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 Vaccine, Lot Number: EP7533; Expiration Date: Jul 2021), dose 2 via an unspecified route of administration, administered in Deltoid Left on 07Apr2021 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 07Apr2021, that evening about 12 hours after the shot, the patient experienced most of the side effects, fever, chills, joint pain, headache, it triggered a Herpes outbreak. The patient took Ibuprofen and was trying to find out if it is okay that it's okay to take Valtrex, didn't know yet. Ibuprofen on April 7th and 8th and 9th, tablet, 1st time patient took two 200mg tablet and then each time after that one 200 mg tablet. Probably two or three times, patient didn't remember for fever and headache and joint pain. Fever, chills and joint pain have gotten better. The outcome of event herpes outbreak and headache was not recovered, outcome of the other events was recovering. No follow-up attempts are needed. No further information is expected.
mom reports red smooth rash around inj site rt arm noted 9/19/99;seem to be increasing;
Dizziness, mild fever, total body weakness, sweating, body aches, headache, nausea.  Symptoms lasted for 48 hours
Information has been received from a physician concerning a child who was vaccinated with a dose of ROTATEQ. Subsequently, the patient had developed a bloody stool ever since the patient was administered ROTATEQ "when it has been a couple weeks." The patient's outcome was not reported. Upon internal review, haematochezia was considered to be an other important medical event. Additional information has been requested.
Patient returned to the pharmacy today with a sore right arm where he got the PNEUMOVAX vaccine. His arm is noticeably swollen, red and warm to the touch. The patient reported he has pain when he tries to raise his arm above shoulder level. I recommended oral BENADRYL, TYLENOL, and to apply an ice pack. If it isn't improving by Friday to contact his physician.
According to the client, on 11/2/07 he received  flu vaccine IM.  11/4/07, hands began tingling.  After a few days, arms and legs were ached and on 11/13/07 he fainted.  He was taken to the local ER and was transferred to another hospital where he stayed for 5 weeks. He was then transferred to Rehab Unit and had therapy for 3 months. 6/30/08-records received for DOS 11/14-12/6/07-DC DX:Acute infective polyneuritis. Pneumonia due to Streptococcus, panic disorder with agoraphobia. Transferred to rehab. Presented with paresthesias in hands a few days after vaccination and 1 week later on 11/12/07-began having weakness in legs and subsequently fell and has been unable to walk. Arms weak. Neuro exam, general weakness, no fasciculations. HX of diarrhea several days prior to onset of symptoms. Treated with IVIG.  8/5/08-records received for DOS 12/6/07-01/08/08-DC DX: Guillain Barre syndrome with paralysis from neck down with improvement. Involvement of upper and lower extremities and swallowing early on, at time of discharge slight movement of upper extremities and lower extremities.
Patient got the J&J Covid vaccine on 4/2/2021, presented to the ER on 4/20/2021 with complaint of left chest and shoulder pain.  This has been progressively getting worse over the past 3 days.  She denies any overt shortness of breath or cough and her vital signs are stable.
Patient reported itching and a rash on her arm around the time she received her Pfizer vaccine, but she cannot pinpoint the exact day of symptom onset. She stated the itching became more intense and widespread over the next few days. She developed "hives and welts." Subsequently she scheduled a visit with her medical provider on 05/13/2021. She was given a "steroid shot" at that time, noting improvement over the next few days. Patient reported the symptoms have returned and worsened this week.
Epstein Barr plus other health issues; This serious case was reported by a consumer via interactive digital media and described the occurrence of epstein-barr virus infection in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced epstein-barr virus infection (Verbatim: Epstein Barr plus other health issues) (serious criteria GSK medically significant). The outcome of the epstein-barr virus infection was not resolved.   The reporter considered the epstein-barr virus infection to be possibly related to Shingles vaccine.     The company considered the epstein-barr virus infection to be possibly related to Shingles vaccine.   Additional Information: GSK Receipt Date: 05-APR-2023 This case was reported by the patient via interactive digital media. The patient reported that it could not be worse than going on third year with Epstein Barr from the vaccination. The patient received anti-seizure medication as treatment drug for all the other health issue. The follow-up could not be possible as no contact details were available. This case is linked with US2023AMR053239, for the same reporter.; Sender's Comments:  US-GSK-US2023AMR053239:Same reporter.
After the first dose, I woke up feeling like I had a cold. I experienced elevated blood sugar for about 3-4 weeks and high temperature for 4-5 days and elevated temperature for 3-4 weeks. My blood sugar was 10-15 points above and my temperature was 1 point above. I am not Prediabetic and I do not have any health issues. I was concerned I was having a systemic reaction. I had muscle aches, pain and swelling at the injection site, fatigue, chills coming and going. No joint pain or swelling of lymph nodes. About 2 weeks later I had a rash on my neck that lasted 3-4 days. My doctor told me to take a test to see if I had any antibodies. I did have antibodies. We decided not to take the second dose right away. Months later I learned that a lot of people will react to any vaccine with elevated blood sugar. I did not know that. After the first dose I was down for about 5 days. I only took Advil for muscle ache, no other treatment. I had my second dose in October. I only had some swelling at the injection site after the second dose, no other symptoms.  I might have had Covid the year before, I had a really weird lung thing. I tested negative for Covid on 09/2020.
BRUISE ON RIGHT FOOT; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (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 and has been requested. No concomitant medications were reported. On 12-MAY-2021, the subject experienced bruise. The action taken with covid-19 vaccine  was not applicable. The outcome of bruise was not reported. This report was non-serious.
Since my second dose, I've been experiencing migraines, shortness of breath, and an extremely increased heart rate. While attending my routine cycle class (been attending about 3 times a week for several months) I nearly passed out which is extremely unusual. I have also been experiencing a much lighter than usual menstrual cycle. A few days following my vaccination I was also experiencing pain in my left lung (this has since subsided).
Vasovagal syncope: pt states was fasting at time of inoculation, tx with 1L NS bolus
I recently had blood work done for an annual physical. The blood was drawn the same day I received the @nd dose of the vaccine.. I met with the Dr, 4 days later for my physical. He indicated my white blood cells were low and platelets were low. I did not have any adverse side effects other than a slightly sore arm. That particular blood test was accomplished, and the white cell count went back to normal and the platelets are improving, and I still feel no side effects. My primary care provider just wanted me to keep your company informed of the situation.
fever and profuse sweating hours after receiving vaccine. LAsted 24 hours or so. Then developed severe lower abdo and rectal pain. Described as "labour pains" pain  not resolving, ongoing since vaccination.
headache; joint pain; fatigue; This is a spontaneous report from a contactable other hcp (Nurse).  A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EWO153) dose 1 via an unspecified route of administration, administered in Arm Left on 13Apr2021 at 10:30 as DOSE 1, SINGLE for covid-19 immunisation. Medical history included chronic obstructive pulmonary disease from an unknown date and unknown if ongoing , emphysema from an unknown date and unknown if ongoing , asthma from an unknown date and unknown if ongoing. Concomitant medications included hctz (HCTZ) taken for an unspecified indication, start and stop date were not reported; loratadine (CLARITINE) taken for an unspecified indication, start and stop date were not reported; vitamin d nos (VITAMIN D NOS) taken for an unspecified indication, start and stop date were not reported and flax seed. The patient previously took chantix and experienced drug hypersensitivity, hydrocodone and experienced drug hypersensitivity. There were no other vaccines within four weeks of vaccine administration. It was reported that, there was no covid prior to vaccination. Tested post vaccination on 07May201 via nasal swab test, which resulted negative. It was reported that, on 14Apr2021 at 10:00, the patient has experienced headache, joint pain (arthralgia) and fatigue. No treatment was received for the events. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 07May2021. The outcome for the events were not recovered.  Follow-up attempts are completed. No further information is expected.
Started developing joint pains and swelling. Multiple joints and painful swollen joints.; Started developing joint pains and swelling. Multiple joints and painful swollen joints.; This is a spontaneous report from a contactable physician (patient). A 40-years-old non pregnant female patient received bnt162b2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number EH9899, expiration date unspecified), via an unspecified route of ad-ministration, administered in Arm Left on 17Dec2020 as dose 2, single dose for covid-19 immunization at Hospital. Previously the patient received bnt162b2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number EH9899, expiration date unspecified), via an unspecified route of administration, administered in Arm Left on an unknown date as dose 1, single dose for covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Medical history included hypothyroidism from an unknown date and unknown if ongoing. Concomitant medications included spironolactone taken for an unspecified indication, start and stop date were not reported, minocycline taken for an unspecified indication,start and stop date were not reported, ergocalciferol (VIT D) taken for an unspecified indication, start and stop date were not reported. The patient was not diagnosed with COVID-19 prior to the vaccination. Since the vaccination, the patient had not been tested for COVID-19. On 22Mar2021 16:00, the patient started developing joint pains and swelling, multiple joints and painful swollen joints. The adverse events resulted in Doctor or other healthcare professional office/clinic visit. The patient had Nasal swab PCR (polymerase chain reaction test) and results were negative on 22Mar2021. Again, the patient had Nasal Swab (PCR) on 09Apr2021, and results were negative. The patient was treated with Naproxen, steroids, sulfasalazine for the events. The outcome of the events was reported as not recovered.; Sender's Comments: As there is limited information in the case provided, the causal association between the events arthralgia, joint swelling and the suspect drug cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Coughing dry; Chills; Low grade fever; Myalgia; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (coughing dry), CHILLS (chills), PYREXIA (low grade fever) and MYALGIA (myalgia) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939904) for COVID-19 vaccination.     No Medical History information was reported.   In December 2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, the patient experienced CHILLS (chills), PYREXIA (low grade fever) and MYALGIA (myalgia). On 27-Oct-2021, the patient experienced COUGH (coughing dry). At the time of the report, COUGH (coughing dry), CHILLS (chills), PYREXIA (low grade fever) and MYALGIA (myalgia) outcome was unknown.            Concomitant drugs were not reported. Treatment medications were not provided.   This case was linked to MOD-2021-002894, MOD-2021-365406 (Patient Link).
Per nurse 2/21: right upper arm red/swollen/painful/hot to touch; recommend triage in 12-24 hours. PCP note 2/22:  Augmentin 875 mg po BID x 10 days. Triage note 2/25: arm back to normal size.
8 week old child received the Pentacle vaccine (both parts mixed correctly together) and then also was given another ActHIB dose separately. So, ended up with Hib from Pentacel and separately, no ae; Initial information regarding an unsolicited valid non-serious case from a other health professional via Medical Information (MI) (Reference number- 00496085) and transmitted to Sanofi on 26-Feb-2021.  This case involves a 8 weeks old female patient who was vaccinated with 0.5 ml first dose of HIB (PRP/T) VACCINE [ACT-HIB], powder and solvent for solution for injection (lot UJ354AB and expiration date : 08-JUL-2021) via intramuscular route in the left leg and a dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL], suspension for injection (batch number and expiration date were not reported) via unknown route in unknown administration site for prophylactic vaccination on an unknown date and reported that the patient received the pentacle vaccine (both parts mixed correctly together) and then also was given another acthib dose separately. So, ended up with hib from pentacel and separately (extra dose administered).  The patient's past medical history, medical treatment(s), vaccination(s), family history and concomitant medications were not provided.  It was a case of actual medication error due to extra dose administered (same day latency).  Also reported that after getting 2 does of ACTHIB at once and they would to know if there are any safety concerns. Caller asked what to look out for in specific if a patient got 2 doses of ActHIb on the same day? Offered to escalate, caller declined.  It was not reported whether the patient had any adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on batch number (PENTACEL) for this case.
Site reddened and hot. Pain at site only. No treatment. 6 days duration.
This patient reported she waited the recommended time after her injection and then left the facility. She stated as she got in to her car and began to drive away she felt her face become "numb and tingly" and returned to the facility right away. Upon entering the facility and reporting her concern, she was assisted to sit down in the side lobby area and VS assessed. She reported her face felt "numb and tingly." She denied any SOB or difficulty swallowing at that time. She reported her eyes "feel weird," but denied any vision changes. She also reported a scratchy throat and reported it sounded like she was "under water." At 1225 she reported her eyes to be "not that bad anymore." VS reassessed at 1230. She continued to report no SOB or other symptoms. At 1244 she reported her symptoms to be less or unchanged. Final assessed and this patient reported she felt good to go home. She was given Benadryl PO by pharmacy staff and denied any questions.
Patient did not get 2nd dose on the due date; Patient possibly getting 2nd dose after 42 days of getting the 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient did not get 2nd dose on the due date) and TREATMENT NONCOMPLIANCE (Patient possibly getting 2nd dose after 42 days of getting the 1st dose) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 04UA21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient did not get 2nd dose on the due date) and TREATMENT NONCOMPLIANCE (Patient possibly getting 2nd dose after 42 days of getting the 1st dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Patient did not get 2nd dose on the due date) and TREATMENT NONCOMPLIANCE (Patient possibly getting 2nd dose after 42 days of getting the 1st dose) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications reported.  No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-116509 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-116509:Wife case
Patient passed out immediately after receiving injection. pt has history of fainting per her mother.  Patient was alert within a few seconds and then vomited.  Pt sat and was observed for approx 25 minutes and was feeling ok to leave with mother.
Pt called triage RN on 11/3/19 to report SE. States (L) arm pain [7/10], swelling, feeling warm, fatigue, & nausea. States swelling is 3 inches larger than normal. Symptoms onset early on 10/3/19 AM.
He received the vaccine during a medication review that afternoon, developed a fever (101 degrees F) and moderate to severe itching on the inside of the arm the injection was given into. He went to sleep and woke up with no other effects the following morning except continued deltoid muscle pain. The pain went away in about 2 days.
Vaccine brand: Pfizer / BioNTech/Product: COVID 19 Treatment; Vaccine brand: Pfizer / BioNTech/Product: COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32-year-old male patient received BNT162b2 (BNT162B2), on 22Nov2021 at 15:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 31 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: DAYQUIL, start date: 17Apr2022, stop date: 20Apr2022. Vaccination history included: Covid-19 vaccine (Previous immunization series complete, MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Vaccine brand: Pfizer / BioNTech/Product: COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.