chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Administered vaccine after 33 days in the refrigerator; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator) in a 65-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator). On 18-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2021-356818 (Patient Link).
Same night of vaccine had the most intense bout of the periperal neuropathy I frequently get from degenerative disks and pinched nerves I have suffered with for years. It was in both legs and feet and I usually only have one side stabbing me at night after I lay down. It lasted all night long as it usually does but the intensity was hard to deal with. It did stop the next day but really shocked me after receiving the J and J
On May 17, ~1130, pt had syncopal episode with vomiting and aspiration. Had been straining on the toilet, presumed vasovagal. Felt as if BP dropped - diaphoresis and lightheadedness prior to syncope.  At ED, VS WNS, was provided 1L NS and KCl 20meq for K 3.0.  Returned to baseline, discharged to home. Approx 9 hours between event and discharge.
Allergic reaction; Left arm started to itch (incredibly itchy); Left arm became swollen; Left arm became red at injection site and 5" below; Her back on the left side became incredibly itchy; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (Allergic reaction), PRURITUS (Her back on the left side became incredibly itchy), VACCINATION SITE PRURITUS (Left arm started to itch (incredibly itchy)), VACCINATION SITE SWELLING (Left arm became swollen) and VACCINATION SITE ERYTHEMA (Left arm became red at injection site and 5" below) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to antibiotic (Amoxicillin) and Leg pain. Concomitant products included GABAPENTIN for Leg pain.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jan-2021, the patient experienced PRURITUS (Her back on the left side became incredibly itchy). On 25-Jan-2021, the patient experienced HYPERSENSITIVITY (Allergic reaction), VACCINATION SITE PRURITUS (Left arm started to itch (incredibly itchy)), VACCINATION SITE SWELLING (Left arm became swollen) and VACCINATION SITE ERYTHEMA (Left arm became red at injection site and 5" below). On 19-Jan-2021, PRURITUS (Her back on the left side became incredibly itchy) had resolved. At the time of the report, HYPERSENSITIVITY (Allergic reaction), VACCINATION SITE PRURITUS (Left arm started to itch (incredibly itchy)), VACCINATION SITE SWELLING (Left arm became swollen) and VACCINATION SITE ERYTHEMA (Left arm became red at injection site and 5" below) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
full on hives; bad body rash; underarm pain; armpit swelling; Exhaustion; This is a spontaneous report received from a contactable consumer (patient) via Medical Information Team. A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 15Mar2021 as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient previously took BNT162B2 (first dose) for COVID-19 immunisation. The patient experienced underarm pain on Mar2021, armpit swelling on Mar2021, exhaustion on Mar2021, full on hives on 18Mar2021, bad body rash on 18Mar2021; all (non-serious). The caller stated that she received her second dose of the Pfizer COVID-19 vaccine on 15Mar2021 and she had the "basic" side effects of "underarm pain, armpit swelling and exhaustion." She stated that 3 days after her second dose she experienced "full on hives, a bad body rash." She stated that did not experience any throat swelling or difficulty breathing, no anaphylaxis. She did go to the hospital to be evaluated due to the severity of the rash and hives and out of fear that it may get worse and turn into anaphylaxis. She was not admitted to the hospital but she was kept for observation and treated with steroids which did help improve her symptoms. She is still currently on a course of steroids now. Her doctor told her to report this reaction to Pfizer. She stated that she gone online and reported her side effects and spoken with someone at Pfizer and filed a report regarding her symptoms. She would like to know if her experience is common and if it has been previously reported. She stated that she did not have any side effects at all after her first dose of the Pfizer COVID-19 vaccine. Response: The following adverse reactions have been identified during post authorization use of Pfizer-BioNTech COVID-19 Vaccine. Because these reactions are reported voluntarily, it is not always possible to reliably estimate their frequency or establish a causal relationship to vaccine exposure. Immune System Disorders: severe allergic reactions, including anaphylaxis, and other hypersensitivity reactions (e.g., rash, pruritus, urticaria, angioedema). Also let the caller know that we would refer her back to HCP regarding any future doses of the Pfizer COVID-19 vaccine based on her reaction to the second dose. For event, underarm pain, outcome was unknown, for armpit swelling, outcome was unknown, for exhaustion, outcome was unknown; for full on hives, outcome was recovering, for bad body rash, outcome was recovering.    Information about batch/lot number has been requested.
This patient had a rash, and papular patches develop on her arms, exterior surfaces,  spread to her shoulders, legs, and also facial edema; on Saturday. Medrol IM given in the office and Allegra.
Urgent care visit on 7/23/21. Symptoms included fatigue, chills, generalized body aches and sinus problem. Antigen test performed on 7/23/21 and came back detected. Case investigation interview with patient has not been performed as of time of this note.
Case number PHEH2012US020266 is an initial spontaneous report received from a pharmacist on 05 Oct 2012. This report refers to a female patient whose age was not reported. She was vaccinated with FLUVIRIN (batch number: not reported) on an unknown date (vaccination date was reported as a month ago). It was reported that she was not pregnant at the time of administration of FLUVIRIN from a multi dose vial, but she got pregnant after receiving vaccine. No adverse reactions were reported. 11 Jun 2014: Multiple attempts have been made to obtain follow-up information and outcome of pregnancy event without success. This case is considered lost to follow-up.
breakthrough COVID case about 6 months after vaccination; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 08-Dec-2021 and was forwarded to Moderna on 09-Dec-2021.    This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (breakthrough COVID case about 6 months after vaccination) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (breakthrough COVID case about 6 months after vaccination). The patient was treated with Immunotherapy (Regeneron monoclonal antibodies as treatment) for COVID-19. At the time of the report, COVID-19 (breakthrough COVID case about 6 months after vaccination) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Symptoms: It was reported that the patient had experienced Breakthrough COVID-19 infection after 6 months of vaccination and wanted to knew when should they get booster dose of vaccine.  No concomitant medications were reported  The patient was received the Regeneron monoclonal antibodies as treatment.   Reporter did not allow further contact; Sender's Comments: This spontaneous case is concerning a patient of unknown age and gender with no medical history reported, who received mRNA-1273 vaccine on an unknown date, experienced the unexpected, AESI of COVID-19. The event occurred on an unknown date after the unknown dose of mRNA-1273 vaccine. The outcome was reported unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report
Patient was given adult Pfizer vaccine at a pediatric dose of 0.2 ml intramuscularly. Incident was discovered at time of second dose when lot number used was not correct. Patient's father was contacted about the incorrect dose. No adverse effects were reported by the father. Patient intends to receive second dose as scheduled after 3 weeks.
10 minutes after receiving second Covid vaccine, tongue and mouth felt tingly and scratchy.  denies difficulty breathing or throat closing.  Had similar symptoms with the first vaccine., Discussed with her PCP who gave her a note to have her second Covid vaccine but to take Benadryl 50 mg po one hour prior to shot which she did. Denies any drowsiness, stating she takes benadryl on a regular basis frequently. Ambulated with staff to med: Appears somewhat anxious, oropharynx patent, pink, moist mucus membranes, BP 128/62, T 98.6, Chest: CTA. RRR, HR 64. AAOx3, clear in conversation, ambulatory without difficulty. Declined transport to the ED or urgent care for continued care/follow up, although symptoms are not worsening but stable, and her anxiety decreased, during her 40 minute stay after the vaccine. Again, denied drowsiness and symptoms abating. She then left the unit for home at 2:40pm
patient died within 3 hours of the jab; Initial information received on 07-Dec-2020 regarding an unsolicited valid serious social media case received from a consumer or non-healthcare professional.  This case involves a male patient (age not reported) who died within 3 hours after he received INFLUENZA VACCINE.  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   In 1976, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) (lot number and expiry date not reported) via an unknown route in an unknown administration site for prophylactic vaccination.  In 1976, the patient died within 3 hours following the administration of INFLUENZA VACCINE. This event was assessed as medically significant.  The reporter also reported that vaccine manufacturers cannot be held liable for death or injury from a flu vaccine. Would you buy tires from someone knowing they do not stand behind their product? Why would you inject toxins, poison, aborted baby fetal tissue into your bloodstream to avoid getting a virus with a 99.7 percent survival rate? More people die of the side effects of the vaccine than the disease itself.  The details of laboratory data were not reported.   It was not reported if the patient received a corrective treatment before he died.  It was unknown if an autopsy was done. The cause of death was not reported.  Information on the batch number was requested.; Sender's Comments: This poorly documented social media case concerns a male patient (age not reported) who died within 3 hours after vaccination with INFLUENZA VACCINE (unknown manufacturer). Also, patient's medical condition at the time of vaccination, autopsy result and lab tests ruling out alternate etiologies were not reported. Based upon the reported information, the role of the suspect vaccine cannot be assessed.; Reported Cause(s) of Death: patient died within 3 hours of the jab
Approximately 3 hrs after receiving the H1N1 nasal mist employee developed temp. of 101.3, server sore thoat, headache and muscle pain lasting somewhat more than 48 hours.
Received vaccine 9/16/16. Called 10/4/16 complaining of upper body pains. Pain in both arms. Advised to contact her physician.
Breastfeeding mother received vaccine; This spontaneous case was reported by a consumer and describes the occurrence of EXPOSURE VIA BREAST MILK (Breastfeeding mother received vaccine) in a patient of an unknown age and gender exposed to mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) , while the mother received the product for COVID-19 vaccination.     No Medical History information was reported.    On 22-Mar-2021, the mother received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 22-Mar-2021, the patient was diagnosed with EXPOSURE VIA BREAST MILK (Breastfeeding mother received vaccine). On 22-Mar-2021, EXPOSURE VIA BREAST MILK (Breastfeeding mother received vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Transmammary) was unknown.       No relevant concomitant medications were provided. No treatment information was provided.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 67 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing). The patient had no allergy. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 including Paxlovid from 16Jan2023 to 20Jan2023.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Based on available information, a lack of efficacy with the suspect vaccine BNT162B2 in this patient cannot be completely excluded.
I have long covid. It had improved significantly before I got the 2nd vaccine; I have long covid. It had improved significantly before I got the 2nd vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 42 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 21May2021 (Lot number: EW0179) at the age of 42 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Endometriosis" (unspecified if ongoing); "Known allergy-Not fully allergic, but intolerant to many medications and foods" (unspecified if ongoing), notes: Not fully allergic, but intolerant to many medications and foods. Concomitant medication(s) included: CLARITIN ALLERGIC. The following information was reported: DRUG INEFFECTIVE (disability, medically significant), COVID-19 (disability, medically significant) all with onset 12Jun2021, outcome "not recovered" and all described as "I have long covid. It had improved significantly before I got the 2nd vaccine". The event "i have long covid. it had improved significantly before i got the 2nd vaccine" and "i have long covid. it had improved significantly before i got the 2nd vaccine" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: covid-19: positive, notes: I have long covid. Therapeutic measures were not taken as a result of drug ineffective, covid-19.  Clinical course: Patient had long COVID. It had improved significantly before patient got the 2nd vaccine. Adverse event resulted in doctor or other healthcare professional office/clinic visit, Disability or permanent damage. patient did not received any other vaccine within 4 weeks of COVID Vaccine.   Follow-up attempts are completed. No further information is expected.
5/8/21: Tingly, burning sensation around injection site and upper shoulder area. No visual symptoms 5/9/21: Progressive tingling sensation. No visual Symptoms 5/10/21: Rash breakout on left shoulder above injection site  From 5/10, until 5/12: rash spreading with slight increase in pain/tingling sensation.  5/13/21: Pain significantly worse. Deep muscular pain, not itchy pain. Visit Dermatologist and received Shingles diagnosis.
Patient complains of having rashes on his face on day 08/30/2018 and he thought " it was just regular rash". But, next day he had rashes on his back and torso, and then he realized it is SHINGLES. So, he visited his doctor for treatment and doctor prescribed him " VALTREX 500mg: 1 tablet once a day" for 7 days. Patient also complains that - VALTREX did not help him. Also, He said - symptoms of Shingles were just toplical and he did not have nerve pain from shingles. Shingles symptoms (rashes) lasted for almost 1 month. No scars from rashes and no nerve pain after that.
sleepless nights; loss of taste; feeling tired; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (sleepless nights), AGEUSIA (loss of taste) and FATIGUE (feeling tired) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, the patient experienced INSOMNIA (sleepless nights), AGEUSIA (loss of taste) and FATIGUE (feeling tired). At the time of the report, INSOMNIA (sleepless nights), AGEUSIA (loss of taste) and FATIGUE (feeling tired) outcome was unknown.        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.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
pt states he has been off balance ever since he took the 1st dose covid vax 1/8/21.  He waited a half hour after getting the vax to leave but as soon as he walks he feels off balance.  If he is sitting he is fine but as soon he gets on his feet he has a feeling of being unbalanced.  He got his 2nd dose on 2/2/2021 Lot # 012M20A with no changes.  Today 3/25/2021 he is still experiencing a balance issue.  Pt will contact his PCP regarding these symptoms.
HYPOTENSION 2/11/2023 &  3/21/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
vaccinated on 3/17/21 & 4/7/21 and diagnosed with Covid on 8/8/21 U07.1 - COVID-19 J12.82 - Pneumonia due to coronavirus disease 2019
Came down with COVID two months after my second and last booster which was indicated above.  Symptoms included, congestion, sore throat and tired.  Tested positive using a home kit.  Went to Urgent Care on 6/22/2022 and was prescribed Paxlovit.   Took all dosages and after two days felt better.  Tested negative on June 29.  Retested July 1st and was positive with the same symptoms as before though milder.  Finally tested negative July 12 2022 and have been negative since.
12 hours post immunization patient came down with severe muscle pains, chills, and intense flu like symptoms that lasted for 48 hours. She was bed ridden and unable to eat. She also developed severe injection site reaction that lasted for 7 days. Site was very swollen, very red, and sore.
pt recvd vax; fever on 15nov 99.5; apap given; arm very tender & red; arm very swollen & warm, redness & swelling start 1 inch below inject site;
Information has been received from a medical assistant referring to a 4 years old patient of unknown gender. Information regarding the patient's concomitant medications, medical history and drug reactions/allergies was not reported. On 12-SEP-2016, the patient was vaccinated with an improperly stored dose of PROQUAD (lot# M015695 with expiration date 26-SEP-2017, therapy type rHA; dose and route were not reported) for prophylaxis. It was reported that the vaccine was improperly stored at -3.5 degrees Celsius for 1 hour and 6 minutes. There was no previous temperature excursion. Data logger was involved. No symptoms were reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information is not expected as all scheduled correspondence was received. Sender's Comments:  US-009507513-1610USA011133: US-009507513-1610USA011245:
36 HOURS AFTER ADMINISTRATION OF 3RD ADULT DOSE OF HEP B VACCINE, PATIENT C/O SWOLLEN LYMPH NODES IN NECK AND JAW, STIFF NECK, BODY & JOINT ACHES.  NO FEVER, HIVES OR SOB.  TREATED SELF WITH N-SAIDS AND REST.  REPORTED TO NURSE ON 3RD DAY AFTER ADMINISTRATION, NO SYMPTOMS AT THAT TIME.
arm soreness; This case was reported by a nurse via sales rep and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On an unknown date, the patient received the 2nd dose of Shingrix .5 ml. On an unknown date, less than a year after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovering/resolving.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: This report was customer retrospective self report. The batch number and expiry date for Shingrix was not reported. The patient received both the doses of Shingrix in the first quarter of 2019. The patient experienced very sore arm and that exercise helped her to resolve some of the pain that was associated with Shingrix. This case was linked with the case US2019AMR071496 reported by the same reporter.
Immunization given in left deltoid at 10:30am. By 11:00am right side of neck stated to ache. Pain radiated to back of neck and became sharper, then developed into a headache. Headache worsened into evening. Tylenol given with minimal effect. Awoke the next am and pain was gone. No other complaints.
Pt with initial syncope, nausea, lasting several minutes post injection. Was monitored for 20 min and was normal. 1 week later developed chest pain, arm and leg pain with dizziness. Normal exam. Mom concerned RE clot. CT done, NEG for embolus.