chrisvoncsefalvay/vaers-outcomes huggingface dataset:
dose administered to patient after more than 1 temperature excursion; dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion) in a 95-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2021 at 9:52 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 17-Feb-2021 at 9:52 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The vial was initially stored in the fridge on 11-Feb-2021, moved to clinic on 17-Feb-2021 and proposed beyond use date was 13-Mar-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  It was reported that each time a vial was put into a cooler, sometimes there was a period of time of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34 or 35 degree Fahrenheit.  On the date of administration, at 08:00 A.M, the temperature recorded was 20 degree Fahrenheit and at 09:00 A.M, the temperature recorded was 22 degree Fahrenheit, that has been reached by the vial.  Temperature recordings were taken using a traceable temperature monitor at every hour.  The vial was not in a frozen state at the time of vaccine administration.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  No treatment information was provided.   This case was linked to MOD-2022-566976 (Patient Link).
devel gen macular papular rash, w/1 vesicules lesion day 2, on day 3 would not walk p/a dose of Ibuprofen was able to walk & play on day 4 had a gen confluent rash, sl eyelid edema, walking & playing nl on day 6 the rash resolved & was nl
First dose: her arm hurt a little; First dose: nauseous; First Dose: a headache; sed. rate had gone from 30 before the vaccination to 130 after the vaccination; This is a spontaneous report from a contactable consumer (patient herself). A 69-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection and lot number: EW0196) via an unspecified route of administration in left upper arm on 22Jun2021 15:00 as single dose for COVID-19 immunization. Patient medical history included only has one kidney and fibro from 1992 both are ongoing. Concomitant medications were not reported. Lab testes included patient stated that she had gone to the doctor in the beginning of Jun and got a blood test done with unknow results. Sed. Rate: Caller states the sed. rate of 30 was done before the first vaccination, before 22Jun2021, but unsure of when. sed. rate had gone from 30 before second vaccination to 130 after the vaccination on 14Jul2021. On an unspecified date in 2021 it was reported as patient sed. rate had gone from 30 before the vaccination to 130 after the vaccination and after the first dose her arm hurt a little, she was nauseous for one day and had a headache for a day and a half. Caller confirms began on 22Jun2021 and the arm hurting a little and nausea ended on 23Jun2021 and the headache left another day on 24Jun2021. Caller confirms she has recovered completely. Outcome of event her arm hurt a little and nauseous was recovered on 23Jun2021, headache was recovered on 24Jun2021 and unknown for other event.  Follow-up attempts are completed. No further information is expected.
Rheumatoid Arthritis; Elevated liver enzymes; This is a spontaneous report from a Pfizer sponsored program received from a contactable consumer (patient). A 76-year-old patient of an unspecified gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 28Feb2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient previously received the first dose of BNT162B2 on an unspecified date for COVID-19 immunization. The patient experienced rheumatoid arthritis and elevated liver enzymes on an unspecified date in 2021. It was reported that patient had second dose of Pfizer Covid vaccine on 28Feb2021. Patient have recently been diagnosed with Rheumatoid Arthritis. Patient have never had RA before. Patient also have elevated liver enzymes. Patient will have a workup by a Rheumatologist as soon as patient can get an appointment. Patient would like any information regarding the onset or flare-up of RA after the vaccine. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
This patient's mother called on 03/16/2001 and stated the child broke out with the chicken pox in the face, elbows, ears, and stomach.
This was my second dose of Moderna (there was no side effect for the first dose).  The side effects were very strong: fever, headache, and body pain (mostly my lower back), and overall weakness. It started about 12 hours after I received the shot and lasted about 30 hours.  What prompted me to file this report was the intensity of pain. It's excruciating. It's debilitating. I couldn't even stand straight. It felt worse than the flu. I have always been physically active and healthy my whole life.  I didn't go to the doctor because I knew there would be side effects (but I didn't expect it to be this powerful).
On March 27, which was 12 days after smallpox vaccine, Pt developed swelling and pain in joints of shoulders and knees some in others. Denies fever. Went to doctor on April 9, 2003 and had testing done. Pt did not miss any work and is managing her usual activities. 4/14/03 Pt reports all tests for rheumatoid arthritis or colloid or other disease are negative, probably mild osteoarthritis.
back pain; trouble sleeping; body aches; chills; tired; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (back pain), INSOMNIA (trouble sleeping), MYALGIA (body aches), CHILLS (chills) and FATIGUE (tired) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-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 BACK PAIN (back pain), INSOMNIA (trouble sleeping), MYALGIA (body aches), CHILLS (chills) and FATIGUE (tired). At the time of the report, BACK PAIN (back pain), INSOMNIA (trouble sleeping), MYALGIA (body aches), CHILLS (chills) and FATIGUE (tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications information was reported. No treatment medications were provided.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Achy after 1st dose; Arm really swollen after 1st dose; Arm really sore after 1st dose; a little tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Achy after 1st dose), PERIPHERAL SWELLING (Arm really swollen after 1st dose), PAIN IN EXTREMITY (Arm really sore after 1st dose) and FATIGUE (a little tired) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022m20a and 046a21a) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On an unknown date, the patient experienced PAIN (Achy after 1st dose), PERIPHERAL SWELLING (Arm really swollen after 1st dose), PAIN IN EXTREMITY (Arm really sore after 1st dose) and FATIGUE (a little tired). At the time of the report, PAIN (Achy after 1st dose), PERIPHERAL SWELLING (Arm really swollen after 1st dose), PAIN IN EXTREMITY (Arm really sore after 1st dose) and FATIGUE (a little tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
No abnormal signs or symptoms have been reported for this patient; She reports this was a vaccine selection error as the provider intended to administer MMR vaccine instead of Proquad; She reports this was a vaccine selection error as the provider intended to administer MMR vaccine instead of Proquad; patient received 0.5 ml of Varivax and 0.5 ml of Proquad due to vaccine selection error; This spontaneous report was received from a medical assistant and refers to a 12-month-old female patient. The patient's concurrent conditions, concomitant therapies and medical history were not provided.  On 12-APR-2022, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) dose of 0.5 ml, subcutaneously in the left thigh, lot # U027947, expiration date was reported as 12-APR-2023 but upon internal validation process it was established as 08-SEP-2023 and measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant Human albumin (rHA) (PROQUAD) dose of 0.5 ml, subcutaneously in the right thigh, lot # U029324, expiration date 19-MAR-2023, albumin status has been verified as recombinant human albumin (rHA). Both vaccines were administered for prophylaxis. This was a vaccine selection error as the provider intended to administer measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) instead of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD). Administration error was discovered on the evening of 12-APR-2022 (also reported as on 13-APR-2023, discrepant information) after the patient was discharged to home with her parents. No abnormal signs or symptoms have been reported.
- 4/7/21 PCP clinic visit: Received J&J vaccine at the end of scheduled follow up visit.  - 4/14/21 PCP clinic visit: Presented with 1 day of nausea, subjective fever, acute worsening of dyspnea, generalized weakness (specifically in neck and upper torso) and muscle aches. ECG negative for acute ischemic changes, CXR negative for acute processes (stable findings from 3/2019 xray). Labs notable for AKI with Cr 4.04 (baseline Cr 2s). Normal D-dimer, normal troponin x 1, normal wbc. I recommended ED admission for additional evaluation given results finalized late Friday afternoon and patient's symptoms were progressively worsening.  - 4/14/21 ED admission: IVF administered, diuretics and lisinopril held with subsequent improvement in renal function. ECHO ordered and completed prior to discharge home on 4/15/2021. Probability for VTE thought to be low, no further work up done.  - 4/20/21 PCP clinic visit: ED visit follow up. Dyspnea on exertion reportedly improving, although not back to baseline function (judged by distance able to ambulate around his neighborhood).  CBC and CMP ordered. Renal function trend worsening since hospital discharge on 4/15. Attributed to patient's decision to continue lisinopril despite being instructed at discharge to stop medication.  I advised he stop lisinopril . Had Nephrology appt scheduled for 4/22. In light of this, no further recommendations were made.  - 4/21/21 ED visit: Patient presented after acute onset of chills, itching all orver, lighheadedness, and "upper torso pain only with exertion" per HPI from ED note. Patient also reported concern that his skin seeems to be bleeding more easily than normal and pointed to several small lesions on his skin. "Today he is complaining of shortness of breath, cough and diarrhea" per ED physician. Labs ordered including CMP, CBC, troponin x3, BNP- all stable and reassuring for nonischemic event. ECG stable from 4/14/2021- sinus bradycardia with 1st degree AVB, LAD, no acute ST/T changes. Patient was discharged home with instructions to stop lisinopril, continue Imdur and f/u with Nephrology as discussed during pcp appt on 4/20/21. - 4/26/21 PCP clinic visit- symptoms improved, nearly resolved. Labs from 4/29/21 show stable anemia and improved renal function.
Diarrhea 3 hours after injection. No other reactions until 1 week after injection . Then site of injection became hard, red, hot and itchy. Redness measuring 4.5 X 5.0 inches on 01/25/2021 (today)
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No information regarding the patient's medical history and concurrent conditions was provided. The pharmacist reported that the unspecified patient, who was in the pharmacy at the time of reporting, would be receiving a dose of improperly stored ZOSTAVAX, lot # L037790, expiration date: 30-DEC-2016, (dose, dose number, route of administration and injection site were not provided) on 13-SEP-2016. There were no concomitant medications reported. It was stated that the vaccine underwent a temperature excursion of 35 degrees Fahrenheit for 5 hours. No previous excursions were reported. No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information is not expected as the reporter did not wish to be contacted.
I have developed an itchy, bumpy, red rash on both arms with the left arm being worse than the right.
pain, lump, itchiness, swelling (left arm) injection site; pain, lump, itchiness, swelling (left arm) injection site; pain, lump, itchiness, swelling (left arm) injection site; pain, lump, itchiness, swelling (left arm) injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE MASS (pain, lump, itchiness, swelling (left arm) injection site), INJECTION SITE PRURITUS (pain, lump, itchiness, swelling (left arm) injection site), INJECTION SITE PAIN (pain, lump, itchiness, swelling (left arm) injection site) and INJECTION SITE SWELLING (pain, lump, itchiness, swelling (left arm) injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Feb-2021, the patient experienced INJECTION SITE MASS (pain, lump, itchiness, swelling (left arm) injection site), INJECTION SITE PRURITUS (pain, lump, itchiness, swelling (left arm) injection site), INJECTION SITE PAIN (pain, lump, itchiness, swelling (left arm) injection site) and INJECTION SITE SWELLING (pain, lump, itchiness, swelling (left arm) injection site). The patient was treated with LOSARTAN at an unspecified dose and frequency and ASPIRIN [ACETYLSALICYLIC ACID] at an unspecified dose and frequency. At the time of the report, INJECTION SITE MASS (pain, lump, itchiness, swelling (left arm) injection site), INJECTION SITE PRURITUS (pain, lump, itchiness, swelling (left arm) injection site), INJECTION SITE PAIN (pain, lump, itchiness, swelling (left arm) injection site) and INJECTION SITE SWELLING (pain, lump, itchiness, swelling (left arm) injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was provided by the reporter. Patient had used cold cloth for swelling. Patient had applied cold pack and alcohol on injection site but it was not getting better.
Red, itchy, swollen patch directly under the injection site, one week after injection. The reaction lasted for 3 days.
I experienced chest pains, tightening around my neck, sides, and back, and shortness of breath.  My arms were tingling and I broke out in a sweat.  This continued for approximately an hour and a half.  I self-medicated by chewing 325 mg. of Bayer aspirin and swallowed 6 mg. of Chlorpheniramine Maleate with lots of water.
Sudden onset of chills, joint pain, headache, ear ringing, and tiredness.  No fever, sneezing, coughing or shortness of breath. Took Covid 15-minute test and it was negative. Symptoms were gone this morning.  This was almost two weeks to the day after my booster shot -- I'd had a little tiredness after the first shot and nothing after the second. All were Pfizer.
progressive weakness, not feeling well and decreased appetite for couple weeks. requiring high flow O2 started on decadron 6mg qday
Sever Allergic reaction.  Had hives on face, head, neck, shoulders, back, chest, rib cage, arms and hands.  Moved to the mouth and lips.  Self administered 25mg of benedryl at 1920.  Symptoms worsened.  When swelling moved towards mouth at around 2010, patient went to the ED.  ED administered 25mg of benadryl and 20mg of pepcid.  At 2130 swelling noticeably decreased patient discharged without seeing ED physician.  As of 0700 next morning all swelling had dissapated.
Administered an expired Bexsero; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 17-year-old female patient who received Men B NVS (Bexsero) (batch number ABXB37AA, expiry date 31st July 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 1st August 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 1st August 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 01-AUG-2022 Reporter's Comments: The medical Assistant called into inquire, how to proceed and did the patient need to be revaccinated. The reporter reported that they inadvertently administered an expired Bexsero dose to a patient. No other details provided.  The reporter did not consent to follow-up.
This spontaneous report as received from a health care worker refers to a 8 patients of unknown age and gender who in September 2013 were vaccinated with VARIVAX 0.5 ml, Subcutaneous (lot # reported as H015222, expiry date 10-AUG-2014). It was reported that the vaccine of VARIVAX were stored in temperature conditions that were not supported by it in house stability data. No adverse effects were reported. This report is linked to 1309USA008246. Additional information has been requested.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Nurse).  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Yes" (unspecified if ongoing). The patient's concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received treatment of Paxlovid for COVID-19.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information provided in the narrative, a causal association between the events and the suspect drug cannot be completely excluded.
Information has been received from a pharmacist referring to 2 newborns. Background: Since June 2015, there had been 1645 times (30 minutes each time= 822.5 hours) that the temperature dropped below 36F. Of course, there was 144 times (30 minutes each time=72 hours) that temperature was below 32F, the lowest being 29.7F. On 04-JUL-2015, there was a low temperature of 30.2F. On 17-AUG-2015 the patients were vaccinated with the improperly stored RECOMBIVAX HB strength 2.5/0.5 (units not provided) (lot number K020216 and expiration date of 17-SEP-2016) (dose and route of administration were not reported). There was no product quality complaint (PQC). This is one of several reports received from the same reporter.
Big pressure feeling with back and chest pain; Big pressure feeling with back and chest pain; Clarified headache was very slight; sore arm; This is a spontaneous report from a contactable consumer or other non HCP (patient). A 85-years-old female patient received bnt162b2 (BNT162B2, formulation; Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right on 13Feb2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE (at the age of 85-year-old) for covid-19 immunisation. Medical history included Sleep apnea, insomnia, Flu shot (Arm was sore just a little bit more than the Flu shot or shingles shot. Was nothing to be concerned about. Caller did not provide lot/Exp for Shingles shot or Flu shot.) from an unknown date and unknown if ongoing and ongoing to sleep (patient taking Concomitant Products Trazodone (Verbatim): to sleep). Concomitant medications included esomeprazole sodium (NEXIUM [ESOMEPRAZOLE SODIUM]) and trazodone taken to sleep. The patient had a sore arm (Only in injection arm, which was the right arm), which she expected. Tuesday night and this morning, she had just a slight headache with a lot of back and chest pain at the same time. It felt like a big pressure each time. Within half an hour it went away each time. A month before the COVID-19 Vaccine, she had her shingles vaccine. Doesn't think it has anything to do with the spacing between vaccines. Had shingles shot and COVID-19 Vaccine in different arms. Arm was sore just a little bit more than the Flu shot or shingles shot. Was nothing to be concerned about. By the next day she didn't feel her arm soreness. Clarified headache was very slight and occurred at the same time she felt that big pressure, patient was not someone who gets headaches. Big pressure feeling with back and chest pain had occurred on 16Feb2021 and 19Feb2021. Each time it subsided within half an hour. Second COVID-19 Vaccine would be on 06Mar2021. The patient underwent lab tests and procedures which included physical examination: everything was good including her heart on unknown date in Jan2021. The outcome of events sore arm recovered on 14Feb2021 and for other events reported as recovered on 19Feb2021.  Information for Lot/Batch number is requested.  Follow-up attempts are completed. No further information is expected.