chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Feb-2021 at 10:45 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 13-Feb-2021 at 10:45 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 35.04 for dose administered on 13-Feb-2021.  Batch number 031L20A underwent temperature excursion on 13-Feb-2021 with temperature 32 degrees Fahrenheit at 9 am. This vial was moved to fridge on 09-Feb-2021 and beyond use date for the vial was reported as 10-Mar-2021. Product moved to clinic on 13-Jan-2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34 or 35 degrees Fahrenheit. Temperature recordings were taken using a traceable temperature monitor at every hour.  No concomitant and treatment medications were reported.   This case was linked to MOD-2022-566976 (Patient Link).
Narrative: Patient passed away due to COVID-19. He had received a COVID-19 Vaccine.
4/26/2021 Physical Therapy visit: Patient reports he thinks his 2nd covid vaccine was given too close to his shoulder joint (Glenohumeral joint). He received his Covid vaccine on Saturday 4/24/21. Today he reports severe R shoulder pain and he is not able to move his arm. He avoids shoulder movement and cannot fully extend his elbow. He reports he was seen earlier today by urgent care and has work restrictions and is unable to use his right arm. He reports he has been referred to a joint specialist for further assessment
Chest pain occurred the next day and lingered for 3 days. Pain throughout upper shoulders, neck and arms began on the third day and is still present and getting worse.
Information has been received from an office manager concerning a 70 year old male patient with no allergies or drug reactions, diabetes, hypertension, hyperlipidaemia, benign prostatic hypertrophy, degenerative joint disease, ischaemic heart disease and chronic obstructive pulmonary disease who on 16-OCT-2009 was vaccinated with a dose of 0.65 mL of ZOSTAVAX (Merck) (Lot # and expiration not reported). Concomitant therapy included ZYLORIC, SIMCOR, AVANDAMET, HCTZ/triamterene, naproxen and NORVASC. The office manager reported that on 20-MAY-2011 the patient developed shingles blisters on his left chest wall to the back. No laboratories were performed. The patient sought unspecified medical attention. As treatment the patient received VALTREX 1mg twice daily, "CALADRYL" lotion three times daily and an unspecified paid medication. At the time of reporting the patient had not recovered. Additional information has been requested.
I tested positive for covid on 11/08/2022, I went to the urgent care, and they gave me an infusion.  Experienced a headache and a consistent runny nose. Alos I was experiencing a lot of fatigue and chills throughout the day. They also prescribed Claritin and ibuprofen for some of the symptoms. It took a month for the cough to go away. Just recently I started to feel a little better still experiencing fatigue and a heavy feeling in my legs.
Friday 7:30 nausea- took zofran sublingual.  7:30-3pm headache , runny rose, body ache, shakiness, watery eyes.  3-6pm felt recovering. Friday 9pm-Sunday 4pm abd pain got added to the mix with bloating and abd distension.  Friday?s symptoms lessen.  Took meds and alkaline products to balanced things out. Ate bread crackers constantly to help with acid buildup and damage of mucosal lining.  Protonix 40mdg only alleviate pain for 30 minutes. Could not sleep for over 24 hrs.  Pale white stool. Axillary lymph nodes pain. Monday and pain better. Felt lethargy and numbness to hand and feet. Mild Headache still persist.
Vesicular rash at site of varicella vaccine about 10-14d after vaccination.
PATIENT STATES SHOT GIVEN TOO HIGH-SHOT GIVEN I.M. IN ARM.
In both doses, I had extreme swelling of my eyes.  In dose 1 it occurred at the 27 hour mark, first in my left eye and later in the right eye.  In dose 2, I had extreme, sudden onset of swelling in both eyes.  I barely got my contacts out before my eyes swelled closed.  I took Benadryl and monitored closely to determine if I needed to go to hospital.
Rash on the buttocks or upper thigh, ecchymotic appearance; Rash on the buttocks or upper thigh, ecchymotic appearance; This is a spontaneous report from a contactable nurse reporting same event under the same suspect product for four patients. This is one of four reports. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Lot number and expiration date was not reported) as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced rash on the buttocks or upper thigh, ecchymotic appearance on an unspecified date. The rash begins with an appearance similar to shingles. After about a week the lesions are flat with an ecchymotic appearance. The outcome of event was unknown.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021375425 same drug, event, different patient; US-PFIZER INC-2021375443 same drug, event, different patient
4/12-swelling to back of left arm at injection site. Redness and warm. Swelling about the size of 3 quarters together per mom. Mom called 4/13 to let us known and ask about what to do for itching. Told her to try an ice pack. BENADRYL gel. 4/16-mom states it's much better. Small amount of swelling and redness still but going down.
Mild headache, 2 degrees fever, chills. Onset 6 hrs after vaccination, lasted about 36 hours
The patient is a 29-year-old adult male with severe intellectual/developmental disabilities, is Deaf and blind, and doesn't communicate with words. Since oral sedation was unavailable at the time of vaccination, extra precaution was needed to ensure that he was calm and relaxed before administration. Various distracting techniques were used, and being in his own environment mitigated stress that he might have experienced had he been in an unknown facility. Unfortunately, due to the nature of how quick the dose needed to be administered before he noticed that something was wrong, only about three fourths of the dosage (0.5 ML) was administered, possibly around 0.3 or 0.4. The provider is going to attempt to compensate for this in the second dose series after they are able to order an oral sedative from his primary care provider. No adverse reactions are noted at this time.
Symptoms started around midnight on 1/7/2021 Symtpoms: Burning red face, entire body was itchy, tongue and inside of the mouth was itchy, rash on upper body and swollen inflamed painful lips.
Second shot on April 7th ? Pfizer. On April 8, didn?t feel so great.  9th and 10th:  Better, but not 100%. On April 11, BP very low (80?s), and I didn?t feel well.  I had chest pain while walking for exercise. On April 12, BP again very low (90?s), and I didn?t feel well.  I had chest pain while walking again, and excruciating back pain, which stopped when I stopped walking.  Called my cardiologist. Stopped BP meds on the 13th, didn?t walk, felt better. Cardiology appointment on April 14.  ECG was not normal ? ?New lateral T wave abnormality? ? sent me to the ER. There I had positive troponin tests.  Echocardiogram showed reduced function.  The left ventricular ejection fraction was 44%. Went to the cath lab.  Arteries clear.  Stent placed in 2018 beautifully open. Diagnosis:  Stress induced cardiomyopathy -- no known cause. Treatment is a beta blocker, and reduced activity.  I am starting cardiac rehab in June. I asked if the "stress" could have been the vaccine, and they did not rule it out, but they had no other cases. I thought with the recent news on myocarditis and the vaccine that I would report this.
Immediately after receiving shot, c/o feeling "woozy" passed after 20 mins.  That evening pt c/o feeling exhausted, dizzy, weak - continued next morning.  Patient went to ED & received IV fluids.
keeps getting Coronavirus and he has been vaccinated; keeps getting Coronavirus and he has been vaccinated; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "keeps getting Coronavirus and he has been vaccinated". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: he was positive.  Clinical information: Reporter states her Cousin keeps getting Coronavirus too and he has been vaccinated. He is of (Ethnicity withheld) decent, and (Ethnicity withheld) people have a gene where they get sick all the time, like (Ethnicity withheld) people get Sickle Cell. She doesn't know if Pfizer took that into consideration. It doesn't seem like the vaccine has any effect on the patient. She states she was around her cousin hugging him and sitting close to him and he was positive and he asked if she got the coronavirus and she did not. Reporter declines to complete a report for her cousin.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201356307 similar report from same reporter;
The vaccines were "short dated" and new expiration date of 6/30/2023 was given; had a temperature excursion 3/31/2023 / The vaccines were "short dated" and a new expiration date of 6/30/2023 was given. / The products were labeled but still accidentally administered after the new short dated expiration date.; This spontaneous report has been received from an office manager referring a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported.   On 31-MAR-2023, a temperature excursion of 50 degrees Fahrenheit ocurred for a time frame of 6 degrees Fahrenheit up to 14 degrees Fahrenheit 4 hours 0 minutes; 14 degrees Fahrenheit up to 46 degrees Fahrenheit 4 hours 0 minutes ; 47 degrees Fahrenheit to 77 degrees Fahrenheit (50 F) 3 hours 57 minutes (TOTAL: 11 hours 57 minutes).   On 30-JUN-2023, the patient was accidentally vaccinated with an improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (recombinant Human albumin (rHA) subcutaneous Injection, at a dose of 0.5 ml, lot number W035470 that has been verified to be valid, the vaccine was "shor dated"and new expiration date was reported as 30-JUN-2023 but upon internal review established as 06-MAY-2024, for prophylaxis (strength, vaccination scheme, route of administration and anatomical site of application were not provided). The vaccine was labeled but still accidentally administered after the new short-dated expiration date (Product expiration date issue and Improper storage of product in use).  This is one of several reports received from the same reporter.
Persistent Myalgias. The patient had diffuse myalgias for 48 hrs following vaccination. No mid back pain has persisted for greater than 72 hours after vaccination.
VACCINE VIAL WAS FROZEN TOO LONG. VACCINE MAY HAVE BEEN COMPROMISED.
Patient experience soreness in arm 6-28-18 and complained of headache starting 6-29-18. On 6-29-18, patient woke up with flu like symptoms - fever, headache and overall aches. On 6-30-18, patient noticed the rash starting to appear. The rash is mainly on one side of injection site, slightly warm and slightly itchy.
Nurse administered Menveo too early.  After reviewing the chart, it appears the patient had a menveo at 11 years.  Due to an interface issue b/t systems, the immunization showed up as Meningococcal C.  When the nurse reviewed "immunizations due today" in system it showed that the patient was due for menveo.  The patient did not have a reaction to the vaccine.
pt recv vax 12MAR96 & 7FEB97 pt exp chickenpox;9 other pt were reported as well (WAES 97030174, 97030176, & 970030178-97030184;
This case meets criteria for vaccine breakthrough review. SxS include 3 days PTA abdominal pain, cough, generalized weakness.
it was rpt fr a consumer concerning a pt who was vax in 1999 & subsequently in 16jan99 pt devel chickenpox consisting of around 30-40 lesions
Crying inconsolably after immunizations (R) thigh red and swollen he calmed down after mother gave him a dose of gas gtts. Advised BENADRYL and compresses.
12 People were vaccinated with the Moderna Covid 19 vaccine past its beyound use by date; 12 People were vaccinated with the Moderna Covid 19 vaccine past its beyond use by date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (12 People were vaccinated with the Moderna Covid 19 vaccine past its beyond use by date) and PRODUCT STORAGE ERROR (12 People were vaccinated with the Moderna Covid 19 vaccine past its beyound use by date) in a 55-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    In July 2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In July 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (12 People were vaccinated with the Moderna Covid 19 vaccine past its beyond use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (12 People were vaccinated with the Moderna Covid 19 vaccine past its beyound use by date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (12 People were vaccinated with the Moderna Covid 19 vaccine past its beyond use by date) and PRODUCT STORAGE ERROR (12 People were vaccinated with the Moderna Covid 19 vaccine past its beyound use by date) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  Number of doses/vials reported were 3 vials and 12 doses. The dates of administration and number patients were reported as on16-Jul-2022 3 patients, on 23-Jul-2022 5 patients, on 24-Jul-2022 4 patients. All the vials were moved to fridge on the same day on 13-Jun-2022. The vial did not undergo any temperature excursions.   No treatment medication was provided.  This case contains information for the first of the 12 patients who received the vaccine on an unknown date in Jul-2022 as described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-615215 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2022: Followup received and narrative updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-615215:Master case
On 1/9/01 the pt was irritable and experienced a fever of 102. Seen in office. On 1/10/01 was seen in the ER.
Pfizer COVID19 vaccine, part 1.  Nausea for more than 10 days, sharp pain in ankle and knee joints for 3 days.
Information has been received from a healthcare worker (certified medical assistant) referring to an unspecified number of patients of unknown ages and genders. Concurrent condition and medical history were not reported. On unspecified dates, the patients received improperly stored doses of RECOMBIVAX HB (lot # K008986, expired date 01-APR-2016, thimerosal status, strength, dose, frequency and route were not provided (incorrect product storage). No adverse effect was reported. This is one of two reports received from the same source. Additional information has been requested.
prob bland (swollen & tender) inflammation caused mass, superficial desquamation; has residul soft tissue; mass 4x4 cm p/4months;
After giving the HPV vaccine, I asked the patient if she was feeling ok. She replied yes. As I was talking to mother about patients sibling, I heard a noise. The patient got off the exam table when I was talking to mother and she had fallen back against the wall. The physician came in and checked her vitals. She regained consciousness and was told to sit in the chair. After a few minutes she was helped on the exam table to lie down. Vitals were rechecked and did not leave until the physician gave the ok for her to leave.
Information has been received from the authors of the article. The authors reported that the aim of the study was to assess the rate of adequate immune response to primary hep B vaccination series (manufacturer unknown) in patients with inflammatory bowel disease (IBD). The authors also reported that they performed a retrospective chart review of patients with IBD who had serologic samples tested for hepatitis B surface antigen (HbsAg) and hepatitis B surface antibody (HbsAb) from February 2012 to July 2015. The study was conducted at hospital. Patients up to 22 years of age were included. Adequate immune response to hep B was considered to be present when the HbsAb level was above 8 mIU/mL by our laboratory standard. Age, gender, body mass index (BMI) (presence of obesity), type of IBD, and medications were noted to assess association to these factors with inadequate response to hep B vaccination. HbsAg and HbsAb levels were tested in 98 children with IBD. Mean age of the patients was 16 (+3) years; 37 females and 61 males. Thirty-seven patients had ulcerative colitis and 61 patients had Crohn's disease. None of the patients had a positive HbsAg. This case concerns to 63 (64%) patients of unknown age and gender. The patients' medical history and concomitant therapies were not reported. On an unknown date the patients were vaccinated with hepatitis B vaccine (manufacturer unknown) (dose, dose number, route and anatomical location were unspecified). On an unknown date the 63 patients were found to be non-immune to hep B, with HbsAb level less than 8 mIU/mL (hepatitis B surface antibody negative). The outcome of the hepatitis B surface antibody negative was unknown. The authors considered the hepatitis B surface antibody negative to be related to hepatitis B vaccine (manufacturer unknown). The authors also considered that the immunity to hepatitis B after primary vaccination series is lower in patients with IBD as compared to the known immune response in the general population (64% versus 90% respectively). Additional information has been requested.
. patient was administered flublok which is not approved for her age .had high fever and flu like symptoms. dad took her to the dr and gave her tylenol
pt recv vax 16APR96&mom noticed marked swelling of leg&erythema @ inj site;seen @ hosp by MD who dx allerg rxn
Patient reports experiencing pain at the site of injection on the first day, 6/23/22, which resolved by the end of the day.  On Friday, 6/24/22, patient began to have pain and swelling in the left axilla.  Patient returned to the same medical office where the vaccine was administered on 6/27/22, to report pain and swelling in her left axilla.  The swelling had resolved at the time of the appointment, but she still reports pain in the left axilla.  Patient also shared that she felt tingling in her arm while pushing boxes at work for the first time today, 6/27/22, which also resolved without treatment before her office visit.
p/vax pt c/o arm starting to hurt 11/4/99;seen in clinic 11/5/99;rt arm upper swollen & hard to touch;11/5/99 went to pvt  clinic, told to use warm compressor  11/8/99;arm improving;
left arm was sore; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 02Mar2021 (Lot number: EN6198) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Spinal leak (Diagnosed with a spinal leak" (ongoing), notes: Spinal Leak, 1-1/2 year ago; "Oral lichen planus" (ongoing), notes: Oral lichen planus 10-15 years ago; "Rheumatoid arthritis" (ongoing); "food allergies" (unspecified if ongoing); "long as she stayed away from gluten, chicken, tomatoes & some other things" (unspecified if ongoing), notes: she stayed away from gluten, chicken, tomatoes & some other things, she did not have a problem with her rheumatoid arthritis.; "long as she stayed away from gluten, chicken, tomatoes & some other things" (unspecified if ongoing); "fractured her L4 vertebrae", start date: 2020 (unspecified if ongoing); "sciatica", start date: Feb2020 (unspecified if ongoing), notes: sciatica from Feb2020 (pinched sciatic nerve since Feb2020),; "Bone density issue" (unspecified if ongoing), notes: Bone density issue.; "she stayed away from gluten" (unspecified if ongoing). Concomitant medication(s) included: DIPHENHYDRAMINE; TYLENOL; ADVIL [IBUPROFEN]; GABAPENTIN. Past drug history included: Gluten, reaction(s): "triggered her rheumatoid arthritis". Vaccination history included: Flu vaccine, reaction(s): "Mouth sores". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "recovered" (2021), described as "left arm was sore". Therapeutic measures were not taken as a result of pain in extremity.  Additional information: Patient said that her left arm was sore after her first COVID-19 Vaccine dose. She said she didn't treat her left arm soreness, and the left arm soreness went away after 2-3 days. She clarified she had a flu vaccine about 15 years ago, and the day after the flu vaccine, she got mouth sores, and the mouth sores got worse. She said her local doctors didn't know how to treat. She stayed away from gluten, chicken, tomatoes & some other things, she did not have a problem with her rheumatoid arthritis.  No follow-up attempts are possible. No further information is expected.
Information has been received from a registered nurse concerning a 6-month-old patient who was vaccinated with the first dose of Rotateq. It was unknown if medical attention was sought. No symptoms were reported. Additional information has been requested