chrisvoncsefalvay/vaers-outcomes huggingface dataset:
doses administered after more than 1 temperature excursion; doses administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Apr-2021 at 11:59 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Apr-2021 at 11:59 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (doses administered 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.   On 03-Apr-2021, Excursion time was 09 AM, temperature was 34, total doses given for the day was 210, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 30-Mar-2021, vial was moved to clinic on 03-Apr-2021. 20 vials were sent to clinic. Vaccine BUD date was 29-Apr-2021. Vial was stored on cooler 1, on 03-Apr-2021, Excursion duration At 8AM :38, 9 AM: 34, 10 AM: 38, 11 AM: 42, 12 AM: 41, 1PM: 41, 2 PM : 41, 3 PM: 40, 4 PM: 40 and 5 PM : 41. The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. Temperature recordings were taken using a temperature monitor at every hour. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature. It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F. Treatment medications were not reported.
Arm became swollen, red, and painful.  Redness and swelling resolved.  Pain continues to this day, unable to lift arm without pain.
Patient stated has left arm pain without redness, swelling, fever (etc). He states he has had it since vaccine administration on 9/22/18 and has not gone away. He mentioned it to his doctor during an unrelated office visit but was not addressed. I recommended NSAIDs, ice, and a follow up with HCP as the normal body healing time has now exceeded.
06/18/99 pt received second pertussis vax along with other vaxs. On an unknown date, the pt was exposed to an aunt who had pertussis. On 07/09, the pt tested positive for pertussis and was not hospitalized. She was treated with Zithromax for her cough. Subsequently, she recovered.
I broke out with a rash - all over my body.  I have been to a Dermatologist and had tests taken, including biopsy.  Told it was Eczema. I was prescribed a dermal cream that only helps a little. I have NEVER had anything like this in my life.  A small spot on my eyebrow showed up after my first vaccine on 01/19/21. After the second dose is when it went crazy and is now all over my body.  Some spots are small, some are larger than 2 inches in diameter.  I have now 3 spots on my face, and it's all over my back, abdomen, buttocks, and legs.
Swelling at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Swelling at the injection site) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jan-2021, the patient experienced VACCINATION SITE SWELLING (Swelling at the injection site). At the time of the report, VACCINATION SITE SWELLING (Swelling at the injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant and treatment information not provided.  Company comment:Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
given a Moderna shot 14 days after expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (given a Moderna shot 14 days after expiration) 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 EXPIRED PRODUCT ADMINISTERED (given a Moderna shot 14 days after expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (given a Moderna shot 14 days after expiration) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.
encephalitis; post-herpetic neuralgia; shingles; Information has been received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding medical history, concurrent conditions and concomitant medications. In or about 2012, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (lot number, expiration date, dose and route of administration were not provided) by a nurse in a medical group practice for the long-term prevention of shingles and zoster-related conditions. Subsequently to zoster vaccine live (ZOSTAVAX) inoculation, the pt was treated by healthcare providers for shingles, post-herpetic neuralgia and encephalitis. The outcome of shingles, post-herpetic neuralgia and encephalitis was not reported. The reporter considered shingles, post-herpetic neuralgia and encephalitis to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review, the event of encephalitis was determined to be medically significant.
boil under his right arm; boil under his right arm was reported as worsened; redness on his right arm; fever; This is a spontaneous report from a contactable consumer. This consumer reported for a 62-Year-old male patient (husband) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: EN6206), via an unspecified route of administration, administered in arm right on 06Mar2021 as dose number unknown, single for COVID-19 immunization (age at vaccination: 62-Year-old). Medical history included COVID-19 from on an unspecified date in Mar2020. The patient's concomitant medications were not reported. On 07Mar2021, the patient had big red boil on his arm and fever. Stated that it has gotten worst, and it is next to the breast. Also stated that when they did the test that he had already had COVID and that he thought he had the flu, and it was COVID. It was reported that he found out two months later when he had the test. Timeframe between vaccination and starting of symptoms was 01 day. The patient did not receive any treatment for the adverse events. The patient underwent lab tests and procedures which included blood test: unknown results (stated that they take his blood out every three months because it is heavy) and test included: COVID (stated that when they did the test that he had already had COVID). The patient recovered from fever on 07Mar2021. The outcome of events boil under his right arm, boil under his right arm was reported as worsened and redness on his right arm was not recovered.  No follow-up attempts are possible. No further information is expected.
fever more than 24 hours after shot; chills; body aches; lethargy; This is a spontaneous report from a non-contactable healthcare professional. A 27-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE;Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 17May2021 at 14:30 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. The patient had no known allergies to medications, food or other products. Concomitant medication included birth control (unspecified); taken for an unknown indication from an unknown date. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 18May2021 at 05:00, the patient experienced fever more than 24 hours after shot, chills, body aches and lethargy. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events fever more than 24 hours after shot, chill, body aches and lethargy was not resolved at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Pulmonary embolism given blood thinner. Skin rash.misdiagnoses Back arthritis
lack of efficacy- Fully vaccinated for CV19 with symptoms 14Sep2021 and positive CV19 test 15Sep2021; lack of efficacy- Fully vaccinated for CV19 with symptoms 14Sep2021 and positive CV19 test 15Sep2021; This is a spontaneous report from a contactable other hcp. A 41-year-old male patient of an received Second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Batch/Lot number: EL3247), via intramuscularly, administered in Arm Left on 15Feb2021 (age at vaccination was 41 years old) as DOSE 2, Single and first dose BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Batch/Lot number: EL3247) via intramuscularly, administered in Arm Left on 26Jan2021 (at the age of 41 years old) as DOSE 1, Single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Prior to the vaccination, the patient was unknown if diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 14Sep2021, the patient experienced lack of efficacy- fully vaccinated for cv19 with symptoms 14sep2021 and positive cv19 test 15sep2021. The patient underwent lab tests and procedures which included sars-cov-2 test result was positive via Nasal Swab on 15Sep2021. Facility where the most recent COVID-19 vaccine was administered was clinic. The patient did not received any treatment. The outcome of the event was recovering.; Sender's Comments: As there is limited information in the case provided, the causal association between the events Vaccination failure, COVID-19 and the suspect drug BNT162B2 cannot be excluded. The case will be reas-sessed once new information is available.
Enlarged heart (myocarditis); Enlarged heart (myocarditis); shortness of breath; This is a spontaneous report from a contactable consumer (patient himself) via COVID-19 Vaccine Adverse Event Self-Reporting Solution portal. A 56-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in the right arm on 06Jun2021 at 12:00 at the age of 56 years old  (Batch/Lot Number: Ew01191, Expiration date: unknown) as dose 1, single for COVID-19 immunization. The facility where the most recent COVID-19 vaccine was administered was at the pharmacy or drug store. Relevant medical history included high blood pressure, heart failure, and diabetes; all from an unknown date and unknown if ongoing. The patient had no relevant past drug history. Concomitant medications included metformin and glipizide; both taken for an unspecified indication, start and stop date were not reported; the patient received these medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19 via nasal swab with unknown result on an unspecified date. On 09Jun2021, the patient experienced enlarged heart (myocarditis) and shortness of breath, which all led to hospitalization and disability and were also considered medically significant. The patient considered them severe as he had been in an out of the hospital. The patient was hospitalized for enlarged heart (myocarditis) and shortness of breath for 3 days. The adverse events did result in an emergency room/department or urgent care. Therapeutic measures were taken as a result of enlarged heart (myocarditis) and shortness of breath, which included catheter heart surgery. The patient was not recovered from the events.
The child is up to date for the IPOL.  MA administered the IPOL early today 01-09-2023. The child doesn't has any reaction on the left thigh.
Small bumps red. Exposed to chickenpox 2 weeks prior Probable Varicella by appearance although not typical distribution and evolution
HSV increased frequency of flares, myasthenia gravis symptoms started 5/9/21, requiring higher dosage of levothyroxine though stable for years with prior dosage
8/22/02 slight fever, cold compressed Benadryl elevate arm. 8/23/02 office visit-swelling/erythema possible abscess. Augmentin 300mg po q 12 x 10 days.
Patient said she could not breathe within seconds of receiving the pneumococcal shot. She said she had a sharp pain in her back that traveled to the groin area within five minutes. Approximately 2 hours after the pneumococcal shot she felt weakness in her legs and had chills. By the following day she felt fine.
Case number PHEH2013US026270, is an initial spontaneous report received from the nurse on 20 DEC 2013. This report refers to a 14-year-old male patient. His medical history  and concomitant medications were not reported. He received only Men C, Y, W-135 liquid conjugate component of MENVEO (batch number: M13015, expiry date: SEP 2014), intramuscularly without being reconstituted with Men A lyophilized conjugate vaccine component on 10 DEC 2013. No adverse event was reported following this administration error.
tested positive after 1st dose; tested positive after 1st dose; This is a spontaneous report from Pfizer sponsored program. A contactable consumer reported that a female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Lot number, expiration date: unknown) as single dose for covid-19 immunisation. The patients medical history and concomitant medications were not reported. The patient tested positive after 1st dose on an unspecified date. The patient underwent lab tests and procedures which included sars-cov-2 antibody test: positive on an unknown date. The patient is scheduled to get 2nd dose on 27Feb2021. The outcome of the event was unknown.  Information about lot/ batch number has been requested.
This spontaneous report was received from an office manager who is a licensed social worker and refers to a 19-year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with the first dose of an adult formulation of RECOMBIVAX HB (dose, route of administration, lot# and expiration date were not reported). There were no adverse symptoms reported.
chills; body aches; low grade temperature; left axilla has become very swollen and painful; left axilla has become very swollen and painful; fluid accumulation in the subcutaneous tissue; This is a spontaneous report from a contactable physician (patient). A 43-year-old male patient received his second dose of bnt162b2 (BNT162B2 reported as Pfizer COVID 19; lot number: EL3247; expiration date: unknown), via an unspecified route of administration left arm on 17Jan2021 09:30 at a single dose for covid-19 immunization. Medical history included known penicillin allergies. The patient was not diagnosed with COVID prior vaccination. The patient's concomitant medications were none. The patient previously took sulfamethoxazole-trimethoprim (BACTRIM) but had allergies. The patient historically vaccine included first dose of bnt162b2 (BNT162B2 reported as Pfizer COVID 19; lot number: EL0140; expiration date: unknown) at the age of 43-year-old via an unspecified route of administration right arm on 29Dec2020 10:00 AM at a single dose for covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and any other medications the patient received within 2 weeks of vaccination. The patient received the vaccine in a hospital but 36 hours after the vaccine (18Jan2021), the patient developed chills, body aches and low-grade temperature. Then 48 hours later, her left axilla has become very swollen and painful. The pain has subsided but remains mild and swelling persists. The area seems to show fluid accumulation in the subcutaneous tissue but no erythema or e/o [evidence of (pending confirmation)] abscess infection noted. It's now been present for 4 days. The patient received treatment which included NSAIDs. The patient had not been COVID tested post vaccination. The outcome of the events was not recovered.
Red rash at the site of the injection; Area has decreased in size but still irritated; red rash at the site of the injection.; This case was reported by a consumer via interactive digital media and described the occurrence of injection site erythema in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 10th August 2021, the patient received the 1st dose of Shingles vaccine. In August 2021, less than 2 weeks after receiving Shingles vaccine, the patient experienced injection site erythema, injection site irritation and injection site rash. The patient was treated with neosporin (nos) (Neosporin) and hydrocortisone. On an unknown date, the outcome of the injection site erythema and injection site irritation were recovering/resolving and the outcome of the injection site rash was not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema, injection site irritation and injection site rash to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by the patient. The age at vaccination was not reported. The patient received Shingles vaccine and experienced a red rash at the site of the injection. The area has decreased in size but it still irritated so the patient was not wearing sleeves and keeping Neosporin or hydrocortisone on it.
Around 8pm, I started having chills. Around 10pm, I started having body aches, joint pain, and headaches. The next morning had a low-grade fever. On Monday, I was almost symptom free. On Monday night, my symptoms came back. On Tuesday night, I nausea and vomiting. My symptoms continued on Wednesday and Thursday. On Friday, I was symptom free. On Saturday, my symptoms came back. On Sunday, I had difficulty breathing and had brain fog. My eye started swelling.
Pt. received vaccine 10-29-13. Pt was seen on 11/4/13 with injection site reaction. Pt complained arm was red and swollen for a few days after injection and then a wound appeared. It was tender red with large white center was give Dig cellulitis. P has been seen several times by multiple doctors as well as ER visit. Has been dig 11/13/13 with Eschar tissue.
This case was reported by a consumer (the subject) and described the occurrence of hive in a 49-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline) . A physician or other health care professional has not verified this report. The consumer reported that she had previously received flu vaccine (unspecified manufacturer) in 2008 and had experienced a "slight reaction" of breaking out in hives which resolved with BENADRYL. She received flu vaccines (unspecified manufacturer) in 2009 and 2010 and experienced no adverse events. Concurrent medications included unknown (unspecified medication). On 1 September 2011 at 9:00 the subject received 1st dose of FLULAVAL (.5 cc, unknown route, right arm). The lot number was reported as AFLLA6838A from the reporter; however, based on safety lot number review, the lot number was updated to AFLLA683BA. On 1 September 2011, 2 hours after vaccination with FLULAVAL, the subject experienced hives, swollen eye lid, erythema of eyelid, itchy eyelids and itching. The subject developed hives on inside of both elbows 2 hours after vaccination with FLULAVAL. Her eyelids then became swollen, red and itchy. At the time of reporting, the hives were on her chest, upper arms and legs, and the subject was itching "like crazy" and stated that "it looks terrible". The subject consulted a physician and reported that the physician told her that because she was not allergic to eggs, it is probably the preservative in the shot. The subject was treated with BENADRYL. At the time of reporting the events were worse.
Patient just told me today and mentioned that 3 hours after the vaccination they felted bad and went to the Emergency room. Also mentioned that they are currently seeing their MD concerning this.  She came to the pharmacy today to retrieve a copy of her consent form so that she could provide the information for her doctor.
Patient presented to ED for altered mental status, numbness, weakness. Subsequently found to be positive for COVID.
Stomach cramping that would come and go, causing difficulty with working. Diarrhea. Home remedy treatment. Started around 7:50 am. Still faintly occurring as of 12:18 pm.
Eye & face tics less than 24 hours after the Flumist. Now you have a record of an event. I have been told that there is no record of this happening even though I can find it all over the internet by other concerned parents.
Dizzy, nauseous, pale, cold extremities, weak pulse. BP 90/44, HR - 44. O2 sat 96-99%. Blood sugar 127. Patient lay down, with feet elevated. Symptoms resolved.
First my arm became sore and hurt to move or use, the next day it was swollen and the paint continued; them about 2 days later the pain subsided but the swelling remained and a day later the area became red with a rash and itching. Today is Friday 4/22/2016 and the area still has some swelling, is warm to the touch and the rash and itching continues. I guess it will clear up, but it has been 5 days already.