chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No additional adverse events reported; improperly stored vaccines may have been administered to patients; This spontaneous report has been received from a nurse, referring to a patient of unknown gender and age. Information about the patient's pertinent medical history, concurrent conditions, and previous drugs reactions or allergies were not provided.  On 16-DEC-2019, the patient was vaccinated with an improperly stored (product storage error) hepatitis a vaccine, inactivated (VAQTA), (Therapy type: Digital Data Logger), lot number S010727 and expiration date 26-JUL-2020 for prophylaxis (strength, dose, dose number, frequency, route of administration, and anatomical location, were not provided).  The vaccine was stored at a temperature above 47 degree Fahrenheit (47.1 Fahrenheit), for a timeframe of 8 to 16 minutes, with no previous temperature excursion. The call was due to a Digital Data Logger.  No additional adverse events were reported.  This case is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2001USA009007:
Immunizations given at noon, swelling noted at 8:30 in am right thigh to knee, unable to bend knee, Pt with limping. Erythema. swelling decreased with Ibuprofen.
temperature excursion vaccine administered by patient with no reported adverse event; Initial information received on 07-Nov-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to case 2023SA352408.  This case involves an unknown age and unknown gender patient who was administered temperature excursion vaccine IPV (VERO) [IPOL] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received unknown dose of temperature excursion vaccine IPV (VERO) with no reported adverse event (poor quality product administered) (latency: same day) (Suspension for injection) (lot number and expiry date not reported) via unknown route in unknown administration site for Immunization. Information on the batch number was requested.   It was reported that "Nurse asks for stability information following a temperature excursion which lasted for a total of 5 days. Reason: Refrigerator issue Max/low temperature reached: NEGATIVE 1.6 Celsius Human error? No. was the product administered to a patient? Yes."   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Initial and follow up information has been received from a medical assistant, concerning a 61 year old male patient, who on 10-JUL-2007 was vaccinated SC in the left arm, with a dose of PNEUMOVAX (Lot #657039/0698U).  On 12-JUL-2007, he developed swelling, redness and pain that extended down to his elbow, with moderate erythema and edema, and induration of his left arm at the vaccination site.  He was diagnosed with cellulitis (treatment was not specified).  At the time of this report, the patient had recovered from the cellulitis (date and duration not provided).  The MA reported that of the 6 vaccinations with PNEUMOVAX administered from Lot #657039/0698U, (3 male and 3 female patients with an age range from 28-61 years) 4 additional patients developed fatigue, redness, warmth and extreme pain (WAES #0707USA04971, 0708USA04275 and 0708USA04276), and 1 additional patient experienced a "minimal reaction" (WAES 0708USA00702).  The records of testing prior to release of the lot in question, have been rechecked and found to be satisfactory.  The lot complies with the standards of the research center and was released.  Additional information is not expected.
I tested positive for Covid on 5/14. Runny nose, persistent cough and fatigue. Went to the doctor and was RX'd Paxlovid. Feeling fully recovered.
Pt was admitted to psych unit after an intentional overdose.  She was negative on admission to the ER, but due to exposure on the unit was retested and was COVID positive.
This event is reported because patient received COVID-19 Pfizer vaccine 1 day too early (16 days post dose #1) due to scheduling error. First dose given 4/6/21 and second dose given 4/22/21. Error was caught prior to 2nd dose administration, but patient is scheduled for international trip the next day (based on the original schedule after 1st dose) so patient elected to receive the 2nd dose 1 day too early. There is no adverse event, it is reported due to scheduling error.
Syncopal episode immediately after immunizations.  Recovered over period of 30 minutes.  Oxygen saturations normal.
Very red and swollen at site spread out as days progressed. Still red and painful after 4 days. Headache ... triggered a migraine . Area feels like a bad burn.
did not feel well after having received the second dose of the Pfizer COVID vaccine; This is a spontaneous report from a non-contactable consumer. A male patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number and expiration date unknown), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reporter that last week on a zoom call for work, a male participant told the group that he was not turning on his camera because he did not feel well after having received the second dose of the Pfizer COVID vaccine. The outcome of the event was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected
COVID-19 case, I started feeling symptoms on 8/30 I had sore throat, coughing, mild fever, fatigue. Not too bad but definitely sick. Sneezing with a lot of congestion. Acute symptoms lasted about a week. Then another week of further resolution of coughing. On the November holiday 2022 I experienced a sudden acute loss of vision in 1 eye. I couldn't see so went to the ER and was sent to the Ophthalmology clinic. It started to resolve in a few hours but still obscured. They are looking into it without rational as to why it happened.
Rash just below injection site about four days after injection.. Started out small, but has spread down to the middle of upper arm. Warm to the touch. No pain, no itching.
About 24 hours after receiving flu vaccine in (L) arm, the (L) arm became very red, swollen, tender, tight and itchy 19 cm x 27.5 cm extending to just above elbow. Pt was instructed to use scheduled Motrin, Benadryl, and ice packs. Also treated with short course of Prednisone.
Vaccine given 9/19/19.  Patient began itching on right rib cage morning of 09/21/19.  Broke out in rash by same afternoon.  Patient presented to local ER 0830 on 9/22/19 and was diagnosed with shingles.  Prescribed Gabapentin, Hydrocodone and Acyclovir.
Admitted to hospital 11/11/11 approximately 2 weeks after flu vaccination with progressive weakness. Currently treating for Guillain-Barre, received IVIG course followed by plasmaphoresis.  Currently mechanically ventilated finishing the plasmaphoresis course.
Information has been received from a woman in a physician's office concerning a 3 year old female with no medical history who on 12/18/00, was vaccinated SC in the left leg with the first dose of varicella virus vaccine live, 0.5ml (lot # 635451/1143K). There was no illness at the time of vaccination. It was reported that in July 2003, the patient developed an on and off fever (x 2-3 weeks) with the onset of red spots all over her body (x 2-3 days). Medical attention was not sought and no laboratory/diagnostic tests were performed. In July 2003, the patient's red spots resolved. At the time of this report, the outcome of the patient's fever was unknown. Additional information has been requested.
2nd shot made him off on every bone like he has a flu; fatigue; Every part of his body hurts even his toe nails hurt; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 48 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose number: 1), for Covid-19 immunization, reaction(s): "1st dose didn't feel anything". The following information was reported: INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "2nd shot made him off on every bone like he has a flu"; FATIGUE (non-serious), outcome "unknown", described as "fatigue"; PAIN (non-serious), outcome "unknown", described as "Every part of his body hurts even his toe nails hurt".  Additional Information: Pfizer 2nd shot made him off on every bone like he has a flu and fatigue. Every part of his body hurts even his toenails hurt. 1st dose didn't feel anything. Spoke to his Dr and told him to call Pfizer. Is this something common? PQC was not present. AE present was reported as yes. Case was reported as non-serious.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
L arm swelling with L supraclavicular Lymphadenopathy. Treated with BENADRYL and chose follow up 2 day/2 weeks (observation dr office)
Narrative: Patient called telephone triage one month after receiving the Janssen vaccine to report 2 weeks of arm muscle soreness. Patient has not been available by phone for provider follow up.
From initial information received on 7/19/04 from the patient regarding an adverse event occurring in the USA, it was reported that a 65 year old male patient with second degree burns on the hand (extent and side not specified), received a TD ADS ADULT vaccination, lot number not provided, administered IM in the left arm on 4/4/04. About ten days post vaccination he developed intermittent tingling in his left shoulder, arm, and neck. At the time of the report the tingling was persisting. The patient's recovery status is unknown. From additional information received on 8/31/04 from the patient, he received no other products within four weeks of receiving the TD ADS ADULT vaccination. He has not recovered from this event. From additional information received on 11/22/04 from a registered nurse, it was reported that the patient was vaccinated on 4/19/04, not 4/4/04 as previously reported. The onset date of the adverse events is unknown. No relevant laboratory data or diagnostic tests were obtained. The physicain's office made two attempts to contact the patient on 11/16/04 in order to obtain additional information. Messages were left as well. Additional requests for information from the initial reporter were also attempted with no response. It is unknown whether the patient recovered from this event. Further information is not anticipated, this case is considered closed.
Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 day beyond use; No adverse event; Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 day beyond use; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 day beyond use), PRODUCT STORAGE ERROR (Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 day beyond use) and NO ADVERSE EVENT (No adverse event) in a 31-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 052D22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 23-Nov-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 23-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 day beyond use). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 day beyond use) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 day beyond use), PRODUCT STORAGE ERROR (Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 day beyond use) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 day beyond use) and PRODUCT STORAGE ERROR (Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 day beyond use).    No concomitant medications were reported.   Before use date reported was 17-Nov-2022.  No treatment details were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-704416  (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 24-Jan-2023: Follow-up information included patient and vaccination details updated. On 24-Jan-2023: Follow-up document included no new information.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704416:Master case
Pt presented to clinic 11/23/22. Reported LMP as 10/28/22.  No report of pregnancy. No visual signs of pregnancy. Above Vaccines administered without problems. Pt presents to clinic 12/8/22 for Reproductive Health Services/UPT. UPT positive 12/8/22. Reports Last period as 4/13/22 and was aware of pregnancy, but did not want pregnancy and was afraid to tell her parent. Has not had prenatal care.   Pt was referred to OBGYN who reported labs and Ultrasound WNL. Immunization record from 11/23/22 visit , sent to Dr. per patient request.  No problems at present. Date of Expected Delivery 1/16/23.
had the vaccine for shingles, now they say I have them internally/suspected vaccination failure; I have them internally; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 13-JUN-2022 Reporter's Comments: The case was self-reported by the patient via interactive digital media. The patient received dose of Shingles vaccine for shingles and now they said the patient had them internally.  The patient asked that how this could be. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up would not possible as no contact details were available.
Administered MMR 6/20/02, 6/27 developed fever 102 rectal and measles like rash 6/30. Possible rubella 7-10 d post vaccine.
Patient experiencing extreme muscle pain in arms and legs. Started approximately 1 wk. after vaccine. Still ongoing.
affected his heart; has to walk with a walker; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (first dose), for Covid-19 immunization; Bnt162b2 (second dose), for Covid-19 immunization. The following information was reported: CARDIAC DISORDER (non-serious), outcome "unknown", described as "affected his heart"; GAIT DISTURBANCE (non-serious), outcome "unknown", described as "has to walk with a walker".  Additional information:Caller said that she was calling about the Pfizer booster shot. Caller said that she is trying to speak to someone about her Pfizer Booster shot, but in the phone tree the recording cut off. She got her booster shot at withheld on 25Sep2021. While reporting on herself, the caller stated that her friend's husband had the booster dose and it affected his heart and he has to walk with a walker.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Mild headache - 3 days, Chills - 2 days, evening hours, Extreme pain - 2 days, Dull ache - 5 days Redness - size of half dollar for 3 days and increased to an area 4-5 times that size for 2 days still present but is lightening and have minor itching. This shot was not given in the deltoid area given in the side of my upper arm about 4? below my shoulder felt like a knife when it was injected.
Swelling to 3in diameter with warm, edema and tenderness to top of shoulder.  Erythema but not well demarked.
I experienced severe headache for 10 hours which made me dry heave. There was no let up in severity for the full 10 hours. Then for a week I would wake up in the morning with a bad headache. I had the same reaction to the first 2 Pfizer vaccines.
I95.9 HYPOTENSION 5/24/2022 HYPOTENSION I95.9 HYPOTENSION 5/24/2022 NONALCOHOLIC CIRRHOSIS I95.9 HYPOTENSION 5/24/2022 DIASTOLIC HEART FAILURE, ACUTE I95.9 HYPOTENSION 5/24/2022 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED
Unable to lift arm. Extreme soreness. Loss of movement and mobility. Sharp pain in shoulder.
91 y/o male, BMI 38, PMHx CHF, dementia, HTN, and paroxysmal Afib, admitted for acute onset altered mental status, SOB, Covid19, and pulmonary edema on 4/12/21. No reports of fever but tested positive for Covid19. Chest x-ray presents cardiomegaly with bibasilar opacities suggesting atelectasis and/or pneumonia. Covid treated with supportive care. Discharged home with hospice on 4/14/21.
Erythema, swelling, mild pain of the left deltoid at the site of injection.
Pain in the bones; Headache; chills; This spontaneous case was reported by a consumer and describes the occurrence of BONE PAIN (Pain in the bones), HEADACHE (Headache) and CHILLS (chills) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (discharged on 25Mar2021) on 12-Mar-2021. Concurrent medical conditions included Arthritis and Loss of smell (started when diagnosed with COVID and not after the first dose of the vaccine) since 12-Mar-2021. Concomitant products included PARACETAMOL (TYLENOL) for Arthritis.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced BONE PAIN (Pain in the bones), HEADACHE (Headache) and CHILLS (chills). On 09-Apr-2021, BONE PAIN (Pain in the bones), HEADACHE (Headache) and CHILLS (chills) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Mar-2021, SARS-CoV-2 test: positive (Positive) COVID-19 positive.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Treatment medication information was provided, however patient was not sure if it was Tylenol or naproxen.   This case was linked to MOD-2021-143384 (Patient Link).
PATIENT STATES SHE HAD A KNOT AT INJECTION SITE; RED ON THE WHOLE TOP OF HER ARM; ACHING ALL OVER; VERTIGO; ACTUALLY FELL DOWN INTO A CHAIR.
Itching, swelling, redness larger than size of silver dollar on arm at injection site beginning one week after first dose. Began while exercising on 1/6/21 and continues to worsen as of 1/7/21.
Information has been received from a medical assistant concerning a 35 year old female with no pertinent medical history or drug reactions/allergies who on 30-SEP-2008 was vaccinated with a first dose of RECOMBIVAX HB (lot # 653786/0185F) 1.0 ml IM in the left arm. There was no concomitant medication. On 2-OCT-2008 the patient experienced developed swelling and burning sensation at the injection site, 2 days after administration of the first dose of RECOMBIVAX HB. The patient was examined in the office on 17-OCT-2008 but it was not known if the treatment was prescribed. No further information was provided. Additional information has been requested.
zoster rash which encompassed her left breast and wrapped around her back and was accompanied by severe pain, diagnosed with herpes zoster; Information has been received from a lawyer regarding a case in litigation concerning a female patient(pt) of unknown age. The pt's medical history, concurrent conditions and concomitant medications were not provided. On an unknown date, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (lot number, dosage, and route of administration not provided) for routine health maintenance and for the prevention of shingles. After receiving the vaccination, the pt suffered a zoster rash which encompassed her left breast and wrapped around her back and was accompanied by severe pain. As a result of these symptoms, the pt presented to a medical provider and was diagnosed with herpes zoster. Thereafter, the pt had continued to suffer from outbreaks of zoster rashes on her breast, torso and back, accompanied by sudden sharp pains. As a result, the pt has suffered and will continue to suffer significant medical expenses, pain and suffering and other damages. The outcome of    Additional information has been requested.
8/3/02 pt R arm was swollen from shoulder to elbow. Rash noted. Mom c/o child itching. Mom called hospital. Pt given Keflex and Benadryl. Pt's arm was fine by 8/7/02.
Severe pain and increased temperature (mild) around injection site. Pain radiated to axilla with small adenopathy 0.5x0.5cm. TC: Pain control, Ibuprofen/Tylenol 4 Codeine, local measures.
patient states 10 hours after receiving second moderna he experienced difficulty breathing and ended up at the hospital intubated for 9 days
Diarrhea starting approximately 3 hours after injection.  Moderate abdominal cramps and lower back muscle pain continuing for approximately 48 hours.  Nausea and vomiting on second day following injection.  Recurring fever of 101-103.5 degrees on second and third day.  Fever responds to Tylenol and Ibuprofen.  No headache but general joint pain and fatigue.
Pt was lightheaded, sweaty, nauseated and dizzy. He had to lay down. Urgent care staff came to take BP and blood sugar. BS normal and BP low. HR low
Aches/fever/headache/cough/little appetite/wheezing/conjunctivitis.