chrisvoncsefalvay/vaers-outcomes huggingface dataset:
an expired Daptacel was given to a patient/ No AE; Initial information received on 19-Jul-2019 regarding an unsolicited valid non-serious case received from a nurse by phone.  This case involves a 32 months old female patient who was vaccinated with an expired 0.5 ml fourth dose of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (Batch number: C5202AA and expiry date: 16-May-2019) via intramuscular route in the right thigh on 19-Jul-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A VACCINE) on an unknown date.  It was a case of actual medication error due to expired vaccine used.  No adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the 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.   Documents held by the sender: none.
blood pressure spikes after her 2nd dose/high blood pressure like 144/70 3 days after the 2nd dose; This is a spontaneous report from a contactable consumer via Pfizer-sponsored program. A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as SINGLE DOSE for covid-19 immunization. Patient medical history and concomitant medications were not reported. On an unspecified date she had some blood pressure spikes after her 2nd dose. Patient was asking if it's normal to have high blood pressure like 144/70 3 days after the 2nd dose. The patient underwent lab tests and procedures which included blood pressure measurement: 144/70. Outcome of the event was unknown.  Information about the Lot/batch number has been requested.
whole left arm hurt; a lot of pain and suffering; arm killing her; keeping her up at night; can't lift arm since that first dose; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (whole left arm hurt), PAIN (a lot of pain and suffering), LIMB DISCOMFORT (arm killing her), INSOMNIA (keeping her up at night) and LIMB DISCOMFORT (can't lift arm since that first dose) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0381C20A and 015N20A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Mar-2021, the patient experienced PAIN IN EXTREMITY (whole left arm hurt), PAIN (a lot of pain and suffering), LIMB DISCOMFORT (arm killing her), INSOMNIA (keeping her up at night) and LIMB DISCOMFORT (can't lift arm since that first dose). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (whole left arm hurt), PAIN (a lot of pain and suffering), LIMB DISCOMFORT (arm killing her), INSOMNIA (keeping her up at night) and LIMB DISCOMFORT (can't lift arm since that first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported.   This case was linked to INC.-MOD-2021-078028 (E2B Linked Report).; Sender's Comments: INC.-MOD-2021-078028:Dose 2
Jynneos vaccine was thawed longer than 8 weeks; Affected Jynneos vaccine was administrated; Case reference number US-BN-2022-003958 is a spontaneous case report initially received on 05-Oct-2022 from nurse via Communications (reference number: USBAV22-1628) and concerns a patient of unknown demographics (third out of ten).  The patient's medical history and concomitant medication details were not provided.  On 3-Oct-2022 and 4-Oct-2022, the patient was vaccinated with Jynneos vaccine (Smallpox and Monkeypox Vaccine, Live, Nonreplicating; batch number unknown) at an unknown dose, route and site of administration for monkeypox/smallpox prophylaxis. Jynneos vaccine was thawed longer than eight weeks before administration (explicitly coded as 'product storage error' and product administration error').  At the time of this report, it was unknown if the patient experienced any adverse events.  Additional information received on 05-Oct-2022 from a nurse via Communications (reference number: USBAV22-1630): new information included clarification regarding number of patients involved.  The case is linked to the cases US-BN-2022-003913, US-BN-2022-003956, US-BN-2022-003959, US-BN-2022-003960, US-BN-2022-003961, US-BN-2022-003962, US-BN-2022-003963, US-BN-2022-003964 and US-BN-2022-003965, due to same reporter.; Reporter's Comments: A patient of unknown demographics was vaccinated for monkeypox/smallpox prophylaxis with Jynneos vaccine that was thawed longer than eight weeks before administration, which is considered as product storage error and product administration error. Product storage error and product administration error are considered listed per company convention. At the time of this report, it was unknown if the patient experienced adverse events. The patient's medical history and concomitant medication details were not provided. Product storage error and product administration error have been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A patient of unknown demographics was vaccinated for monkeypox/smallpox prophylaxis with Jynneos vaccine that was thawed longer than eight weeks before administration, which is considered as product storage error and product administration error. Product storage error and product administration error are considered listed per company convention. At the time of this report, it was unknown if the patient experienced adverse events. The patient's medical history and concomitant medication details were not provided. Product storage error and product administration error have been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Itchy rash appeared on the left side of my face (same side as injection site) about 24 hours after receiving the injection.  Rash did not have a red appearance but the skin felt scaly and itchy similar to hives.  The rash lasted several days.
102 fever. Chills. Aches. Diahrrea vomiting. Cramping. Numbness in big toes and fingers
Mild pain at the injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 21Mar2021 (Lot number: ER8727) at the age of 45 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: CALCIUM; VIT D; MAGNESIUM. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 21Mar2021 18:00, outcome "recovering", described as "Mild pain at the injection site". Therapeutic measures were not taken as a result of vaccination site pain.  Additional information: The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine (prior vaccination was none). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Facility where the most recent COVID-19 vaccine was administered reported as Pharmacy or Drug Store. No known allergies. Upon follow-up response received for query. Patient arm started to become sore a few hours after vaccination.   No follow-up attempts are possible. No further information is expected.
On 3/12/21 left arm was red and had a rash that became itchy.
Information has been received from a physician via Company representative concerning to a patient of unknown age and gender. Concurrent and historical conditions were not reported. Concomitant therapies were not provided. On 12-JAN-2015, the patient was vaccinated with an improperly stored dose of GARDASIL (Lot No. K001631, exp. 06-NOV-2016) (dose and site not reported). On an unspecified date, the GARDASIL vaccine had temperature excursion of 256 hours. The highest recorded temperature was 59 (15 Celsius degrees). The vaccine status was reported as 'in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator(R)". No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
On Sept 30th 2018, I woke up with a severe headache and a buzzing feeling. My ankles were swollen, and my knees felt weak and shaky. My legs were heavy. I had blood work 10/4/18 and regular check-up 10/11/18 with my PCP. Everything was good. I went back to Dr 12/4/18. He gave me a prescription for methylprednisolone tablets - 4 mg - for 6 days. I have taken all of the pills and feel a little better, but I still have the buzzing feeling, headache off and on and heaviness in my legs. Never had a problem before. Please advise next course of treatment. Keep in mind, it takes 2 months to get an appointment with my PCP at this time of the year.
Nurse at the monitoring area noticed the pt is pale and losing conciousness after he received vaccination. His SBP was 80 and stated that he does not feel alright. He stated that he does not have preexisting condition but he was afraid of the needle and it was painful when he received the injection.  The nurse called 911 and the pt was taken to ER approximately 40 minutes after receiving the covid vaccine.
I have swelling and redness slowing growing on and around the smallpox vaccination site. I have received smallpox vaccine long time ago as a child.
Headaches, dizziness x 25 minutes associated with laughter and unsteady gait; Gradual improvement over 45 minutes. Released home in 45 minutes.
I had fever, chill, cough, serve headache, congestive and unable to sleep.  These lasted for about a week.  I call my healthcare provider.  She wanted to have the antibody fusion.  On  Jan 2nd, I got test for Covid-19, positive result.
I had chills, muscle ache, low grade fever of 99, chest congestion, and little bit of cough. These symptoms did not last long but I am tired today. I took a test at the doctor office but I wasn't going to get the results until a couple days later. I ended up taking an at home test at home and it came up negative for COVID-19. I got my results back from my COVID-19 test I took at the doctor's office and that one came back positive for COVID-19.
Almost 2000 people had a similar reaction (not the redness)/hearing loss response; Almost 2000 people had a similar reaction (not the redness)/tinnitus; similar reaction; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 23-Apr-2021. The most recent information was received on 28-May-2021 and was forwarded to Moderna on 28-May-2021.    Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of DEAFNESS (Almost 2000 people had a similar reaction (not the redness)/hearing loss response) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DEAFNESS (Almost 2000 people had a similar reaction (not the redness)/hearing loss response) (seriousness criterion medically significant), TINNITUS (Almost 2000 people had a similar reaction (not the redness)/tinnitus) and VACCINATION COMPLICATION (similar reaction). At the time of the report, DEAFNESS (Almost 2000 people had a similar reaction (not the redness)/hearing loss response), TINNITUS (Almost 2000 people had a similar reaction (not the redness)/tinnitus) and VACCINATION COMPLICATION (similar reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment information was provided.  Very limited information regarding these events have been provided at this time.   Most recent FOLLOW-UP information incorporated above includes: On 28-May-2021: Follow- up received  added new events which upgraded the case to serious.; Sender's Comments: Very limited information regarding these events have been provided at this time.
Patient had first case of shingles for the first time ever/ Had 7 outbreaks of shingles approximately each month each lasting for 7 days; Tired; Fever; This spontaneous case was reported by a pharmacist and describes the occurrence of HERPES ZOSTER (Patient had first case of shingles for the first time ever/ Had 7 outbreaks of shingles approximately each month each lasting for 7 days), FATIGUE (Tired) and PYREXIA (Fever) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939906) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Johnson and Johnson (Johnson and Johnson primary vaccine). Past adverse reactions to the above products included No adverse reaction with Johnson and Johnson.    On 02-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Nov-2021, the patient experienced FATIGUE (Tired) and PYREXIA (Fever). In February 2022, the patient experienced HERPES ZOSTER (Patient had first case of shingles for the first time ever/ Had 7 outbreaks of shingles approximately each month each lasting for 7 days). In 2022, HERPES ZOSTER (Patient had first case of shingles for the first time ever/ Had 7 outbreaks of shingles approximately each month each lasting for 7 days) had resolved. At the time of the report, FATIGUE (Tired) and PYREXIA (Fever) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was reported.  On 02-Nov-2021, the patient received first Moderna booster dose.  On an unknown date of Feb-2022, the patient had first case of shingles for the first time ever. The shingles resolved after 10 days but however since February, the patient has had 7 outbreaks of shingles approximately each month each lasting for 7 days.  The patient received second Moderna booster dose on 02-May-2022 in right arm, with lot number 004M21A and expiration date was not known. The patient had no adverse reactions.  Patient asked if the Moderna bivalent vaccine was available.  No treatment medication information was reported.
Cellulitis left upper arm, area of redness measures 15.0 cm x 10.o cm, warm to touch, itchy
Immediately after immunizations, Hep A, Hep B, MMR, TB; collapsed and began 10 sec generalized seizure. 911 called, paramedic transported to ER. CT scan negative, discharged home.
2mins post vaccination pt had a syncopal event w/ associated flushing/sweating.  LOC x30seconds.  Provider on all was called Vitals: 96/56, 54, 22, 100% -- > 09:18 110/68, 62, 100% -- > 09:20 103/61, 60 Pt stable and released from the vaccination site @09:24
A two and a half year old female patient with allergies to AUGMENTIN, AMOXICILLIN, and OMINICEF developed hives from head to toe within 6 hours of receiving third intramuscular dose of FLUZONE SV 2008-2009 (lot number reported as U0758AA, which is invalid) on 25 October 2008. The patient also reported vomiting. Both of her symptoms cleared within 24 hours. The patient had a doctor's visit, however no further details were provided. The patient recovered from the events.
This spontaneous report as received from a nurse (other health professional) refers to a patients of unknown age and gender. On unspecified date in September 2014 the patients were vaccinated with 2 unsupported, improperly stored doses of GARDASIL lot # J010668, exp. date: 29-APR-2016; 0.5 ml, intramuscularly. No adverse effect was reported. Additional information has been requested. This is one of several reports received from the same reporter.
Heartbeats irregular; I took an extra blood pressure medication/it's 'like' my blood pressure; This is a spontaneous report from a contactable consumer (patient). A 67 years old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration, administered in left arm on 10Feb2021 (Batch/Lot Number: EL9265) as 66 years old as DOSE 1, SINGLE, and booster dose via an unspecified route of administration, administered in left arm on 19Oct2021 at 11:00 (Batch/Lot Number: EW0181) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation; and lisinopril via an unspecified route of administration from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at 5 mg (took 10 mg this morning) for blood pressure. Medical history included high blood pressure. The patient's concomitant medications were not reported. No prior vaccination (within 4 weeks). The first vaccination was 10Feb2021 and her 2nd vaccine was in Mar2021 (in left arm, lot/batch number: EN6202). The patient had her COVID vaccine booster, yesterday (19Oct2021) and it's 'like' her blood pressure (Further clarification Unknown) and she had heart beat. The patient clarified she had high blood pressure (Intent: Medical Condition) she take a small 5mg of Lisinopril to control it and its been under control and she took her blood pressure before she went yesterday and it was normal. She got it at 11 clock yesterday AM and she was still experiencing all of those symptoms today (20Oct2021) she just wanted to let you know and she did phone her doctor she seen her doctor 12:30. She was just concerned about her irregular heartbeat. Laboratory test included patient had a comprehensive lab test recently and everything was normal. Her first vaccination she didn't reported but she had all these symptoms as well. Treatment included patient took 2 Ibuprofen (treatment) and she took this morning (20Oct2021) when she wake up she took an extra blood pressure medication, she took extra 5mg this morning so she took 10 mg this morning of Lisinopril. The patient underwent lab tests and procedures which included blood pressure measurement: abnormal, blood pressure measurement: normal, Heartbeats: irregular, comprehensive lab test: normal all on an unspecified date. The action taken in response to the events for lisinopril was dose increased. The outcome of events was not recovered.  Follow-up attempts are completed. No further information is expected.
Mother called office today and reported patient had experienced redness and itching after YF immunization. Patient showed her the site on Monday morning (2/23/2009) before going to school. Lesion is resolving and pruitus gone today.
Increased redness, swelling (L) thigh. Wheal and flare. Seen again 8/6 resolving = description c/w hive.
Soreness in arm, fast heart rate, dizziness, feeling weak, urinated self,  sweats, warm to the touch
Not feeling well two hours after vaccine.  Threw up about 3 hours after.  Threw up after dinner.  Dry heaves and temp up to 103.7 during night.  temp down to 100 by mornig.  Normal temp by afternoon
Approximately 10 minutes after receiving the injection, patient states that he felt hot, lightheaded, and had stomach pain. As he was moving to a recliner, patient passed out. The pharmacist called 911, and raised patient legs onto a chair. Patient woke back up, and the pharmacist said that his eyes were "not normal".  Paramedics arrived, and transported patient to the emergency room. Patient states that he was at the ER for approximately 2 hours, and then discharged. While at the ER, he received IV fluids and blood work was performed. He has not had any other complications besides a sore arm at the site of injection.
Breakthrough case after 3 vaccines Pfizer 3/31/21 Lot# EN6208;  Pfizer 4/21/21 Lot# ER8732; Pfizer 9/20/21 Lot# FC3182
No adverse event; received Moderna original 0.5ml doses instead of the bivalent booster; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (received Moderna original 0.5ml doses instead of the bivalent booster) and NO ADVERSE EVENT (No adverse event) in a 66-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052b22a) for COVID-19 prophylaxis.     No Medical History information was reported.    On 26-Oct-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 26-Oct-2022, the patient experienced WRONG PRODUCT ADMINISTERED (received Moderna original 0.5ml doses instead of the bivalent booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (received Moderna original 0.5ml doses instead of the bivalent booster) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (received Moderna original 0.5ml doses instead of the bivalent booster).    Concomitant medications were not reported.  Patient received Moderna original 0.5ml doses instead of the bivalent booster.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 26-Oct-2022: Live follow up received was contains Patient details were added.
Arm swelling, red, hot, achy - 12 hours after injection. She iced area took BENADRYL and TYLENOL, improving within 20 hours.
Myopericarditis 2/13/07 Received medical records from hospital which reveal patient experienced SOB worse on exertion & progressively worsening with sharp left pleuritic chest pain which improved w/lying down & worsened w/sitting up, diaphoresis, chills & fever, lightheadedness & productive cough of thick brown sputum.  Exam revealed  a focal pericardial rub & tenderness to palpation of left chest. Continued to experience intermittent chest pain while hospitalized FINAL DX: myopericarditis.
FEVER, fever of 102.7 by midnight of 1/22. Sore throat and soreness at vaccine site Narrative:
On day 8 (today) I developed a 3 1/2-4 inch rash next to my injection site and also experienced some swelling in my hand.
Shivering, Nausea, whole body Aching, Fever, Cold Sweats, Cold Feet and Headaches.
6th nerve palsy of the left eye, persistent for almost 2 months now without improvement. MRI, MRA and CT scan of the head was negative for stroke.
hives, 11AM 14OCT92, fever 101 R APAP given;
Mild heart attack 3/25/21 3:15 Shoulder and back pain, nausea, heart bypass surgery 3/29/21 8:30 am, surgery successful In recovery
5PM 16JAN91, fever, vomiting, fever reached 104; liquiprin given-rectal supp for vomiting; By 830AM 17JAN91 t98.6- no vomiting
Patient returned to pharmacy on 9/19/12 with blotchy redness in the area of the injection. Patient went to the doctor and she states they diagnosed her with a skin infection. Patient filled a script for methylprednisolone at our pharmacy on 9/21/12/