chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021; Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2021 at 1:50 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 17-Feb-2021 at 1:50 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021). In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 75.19 years.  Concomitant products were not provided.  On 11-Feb-2021, the vaccines were moved to fridge. On 17-Feb-2021, five vials were moved to clinic. On the same day at 08 AM and 09 AM, the vials underwent temperature excursion with temperature 20 and 22 degrees Fahrenheit respectively. The condition of vaccine prior to vaccination was not frozen. The vaccine beyond use date was reported as 13-Mar-2021. It was reported that, the storage condition at the time of the excursion was cooler storage during high-pace COVID-19 vaccination clinic.  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 traceable temperature monitor at every hour.  It was reported that, the patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021. The health care professional explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34- or 35-degree Fahrenheit.  Treatment medications were not reported.   This case was linked to MOD-2022-566976 (Patient Link).
Pain at injection site; redness at injection site; Shivering; gastro intestinal effects; Nausea; Stomach pain; Fever; Tiredness; Fast heart rate; Lymph gland under arm, swollen up huge; lymph gland was tender; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In August 2022, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 3 months after receiving Shingrix, the patient experienced injection site pain, injection site erythema, shivering, gastrointestinal disorder, nausea, stomach pain, fever, tiredness, heart rate increased, enlargement of lymph nodes and lymph node tenderness. On an unknown date, the outcome of the injection site pain, injection site erythema, shivering, gastrointestinal disorder, nausea, stomach pain, fever, tiredness, heart rate increased, enlargement of lymph nodes and lymph node tenderness were recovered/resolved.   It was unknown if the reporter considered the injection site pain, injection site erythema, shivering, gastrointestinal disorder, nausea, stomach pain, fever, tiredness, heart rate increased, enlargement of lymph nodes and lymph node tenderness to be related to Shingrix.   Additional Information: GSK Receipt Date: 25-OCT-2022 Reporter's Comment: The case was reported by the patient.  The patient reported that, she got her Shingrix vaccine.  The patient reported that, she had all the symptoms that were described as common side effects.  The patient reported pain at injection site, redness at injection site, shivering, gastro intestinal effects, like nausea and stomach pain, fever, tiredness and fast heart rate.  These side effects were last about 24 hours and they had resolved.  The patient reported a lymph gland under the arm swollen up huge. The patient reported that, the under the right arm where she got the vaccine the lymph gland was swollen and tender.  This last the longest and it resolved in about a week.  The lot and expiry date of the vaccine were unknown. Not all information was available. The reporter consented to follow up with HCP.
I almost immediately felt something behind my sinuses and at the injection site and ignored it, however, about 50 hours later I started itching around my neck and chest, then arms and back, face, and hands, knees, etc. I called the pharmacy on Saturday to make sure I could take Allegra for the itching and they said I could take what I had (Allegra). The itching did subside until Sunday afternoon and a stomach ache began. I have had stomachaches before, not infrequently, but this ache was more like acid indigestion. The stomach ache persisted and I took an antacid and fell asleep.  The ache has persisted and is still bothering me. Along with the itch came sneezing and a runny nose which has not been as persistent as the itch and stomachache, but still ongoing. I don't know if my chapped lips are due to the vaccine or not, but I seem to have chapped lips out of character. I have also experienced hot flashes and chills intermittently.
CHEST TIGHTNESS; SHORTNESS OF BREATH; This spontaneous report received from a patient concerned a 40 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included pollen allergy, alcohol use (socially), no smoking, and  no drug abuse or illicit drug usage.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805022) dose was not reported, administered on 06-MAR-2021;11:00 am, into left arm, for prophylactic vaccination. No concomitant medications were reported.  On 06-MAR-2021, the patient experienced chest tightness and shortness of breath. Patient complained of chest tightness which began approx. 2 min after injection.  Patient also stated that he had to breathe slowly and "not heavy", and felt short of breath. The dose of covid-19 vaccine ad26.cov2.s was not changed. The patient had not recovered from chest tightness, and shortness of breath. This report was serious (Other Medically Important Condition).; Sender's Comments: Chest tightness, and shortness of breath. This event(s) is considered related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are no other factors more likely to be associated with the event(s) than the drug.
Developed a metallic taste in his mouth; This spontaneous case was reported by a patient and describes the occurrence of DYSGEUSIA (Developed a metallic taste in his mouth) in a male patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 03-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In October 2022, the patient experienced DYSGEUSIA (Developed a metallic taste in his mouth). At the time of the report, DYSGEUSIA (Developed a metallic taste in his mouth) had not resolved.            No concomitant medications were reported.  On 03-Oct-2022, patient got the booster dose of Moderna COVID-19 vaccine, Bivalent. Felt fine after. In the last 2 weeks patient developed a metallic taste in mouth that won't go away.  No treatment medications were reported.   Reporter did not allow further contact
Patient started experiencing COVID-19 symptoms and was admitted into the hospital on 08/05/2021, discharged on 08/08/2021. Patient and close contacts have been fully vaccinated, has pre-existing medical conditions (Cardiovascular, Diabetes Mellitus,)
2 hrs after recv vaccine labored breathing and hot flashes (internally) she wasn't hot or running a fever she was ripping her clothes off screaming and yelling telling me she was hot. Dr visit ER visit & hospital stay-3 days total nebulizer tx; epinephrine; steroid, oxygen, x-rays and BENADRYL given.
Chest pain; Back pain; Trouble breathing; Pleurisy; This is a spontaneous report from a non-contactable consumer, the patient. A 33-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3184) via an unspecified route of administration in the left arm on 31Aug2021 at 16:15 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure (HBP). The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medication included lisinopril (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0169) via an unspecified route of administration in the left arm on 10Aug2021 at 16:15 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. On 01Sep2021 at 09:30, the patient experienced chest and back pain and trouble breathing and the patient was presented to emergency room (ER) on 01Sep2021 at approximately 10:30. It was reported that the patient was diagnosed with pleurisy as a result of the immune response from the vaccine. The events resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of the events and included treatment with unspecified medication. The clinical outcome of the events chest and back pain, trouble breathing and pleurisy was resolving at the time of this report.  No follow-up attempts are possible. No further information is expected.
Patient noticed the evening after receiving the vaccine that her arm began to itch an develop a rash.
Systemic: Tinnitus-Severe, Additional Details: Patient has tinnitus from 01/04/2022 and she will go to the dr and update Pharmacy about the same.
he developed an itchy rash on chest after receiving COVID vaccine; This is a spontaneous report from a contactable consumer based on information received by Pfizer, (manufacturer control number US-AMGEN-USASP2021138021),   This non-serious spontaneous report (USASP2021138021) was reported to Regulatory authority on 03/SEP/2021 by a consumer and involves a male patient who developed an itchy rash on chest after receiving COVID vaccine [PT: rash pruritic] while receiving Enbrel, Single Dose Prefilled Syringe. No historical medical condition was reported. The patient's current medical condition included psoriasis, unspecified. The patient's concomitant medications included calcipotriene, meloxicam and Tylenol (paracetamol). The patient's co-suspect medication included COVID-19 (Coronavirus disease 2019) Vaccine. The patient began Enbrel with Single Dose Prefilled Syringe on an unknown date. On an unknown date, the patient developed an itchy rash on chest after receiving COVID vaccine. Patient stated it was beginning to improve but still present. No treatment information was received. The outcome of the event rash pruritic was reported as recovering/resolving. Action taken with Enbrel and Single Dose Prefilled Syringe was reported as unknown for the event rash pruritic. The causal relationship between the event rash pruritic and Enbrel with Single Dose Prefilled Syringe was not provided by the consumer.   The reporter declined consent for follow up.   No follow up attempts are possible. No further information is expected.
Extremely low white blood cell count: Aprox. 1.5l; This is a spontaneous report from a contactable consumer (patient). A 63-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0170) via an unspecified route of administration on 06May2021 (at 63-year-old) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included Prostate Cancer Treatment 2019 Now Cancer Free and Possibly Gluten Allergy. Concomitant medications included sertraline; morniflumate (FLOMAX); dextroamphetamine; and pantoprazole (PANTOPRAZOL). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received the first single dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EC6817) on 10Apr2021. The patient reported for Extremely low white blood cell count: Aprox. 1.5l. He had never had this condition before. They found it via Routine Physical. The adverse event result in Emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the event was not recovered.
Vaccine given on 8/23/21. Vaccine expiration date was 8/21/21.
Heart palpitations; Hard time breathing; This is a spontaneous report from a Pfizer sponsored program report received from a contactable consumer or other non-health care professional. A 66-year old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number EW0150), via an unspecified route of administration in the arm right on 05Apr2021 at a 11:30 (at the age of 66-year-old) as a dose 1, single for COVID-19 immunization. The patient medical history included ongoing cholesterol (Verbatim: Cholesterol). Concomitant medications were not reported. On an unspecified date, the patient experienced heart palpitations, congestion and hard time breathing. The patient stated that he was congested and never had this before and it was hard to breathe. He said he worked out and ran. All the events were non-serious. The outcome of all the events was not recovered.  Follow-Up (20Jul2021): Follow-up attempts are completed. No further information is expected.
Sore Throat; Sore Throat; Runny Nose; symptoms of a cold such as sore throat and runny nose; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 27-year-old female patient received BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EN6199 and expiry date was not reported), via an unspecified route of administration in arm left, on 10Mar2021 (last Wednesday) (age at vaccination: 27 years), as a dose 2, single for COVID-19 immunization/to prevent COVID. The patient's medical history and concomitant medications were not reported. The patient historical vaccine includes BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EL9265 and expiry date was not reported), via an unspecified route of administration in arm left, on 17Feb2021, as a dose 1, single for COVID-19 immunization. On 14Mar2021 the patient stated that she has a sore throat and a runny nose and she thinks it was a cold. The patient reported that when she contacted her HR person, who the patient doesn't really know anything about it, they said to call the Health Department, they sent her to Pfizer. Caller wants to know does she need to get tested or quarantine or are these normal side effects. The patient stated that she was a home based therapist, so she needs to know because she doesn't want to spread anything. Reportedly as a corrective medication the patient received nyquil and Dayquil. On 16Mar2021 the outcome was recovered for the event runny nose. The outcome was not recovered for the event sore throat. The outcome was unknown for the other events.  No follow-up attempts are possible. No further information is expected.
Been having acute gastroentinitis for over 4 weeks.  From 7/17/21 to present (8/14/21); Can't eat regular yet; Uneasy stomach; Lost 21 lbs; This is a spontaneous report from a contactable consumer, the patient.  A 16-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: EW0182), via an unspecified route of administration, administered in Left arm on 28May2021 as dose 2, single (at the age of 16 years), for covid-19 immunization, at Hospital. Medical history and concomitant medications were not reported. There were no known allergies. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: EW0173), via an unspecified route of administration, administered in Left arm on 07May2021 as dose 1, single (at the age of 16 years), for covid-19 immunization, at Hospital. There were no other vaccine in four weeks and no other medications in two weeks. The patient reported that, since 17Jul2021, he had been having acute gastroenteritis (for over 4 weeks to present 14Aug2021) and since unknown dates in 2021, he could not eat regular yet, had uneasy stomach and lost 21 lbs. Adverse events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient did not have Covid prior to vaccination. The patient was tested for covid post vaccination. The patient underwent lab tests and procedures which included Covid-19 virus test (sars-cov-2 test) via Nasal Swab, Nasopharyngeal on 07Aug2021 with negative result and on an unknown date in 2021, measured weight in which realized he lost 21 lbs. Therapeutic measure for Acute gastroenteritis was taken, received IV for dehydration (IV drug was not specified). The outcome for the event Acute gastroenteritis was not recovered at the time of report, however the outcome for the rest of the events was unknown.
expired dose administered; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 45-year-old male patient who received HAV (Havrix) (batch number NZ7GR, expiry date 17-JUN-2023) for prophylaxis.   On 22-JUN-2023, the patient received Havrix. On 22-JUN-2023, an unknown time after receiving Havrix, the patient experienced expired vaccine used (Verbatim: expired dose administered). The outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 22-JUN-2023 The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up via email. The patient received an expired dose of Havrix, which led to expired vaccine used.
HA; slight fever; This is a spontaneous report from a contactable consumer. This consumer reported similar events for two patients. This is 2nd of two reports. A male patient (reporter's Grandson) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot/Batch Number and Expiration Date unknown) via an unspecified route of administration on an unknow date at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications was not reported. On an unspecified date the patient Headache (HA) and slight fever. The outcome of events was unknown.  Information on the batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021024982 Same reporter/drug/event, different patient.
The evening after receiving the vaccine, about 11 pm started running a temperature of 101.4, injection site pain, headache, shivers, aching and brain fogginess.  Poor sleep.  Today, 02.24.2021 as of 1:00 pm symptoms have not subsided.  Feels the same as original Covid infection.
This is in follow-up to report(s) previously submitted on 1/16/2007. Information has been received from a healthcare professional concerning a 16 month old female patient with no known history who on 06-DEC-2006 at 16:30 was vaccinated with SC in the left thigh with a dose of Zostavax (Merck) (lot # 652965/0622F) instead of Varivax (Merck). Concomitant vaccination included a first dose of MMR II (lot # 653626/0426F) given SC in the right thigh, a fourth dose of PROHIBIT (lot # 4E955AA) given IM in the left thigh, and a fourth dose of TRIPEDIA (lot # U1891AB) given IM in the left thigh. Other concomitant therapy included TYLENOL or MOTRIN prn. There was no illness at the time of vaccination. The practice was out of Varivax vaccine (Merck) and the vaccines were stored side by side in the freezer. The administering nurse saw "varicella" on the vial and grabbed the vaccine without double checking. The child was fine the day of vaccination and the next day. No symptoms were noted. There was no product quality complaint involved. Additional information has been requested. Additional information indicated that the patient was given ZOSTAVAX (Merck) instead of VARIVAX (Merck) and wrong bottle was grabbed by the CMA in the freezer. No adverse events were noted after injection, the patient had no problems, Medical attention was not sought. No further information is expected.