chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt seen in local ER for swelling and redness at site of Varicella injection, right arm.  Cellulitis diagnosed.  Treatment with Cephalexin ( for 7 days ) and hot compresses (02/21/04)
bronchitis; This is a spontaneous report from a contactable consumer (patient). The patient reported for herself that  A 78-years-old non female patient received bnt162b2 ((PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: UNKNOWN),1 via an unspecified route of administration on an unspecified date and The patient medical history was not reported.The patient's concomitant medications were not reported.The patient experienced bronchitis on an unspecified date and I've contracted bronchitis. What's the recommendation for getting my 2nd dose of the Pfizer COVID 19 vaccine next week and reporter replied Caller states that she has received her first dose of the Pfizer COVID 19 vaccine and has been diagnosed with bronchitis. She's 78 years old. and outcome of event was unknown   No follow-up attempts are possible; information about lot number cannot be obtained.
could not breathe; had a fast beating heart; felt very dizzy; advanced stage Emphysema; This is a spontaneous report from a contactable consumer or other non-health care professional via a Pfizer sponsored program. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number and Expiration date were not reported), via an unspecified route of administration on an unspecified date as dose 1, single for Covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date (8 hours after the vaccination), the patient experienced "could not breathe", had a fast beating heart, felt very dizzy, advanced stage emphysema. It was reported that the side effects started 8 hours after first dose. She stated she felt like she was going to die. She cancelled her second appointment because she feared the side effects from first dose. The outcome of all events was  unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Soreness in injection site; This is a spontaneous report from a contactable consumer, the patient. A 22-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0198) via an unspecified route of administration in the left arm on 10Jul2021 at 17:00 (at the age of 22-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. The patient did not receive any medication within 2 weeks of vaccination. Prior to the vaccination, the patient was not 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 10Jul2021 at 18:00, the patient experienced soreness in injection site. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the event soreness in injection site was not resolved at the time of this report.
Client recieved vaccine at 2:28pm. Client was waiting post vaccine and stated she felt funny. RN assessd client. Client co of headache and feeling "foggy". Client was a&o x3 vitals were WNL. 2nd RN called to room. Client stated she felt like her tongue was swelling. RN noted swelling of tongue. 911 called, EMS arrived. Assessed client. Client vitals remained WNL. EMS encouraged client to be evaluated by local hospital. Client refused. Client continued to be observed, client stated she felt like the swelling of her tongue was decreasing. EMS felt client could be released from health dept to home. Encouraged client to take bendadryl and to seek medical attention if condition worsened.
2-3 days after 1st dose given on 5/22/21: heart palpitations and chest pain/pressure 12 hours after 2nd dose given on 6/12/21: numbness/cooling feeling in lower extremities (lower legs/feet), hot/tingly hands, feet/toes, weakness and muscle stiffness in both legs, hot/cool feeling in upper legs, continued heart palpitations and chest pressure
Patient reported on 1/10/2019 a minor case of shingles behind her left ear and also Bell's palsy on the left side of her face which lasted 5 weeks.
Men A mixed with sterile diluent instead of Men c y w -135 liquid conjugate
After the second dose, I experienced extreme exhaustion and body aches. In the following weeks, I had terrible headaches and inflammatory swelling in my hands and feet, flushing and pain in my joints. I was treated with steroids.
LOSS OF SMELL; BODY ACHES; STOMACH ISSUES; NOT TASTING AT ALL; TASTE IS METALLIC LIKE PENNY/ THINGS STARTED TASTING WEIRD; STRANGE METALLIC SMELL; BODY ODOR CHANGED; BAD HEADACHE; FEVER; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced loss of smell, body aches, stomach issues, not tasting at all, taste is metallic like penny/ things started tasting weird, strange metallic smell, body odor changed, bad headache, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, stomach issues, bad headache, and fever, had not recovered from not tasting at all, taste is metallic like penny/ things started tasting weird, loss of smell, and strange metallic smell, and the outcome of body odor changed was not reported. This report was non-serious.
Information has been received from a pharmacist concerning a 15 year old female patient with no known medical history and no known drug reactions/allergies who on 14-SEP-2010 was vaccinated with the first dose of GARDASIL (route and lot# not reported). There was no concomitant therapy. On 14-SEP-2010 the patient experienced right leg twitching since 2 hours after receiving the first dose of GARDASIL. The patient also experienced a fall during dance class. The patient was evaluated at a local urgent care facility and unspecified blood work was ordered. The blood work results were pending. At the time of the report, the patient had not recovered. The patient sought medical attention by contacting pharmacist. Additional information has been requested.
Headache continued; Axillary node remains swollen; Continues to have mild pain; Axillary node pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31 year-old patient received bnt162b2 (BNT162B2), intramuscular, administered in deltoid left, administration date 01Sep2021 11:30 (Batch/Lot number: unknown) at the age of 31 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hypothyroidism", start date: 2006 (ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Time: 13:30, Anatomical site of injection: Left Deltoid, Route of administration: Intramuscular, Batch/Lot number: EW0172), administration date: 11Aug2021, for COVID-19 Immunization, reaction(s): "Axillary lump", "Headache", "Menstrual change". The following information was reported: HEADACHE (non-serious) with onset 2021, outcome "recovered" (03Sep2021), described as "Headache continued"; LYMPHADENOPATHY (non-serious) with onset 2021, outcome "not recovered", described as "Axillary node remains swollen"; PAIN (non-serious) with onset 2021, outcome "not recovered", described as "Continues to have mild pain"; LYMPH NODE PAIN (non-serious) with onset 2021, outcome "not recovered", described as "Axillary node pain". The events "axillary node remains swollen" and "axillary node pain" were evaluated at the physician office visit.  Additional information:Headache continued until 03Sep2021. Axillary node remains swollen and continues to have mild pain. This is still an ongoing issue.  . Follow-up attempts completed. No further information is expected.
4/10 arm swollen, stomach ache. 4/11 fever, joint pain. 4/12, arm swelling, red streaks down upper arm, up onto shoulder, lymph nodes swollen.
Arm was sore to the touch; Arm puffed (at injection site); This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Arm was sore to the touch) and VACCINATION SITE SWELLING (Arm puffed (at injection site)) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced VACCINATION SITE PAIN (Arm was sore to the touch) and VACCINATION SITE SWELLING (Arm puffed (at injection site)). At the time of the report, VACCINATION SITE PAIN (Arm was sore to the touch) and VACCINATION SITE SWELLING (Arm puffed (at injection site)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications details was not reported by the reporter. Treatment details was not reported by the reporter. Reporter stated that patient was doing exercise for adverse events.   This case was linked to MOD-2021-372414, MOD-2021-372416 (Patient Link).
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Apr-2021 at 2:43 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 29-Apr-2021 at 2:43 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown. Not Provided    For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 41.59 for dose administered on 29-Apr-2021.  No concomitant medications were reported.  Batch number 007C21A underwent temperature excursion on 29-Apr-2021 with temperature 33 degrees Fahrenheit at 10:00 AM. This vial was moved to fridge on 19-Apr-2021 and beyond use date for the vial was reported as 19-May-2021. Product moved to clinic on 29-Apr-2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a traceable temperature monitor at every hour.  No treatment medications were reported.
The only symptom he has is left sided anterior chest pain with inspiration and he states it started 3-4 weeks after the second dose of Moderna vaccine which he received on 08/09/21.His EKG is consistent with pericarditis. His labs/CXR and repeat EKG as well as Cardiology evaluation are pending. He is on Ibuprofen which helps him.
PATIENT REQUESTED TO BE VACCINATED BY FIRST DOSE OF PFIZER BRAND VACCINE FOR COVID 19. VACCINATION HAPPENED AT AROUND 9:39 PM PST. FEW MINUTES AFTER VACCINATION, PATIENT REPORTED FEELING DIZZY. IMMEDIATELY AFTER THAT, HIS BODY STARTED TO EXPERIENCE JERKINGS AND HIS EYES SEEM TO POP OUT. THIS LASTED FOR AROUND 30 SECONDS. PATIENT REGAINED NORMAL STATE OF CONSCIOUSNESS AFTER THOSE 30 SECONDS. HE MENTIONED FEELING FINE. 911 WAS CALLED. PARAMEDICS CAME AT AROUND 10:40 PM. PATIENT WAS CLEARED TO BE NORMAL BY THEM AFTER WHICH HE LEFT THE FACILITY
No additional adverse events reported; an extra dose of VARlVAX was administered to a patient (third dose); This spontaneous report has been received from a nurse, referring to a 16-year-old patient of unknown gender. The patient's pertinent historical vaccines included measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD). The patient's drugs reactions or allergies and concomitant medications were not reported.  On an unknown date, the patient was vaccinated with the first dose of varicella virus vaccine live (Oka/Merck) (VARIVAX), then on 23-MAR-2011, the patient was vaccinated with the second dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) both were received as prophylaxis (strengths, doses, exact frequencies, routes of administration, anatomical injection sites, lot numbers and expiration dates were not reported).  On 31-JAN-2022, the patient was vaccinated with the third dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) at the dose of 0.5 milliliter (strength, route of administration, anatomical injection site, lot number and expiration date were not reported) as prophylaxis (extra dose administered). These was outside the recommendations of the prescribing information. It was reported that the patient received three dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) because when they entered the administration date into their electronic health record, they noticed the other two doses of this vaccine, previously they only noted the historical vaccine measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD). No other information given. No additional adverse events reported.
Went to bed feeling fine. Woke up an hour later with chills and a fever. Condition continued and couldn?t fall back asleep for a few hours. Took 4 Advil around 4am and was able to fall asleep shortly after. Slept straight through until 5:30pm on 4/19/21. Woke up feeling a little weak and tired, but no more fever or chills.
that I had a pretty serious reaction to the moderna vaccine on Wed 1/6.  12 hours after the dose I started with chills and fever.  I also got a headache and muscle/joint aches.  I ended up missing work the day after the vaccine.
Patient had notable bruising and nose/gum bleeding the week of December 11, 2017 (2 weeks prior to a scheduled tonsillectomy). Patient CBC w/ Diff noted below. Treatments have been WinRho et IVIG.
lip swelling, tongue face, lower jaw, throat, body aches, chills, headaches, possible fever, nausea
PUNCTURED VIAL OF THE VACCINE WAS ADMINISTERED EXCEEDED TIME FRAME BY 1 ONE HOUR OUTSIDE OF THE 6 HOUR TIME PERIOD; VIAL OF VACCINE WAS PUNCTURED OUTSIDE OF THE 6 HOUR TIME PERIOD; This spontaneous report received from a health care professional concerned a 48 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 211A21A expiry: 14-DEC-2021) dose was not reported, administered on 26-OCT-2021 15:05 for prophylactic vaccination. No concomitant medications were reported. On 26-OCT-2021, the patient experienced punctured vial of the vaccine was administered exceeded time frame by 1 one hour outside of the 6 hour time period. On 26-OCT-2021, the patient experienced vial of vaccine was punctured outside of the 6 hour time period. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the punctured vial of the vaccine was administered exceeded time frame by 1 one hour outside of the 6 hour time period and vial of vaccine was punctured outside of the 6 hour time period was not reported. This report was non-serious.
Significant  shoulder pain and restricted range of motion in shoulder and arm.  Pain radiated down through arm to thumb.  Resulted in lack of sleep due to pain at night.  Naproxen taken for pain with no result.
Achy arm, painful glands in armpit and chest, painful if deep breath, exhaustion
Injection site pain; Chills; nausea; fever 99.5; This is a spontaneous report from a contactable consumer.  A 50-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on the right arm on 30Jan2021 10:00 at a single dose for COVID-19 immunization in a clinic. Medical history included high blood pressure and COVID-19 prior to vaccination.  The patient was not pregnant. Concomitant medication included hydrochlorothiazide, lisinopril hydrochlorthiazid, loratadine, and fluticasone propionate (FLONASE). The patient experienced injection site pain, chills, nausea, fever 99.5 on 30Jan2021 10:00. The patient did not receive any treatment for the events. The patient was recovering from the events.  Information on lot/ batch number has been requested.
Information has been received from a consumer concerning her now 18 year old son who on an unknown date when he was younger, was vaccinated with VARIVAX (Merck) (lot # not reported). Subsequently the patient developed chicken pox. Unspecified medical attention was sought. No further information was available.
Systemic: Allergic: Rash Generalized-Severe, Systemic: Body Aches Generalized-Severe, Systemic: Chills-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Nausea-Severe, Systemic: Unable to Sleep-Severe
This spontaneous report was received from a pharmacist who reported that five infant patients between 2 and 10 months of age (gender not provided) were inadvertently administered a third dose of PEDVAXHIB (dose, route, frequency and lot# not provided) two months after a second dose. No adverse effects were reported. Follow up information was received from the pharmacist. Patient identifiers (initials and birthdates) were provided. Lot numbers and expiration dates were unavailable at this time. This is one of several reports received from the same source. Additional information has been requested.
Patient received 4 doses of Shingrix. 2 doses given at Pharmacy in 2018 and 2 doses given at another pharmacy last year. No adverse effects reported.
received second after six months/ First dose in Nov2020 and second dose on 30Apr2022; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 60-year-old female patient who received Herpes zoster (Shingrix) (batch number DP2D3, expiry date 25th May 2023) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in November 2020).   In April 2022, the patient received the 2nd dose of Shingrix. In April 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK receipt date: 19-Sept-022 Reporter's comment: The reporter did not consent to follow-up. The case was linked with case US2022134473, reported by same reporter. Additional supportive information: The patient received 2nd dose of Shingrix later than the recommended interval, which led to lengthening of vaccine schedule.; Sender's Comments:  US-GSK-US2022134473:Same reporter
7/10/19 Symptoms started within 2 hours, red at injection site. The next day 7/11/2019 05:00pm patient had fever, cold chills flu like symptoms. At 02:00am 7/11/19 patient took 2 Tylenol and was sweating.  on 7/12/2019 symptoms have resolved as of 01:11pm except redness at injection site.
A few weeks after, had nausea. Vomiting blood and bloody stools. Over time blood counts low. Upcoming surgical procedure , upper GI tract.
PATIENT CAME IN TO RECEIVE HER 2ND DOSE OF COVID 19 VACCINE PFIZER. SHE HAD RECEIVED HER FIRST PFIZER DOSE AT THIS LOCATION ON 8/7/2021. UPON PROCESSING THE VAR FORM WE DISCOVERED THAT THE PATIENT ALREADY RECEIVED THE COVID 19 VACCINE JANSSEN  ON 4/12/2021. WE INFORMED THE PATIENT THAT WE WOULD NOT BE ABLE TO PROVIDE HER A 2ND DOSE OF PFIZER AT THIS TIME BECAUSE SHE HAD COMPLETED THE JANSSEN SERIES AND RECEIVED 1 DOSE OF THE PFIZER VACCINE ALREADY. NO ADVERSE EVENT REPORTED
I had dysphagia, deep body aches, nausea, extremely weird dreams. I took my Celebrex and that did not help with the body aches. I took have of a Norco that had been prescribed and that helped to relieve some of my discomfort. It felt worse than when I had COVID. Extremely low energy.
skin flaked off on checks and around my mouth; Burning sensation; Raised red rash on my face and neck; This is a spontaneous report from a contactable Consumer. A 53-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 19Feb2021 14:00 (Batch/Lot Number: EL9267; 53-year age at time of vaccination) as SINGLE DOSE for covid-19 immunisation . The patient medical history was not reported.  There were no concomitant medications. The patient previously took bnt162b2 first dose Left arm on 23Jan2021 02:00 (Lot number= EL0142) for covid-19 immunisation; Allergic to betadine, Balsam. On 19Feb2021 14:00, it was reported raised red rash on my face and neck. burning sensation and skin flaked off on checks and around my mouth. Patient received treatment with steroids. Patient not had covid prior vaccination; covid not tested post vaccination. The outcome of the events was recovering.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the Skin Disorders, Burning Sensation, Rash Erythematous and the suspect BNT162B2.