chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Soreness, bruising at injection site; Soreness, bruising at injection site; dry+ scratchy throat with nasal congestion; dry+ scratchy throat with nasal congestion; dry+ scratchy throat with nasal congestion; Dose 1: 20210501 and Dose2: 20210515; This is a spontaneous report from a contactable consumer, the patient. A 16-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE: Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 15May2021 at 12:30, (at the age of 16-year-old) as a single dose for COVID-19 immunisation. Medical history included anemia, oral allergy syndrome and allergy to penicillin. Concomitant medications included cetirizine hydrochloride (ZYRTEC), for unknown indication from an unknown date. The patient previously received the first dose BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE: Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 01May2021 at 14:30, (at the age of 16-year-old) as a single dose for COVID-19 immunisation. 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 16May2021, the patient experienced Soreness, bruising at injection site, and dry + scratchy throat with nasal The patient did not receive any treatment for the reported event. The clinical outcome of the event vaccination site pain, vaccination site bruising, dry throat, itchy throat and nasal congestion was recovered on 16May2021.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
This spontaneous report was received from a registered nurse and refers to a female patient of unknown age. The patient's pertinent medical history and concurrent conditions were not provided. On 29-JAN-2016, the patient was vaccinated with a dose of MMR II lot # K000255, expiration date 08-JAN-2016 (route was not provided). Concomitant therapy information was not provided. On 29-JAN-2016, an expired product was administered as the patient accidentally received an expired dose of MMR II. No adverse event was reported. It was unknown if the patient sought medical attention. At the time of the report, the patient's status was unknown. Additional information has been requested.
I had hives despite having taken my daily dose of Claritin that seemed to get worse as the day continued. I reached out to my Healthcare clinic and they were unsure if there was a simple treatment and almost required me to go the emergency room for this. I conducted a telehealth consultation with a doc who was not my primary care physician and was unfamiliar with my preexisting exercise urticaria condition that occasionally results in light hives but never anaphylaxis for me without Claritin. I declined going to the emergency room since this did not seem that serious and instead took another Claritin to try to get the somewhat worsening hives with no apparent cause to stop without an unnecessarily escalated situation. My throat was slightly itchy but I never became anaphylactic likely due to taking an additional Claritin and not doing anything requiring physical effort for the day beyond telecons from home because I left the office to telework mid morning after I started getting continually slightly worse hives. By evening I was ok and the next day just had a slightly sore throat but was able to work and just started the day with 2 Claritin without any further instance of hives appearing. The day after that I returned to my standard 1 Claritin dose with no ill effects. From this event, it seems clear that a 72 hour downing period from dose 1 is insufficient and should be upped to 96 hours. Prior to this more severe event, I had, on days 2 and 3, a sore left arm at injection site that prevented me from even reasonably lifting my arm to a height sufficient to grab my cell phone off it's charger while lying in bed without serious discomfort. That level of arm discomfort prevented me from working out or would have prevented me from anything other than light office work involving my vaccine arm. My level of tiredness for the couple days following this dose also required that I take an hour long nap days 1 and 2, and no nap at all is usually the norm for me.
On 12/11/14 @ approx 9pm, her left toes became numb. By 10pm both feet were numb (sensory-very cold, like ice). On 12/13/14, she had complete parasthesis from waist down with very numb perineum. She vomited twice late in the evening and was admitted to Emerg Dept that night around 8pm. After initial work up, she was admitted to hospital overnight. She was discharged on 12/14/14 under the care of neurologist. Nerve conduction studies of legs and feet were negative. The first MRI was done on 12/19/14 of thoracic and lumbar spine. The results were demyelination of posterior spinal cord at T3 to T5. The second MRI was performed on 12/31/14 of brain and cervical spine. The results were negative. A lumbar puncture was performed on Jan 7th. The results showed an elevated WBC count but negative for oligoclonal bands. She received Methylprednisolone 1000mg daily via IV infusion x 3 days. To date, the condition has improved but has not resolved.
DEATH; ANAPHYLAXIS; HEART ATTACK; UNRESPONSIVE; This spontaneous report received from a consumer via a company representative via a social media concerned a female of unspecified age of unspecified race and ethnicity. 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: Unknown) 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. The reporter stated that, "your vaccine killed the patient. Not all and epi does not save everyone anaphylaxis can cause a heart attack. This was how my friend's sister died. Within 13 hours of getting the jab she was unresponsive". The patient died on an unspecified date from an unknown cause. It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable The outcome of anaphylaxis, heart attack and unresponsive was not reported. This report was serious (Death, and Other Medically Important Condition).; Sender's Comments: V0: 20211107237-covid-19 vaccine ad26.cov2.s -Death, heart attack, unresponsive. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). 20211107237- -covid-19 vaccine ad26.cov2.s-Anaphy?laxis This event(s) is labeled per Regulatory Authority and is therefore considered potentially related.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Muscle spasms throughout the entire left side of body and all over body aches with a headache
Approx 5 mins after receiving flu shot, pt found sitting slumped and mumbling in chair. Patient was conscious but not responding to questions. Rph asked staff member to call 911 immediately and 2nd rph prepared epipen for administration. rph returned to patient who (approx ~10 seconds after being found) was responsive to questioning and coherent. Patient claimed to have upset stomach and dizzy/had to use bathroom. patient was sweating and clammy. Rph engaged patient in conversation until paramedics arrived. Paramedics said blood pressure was low at sitting and standing position and determined patient needed to go to er for further evaluation. (Epipen not given to patient at store).
feeling terrible; He started experiencing side effects like fever, nausea, dizziness, and sweats the same night that he received his 2nd dose.; dizziness; fever; nausea; This spontaneous case was reported by a patient family member or friend and describes the occurrence of FEELING ABNORMAL (feeling terrible), HYPERHIDROSIS (He started experiencing side effects like fever, nausea, dizziness, and sweats the same night that he received his 2nd dose.), DIZZINESS (dizziness), PYREXIA (fever) and NAUSEA (nausea) in an adult male patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19 (Patient was diagnosed with COVID in 2020.) in 2020.    On 02-Jan-2023, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 02-Jan-2023, the patient experienced FEELING ABNORMAL (feeling terrible), HYPERHIDROSIS (He started experiencing side effects like fever, nausea, dizziness, and sweats the same night that he received his 2nd dose.), DIZZINESS (dizziness), PYREXIA (fever) and NAUSEA (nausea). At the time of the report, FEELING ABNORMAL (feeling terrible), HYPERHIDROSIS (He started experiencing side effects like fever, nausea, dizziness, and sweats the same night that he received his 2nd dose.), DIZZINESS (dizziness), PYREXIA (fever) and NAUSEA (nausea) had not resolved.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  Reporter was calling on behalf of her husband. Reporter stated that her husband received 2nd dose of the Moderna COVID-19 vaccine on 02-Jan-2023. The patient started experiencing side effects like fever, nausea, dizziness and sweats the same night that patient received 2nd dose. Also said that the patient had been feeling terrible since receiving the vaccine. The patient was told that the side effects could last for 3 days but patient's side effects were ongoing at the time of report. Reporter would like to know if it was normal to experience side effects for so long.  No treatment information was provided.   Reporter did not allow further contact
Got scheduled second dose in 45 days which is outside the window period; This spontaneous case was reported by an other health care professional and describes the occurrence of OFF LABEL USE (Got scheduled second dose in 45 days which is outside the window period) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced OFF LABEL USE (Got scheduled second dose in 45 days which is outside the window period). At the time of the report, OFF LABEL USE (Got scheduled second dose in 45 days which is outside the window period) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Her second dose scheduled on 04-SEP-2021 and couldn't take it due to health conditions.  No concomitant medications reported.  No treatment information was reported by reporter.
approximately 10 minutes after administration of vaccines patient became silent and stiff. Code blue was announced, V/S were taken, patient was seen by pediatric provider to be referred to Neurology for further work up.
REVACCINATION WITH DIFFERENT COVID-19 VACCINE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient through other manufacturer (Pfizer) concerned a 29-year-old female. The patient's height, and weight were not reported. The patient was not pregnant at the time of reporting. The patient stated that she was taking other medication or products within 2 weeks of starting covid-19 treatment (Paxlovid). The patient was previously experienced significant vomiting when treated with oseltamivir phosphate(Tamiflu) and it was classified to be an allergic reaction.  The patient previously received non-company suspect vaccine Moderna Covid-19 vaccine (elasomeran) (dose number in series 1) (form of administration, route of administration, batch number were not reported, expiry: unknown), dose was not reported, administered on 08-OCT-2021 to right arm for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination with Moderna Covid-19 vaccine (elasomeran) (dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of administration, batch number were not reported, expiry: unknown) dose was not reported, 1 in total was administered on 11-MAR-2022 to right arm for covid-19 prophylaxis which was an revaccination with different covid-19 vaccine (dose number in series 2). The batch number was not reported and has been requested. Age at time of vaccination 28 years old. Concomitant medications included amfetamine aspartate/amfetamine sulfate/dexamfetamine saccharate/dexamfetamine sulfate, (D Amphetamine Salt Combo), and levonorgestrel (Mirena).  On an unspecified date in 2022, the patient experienced COVID-19 which was coded as suspected covid-19 infection (dose number in series 2). On 27-OCT-2022, the patient was treated with non-company suspect drug Paxlovid (route of administration, batch number and expiry were not reported) dose and frequency were not reported for covid-19 treatment and last administered on 01-NOV-2022. On 02-NOV-2022; 08:00, approximately 24 hours after non company suspect drug paxlovid treatment, the patient symptoms started to resurface that had previously disappeared particularly the patients cough/lung irritation (dose number in series 2). The patient never had nasal drainage at any point while having COVID and had all congestion in her chest. After finishing the non company suspect drug paxlovid treatment, On 02-NOV-2022, after paxlovid treatment the patient started to had an significant amount of nasal drainage. The patient was exhausted the entire time when she had COVID, however the exhaustion was significantly worse after finishing paxlovid (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable and with Paxlovid was drug discontinued on 01-NOV-2022. The patient had not recovered from suspected covid-19 infection and the outcome of revaccination with different covid-19 vaccine was not reported. This report was non-serious.
body soreness; swelling; Fatigue; headache; fever; chills; itchy; This is a spontaneous report from a contactable consumer (patient). A 53-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EN6203 and expiry date was not reported), via an unspecified route of administration, in Arm Left, on 01Mar2021 at 10:00 AM (age at vaccination: 53 years), as a single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient's medical history included diabetes type 2 and thyroid. Concomitant medications were not reported. It was unknown if the patient had known allergies. The patient was not diagnosed with COVID prior vaccination. The patient was not tested for COVID post vaccination. The patient did not receive any other vaccine in four weeks. On 01Mar2021 at 11:30 AM, the patient experienced fatigue, headache, body soreness, fever, chills and a week later COVID arm at injection site, soreness and itchy with swelling. The patient did not receive any treatment for the events. Outcome of the events was resolved on an unspecified date in Mar2021.  No follow-up attempts are possible. No further information is expected.
Information has been received from a medical assistant referring to a patient of unknown age and gender. Information of concomitant therapy, pertinent medical history and drug reactions/allergies was not reported. On 28-NOV-2018, the patient was vaccinated with improperly stored PNEUMOVAX 23 (lot # R018731, expiration date: 27-FEB-2020, strength, dose, frequency and route unknown) for prophylaxis. No adverse effects were reported. The vaccines were exposed to temperature of 47 Fahrenheit (F) for 37 minutes. The temperature excursion was detected by a data logger. Previous temperature excursions were reported as 47 Fahrenheit (F) for 50 minutes. Sender's Comments: US-009507513-1901USA004786.
This Morning I noticed my left arm itching at the site of the shot by night it was even more read and itchy but also achy and feverish. I did sleep on that side last night some and I usually do not sleep on that side at all. I washed my arm with a cold wash cloth and left the cold compress on it for a few minutes. It took away the itchyness but it still felt feverish but also not achy as much
other side of back is pain; Chills; Fever; threw up two times; Headache; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (other side of back is pain), CHILLS (Chills), PYREXIA (Fever), VOMITING (threw up two times) and HEADACHE (Headache) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 049C21A and 061E21A) for COVID-19 vaccination. No Medical History information was reported. On 01-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Nov-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced BACK PAIN (other side of back is pain), CHILLS (Chills), PYREXIA (Fever), VOMITING (threw up two times) and HEADACHE (Headache). At the time of the report, BACK PAIN (other side of back is pain), CHILLS (Chills), PYREXIA (Fever), VOMITING (threw up two times) and HEADACHE (Headache) was resolving. No concomitant medications were provided by the reporter. No treatment medications were provided by the reporter.
This spontaneous report received from a patient concerned a 54 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate to severe rheumatoid arthritis, moderate to severe chronic plaque psoriasis, and moderate to severe ulcerative colitis, and other pre-existing medical conditions included: The patient had no known allergy, no concomitant drugs taken and no relevant medical history. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: UNKNOWN) dose, start therapy date were not reported, and dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: upadacitinib (form of admin unknown, oral, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe rheumatoid arthritis, moderate to severe chronic plaque, and moderate to severe ulcerative colitis. No concomitant medications were reported. On an unspecified date, the patient experienced Covid-19 infection, off label use, and inappropriate schedule of vaccine administered. The action taken with Covid-19 vaccine ad26.cov2.s, and upadacitinib was not applicable. The outcome of the off label use, Covid-19 infection and inappropriate schedule of vaccine administered was not reported. This report was non-serious. This case, involving the same patient is linked to 20220345561.
I had a hard time sleeping, nose was running, so I stayed home from work. On the third day I woke up with an extremely sore throat, and I went to the doctor, and he tested me and told me that I had COVID.  He prescribed LAGEVRIO (MOLNUPIRAVIR) 200 MG. I started taking it and within 3-4 days felt much better. I still quarantined at home for 10 days after the onset of my illness.
Developed a generalized raised, red rash within 48 hrs after receiving the vaccine. (04/19/2018) Rash appeared like stages of chicken pox rash and very itchy. Several calls were made to the clinic regarding the rash, but it was felt that it was not d.t. the vaccine. However, when seen my Dr. on 05/02/2018, it was determined to be a reaction to the SHINGRIX vaccine. Prednisone was described for 6 days and rash subsided.  Aprox. 48 hrs after last dose of prednisone, the rash reappeared and a 10 day course of Prednisone was prescribed. At this time, one week after the last dose of Prednisone, there are still patchy, itchy areas that are still appearing or have not gone completely away.
diagnosed with hyperthyroidism; This is a spontaneous report received from a contactable reporter(s) (Physician) via Regulatory Authority.  A 55 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administration date 15Oct2021 (Lot number: FF2589) at the age of 55 years as dose 2, single for covid-19 immunization in Physician office. The patient was not pregnant when administration. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose number=1, lot number=FF2589, administrator route=Intramuscular), administration date: 24Sep2021, when the patient was 55 years old, for COVID-19 immunization. The following information was reported: HYPERTHYROIDISM (medically significant) with onset Dec2021, outcome "unknown", described as "diagnosed with hyperthyroidism". The event "diagnosed with hyperthyroidism" was evaluated at the physician office visit. It was unknown if therapeutic measures were taken as a result of hyperthyroidism. The patient called and informed the reporter that she was diagnosed with hyperthyroidism approximately a month after the second Pfizer vaccination.; Sender's Comments: As an individual case report there is not enough evidence to establish a causal relationship with the suspect vaccine. Currently there is no clear biological plausibility between the vaccine use and the even onset.  More information such as complete medical history and concomitant medications are needed for fully medical assessment.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
This spontaneous report was received from a nurse concerning a patient of unknown age and gender. Pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On 25-MAY-2018, the patient was vaccinated with second dose of GARDASIL 9 injection lot # N023828 expiry date: 25-JUN-2020 for prophylaxis (strength, dose, dosage schedule and anatomical location were not provided). The nurse reported that the patient received the first dose of GARDASIL 9 on 17-APR-2017. No adverse effect was reported.
He caught a seizure and he suffers from seizures.; 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 38-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SEIZURE (medically significant), outcome "unknown", described as "He caught a seizure and he suffers from seizures.". The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
patient had tingly lips and mouth after 8 minutes, monitored for 30 minutes with no worsening of symptoms. BP 140/95 when first had symptoms with pulse of 88. at end BP was 140/98 with pulse of 80. patient had no other symptoms of allergy. recommended to follow up with urgent care and had husband drive her home