chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a vaccine coordinator refers to unspecified number of patients of unknown age and gender. The patients' pertinent medical history, drug reactions, allergies and concomitant medications were not reported. On an unknown date the patients were vaccinated with improperly stored doses of GARDASIL 9 (dose and route were not reported) lot # L040054 and expiry date: 26-DEC-2017. The vaccine was exposed to a temperature frame of 33.20 Fahrenheit for 20 minutes. There were no previous excursions and there was no data logger involved. No adverse events were reported and there was no product quality complaint (PQC). This is one of the two reports from the same reporter. Additional information has been requested.
CONFIRMED COVID-19 INFECTION; BLOOD CLOTS IN LUNGS; This spontaneous report received from a consumer 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: Unknown) dose, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient was hospitalized. The patient was diagnosed with corona virus disease a week after vaccination. On an unspecified date, the patient experienced blood clots in lungs. The patient was moved to intensive care this week. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from blood clots in lungs, and the outcome of confirmed covid-19 infection was not reported. This report was serious (Hospitalization Caused / Prolonged). This report was associated with product quality complaint: 90000183689.; Sender's Comments: V0: 20210648173-COVID-19 VACCINE AD26.COV2.S-Confirmed COVID-19 infection. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS 20210648173-COVID-19 VACCINE AD26.COV2.S-Blood clots in lungs. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Information has been received from a physician concerning an adult female who on an unspecified date was vaccinated with the first 0.5mL dose of pneumococcal 23v polysaccharide vaccine. On approx 14Nov05, week of 14Nov05, the pt developed injection site redness, swelling and fever. The pt sought unspecified medical attention. At the time of this report, the pt had recovered from the events (date unk). Additional information has been requested.
No additional AE reported; RECOMBIVAX HB had been inadvertently administered after its labeled expiry date; This spontaneous report was received from a physician who refers to a 14-year-old female patient. Information regarding the patient's drug reactions or allergies, concomitant therapies and her pertinent medical history was not provided. On 02-JUN-2021, the patient was inadvertently vaccinated with expired hepatitis b vaccine (recombinant) (RECOMBIVAX HB) vial, lot # R021372, expiry date 25-MAY-2021, for prophylaxis (concentration, dose, dose number, route of administration, frequency, were not reported). The physician inquired if the vaccine was still viable and if the patient would need to be revaccinated. No additional adverse event was reported. No product quality complaint (PQC) was involved.
Went to urgent care after the first dose; Walking is very difficult after the vaccine; pain; muscle pain is much worse; Chills; Joint pain which are still there; Headaches feel worse after second dose; There's always different muscles that hurt; my arm was sore for a day or two; muscle aches got worse overtime; less than 10 minutes, I had fatigue very strong; body feels like I have flu; This spontaneous case was reported by a consumer and describes the occurrence of GAIT INABILITY (Walking is very difficult after the vaccine), PAIN (pain), CAREGIVER (Went to urgent care after the first dose), MALAISE (body feels like I have flu) and MYALGIA (muscle pain is much worse) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and Lot# 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Multiple sclerosis.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced MALAISE (body feels like I have flu), FATIGUE (less than 10 minutes, I had fatigue very strong), ARTHRALGIA (my arm was sore for a day or two) and MYALGIA (muscle aches got worse overtime). On 01-Apr-2021, the patient experienced GAIT INABILITY (Walking is very difficult after the vaccine), PAIN (pain), MYALGIA (muscle pain is much worse), CHILLS (Chills), ARTHRALGIA (Joint pain which are still there), HEADACHE (Headaches feel worse after second dose) and MYALGIA (There's always different muscles that hurt). On an unknown date, the patient experienced CAREGIVER (Went to urgent care after the first dose). The patient was treated with TRAMADOL at an unspecified dose and frequency. At the time of the report, GAIT INABILITY (Walking is very difficult after the vaccine), PAIN (pain), CAREGIVER (Went to urgent care after the first dose), MALAISE (body feels like I have flu), MYALGIA (muscle pain is much worse), CHILLS (Chills), ARTHRALGIA (Joint pain which are still there), HEADACHE (Headaches feel worse after second dose), FATIGUE (less than 10 minutes, I had fatigue very strong), MYALGIA (There's always different muscles that hurt), ARTHRALGIA (my arm was sore for a day or two) and MYALGIA (muscle aches got worse overtime) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.   This case was linked to MOD-2021-106452 (Patient Link).
At first, hives all over the body. There were welts which were very itchy. The hives would appear in one place, then after several hours disappear and then reappear someplace else. At the same time, red rashes would also appear and disappear, only to reappear elsewhere on the body. His entire body was effected including scalp, arms, faces, legs, and buttocks. The hives were very itchy and it was hard to control them and antihistamines didnt really work much. it has been 20 days since the hives started and at this point it has now become  the red rash that appears and disappears, there does not seem to be the hives anymore. Also, the entire time this was happening there was dermagraphia and there is still dermagraphia. Anything that rubbed the body leaves  red raised marks which linger for hours and finally disappear, only to reappear when the skin is rubbed one scraped in the least way.
15 minutes after vaccine was administered, client c/o generalized itching and hives to arms.  EMS was onsite and immediately transported to local hospital.  Per EMS report, 1 dose of Epi was administered in route to hospital due to respiratory symptoms.
Patient had a syncopal episode after 15 minutes of taking the vaccine that caused an MVA.
I am still little nauseous; This is a spontaneous report from a contactable consumer (patient). This unknown age and gender patient received BNT162B2 (COVID Vaccine, Batch/lot number: EL3246) on an unspecific date at single dose for COVID-19 immunization. Medical history and concomitant drug were not reported. Patient stated that feeling nauseous. 'I took it on Wednesday, 6th (not clarified) and I am still little nauseous'. Outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected.
Erythema multiforme devel w/in 48 hrs of vax; WBC 20,000 cultures-neg;
radiating pain; numbness; tingling; fatigue; malaise; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (radiating pain), HYPOAESTHESIA (numbness), PARAESTHESIA (tingling), FATIGUE (fatigue) and MALAISE (malaise) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Respiratory infection (Respiratory issues like (asthma,lung damage, frequent  sinus conditions)) and Lung damage.    On 03-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 2. On an unknown date, the patient experienced PAIN (radiating pain), HYPOAESTHESIA (numbness), PARAESTHESIA (tingling), FATIGUE (fatigue) and MALAISE (malaise). The patient was treated with ACETAMINOPHEN (oral) ongoing since an unknown date at a dose of 1000 mg and METHYLPREDNISOLONE (METHYL PRED) (oral) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, PAIN (radiating pain), HYPOAESTHESIA (numbness), PARAESTHESIA (tingling), FATIGUE (fatigue) and MALAISE (malaise) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Acetaminophen-1000mg and methyl [prednisolone drugs are used as treatment
Blood work came back with a low white blood cell count of 3.1; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: ER2613) via an unspecified route of administration in the right arm on 14Apr2021 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient did not have any other medications in two weeks. The patient previously took codeine (MANUFACTURER UNKNOWN) for an unknown indication on an unknown date and experienced rashes. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number, unknown) via an unspecified route of administration in the right arm on 24Mar2021 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the 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. On an unknown date in 2021, the patient blood work came back with a low white blood cell count of 3.1(unspecified units). The patient never ever had a low white blood cell and the patient gets her blood tested twice per year. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event blood work came back with a low white blood cell count of 3.1 was unknown at the time of this report.  No follow-up attempts are needed. No further information is expected.
PATIETN FELT  DISSNIEY AFTER THE BOOSTER PFIZER DOSE  LIGHT HEADED HAD TROBLE BREATHING AND TINGLING IN HIS HANDS
This spontaneous report as received from a nurse refers to a patient of unknown age. The patient's medical history was not reported. On 06-JUL-2017, the patient was vaccinated with an improperly stored dose of VARIVAX (Strength, dose, frequency, route, anatomical location and expiration date were not reported) of lot # M034586 for prophylaxis. Concomitant therapies included sterile diluent. The nurse confirmed that the sterile diluent used to reconstitute the VARIVAX was properly stored. No adverse effects reported. The vaccines were exposed to multiple defrost cycles with respect to temperature for an unknown timeframe. There was no temperature excursion. There was no digital data logger involved. There was no product quality complaint involved.; Sender's Comments:  US-009507513-1708USA008906: US-009507513-1708USA008905: US-009507513-1708USA008904: US-009507513-1708USA008907:
A report from a nurse concerns a 9 year old female. Relevant medical history and concomitant diseases were unknown. During Oct-2013, patient received nasal FLUMIST QUADRIVALENT. During Dec-2013, the patient was tested positive for influenza A. Action taken with FLUMIST QUADRIVALENT was unknown. At the time of reporting the outcome of the event of influenza A was unknown. The report was considered to be non-serious by the reporter.
Moderna COVID-19 Vaccine EUA.   Diagnosis of erythema nodosum which started 10 days after second vaccine.
Patients where administered with vaccines that experienced more than 1 temperature excursion during 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 (Patients where administered with vaccines that experienced more than 1 temperature excursion during 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 96-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2021 at 10:50 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 07-Jan-2021 at 10:50 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patients where administered with vaccines that experienced more than 1 temperature excursion during 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 (Patients where administered with vaccines that experienced more than 1 temperature excursion during 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.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 96.36.  Concomitant products were not provided.  On 07-Jan-2021, At excursion time 09:00 AM, temperature was 34, total doses given for the day was 96 and at 10:00 AM, temperature was 34, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 05-Jan-2021, vial was moved to clinic on 07-Jan-2021. 6 vials were sent to clinic. Vaccine BUD date was 27-Jan-2021.  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 vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
Information has been received from a LPN concerning a male patient was on 06/16/1997 was vaccinated with varicella virus vaccine live and was vaccinated a second time on 06/21/1997 (product misuse) with varicella virus vaccine live. A booster shot of varicella virus vaccine live was administered in January, 1999. On 10/26/2000, the patient had another titer drawn which still showed no seroconversion. The patient was "just exposed to a hospitalized patient who had open, draining shingles". The patient sought unspecified medical attention. Additional information has been requested.
Tinnitus started in the early morning after the shot. Was loud for about 24 hours. The second day after,  I woke up, and it has subsided a bit. As I type this at 01:23 PM on 4/28/2021, it seems to be getting louder again. Primary care doctor said there was nothing they could do.
I had vaccination on 09/21/2022. On 10/18/2022 I started to have heart palpitations in bed my heart rate 115 to 135 for every 1 to 2 minutes. I was able to get the hard data from my apple watch. I have had a history of these palpitations but have never been diagnosed. This lasted about 30 minutes intermittingly. I have been having more episodes than I have had in the past. I saw urgent care 10/19/2022 and had an EKG. Doctor recommended following up with cardiology.
By the night came she had the chills very bad. Her skin felt like it was burning all over and she had a rash for three days.  A month after taking the booster she started experiencing some neurological issues.
This spontaneous report as received from a nurse refers to a patient of unknown age. The patient was vaccinated with RECOMBIVAX HB intramuscular (dose, and lot # not reported). No other co-suspects were reported. No concomitant medications were reported. A preterm infant received RECOMBIVAX HB, intramuscularly at birth, and also at 2 months and 4 months after birth. No known adverse effects. No treatment information was reported. No further information was available. Additional information has been requested.
patient is not in great health; This is a spontaneous report from a Pfizer sponsored program. A contactable pharmacist reported that a 76-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry date not reported) in Jan 2021 via an unspecified route of administration as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unknown date in 2021, the patient was not in great health and was just admitted to nursing home and the nursing home doctor called. She said it was 21 to 42 day out for the second dose and asks for confirmation on that window and asked whether it needs to be started. She says that she asked her to at least do a test for antibodies but she is not sure It was reported that it has now been 3 months out and asked whether the patient can take the second dose and whether it would still be effective. The outcome of event was unknown.  Information on the lot/batch number has been requested. Additional information has been requested; Sender's Comments: Based on the known safety profile of the vaccine BNT162B2, a temporal relation between the event asthenia and the administration of the vaccine cannot be excluded.
On 12Aug2021, symptoms started in the evening. On 14Aug2021: PCR (nasal swab) COVID test was taken. On 17Aug2021: notification of positive test; On 12Aug2021, symptoms started in the evening. On 14Aug2021: PCR (nasal swab) COVID test was taken. On 17Aug2021: notification of positive test; This is a spontaneous report from a contactable consumer (patient). A 55 year old female patient received bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, solution for injection), dose 2 intramuscular, administered in Arm Left on 16Feb2021 08:00 (at the age of 54 years old) (Lot number was not reported) as dose 2, single; the first dose intramuscular, administered in Arm Left on 26Jan2021 08:00 (Lot number was not reported) as dose 1, single for COVID-19 immunisation. Medical history included known allergies to amoxicillin. There were no concomitant medications. Prior to vaccination, patient was not diagnosed with COVID-19. Patient was not pregnant at the time of vaccination. No other vaccines received within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications received within 2 weeks of vaccination. On 12Aug2021, symptoms started in the evening. On 14Aug2021: PCR (nasal swab) COVID test was taken. On 17Aug2021: notification of positive test. The event resulted in a Doctor or other healthcare professional office/clinic visit. No treatment was given for the events. Since the vaccination, the patient has been tested for COVID-19. The outcome of the event was recovering.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Tightness in neck; This is a spontaneous report from a contactable nurse, the patient. A 71-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6205) via an unspecified route of administration in the left arm on 03Mar2021 at 14:30 (at the age of 71-year-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism, gastroesophageal reflux disease (GERD), arthritis and chronic back pain. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included levothyroxine sodium (LEVOTHYROXIN), gabapentin (MANUFACTURER UNKNOWN) and famotidine (PEPCID); all from an unknown dates for an unknown indication and unknown if ongoing. The patient previously received codeine (MANUFACTURER UNKNOWN) and morphine (MANUFACTURER UNKNOWN) for an unknown indication on an unknown date and experienced severe nausea. On 03Mar2021 at 23:00, the patient experienced tightness in neck. No therapeutic measures were taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event neck tightness was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Patient presented with Lethargy, Fainting, Dizziness, temporary loss of vision, sweatiness, temporary loss of hearing, 911 was called
Patient stated that on Thursday night, October 14th, that she started having a headache and that the headache carried over into Friday the 15th. Pt stated that the headache got worse on Friday and that it was a shooting pain behind her eye and that the bright lights at work were making it worse like she needed to wear sunglasses or leave. She ended up leaving work early afternoon. Pt stated that night (Friday October 15th) that she was eating dinner (enchiladas) and she went to swallow her food and it got stuck. Pt stated that during the time the food got stuck she could still breath and wasn't choking. Pt stated it took 6-7 minutes to get the food to go down and she tried to remain calm. Didn't go to the ER because she didn't feel like it was an emergency. Pt stated that she didn't eat anymore and just drank hot water and that the next day her throat was sore like it was bruised but that the headache had  gone away. She stated that she has been able to swallow fine since and today (Monday October 18th) is feeling better. Instructed pt to talk with her doctor and let them know what happened, pt verbally understood and stated she was seeing him today.
No adverse reaction at present - second dose of influenza vaccine administered inadvertently 35 days after previous influenza vaccine. Patient was originally in for a COVID-19 Bivalent Booster vaccine and due to miscommunications at the patient and pharmacy levels, a influenza vaccine was administered instead,
grandma called stated pt looked pale this am while babysitting; had episode where had trouble breathing, lips were blue & was unresponsive; instructed by RN to take to ER;
19 days after receiving vaccine I had a nose bleed that I couldn?t stop and neither could ER until they packed my nose after four hours of continued bleeding. I never had a nosebleed before and have had one weekly since then.