chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Bell''s palsy; Mouth paralysis; Eye is running and tearing; Dry eye; Funny taste in mouth; Headache; Numbness lips; This is a spontaneous report from a contactable consumer (patient). A 68-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 3 via an unspecified route of administration, administered in Arm Right on 11Oct2021 14:30 (at the age of 68-years-old)  (Batch/Lot Number: FE2590) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation. Medical history included ongoing atrial fibrillation Verbatim: heart condition with a-fib, stroke from Feb2021 to an unknown date Wife had a stroke in Feb2021. There were no concomitant medications. The patient previously took Dose number: 1, LOT: EL9267 of bnt162b2 on 10Feb2021, and Dose number: 2, LOT: EN6198, EXP: 30Jun2021 on 03Mar2021, penicillin [benzylpenicillin] and experienced Allergic to penicillin. On 13Oct2021, the patient experienced headache, Was behind his right ear. Put ice on it. Then was using a heating pad. Wasn't really bad, felt more like a toothache throb. On 14Oct2021, the patient experienced funny taste in mouth. Was like salivation gland was going (withheld). Was like he had something sweet in his mouth. Was the whole mouth. On 17Oct2021, the patient experienced eye is running and tearing Right eye is droopy, and right corner of his mouth is sagging. It is obvious, Now is more like a dry eye. Doctor prescribed him artificial tears to make sure eye stays hydrated. Right eye doesn't cooperate. Has to struggle to close his right eye and blink. Right eye will close when he is closing both eyes at the same time. Right eye won't cooperate when he tries to close it by itself. He can blink his left eye, and mouth paralysis (medically significant) started coming on really slow. He really noticed it on the 17Oct2021. On 20Oct2021, the patient experienced Bell's Palsy. In Oct2021, the patient experienced numbness lips, can't tell if the numbness is also on his tongue. Mostly can tell on the lips. When tries to smile, the right side of the mouth doesn't respond. Difficulty drinking: Clarified he doesn't have difficulty swallowing. When he eats, tends to bite that lip. When he takes a drink out of a bottle, it dribbles out. States it's a lot easier to drink from a straw than a bottle. The outcome of the event headache was recovered, Mouth paralysis was not recovered, Funny taste in mouth was recovering, while unknown for the other events.  Follow-up attempts are completed. No further information is expected.
Patient has mild- flu like symptoms (muscle/joint soreness/ weakness) to first vaccine. Thought he may have had flu, but tested negative. For second dose series, patient had to leave work early the next day, his entire body felt very weak, and barely made it to car. Patient's joints hurt so bad, and he is very active, and was worried he would never be able to go to gym again. The following morning, patient woke up, and was in no pain at all, as if nothing had happened day before.
I tested positive for COVID-19 on August 8, 2022 my symptoms were fever of 103.0, headache, loss of appetite, headache, fatigue. I was prescribed PAXLOVID for my symptoms.
BREAK THROUGH INFECTION; SUSPECTED CLINICAL VACCINATION FAILURE; This spontaneous report received from a patient concerned a female of unspecified age, 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 expiry: unknown) dose was not reported, 1 total administered on 19-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 08-AUG-2021, the patient experienced break through infection, and tested positive for covid-19. She also had suspected clinical vaccination failure on 08-AUG-2021. On 28-AUG-2021, the patient tested negative for covid-19.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from breakthrough infection on 28-AUG-2021, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition).  This report was associated with product quality complaint: 90000191521. This case is a duplicate of 20210860224.; Sender's Comments: V0 2021086210-COVID-19 VACCINE AD26.COV2.S-breakthrough infection. 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).  2021086210-COVID-19 VACCINE AD26.COV2.S-suspected clinical vaccine failure. 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.
Given FLUZONE vaccine injection on 9-4-09; family came in to clinic on 9-10-09 and received flu vaccine injection again a 2nd time.
bilirubin is so high (13); Liver enzymes have increased; bilirubin is so high (13) that patient is now yellow; This is a spontaneous report from a contactable consumer, the patient.  A patient of unspecified age and gender received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), on 08Jan2021, via an unspecified route of administration as a single dose for COVID-19 immunisation.  Medical history included colon cancer with liver METS for which the patient had been treated very well with chemotherapy (unspecified) with no negative effects. The patient's concomitant medications were not reported. The patient previously received first dose of BNT162B2, on 19Dec2020 via an unspecified route of administration for COVID-19 immunisation. On an unknown date since the vaccine was administered (Dose 1 on 19Dec2020 and 2nd dose 08Jan2021), the patient experienced liver enzymes increased and bilirubin so high (13) that the patient is now yellow.  The patient reported that the experts in cancer care are baffled by the cause. The patient inquired if it is possible the vaccine is responsible for elevated enzymes in immunocompromised patients? The clinical outcome of the liver enzymes increased and bilirubin so high that the patient is now yellow was unknown.    The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Headache, dizziness, lightheadedness, tiredness  it?s persistent not going away since vaccination until now, will have a follow up with the doctor this week
Subdural hematoma; CSF leak; headache; This is a spontaneous report from a non-contactable consumer.   A 53-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: ER8731), via intramuscular on 04Sep2021 as dose 1, single for covid-19 immunisation.  Medical history included asthma from an unknown date and unknown if ongoing. Concomitant medication included diphenhydramine hydrochloride (ZZZQUIL) taken for an unspecified indication, start and stop date were not reported. On 04Sep2021, patient developed headache a few hours after receiving first dose. Over the subsequent days and weeks, the headaches worsened. Ultimately presented to Emergency Room (ER) and was admitted with Subdural hematoma and Cerebrospinal Fluid (CSF) leak. The patient treat with an epidural blood patch. The patient underwent lab tests and procedures which included Computed tomography (Ct) and magnetic resonance imaging (MRI) of head and spine (no results). The outcome of the events was not recovered.   No follow-up attempts are possible. No further information is expected.
Headache, Myalgia, Arthralgia, NauseaVomiting, Injection site pain, fatigue, chills
ache inside of her left eye; she has a continuous runny nose; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer reported for a female patient (wife) that received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration on 25Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported.  The patient experienced ache inside of her left eye on an unspecified date with outcome of unknown , she has a continuous runny nose on an unspecified date with outcome of unknown.    The clinical course was reported as follows: The patient has an ache inside of her left eye and she has a continuous runny nose but no fever.They are both scheduled for their 2nd dose tomorrow 15Apr2021 and the caller wanted to know if her wife can go to receive her second dose. Both of them received the 1st dose on 25Mar2021.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
This spontaneous report as received from a other health professional refers to a patient of unkonwn age. No medical history or concurrent conditions were reported. On 10-JAN-2014 the patient was vaccinated with ZOSTAVAX lot # J011882. It was reported that the patient was administered ZOSTAVAX that may have gone through an unsupported temperature excursion due to delayed shipping from 13-DEC-2013 to 17-DEC-2013. No adverse effects were reported and no further information was provided. This is one of a total of two reports from the same source document. Additional information has been requested.
48-year-old male healthy presented with increased shortness of breath.  He mentioned he had COVID-19 vaccine first dose almost 3 weeks ago then symptoms started of having shortness of breath with swollen upper and lower extremity not improving since it started.  One week after vaccine developed generalized swelling in hands and feet up to thighs with  firey red rash now on arms and inner thighs, felt warm.  No itching.  Reports some shortness of breath and chest pain. Treated outpatient with lasix without improvement, therefore required hospitalization for generalized anasarca. CT- pulmonary edema.  Urine Protien/Cr ratio 0.16 - nephrotic syndrome unlikely, B/L lower extremity duplex negative for DVT,  2D echo showing normal EF of 60%
a patient who had previously had 2 doses of Pfizer vaccine (he doesn't know when) received 1 dose of the Moderna vaccine on 21Jul2021; This spontaneous case was reported by a health care professional and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (a patient who had previously had 2 doses of Pfizer vaccine (he doesn't know when) received 1 dose of the Moderna vaccine on 21Jul2021) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    No Medical History information was reported.   On 21-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient received first dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, received second dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) dosage was changed to 1 dosage form. On 21-Jul-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (a patient who had previously had 2 doses of Pfizer vaccine (he doesn't know when) received 1 dose of the Moderna vaccine on 21Jul2021). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (a patient who had previously had 2 doses of Pfizer vaccine (he doesn't know when) received 1 dose of the Moderna vaccine on 21Jul2021) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medication was received by the patient No Treatment was received by the patient.  Patient had had 2 doses of Pfizer vaccine (he doesn't know when it has been administered)
Patient complains of extreme soreness, a lump in arm, fever, loss of appetite, cold/shiver.
sinus headache; bad reaction; migraine; earache; sluggish; couldn't stand up; vomiting; nausea; intense fever; This spontaneous case was reported by a consumer and describes the occurrence of SINUS HEADACHE (sinus headache), ADVERSE DRUG REACTION (bad reaction), MIGRAINE (migraine), EAR PAIN (earache) and SLUGGISHNESS (sluggish) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and 021B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included VITAMINS NOS for an unknown indication.   On 14-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to dosage form. On 14-Apr-2021, the patient experienced SINUS HEADACHE (sinus headache), ADVERSE DRUG REACTION (bad reaction), MIGRAINE (migraine), EAR PAIN (earache), SLUGGISHNESS (sluggish), ASTHENIA (couldn't stand up), VOMITING (vomiting), NAUSEA (nausea) and PYREXIA (intense fever). At the time of the report, SINUS HEADACHE (sinus headache), ADVERSE DRUG REACTION (bad reaction), MIGRAINE (migraine), EAR PAIN (earache), SLUGGISHNESS (sluggish), ASTHENIA (couldn't stand up), VOMITING (vomiting), NAUSEA (nausea) and PYREXIA (intense fever) outcome was unknown. Not Provided          Concomitant products included cholesterol meds. Patient informed that she had not taken concomitant products these days (at the time of report).
A couple hours after taking flu shot she states her eyes suddenly turned red and matted up and started feeling a tightness in chest.  Waited until 3:30 pm to go to clinic to see dr.
Patient is experiencing pain at the injection site. She also mentioned the injection itself was painful. Her arm is very sore and it is also red and warm to the touch. I (the pharmacist) recommend she try ibuprofen and ice therapy. She said she has tried that already with minimal benefit. She had only tried 200 mg of ibuprofen at a time. I told her she could take up to 600 mg every 6-8 hours as needed.
Narrative: COVID infection following COVID vaccine series 01/20, Pfizer, dose #1 02/23, Pfizer, dose #2 12/01 COVID swab, result: detected 11/28 pt cc: fatigue, fever, myalgias, exposure: unknown 12/01 SARS-COV-2 Variant Sequencing
Peripheral neuropathy and paresthesia.  Doing Physical Therapy and exercising at home.   Slowing getting better.
Fevery 100.5, headache, body aches, congestion, fatigue; Fevery 100.5, headache, body aches, congestion, fatigue; Fevery 100.5, headache, body aches, congestion, fatigue; Fevery 100.5, headache, body aches, congestion, fatigue; Fevery 100.5, headache, body aches, congestion, fatigue; This is a spontaneous report from a contactable consumer (patient). A 14-year-old non pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, administered in Arm Left, on 20Aug2021 18:30 (at the age of 14-year-old), as single dose for COVID-19 immunization. There were no medical history and concomitant medications. The patient did not have any known allergies. The patient did not receive any other vaccine in four weeks and any other medications in two weeks. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, administered in Left arm on 03Aug2021 04:30 PM (at the age of 14 years old) for COVID-19 immunization. The patient was not diagnosed with COVID prior vaccination. The patient was not tested for COVID post vaccination. On 21Aug2021 at 23:00, the patient experienced Fevery 100.5, headache, body aches, congestion, fatigue. The patient did not receive any treatment for the events. Outcome of the events was recovering.  Follow attempts completed; information about lot/batch number cannot be obtained. No further information is expected.
This case was reported by a consumer via call center representative and described the occurrence of shoulder pain in a 58-year-old male patient who received SHINGRIX for prophylaxis. In August 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced shoulder pain. On an unknown date, the outcome of the shoulder pain was not recovered/not resolved. It was unknown if the reporter considered the shoulder pain to be related to SHINGRIX. Additional information received as follows: Till the reporting time, the patient's shoulder was hurting. The patient asked about the 2nd shot of SHINGRIX if that would be as bad on the other arm.
pt recv vax; gene muscle aches approx 2 1/2 wk p/ immun; pain resolved 2 wk p/ onset;however pt exp inc fatigue (sleeping 18 hr per day);oth tests neg x/ for parvovirus titer (mom's hx);dx as chronic fatigue synd;dx not related to vax;
Admitted for COVID pna. Fully vaccinated in April. Treated with O2, steroids, cefepime, vit-c, vit-d, zinc, singulair. Improved and discharged home with O2.
14 hours after vaccination, fever and body aches began. Fever lasted 20 hours and was 101-104.7 at the highest with fatigue and body aches. Fever broke beginning Day 3 with heavy sweating through my clothes and foul odor. Headache and fatigue from Days 3-4. Nausea and Fatigue Days 4-9. Today is Day 10 and it's the first day I haven't felt nausea and overly tired.
tired; feeling dizzy; headaches; had slight flu like symptoms and was really dizzy and tired; lost the sense of smell and taste; lost the sense of smell and taste; This is a spontaneous report from a Pfizer-sponsored program received from a consumer (patient) reporting for herself. A 31-year-old female patient (31 years age at vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EP6955, Expiration Date: 30Jun2021), via an unspecified route of administration in left arm on 23Mar2021 at 10:00 as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Prior to the first dose of vaccination, she did not receive any vaccinations within 4 weeks. No additional vaccines were administered on same date of the suspect vaccine. The patient stated that 7 after vaccination on 30Mar2021, she noticed she had no smell or taste or anything and asked whether it was an allergic reaction and should she be tested for the virus. She felt very dizzy and tired, and it was a lot more severe. She added that she felt flu like symptoms and believed the event continued at the time of report. She did not require treatment or a visit to her HCP or the Emergency room. She did not receive the 2nd dose of the Pfizer vaccine at the time of report. The clinical outcomes of the events loss of smell and taste, dizziness, tiredness, headache, and flu like symptoms were reported as unknown at the time of report.  No follow-up attempts are needed. No further information is expected.
Severe eye twitch for 3 days, increased leg muscle twitching ongoing and increasing in severity for weeks, visible twitching, at rest and otherwise. Discomfort in calf muscles due to ongoing twitching
Nausea and fever (99.8) lasted one day.  Muscle aches last for 2.5 days.  Injection site reaction on right arm (where PPSV was administered) with 4-in x 2-in redness, swelling, & pain (both to the touch & to movement of arm). Site reaction was also hot to the touch.
After the second shot, major inflammation; Extreme shoulder, arm and neck pain; Extreme shoulder, arm and neck pain; Extreme shoulder, arm and neck pain; Sleeping has also been very difficult; This is a spontaneous report from a contactable consumer or other non hcp (patient) and Other HCP. A 53-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: ER8731) via an un-specified route of administration, administered in left arm on 15Apr2021 11:15 (at the age of 53-year-old) at dose 2, single for covid-19 immunisation. Medical history included mild osteo arthritis. Patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medications included estradiol (ESTRADIOL); progesterone (PROGESTERONE), both taken for an unspecified indication, start and stop date were not reported, patient received them within 2 weeks of vaccination. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EP6955) via an unspecified route of administration, administered in left arm on an unspecified date in Mar2021 11:15 (at the age of 53-year-old) at dose 1, single for covid-19 immunisation and experienced mild inflammation. On 26Apr2021 the patient experienced after the second shot, major inflammation, extreme shoulder, arm and neck pain, sleeping has also been very difficult. Reported Event: After the first shot, some mild inflammation. After the second shot, major inflammation. Day 12 after 2nd dose, extreme shoulder, arm and neck pain. Saw Dr. on day 16. I have been in Physical Therapy since May 11th working on the pain. I have been unable to wear my wedding rings since the second dose. Sleeping has also been very difficult. Adverse events resulted in doctor or other healthcare professional office/clinic visit. Patient received treatment with anti-inflammatory, flexorall for the adverse events. Outcome of the events was not resolved.  Follow-Up (30Jun2021): Follow-up attempts are completed. No further information is expected.
Joint pain (particularly leg/knee), inflammation, extremely heavy (and early) period passing blood clots. Three weeks (and continuing) for inflammation, two days for period symptoms.
This spontaneous report as received from a pharmacist refers to a female patient of an unknown age. The patient's concurrent conditions included chronic obstructive pulmonary disease (COPD). There was no information regarding the patient's medical history reported. On 08-FEB-2016, the patient was vaccinated with ZOSTAVAX 0.65 ml, once, subcutaneously, lot# reported as L037727 and expiration date: 09-DEC-2016. Lot# L037727 is an invalid lot number for ZOSTAVAX. The patient's concomitant medications included VENTOLIN and SPIRIVA. On an unspecified date in February 2016 (reported as within "two days after receiving" ZOSTAVAX, the patient experienced exacerbated COPD symptoms. On an unspecified date, the patient sought medical attention from her physician and was prescribed prednisone (manufacturer unknown) 10 mg, daily for 30 days as a treatment for the "COPD symptoms". The outcome of the event was reported as not recovered at the time of the report. The causality assessment between the event and ZOSTAVAX was not provided. Additional information has been requested.