chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Bells palsy; Fever; This is a spontaneous report from a contactable other hcp (patient). A 25-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 intramuscular, administered in Arm Right on 23Jan2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE at the age of 25-years-old for covid-19 immunisation.  Medical history included  none.The patient's concomitant medications were not reported. Patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for covid-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.The patient experienced bells palsy on 23Jan2021, fever on 23Jan2021. Outcome of events was recovered. No treatment received.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on the close temporal relation, the association between the event of Bell's palsy and the suspect product of BNT162B2 cannot be completely ruled out. 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.
5 minutes after vaccine administration pt complained of feeling light headed and "strange". Began sweating, chills 10 minutes after administration. Pulse reported by rph on duty as "low" 7 minutes after administration and Called EMS at that time. BP 177/100 20 minutes after administration. Patient reported seizure under care of EMS. Patient was not admitted and reports doing well today 10-31-22.
Redness, swelling, itching of (R) arm approximately 2 hours after vaccination. Same sx in (L) arm at 1 hr. later. No prior hx of rxn. and no fever. (L) arm 10cm x 14cm redness warmth induration. (R) arm 17cm x 17xm area of redness, warmth and induration. Treated with cetirizine and hydroxyzine.
Nausea and vomiting, inability to eat normal size meals. Severe jaundice and icterus, dark urine and pale stools.  Admitted to hospital on 12/23/2021. Discharged on 12/28/2021. Currently taking Budesonide 3mg daily due to diagnosis of autoimmune hepatitis.
Tired; Not wheezing but breathing fast; Heart beat was pumping; This is a spontaneous report from a contactable consumer. This 42-year-old male consumer (patient) reported.   A 42-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot Number: EW0168), dose 1 via an unspecified route of administration, administered in Arm Right on 06May2021 as dose 1, 0.3 ml single for COVID-19 immunization.The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccine prior to COVID-19 Vaccine. It was reported that the patient got some kind of side effect that's why he was calling to record. He was in bed and he could feel his heartbeat was pumping (on06May2021) after that day in the evening until Saturday night between 08May2021 and 09May2021. On 10May2021 in the morning he felt normal. . After the first dose, for two days he was so tired (on 07May2021). He saw that it was one of the side effects. The patient also experienced not wheezing but breathing fast on 07May2021 after his first dose. The patient asked if he could take the second dose or not. Someone in his family was a doctor and he said to call that number to see if anyone had the symptoms. The patient did not want medication, he wanted to know if he should move to second dose or not. On 10May2021, the events were resolved.   No follow up attempts are needed. No further information is expected.
The day after I received the vaccine, I got the common side effects, chills, loose stool, nausea. I also began having heartburn/indigestion.It has been 16 days since the first dose, and the loose stool and  heartburn/indigestion remain; The day after I received the vaccine, I got the common side effects, chills, loose stool, nausea. I also began having heartburn/indigestion.It has been 16 days since the first dose, and the loose stool and  heartburn/indigestion remain; The day after I received the vaccine, I got the common side effects, chills, loose stool, nausea. I also began having heartburn/indigestion.It has been 16 days since the first dose, and the loose stool and  heartburn/indigestion remain; The day after I received the vaccine, I got the common side effects, chills, loose stool, nausea. I also began having heartburn/indigestion.It has been 16 days since the first dose, and the loose stool and  heartburn/indigestion remain; This is a spontaneous report from a contactable healthcare professional (HCP [patient]). A 43-year-old male patient received first single dose of BNT162B2 (Pfizer, Solution for injection, lot number and exp date not reported), intramuscular (vaccine location: left arm) on 28Dec2020 for COVID-19 immunization. Facility type vaccine: Nursing Home/Senior Living Facility. Medical history included gastric sleeve and surgery. The patient had no known allergies. Patient did not have Covid prior vaccination. There was no other medical history. There were no concomitant medications. There were no other vaccine/s within four weeks. No other medications in two weeks. The day after patient received the vaccine, she got the common side effects on Jan2021: chills, loose stool, and nausea. She also began having heartburn/indigestion (Jan2021). It had been 16 days since the first dose, and the loose stool and heartburn/indigestion remain. Not sure if it's because of having the gastric sleeve done years ago, or not, as the surgery changed her metabolism and the like. No treatment was provided. Nasal Swab on 11Jan2021 was negative. The outcome of the events was not recovered.  Information about lot/batch number has been requested.
Coughing with diagnosed bronchitis diagnosed, even with taking Levaquin antibiotics. Had to take Biaxin in addition to this antibiotic. 11/25/2009 ED record for 11/21/2009, Impression Acute bronchitis patient presents with c/o's cough. CXR norm
red patch on her arm that itch a lot and redness is evident; Allergic reaction; pain all over the body; itchiness; arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (pain all over the body), PRURITUS (itchiness), PAIN IN EXTREMITY (arm soreness), ERYTHEMA (red patch on her arm that itch a lot and redness is evident) and HYPERSENSITIVITY (Allergic reaction) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included Multivitamins                                                  supplement, CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000), Probiotics                                                     supplement and Tagamet                                                        Antacid for an unknown indication.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jan-2021, the patient experienced PAIN (pain all over the body), PRURITUS (itchiness) and PAIN IN EXTREMITY (arm soreness). On 02-Feb-2021, the patient experienced ERYTHEMA (red patch on her arm that itch a lot and redness is evident) and HYPERSENSITIVITY (Allergic reaction). On 25-Jan-2021, PAIN (pain all over the body) had resolved. At the time of the report, PRURITUS (itchiness), PAIN IN EXTREMITY (arm soreness), ERYTHEMA (red patch on her arm that itch a lot and redness is evident) and HYPERSENSITIVITY (Allergic reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details included Applied Hyderocortisone cream 1%.   Reporter did not allow further contact
mkay; Throwing up everywhere, she can't keep her food down, she can't keep no liquid down; She does not feel good; She's burning up hot; she's burning up hot; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A 25 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 25 years as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FEELING ABNORMAL (non-serious), outcome "unknown", described as "mkay"; VOMITING (non-serious), outcome "unknown", described as "Throwing up everywhere, she can't keep her food down, she can't keep no liquid down"; MALAISE (non-serious), outcome "unknown", described as "She does not feel good"; BURNING SENSATION (non-serious), outcome "unknown", described as "She's burning up hot"; FEELING HOT (non-serious), outcome "unknown", described as "she's burning up hot".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Next day neck achy/back achy. 2nd day cheeks hot. 4th day cough (continuous) last 5 days called for LEVAQUIN took for 5 days. Lungs kept getting worse wheezy, 2nd week coughing wheezy short of breath. Seen Dr Cx ray 3rd week unable to breath chest tight.
Headache to the brain stem then a dull continuous throbbing lasting 3 days. A temperature lasting 3 days, tingling in both feet, malaise, lethargy, muscle weakness, unable to sit for for more than 10 minutes for 48 hours, taste in impaired, every thing smells fresh like meat even after 4 days, blurry vision, unable to eat for 24 hours,  still cannot eat a full meal after 4 days, lost 3.5 lbs. After 4 days still has a low grade temperature and unable to eat a full meal.
Complained of severe headache on 11-19-02. Seen in Emergency Room on 11-22-02. Cat Scan & Lumbar puncture done. Hospitlized 11-22-02 to 11-29-02 at hospital.
Vomited after booster; This spontaneous case was reported by a patient and describes the occurrence of VOMITING (Vomited after booster) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VOMITING (Vomited after booster). At the time of the report, VOMITING (Vomited after booster) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2022-529319, MOD-2022-529320 (Patient Link).   Reporter did not allow further contact
my legs itching bad; rash on my leg; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (my legs itching bad) and RASH (rash on my leg) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Lupus erythematosus.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PRURITUS (my legs itching bad) and RASH (rash on my leg). At the time of the report, PRURITUS (my legs itching bad) and RASH (rash on my leg) outcome was unknown.            No treatment/concomitant medications were reported.
huge floater in the center of my vision; nerve damage vertigo; Vertigo; shingles in eye; This case was reported by a consumer via interactive digital media and described the occurrence of ophthalmic herpes zoster in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included ophthalmic herpes zoster (the patient got shingles on left side of his/her scalp, face and eye and also in his/her eye in December 2019, refer case US2021AMR196906).   On an unknown date, the patient received the 1st dose of Shingles vaccine. In April 2020, unknown after receiving Shingles vaccine, the patient experienced ophthalmic herpes zoster (serious criteria GSK medically significant). In April 2021, the patient experienced floaters, vestibular nerve damage and vertigo. On an unknown date, the outcome of the ophthalmic herpes zoster was unknown and the outcome of the floaters, vestibular nerve damage and vertigo were not recovered/not resolved.   It was unknown if the reporter considered the ophthalmic herpes zoster, floaters, vestibular nerve damage and vertigo to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient reported that, he/she got the single Shingle vaccine when Medicare started paying for it, the patient got shingle again in eye in April 2020 and caused a huge floater in the center of his/her vision and nerve damage vertigo.  The patient stated at the time of reporting that, he/she still dealing with vertigo and floater. The patient said that, he/she would get the second one this month (September 2021). The follow-up would not possible as no contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR196906:same reporter
Around 7:00 pm on the day of the shot (about six hours after receiving the vaccine), I began to feel feverish and cramping. I took 600 mg of Tylenol as mentioned by the pharmacist for those that are feel side effects. Around 1:00 am, I woke up shivering with a 104.5 fever and nausea. I took another 600 mg of Tylenol, which brought the fever down to 100.5 for the six hours. I also threw-up around 2:00 .
Reaction on the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (Reaction on the vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ADVERSE REACTION (Reaction on the vaccine). At the time of the report, ADVERSE REACTION (Reaction on the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported.  Treatment medications was not provided by the reporter
On 1/7 extreme exhaustion, stayed in bed. On 1/8 febrile @ 101.2, extreme exhaustion, stayed in bed. On 1/9 afebrile but extreme exhaustion, stayed in bed. Felt normal on 1/10.
Fever 101.0; Chills; Body aches; Headache; Typical flu like symptoms
Itching, lips swelling, redness of sclera nasal congestion.  Epinephrine 1:1000, 0.5ml IM given in left deltoid.  911 called.
SORE THROAT; RUNNY NOSE; HEADACHE; LOW GRADE FEVER; WET COUGH THAT'S INTERMITTENT AND THE COUGH IS PRODUCTIVE; THICK YELLOWISH GREEN DRAINAGE; This spontaneous report received from a patient via a company representative concerned a 62 year old female. 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: 205A21A, and expiry: UNKNOWN) dose was not reported, administered on 20-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On JUN-2021, the subject experienced wet cough that's intermittent and the cough is productive. On JUN-2021, the subject experienced thick yellowish-green drainage. On 12-JUN-2021, the subject experienced sore throat. On 12-JUN-2021, the subject experienced runny nose. On 12-JUN-2021, the subject experienced headache. On 12-JUN-2021, the subject experienced low-grade fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore throat, runny nose, headache, and low-grade fever. on JUN-2021, and had not recovered from wet cough that's intermittent and the cough is productive, and thick yellowish-green drainage. This report was non-serious.
Misadministration - Twinrix given to a 13 month old instead of Ped Hep A #1 and Ped Hep B #1 - no adverse event.
Itchy rash at injection site starting one week post injection, swollen lymph node in a right arm pit
From initial information received on 24May04 from another manufacturer, regarding an adverse event occurring, it was initially reported by a registered nurse that a 28 year old female pt received a dose of TET TOX ADS USP, lot number not reported, administered in the right arm and a first dose of Engerix B, lot number Eng5521A2, administered in the left arm on 15Apr04. The routes of administration were not reported. Approximately seven days later, the pt experienced numbness of the lower right inner calf muscle. As of 18May04, the numbness has improved.
Feels dizzy while walking; Can not get up; Bad chills in night and Teeth chattering; Passed out for couple of hours; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out for couple of hours) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Dysautonomia, Neurocardiogenic syncope and Orthostatic hypotension.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (Passed out for couple of hours) (seriousness criterion medically significant) and CHILLS (Bad chills in night and Teeth chattering). On 21-Apr-2021, the patient experienced DIZZINESS (Feels dizzy while walking) and ASTHENIA (Can not get up). At the time of the report, LOSS OF CONSCIOUSNESS (Passed out for couple of hours) and DIZZINESS (Feels dizzy while walking) had not resolved and ASTHENIA (Can not get up) and CHILLS (Bad chills in night and Teeth chattering) outcome was unknown.            There was no treatment information provided.  Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded. However, her concurrent medical conditions of Dysautonomia, Neurocardiogenic syncope and Orthostatic hypotension are cofounders.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded. However, her concurrent medical conditions of Dysautonomia, Neurocardiogenic syncope and Orthostatic hypotension are cofounders.
Pt presented with CHF and covid. Treated with iv diuretics. pt didn't repond to treatment and was admitted to hopice and deceased.
(for 4 days) left anterior thigh with 2 1/2" x 3 1/2" of hard/indurated erythema and swelling of soft tissues (almost 90% of anterior thigh).
Patient received ZOSTAVAX in her upper right arm on 5/12/16. On 5/13/16 she developed a rash, itchiness and swelling around injection site. She was evaluated in office on 5/16/16 and was told to use over-the-counter ZYRTEC. Symptoms were improving as of 5/16/16.
Headache; I am feeling down always like I want to be sleeping everyday; I am not hungry; I had a temperature twice; I am feeling down; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on 16Aug2021 as dose 1, SINGLE for covid-19 immunisation. The patient medical history was not reported. There were no concomitant medications. On an unspecified date in Aug2021, patient experienced headache, feeling down always like want to be sleeping everyday, not hungry and had a temperature twice. The patient got first vaccine last Monday and was good till Tuesday, like maybe, the patient would say 15, it was 12 hours after I put it on, the patient started having like headache, felt down and not hungry. The patient stated nothing like that, but the worst thing was got headache. The patient had a temperature twice, just a little bit, a 101 for like 2 hours and went away and never came back but right now felt a lot of headache and not hungry and feeling down always like wanted to be sleeping every day. The patient was wondering was that normal. On an unspecified date in Aug 2021, the patient underwent lab tests body temperature with results a 101 for like 2 hours. The outcome of the event body temperature increased was recovered on an unspecified date in Aug 2021. Outcome of the other events were unknown.  The lot number for the vaccine [bnt162b2] was not provided and would be requested during follow up.
Hive like rash that covers my whole body except for palms and bottom of my feed.  Heavy rash on front and back of torso.  Heavy rash on back of neck.  Rash similar to hives.  I have never had a rash like this my entire life.  There is itching and mild pain when pressure is applied to the rash area.  I am now at day 7 with this rash and it has not shown signs of going away.
Patient's reaction(s) noted during COVID vaccine observation period:  lips tingling  Actions Taken: Vital signs taken and within normal for pt. Pt felt okay enough to leave   Disposition: Patient declined ED visit
Information has been received from a pharmacist referring to a patient of unknown age and unknown gender. Information about pertinent medical history, concurrent conditions, and drug reactions/allergies was not provided. Concomitant medication included sterile diluent. On 10-MAR-2019, the patient was vaccinated with a dose of VARIVAX (injection, lot # R021098, expiration date: 23-JUL-2020; dose, strength, and frequency were not reported) intramuscularly for prophylaxis (inappropriate route of vaccination). No adverse effects were reported.
Parents reported that 1 week after vaccination that child developed a fever (high of 100.4) and then the following day developed a rash that looked like chicken pox but it never blistered. By the morning of 8/3, the fever and rash had resolved.
bullous pemphigoid; This case was reported by a physician via sales rep and described the occurrence of bullous pemphigoid in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix .5 ml. On an unknown date, unknown after receiving Shingrix, the patient experienced bullous pemphigoid (serious criteria GSK medically significant). On an unknown date, the outcome of the bullous pemphigoid was unknown.   It was unknown if the reporter considered the bullous pemphigoid to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The age group was not reported but it was selected adult as per vaccine indication. The patient developed bullous pemphigoid after receiving the Shingrix vaccine. The permission to follow up was denied. This case has been linked with US2021AMR001842, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR001842:same reporter
20 minutes after injection:  tingling in lips, numbness in throat (parked in ER parking lot in case symptoms worsened.  Then drove home and took Benadryl and Tylenol)  Next day:  Fatigue, body aches and chills