chrisvoncsefalvay/vaers-outcomes huggingface dataset:
facial paralysis; Sore arm; dull headache; dizzy; ringing in the ear; felt like I would black out; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 16Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FACIAL PARALYSIS (medically significant) with onset May2021, outcome "unknown", described as "facial paralysis"; PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "Sore arm"; HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "dull headache"; DIZZINESS (non-serious) with onset 2021, outcome "unknown", described as "dizzy"; TINNITUS (non-serious) with onset 2021, outcome "unknown", described as "ringing in the ear"; FEELING ABNORMAL (non-serious) with onset 2021, outcome "unknown", described as "felt like I would black out". Caller states she received the first shot on 16Apr2021 and has complains of the following side effects: "Sore arm, dull headache, dizzy, ringing in the ear, felt like I would black out." It was reported that Onset of facial paralysis was Day 37 after Dose 1 (participant did not receive Dose 2).   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Shortly after receiving Covid vaccine on 1/9/2023, parents noticed that patient had a bald spot. Since noticing, hair has not grown back in but also has not gotten worse.
The mother states the pt developed a low grade fever 24 hours post vax. 48 hours post vax, the pt developed a fever of 105. The pt was given Advil. Advised to call doctor if fever does not decrease. On 3/22/01, the pt was seen by PMD who states the pt had a "virus".
Missed 2nd dose; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed 2nd dose) in a 37-year-old male patient 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed 2nd dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Missed 2nd dose) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing was delayed on an unknown date.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant product use was provided by the reporter.  No treatment medication was provided.   The patient got 1st shot of Moderna vaccine in Dec2021. He somehow missed the six weeks window and then he said everyone turned him away for getting the 2nd shot as he was out of the six weeks interval. He asked the pharmacist to give him the Johnson n Johnson Vaccine today on 20MAY2021. Pharmacist did not administer him any 2nd dose.
Initial information received on 02-Oct-2018 regarding an unsolicited valid non-serious case received from a consumer. This case involves a 78 years old female patient who experienced had severe diarrhea that lasted one week and lost 10 pounds, diarrhea, throwing up and had soreness in left upper arm where shot was given, while she received vaccine FLUZONE HIGH DOSE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 14-Sep-2018, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number not reported via unknown route in the left arm (expiry date and dose were unknown). On 18-Sep-2018, the patient developed a non-serious diarrhea that lasted one week and lost 10 pounds, diarrhea, throwing up and had soreness in left upper arm where shot was given, four-days following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. Relevant tests were not reported. Final diagnosis was had soreness in left upper arm where shot was given, throwing up, diarrhea and had severe diarrhea that lasted one week and lost 10 pounds. The patient was treated with IMODIUM for Product used for unknown indication but that did not help much with the diarrhea. On 19-Sep-2018, the patient was recovered from throwing up. On 23-Sep-2018, the patient was recovered from diarrhea. On an unknown date, the patient recovered from other events. List of documents held by sender: none.
Left shoulder extreme pain. Could hardly move arm 2 days after shot, then legs hurt could hardly walk - 3 days after shot. Lasted for 3 weeks. Headache, then turned into cough which turned into croup. Still have a lot of mucus still ill. I never was sick before the shot.
Swollen lymph nodes in underarm, outer breast area of side where vaccine was administered; This is a spontaneous report from a contactable consumer (patient). A 43-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: EM9809, patient was 43-year-old at the time of vaccination), via an unspecified route of administration, administered in Arm Right on 09Feb2021 at 03:45 PM as DOSE 1, SINGLE for covid-19 immunisation. Medical history included Hashimotos, PCOS, High Blood pressure, asthma, penicillin allergy, thyroid. Patient received unspecified medication for BP Meds, Birth Control, Thyroid in two weeks. It was reported that no other vaccine received in four weeks. No covid reported prior vaccination, not tested for covid post vaccination. On 10Feb2021, the patient experienced swollen lymph nodes in underarm, outer breast area of side where vaccine was administered. No treatment was received for event. The outcome of event was not recovered.  Information on the batch number has been requested.  Follow-up (14May2021): Follow-up attempts completed. No further information expected.
Information has been received through a pregnancy registry from a physician concerning an 11 year old female with no allergies or medical history who on 9/18/04 was vaccinated with a dose of varicella virus vaccine live. On that same day a tuberculin purified protein derivative was also placed. On 9/18/04, the patient's pregnancy test was positive. Unspecified medical attention was sought. Follow up information received from a nurse indicated that she had no way of knowing who the patient was as this is a busy pediatric office. Additional follow up information received from a nurse indicated that the patient terminated her pregnancy. No additional information is expected.
Administer expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine) in a 36-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine). On 18-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The vaccine was stored in the freezer and one to two vials were taken out and placed in the fridge each day as needed.  No concomitant medicines were reported No treatment medicines were reported
Severe headache, nausea, vomiting, dizziness?woozy, extremely tired
Vaccines administered at 1300. Pt. became diaphoretic, dizzy, and tired. Sucker, fruit bar, water, fan to pt. Helped a lot. BP 107/65 - HR 59 - 97% RA at 1304. BP 116/76 - HR 59 - 97% RA at 1307. Pt walked out to waiting room at 1308. Pt. left facility at 1312.
Flu like symptoms 24hrs after 2nd shot.   I was happy because I felt the Vacine was working and my body was building antibodies  I have had three Covid 19 tests the last week from Embry Womens Health care Phx Arizona on 6/21 and  6/23 both positive and another test yesterday still waiting results.   I have Clogged sinus cavities like a cold or I am swimming are the only symptoms.   I am reporting this as I think I have a breathru variant possibly Delta
he had arm soreness at the area of injection/Injection site pain/patient mentioned that he was experiencing arm soreness at the site of injection; This is a spontaneous report received from a contactable Pharmacist.  A 10 year-old male patient received BNT162B2 (COMIRNATY), intramuscular, administered in arm left, administration date 09Nov2021 18:15 (Lot number: FK5127) as dose 1 , 0.2 ml single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications.  The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 10Nov2021, outcome "recovered", described as "he had arm soreness at the area of injection/Injection site pain/patient mentioned that he was experiencing arm soreness at the site of injection". Therapeutic measures were not taken as a result of vaccination site pain.  Additional information: the patient received his first dose of Comirnaty, and mentioned that he had arm soreness at the area of injection approximately 13 hours after receiving the vaccination.  Follow-up attempts are completed. No further information is expected.
LMP 12/10/2021 positive pregnancy test in January 2022 Pfizer booster on 1/19/2022 LOT # SK 9229 patient states vaginal spotting on 1/16/22-1/17/22  EDD: N/A
8 min after administration, described a light-headedness and sinus pressure. Also hypertensive. 144/91 immediately, then 129/88 2 min later. Symptoms resolved around 5 min later, other than some dizziness when trying to stand. Resolved after 20 minutes.
Vaccine DTaP given in left upper deltoid muscle on Tuesday 05/27/2003.  On 05/28, redness and swelling at site.  On 05/29 woke up spread down arm to elbow.
After my second dose of the Moderna Vaccine I started experiencing headache, chills, chest pain and fatigue. It is still happening 7 days in.
Dose administered past the expiration/beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered past the expiration/beyond use date) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Sep-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 EXPIRED PRODUCT ADMINISTERED (Dose administered past the expiration/beyond use date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered past the expiration/beyond use date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant  and treatment medications were not provided. The went straight from freezer to thawed on 21-Sep-2021.
(unknown route) 1 dosage form. On an unknown date, the patient experienced PRURITUS (itchy arm). At the time of the report, PRURITUS (itchy arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided by the reporter.
Pt admitted to the hospital with SOA and diagnosed with COVID. Pt states that they are vaccinated x2 plus booster for COVID. Unable to obtain manufacturer or dates of vaccines at this time
patient reported rashes and unusual join pain after the administration of Prevnar-13. Also reported of fever and fatigue right after 2 hours of vaccination.  The rashes started after 2 hours of muscle pain.
Lupus; This is a spontaneous report from a contactable Nurse (patient).  A 52-year-old female patient received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number was not reported), via an unspecified route of administration on 19Aug2021 at 15:01 as single dose for covid-19 immunisation . The patient medical history and concomitant medications were not reported.  Previously on an unspecified date, patient had the first dose of the vaccine for covid-19 immunisation.Patient had a booster shot on 19Aug2021 at 15:01. The patient experienced lupus on an unspecified date in 2021 with outcome of unknown.The lot number for BNT162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the information available and close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events . The case will be reassessed once new information is available   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.
Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 19-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 23-May-2021, the patient experienced DIARRHOEA (Diarrhea). At the time of the report, DIARRHOEA (Diarrhea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant products and treatment medication were reported. The patient reported that she was home-bound . After getting the jab She could not get to her vaccination card to give the rest of the information. She had not taken medication but had eaten foods related to easing diarrhea. She had not seen her doctor.   Most recent FOLLOW-UP information incorporated above includes: On 23-Jun-2021: Follow up received on 23-JUN-2021. Follow up contains no new information
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 25-SEP-2014 the patient was vaccinated with ZOSTAVAX lot # J001694 and expiry date: 08-MAY-2014 (dose and route not reported). On 25-SEP-2014 the patient received an expired dose of ZOSTAVAX. No adverse effects were reported. Additional information has been requested.
Severe fever of 105.4, loss of consciousness from fever, vomiting.  Fever lowered with multiple ice bags and high dose Tylenol. Fever broke after 48 hours. Memory problems which lasted 4 months after vaccine.  Treatment by at home nurse during the reaction.
62 y/o pt immunized 24SEP91 & w/in 12 hrs post vax, pt exp weakness in the lt arm & leg; Hospitalized on 26SEP; dx w/transverse myelitis; tx w/high dose IV steroids; pt stable, still hospitalized as of 8OCT91;
After receiving the first dose experienced a burning tingling sensation in her chest and tingling sensation in her arm; After receiving the first dose experienced a burning tingling sensation in her chest and tingling sensation in her arm; Sometimes like in between when I was getting those shots, I had this hotness; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 56-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration on 18Mar2021 (Batch/Lot Number: EN6208) as DOSE 1, SINGLE, dose 2 via an unspecified route of administration on 08Apr2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included estradiol taken for an unspecified indication, start and stop date were not reported. Patient stated, "Sometimes I feel a little bit of that tingling in my arm and when I got the vaccine, I got one in left arm and one in the right arm. I was just doing some experiment in different way just to see (sentence incomplete). Also, sometimes like in between when I was getting those shots, I had this hotness, '' it was like I need help with someone'' (not clear). I did have lab work done when I went to the hospital on March 31st, but they said everything was normal with the lab work and also with the EKG and the chest x-ray that was performed." (Not clarified further). She did receive the second dose and stated that she had these mild symptoms off and on since getting the second dose. She did also make the statement that she knows people who received the COVID vaccine and did not state if it was the Pfizer product, who became sick or tested positive for COVID after getting the first dose and decided not to get the second dose but again she did not confirm if those were Pfizer products or not (further clarification unknown)." Patient further stated, "I just had a question if it was anything to do with vaccine or not as it just happened within the time of getting the vaccine, that was why I was calling and if other people had reported the same symptoms or not." The events resulted in visit to emergency room. The clinical outcome of the events was unknown at the time of report.  No follow-up attempts are possible. No further information is expected. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021460628 same reporter/drug, different event/patient
Lower back and leg pain, stiffness in joints making movement very hard and unsteady.  Fever 26 hrs, chills 5-6 hrs, sweets 14 hrs.  Extremely nausiated. Some headache not intense.  injectionsight swollen and red size of baseball.  swelling in armpit and on upper side of chest 5" w x 7"h. entire shoulder area hurt.
*Severe dizziness for 24 hours beginning 5 hours after the injection, my forehead felt like it was swirling, life disrupting dizziness lasted 3 more days, on day 5 slight dizziness and a spacey feeling, now 13 days later at times I start to veer left or right and focus to walk straight. *Extreme fatique-the day after the injection I stayed in bed all day except to eat, bathroom, or to breakup the bedtime. I stayed in bed due to fatigue and dizziness. *The evening of the shot, 12/27 I had uncontrollable shaking due to fever. I put on all my winter clothes and wore them to bed. The next morning the fever was better. I did not take the temperature because our thermometers don't work. *Gums hurt to chew soft food. *Achey all over for a couple days. Area of shot very sore for 8 days. Still slightly sore.
According to the wife, the patient experienced hives, rash and fever after he received this Fluad shot a few days after 10/31/19.  Since their daughter is a physician, they were told by the daughter that Fluad is not as good as the Fluzone High Dose and more additives are supposed to be in the Fluad vaccine.
Flu like symptoms, with no high temp since original vaccination and continued with 2nd vaccination. Muscles, joints shoulder neck, head. Tonge very sensitive to any acidic , spicy or rough food
Pfizer covid vaccine EAU I still have a fever of100.6 without. Tylenol. Lower but still present with Tylenol.
Several discrete papules within 3 inches of injection site. Within 48 hours lesions itched, scabbed and resolved within one week. No fever, arm swelling, or other symptoms.
Adverse event; Inappropriate schedule of vaccine; This case was reported by a pharmacist via call center representative and described the occurrence of adverse event in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In April 2018, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced adverse event and incomplete course of vaccination. On an unknown date, the outcome of the adverse event and incomplete course of vaccination were unknown.   The reporter considered the adverse event to be unrelated to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. After 1st dose, the patient underwent treatment that was unrelated to Shingrix, and did not get the 2nd dose until July, 2019, which led to incomplete course of vaccination.  The reporter consented to follow up.
15 minutes after injection. Tachycardia, Diaphoresis, mildly hypertensive, facial flushing, waxing and waning symptoms
Left arm became red and swollen. The arm was also painful. I was given cephalexin 500mg capsule and BENADRYL.
Redness and swelling around the left upper arm where the vaccine was administered. Muscle stiffness and itchiness in the above area. The entire left upper arm was warm to touch.
Headache, Myalgia, Arthralgia, Shooting pain to fingers and fatigue Narrative:
Information has been received from a nurse referring to multiple unspecified patients of unknown age and gender. There was no pertinent medical history, concurrent conditions, concomitant medications or drug allergies/drug reactions described. On unknown dates, the patients were administered improperly stored GARDASIL 9 (Lot # L020015 with expiration date of 16-AUG-2017), (dose and route were not reported), which were stored at 1.8 C for 1 hour and 45 minutes. The vaccines did not have previous temperature excursion. No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Blanching rash Rt leg, area hard to touch about 1" long X 13" width. Tx: Augmentin 600mg bid; Benadryl Cream bid, Benadryl 1 tsp qid. Seen by MD.
Rash on legs and arms; This spontaneous case was reported by a physician and describes the occurrence of RASH (Rash on legs and arms) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ulcerative colitis.    The patient's past medical history included No adverse event. Patient's concomitant products included DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for an unknown indication. No treatment information was provided.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form; likewise, on an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and patient also received ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose.   On an unknown date, the patient experienced RASH (Rash on legs and arms).   At the time of the report, RASH (Rash on legs and arms) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) administered intramuscularly in response to events was unknown.  For mRNA-1273 (COVID 19 Vaccine Moderna) administered intramuscularly, the reporter did not provide any causality assessments.
Red and swollen left arm, onset 06/29/2006, with a duration of 2 days ending on 07/01/2006. Had no fever but was irritable. Treated with Benadryl (1 teaspoon every 4 hours for 2 days) and Acetaminophen (2 tablets every 4 hrs for 1 day).
I had a severe cough, congestion, sore throat, body aches, headache. I took antibiotics and got sick again and returned to my doctor again for more antibiotics.
fussy and lowgrade fever day of immunization (early evening)- Tylenol admin and effective. loose BM , greenish in color 04/02 - 04/05/09. Then on 04/06/09, 4 loose BM, mucous present and "specks of red". Child happy, no fever