chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 71-year-old patient received BNT162b2 (BNT162B2), on 25Sep2021 as dose 1, single (Lot number: FF8839), in left arm, on 25Feb2022 as dose 2, single (Lot number: EM9809), in left arm, on 17Mar2022 as dose 3 (booster), single (Lot number: EN6207), in left arm and on 01Apr2022 at 10:00 as dose 4 (booster), single (Lot number: FL3198) at the age of 70 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Mild Htn" (unspecified if ongoing), notes: Mild Htn; "cataracts" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE BESILATE, start date: 01Sep2016, stop date: 05Jul2022. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 05Jul2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (05Jul2022) Positive; (08Jul2022) Positive; (10Jul2022) Positive; (12Jul2022) Positive. Therapeutic measures were taken as a result of covid-19, drug ineffective.  Clinical course: Patient received other medication in 2weeks: Yes. Patient tested positive for COVID on 05Jul2022 took 5 day course of Paxlovid and completed it on 10Jul2022. Sx rapidly disappeared but on Day 9 post initial dx I began to experience mild congestion runny nose and sneezing. I have tested on Days 05Jul2022, 08Jul2022, 10Jul2022 and 12Jul2022 with all positive results. Patient was recovering and no treatment and patient had no known drug allergies. Device timestamp on 17Jul2022.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the known safety profile of the vaccine  BNT162b2, a causal relation between the reported events Covid-19, Drug ineffective and the administration of the vaccine cannot be excluded.
This spontaneous report received from an office manager referred to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. The patient was administered an expired dose of M-M-R II (lot: K021152, expiry date: 02-NOV-2016) on 09-DEC-2016. No adverse effects reported. Additional information has been requested.
Noticed a large red mark on arm around vaccination site extending from shoulder to elbow on outside of arm.  Area was lighter on the inside and redder at the edges.
p/vax pt devel hives w/pruritus over entire body; taken to med center given benadryl, prednisone, atarax
Reactivation of previous shingles. Tingling on side of face, eye pain, ear pain.  Flu like symptoms.   I had 1 episode of shingles 15 years ago in which I loss about 50% of my hearing in my left ear.   Symptoms this time were all on the left side of my face.
Onset of severe vertigo with nystagmus on 3/12/98. Some "black holes" on MRI, initiated dx uncertain. Progression of symptoms over the next 2 years with some episodes of numbness and weakness and progression of MRI findings, including enhancing lesions led to dx of Multiple Sclerosis made in 2/00.
PATIENT CAME IN 10/19 WITH A SWOLLEN/RED ARM. PATIENT ALSO MENTIONED THAT HE HAD TROUBLE BREATHING LAST NIGHT (DELAYED FROM 10/17 WHEN HE RECEIVED THESE SHOTS). THIS BREATHING GOT BETTER AFTER USING SYMBICORT. PATIENT WAS BETTER TODAY IN TERMS OF BREATHING BUT STILL HAD RED SWOLLEN ARM. I RECOMMEDED HIM TO TAKE BENADRYL AND MONITOR HIS BREATHING.
I have had an irregular period since my second shot. They have been every 3 weeks and last longer. I have also have had a unusual amount of spotting.
Immediate lightheaded for 1/2 hour. Immediate joint pain for 10 minutes. Sore arm for 2 days. Beginning day after vaccine, joint pain and reoccurring severe Charley horses in both feet and left hand for 2.5 days. Nausea.
Pt seen at office on 3/26/07 c/o itchy rash to face. Reports XS began 2 days previously. Seen by DR noted macular rash face and neck and ordered Benadryl, Prn.
Severe (R) arm erythema & swelling. Suspect localized reaction no evidence of cellulitis.
Extreme chills, shaking uncontrollably, couldn't feel hands, very high fever, worse headache of my life, despondent and depressed. I've never felt so sick in my life.
I become Very sick 25 hours after vaccine. High fever 101/102 headache body ache dizzy stuffy nose sore throat cough tight chest heart racing  still feeling sick 48 hours after vaccine
no taste or smell; no taste or smell; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 43-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 11Aug2021 as dose number unknown, single for covid-19 immunisation. No relevant medical history and concomitant medications were reported. On an unspecified date in 2021, the patient experienced no taste or smell. Patient question if it was normal. The outcome of the events no taste or smell was unknown.     The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
This spontaneous report as received from a medical assistant refers to a 4 year old patient of unspecified gender. On 13-MAR-2017, the patient was vaccinated with an improperly stored dose of M-M-R II (lot # L009213 exp date 17-MAR-2017) (dose and route not reported). The temperature of excursion was 47 °F to 77 °F with a highest temperature of 55.1 °F for 15 minutes. There was no previous temperature excursion. A data logger issue was reported. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1703USA007644.
severe local rxn w/abscess & 8cm induration;fever >104, severe pain & cervical lymphadenopathy;
After about 15 minutes a VERY strong metallic taste in back of throat...lasted approx. 3-4 days after 1st dose...happened again after 2nd dose but much fainter and only for a day or 2; This is a spontaneous report received from a non-contactable reporter (Consumer or other non HCP). The reporter is the patient.   A 57-year-old female patient (not pregnant) received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administered in left arm, administration date 26Mar2021 (Lot number: ER8730) at the age of 57 years as dose 1, single and COVID-19 VACCINE (MANUFACTURER UNKNOWN), administered in left arm, administration date 23Apr2021 (Lot number: ER8731) at the age of 57 years as dose 2, single for COVID-19 immunisation. The patient's relevant medical history was not reported. Concomitant medications included: VITAMINS, CALCIUM CITRATE and OMEPRAZOLE. The following information was reported: DYSGEUSIA (non-serious) with onset an unknown date in Mar2021, outcome "recovered" (an unknown date in Apr2021), described as "After about 15 minutes a VERY strong metallic taste in back of throat...lasted approx. 3-4 days after 1st dose...happened again after 2nd dose but much fainter and only for a day or 2". Therapeutic measures were not taken as a result of dysgeusia.  Additional Information: The patient did not receive any other vaccines within four weeks prior to COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care.  No follow-up attempts are possible. No further information is expected.
She got her vaccine, booster, the rashes started to spread on the side of her face, going up the side of her face on both sides, up her nose, went to her entire face.  She made an appointment with a dermatologist at that point as it was so out of control, and at this point they are still trying to get it under to control even now.  It then spread to her neck, was still getting the herpes outbreaks in the vaginal area.  Her dermatologist did tell her it was possibly due to the vaccine.  She does not wear any make up, does not take any medicine or vitamins, so not sure what it was like.  She did not get COVID and was told that there were a few people coming in with similar symptoms.  Felt like the vaccine triggered the outbreak and trying to get it under control with injection shows to get them under control.   She does feel it is due to the vaccine as there was nothing coming into her body for years and years.  After the booster the condition got worse and does not know if it can get under control or not.  She was getting Dupixent, and had an allergic reaction to that, and then was put on the Avery, and the rashes are breaking through that medicine, and is still dealing with the condition now.    The herpes outbreaks have seem to subside, and the rashes are not as bad as they were, but it is still present.    With the first two vaccines she began getting rashes around her mouth on top of her lips.  Did not connect it to the vaccine.  Put a cream that she would use on a rash, would go away for a day or two and would come back, and kept recurring.  This was then spreading around her mouth, circling her lips, and kept coming and going.  She also started getting a herpes outbreak in her vaginal area, very like a deep cut from a knife that kept coming and going as well.  Very uncomfortable, put vitamin E on it, (not sexually active for many years).  It would go away and kept coming back, and did not know what was causing it.  She was living with the condition and uncomfortableness of it.   The rash is very difficult around her face and her eyes which is extremely difficult.    She did have an eczema outbreak when she was pregnant around 30 years ago, which was all over her body, due to the hormone shift of the pregnancy, this cleared up since her daughter a year to 18 months old and nothing since until the COVID vaccines.
light case of chickenpox first noted 17DEC was expected to disease 4DEC;had vax 12FEB97, given @ another clinic;
Outbreak of hives on legs for a duration of 2-2.5 months. Non perscription topical ointment used.  Experation of vaccine 10/19/21 Dosage: 50 mcg/0.5 ml
This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 71-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included chickenpox (in 1988). Concomitant products included SHINGRIX. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, 1 day after receiving SHINGRIX, the patient experienced injection site swelling, injection site itching, injection site pain and injection site erythema. On an unknown date, the outcome of the injection site swelling, injection site itching, injection site pain and injection site erythema were recovered/resolved. It was unknown if the reporter considered the injection site swelling, injection site itching, injection site pain and injection site erythema to be related to SHINGRIX. Additional details were reported as follows: This report was received via healthcare professional (HCP) only email forum. The patient noted that, she was not an HCP but that was the only way to contact GlaxoSmithKline. The age at vaccination was not reported. But, it could be 70 or 71 years old. The patient received the 2nd dose of SHINGRIX with exactly 2 months apart from the 1st dose. The patient had local reaction described as unpleasant local swelling, soreness, and severe itchiness. The patient further stated that, the redness and swelling at the site was 2.5 inches in diameter and it was worst. The reaction began to develop in the morning of the day after vaccination and grew for at least 8 days. The patient stated that, the events lasted for 2 weeks and she never had shingles. No further information was provided. For tolerance after the 1st dose of SHINGRIX for this patient, refer case US2018107157.
This spontaneous report as received from a pharmacist refers to a 86 year old patient. The patient's medical history includes history of skin cancer, high blood pressure, diabetes, chronic obstructive pulmonary disease, heart failure, hyperplasia of the prostate. The patient's concomitant medications included 8 chronic medications and 5 medications as needed. Medications were not specified but ncluded a statin and diabetes medication. On 02-JUN-2016, the patient received the first dose of ZOSTAVAX subcutaneous for prophylaxis. On 27-SEP-2017, the patient was vaccinated with the second dose of ZOSTAVAX subcutaneous for prophylaxis. No adverse effects were reported. The patient did not seek medical attention.
Pt recvd 3 doses of Engerix-B 14SEP90, 29OCT90, & 25MAR91 & 3JUN91 lab test indicated "did not convert"; recvd a booster dose of Engerix-B 24JUN91; 15AUG91 lab tests indicate pt did not convert;
This spontaneous report as received from a medical assistant refers to a 16 month old patient of unknown gender. The patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 22-OCT-2018, the patient was vaccinated with improperly stored dose of VAQTA ped 0.5 ml vial (dose, frequency and route were not reported) (lot # R009953, expiry date: 12-JUN-2019) for prophylaxis. On 06-SEP-2018, the vaccine was exposed to the temperature of 32.21 degree Fahrenheit (°F) (32F to 35 F) for 3.5 hours. Previous excursion was 50.37 °F for 4.5 hours as recorded by a data logger. No adverse effect was reported. No product quality complaint was involved. This is one of the several reports received from the same reporter source. Sender's Comments: US-009507513-1809USA002868:Original Case : 1809USA002868 US-009507513- 902USA009324:Original Case : 1902USA009323 US-009507513-1902USA009325:Original Case : 1902USA009323 US-009507513-1902USA009326:Original Case : 1902USA009323.
Local redness and swelling at injection site. 6-18-08 - Doctor saw client - recommended TYNLENOL And cool compresses. 6-19-08 Visited health clinic.
Patient received Janssen COVID vaccine on 7/28/21. On 9/6/21, patient was admitted to our facility CCU for hypoxia (requiring intubation), sepsis, AKI, and COVID/bacterial pneumonia. COVID status positive upon admission. As of 9/9/21, patient is still in CCU and intubated with severe refractory hypoxemia.
IMMEDIATELY AFTER INJECTION PATIENT BECAME DIZZY, EYES STARTED ROLLING BACK AND FORTH, PATIENT'S BODY BECAME HOT, PATIENT'S BODY BECAME TENSE AND STIFF, AND PATIENT VOMITTED.  911 WAS IMMEDIATELY CALLED AND PATIENT WAS TAKEN BY PARAMEDICS.
This spontaneous report as received from a physician via company representative refers to a 12 months old patient of unknown gender. In approximately 2014 (within the last 6 months) the patient was vaccinated with first single dose MMR II (injection, route of administration, lot#, expiry date were not reported). Concomitant therapy included VARIVAX. In approximately 2014 (within the last 6 months) the patient developed malaise, rash and fever thought to be consistent with mumps. The outcome of malaise, rash and fever was unknown. The relatedness between malaise, rash and fever and MMR II was unknown. This is one of three reports from the same reporter. Additional information is not expected.
received booster at the same time; Coughing; stuffy nose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2), administration date 17Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (Dose 2, MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 17Nov2021, outcome "unknown", described as "received booster at the same time"; COUGH (non-serious) with onset Nov2021, outcome "unknown", described as "Coughing"; NASAL CONGESTION (non-serious) with onset Nov2021, outcome "unknown", described as "stuffy nose".  Additional information: Husband received booster at the same time. He did not experienced the same. However, in the same week, he started coughing and stuffy nose. But we assume, he caught that from the reporter.   The lot number for bnt162b2 was not provided and will be requested during follow up.
12 n Mother gave child TYLENOL 0.4ml but did not take temp.  1pm Mom woke child for feeding.  Mother stated he was upset, he could not decide if he wanted to cry or breath.  Mom called 911, child was not blue did not feel hot or clammy.  Child stopped crying - paramedic neighbor arrived first, child was then in a "ball" with bubbles from mouth, eyes open a little not rolled back, good color body / abdomen tight.  When rescue squad arrived child was normal, 15 on Glascow coma scale, skin normal, pupils PERLA.  No transport to hospital No ER or doctor visit.  Observed at home by parents.  4pm temp 100.4 Rx
5JUN92 pt recvd Engerix-B & 10 days later devel severe flu-like sx which lasted 4 days;
numbness in legs; tingling in legs; This spontaneous case was reported by an other health care professional and describes the occurrence of HYPOAESTHESIA (numbness in legs) and PARAESTHESIA (tingling in legs) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPOAESTHESIA (numbness in legs) and PARAESTHESIA (tingling in legs). At the time of the report, HYPOAESTHESIA (numbness in legs) and PARAESTHESIA (tingling in legs) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.  No treatment medications were provided.
I've lost my taste, again.; felt cruddy; feverish; 1st dose on 10-Oct-2021 and 2nd dose on 20-Nov-2021; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (I've lost my taste, again.), FEELING ABNORMAL (felt cruddy), PYREXIA (feverish) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose on 10-Oct-2021 and 2nd dose on 20-Nov-2021) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 068F21A and 037F21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Lost his sense of smell & taste.Over the last 10 months his taste had been coming back pretty well.) in December 2020.   On 10-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Nov-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Nov-2021, the patient experienced AGEUSIA (I've lost my taste, again.), FEELING ABNORMAL (felt cruddy), PYREXIA (feverish) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose on 10-Oct-2021 and 2nd dose on 20-Nov-2021). On 20-Nov-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose on 10-Oct-2021 and 2nd dose on 20-Nov-2021) had resolved. At the time of the report, AGEUSIA (I've lost my taste, again.), FEELING ABNORMAL (felt cruddy) and PYREXIA (feverish) outcome was unknown.            No concomitant medication information provided. No treatment medication information provided. The patient had Covid between Christmas & New Yr last yr & lost my sense of smell & taste. Over the last 10 months taste had been coming back pretty well. After 2 doses of Moderna Covid-19 vaccine, he had lost taste, again.  Company comment: This case concerns a male patient with no relevant medical history, who experienced non-serious unexpected AESI of ageusia, that occurred on the same day after the 2nd dose of the mRNA-1273.  Additionally, there was an inappropriate schedule of vaccine administration since time between doses was more than 35 days. The rechallenge was not applicable due to occurrence after the 2nd dose. The benefit-risk relationship of mRNA-1273 is not affected by this report.    This case was linked to MOD-2022-460249 (Patient Link).; Sender's Comments: This case concerns a male patient with no relevant medical history, who experienced non-serious unexpected AESI of ageusia, that occurred on the same day after the 2nd dose of the mRNA-1273.  Additionally, there was an inappropriate schedule of vaccine administration since time between doses was more than 35 days. The rechallenge was not applicable due to occurrence after the 2nd dose. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Major headache, site pain, chills, complete body aches, and nausea. All started around 7pm the following day.  Ended on the Sunday after.
Initial report received from a physician (who is the patient's grandparent) on 04 December 2006. A 15 year old, female patient (with a medical history of hypothyroidism, positive thyroid antibiotics) developed a headache, 1 week after she received an injection of Menactra (lot number was unknown, route and site of administration not reported) on 09 October 2006. The reporter stated the headaches was no chronic and varied in intensity. The patient also has left sided arm and leg pain. She did not have any illness at the time of vaccination. She was seen by a neurologist and had an MRI, MRH and Sed Rate. At the time of the report, the patient was not recovered.
Client has a history of reactions and had a 30 minute wait in waiting room. She immediately had itching and AW gave 20ml of benadryl. Assessed patient and itching continued all over body. Waited 10 minutes and administered 20 more ml of benadryl. No s/s of swelling, difficulty breathing or hives. Patient felt good to go home and was going to take prescribed medication. Patient stated that this is normal. Released from waiting room at 4:35pm
Second dose: small headache; Second dose: feeling dizzy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 07May2021 (Lot number: EW0158) at the age of 70 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Blood pressure" (ongoing), notes: Verbatim: Blood pressure. Concomitant medication(s) included: METOPROLOL taken for blood pressure abnormal (ongoing). Vaccination history included: Bnt162b2 (First dose), for covid-19 immunisation.  The following information was reported: HEADACHE (non-serious) with onset 08May2021, outcome "not recovered", described as "Second dose: small headache"; DIZZINESS (non-serious) with onset 08May2021, outcome "not recovered", described as "Second dose: feeling dizzy".  Additional information: On the 08May2021 he had the dizziness and the headache. He had gotten up from sleeping and his head started feeling dizzy with a small headache, he's continued to have it. He was supposed to go somewhere with his wife this morning, 19May2021 but he told her to go without him and he would call Pfizer and ask for some guidance on what he needs to do. AE(s) following prior vaccinations was None. The events did not cause Emergency Room or Physician Office visit.   No follow-up attempts are possible. No further information is expected.
Moderately severe muscle aches, fatigue and scalp tenderness gradually starting to improve after eight days
Shortly p/DTP/OPV/HIBTITER, MD child devel red, runny eyes, coughing & sneezing which lasted about 2-3 hrs; no wheezing; pt subsequently fine;