chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Nov2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 46 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: product: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Case number PHEH2014US019555 is an initial spontaneous report from the health care professional received on 25 Sep 2014. This report refers to a patient of unknown age and gender. The patient was inadvertently vaccinated with only Men A lyophilized component of MENVEO (batch number: not reported) which was reconstituted with another diluent instead of Men CYW liquid component. No adverse event reported following this medication error.
First dose on 4May2021 and did not yet receive second dose; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (First dose on 4May2021 and did not yet receive second dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-May-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 PRODUCT DOSE OMISSION ISSUE (First dose on 4May2021 and did not yet receive second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (First dose on 4May2021 and did not yet receive second dose) had resolved.        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 medication were reported.   Reporter did not allow further contact
In middle of night around 3 am after the vaccine I started coughing very badly and I had coughing asthma. I was having asthmatic reaction and so I kept coughing and coughing, and I wasn't anywhere near my inhaler because I switched bedrooms. I was having asthmatic kind of reaction and I was getting very winded and tight chested and the inhaler that I had was not helping me and I was bringing up a lot of mucous and secretions from chest and so I was getting concerned. It was just a very bad asthmatic reaction that was persisting, and my inhaler wasn't helping. I was concerned if I should be taking the second shot since it will be coming up, so I called my internist and she wasn't there and I was sounding very hoarse and bringing up a lot of mucous from lungs and the person I was given as substitute because my Dr wasn't available she wanted me to go to urgent care and the PA there said my lungs were definitely congested and that person thought it was pneumonia. I had a chest x ray that did not show pneumonia. They put me on steroids and they gave me a different inhaler and told me that I should have a different regimen with it. They said if it didn't break it after those 3 days then I need to be seen by pulmonologist. Had I not called Dr it probably would've just kept going on and on. Although big asthmatic reaction did break after 6 days I still would be coughing and bringing up phlegm for a while but it wasn't as bad as the first three weeks. This lasted 2 ½-3 weeks before I was sent to the urgent care. That same night I got vaccine it started. I didn't have any other symptoms like the usual symptoms. No covid test was performed at the urgent care but the PA did ask me covid related questions. I do cough much more since this happened and I do sound more gravelly. Urgent Care.
Generalized malaise, decreased appetite, rhabdomyolysis. IV fluid hydration for rhabdomyolysis.
post nasal drainage- nonproductive cough- sinus congestion- nasal congestion.        Patient denies headache- sore throat- fever- chills- shortness of breath- body aches- loss of taste- loss of smell- diarrhea- ear pain- swollen glands- chest congestion- chest tightness- chest pain- wheezing- sneezing- itchy eyes- ear drainage- ear fullness. symptoms starting 12/31/21
Initial unsolicited report received from a pharmacist on 05 November 2015. This case involves a female (age unknown) patient who was vaccinated with a dose of RABIES VACCINE (RABIES) (batch number, expiry date, route and site of administration were not reported) on an unspecified date (six months ago). Medical history and concomitant medications were not reported. On an unspecified date, six months following the vaccination patient experienced headaches. Laboratory investigation and corrective treatment were not reported. The outcome of event was unknown. List of documents held by sender: none.
I started coughing in the middle of December.  I had a lot of head congestive and a low-grade fever.  I went to the doctor about this. They did an exam, Covid-19, and flu test, negative results.  I got worst and then went back the next week to see my doctor again.  I had serve fatigue also well.  They gave me a steroid shot.  It went on for 14 days before a felt a little better.  It took over a month for me to feel back to normal.
difficulty of breathing; chest pain; This is a spontaneous report from a contactable consumer or other non-healthcare professional. A 55-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiry date was not reported), dose 1 via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. Medical history included he had a lot of issues because he had a very rare disease called Von Hippel-Lindau (VHL) Disease. This disease causes him to be screened for tumors every single year. He already had 2 craniotomies to remove tumors, 2 radiation surgeries, a pancreas full of tumors and cysts which causes him to be diabetic, a few close calls, a history of a blood infection 2 years ago, and a recently broken neck. He was immunocompromised. Concomitant medications included ciclosporin (NEORAL) and prednisone (PREDNISONE) (He is immunocompromised because he takes Neoral and prednisone for life due to a kidney transplant 35 years ago). On an unspecified date, the patient experienced difficulty of breathing and chest pain. The patient was advocated to get the vaccine. The patient was scheduled for a nuclear stress test for his heart because he has been showing symptoms like difficulty of breathing, and chest pains that might be related to reflux. They wanted to know if the test may affect the vaccine and when would it be best to get the 2nd dose. It was originally thought that he would be getting the Moderna vaccine, but he got the Pfizer vaccine and that was great. The patient would love to help with the research especially because they have read that the vaccine has not been tested yet on immunocompromised people. A V-safe report has been filed. No treatment received for difficulty of breathing and an unspecified treatment received for chest pain. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained
The evening of 12/16/2019 he reports tired and achy feelings. Assumed he needed to go to bed early. Upon waking up 12/17/2019 he states that he had a fever 99.7, chills, sweating, and coughing with fatigue.
About 15 minutes after the injection I felt a warm sensation throughout my body and it went away immediately. About 10  minutes after that, my throat started feeling scratchy/itchy/tingling, then my tongue and lips. After about 10 minutes it went away. I felt ok so I left the vaccination area and went back to my department I work in. For several hours the same symptoms came and went in waves, lessening over time. At 8:30pm the same day, I took 25 mg PO Benadryl to feel safe while sleeping. I felt fine the next day and reported it to the pharmacist in the vaccination clinic. I never felt like my airway was compromised.
pt devel fever & varicella rash 3hr p/vax;probable natural infect & not vax related;
This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 84-year-old female patient who received SHINGRIX (batch number J4D5J, expiry date February 2019) for prophylaxis. On 28th August 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). On 28th August 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX on the left arm. On the same day, the patient experienced arm soreness and 1 month later, she still had this adverse event. The batch number reported for SHINGRIX (J4S5J) did not exist and was updated to J4D5J, as per sales database. This case has been linked to the US2018178307, reported by the same reporter.
Stomach pain, nausea, vomiting & diarrhea following Covid infection, lasting several weeks and resulting in hospitalization, removal of gall bladder (didn't affect symptoms which continued post-surgery), subsequent loss of feeling in legs and feet.  Fall at home resulted in ambulance ride to ER and admission to hospital for 2 weeks. Many tests including lumbar puncture, EMG study, etc. were inconclusive with 'myopathy' and 'neuropathy' of lower extremities.  8 months later after months of Physical Therapy she still can't walk on her own and experiences numbness, pain and swelling in her legs and feet.
2 hours after receiving vaccine, I became itchy all over body and could not stop. My head, legs, arms, ears, eyes, up my nose, etc were itchy.; I did not have hives., just redness from scratching non stop; I did not have hives., just redness from scratching non stop; This is a spontaneous report from a contactable nurse (patient). A 37-year-old female patient (not pregnant) received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot Number EL3248 and Expiration Date unknown) via Intramuscular on 07Jan2021 12:30 PM (vaccine location: Arm Left) at single dose for COVID-19 immunisation. The patient's medical history was reported as Endometreosis, Polycystic ovary (PCOS), anxiety and known allergies to Penicillin. The concomitant medications included duloxetine hydrochloride (CYMBALTA), topiramate (TOPAMAX), Spironolactone, Gabapentin, cetirizine hydrochloride (ZYRTEC), birth control. 2 hours after receiving vaccine on 07Jan2021 02:30 PM, patient became itchy all over body and could not stop. Her head, legs, arms, ears, eyes, up nose, etc were itchy. Patient did not have hives, just redness from scratching non stop, she went home and took Benadryl 50mg, and was still itchy, but not constantly. On 08Jan2021, patient was still itchy all day, but only needed 25 mg of Benadryl to help symptoms and it wasn't nearly as bad as day before. By 09Jan2021, the itching was gone. The outcome of event was recovered on 09Jan2021.
At 1358 the patient received her first dose of Pfizer COVID vaccine, Lot ( FK9894). At 1415 Client alerted EMT that she was feeling dizzy. Client was sitting in chair comfortably under no apparent distress.  The EMT helped client onto anti-gravity chair. At 1417 client was sitting in anti-gravity chair under no apparent distress. Client reported she had not eaten or drank anything all day. At 1417 client was given water and a snack. Client was able to consume water and snack with no difficulty.  Client denied medical history, medications, and allergies. Client denied difficulty breathing, chest pain, HA, itching or tingling. Vitals obtained at 1420 were as follows: HR: 86, BP: 152/90. Client was sitting comfortably in chair comfortably in chair. She did not display tripod breathing , muscle retractions, or nasal flaring. Client was A&Ox4.  At 1423 client was given juice. Client was able to consume juice with no difficulty. At 1423 client reported feeling better. Vitals obtained at 1432 were as follows: HR: 86, BP: 158/90. Client did not display tripod breathing, muscle retractions, or nasal flaring. Client was A&Ox4. Client denied pain, difficulty breathing, HA, or dizziness. At 1433 the RPH ,called 911. At 1441 paramedics arrived and care was transferred over. At 1445 client signed the form declined to go to hospital with paramedics. At 1451 client left vaccination site with a steady gait accompanied by her family member. Client was educated by the RN on signs and symptoms of an allergic response and when to seek higher level of care
Information has been received from a pharmacist referring to a patient of unknown age and gender. Information about medical history, concurrent condition and concomitant medication was unknown. On 14-FEB-2019, the patient inadvertently received a dose of expired M-M-R II (lot # N002337 with expiry date of 20-JAN-2019; dose, frequency and route were unknown) for prophylaxis (expired product administered). No adverse effects were reported.
Had influenza vaccine approx 1:30 pm.  About thre hours later, eyes began to swell, red and itching.  Approx 1/2 hr later lungs felt congested, face flushed, bottom lip swelling.  Muschle ache/pain and fever followed.  He took his regular nebulizer albuterol that he has for asthma, dayquil
Left deltoid muscle with swelling and pain at vaccine site and limmited ROM and pain on patient's left arm. No redness, no fever, no chills reported. Patient states was seen at the ER department yesterday.
My period came almost 10 days early. This happened after both my first and second shot. I have very regular periods and have not had anything like this ever before and not since.
Severe soreness at injection site still on going 4 days after. Severe joint pain still on going 4 days after. Severe fatigue still on going 4 days after. Severe headaches still ongoing 4 days after. Fever of 100 on the evening of day 2 and resolved on morning of day 3.  Metallic taste in my mouth came on within 15 minutes after injection and resolved on the morning of day 3.    ***I tested positive for Covid-19 back on September 7, 2020.
body aches, eye tender with blood in white of eye Narrative: patient wanted to report side effects from covid vaccination on 4/2/2021. he states on Friday evening after receiving the shot he had severe body, muscles aches. Patient woke up on Saturday morning with his right eye tender to touch and blood in the white of his eye. he states that eye still has minor spots but is much
Dizziness, Myalgia, Arthralgia & Fever Narrative:   Other Relevant History:
12 year old daughter a few minutes after vaccine, says she didn't feel well and eyes closed and she dropped.  I quickly grabbed and held her as she would have hit her head from passing out.  The paramedics came and she lost 20 points of blood pressure and then ambulance took her to the hospital where she was released.
This is a spontaneous report received from a noncontactable consumer or other non-HCP (patient), for a Pfizer sponsored program (159558). A female patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), on Sep 8, 2021, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient experienced muscle twitching and pelvic pain, with outcome of unknown. Additional information: After the first dose of the COVID-19 vaccine yesterday, patient experienced muscle twitching and pelvic pain. Patient declined to share any contact information. Medical questions were addressed and/or forwarded/referred appropriately. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Splotchy red skin discoloration appeared on hand on the same arm vaccination was given in.  The discoloration has not resolved to date.
Patient stated of abdominal pain , Pain started on 4/15 after first vaccine dose. Pain started in am. Patient returned to clinic 4/17 for second dose with complaint o RLQ pain and right flank pain,  Reviewed by provider with normal bowel sounds  Second rabies vaccine given. Patient than followed with family provider no notes of that visit
Fever, night sweats, cough, muscle pains, dizzy, mouth ulcers, muscle twitching.
Patient presented on 3/30/21 for his first COVID vaccine appointment. Patient checked in at the pharmacy and came back to the clinic location. During the screening process, the patient did state he has an issue with needles in the past. Patient was with his wife who confirmed that it has never been due to the medication but just a fear of needles. Patient gets lightheaded. After giving the vaccine, the patient was fine at first but then did state he wasnt feeling well. The wife, came and held his hands and I was holding his back and head. Patient did tense up and shook once (not a seizure) and did lose consciousness for about 10 seconds. Had a tech call a code white and store management did come. Patient came back to and seemed fine. He had a Gatorade and drank that and also a bottle of water. Patient started to feel a little better but had a second minor episode (did not seem to lose consciousness). We also got a cold pack and placed on patient's head/neck. He ultimately took about 45 mins to an hour post dose and was able to leave under his own power. Patient and wife appreciative of efforts.
Slept from 1pm to 6am; Sore throat; Warm head; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat), FEELING HOT (Warm head) and SOMNOLENCE (Slept from 1pm to 6am) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat) and FEELING HOT (Warm head). On 16-Mar-2021, the patient experienced SOMNOLENCE (Slept from 1pm to 6am). On 17-Mar-2021, OROPHARYNGEAL PAIN (Sore throat), FEELING HOT (Warm head) and SOMNOLENCE (Slept from 1pm to 6am) had resolved.            Concomitant medications were not reported.  Patient had experienced events after second dose.  No treatment medications were used for events.   This case was linked to MOD-2021-076601 (Patient Link).
Rash around injection site on Left thigh a day or two after injection. Rash on trunk, face and back starting 5/27/19.
Localized swelling and excessive bleeding at entry site of needle within seconds of administration. Patient advised to ice and watch for further symptoms related to more severe reactions including anaphylaxis. Monitored patient for 15 minutes post injection for any further symptoms and none took place. Placed phone call within 48 hours after for update. Patient placed ice pack and swelling had subsided by end of day on day of immunization. Patient reported bruise and soreness in arm but nothing excessive or out of ordinary.
Vaccine reaction; Slight dizziness/light headedness; Blood Pressure High; Little Nauseous; Strong heart beating on chest; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (Blood Pressure High), VACCINATION COMPLICATION (Vaccine reaction), NAUSEA (Little Nauseous), HEART RATE IRREGULAR (Strong heart beating on chest) and DIZZINESS (Slight dizziness/light headedness) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004C21A and 041C21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Allergic to Aspirin). Concomitant products included COLCHICINE for Gout, ASCORBIC ACID (VIT C) and FISH OIL for an unknown indication.   On 04-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-May-2021, the patient experienced HYPERTENSION (Blood Pressure High), NAUSEA (Little Nauseous) and HEART RATE IRREGULAR (Strong heart beating on chest). On an unknown date, the patient experienced VACCINATION COMPLICATION (Vaccine reaction) and DIZZINESS (Slight dizziness/light headedness). At the time of the report, HYPERTENSION (Blood Pressure High) had not resolved and VACCINATION COMPLICATION (Vaccine reaction), NAUSEA (Little Nauseous), HEART RATE IRREGULAR (Strong heart beating on chest) and DIZZINESS (Slight dizziness/light headedness) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-May-2021, Blood pressure measurement (120-80): 157/101 (High) blood pressure at 10:25AM 157/101, 157/93 (High) at 10:50AM 157/93 and 165/103 (High) at 12:13PM 165/103, 70. On 05-May-2021, Heart rate: 61 (Low) 10:25AM, 63 (Low) at 10:50 AM and 70 (normal) at 12:13 PM.     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 treatment medications were provided by reporter.   This case was linked to MOD-2021-213383 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2021: Non significant follow up received on 08-JUN-2021, patient demo graphics updated, events updated
Information has been received from a physician concerning a female who "about a year ago" in approximately 2007 was vaccinated with a dose of GARDASIL, Lot number was not provided.  The physician reported that the patient's mother reported that her daughter experienced severe mood/personality changes "about a week post vaccination" after receiving GARDASIL.  At the time of the report, the patient's outcome was unknown.  This is one of two patients concerning the same source.  Additional information has been requested.
Teeth chattering chills that required me to go home.  Put several blankets on and was still freezing cold.  Also had a temperature 102 degrees.  Body aches.  Very uncomfortable.
FEVER (101.1), RUNNY NOSE, COUGH, ACHY, AND TIRED