chrisvoncsefalvay/vaers-outcomes huggingface dataset:
blasting headaches; chills all night; dry heaving all night; Nausea; no fever but her skin felt hot; sore left arm; This is a spontaneous report from a contactable nurse for herself. This 64-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscular on 18Dec2020 at single dose on left upper arm (lot: EKS730), via an unspecified route of administration on 05Jan2021 14:30 at single dose (lot: EL1284 or EKI284) for COVID-19 immunisation. Medical history and concomitant medications were none. The patient did not have anything with the first shot except a sore left arm on 18Dec2020. She stated that if she lays on left side it is sore. The patient had the sore left arm both times that she got the vaccine. She got second dose of vaccine on 05Jan2021 at 2:30pm and had a blasting headache and just had chills that went away about hour ago on 05Jan2021. She did not have a fever but her skin felt hot on 05Jan2021. She stated that she had dry heaves on 05Jan2021. The patient started that she had a blasting headache within a few hours of the vaccine and it gradually got worst by the time she went to bed. Stated that the chills and dry heaves started then and throughout the night. The chills stopped an hour before she got up. Stated that she went to check her temperature and did not have a fever despite having chills and her skin feeling hot. Stated that nausea started about 10 at night on 05Jan2021. Seriousness for blasting headache, chills and dry heaves was disabling, for nausea was medically significant, for other events was non-serious. The patient took Ibuprofen for the headache. Stated that she was going to try to drink something. The outcome of sore left arm was not recovered; of chills was recovered on 06Jan2021. The outcome of other events was recovering. The causality for blasting headache, chills, dry heaves, nausea and skin felt hot was related (Source of assessment: Primary Source Reporter, Method of assessment: Agency Information on the batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the headache, chills, dry heaves and other reported events due to temporal relationship.  There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications.   This case will be reassessed once additional 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.
This spontaneous report was received from a medical assistant refers to a 17 year old patient of unknown gender. The patient's concurrent conditions, medical history, drug reactions and concomitant medications were not reported. On 29-MAR-2017, the patient was vaccinated with first dose of GARDASIL 9 (dose, units and frequency not reported) (lot# and expiration date not reported), intramuscularly, on 26-SEP-2017, the patient was vaccinated with second dose of GARDASIL 9 (lot# N019923 and expiration date: 28-APR-2019), on 04-DEC-2017, the patient was vaccinated with third dose of GARDASIL 9 (lot# N019923 and expiration date: 28-APR-2019) and on 01-MAY-2018, the patient was vaccinated with fourth dose of GARDASIL 9 (lot# N004798 and expiration date: 31-OCT-2018). Reporter stated that the patient received the vaccines outside of the schedule. No adverse effects reported. No product quality complaint was involved.
I contracted COVID-19 on 05/24/2022 with symptoms of scratchy throat, runny nose, cough, congestion, fatigue, and mild headaches. I had a telemedicine visit and was advised to take vitamin C, zinc and TYLENOL as needed, due to it being a mild case. My symptoms began to abate after 5 to 6 days. I am fully recovered with no lingering symptoms.
Information has been received from a physician concerning a 9 week old female with no pertinent medical history and no drug reactions or allergies who on 10-DEC-2010 was vaccinated with a dose of ROTATEQ (lot # 668264/0854Z). There was no concomitant medication. On 10-DEC-2010 the patient experienced hematochezia after receiving ROTATEQ. The patient sought unspecified medical attention. No lab diagnostics studies were performed. At the time of the report, the patient had recovered. Follow-up information was from a registered nurse indicating that on 10-DEC-2010, the patient received the first dose of ROTATEQ (lot # 668264/0854Z) and concomitantly received the second dose of RECOMBIVAX HB (Lot # 666186/1483Y, thimerosal free) and received the first dose of PREVNAR 13 and the first dose of PENTACEL. On the evening of 10-DEC-2010, the patient's mother reported that the patient had blood streaks in her stools and mucus in her stools. The patient's mother was advised to have the patient be seen by the physician if the blood and mucus in her stools persisted. There was no documentation which indicted that the patient had a follow-up appointment due to blood and mucus in her stools. The R.N. stated that there were no issues of bloody stools that followed. The R.N. stated that the patient had recovered. The physician had discontinued ROTATEQ. On 18-JAN-2011, the patient was seen by the physician for cough, vomiting and watery stools. The R.N. stated that the patient was diagnosed with a virus (not specified). Follow-up information has been received from a physician and medical records indicating that a two month old female who on 10-DEC-2010, received the first dose of ROTATEQ (lot # 668264/0854Z) and concomitantly received the second dose of RECOMBIVAX HB (Lot # 666186/1483Y, thimerosal free), the first dose of PREVNAR 13 and the first dose of PENTACEL. On 10-DEC-2010, the patient experienced blood in stool. The patient recovered on approximately 15-DEC-2010. The second and third doses of ROTATEQ were not given. At the time of the report, the outcome of virus (not specified) was not reported. This is one of several reports received from the same source. All available medical records will be provided upon request. Additional information is not expected.
Report A0367702A describes arthritis in a pt of unspecified age who rec'd Lyme disease vaccine recombinant OspA (LYMErix). This report was rec'd from the pt and has not been verified by a physician or other healthcare professional. On an unspecified. On an unspecified date, the vaccine rec'd an injection of LYMErix; it was not known if she had rec'd previous injections of LYMErix. the reporter stated that subsequent to her LYMErix vaccination she had some arthritis. As of 5/3/02, the outcome of the event was unknown. Additional information will not be available. The adverse event "arthritis" does not meet ICH serious criteria, but is being submitted as an expedited report by special FDA request per the 6/28/00 letter.
This spontaneous repot as received from a pharmacist refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies were not provided. On 22-DEC-2014, the patient was vaccinated with an expired dose of PNEUMOVAX23 (dose and lot number were not provided). The expiration date was reported as 26-SEP-2014. Additional information is not expected since reporter would not like to be contacted.
approx 36hr p/vax pt exp nausea, weakness, appetite loss, aching legs & arms, soreness all over & severe h/a;7JUL96 vomiting, sore throat, rash on arm & legs;seen in ER 7JUL96 given med;
Experiencing all general side effects: fatigue, headache, muscle pain, joint pain, chills, nausea, vomiting and fever
Information has been received from a registered nurse, concerning a 24 year old female patient, with no pertinent medical history and not known drug reactions or allergies, who on 26-MAR-2010, was vaccinated intramuscularly with the first 0.5 mL dose of GARDASIL (lot number 662299/1099Y). There was no concomitant medication. The nurse reported that within second of receiving the vaccine, the patient had a warm sensation and then fainted. The patient was lowered to the floor and was not injured. The patient was unresponsive for 30-60 seconds. The patient laid down for 15 minutes and was then able to leave the office. The patient sought unspecified medical attention. No labs or diagnostics studies were performed. At the time of the report, the outcome of warm sensation was not reported. Follow-up information has been received from a registered nurse, concerning the female patient who on 26-MAR-2010, at 9:00AM, received in the left deltoid the first dose of GARDASIL. The registered nurse stated that on 26-MAR-2010, at 9:00AM, within minutes of receiving GARDASIL, the patient complained of not feeling well, asked for water and then fainted. The patient came to in approximately 1 minute. The patient was taken to exam room to lie down for 15 minutes. At the time of reporting, the patient had recovered. No further information is available.
Had fever reaching 103 degrees.  Lasted 2 days before returning to normal. Tested positive on 2/26/21.  Had negative tests on 3/15/21 and 3/18/21. It was like having COVID all over again, except it didn?t last as long and I wasn?t fatigued after the fever left. I?m wondering what will happen on my 2nd shot scheduled for 5/6/21?
Headache Pain at the inj. site. fatigue ,rash on R. shoulder and  joint pain. Narrative:  Other Relevant History:
Patient was  given  second dose of Moderna vaccine at a 21 day interval not 28
Erythema, edema, warmth at site of DTap #5. Estimate 8 diam onset with 30 hours after injection. NO systemic DX. Pt Rec'd MMR  adm arm posteriorly.
A few minutes after receiving the vaccination, she began to feel nauseous with dry heaves. 4:13 pm BP (right arm) = 108/68. 4:25 pm BP (right arm) = 118/80. After resting for 45 minutes she felt better and went home. 10/25/17, 6:45 pm, followed up with patent and she stated she had no further reactions except for "feeling a little under the weather" for the last few days.
Lymph node size of a grape on left collar bone; Chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), HEADACHE (Headache) and LYMPHADENOPATHY (Lymph node size of a grape on left collar bone) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID] and MECLIZINE [MECLOZINE] for an unknown indication.    On 01-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-May-2021, the patient experienced CHILLS (Chills) and HEADACHE (Headache). On 05-May-2021, the patient experienced LYMPHADENOPATHY (Lymph node size of a grape on left collar bone). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 03-May-2021, CHILLS (Chills) and HEADACHE (Headache) had resolved. On 13-May-2021, LYMPHADENOPATHY (Lymph node size of a grape on left collar bone) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Other concomitant medications included Tylenol.
Allergic rxn to Hep-B vs angioedema. Swelling of face & lips. Intermittent hives & swelling. Pruritic rash. Hives on outside of thighs. Swelling index fingers-given Benadryl.
I did not feel adverse side effect, just sore arm. But there was bleeding that night, continuing that night and into Sunday. I went to my OB on Monday, I was 8 weeks and 4 days. They determined that the baby had stopped growing and there was no heartbeat and they declared it a miscarriage. Est due date was December 11 2021. No fever or any other side effects.
Pt reports acute swelling, mild pain, and episodic numbness and tingling into her 4th and 5th fingers.
Received Rotateq 4/02/07 0695F PO. 5/18/07 seen in office with diarrhea and dehydration. Admit to hospital, discharge 5/22. 5/24/07 Seen in office Diarrhea - referred to ER for IV fluids and Rotavirus. 6/5/07 Received vax records from PCP which confirm lot & dose # as reported.  7/6/07 Received hospital medical records which reveal patient experienced diarrhea, dehydration & metabolic acidosis.  Had been recently d/c from hospital w/rotavirus & parainfluenza infection (5/19-5/22/07).  Current admit 5/24-5/27/07.  GI consult done revealed dx milk protein allergy that developed after rotavirus infection due to sensitization & also suggested metabolic disease w/u to be done.  FINAL DX: Diarrhea, dehydration & metabolic acidosis, resolved; milk protein allergy.
Nausea and sweating within five minutes of receiving vaccination. Menstrual cycle began early, the day after vaccine was administered.  Usually use a light tampon had to use super extra and went through that in approx an hour or two. Very abnormal. Extreme headache with no relief with Acetaminophen. Most symptoms resolved within 8 days.
COVID-19 Treatment; COVID-19 Treatment; Interchange of vaccine products; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 83-year-old female patient (not pregnant) received BNT162b2 (Pfizer-BioNTech COVID-19 Vaccine), on 03Apr2022 as dose 4 (booster), single (Lot number: FK9893) at the age of 83 years, in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 23Jan2021 as dose 1, single (Batch/Lot number: unknown), in right arm, on 19Oct2021 as dose 2, single (Batch/Lot number: unknown), in right arm and on 26Feb2022 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Angina" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing); "thyroid under active" (unspecified if ongoing); "allergies" (unspecified if ongoing); "osteo arthritis" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: BUPROPION; DILTIAZEM; ESTRADIOL; LEVOTHROID; LIOTHYRONINE; NITROGLYCERIN; POTASSIUM CHLORIDE; PRADAXA; PRAVASTATIN. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 03Apr2022, outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: Blood pressure measurement: High; SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.
Nothing happened after the vaccine, no reaction at all. But two months later, it seems like a I had muscle ache, burn on the chest, it comes and goes, it happened before I got the vaccine, I never had breathing problems even when I had COVID twice, but that night was strange I had problems breathing, it hurt when the air was going out, the chest area was sort after a week. I called the doctor the next day, and the doctor didn't get back to me for two weeks. I went in and they did a EKG and said was my heart was fine. I had partial hearing lost from COVID/OMICROM last January 2022.
Patient was accidentally given a MENACTRA vaccine instead of a PNEUMOVAX vaccine, patient denies any adverse reactions.
About five hours after I receive the vaccination, I had hives that began behind my right ear. The hives spread to my scalp and down my neck and onto my chest. I took Benadryl to manage the reaction. I continue to take Benadryl through the night. I was still having a reaction in the morning with hives on my abdomen and itching on my wrists ankles in the bottoms of my feet.  I called my father-in-law who is a doctor. He suggested taking Zantac in addition to the Benadryl. Zantac was unavailable at the pharmacy and the pharmacist suggested Pepcid as a histamine blocker. I took those two. The symptoms were quite a bit less on Monday morning to days later. I had very little symptoms on Tuesday as I continued with the medication. On Wednesday, I had a couple of instances of itching and hives nothing significant and prolonged.  Today, Thursday, was five days out from the vaccination. I still had a bit of itching and hives today.
2SEP93 seen in ER temp elev 103.6; awakened w/pain neck, shoulders, upper back; 6SEP93 ER numbness in hands all fingers & feet; 9SEP93 weakness & hands & legs unable to stand; GBS;
On 12/31 woke with fatigue and lymph node pain under left arm.  Driving in a car later in the day I noticed pressure/a tone in my ears.  Went away after leaving vehicle.  Comes back with every enclosed space where their is a pressure issue and continues for hours after.  Ibuprofen helps with some of the pain but no all of it.  Working in a positive pressure lab causes ear pain/pressure/ringing in the ears.
Rash on her lower front of her legs /it is bright red, about 5-6 inches long and 3-4 inches wide; Rash on her lower front of her legs /it is bright red, about 5-6 inches long and 3-4 inches wide; Soreness left upper arm at injection site; Swelling left upper arm at injection site; This is a spontaneous report from a contactable nurse (patient). A 85-years-old female patient received first dose of bnt162b2 (BNT162B2, solution for injection), via an unspecified route of administration, administered in arm left on 11Feb2021 16:00 (Batch/Lot Number: EL9269) (at the age of 85-years-old) as SINGLE for covid-19 immunization. The patient denied for any Medical history and concomitant medications. On 11Feb2021, she just had a little soreness and swelling at injection site in upper left arm. Also, stated on Sunday morning, 14Feb2021 at 7 AM when she woke up she had a rash on her lower front of her legs, states it is bright red, about 5-6 inches long and 3-4 inches wide, for no reason. The patient did not treat rash, went to dermatologist, just her 6 month regular visit, doctor went through the list of everything she could have had been allergic to, the only thing they have done differently is the Pfizer vaccine, dermatologist gave her some cream to start, will start treating the rash today, medication was triamcinolone cream. The outcome of events little soreness and swelling at injection site in upper left arm was recovered on 11Feb2021 whereas, other events was not recovered.  Follow-up attempts completed. No further information expected.
This spontaneous report as received from a healthcare worker refers to a 15 year old patient of unknown gender. On 19-AUG-2015, the patient was vaccinated with a dose of improperly stored GARDASIL (Lot # K011562, expiration date 08-APR-2017) (strength, dose and route were not provided). No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
Moderna COVID-19 Vaccine EUA: patient presents to primary care clinic for follow-up after reaction to immunization. Within 20-25 minutes of immunization, reported becoming splotchy from waist up, itching, and throat feeling tight. Patient self-administered Epi-Pen prescribed for other allergies. Reports hives persisted and took fexofenadine and diphenhydramine. Nine days later in clinic patient still taking antihistamines and still has rash and hives from waist up. Vital signs within normal ranges. Injection site is raised, erythematous, and warm. Patient to follow-up with allergist, continue antihistamines, and given instructions for when to go to emergency department.
pt recvd vax;muscular/skeletal could not move neck w/out severe discomfort & pain; Ibuprofen for discomfort & pain;MD advised 3 pills  per day;
TERRIBLE FEELING; FEVER; HEADACHE; NAUSEA; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers.  No concomitant medications were reported. On an unspecified date, the subject experienced terrible feeling, fever, headache, and nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, headache, nausea and terrible feeling was not reported. This report was non-serious.
Pt reported injection site swelling and pain as well as the site feeling warm to the touch. She says it has gotten worse as the day went on and she tried a warm compress. She is going to Dr.
This case was reported by a consumer and described the occurrence of foot pain in a 8-year-old female subject who was vaccinated with hepatitis B vaccine recombinant (Hepatitis B vaccine, manufacturer unspecified).  A physician or other health care professional has not verified this report.  Previous vaccinations included the 1st and 2nd doses of hepatitis B vaccine recombinant;  manufacturer unspecified; given on an unspecified dates.  On an unspecified date in 1994, the subject received the 3rd dose of a Hepatitis B vaccine (unknown).  At an unspecified time after vaccination with Hepatitis B vaccine in 1994, the subject experienced foot pain.  At the time of reporting, the outcome of the event was unspecified.
Got injection around 2:30 pm and by 5 pm had severe chills-intense headache and joint pains all over body. By 7 pm heart rate increased and developed cough. No fever. Went to ER.
Hemolytic anemia; He started feeling bad two days later; Fatigued / feeling tired; feeling sick; 102 Fever; sweating; This is a spontaneous report from a contactable consumer (patient's wife). A male patient of an unspecified age received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown), via an unspecified route of administration on an unspecified date, as a single dose, for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient received a flu shot on the 26th (as reported). The patient's wife reported that her husband received the BNT162b2 vaccine on the 11th and he started feeling bad two days later and a little bit fatigued and then by Wednesday, he was feeling very sick and sweating. He had to come home from work. It was also reported that since Saturday, the patient started feeling tired. He could not stop sweating and then he was just feeling extremely fatigued and then yesterday (20Mar2021), he had a 102 fever, fatigued and he went to the urgent care and they made him go to the hospital and now all of his blood is out of whack. He is having hemolytic anemia where his body is attacking his red blood cells (as reported) and they do not really know what is causing it. They are perplexed. The patient's wife told the infectious disease doctor and blood doctor that her husband had the vaccine. The patient tested negative for COVID-19 four times. The clinical outcome of the started feeling bad, a fatigued/feeling tired, feeling very sick, sweating, 102 fever and hemolytic anemia was unknown.   The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow up.