chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received via Pfizer from a 50-year-old female patient regarding herself. The patient's current conditions included vitamin D deficiency, vitamin C deficiency, sinus and allergy issues. She had allergy and sinus issues for her whole life, but seemed to be gotten worse with age. No relevant family history relevant. She stated that her primary care provider did not give her the vaccine but referred her to an allergist who gave her the shot. The allergy specialist that she visited did some immune testing and it showed that her immune system vas very low. He thought the PNEUMOVAX 23 or PREVNAR 13 (reported as Prevnar 13) would help her. On an unknown date in February 2017, the patient was vaccinated with PNEUMOVAX 23 or PREVNAR 13 in the left arm for immunisation. There no reactions to prior vaccinations and patient's illness at time of vaccination was none. Concomitant therapies included fluticasone propionate(FLONASE), albuterol, cetirizine hydrochloride(ZYRTEC), vitamin D (unspecified), vitamin E and ascorbic acid. The patient clarified that she believes that she got the PNEUMOVAX 23 (reported as Prvevnar 23 shot). The following morning after vaccination, she could not move her arm (Vaccination site joint movement impairment). She had joint pain (and arthralgia) and the joint was stiff, swollen and warm (joint stiffness, joint swelling and joint warmth). She called the doctor's office and was advised that some of the vaccine might had had gotten caught up in her muscle. She was asked to just ice it. She iced and babied her arm. Finally, after 3 or 4 weeks, she was able to move it more. However, she was still experiencing stiffness in her left shoulder that was persistent. She had since had her immune levels retested and they were increased. She also thought she received allergy shots around the same time that she received the vaccine (no details reported). The outcome of joint stiffness was reported as not recovered/not resolved. The outcome for the other events was unknown. No causality assessment was reported.
5/4 Chills, Nausea, fever, headache, body ache, sore arm 5/5 nausea, body ache, rash developing on chest and stomach, sore arm 5/6 more rash, shakiness, dizzy, nausea, felt like a rock was on my chest, extreme sore throat, biting inside of cheek
Pt was given booster dose of Janssen vaccine and seasonal flu vaccine.  Pt began to feel lightheaded and dizzy approximately 5 mintues after administration.  When I went to check on patient, he fainted in the pharmacy's immunization booth.  Patient briefly lost consciousness and denied any itching, swelling, difficulty breathing.  Sat patient up and gave him water.  Patient states began to feel a little better with water, but was still lightheaded and dizzy.  Did not administer Benadryl or epinephrine due to patient denying anaphylactic symptoms.  Patient hit forehead when he fainted, and EMS arrived approx 10 minutes after event started to evaulate patient.  Patient was with significant other who denied any prior reaction to any vaccine.
Information has been received from a Licensed Practical Nurse referring to an unspecified number of patients of unknown age and gender. There was no medical history or concurrent condition reported. On 28-AUG-2015 the patients were administered an unspecified number of improperly stored doses of (Oka/Merck) VARIVAX (lot # L016123, expiration date 06-MAY-2017) (dose and route were not reported). There was no concomitant medication reported. No adverse effect was reported. Additional information has been requested.
This case was reported by a consumer (the subject's spouse) and described the occurrence of apnea in a 48-year-old male subject (a physician) who was vaccinated with ENGERIX B (GlaxoSmithKline). A physician or other health care professional has not verified this report. On 20 July 2011 the subject received booster dose of ENGERIX B (details unknown). On 20 July 2011, less than one day after vaccination with ENGERIX B, the subject experienced intermittent flushing, shortness of breath upon eating or drinking, weight loss and no appetite "for even fluids". On 31 July 2011, the subject experienced insomnia, tingling of extremity, low blood pressure, abdominal cramp and diarrhea. On 01 August 2011, the subject experienced arthralgia, stiff neck, influenza like symptoms and migraine. The subject also experienced blurred vision, tachycardia, apnea, bronchospasms ("cannot breath due to spasms"), musculoskeletal weakness, musculoskeletal pain and feeling out of sorts due to off balance. The subject had lost 15 pounds of weight in 11 days. The subject went to the Emergency Room on 30 July 2011 at 01:00 hours and was hospitalised. He was discharged on 31 July 2011 to home. Relevant test results included cardiac angiogram, CAT scan and stomach endoscopy which were all negative. The subject was treated with TYLENOL. At the time of reporting the intermittent flushing, shortness of breath upon eating or drinking, weight loss and no appetite were unresolved. The outcome of the other events was unspecified.
Severe Fever: 101.6 Muscle Aches, Agitation,and Headache All lasting overnight (total of 12 hours)
Rash/Hives in armpits, waist, genital area, feet and legs. Symptoms occurred 1-2 days after shot. Symptoms are still present. They appear to be peeling starting in the center of the rash/hive. I have applied antihistamine cream and taken Benadryl caplets.
Fever, feeling flushed, tunnel vision, light headedness, headache/pressure, chills, elevated pulse rate, elevated blood pressure. Took migraine medication for headache, outcome unknown
No adverse effect; patient that is 21 years old received a dose of PROQUAD on 6/5/2019; This spontaneous report was received from a nurse and refers to a 21 year old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant therapies were not provided.  On 05-JUN-2019, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD)lsubcutaneusly, lot # R030797, expiration date 22-APR-2020, for prophylaxis.  No adverse effects reported.
Drug ineffective; COVID-19; Itching; Dry skin; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  An 80-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 80 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, 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), outcome "unknown"; COVID-19 (medically significant), outcome "unknown"; PRURITUS (non-serious), outcome "unknown", described as "Itching"; DRY SKIN (non-serious), outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Postive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Originating AE Request: REQ-1093092. PQC Details: Request Name: REQ-1093092. Question: Caller mentioned she is just getting over covid and was given Paxlovid. She mentioned she did not have any side effects mentioned in the information she got. She stated she had been "exposed to a lot of people in her job and did not how long she get it (covid). She mentioned she was vomiting, had headache, severe nausea a long time before taking paxlovid, and she also have itching from dry skin before (Paxlovid). She wanted to compare Paxlovid's effects to another treatment option for mild to moderate covid which is Remdesivir (Veklury) (see response REQ-1093101). She got the Pfizer booster shot and wanted to know why she got had it (covid) so bad even though she got the shot (addressed in this REQ-1093092). DSU: Adverse event warm transferred to RA NTID: (ID woithheld), Reportum. Documenting additional AE details captured after listening to the call. Request Name: REQ-1093136. Product: NO PRODUCT. Question: Caller said she did not have anymore tests left to check Covid. She wanted to know who she should reach out to. Request Name: REQ-1093101. Product: PAXLOVID. Question: Caller was getting over covid and was given Paxlovid.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300112793 Same patient/product, different dose/events;
Tingling in fingers on 12/1 that lasted two hours. 12/2: Neck/shoulder pain, with Sore throat, itchy eyes following a visit to her aunts.  Aunt has pets, which she is allergic.  Also, Patient was caring for mother who had viral URI that developed the day of vaccine administration.  Symptoms progressed on 12/3-4, worse on Sunday, given motrin 600mg which helped.  Seen on Monday morning.
As soon as I pulled the needle out of her arm, she began to fall forward as she had passed out.  I tried to catch her but she hit her head on a cabinet and I lowered her to the ground.  911 was called immediately.  She regained consciousness in about 10 seconds.  She had a small amount of blood coming out of her left nostril and was bleeding from her head.  EMT's evaluated her and found an abrasion on the top of her head.  After they evaluated her, they got her on her feet and then sitting down on a bench.  Her blood pressure was 158/85.  They deemed it unnecessary to go to the hospital.  She sat for at least another 15 minutes.  She had no dizziness or lightheadedness.  The only symptom she had was pain at the abrasion site.  She was released with her husband. Her husband had told me that she has an extreme anxiety of needles.
8 days post-vax the patient experienced a fever for 3 days, a generalized rash and body and joint aches.
Soreness after the vaccine. Within 24 hours started running a fever of 101 F.
Pt had a flu shot in left arm & pneumonia shot in right arm. Called to inform next day swollen arm from flu shot & hives down arm. Took BENADRYL now fine.
Transition drop in platelet count from baseline of 333K (13 Oct 2022), to 49K (14 Oct 2022)  increased spontaneously to 80K (17 Oct 2022)
Chest pain, headaches, abdominal pain, ringing, metallic taste/smell, experienced for two weeks at different times in strong waves. The third week was significantly less frequent and intense. At end of third week, I still have infrequent headaches and overall weakness when performing strenuous activity. As of Jan 10, 2022, I still get very mild headaches several times a day and manageable ringing in ears. In conjunction to the above symptoms, on the second day (Nov. 26, 2021) I attempted to jog my regular 1.7 mile route. I made it 0.2 miles before stopping because of chest pains. I walked for some time and attempted to run again, I made it 0.25 miles before stopping because of a pain deep in my left calf. This pain persisted for several days before I ultimately decided I need to see my doctor (lack of health insurance was a factor). I was diagnosed with Chronic Venous Insufficiency. I have several pages of detailed logs.
Patient received an expired vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received an expired vaccine) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007J21-2a) for COVID-19 vaccination.     The patient had never been tested positive or diagnosed with COVID disease. The patient had no allergies to medications, food and other products. The patient had no medical history related to mentioned adverse events and did not have any acute and chronic illnesses at the time of vaccination. The patient did not receive any other vaccine within 1 month prior to Moderna COVID-19 vaccination.  Concurrent medical conditions included Asthma.    On 20-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received an expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received an expired vaccine) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. No treatment information was provided.  On 20-Apr-2022, the patient received the first booster dose of the vaccine.
Pain at injection site on 9/21/06.  Erythema, tender, warm with pruritus on 9/22/06.  Seen in emergency department.  Given IM steroid-improved today in clinic only had pruritus under arm.
Starting in July I started having serious leg pains and fatigue. Can?t stand for long periods of time. Swelling in ankle. Ankle turned purple under skin. Purple ness spread up my ankle and down my foot. Had to leave my job because I was incapable of standing for long periods of time
Patinet called pharmacy today (18Sept21) and stated that within 24 hours of vaccine administration, patient states began itching all over body.  Over the course of the next days, patient states bumps have appeared all over her arms, neck, thighs and lower back.  Patient states she is itchy everywhere.  States the bumps feel almost blister like.  Patient states she took single dose of benadryl on the first night (Sept 15) but has not repeated the dose.  Patient states she went to bed immediately after taking single dose of benadryl and does not know if it helped or not.  I have advised the patient to call her primary care and to go to an urgent care facility as soon as possible for evaluation of the reaction.  I informed the patient my concern would be a potential ongoing delayed reaction.  Patient states she does not want to take the second dose - I advised the patient she would need to see a physician for adivse on second dose pending the evaluation of the ongoing reaction. Patient states she has not been able to go to primary care or urgent care facililty (as of 4pm on 18Sept21) but states she would get to urgent care tonight.
Patient developed a red bump at injection site approximately 2 inches in diameter. Patient has not developed any additional symptoms.
4 hours after vaccine received, soreness at injection site  8 hours after vaccine received, headache and chills 19 hours after vaccine received,          fever (T max 101.7) lasting 18 hours           Body muscle aches/pains lasting 18 hours           Headache lasting 24+ hours           Nausea  lasting 24 hours
tested positive for Covid on 04Apr2021; This is a spontaneous report from the Pfizer sponsored program from a contactable consumer, the patient.  A 36-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in the left arm on 26Mar2021 at 10:00 (Batch/Lot Number: ER8733) as a single dose (at the age of 36-years-old) for COVID-19 immunisation. The patient had no relevant medical history and no relevant family medical history.  There were no concomitant medications. The patient had no other vaccinations within 4 weeks of the vaccination and no other vaccines administered on the same date as bnt162b2. The patient developed symptoms (unspecified) on 03Apr2021, and tested positive for COVID-19 on 04Apr2021. The patient was calling to see when he can receive the second dose. The patient underwent lab tests and procedures which included SARS-COV-2 test: positive on 04Apr2021. The clinical outcome of the event was unknown.
Possible cellulitis; rash on entire arm/ Pain; rash symtpom-Itching; rash symptom-red; rash symptom -hot; This case was reported by a pharmacist via call center representative and described the occurrence of cellulitis in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 2 days after receiving Shingrix, the patient experienced cellulitis (serious criteria GSK medically significant), painful rash, itchy rash, red rash and skin warm. The patient was treated with lidocaine (Lidocaine Patch). On an unknown date, the outcome of the cellulitis, painful rash, itchy rash, red rash and skin warm were unknown.   It was unknown if the reporter considered the cellulitis, painful rash, itchy rash, red rash and skin warm to be related to Shingrix.  Additional details were received as follows: The reporter was a consulting pharmacist and was not in direct care of the patient but was given the information from the patient's physician. The age at vaccination was not reported but it could be 59 years or 60 years. Two days after receiving Shingrix, the patient developed a rash on arm on the side of injection.  It was initially 2 by 2 inches and then spread to the entire arm.  The rash symptoms included pain, itching, hot and red.  Pain was not relieved by lidocaine patch. The PCP (primary care provider) for the patient was investigating if it had developed into cellulitis. The reporter consented to follow up.
Pediatric dose given to adult patient; Pediatric dose given to adult patient; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of underdose in a 60-year-old male patient who received HBV (Engerix B pediatric) (batch number Y5AJ9, expiry date 03-MAR-2025) for prophylaxis.   On 24-MAR-2023, the patient received Engerix B pediatric. On 24-MAR-2023, an unknown time after receiving Engerix B pediatric, the patient experienced underdose (Verbatim: Pediatric dose given to adult patient) and adult use of a child product (Verbatim: Pediatric dose given to adult patient). The outcome of the underdose and adult use of a child product were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 24-APR-2023 The reporter consented to follow up via email. A pediatric dose of Engerix-B was given to an adult patient, which led to underdose and adult use of child product.
Patient had panic attack after receiving vaccination becoming hot and shortness of breath. Throat did not swell up
patient experienced all over hives, he has been applying topical steroids for symptoms and if it gets worse he will call his doctor
15 y/o male came in with his mother for Pfizer Bivalent booster with mother's consent. After vaccine administration, patient started to become quiet, looked pale and feel weak. Gave water to drink and stabilized patient's position. 2 more nurses assisted patient to lay down on a cot and elevated legs. Vital signs every 5 minutes were 96/62 hr 60, 102/84 hr 58, and 104/74 hr 65, O2 sat was 98. Patient was alert, oriented, and did not lose consciousness. He developed some redness on the side of both ears and on top of forehead lasting for a few minutes and went away on its own. Patient has not had any meal and mother stated he had some stress reaction after his first Covid vaccine and none with his last two Covid vaccines. Patient's cheeks were looking pinker.  Assisted patient to sit on the side of the bed and walked with patient to their car. Advised mother to monitor her son, inform his doctor, and for patient to eat breakfast, drink water and encouraged mother to register on program with the paper given. Mother came back an hour or so later to have her other family vaccinated and she mentioned that her son (patient) is doing much better and she informed his doctor as advised.
Within minutes of vaccine receipt, patient suddenly felt very energetic/amped up but cannot specifically recall heart racing or palpitations. Then noted a strong metallic taste in her throat. Walked from immunizations to flight med for PHA and about 5 min later developed raspy voice and frequent throat clearing with lump in throat sensation and trouble swallowing. Her clinic recommended ER evaluation after checking her vitals which were reported as normal. She was taken to local ER where throat symptoms were documented without hives or flushing. Normal BP 123/93 and HR= 64 bpm. Was treated with solumedrol, benadryl and famotidine. Released when symptoms had resolved and went home where she slept for 4 hours. No further symptoms reported. Neither shoulder swelled or was immediately red or painful but the site where she received her anthrax injection was achy about 1 week later.
Had prostate cancer and two days after being cleared of that, primary care did bloodwork  that showed I had become anemic for the first time and found out I had stage one multi- myeloma
Joint pain in multiple areas, wrist, elbows, shoulder, and hip pain. Lasted 2 months.
A report was received from a health care professional on 12/3/03 concerning eight vaccinees of unspecified sex and under 4 years of age who inadvertently received Fluvirin on an unspecified date. On an unspecified date, eight vaccinees under 4 years of age inadvertently received Fluvirin. At the time of the report no adverse events had been reported. There was insufficient information to determine the reporter's causality. Update 1/20/04: Follow up information received from a health care professional indicated that a 2 year old female vaccinee inadvertently received Fluvirin on 11/18/03. No follow up pending.
Swollen, red arm when MCV 4 given, area on left deltoid area per Mom.  Complained of pain with injection, next day swelling about 1/2 dollar size.  Complained of severe pain.
Patient report the vaccinator administered her shot too high up in the arm.  client c/o of instant pain right after shot was administered, c/o of burning  and pain rate at 8 out of 0-10 scale.  stated has some tingling and twinges pain to that left arm with movement. denied any numbness.  states pain is getting better, denies any redness or swollen.
Involuntary movements on my right hand finger (index) Contacted Moderna for clarification, they said that it was up to me to receive the second dosis since it was not approved by CDC. I was supposed to have the second shot last weekend, I did not take. The Moderna employees referred me to to the fact sheet of the vaccine. One of the components is PEG-2000, Polyethylene Glycol. Reading the CAS it says that this product is not to be used by animals or humans. Please clarify
normal pain after getting the vaccines; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (normal pain after getting the vaccines) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007B21A and 033C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-May-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, the patient experienced VACCINATION SITE PAIN (normal pain after getting the vaccines). In April 2021, VACCINATION SITE PAIN (normal pain after getting the vaccines) had resolved.            No Concomitant Drug details were reported.  No Treatment information was provided.  Patient went to get the second dose was instructed by the pharmacist to start the series all over. And so, got a second dose and a third dose as a new primary series.   This case was linked to MOD-2022-455747 (Patient Link).