chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. There was no information about patient's pertinent medical history, concomitant medications, drug reactions or allergies provided. On 06-NOV-2015, the patient was vaccinated with improperly stored dose of VARIVAX (Merck) injection (lot# K010437, expiration date 22-JUL-2016, dose, anatomical location and route of administration were not reported). No adverse events were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
I got diagnosed with COVID on 02/23 and had no reaction to the vaccine. The week before 02/23 I had a dry cough and then my husband got it too. I got tested and it was a positive test and I was already starting to feel very fatigued and had somewhat of an upset stomach. On 02/24/21 I went and got the monoclonal antibodies and I stayed home and was very tired and fatigued and my son came over 03/03/21 because I wasn't responding to any phone calls and so I went to the hospital and they put me on oxygen, but when I came home I couldn't function. The next day I had a high fever, and the nurse came over and she said to go back to the ER, and that hospital stay I was hospitalized and I was back into the hospital and in the ER for a whole day and they moved me to a room and I went into a rehab center for two weeks and was isolated there where I started to feel a lot better. On 03/19/2021 I was still on 6 liters of oxygen and got solumedrol that helped my lungs. I never went into ICU. I went to rehab center and still couldn't walk and after that I had hypoxia and my oxygen dropped into 70s and I couldn't walk for several weeks after that. I was in the Hospital 03/03/21 and I came home on 03/10/21(6 days)and I went back and was hospitalized from 03/11/21-03/19/21. I was in Rehab until 04/04. I did get the antibodies the day after I got diagnosed with COVID and in the hospital I had the solu-medrol that helped with lungs. When I came home I came home with oxygen and I had gotten down to 4 liters and then 2 liters but my lungs weren't getting better and I didn't get off oxygen until July and I upped oxygen and it seemed my lungs felt better and my lungs are so weak. I put oxygen at 4 for several weeks and immediately started feeling better. I was not 100% incontinent in hospital and I couldn't do deep breathing and diaphragm wouldn't work, then I was no longer incontinent and could use diaphragm for deep breathing and I had hypoxia. It was lingering for awhile but I don't think I still have any leftover covid in my body. 07/01/21 I felt a lot better and my Doctor said he felt my lungs recovered from it even though I still had some covid in my lungs. Dr said  2nd dose should be fine to get.
Fainting/mild syncope. Pale, sweaty and nausea - patient laid on table to help with the episode.
He began to feel pain in his back, right side above his hips. He cannot stand for more than 5 minutes without feeling pain. Also his allergies are more frequent and he cannot stop sneezing easily.
Developed varicella rash about 7 days after vaccination.  Rash lasted approximately 1 week.  Treated with hydroxyzine syrup for itching.  Resolved completely without problems.
Information has been received from a healthcare professional concerning an 18 year old female patient with no drug reaction or allergies and no pertinent medical history, who on 27-OCT-2011 was vaccinated with the first dose of GARDASIL (lot no. not reported) 0.5 ml, intramuscular. On 14-FEB-2012, the patient was vaccinated with the second dose of GARDASIL (batch No. 1229AA, lot No. 670050/1229AA, Expiration date 12-NOV-2013), 0.5 ml, intramuscular. There was no concomitant medication. It was reported that the patient received the second dose of GARDASIL while pregnant. Her last menstrual period was on 27-JAN-2012 and estimate delivery date was on 02-NOV-2012. Positive urine beta-human chorionic gonadotropin test was performed. No treatment was given. No adverse effect reported. It was reported that the patient sought unspecified medical attention. Follow-up information has been received from physician concerning a 18 year old female patient. The patient was a healthy adolescent. All telephone attempts to obtain follow up had been unsuccessful. Additional information is not expected.
pt recvd vax;difficulty getting a breath;"started sometime p/ got flu shot;episodes last for 30 mins; occur to 2x per day;
A serious spontaneous report of pneumonia has been received from a health professional concerning an adult female, subsequent to FLUMIST. Neither medical history nor concomitant medication was reported for this patient. On an unknown date, the patient received FLUMIST. On an unknown date, the patient ended up in the ER with pneumonia. The outcome of the event pneumonia was unknown.
Information has been received from an RN concerning a 16 year old white female student with no medical history who on the afternoon of 12-OCT-2007 was vaccinated IM with her second dose of Gardasil, lot #658560/1062U. On the afternoon of 14-OCT-2007 the patient developed lymphadenopathy, left axilla. No medical attention was required. Subsequently, the patient recovered. No further information is available.
About 7 days after the shot, I had a hard, red lump about the size of a cherry pit form about three inches below the injection site. The redness began to spread and feel warm to the touch. The rash on day 9 is about four inches wide and four inches long in an oblong shape.  The lump feels slightly less concentrated, but the rash is a discolored reddish brown.
I feel severe headache yesterday and today i took Tylenol and i felt better today again same time headache start and i feel like little dizzy,  sharp pain in my legs between ankle and knee,
DTP given 20SEP91 fever & swelling @ inject site, approx 8 hrs  post vax; not eating well & won't sleep on 2nd day; temp wen up to 104.6 on 21SEP91;
I broke out in hives 5 days after on my arms and on the back of my legs. Then on the 7th day I started getting, I guess more hives on my left hand (the same arm I got the injection). The bumps have turned into what looks like blood blisters the morning after. They are EXTREMELY itchy.
Pt had pain when receiving vaccination in deltoid muscle.  She said within 15 minutes she had pain in shoulder.  Three weeks later she still has pain in shoulder but she said it is getting a little better.
Initial information received on 05-Nov-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to cases 2018SA308764, 2018SA308765, 2018SA308766 and 2018SA308767. This case involves a 43 years old female patient who was vaccinated with a dose of FLUZONE HIGH DOSE Batch number: UJ029AB, expiration date: 02-May-2019, route: intramuscular and site of administration was not reported) on an unknown date instead of FLUZONE QUADRIVALENT (Batch number, expiration date, dose, route and site of administration was not reported) on an unknown date. The patient's medical history and concomitant medications were not reported. It was an actual medication error due to inappropriate age at vaccine administration (administered FLUZONE HD to 43 year old patient) and wrong vaccine administered (administered FLUZONE HD instead of FLUZONE QUAD). It was unknown whether patient experienced any adverse event following vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Pfizer 0.3 mL covid-19  (NDC 59267-1000-01 lot 301358A exp 11/21) was administered to the patient. About 5 minutes after administrating the shot,  the patient complained of vision changes, seeing a bright light, burning throat, weakness, shortness of breathe. When I talked to the patient he had a delay in response compared to before the shot was administered, I had the EPI pen ready as the patient was declining in condition, I decided to give 10ml of Benadryl after calling 911, I took the patients blood pressure and did not note hypotension.                                                                                                                            The fire department arrived and took patients vitals everything looked ok, but the patient did not look okay, the gentleman from the fire department agreed the patient did not look good, patient looked pale, and not responding. Patient developed shaking in his right hand. The fire department asked the wife if she wanted to drive him, or should they call EMS. Wife requested an ambulance. Patient was taken by ambulance to destination chosen by EMS.  Patients wife showed up after I closed the pharmacy and informed me the patient went to medical center and emergency room doctor sent her back to the pharmacy to get aspirin 81mg per patients wife emergency room doctor said patient had a neurological even after the vaccine, I talked to patients wife about the aspirin dose and formulation patients wife was a very nice lady as well as patient.
p/vax pt passed out ? ear into a wall & dad was right there & caught pt before hit head;mom states performed CPR;weak & has poor coordination;test done in ER;
having severe body aches and pain in her hands that she could barely move them, bad tightness her in throat and shortness of breath. tingling in her hands, legs and toes, having spams in legs to where she can hardly walk, extremely sore and weak
I started having rashes on my neck, both arms, back and stomach about 9 days after my 2nd booster shot.  I saw my primary physician who put me on Zyrtec.  I saw an allergist on 10/7 when it continued to happen.  He put me on Xyzal and said it was related to the second booster shot.  My Mast cells overreacting as far as I know.
Phizer-BioNTech COVID-19 Vaccine EUA - fever, severe headache, body and muscle aches, and pain behind left shoulder blade
This spontaneous report was received from a lawyer and a patient of unknown age and gender regarding a case in litigation on 21-JUN-2022. The patient's concurrent conditions, medical history, drug reactions or allergies were not reported. In or around 22-OCT-2014, the patient was inoculated with Zoster Vaccine Live (ZOSTAVAX) (dose, lot #, expiration date, route of administration, and anatomical location was not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving Zoster Vaccine Live (ZOSTAVAX), the patient suffered aphasia, slurring of speech and right sided weakness and was diagnosed with stoke (cerebrovascular accident). As a direct and proximate result of using Zoster Vaccine Live (ZOSTAVAX), the patient's symptoms had resulted in physical limitations not present prior using Zoster Vaccine Live (ZOSTAVAX). Also, experienced mental and emotional distress due to resulting physical limitations and seriousness of patient's conditions. As a result of the manufacture, marketing, advertising, promotion, distribution and or sale of Zoster Vaccine Live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence the patient suffered serious, progressive, permanent and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, the patient had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. At the reporting time, the outcome of the event cerebrovascular accident was considered as not recovered. The reporter considered the event to be related to Zoster Vaccine Live (ZOSTAVAX).  Upon internal review the event cerebrovascular accident was considered to be medically significant and disabling event.
I was mistakenly given the monovalent covid 19 vaccination instead of the bivalent one. I have not had any symptoms or side effects other than a sore arm.
This is a spontaneous report received from a contactable reporter(s) (Other HCP). A 42 year-old female patient received bnt162b2 (BNT162B2), administered in arm left (Batch/Lot number: unknown) as dose 1, single for Covid-19 immunisation. Relevant medical history included: "Fibromyalgia" (ongoing), notes: Since 5-6 Year of Age; "Urticaria" (ongoing), notes: Since 5-6 Year of Age; "Raynaud's phenomenon" (ongoing), notes: Verbatim: Raynaud's disease. There were no concomitant medications. The following information was reported: DIZZINESS (non-serious), outcome "unknown", described as "First Dose: dizzy". Therapeutic measures were taken as a result of dizziness. Additional information: Reporter stated the dates of the adverse events are unknown but they were like hers, dizzy with the first and then right after second one, it hit her like a ton of bricks with the side adverse effects are the exact same as she had. The patient had treatment with Motrin and Tylenol and stayed home. Stated her sister got her vaccine at her place of work. Follow-up attempts completed. No further information is expected.
Pt was dizzy but thought it was because she had not eaten. Gave pt juice to drink and checked on her several times she complained of vision pblms later so called EMS.
This spontaneous report as received from a pharmacist refers to an elderly male patient. On 24-APR-2014 the patient was vaccinated with expired ZOSTAVAX lot # H016762 (expiration date 11-DEC-2013) (unknown dose), route not reported. No adverse events were reported. Additional information has been requested.
didn't feel good; felt run down - feels tired, need to take nap; Headache; Achy; had low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (didn't feel good), FATIGUE (felt run down - feels tired, need to take nap), PYREXIA (had low grade fever), HEADACHE (Headache) and MYALGIA (Achy) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Thyroid operation (She undergone procedure 4 months ago, still having thyroid problems and taking medication for it.).    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jan-2021, the patient experienced PYREXIA (had low grade fever). On an unknown date, the patient experienced MALAISE (didn't feel good), FATIGUE (felt run down - feels tired, need to take nap), HEADACHE (Headache) and MYALGIA (Achy). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. On 26-Jan-2021, PYREXIA (had low grade fever) had resolved. At the time of the report, MALAISE (didn't feel good), FATIGUE (felt run down - feels tired, need to take nap), HEADACHE (Headache) and MYALGIA (Achy) outcome was unknown.        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 reported.   Most recent FOLLOW-UP information incorporated above includes: On 12-Jun-2021: Follow up information received on 12-JUN-2021 and contains no new information.
Prior to vaccination able to over produce breast milk, once vaccination was received a few weeks later noticed an extreme drop in breast milk supply. Able to fill 3 - 8oz bottles with breast milk in one pumping session, once vaccinated unable to create more than 4 ounces of breast milk in 2 pumping sessions.  Eventually needed to supplement with powdered formula, breast milk supply did not increase, and powdered formula was used to replace breast milk completely.
I got very light-headed when I got up this morning. I felt like I was going to throw up when I brushed my teeth. I then got very dizzy and fell back into bed to avoid passing out. That was 3 hours ago and I think I just need to stay in bed today.  Also - I'm taking 800 mg ibuprofen q6h for the arm pain. Pain is tolerable with the medication.
Started having my period, which I don?t normally have at all because of my birth control. I haven?t missed a pill or had anything else that would cause this (not sexually active, live alone). Also have had abdominal pain.
Initial report received from a health care professional on 04 November 2010. An 18-year-old female patient received inadvertently on 01 November 2010 a second injection (route and site not reported) of ADACEL, lot number not known. The patient received the first dose of ADACEL on 20 October 2010 for an injury. The patient's medical history and concomitant medications were not known. The patient received both doses for an injury that was not specified. On the 01 November 2010, the patient developed sore throat, chills and muscle aches. On 04 November 2010 she had reported the symptoms to her physician. The patient's medical records were not available. The outcome was reported as unknown. Documents held by sender: None
PT had an episode of syncope post vaccinations and wart removal.  PT was assessed and monitored, vitals stable in care to mother to home.
Patient presented to ED with chest pain 10/10 at about 16:48 . Aspirin 324 mg chewed at 17:51. Stat EKG done, STEMI discovered, patient went to cath lab for intervention at 17:20. No recreational drug usage noted. Patient admitted to ICU following procedure for continuing care.
Information has been received from a 71 year old male pharmacist via company representative referring to himself. In approximately 2012, about three years ago, the patient was vaccinated with ZOSTAVAX (lot#, expiration date, dose and route unspecified). On an unknown date the patient experienced a "mild" rash while on therapy with ZOSTAVAX. The rash resolved itself within a few days. The patient did not seek medical attention. Additional information is not expected because the reporter refused additional contact.
L arm from shoulder to elbow became red, hot, swollen, very painful X 2 to 4 days. She also felt nauseated, headaches, lightheaded X 2 to 3 days.
a lack of effect with his RECOMBIV AX medicationthe vaccine "didn't work" and contracted hepatitis B during "the past few months".; the 1st shot on 01/02/2018, the 2nd shot on 03/09/18, and the 3rd shot on 06/11/18; the 1st shot on 01/02/2018, the 2nd shot on 03/09/18, and the 3rd shot on 06/11/18; This spontaneous report was received from a 55-year-old male patient referring to himself. The patient's did not have pertinent medical history, drug allergies/reactions neither concomitant medications.   On 02-FEB-2018, the patient was vaccinated with the first dose of hepatitis b vaccine (recombinant)(RECOMBIVAX HB), then on 09-MAR-2018 (inappropriate schedule of product administration) and on 11-JUN-2018 (inappropriate schedule of product administration) he was vaccinated with the second and third dose respectively (route reported as injection, dose and anatomical site of vaccination not reported; lot number reported as 4795H) for hepatitis B (HEPB) prevention.  On an unknown date (reported as the past few months), the patient contracted hepatitis B. The patient stated that the vaccine did not work/lack of effect (vaccination failure).  At the reporting time, he had not recovered of vaccination failure.  The causal assessment between the event and therapy with hepatitis b vaccine (recombinant)(RECOMBIVAX HB) was considered as related.  Lot number 4795H is an invalid lot number for hepatitis b vaccine (recombinant)(RECOMBIVAX HB). Lot number 4795H does not match any Company product as confirmed by Lot Verification team.
Date of Admission  05/28/2021   Date of Discharge  06/02/2021   Reason for Hospitalization - COVID with O2 requirement  Hospital Course - 63yo male with PMH of HLD, hypothyroidism, T2DM, HTN, intellectual disability, OSA, asthma who presented to the ED due to hypoxia after having positive COVID test on 5/27, symptom onset 5/23. Patient required 2-3L to maintain saturations, vital signs otherwise stable. Labs significant for WBC 3.38, Hgb 13.1, normal renal and liver function, troponin 75 with 2 hour delta 66 and 6 hour of 55. EKG with new T wave inversions in II, III, aVF. Cardiology consulted and the recommend heparin drip for 48 hours and continuing daily ASA, no Plavix. Echo obtained 5/29 and shows preserved EF without significant valvular abnormality. Cardiology also recommended stress test, but unable to do over the weekend. Pharmacological stress test performed on 6/1 which noted findings consistent with fixed inferior wall defect, no reversible defects noted, and LV function 44.  Cardiology fellow notified and no intervention needed at this time. Treated with remdesivir from 5/28-6/1 and dexamethasone 6 mg daily from 5/28 until discharge on 6/2.  Prior to discharge patient was able to wean down to room air.  6-minute walk eval was performed and patient did not need any oxygen, however was unable complete full test due to fatigue.
Extreme fatigue for 15 weeks The first 6 days I had vomiting and diarrhea. The first 4 days I had severe muscle and joint pain.  And muscle cramping. Diarrhea started 4/23 and lasted until 8/14 On 5/3 my hands , feet and lips started to tingle and were kind of numb.  That lasted u til 5/20. On 5/5 my gums swelled, worse on the left side. It was very painful to eat.  This will last for about 4 days then go away.  Continued issues with this as 8/26. On 5/9 severe vertigo. Vertigo continues as of 8/26.  Have been seeing a physical therapist. It?s currently mild. On 5/19 Lymph nodes on the left side of body swelled to golf ball size.  After 3 weeks they shrunk to about pea size.  Today, 8/26, they will shrink and then swell to pea size randomly. 6/3  broke out in hives just on arms and hands. Spiked a fever of 100 that lasted for about 3 days. 6/3 severe chills at night.  I have uncontrollable shivering and teeth chattering.  This continues to happen at least once a week.  Keeps me awake because I can?t get warm.  No fever with chills. 6/6 left side of my face has uncontrollable muscle twitches.  This continues today, 8/26 6/11 hands, feet and ankles swelled to twice their size and was painful to walk.  Last about 12 hours 8/6 headache came on and has Remained Ocular migraines since 5/17
Red Bumps (rash) over torso, under arm pits, over breasts, upper thighs near groin area Shortness of breath
This non-serious spontaneous case, initially received from other non-health professional on 02-Nov-2018, concerns a 77-year-old, elderly patient of an unspecified gender. It was reported that, the FLUAD (TIV) vaccine underwent temperature excursion for the first time. The vaccine was out for around 48 hours and it reached 11.6 degree Celsius. On 15-Oct-2018, the patient was administered FLUAD (TIV) which underwent temperature excursion [route of administration: intramuscular, anatomical location: left deltoid, batch number: 250795, expiry date: 30-Apr-2019 and dose: not reported]. At the time of this report, no adverse event was reported. This case 201805473 was crossed linked to original case 201804863 due to same reporter.
fever; fatigue; injection site pain; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer reported for a female patient(wife) of unknown age who received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on 08Apr2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unknown date in 2021 the patient had mild fever, fatigue and injection site pain after receiving the vaccine. The event outcome was unknown  No follow-up attempts were needed; information about lot/batch number could not be obtained.