chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Rebound of milder Covid symptoms around day 10/11 and tested positive after tested Negative; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Rebound of milder Covid symptoms around day 10/11 and tested positive after tested Negative) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment.    Concurrent medical conditions included Ulcerative colitis and Drug allergy (Name of the drug was reported as Mo).   On 16-Nov-2021 at 12:00 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Apr-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On 07-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (Rebound of milder Covid symptoms around day 10/11 and tested positive after tested Negative). On 12-May-2022, COVID-19 (Rebound of milder Covid symptoms around day 10/11 and tested positive after tested Negative) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-May-2022, SARS-CoV-2 test: positive (Positive) Positive. On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient did not take any other medications/products within 2 weeks of starting COVID-19 treatment and patient previously receive a COVID-19 Vaccine  No concomitant medications was provided by the reporter. No treatment medications was provided by the reporter. Company comment: This spontaneous case concerns a patient of a 36-year-old female patient, with no relevant medical history, who experienced the non-serious unexpected AESI of COVID-19 approximately 6 months after an unspecified dose of mRNA-1273 vaccine. No details of previous doses were provided. As per narrative of the source document, she experienced milder Covid after treatment with Paxlovid (ritonavir) and tested positive having previously had a negative test. No further clinical information was provided for medical reviewing. The benefit-risk relationship of the mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a patient of a 36-year-old female patient, with no relevant medical history, who experienced the non-serious unexpected AESI of COVID-19 approximately 6 months after an unspecified dose of mRNA-1273 vaccine. No details of previous doses were provided. As per narrative of the source document, she experienced milder Covid after treatment with Paxlovid (ritonavir) and tested positive having previously had a negative test. No further clinical information was provided for medical reviewing. The benefit-risk relationship of the mRNA-1273 is not affected by this report.
Within 12 hours patient got hives on inner thighs.  Was given Claritin antihistamine to counteract reaction.  Hive eased for 12 hours, then returned on lower legs, arms, hips, and stomach.  Was given a second Claritin to try and help sleep.  Hives eased 8 hours later.  Called Dr. for further advise.  Hives again returned on back and buttocks 8 more hours later.  Also a persistent cough developed.  Went to Urgent care pm of the 2nd day after and was given a prescription for Prednisone.  Hives again eased for 24 hours, then returned slightly on feet 4 days later.  Patient is currently on the Prednisone regimen.  Most of the hives are healing and the cough is much better. All other allergic agents have been ruled out. Patient also passed out within minutes of receiving the flu shot, but it was initally attributed to nerves.
Patient received booster vaccine two months earlier than the 6-month recommended CDC interval (had second dose in September 2021 and received booster in January 2022) due to error in reading vaccine card from other facility. No signs or symptoms immediately after vaccination.
cried for 8 hr beginning 4 hr p/vax; t98.6;
I had a sore arm for about three days, I had fatigue and brain fog for a couple of days. On the morning of August 24 I woke up and realized I was having trouble hearing out of my right ear. I had some hearing loss, accompanied with ringing in my ear. This did not affect my balance or other function, but persisted for three days. At times I felt slightly disoriented. As my hearing recovered over the three days, the ringing in my year was more apparent, and on the fourth day I woke up and could not notice any ringing or hearing loss.
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Mar2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 60 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) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "severe sleep apnea" (unspecified if ongoing); "allergies" (unspecified if ongoing); "thyroid insufficiency" (unspecified if ongoing). Concomitant medication(s) included: ZYRTEC [CETIRIZINE HYDROCHLORIDE]. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: Positive, notes: tested positive 7 days after stopping Paxlovid; Negative, notes: 5 days after testing negative. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid from 11Jul2022 to 15Jul2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on plausible dose -event relationship post vaccination and no other alternate explanation the causal role of BNT162B2 cannot be excluded for the reported LOE events.
Rash (redness and itchy) at injection site started after 10 days. Mild at first but has gotten worse. Still persistent at day 15. On day 14, doctor stated not to worry and to get second dose.
Generalized abdominal pain to touch with sharp intermittent abdomen pain. Started 2hrs after receiving vaccine until present. 11/18/09 went to ER-CT scan urine and blood testing and was sent home.
Developed headache, which is abnormal for the patient.  Progressed to thigh pain bilaterally and back pain.  Legs became increasingly weaker until walking was difficult.  Patient presented to the ED on 2/6/10 and was subsequently admitted.  Also had a rash on the under side or arms and armpit and across cheek.
Syncope; Postural orthostatic tachycardia syndrome (POTS); Autonomic Dysfunction; Orthostatic Intolerence; Dizziness; Headache; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a 24-year-old female patient (pt). Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported. On an unspecified date,  the pt was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) injection (lot#, expiration date, dose, route of administration and anatomical location were not reported). On an unspecified date in 2013, the pt experienced following vaccination syncope, postural orthostatic tachycardia syndrome (POTS), orthostatic intolerance, dizziness, headache, and autonomic dysfunction. The outcome of all the events was not provided. The reporter considered all events to be related to quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL). This is one of multiple cases from the same reporter.   Upon internal review, the syncope was considered as a medically significant event.; Sender's Comments:  US-009507513-2301USA007523: US-009507513-2301USA007498: US-009507513-2301USA007524: US-009507513-2301USA007521:
Information has been received from a nurse referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 05-APR-2016 the patient was vaccinated with an improperly stored dose of M-M-R II (rHA) (lot#I023386, expiration date 25-JUN-2017, dose and route unknown). The temperature and time frame were at 14.9 Celsius degree for 280 hours. There was no out of range before. No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Redness just below injection site about the size of my hand appearing about 10 days post injection. Becoming slightly larger
I was 9 months pregnant at the time of the vaccination. My due date was April 3, 2021. The actual date of delivery was March 20, 2021 by C-section. I gave birth to a son weighing 8 lbs 6 oz. I had no complications during this pregnancy. I left the hospital on March 22nd. On March 25, I was experiencing shortness of breath and a low pulse (35 bpm; my usual pulse is in the 50s-60s). My OBGYN told me to go to the emergency room, where they did a CT scan. The CT scan showed a small pulmonary embolism. I was in the hospital until March 27th, where I was treated with Heparin and then was released with Lovenox injections. I am currently on the Lovenox. After seeing the pulmonologist for a follow-up appointment, he advised me that I would be able to stop the injections after 3 months.
Client Nauseous within 10-15 minutes after vaccination, Vomited 4 times. Client reports feeling better after vomiting. Pt was monitored for 30 minutes after getting sick.  Pt reports feeling normal at time of departure
ROUND 3 OF COVID; This spontaneous report received from a patient via a company representative via social media concerned a patient of unspecified age, sex, race and ethnic origin. The patient's height, and weight were not reported. The patient's past medical history included: covid-19 (2 rounds of covid). The patient was previously treated with covid-19 vaccine ad26. cov2. s (Unspecified manufacturer) (Dose number in series 1) (suspension for injection, route of admin, batch number and expiry were not reported) dose was not reported, 01 total administered, start therapy date were not reported for covid-19 prophylaxis.  It was unknown whether patient had any adverse events following vaccination with covid-19 vaccine ad26. cov2.s (Unspecified manufacturer) (Dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (Unspecified manufacturer) (Dose number in series 2) (suspension for injection, route of admin, batch number and expiry were not reported) dose was not reported, 01 total administered, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced round 3 of covid (sicker) (Dose number in series 2). Reporter stated that, "I am on round 3 of covid. This time I am having a hard time getting well. I work in the medical field and we were forced to take it and the boosters. I am sicker now then before" The action taken with covid-19 vaccine ad26.cov2.s was not reported. The outcome of round 3 of covid was not reported. This report was non-serious.
Symptoms: Nauseated and shaking hand Treatment: education, water and snack, had patient wait an extra 15 min. When she left she stated she felt great.
Woke up feeling fatigued and I took it easy. That week I began having pains - joint pain. Joint pain would move around - knees and then hands and then ankles. It didn't stay in one area. I had this pain for 2 1/2 - 3 weeks. Called my Rheumatologist because of my history of auto-immune disease. January 7th was the date. She told me to take Plactinele- anti-malaria medication. I took it for a week. I took Vit D, C and Zinc with this medication. I still had symptoms the week after the medication stopped. The pain didn't stop decreasing until about 3 weeks. Symptoms were not resolved entirely by the time I got second dose of vaccine.. Got the second dose on the 4th week after the 2nd dose of vaccine.
they've been really tired; A spontaneous report was received from a consumer concerning a 102-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced event really tired.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: unknown) via unknown route for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event(s) they've been really tired.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), they've been really tired was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
feeling a metallic taste in my mouth; arm was sore yesterday more discomfort as the day went but I feel better today; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age (reported as Age: 52; Unit unspecified) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported), via an unspecified route of administration on 23Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the first dose of the vaccine yesterday (23Jan2021) and 1 hour into it; 30 minutes after she left the site, she started feeling a metallic taste in her mouth. The metal taste consumed her mouth and she thought it was strange. She didn't think it was anything related. Today, she was reminded of it; a little bit of the taste today (which reminded her of what she experienced yesterday) but not as overwhelming like yesterday. Her arm was sore yesterday (23Jan2021), more discomfort as the day went but she feels better today. She was thinking her arm doesn't have anything to do with her mouth, but she read the metallic taste could be a side effect, so she contacted Pfizer. It was coming from the left side of her mouth and consumed her taste buds. Wondering if that had anything to do with her fillings (she has metal filling on her left side). She feels fine. The patient also wanted to know if there was anything else, she needed to know about the second dose which was scheduled for 13Feb2021. The outcome of the event feeling a metallic taste in my mouth was unknown and recovering for the event arm was sore yesterday more discomfort as the day went but I feel better today.  Information on the lot/batch number has been requested.
Headache, Myalgia, Arthralgia, Fever, Pain, Chills Narrative:
4/10/2000 Local reaction to left leg thigh swelling after 3-4 hours of receiving vax.
PNEUMOVAX 23 (R) arm. Patient reported being very thirsty after administration through the night hours. He awoke having discharge from eyes. On day two he had developed a red rash around arm near injection site & extended down his torso. On day three he reported to Rph with red rash only around arm near injection site. Rph recommended BENADRYL; advise to call MD if persists or gets worse.
03/14/2021 Horrible head ache, nausea, dizzy, exhaustion, brain fog, confused, chills, heart pounding, fainted. Went to ER by ambulance.   The patient still has bouts of a pounding rapid heart beat & brain fog. She states that her head feels full with these bouts.
By 3:00 pm post-vax, the patient was having a heavy heartbeat which lasted several hours. By 5:00 pm, the patient was not feeling well. She felt extremely warm, slightly nauseous, her heart hurt, her arm ached, and the right side of her throat felt swollen. These symptoms lasted about 30 minutes. The patient then had chills. The following day the patient felt tired and weak.
Loud ringing onset in left ear about 2 hours after booster shot.    I have longstanding tinnitus in my left ear but this shot seems to have brought it out of a dormant state and now have loud ringing.   Would never have got this Moderna booster shot if I knew this would occur.   I had two J&J shots in 2021 and had no such problems.     There needs to be a warning about this potential side effect.  Tinnitus in no joke to the suffer.
Still have a light red circle, now the entire diameter is red (rather then just ring); Still slight discomfort; discomfort and itch.; noticed arm itchy, earlier in night; large, red circle that looked like a ringworm circle; circle was around the injection site. The circle was about 4-6 inches in diameter; "covid arm"; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151) via an unspecified route of administration in the left arm on 08Apr2021 at 12:00 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. Medical history included attention deficit hyperactivity disorder(ADHD) and chronic unspecified migraines. Patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included norethisterone (TULANA), methylphenidate (MANUFACTURER UNKNOWN) and topiramate (MANUFACTURER UNKNOWN); all taken for an unknown indication, from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 17Apr2021, the patient noticed arm itchy, earlier that night and she ignored, showered that evening, noticed a large, red circle that looked like a ringworm circle, the circle was around the injection site, the circle was about 4-6 inches in diameter, looked up as "covid arm", found comfort and she went to bed. On 18Apr2021 she still had a light red circle and the entire diameter was red (rather then just ring). On that day also slight discomfort and itch. She reported that she was on hold for 4 hours with the pfizer vaccine hotline, she had documented on her phone as she was filling this report. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events the patient noticed arm itchy, earlier that night and she ignored, showered that evening, noticed a large, red circle that looked like a ringworm circle, the circle was around the injection site, the circle was about 4-6 inches in diameter, looked up as "covid arm", found comfort and she went to bed. On 18Apr2021 she still had a light red circle and the entire diameter was red (rather then just ring), on that day also slight discomfort and itch was not recovered.  No follow-up attempts are needed. No further information is expected.
This spontaneous report was received from a consumer concerning her 5 years old male son who on 25-APR-2012 was vaccinated with MMR II (dose and lot number not reported). The patient's mother reported that by mistake was given another dose of MMR II on 18-AUG-2012. The intention was to have the child get the VARIVAX (Merck) vaccine that day. The mother was reporting that the child had been tested twice for autism and had had a cold and cough since getting the second vaccine. The mother did not want to continue to report and chose to answer no further questions. The patient sought medical attention. At the time of the report, the patient's outcome was unknown. The relatedness for the adverse events were unknown for MMR II. Additional information is not expected.
Medication error/ Drug maladministration; Dysgeusia/Bad taste. Information regarding Flumist (2003-2004 Formula) (influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (forzen)) was received from a healthcare professional regarding a 6 year old female. On 05-Feb-2004 during vaccine administration, part of the Flumist dose was accidentally sprayed onto the patient's cheek and possibly into her eye. The patient experienced a bad taste in her throat. On 05-Feb-2004 during the administration of Flumist, the patient  reared back because of a "bad taste"/ Dysgeusia in her throat. Part of the dose was accidentally sprayed onto patient's cheek and possibly into her eye/ medication error. The patient's eye (reporter did not specify which eye) was flushed with water and no eye irritation was observed. No additional information was available at the time of this report.
loss of smell 4/1 arm soreness 3/31 arm redness 4/1 underarm soreness 3/31
Fever for a few days; Tinnitus, unsure if after 1st or 2nd dose; Received 2 doses, developed shingles today/Suspected vaccination failure; Shingles; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On 12th May 2022, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the patient experienced fever and tinnitus. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles and tinnitus were not recovered/not resolved and the outcome of the fever was recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles, fever and tinnitus to be related to Shingrix. It was unknown if the reporter considered the vaccination failure, shingles and tinnitus to be related to Shingrix.   Additional Information: GSK Receipt Date: 12-MAY-2022 Reporter's Comment: The case was reported by the patient. The patient received 2 doses of Shingrix. She stated that, after her second dose, she experienced a fever for a few days.  She also reported that, tinnitus after receiving Shingrix. The patient was unsure if it was after the first or second dose.  She stated that, tinnitus was still present but was a bit better. She also reported that, she developed shingleson the day of reporting.  She had not yet been diagnosed but stated that, she knew that it was shingles. The reporter did not consent to follow-up. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Pt got a meningitis vaccine 2d ago, and that night the injected area was swollen, red, hot and pruritic.
Approx 10 min post injection c/o abdominal upset, had emesis. Face became blotchy pink and then c/o itching of ears and neck. Was given 1 1/2 tsp po of Benadryl approx 1 hr late pt stilll c/o itching and now c/o skin burning. Skin very red and warm to touch. Pt was then given Epi. 0.2ml SQ and within 15 min decreased redness and no longer warm.
I was at work driving a forklift and started to feel dizzy. In my head I felt off like I knew I was having a conversation but in my head it felt off. When I honked my forklift horn, it sounded so loud like somebody had a microphone to my ear. When I got home my vertigo was acting up. My vertigo was happening every blue moon prior from my shot.This lasted for 3 days. Went to the doctor to get tested for my ultrasound last Tuesday and an MRI.