chrisvoncsefalvay/vaers-outcomes huggingface dataset:
body aches; fever; not feeling good; This is a spontaneous case received from a contactable consumer (patient) via Support. A female patient of unspecified age received second dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number was not reported), via an unspecified route of administration on 07Apr2021 as single dose for COVID-19 immunisation. The patient medical history and concomitant medication was not reported. Historical vaccine included first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number was not reported), via an unspecified route of administration on 11Mar2021 as single dose for COVID-19 immunisation. On an unspecified date in Apr2021, the patient experienced body aches, fever and not feeling well. It was reported that, patient had her 1st dose of Covid 19 Vaccine 11Mar2021 and had her 2nd dose 07Apr2021 that was more than the usual 21 days interval between doses and she experienced body aches and had fever. Her doctor prescribed her the medication -Valacyclovir before and she wanted to know if she can take that now since she is not feeling good. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination. No Medical History information was reported. On 03-Apr-2021 at 2:11 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Apr-2021 at 2:11 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. The age of patient was provided as 47.99 years. Concomitant products were not provided. On 03-Apr-2021, at excursion time 09 AM, temperature was 34, total doses given for the day was 210, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 30-Mar-2021, vial was moved to clinic on 03-Apr-2021. 20 vials were sent to clinic. Vaccine BUD date was 29-Apr-2021. The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. Temperature recordings were taken using a Fisherbrand traceable temperature monitor at every hour. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature. It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F. Treatment medications were not reported.
A few hours pot vax, pt developed rash on arm which spread to torso, legs, pruritic erythematous - urticarial. Follow up Letter states: I am in receipt of your letter dated 08/23/2000 concerning adverse reaction to hepatitis B that was reported by me on 04/17/2000. I am unable to provide the information that you requested, as the vaccine was not given atthis facility. The vaccine was given by the primary care physician.
Muscle ache, tiredness, easily chilled, slight fever (100 F),swelling/redness/inflammation at injection site.
Case PHEH2016US023369 is an initial spontaneous report received from nurse on 13 Sep 2016. This case refers to 68 year old patient of unknown gender. Past medical history and concomitant medications were not reported. The patient was vaccinated with single dose of FLUVIRIN (batch number: 1515701, expiry date: not reported) at a dose of 0.5 ml intramuscular into left arm on 21 Jan 2016. It was reported that, the patient received FLUVIRIN MDV that had been exposed to 8 to 10 temperature excursion and it was administered to unknown number of patients. No adverse event was reported following this medication error.
A report has been received from a Health Professional concerning via a medical representative concerning a 04 year old female patient. Relevant history of patient included wheezing and coughing. Concurrent diseases of patient included allergies to pets and molds. Concomitant medications of patient included diphtheria toxoid, pertussis vaccine acellular, tetanus toxoid. Patient started receiving Nasal FLUMIST 0.2 ml (frequency not provided) on 14-Jan-2013. It was reported that patient experienced asthma attack on 14-Jan-2013 late in the evening and upper respiratory tract infection on an unspecified date. FLUMIST was continued. At the time of reporting the event of asthma attack was recovered and outcome of the event of upper respiratory tract infection was unknown. The report was considered to be non-serious by reporter.
presented to ED and was admitted to med center same day as 2nd COVID vaccine. Patient was exhibiting s/sx of URI at time of vaccine which worsened. admission 04/09-04/11
fluzone quad was administered instead of fluzone hd with no reported adverse event; Initial information received on 05-Oct-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patient where Influenza quadrival a-b vaccine [Fluzone QIV] was administered instead of fluzone hd with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect influenza quadrival a-b vaccine Suspension for injection lot number not reported via unknown route in unknown administration site (dose, strength and expiration date: not provided) for immunization (wrong product administered) (latency- same day). Information on the batch number was requested.  Action taken- not applicable.  At time of reporting, the outcome was Unknown for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive and Regulatory Authority 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.
Localize swollen, redness and warmth measuring 2.5 X 2.5 inches Treatment-Prednisone 20mg 1po BID x 10 days
Extremely tired; slept on and off all day; some pain at the site of the injection; chills; fever; This is a spontaneous report from a contactable consumer or other non hcp. A 72-years-old female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: unknown; Expiration Date: unknown) via an unspecified route of administration on 02Feb2021 10:15 as 1st dose, single for COVID-19 immunization.  Medical history included sulfa drugs allergies, penicillin allergies and covid-19.  Concomitant medication(s) included multi vitamins, atorvastatin, lisinopril and omeprazole. The patient did not receive any recent vaccines for any other conditions prior to the event. The patient has not received any other vaccines around the time of Pfizer-BioNTech COVID-19 Vaccine vaccination. The patient was not tested for COVID-19 since the vaccination. The patient was diagnosed with COVID-19 prior to vaccination. On 02Feb2021 9:30 PM, the patient experienced chills and fever, on 03Feb2021, the patient had fever of 102, some pain at the site of the injection and on an unspecified date, the patient experienced extremely tired, slept on and off all day. Therapeutic measures were taken with acetaminophen. The outcome of the events was recovered.   Information on the lot/batch number has been requested.  Follow-up (11May2021): Follow-up attempts completed. No further information expected.
Information has been received from a physician and a healthcare worker referring to a patient of unknown age and gender. The patient's pertinent medical history and concurrent condition were not reported. The patient was vaccinated with first, second, and third dose of GARDASIL (dose, route and lot number unspecified) in 2010, 2011 and 2012 respectively. On 22-MAY-2015, the patient was vaccinated with the fourth dose of GARDASIL (1 df, lot# L006549, expiration date 06-APR-2017, route unspecified). No adverse effect reported. Additional information has been requested.
103 Temp 7/28. Viral exanthem with fever presented 7/29/04- looked like early pre-blister chickenpox but no vesicles by next day
This spontaneous report as received from a physician refers to one or two sisters of unknown age. The patient was vaccinated with dose 1,2 and 3 of GARDASIL (lot # not reported) in July 2010, July 2011 and July 2012, respectively. No adverse effect was reported. It was unknown if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
I woke up and I couldn't breathe it was very difficult and I was very dizzy & very weak I also had a high fever I had no appetite so I went to urgent care & they did an EKG & was told to go to ER so I went to ER & they also did an EKG and I sat there for about 4 hrs. or more & I got so hungry I left ER & I slept pretty good that night and when I woke up the next morning I was breathing better & the next day I was advised I had been exposed to COVID so I went to the pharmacy & got tested & test was positive.
Information has been received from a physician concerning a 21 year old female who on 25-APR-2007 was vaccinated with Gardasil. Concomitant therapy included ZOLOFT and YASMIN. On 25-APR-2007 the patient reported feeling lightheaded and saw spots. Subsequently, the patient recovered from feeling lightheaded and saw spots. This is one of two reports from the same source. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information has been requested. Information has been received from a physician and a nurse concerning a 21 year old female who on 25-APR-2007 was vaccinated IM into the left deltoid with a first dose of GARDASIL. There was no illness at the time of vaccination. Concomitant therapy included ZOLFT and YASMIN. On 25-APR-2007 the patinet reported feeling lightheaded, like she was going to pass out and sasw spots for 20 to 30 seconds. It was reported that she felt better right away. On 25-APR-207 the patient recovered. The patient had no problems since. This is one of two reports received from the same source. Additional information is not expected.
Immediately after giving Tdap vaccine (ADACEL), patient has some bleeding, which is stopped by cotton balls. Patient has injection site swelling within minutes of the vaccination. When I checked with her in half an hour, she said she has some soreness on the injection site. No other symptoms other than swelling and soreness. Patient was advised to use ice to reduce swelling.
After receiving the vaccination patient reported having severe arm pain that limited her range of movement. It was also very swollen and red. She came into the facility and presented her arm to me which was less red but has a very large hard lump still. She states the pain has lessened but is still present.
Notice red rash-1/2 inch above navel,  ear lobe/neck/back and torso. (blotchy red).  Notified MD friend and he encourag e to take benadryl  one every day.
pt reported injection site tenderness and joint pain on day one and day two after vaccination  Narrative:
Moderna 1/29/21, 2/22/21, 10/27/21. Positive on 7/6/22
9 minutes post vaccination pt c/o scratchy throat feeling of Fullness in throat. She was given Benedryl 25mg po - 15 minutes later she still felt a lesser feeling of Fullness 3:59 she was given 25mg of Benedryl again by 4:15pm she felt better still scratchy. On 1/11/21 she reported to PCP - No symptoms
Patient tolerated well no adverse reaction, dose was given after vial was in the fridge longer than 30 days
Information has been received from a certified medical assistant concerning an 81 year old female with drug hypersensitivities to PERCOCET, PERCODAN, DARVOCT, benazepril, and codeine and a history of high blood pressure, anaemia and osteoporosis who on 20-MAR-2008 was vaccinated with a second dose of pneumococcal 23v polysaccharide vaccine, 0.5 mL IM, (lot# 6562331/0200U). A first dose of pneumococcal 23v polysaccharide vaccine had been given on a unspecified date in 2000 and no adverse symptoms were note. Concomitant therapy included PREMARIN, (therapy unspecified) "CYCLODENZ", alendronate sodium (MSD), zolpidem tartrate, tramadol HCl, candesartan and hydrochlorothiazide (manufacturer unknown). On 20-MAR-2008, the patient called that afternoon to report that she developed swelling, redness and bruising of her upper arm at the injection site. She was treated with ice, and ibuprofen or aspirin. On 21-MAR-2008, the patient went to the emergency room when the symptoms worsened, she was diagnosed with cellulitis at the injection site and treated with KEFLEX. On 25-MAR-2008, she was seen in the office and the condition was reported to be improving. On an unspecified date, the patient recovered. No product quality complaint was involved. Additional information has been requested.
Pt complains of sweating and feels dizzy. Pt states in 2014 he had an anaphalctic
After finishing the administration, patient stated that he is having tingling in his left hand, I had him wait for 10 min. He said it is getting better. He left and I called him after over an hour he said the tingling is gone but his left hand is shaking and he can not bend his thumb.
J96.00 ACUTE RESPIRATORY FAILURE 6/30/2022 ATHEROSCLEROSIS OF AORTA
Pt. reported: Swollen eyelids, lower lip, lower cheeks and below jaw. Pt. called primary care provider, who thinks this an allergic reaction to the vaccine. Advised pt to notify HD.  Pt. did put this info into the v- safe info that was given.
Wheals along the lateral torso. No respiratory difficulty. No angioedema.  Referred to allergist for evaluation.
Allergies are acting up; Sneezing; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: not provided), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. Medical history included allergies. The patient's concomitant medications were not reported. On an unknown date, the patient reported her allergies were acting up and she did not know if she was allowed to take Zyrtec. She has not taken Zyrtec yet, she just didn't know if she could take Zyrtec before or after the second dose of Pfizer Covid-19 Vaccine. She was just being cautious, didn't want to take Zyrtec if she shouldn't. She knows you can't take like a Tylenol or anything like that. If it was not fine to take Zyrtec she just won't take the Zyrtec. Allergies are acting up further described as sneezing and the usual allergies. The patient was getting her second dose of Pfizer Covid-19 Vaccine today, and was not sure who to call. The patient was not received treatment for the events. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Extreme intense pain in right arm - unable to touch or move. Fever 101.7. Dizziness.
persistent colic, gas pain, and reflux since then with 1 episode of blood to stool On amino acid base formula for easier digestion  Probiotic drops to restore GI flora OTC Mylicon and Gripe water as needed for abdominal pain
Information has been received from a consumer concerning a 5 year old granddaughter who was vaccinated "a few years ago" with varicella virus vaccine live. On 14Oct2003 the pt developed a rash on her legs which was four inches wide. The rash extended from her leg up to her groin area. The doctor diagnosed this rash as shingles and gave her acyclovir to treat the shingles. On 17Oct2003 it reported that the pain has gotten better for her since 14Oct2003. It was reported that the pt was recovering with sequelae. There was no product quality complaint involved. Additional information has been requested.
Pt recvd vax & 2 days p/dose 2 exp malaise, fever, chills, & nausea;
26 y.o. male with no PMHx presented 7/29/21 w/ 4 days of intractable nausea and vomiting and decreased PO intake, found to have a systemic inflammatory response and liver dysfunction. Labs that were of particular concern on admission were WBC 14, ALT > AST and Direct hyperbilirubinemnia, D-dimer (severely elevated), but notably NOT anemnia and thrombrocyotpenia. CT Abdomen/Pelvis found distended gallbaldder with wall thickening and diffiuse decrease in heaptic attenuation. CTA Chest found number small PE and pulmonary infarcts. MRI abdomen showed Fatty liver with distended GB and mild thickening but no gallstone or CBD dilatation.  Diffential includes Sepsis (source still unknown), antiphospholipid syndrome vs some other inflammatory condition like an autoimmune condition or vasculitis. I think we also need to consider a vaccine adverse effect like multisystem inflammatory syndrome. Patient received Pfizer Vaccine, Lot #EW0151 on 4/12/21 and then Lot #EW0172 on 5/3/21. He first at symptoms of shortness of breath and exercise intolerance starting 5/25/21. By 7/5/21 he was unable to walk up stairs without dyspnea and increased effort, and was hospitalized on 7/29/21.   Transjuglar liver biopsy was heavily considered but not performed after he clincally improved on anticoagulation.  By 8/2/21 he was starting to have some gross hematuria, vs concerntrated urine. Nephrology was consulted in his care. His urine eventually cleared.
She was observed scratching and when questioned stated she was itchy on her chest and forearms; This is a spontaneous report from a contactable pharmacist. A 64-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283) intramuscularly at right arm on 11Jan2021 08:45 at single dose for COVID-19 immunization. Medical history included seasonal allergies. The patient's concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (lot number: EK5730) intramuscularly on 21Dec2020 at single dose for COVID-19 immunization. Patient received vaccine at 08:45, she was observed for 30 minutes - during which time she took 50mg diphenhydramine hydrochloride (Benadryl) (patient's own med) - she was observed scratching and when questioned stated she was itchy on her chest and forearms. She denied any difficulty breathing, swelling around face, lips, tongue or itchiness anywhere other than her chest and forearms. She was observed for minutes after diphenhydramine hydrochloride and all symptoms had resolved. Patient was instructed to read Fact sheet and report additional allergic symptoms and to follow up if any symptoms worsen. No other vaccine in four weeks. No covid prior vaccination. No covid tested post vaccination. The outcome of the event was recovered on 11Jan2021.
Spoke with patient's father on 12/7/2021.  He reported that had not experienced any adverse effects.
Systemic: Allergic: Anaphylaxis-Mild, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe
QuickVue at home OTC COVID-19 Test: Positive; QuickVue at home OTC COVID-19 Test: Positive; Dose Number: 3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 46 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 07Oct2021 (Lot number: EW0217) at the age of 46 years as dose 3 (booster), single, administration date 17Mar2021 (Lot number: EL3248) as dose 2, single and administration date 24Feb2021 (Lot number: EL3247) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FLU taken for immunisation, administration date 23Sep2021. The following information was reported: IMMUNISATION (medically significant) with onset 07Oct2021, outcome "unknown", described as "Dose Number: 3"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 22Dec2021, outcome "unknown" and all described as "QuickVue at home OTC COVID-19 Test: Positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (22Dec2021) positive, notes: Nasal Swab.Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination, the patient been tested for COVID-19 was reported as Yes.The patient was not received any other medications within 2 weeks of vaccination.    No follow-up attempts are possible. No further information is expected.
Chills; Severe Headache; Fever of 102 (Fahrenheit); This is a spontaneous report from a contactable consumer, the patient. A 22-year-old, non-pregnant female patient received second dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, lot number: EW0162) via an unspecified route of administration, in the left arm on 30Apr2021 at 15:30 (at the age of 22-years-old) as a single dose for COVID-19 immunisation. Medical history included chronic anaemia and low oxygenation. Concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, lot number: EW0153) via an unspecified route of administration, in the left arm on 09Apr2021 at 15:30 (at the age of 22-years-old) as a single dose for COVID-19 immunisation.  Prior to vaccination, the patient was not diagnosed with COVID-19.  Since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 01May2021, at 00:00 the patient experienced chills, severe headache, and fever of 102 (Fahrenheit). Therapeutic measures were not reported as the result of adverse events. The clinical outcome of the events chills, severe headache, and fever was recovered in Apr2021.   No follow-up attempts are needed. No further information is expected.
Taking a shower and starting having severe shortness of breath, got real weak and it lasted about 45 mins. Could barely walk. Went to the ER got admitted and they couldn't find anything. She had to walk with a walker, body and joint aches. Walks very slow now, balance is off and she get lightheaded