chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 49-year-old male patient received BNT162b2 (BNT162B2), on 13Oct2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 49 years, in left arm for COVID-19 immunization; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for COVID-19 immunization. The patient's relevant medical history included: "Obesity" (unspecified if ongoing); "sleep apnea" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "I took another test and it came back positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2022) Negative, notes: I had taken a test on Saturday (about two days ago) and it was negative; (May2022) Positive, notes: I took another test and it came back positive. Therapeutic measures were taken as a result of drug ineffective, COVID-19. No other medications were taken in 2 weeks. Anti-viral Paxlovid (treatment start date: 09May2022 and treatment stop date: 13May2022) was taken by the patient for the treatment of COVID-19.
I had COVID-19 symptoms of sore throat, coughing, runny nose, watery eyes. I tested positive. I took PAXLOVID. My outcome was excellent. As soon as I started the medication, within 2 days at the very most I was feeling much better.
Child vaccinated in left deltoid and then about 15-20 minutes later developed eye swelling and redness to left eye. No itching, no SOB, no rash noted or reported. Eye did not swell completely shut, Benadryl PO given per school nurse, monitored child for approximately 20 minutes after with no further reaction noted or increase swelling. Mother present, a teacher at school and able to keep close eye on her daughter.
This spontaneous report has been received from a pharmacist referring to a female patient of unknown age. Information regarding pertinent medical history, concurrent conditions and drug reactions or allergies was unknown. On 25-MAY-2016, the patient was vaccinated with ZOSTAVAX, injection, (anatomical location, lot#, route, expiration date and dose were not reported). Concomitant therapies were not provided. In 2016, the patient experienced blisters around her mouth. Product quality complaint was not involved. At the time of reporting the outcome of blisters around her mouth was unknown. The relatedness between the event and ZOSTAVAX was not reported. This is one of two reports received from the same reporter. Additional information has been requested.
Fever, headache, body aches, run over by a truck feels, lung pain on inhalation, diarrhea, fatigue
A report has been received from a Health Professional concerning a 1 year old, female subject, who had been receiving Nasal FLUMIST. FLUMIST started on 17-Jan-2014. The reporter FLUMIST given by mistake to 18 month old (Preferred Term: Drug administered to patient of inappropriate age) which started on 17-Jan-2014. The outcome of the event of FLUMIST given by mistake to 18 month old is unknown. The report was considered to be non-serious.
temperature excursion involving multiple lot numbers for GARDASIL 9, MMR II, ROTATEQ, and RECOMBIV AX. Many of the vaccines have been administered to patients; No further AE; This spontaneous report was received from a practice manager and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medication were not reported.   On 14-AUG-2020, the patient was vaccinated with improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 1 injection, lot # R021636 was confirmed to be valid with expiration date 12-MAY-2021(exact dose, route of administration, anatomical location were not reported) for prophylaxis.  The temperature excursion was below 2 Celsius degrees (C) (1.1 C) for 27 hours and 45 minutes and above 9 C for 1 hour and 15 minutes (29 hours cumulative). The digital data logger was involved. No adverse effects were reported.  This is one of two reports received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.  devicelotnumber: R021636; expirationdate: 12-MAY-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other;  followupadditionalinfo :Yes; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2010USA001083:
Herpes Virus associated vesicular rash on top of left foot, with intense, radiating itchiness, inflammation; Herpes Virus associated vesicular rash on top of left foot, with intense, radiating itchiness, inflammation; Herpes Virus associated vesicular rash on top of left foot, with intense, radiating itchiness, inflammation; Herpes Virus associated vesicular rash on top of left foot, with intense, radiating itchiness, inflammation; redness; This is a spontaneous report from a contactable consumer.   A 48-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot number: EW0187), via an unspecified route of administration in the right arm on 02May2021 as a single dose for COVID-19 vaccination. On an unknown date 03:45 PM the patient received second dose of BNT162B2 (Lot number: EW0176), via an unspecified route of administration in the right arm on 02May2021 as a single dose for COVID-19 vaccination. Medical history included hypothyroidism. Concomitant medications were not provided. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine nor any other medications within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to or since the vaccination. The patient experienced Herpes Virus associated vesicular rash on top of left foot, with intense, radiating itchiness, inflammation. On 02Jun2021 08:30 PM, intensely itchy area on top of left foot, which she thought was a bug bite. Topical Benadryl (Diphenhydramine) was applied. On 03Jun2021, two small scabs emerged (approx. 5-8mm wide) that looked like abrasion/scab from excessive scratching. 03Jun2021 - 04Jun2021 itchiness subsided. On 05Jun2021, there was visible redness, inflammation and small vesicle formation around two scabbed areas in conjunction with intense radiating itchiness extending beyond areas of visible inflammation. 05Jun2021 - 06Jun2021 inflammation, intense radiating itchiness and formation of new and larger vesicles ultimately forming a 3' rash across top of foot. On 08Jun2021 the patient consulted with primary care physician (PCP): Weeping vesicles and new vesicles formation noted. Antibiotics and topical cream prescribed, and culture performed. On 11Jun2021: second opinion with dermatologist and testing of affected area positive for Herpes virus. Antiviral medication was prescribed. Treatment for the adverse events included Cephalexin, Mupirocin and Valacyclovir. Outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected.
Information has been received from a physician concerning a 14 month old male who on 22-APR-08 was vaccinated SC with a 0.5 mL dose of zoster vaccine live (Oka/Merck) (lot number 658605/1089U) instead of varicella virus vaccine live (Oka/Merck). The physician indicated that this was a human error because both vaccines were stored in the freezer and the vial was placed turned backwards. Moving forward, they will store the two vaccines in separate places. The physician's suggestions for Merck were: writing in large fonts and different colors on the cap as well as all around the vial; Z and For Adult only and V and For Child only for zoster vaccine live (Oka/Merck) and varicella virus vaccine live (Oka/Merck), respectively. No product quality control issue was reported. No adverse effects were reported. Additional information has been requested.
Vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine given 6 days post expiry) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 011L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.   This case was linked to MOD-2021-395985 (Patient Link).
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2013, the patient was inoculated with the ZOSTAVAX vaccine at a medical office as recommended for routine adult health maintenance and for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster. Later in 2013, the patient was treated at a hospital for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. The patient was prescribed gabapentin for management of her painful symptoms and chronic pain. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Additional information has been requested.
First shot in January temp was 102.8 took Tylenol woke up and temp was 96.5. Second shot two days ago was confined to bed whole body and joints hurt
Within an hour or 1 1/2 hrs. I felt like my body was going to shut down and I was so sleepy. Later that night I had a 4" long - 1" wide rash on my arm. The back of one leg had a 7" long and 4" wide rash that stung and burned. It was gone the next morning.
has to get his teeth pulled because they're really bad.; This is a spontaneous report received from a contactable male consumer (patient). This patient reported for himself that he received the first dose of BNT162B2 (Lot number unknown) at single dose for COVID-19 immunisation on unknown date. Relevant history and concomitant drugs were unknown. The patient sated he had to get his teeth pulled because they're really bad. His boss lady told him to call to re-schedule his second shot because he has a dentist appointment that same day. Outcome of event was unknown.   No follow-up attempts are needed. No further information is expected.
No adverse effects to the patient. Given 4th dose of Pfizer vaccine in error. Patient was assessed every 15 minutes for the total time frame of 45 minutes. No change to patient condition.
Sore arm; Inappropriate Age at Vaccine Administration; This case was reported by a nurse via call center representative and described the occurrence of pain in arm in a 48-year-old male patient who received Herpes zoster (Shingrix) (batch number LS42K, expiry date 4th December 2021) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, less than a month after receiving Shingrix, the patient experienced pain in arm and inappropriate age at vaccine administration. On an unknown date, the outcome of the pain in arm and inappropriate age at vaccine administration were unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were received as follows: The reporter stated that, the patient who was 48 years old was given Shingrix, which led to inappropriate age at vaccine administration. The patient experienced sore arm after vaccination. No other details provided. The reporter did not consent to follow up.
Excessive screaming-unusual highpitched; Lasted 30 mins or so; Did not go to MD but called;
Patient states she started to get arm pain the day after injection (12/3/15). On 12/10/15 patient noticed redness, warmth at injection site. Noted on 12/11/15 an area of erythema, redness and swelling that measures about 5cm x 4cm in size.
Patient developed a welt at the site of the injection that day and then seven days after the injection developed hives to bilateral arms. Currently taking Benadryl to help.
Shortness of breath for past week. Generalized body aches, nonproductive cough. Possible exposure to someone with COVID
post vaccine pt complained of redness on arms and legs. pt has multiple medical issues and multiple prescriptions. pt also complained of lightheadedness and neck pain. pt denied breathing issues and mouth tingling. given Benadryl. Symptoms improved.
positive COVID-19 test; positive COVID-19 test; This is a spontaneous report from a contactable consumer. This consumer reported similar events for two patients. A female patient in her seventies received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection) via an unspecified route of administration on 18Jan2021 as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. It was reported that the patient was tested for COVID-19 on 01Feb2021 and found out that she was positive on Wednesday. The reporter stated that she had relatives who received the first dose of the Pfizer-BioNtech Covid-19 vaccine and then they tested positive for Covid-19. They were scheduled for the second dose of the vaccine this week ("yesterday"). They were confused about when to get it or if they could get it. Their doctor said it was okay that they received the second dose of the vaccine, but the caller wanted to check with Pfizer the recommendations on this topic. She stated that she had heard "all kinds of crazy information", she heard that if someone had a cough and received the second dose of the vaccine, the cough would become more severe. She would like to know if this was true and if it was better to wait for the second dose of the vaccine. She also wanted to know what the longest period was someone could wait to receive the second dose of the Pfizer-BioNtech Covid-19 vaccine after the 21-day period. The clinical outcome of the event positive COVID-19 test was unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021140470 Same reporter/drug/AE and different patients.
Patient is a 5 y/o female here with father with concern for vaccine reaction.  Father reports acute onset of fever along with redness, swelling, and pain of left upper arm at the site where patient received flu vaccine on 03/22/2021. Symptoms began on 03/23/2021 with Tmax of 101 degrees. Fever responded well to Tylenol. Parents have also given Benadryl to help with redness and swelling with some improvement. Patient afebrile when seen in office on 03/24/2021.
a little soreness in her neck; She rubbed below her ear and it was a little sore; Soreness in the lymph nodes for about 2 days; Tiredness/ fatigue; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (a little soreness in her neck), PAIN (She rubbed below her ear and it was a little sore), LYMPH NODE PAIN (Soreness in the lymph nodes for about 2 days) and FATIGUE (Tiredness/ fatigue) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced NECK PAIN (a little soreness in her neck), PAIN (She rubbed below her ear and it was a little sore), LYMPH NODE PAIN (Soreness in the lymph nodes for about 2 days) and FATIGUE (Tiredness/ fatigue). At the time of the report, NECK PAIN (a little soreness in her neck), PAIN (She rubbed below her ear and it was a little sore), LYMPH NODE PAIN (Soreness in the lymph nodes for about 2 days) and FATIGUE (Tiredness/ fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were reported. No treatment medication were reported. No lab data was provided by the reporter   Most recent FOLLOW-UP information incorporated above includes: On 04-Aug-2021: Significant event fu event added
A patient received inadvertently Pentacel instead of Adacel, no AE; A 21 year old patient received inadvertently Pentacel, no AE; Initial information regarding an unsolicited valid non-serious case was received from physician via Medical Information (Reference number- 00645545) and transmitted to Sanofi on 17-Jun-2021.  This case involves a 21-year-old patient (gender not reported) who received inadvertently 0.5 mL dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] (lot number and expiry date not reported) via an intramuscular route in an unknown administration site for prophylactic vaccination on 17-Jun-2021 instead of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (lot number and expiry date not reported) (wrong product administered and product administered to patient of inappropriate age).  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  The reporter inquired if there were any concerns for the patient. The physician was reluctant to provide information on the adverse event (AE).  The details of laboratory data were not reported.  It was a case of actual medication error due to inappropriate age at vaccine administration and wrong vaccine administered (latency same day).  At the time of reporting, no adverse events were reported.  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 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.  There will be no information available on the batch number for this case.
Severe redness/swelling/pain/fever dorsal Lt upper arm onset 4-5 days after immunization.
pt recv vax 28FEB96 & on 6MAR96 pt presented to ofc for crying all noc;suddenly became nonresponsive & blue-CPR-intubation-to hosp shock & resp arrest;bilat adrenal hemorrhage on post
Vaccinated w/1st dose w/o rxn; 2nd dose experienced elevated liver enzymes; third dose lab eval showed alkaline phosphatase 15, SGOT 62, LDH 117, bilirubin 0.5, direct bilirubin 0.2, GGT 320, SGPT 111, BUN 18, & creatinine 1;
Patient was hospitalized due to breakthrough covid-19 infection on 7/27/21 with complaints of shortness of breath, nonproductive cough, daily fevers, decrease taste, chest pain when coughing, and fatigued. Patient completed the Pfizer vaccine series in February. Patients condition worsened over hospital course and he was pronounced deceased on 8/09/21 @21:55. Below information is copied from progress note on 8/08/21:  7/30/21: Patient has had no new issues overnight. He remains on HFNC + NRB 80L/100% maximum support, refusing bipap. Educated on importance of utilizing bipap, still refusing.  Sats remain mid 80s.   8/1: No acute events overnight.  Tol slow wean of HFNC. Bipap overnight.  Hemodynamically stable.    8/2: No acute events overnight.  On FFB overnight 85% 12/8.  Was reportedly in chair most of the day yesterday on HFNC 70%/70l with stable sats. Hemodynamically stable. No fevers.    8/3:Patient sitting up in chair , on HFNC, nostrils bloody and with dry mucus. Requesting to be placed on regular diet with no restrictions. Uneventful night.   8/4: Sats upon intial exam this AM by this provider were 77%.  Pt had just transferred bed to chair with HFNC and NRB. Sats slow to recover but with NRB, slowly improved to 89%.  Pt states that he slept poorly last night and this AM upon getting up had trouble with severe left thigh cramp.  Was given Robaxin, pain med, warm pack to thigh and is better now. Added Melatonin to HS meds prn to help with sleep. Additional aspart given for hyperglycemia.    8/5: no events overnight. Patient remained on BIPAP with no issues.    8/6: Pt required BIPAP d/t decreasing O2 sats to low 80s on HFNC.    8/7: Intubated last night for hypoxemia refractory to FFB 100%.  Currently stable sats on APRN 100%, PH 30.  Sub cut emphysema to neck. AM CXR, ABG, and labs pending. TF ordered. Wife notified of intubation- she was diagnosed with covid at same time as husband.  She will contact her son who has been fully immunized and no current covid s/s.    8/8: patient remained intubated and sedated on ventilator overnight. APRV PH 24, 95% fiO2
did not feel well; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received COVID-19 Vaccine - Manufacturer Unknown, (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MALAISE (non-serious), outcome "unknown", described as "did not feel well".  Updated Information included: Reporter was not sure about the manufacturer or the dosage received.   The lot number for COVID-19 Vaccine - Manufacturer Unknown was not provided and will be requested during follow up.
Right arm redness, pain started several hours after injections, progressed proximally with marked redness, and distally with streaking, accompanied by fevers, rigors. She called clinic and received nurse advice. Symptoms progressed and she presented to ED 1 day after vaccination, discharged for conservative treatment. Later that day 11/27/18, she eturned to ED with further progression and was admitted. Treated with IV ceftriaxone 1-2 doses, ibuprofen, slowly improved and discharged on 11/28/18.
Patient received Flucelvax Quad 2019/20 injection on 9/28/2019  and reports that he had pain on the next day radiating from injection site  up to neck and shoulder blade and down to fingers "nerve" like pain in fingers. Pain reported as 9 out of 10 scale per patient.  On 10/5/2019 patient came into pharmacy to report adverse reaction has pain currently 7 out of 10 scale per patient. Patient wanted to see a doctor and was advised that pharmacy would follow up with him on Monday 10/7/19