chrisvoncsefalvay/vaers-outcomes huggingface dataset:
rash over entire body; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RASH (non-serious), outcome "unknown", described as "rash over entire body". The event "rash over entire body" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of rash.  Additional information: Patient took the first two vaccine shots and broke out in a rash over my entire body. Patient have seen Dermatologist and have taken all the medications he has prescribed all to no avail. They are getting expensive for me as I am on a fixed income. The Dr. even did a biopsy the last visit.  The lot number for bnt162b2 was not provided and will be requested during follow up.
This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of VAQTA lot # M039202 with expiration date 11-MAR-2018 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 13.1 degrees Celsius for 7 hours and 50 minutes. A Digital Data Logger was involved. There were no previous temperature excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA014902: US-009507513-1705USA007303: US-009507513-1705USA007304: US-009507513-1705USA007306: US-009507513-1705USA007307: US-009507513-1705USA007308:
p/ pt recv vax in 8/95, then 7/98 pt devel chickenpox. MD said pt had multiple vesicles
could hardly move, couldn't get out of bed; injection site soreness; fever that spiked; chills; felt like every muscle in his body was being attacked; A spontaneous report was received from an Other Health Professional on 10-FEB-2021, which refers to a Male aged 78 Years, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced vaccination site pain, pyrexia, chills, myalgia and fatigue.   At the time of the event the patient had Cancer, Dermatomyositis. The following drugs are known to have been taken by the patient prior to the event: Prednisone, Ubiquinol, Lasix, Xarelto, Atorvastatin, Zetia and Niacin.  The patient received the first of the two planned doses of mRNA 1273 on 15-JAN-2021. 24 hours later, the patient experienced injection site soreness, fever that spiked, chills, felt like every muscle in his body was being attacked and could hardly move.  The patient also reported that he received the second dose of Moderna COVID-19 vaccine on 29-JAN-2021 and experienced adverse events.  The events were treated with Tylenol and amoxicillin  Follow-up required.  Action taken with mRNA-1273 in response to the events was not reported.  The event was considered Resolved/Recovered.
Sudden onset of tinnitus in my left ear. Still ongoing as of 10 days later. Very prominent hissing.
The nurse attempted to vaccinate the client and did not observe a wheel form upon administration. No signs or symptoms noted after the unsuccessful attempt.
Screaming episode lasted more than 24hrs; unable to comfort, poor feeding, no documented fever;
Patient describes reaction: Red swollen knot about the size of the circle on a coffee cup. She stated other side effects: bones hurt, feels flu like, left side of face red and swollen, body hurts, chills, sweating, runny nose, and having a hard time breathing. Talked to her about monitoring and putting a cool pack on the area. If it gets worse to contact her doctor or if have any major reactions to go the the doctor or ER.
Pt nonresponder to 3 doses of Recombivax received a 1st dose of Engerix B was found to be nonresponder
Breakthrough menstrual bleeding post COVID booster; Breakthrough menstrual bleeding post COVID booster; This is a spontaneous report received from a contactable consumer who is also a Pfizer colleague. The reporter is the patient.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: unknown) as dose 3 (booster), single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: COVID-19 vaccine (dose 1, manufacturer unknown), for COVID-19 immunisation; COVID-19 vaccine (dose 2, manufacturer unknown), for COVID-19 immunisation. The following information was reported: IMMUNISATION (non-serious), INTERMENSTRUAL BLEEDING (non-serious), outcome "unknown" and all described as "Breakthrough menstrual bleeding post COVID booster".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
chills for about 2/12 hours, fever until  1/16. headache, muscle aches, nausea evening on 1/16 with headache  mild shooting pain headache on and off through 1/17; treated with tylenol
headaches; felt like had mild flu; fuzzy head type of feeling; hurt all over; arm was much more sore; booster; Shortness of breath; This is a spontaneous report from a contactable consumer or other non hcp.  A 59-years-old male patient received bnt162b2 (BNT162B2 PFIZER BIOTECH MRNA COVID 19 SOLUTION FOR INJECTION (Batch/Lot number was not reported), dose 3 via an unspecified route of administration, administered in Arm Left on 12Nov2021 as dose 3 (booster), SINGLE for covid-19 immunisation. Medical history included hypertension ongoing diagnosed about 15 years ago, takes medication to treat this and it is not an issue, blood triglycerides increased from an unknown date diagnosed about 15 years ago. The patient's concomitant medications were not reported. No Prior Vaccinations within 4 weeks. Patient previously took first dose and second dose of bnt162b2 (BNT162B2 PFIZER BIOTECH MRNA COVID 19 SOLUTION FOR INJECTION (Batch/Lot number was not reported), dose 1 and 2 via an unspecified route of administration, administered in Arm Left on 2021 SINGLE for covid-19 immunisation. It was reported that, The patient experienced booster on 12Nov2021 with outcome of unknown, shortness of breath on 12Nov2021 with outcome of recovering, headaches, felt like had mild flu, on fuzzy head type of feeling, hurt all over, arm was much more sore, hurt all over on 13Nov2021 with outcome of recovering, arm was much more sore on 12Nov2021 with outcome of recovering.  Therapeutic measures were taken as a result of shortness of breath (dyspnoea), headaches (headache), felt like had mild flu (influenza like illness), fuzzy head type of feeling (feeling abnormal) , hurt all over (pain), arm was much more sore (pain in extremity). The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Within hour mild nausea and pain by 10pm everything increased  freezing, entire arm pain, nausea, intense headache,  chest hurt 2am sweats and chills.  1:45 pm next day back to mild head, nausea,  but extreme whole arm pain
approx. 5 minutes after receiving the vaccine, client started c/o racing heart. Bp was elevated and pulse rate elevated, o2 was normal. EMSA was called due to racing heart. They monitored her for awhile and she refused to go to the hospital and drove herself home, where she said within 30 minutes of getting home she was fine and vital signs back to normal. she had a physical exam 1/20/21.
Pt presented with red swelling near and around injection site on 10/21 the evening she received vaccine. Pt saw MD on 10/23 and he suspected cellulitis and gave pt antibiotic and now 10/28 rash has gone away.
ALCOHOL INDUCED POLYNEUROPATHY PERIPHERAL NEUROPATHY CHRONIC RESPIRATORY FAILURE 2/4/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Swelling and redness on arm. Gland or lymph node swelling in pit of arm. Intense pain with mobility. Applied heat initially, but icing was more helpful.
I am tired all the time. Vaccine has caused my psorcsis the flare up in a way it has never flared up in my life.
Information has been received from a 21 year old female consumer with pertinent medical history reported as unspecified who on 16-FEB-2007 was vaccinated with the second dose of GARDASIL (lot #655618/0186U), injection (form) left arm. Concomitant therapy included YASMIN and AMITIZA. On 17-FEB-2007, the patient experienced dizziness, menstrual cramping and she felt extremely tired and heavily medicated since she was administered Gardasil on 16-FEB-2007. The patient sought unspecified medical attention. The patient advised that her symptoms were becoming worse and have not improved. Additional information has been requested. 07/06/07 This is in follow-up to report(s) previously submitted on 3/14/2007. On 17-FEB-2007, the patient experienced dizziness and nausea (previously reported as menstrual cramping, she felt extremely tired and heavily medicated) since she was administered GARDASIL on 16-FEB-2007. The patient sought unspecified medical attention. On 23-FEB-2007, the patient recovered from the nausea and dizziness. Additional information has been requested.
This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (An HCP accidentally vaccinated a 16 year old with the Moderna COVID-19 vaccination) in a 16-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Dec-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (An HCP accidentally vaccinated a 16 year old with the Moderna COVID-19 vaccination). On 30-Dec-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (An HCP accidentally vaccinated a 16 year old with the Moderna COVID-19 vaccination) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient has no concomitant medications.  Treatment information not provided.
On 10/21 rushed to ER to above hospital. Diagnosed with Guillain Barr syndrome. Was in ICU till 11/28. Transferred to rehab as of 12/13 still there. Discharge summary states respiratory failure. msv Per 60 day follow up report- She had Guillian Barre syndrome. At this time she is home, but still working on walking again. She was paralyzed in ICU for about 2 months. The muscles are still weak.  She has recently contracted a virus, which is making her phyical weak, trembling hands where she needs 2 hands to hold glass.
Heart attack on 12/25/2021,  Admitted to ER at 9:30 AM,  Troponin levels high.  Angiogram was clear, no narrowing, no blockages, no stent required.  No myocardial injury.
Gluten intolerance; Diarrhea; headache/ headaches; Dizziness; This spontaneous case was reported by a consumer and describes the occurrence of GLUTEN SENSITIVITY (Gluten intolerance), DIARRHOEA (Diarrhea), DIZZINESS (Dizziness) and HEADACHE (headache/ headaches) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003A21A and 011M20A) for COVID-19 vaccination.     The patient's past medical history included Gluten free diet (With which diarrhea stopped.) since 15-Apr-2021. Concomitant products included PLANTAGO OVATA (METAMUCIL CITRON) for PRODUCT USED FOR UNKNOWN INDICATION, BIFIDOBACTERIUM INFANTIS (ALIGN) for Probiotic therapy, VALSARTAN (DIOVAN), CLONIDINE, CYCLOBENZAPRINE, TRAMADOL, TEMAZEPAM, PARACETAMOL (TYLENOL), BIOTIN, ASCORBIC ACID, CALCIUM, MINERALS NOS, RETINOL, TOCOPHERYL ACETATE, VITAMIN B NOS, VITAMINS NOS, ZINC (CENTRUM SILVER [ASCORBIC ACID;CALCIUM;MINERALS NOS;RETINOL;TOCOPHERYL ACETATE;VITAMIN B NOS;VITAMINS NOS;ZINC]), OSTEO BI-FLEX [ASCORBIC ACID;BOSWELLIA SERRATA RESIN;CHONDROITIN SULFATE;COLLAGEN;GLUCOSAMINE HYDROCHLORIDE;HYALURONIC ACID;MANGANESE SULFATE;METHYLSULFONYLMETHANE;SODIUM;SODIUM BORATE], KRILL OIL (MEGARED OMEGA 3 KRILL OIL), MAGNESIUM CARBONATE (MAGENSIUM VITAFIT), CALCIUM CARBONATE (OSCAL [CALCIUM CARBONATE]) and MELATONIN for an unknown indication.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced DIZZINESS (Dizziness). On 18-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HEADACHE (headache/ headaches). On 19-Mar-2021, the patient experienced DIARRHOEA (Diarrhea). On an unknown date, the patient experienced GLUTEN SENSITIVITY (Gluten intolerance). The patient was treated with LOPERAMIDE HYDROCHLORIDE (LOMOTIL [LOPERAMIDE HYDROCHLORIDE]) for Diarrhea, at an unspecified dose and frequency; LOPERAMIDE HYDROCHLORIDE (IMODIUM) for Diarrhea, at an unspecified dose and frequency; METRONIDAZOLE (FLAGYL [METRONIDAZOLE]) at a dose of 4 doses; SULFAMETHOXAZOLE at an unspecified dose and frequency and MECLOZINE HYDROCHLORIDE (MECLIZINE [MECLOZINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, GLUTEN SENSITIVITY (Gluten intolerance), DIARRHOEA (Diarrhea), DIZZINESS (Dizziness) and HEADACHE (headache/ headaches) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Apr-2021, Inflammatory marker test: high (High) 9x the normal level.         On 19-Apr-2021 patient had test for celiac disease- result is negative On an unknown date, blood test performed to measure inflammation, results are unknown.   Most recent FOLLOW-UP information incorporated above includes: On 07-Aug-2021: Follow-up received on 7-AUG-2021. Contains, Laboratory details added, intensity and outcome of the events headaches and dizziness was updated, medical history and concomitant medication details.
This spontaneous report as received from a registered nurse refers to three patients of unknown age and gender. No information regarding the patients's medical history, concurrent conditions and concomitant medications was reported. On unknown dates, the patients were vaccinated with doses of PNEUMOVAX23, lot # k012424, (dose, route of administration, injection site and expiration date were not reported). According to the reporter, within two to three hours of vaccination, each patient experienced redness, swelling and pain at the injection site. The outcome of the events was unknown at the time of the report. The relatedness between redness, swelling and pain at the injection site and PNEUMOVAX23 was not provided. Additional information has been requested.
Pain in left leg that started in hip and knee.  Felt like minor muscle strain from more than normal physical activity (pain maybe 1 to 2).  Over the next two days what appeared to be muscle pain increased from minor to a more moderate muscle strain (pain maybe 2 to 3) and pain started to move to the shin - Tibia with more pronounced pain in the shin (pain 3 to 4).  Night of the third day woke up with serious pain in the shin - front of Tibia (pain 8 - constant pain, could not be relieved by massage or change of position, breathing became involuntary with heavy exhale, occasional involuntary moan when change of pressure or position).  Pain was relieved somewhat with over the counter pain med.  Pain has been 24/7 since then for almost 3 weeks.
received a partial dose of Pentacel with sterile water from a Merck MMR vaccine was mixed with the lyophilized hib powder while the DTaP-IPV diluent was not given, no AE; Initial information received on 04-Dec-2019 regarding an unsolicited valid non-serious case received from a consumer (Office Staff).  This case involves a unknown demographic patient who received a partial dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] with sterile water from a Merck MMR vaccine was mixed with the lyophilized HIB powder while the DTaP-IPV diluent was not given.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 04-Dec-2019, while receiving a 0.5 ml dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot number and expiry date not reported) Sterile water from a Merck MMR vaccine was mixed with the Lyophilized Hib powder while the DTaP-IPV diluent was not given was mixed with the lyophilized hib powder while the DTaP-IPV diluent was not given via intramuscular route in unknown administration site.  It was actual medication error due to Inappropriate reconstitution technique.  At the time of report no adverse event was reported.  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 and Module VI of the 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.  Information on the batch number was requested.
Information was received from a registered nurse referring to a patient of unknown age and gender. The patient's medical history and concurrent condition were not reported. On 13-JUN-2016 the patient received improperly stored PROQUAD 0.5 ml subcutaneously. The nurse could specify improperly stored conditions. No adverse effect was reported. Additional information has been requested.
Information has been received from a health professional concerning a 14 year old female who was vaccinated with a series of three mealses virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live second generation immunization.   Subsequently the patient had a negative titer.  Unspecified medical attention was sought.  Attempt to obtain lot number have been unsuccessful Additional information has been requested.
Red, swollen right thigh.  Treatment:  hot pack, Benadryl, Augmentin.
PRURITUS; RASH, localized shingles that appear on left upper side of body Narrative:
Patient is 13 years old and received a pediatric Pfizer 5-11 dose. Spoke with parent as patient is minor.  Plan for the child to have Pfizer 12+ for his 2nd dose
Swelling down arm to elbow-mid arm. Fever of 101.4F, pain in arm, and discoloration in arm (reddish-blue). Called a local traige RN, who suggested not much to pt, and told her to wait it out, and put ice on arm, as pt cannot take Tylenol. When called today (11/18/13) pt did report arm doing better, still discolored, suggested she should go in and have it looked as week out from injection. And to put ice on it also.
within first 24 hours: headache, loss of appetite. within 36 hours: increased headache (moderate-severe), fatigue, loss of appetite. within 72 hours symptoms subsided
Pediarix given 5/23/06. On 05/25/06, left arm red and swollen, warm to touch, larger than 2 inches. TX: Rocephin IM and Augmentin.
Severe depression; anxiety; deep emotional distress; Fatigue; Insomnia; This is a spontaneous report from a contactable consumer (patient). A 55-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 08Apr2021 (Lot number: ER8735) on the right arm as single dose for COVID-19 immunization. Medical history included ADHD, hypothyroidism. No Allergies. Concomitant medication included lisdexamfetamine mesilate (VYVANSE). The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 18Mar2021 (Lot number: EP7534) on the right arm as single dose for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient did not test for COVID-19. The patient did not have covid prior vaccination and did not have covid tested post vaccination. On 09Apr2021, patient experienced severe depression, anxiety, deep emotional distress, fatigue, insomnia. Events resulted in Doctor or other healthcare professional office/clinic visit. There was no treatment received for the adverse events. The outcome of events was not recovered. This report was assessed by the reporting consumer as non-serious.  No follow-up attempts are needed. No further information is expected.
Chills; Tired; Fatigue; Had hard time getting out of bed; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 73 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 19Feb2021 (Lot number: EN6200) at the age of 73 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing), notes: Verbatim: Blood pressure high. Concomitant medication(s) included: PLAVIX; ASPIRINE; DIOVAN taken for hypertension. The following information was reported: CHILLS (non-serious) with onset 19Feb2021, outcome "recovered" (21Feb2021), described as "Chills"; FATIGUE (non-serious) with onset 19Feb2021, outcome "recovered" (21Feb2021), described as "Tired"; FATIGUE (non-serious) with onset 19Feb2021, outcome "recovered" (21Feb2021), described as "Fatigue"; BEDRIDDEN (non-serious) with onset 19Feb2021, outcome "recovered" (21Feb2021), described as "Had hard time getting out of bed".  Additional information:Reporter stated was calling in relation to wife her name is withheld. The reason was calling is wife and reporter both live in. We both took the Pfizer vaccine on 19Feb2021had no problem what so ever, once we took the first shot we waited fifteen minutes before we left area, we took the shot and everything was fine. We came home and that evening wife had a reaction, pretty bad reaction. She had chills and she was tired, she was fatigue and she had hard time getting out of bed. She stayed in bed that was on Friday the 19th of February. She stayed in bed the whole night, got up the next day and she pretty much had the same side effects and she stayed in bed all day Saturday and in the Saturday night, she got better on Sunday. She got better and be able to get out of bed and she was able to start moving around. When the time came to get the second shot which took, the second shot on March the 12th. we took the first shot on February 19th and took the second shot on March the 12. The patient's husband never had any problem what so ever, the shoulder was little sore from the shot and wife did not take the second shot she spoke to her doctor and her doctor said may be she should wait ninety days before she takes the second shot. So, she had waited now because she took the first shot on February 19th. So, May 19th which is tomorrow. Tomorrow is May 19th which would be 90 days. She wants to take the second shot. So calling you to ask you for your advice. Do you think she should or maybe think she should not take second shot. That's what am asking you. It was COVID-19 Pfizer shot.Reporter was provided with the number of  Medical information Department.  No follow-up attempts are possible. No further information is expected.
Syncope - patient fainted and collapsed as she stood up and started walking. Patient was seated, given water and snacks. She immediately slowly regained her alertness and after about 20 minutes, she was fully alert and left the pharmacy with her parents. In a phone call later that day by the pharmacy, the father of the patient confirmed the patient was well and sound.