chrisvoncsefalvay/vaers-outcomes huggingface dataset:
61-year-old patient received Fluzone High-Dose, no AE; 61-year-old patient received Fluzone High-Dose, no AE; Initial information received on 20-Nov-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 61 years old male patient received INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (lot UJ252AA expiry date: 01-May-2020) via intramuscular route in the left deltoid from a month ago.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  No other vaccines given that day.  It was an actual medication error case due to inappropriate age at vaccine administration and overdose.   The patient did not report side effects.  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 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 has been received from a nurse concerning the nurse daughter's a 14 year old female with yeast allergy who was vaccinated IM with 0.5 ml a first dose of GARDASIL (lot number not reported). The patient's mother reported that the 12 hours after the patient received the first dose of GARDASIL, she experienced nasal congestion. It was reported that the patient had a yeast allergy which was not life threatening. The nurse stated that her daughter would not receive last two dosed of GARDASIL. At the time of the report the outcome of the patient was unknown. The patient sought unspecified medical attention. No further information is available.
At approximately 10 minutes after receiving vaccine, patient developed dizziness, fainted for approximately 2-3 seconds patient then came too, patient then fainted again and began seizing, seizure symptoms last 5-10 seconds, patient then came too and stayed stable and alert,  911 was called and patient was monitored until ambulance arrived, patient was transported to emergency room, for additional evaluation and treatment
Information has been received from parents via e-mail concerning their son who was vaccinated with a dose of MMR II on an unspecified date. The patient had clearly injury from MMR II. The chronic diarrhea started a couple days after vaccination and had continued on and off to this day. No further information is available.
Fever of upto 102.1 for about 48 hours; Extreme soreness at injection site; All-over joint pain; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever of upto 102.1 for about 48 hours), VACCINATION SITE PAIN (Extreme soreness at injection site) and ARTHRALGIA (All-over joint pain) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020B71A and 025AZ1A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy and HIV disease since September 2010. Concomitant products included DOLUTEGRAVIR SODIUM, LAMIVUDINE (DOVATO) from October 2020 to an unknown date for an unknown indication.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever of upto 102.1 for about 48 hours), VACCINATION SITE PAIN (Extreme soreness at injection site) and ARTHRALGIA (All-over joint pain). At the time of the report, PYREXIA (Fever of upto 102.1 for about 48 hours), VACCINATION SITE PAIN (Extreme soreness at injection site) and ARTHRALGIA (All-over joint pain) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102.1 (High) 102.1 degrees.         No treatment was provided by the reporter.  Patient mistakenly took 2nd dose a month earlier.   This case was linked to MOD-2021-305663 (Patient Link).
Patient deleveloped rash on neck a day after getting booster dose. Pt did not have any reaction to previous dose
Initial unsolicited report received from a pharmacist on 20-Apr-2017. This case involves 17-year-old male patients, who was vaccinated with a dose of TYPHIM VI intramuscularly (Batch number, expiration date, dose in series and site of administration were not reported) on 02-May-2016. Patient's pre-existing physician diagnosed allergies, birth defects, medical conditions were unknown. Illness at the time of vaccination was none. Patient's concomitant medication were not reported. On an unknown date, following the vaccination, the patient contracted typhoid disease while travelling. It was unknown what strain of typhoid the patient was diagnosed with. It was also a case of vaccination failure. Patient required emergency room/ doctor visit. Patient's lab data was reported as: CDC testing for typhoid disease was done. Patient's corrective treatments was not reported. On an unknown date patient recovered from event. Case was considered serious for the important medical events: contracted typhoid disease and Vaccination failure. List of documents held by sender: none.; Sender's Comments: Based on the information patient received TYPHOID VI POLYSACCHARIDE VACCINE and experienced typhoid (Exact time to onset was not specified) however diagnosis was not confirmed. Considering that the patient received TYPHOID VI POLYSACCHARIDE VACCINE, the patient should have been protected against typhoid. This case is therefore a suspected vaccination failure. It was reported that the reporter that typhoid was confirmed with recent CDC testing however strain of typhoid is unknown. More details regarding relevant medical history, exact time to onset, date of vaccination investigation reports confirming the diagnosis, patient immune statues at the time of vaccination are needed for complete assessment of the case.
Symptoms began 8/27. Site of vaccination was red, nontender and warm. Cold compresses were recommended and Zyrtec for itching.
pt recvd vax in 1990 and 1991 respectively; lab eval following the vax revealed neg rubella titers; No further details were provided;
on the fourth day following the second dose A red area painful appeared on my right breast with a lump about size of cashew nut just above nipple area. It is still there on 6th day although not as sore. I have not received treatment or gone to doctor, waiting to see if it goes away in a few days.
rash, head to toe; painful, head to toe rash, in agony; This case was reported by a consumer via interactive digital media and described the occurrence of itchy rash in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, less than a week after receiving Shingles vaccine, the patient experienced itchy rash and pain. The patient was treated with steroids nos (Steroids). On an unknown date, the outcome of the itchy rash was not recovered/not resolved and the outcome of the pain was unknown.   It was unknown if the reporter considered the itchy rash and pain to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient had 2nd dose of Shingles and less than week later was covered in painful, itching rash head to toe.  The patient had been taking a lot of meds, but another week has gone by and could see no improvement in rash.  Steroids and vitracil helped, but the patient was in agony. This case was linked by US2021AMR216429, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR216429:Reporter tagged the other case's patient in a comment. US-GLAXOSMITHKLINE-US2021AMR216429:reporter tagged in comment
Patient developed a 4 inch are of redness and inflammation on her right arm (site of administration).  The vaccine was administered on Friday 7-31, the rash developed on 8-2.  She presented to the pharmacy on 8-3 and reported that it wasn't as red as it was on Sunday.  She was instructed to use some steroid cream on the area.  I instructed her that if it did not look any better to go see her PCP for further treatment.  I will follow up with her tomorrow morning (8-4).
Information has been received from a pharmacist referring to 2 newborns (numbered 168 and 169). Background: Since June 2015, there had been 1645 times (30 minutes each time=822.5 hours) that the temperature dropped below 36F. Of course, there was 144 times (30 minutes each time=72 hours) that temperature was below 32F, the lowest being 29.7F. On 04-JUL-2015, there was a low temperature of 30.2F. On 05-SEP-2015 the patients were vaccinated with the improperly stored RECOMBIVAX HB strength 2.5/0.5 (units not provided) (lot number K020216 and expiration ate of 17-SEP-2016) (dose and route of administration were not reported). There was no product quality complaint (PQC). This is one of several reports received from the same reporter. Additional information has been requested.
Patient's mother stated that patient was complaining that his right arm was "hurting" when he arrived home from school. She stated that patient was still complaining of pain in the morning before he went to school. The afternoon of 10/12/17, patient's right arm was red, swollen, and hot. She took him to Urgent Care. She states that his temperature at the physician's office was 99.2. Patient was diagnosed with Cellulitis and was treated with KEFLEX three times daily for seven days. She states that patient has recovered and is "fine" now.
In the second week again some muscle cramps, heavy legs; In the second week again some muscle cramps, heavy legs, swollen legs; In the second week again some muscle cramps, heavy legs, swollen legs turning purple; In the second day from first shot tiredness; In the first week after shot headache; Muscle cramps in the legs, especially in the calves.; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the left arm on 10Apr2021 at 09:30 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. The medical history included hepatitis A at 5 years old (in 1989). The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any medications within two weeks of vaccination. On 12Apr2021, in the second day from first shot, the patient experienced tiredness. On an unknown date in Apr2021, in the first week after shot, the patient had headache, muscle cramps in the legs, especially in the calves. On an 24Apr2021 at 20:00, in the second week again the patient had some muscle cramps, heavy legs and swollen legs turned purple. The adverse 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 reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events tiredness, headache, muscle cramps in the legs, especially in the calves, heavy legs and swollen legs turned purple was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
the patient had a negative urine pregnancy test prior the vaccination/ she was vaccinated with VARICELLA/the patient left a message that she had a positive pregnancy test post administration of VARIVAX; This spontaneous prospective pregnancy report as received from a register nurse refers to currently a 24 years old female patient.  The patient's pertinent medical history included gastrooesophageal reflux disease (GERD) and drug allergy to sulfamethoxazole (+) trimethoprim (BACTRIM). Concomitant therapies included omeprazole (PRILOSEC).  On 14-MAY-2019, the patient had a negative urine pregnancy test prior the vaccination; and on the same day, she was vaccinated with properly stored varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection in the left arm, lot # N034558 expiration date reported as 05-DEC-2019 (dosage was not reported) for vaccination catch up. The varicella virus vaccine live (oka/merck) (VARIVAX) was reconstituted with properly stored sterile diluent (dosage, lot number and expiration date were not reported).    On 28-MAY-2019, two weeks later, the patient called her physician and stated that she had a positive pregnancy test post administration of varicella virus vaccine live (oka/merck) (VARIVAX). The patient became pregnant with last menstrual period (LMP) of 23-APR-2019 and a estimated date of delivery (EDD) of 28-JAN-2020 with a initial exposure to varicella virus vaccine live (oka/merck) (VARIVAX) was at 3 week(s) (exposure during pregnancy). At the reporting time, the pregnancy outcome was pending and the fetal outcome was unknown.
This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown demographics. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of M-M-R II (lot #, dose and route were not provided). The vaccine also underwent previous temperature excursion, but no details were provided. Digital data logger was not involved. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1703USA000892:
8 x 10 cm area of erythema and induration at injection site (R. hip). No fever or pain at site.
Fever 102 degrees and weakness, unable to walk, presented to emergency department in septic shock
(L) deltoid 5X6 cm soft tissue swelling. Mild tenderness. No erythema.
PT DEVELOPED A BLISTER/SMALL RASH ON LEFT BUTTOCK DAY AFTER GETTING SHINGRIX SHOT, DESCRIBED RASH  AS BLISTER WITH RASH, ITCHY, MAYBE THE SIZE OF A DIME.  SHE REPORTS SINCE THEN THERE IS SOME IMPROVEMENT IN RASH BUT IT IS STILL THERE AND STILL ITCHY
Within 5 min of injection on 01/16/2021, had slight tongue swelling and tingling feeling in chest and abdomen.  Headed to ER but symptoms began to subside within 20 minutes so did NOT go to to ER.  Symptoms never recurred so went home and monitored. Never needed epi pen.  NO further problems other than slightly sore arm.
strong allergy; strong itchiness; Rash; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), (at the age of 51 years old) via an unspecified route of administration, administered in Arm Left on 26Sep2021 16:45 (Batch/Lot Number: 30145BA, also reported as "30145PA") as dose 1, single for covid-19 immunisation. Medical history included allergy to insects. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included prednisolone. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced strong itchiness and rash on 28Sep2021 02:00, and strong allergy on an unspecified date. The patient stated that she got the vaccine on Sunday 4 PM and she got a very very strong allergy last night (unspecified date) and she doesn't really know what to do. She was going to take allergy medicine, and she just wanted to know what's going to happen next vaccination, if she has to take next vaccination which is in two weeks. The patient wanted to know if it is normal to have allergy or if she just has to stop and not take the second vaccine or if she has to go to the doctor. Therapeutic measures were taken as a result of strong allergy. The events strong itchiness and rash were not treated. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was unknown.
has had other allergies and has broken out in hives before; she developed hives; This is a spontaneous report from a contactable consumer (patient). A 51-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EW0176, Expiry date: not reported), via intramuscular route of administration in right arm on 29Apr2021 15:00 (at age of 51-years-old) as dose 1, single for covid-19 immunization. Medical history included covid-19 from Mar2021 to an unknown date. No patient medical history (including any illness at time of vaccination) was reported. The patient's concomitant medications were not reported. History of all previous immunization with the bnt162b2 vaccine considered as suspect were none. No additional vaccines administered on same date of the bnt162b2 suspect. It was unknown if the patient had received any other vaccine within 4 weeks. The patient was taking bnt162b2 vaccine to protect self and others. On 29Apr2021 at 17:30, the patient experienced she developed hives and had other allergies and has broken out in hives before on an unspecified date. Further reported that patient had a little on her forehead on Friday 30Apr2021. Definitely Saturday everything was gone. Patient has asked that should or shouldn't she get the second shot scheduled for 20May2021. The patient did not require visit to emergency room or physician office due to the adverse events. No relevant tests were performed. The outcome of the event has had other allergies and has broken out in hives before was unknown while the event hives recovered on 01May2021 (at 18:30).  No follow-up attempts are possible. No further information is expected.
Information has been received from an RN concerning 70 year old female who on 16-Oct-2008 was vaccinated with a first dose of PNEUMOVAX 23 (lot# 659199/1541U) intramuscularly. Concomitant therapy included AMBIEN. The patient experienced redness, tenderness and warmth at the injection site after vaccination. The time to onset of the symptoms was not available. The patient contacted the office by phone and was recommended to apply cold compresses. No lab diagnostic study was performed. The patient subsequently recovered after 1 week. Additional information has been requested.
Arm has continually gotten worse. Can?t sleep on it or lift anything. Going to see Dr on December 28th. I imagine the shot was administered too high.  Pain isn?t subsiding
Woke up next morning around 6:30 AM the 18th with a few drops of blood on pillow. Nose was dripping blood. Was able to plug nose and stop bleeding within 15 minutes. No further issues that day, however did wake up with dried blood in nose on the 19th. No further issues after that.
fatigue; swollen lymph node left armpit; swollen lymph node left armpit beginning day after vaccine, currently still somewhat swollen and tender; sinus pain; congestion; full body aches; shivering/chills; hot flashes; cough; cough (from sinus drainage); headache; decreased appetite; insomnia; This is a spontaneous report from a contactable Other Health Care Professional (patient) reported for herself.   A 26-years-old female non-pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EW0202) via an unspecified route of administration, administered in Arm Left on 12Jun2021 (Age at Vaccination: 26-years-old) as DOSE 2, SINGLE for COVID-19 immunization. Medical history includes SVT, GERD, IBS. Concomitant medication included lisdexamfetamine mesilate (VYVANSE), cyproheptadine hydrochloride (PERIACTIN), omeprazole magnesium (PRILOSEC [OMEPRAZOLE MAGNESIUM]), prolactin and medical marijuana taken two weeks of medication. Patient had known allergies of Sulfa drugs and Flagyl. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. Patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EW0175) via an unspecified route of administration, administered in Arm Left on 21May2021 (Age at Vaccination: 26-years-old) as DOSE 1, SINGLE for COVID-19 immunization. On 13Jun2021, the patient experienced swollen lymph node left armpit beginning day after vaccine, currently still somewhat had swollen and tender 6 days later, sinus pain, congestion, full body aches, shivering/chills, hot flashes, cough (from sinus drainage), headache, decreased appetite, insomnia, fatigue, all began 1-2 days after vaccine and continuing presently 6 days after vaccine. No treatment was taken for adverse events. Outcome of all adverse events was not recovered.   No follow-up attempts are possible. No further information is expected.  Other medications in two weeks: Vyvanse, prolactin, Prilosec, medical marijuana
Headache, Arthralgia, tingling on his trunk and itching and dry mouth and fatigue Narrative:  1/21 - 20 min after the vaccine employee noted tingling over his trunk and then developed itching over his trunk/back. Then he felt like his stomach was in knots. He was given Benadryl IM and transferred to the ED. There he was given dexamethasone 6 mg IM and oral benadryl 50 mg po. His physical exam was notable for no respiratory difficulty, no rash and no edema. He was observed for 3 hours and diagnosed with a mild allergic reaction to the COVID-19 vaccine. He was discharged to home with Benadryl prn and Prednisone 20 mg po qd x 3 days. He also developed a headache. 1/22 - medication has relieved the itching but he feels drowsy. He still has a headache and has joint pains today. 1/25 - symptoms have resolved with the exception of mild itching, mild headache and since pressure.
This spontaneous report was received from a physician via a company representative and refers to an unspecified number of patients of unknown ages and genders. The patients' pertinent medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not reported. On an unknown date, the patients were vaccinated with a dose of RECOMBIVAX HB (dose, frequency, route, lot # and expiration date were unknown by the reporter) for vaccination. On an unknown date, the patients had been determinate to have low antibody titers after administration of RECOMBIVAX HB (Hepatitis B surface antibody negative). The patients sought an unknown type of medical attention but, it was unknown if the patients received any treatment. The outcome of the event was not reported. The causality between the event and RECOMBIVAX HB was not reported. Additional information is not expected because no consent for follow up was provided.
cough; chills; nausea; This is a spontaneous report from a contactable consumer (patient) reported for himself. This 55-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 13Mar2021 at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient received the first dose of the vaccine on 13Mar2021, and was scheduled for the second dose this Saturday. This last week (unspecified date in Mar2021), patient had been experiencing cough, chills and nausea when he was about to eat. The outcome of events was unknown.   No follow-up attempts are possible; Information about batch/Lot number cannot be obtained.
Patient received Pfizer vaccine for ages 12+ however should have received Pfizer vaccine for ages 5-11.