chrisvoncsefalvay/vaers-outcomes huggingface dataset:
fever; pulsating migraine; joint and muscle aches and pains; joint and muscle aches and pains; dizziness; fatigue; First dose on 21Dec2020, second dose on 06Jan2021; This is a spontaneous report from a contactable other healthcare professional (HCP) reporting for herself.  A 27-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), intramuscular at Left arm on 06Jan2021 15:15 at single dose for covid-19 immunization. The COVID-19 vaccine was administered at Hospital. Medical history included swine flu. Concomitant medications included buspirone, venlafaxine, amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL XR), ethinylestradiol, levonorgestrel (AVIANE) for birth control, plantago ovata fibre (FIBER SUPPLEMENT), probiotics and women's multi-vitamin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's historic vaccine included first dose of BNT162B2 (lot number: EL0140), Intramuscular at left arm on 21Dec2020 15:15 for covid-19 immunization. On 07Jan2021 11:00, the patient experienced fever, pulsating migraine, joint and muscle aches and pains, dizziness, fatigue - absolutely could not have went to work if she was scheduled that day - just moving from her left side onto her right side took immense effort and tears - haven't experienced anything like it since she had swine flu. No treatment received for the events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the events fever, pulsating migraine, 'joint and muscle aches and pains', dizziness, fatigue was recovered on an unknown date in Jan2021.
Headache Pain at site, headache, feeling sick for days. 6th day painful armpit Narrative:
Myocarditis (3/16/23), elevated DDimer (3/8/23)
Caller says she did not have an anaphylaxis reaction, but had a "temp 103F, cellulitis in whole upper arm and neurological symptoms".; Caller says she did not have an anaphylaxis reaction, but had a "temp 103F, cellulitis in whole upper arm and neurological symptoms".; Caller says she did not have an anaphylaxis reaction, but had a "temp 103F, cellulitis in whole upper arm and neurological symptoms".; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a female patient of unspecified age received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date at a single dose for immunisation. The patient medical history was not reported. Patient was allergic to tetanus. The patient's concomitant medications were not reported. Patient read it (pneumococcal 13-val conj vac (dipht crm197 protein)) was contraindicated for patient allergic to didiphtheria toxoid-containing vaccine. She was not sure which component of vaccine she is allergic to. She did not have an anaphylaxis reaction, but had a "temp 103F (Fahrenheit), cellulitis in whole upper arm and neurological symptoms". Patient was supposed to get the pneumococcal 13-val conj vac (dipht crm197 protein) vaccine at the reporting date but did not. Outcome of events was unknown.   Information on the batch/lot number has been requested.; Sender's Comments: The association between the event cellulitis in whole upper arm with pneumococcal 13-valent conjugate vaccine can not be fully excluded based on the limited information and temporal relationship.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
My adverse event started on 12/06/2022. In the morning around 8:00AM. I had a sore throat, chills, cough, fatigue, runny nose, and headaches. On 12/07/2022 I tested positive for COVID-19. I contacted my doctor on 12/08/2022. My doctor prescribed me PAXLOVID for 5 days and TYLENOL as per needed. I developed pain back after COVID-19 infection. As of today 12/16/2022 I still have some symptoms left. I am recovering slowly.
skin reaction; This case was reported by a consumer via interactive digital media and described the occurrence of skin reaction in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced skin reaction. On an unknown date, the outcome of the skin reaction was unknown.   It was unknown if the reporter considered the skin reaction to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received Shingrix and had skin reactions.
Case number PHEH2016US032977, is an initial spontaneous report received from a pharmacist on 15 Dec 2016. This report refers to a 31 years old male patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with single dose of FLUVIRIN (batch number: 1619901 and expiry date: May 2017) at a dose of 0.5 ml, intramuscularly on 15 Dec 2016. It was reported that, patient vaccinated with FLUVIRIN following a temperature excursion of 56.5 Fahrenheit for 7 hours on 15 Dec 2016. No adverse event was reported following this medication error.
PATIENT HAS REDNESS THAT WAS HARD AND LUMPY SKIN IRRITATION AROUND THE INJECTION SITE - 10CM
Information has been received from a registered nurse referring to an unspecified number of patients of unknown age and gender. On an unknown dates these patients were vaccinated with doses of improperly stored PEDVAXHIB (dose, frequency, route and lot# were not reported). No adverse effects were reported. No product quality complaint was involved. This is one of several cases reported by the same reporter. Additional information has been requested.
10 hours post-vaccination, lightheadedness and one episode of syncope (fainting). Then approximately one hour of shivering and chills.
10 hours after injection, developed some mild body aches, a slight headache, and a very small amount of nausea.  13 hours after injection, I woke with a fever (scanned 99.5-100.7), still had body aches, some bouts of chills, an elevated resting heart rate, still a slight headache and stomach upset.  Took 1 ibuprofen.  By 6:30 am, fever was gone and I felt improved, but still have some body aches and feeling rundown a bit.
Severe fatigue and all over body aches, had to lay down for 8 hours before resuming daily activities. No fever, no nausea or vomiting.
rash over the chest, thighs, arms, and knee area; hives over the chest, thighs, arms, and knee area; being unable to sleep for the past 3 or 4 days due to the rash and hives; rash at the injection site; bruising at the injection site; This case was reported by a consumer and described the occurrence of injection site rash in a 79-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th January 2021, the patient received the 2nd dose of Shingrix. On 13th January 2021, 7 days after receiving Shingrix, the patient experienced rash and hives. In January 2021, the patient experienced injection site rash, injection site bruising and sleeplessness. The patient was treated with cortisone acetate and prednisone. On an unknown date, the outcome of the injection site rash, rash and hives were not recovered/not resolved and the outcome of the injection site bruising and sleeplessness were unknown.   It was unknown if the reporter considered the injection site rash, injection site bruising, rash, hives and sleeplessness to be related to Shingrix.  Additional details were provided as follows:  The patient experienced bruising and rash at the injection site within 24 hours of vaccination  The patient experienced rash and hives over the chest, thighs, arms, and knee area.  The patient was unable to sleep for the past 3 or 4 days before the date of reporting due to the rash and hives.  Cortisone and prednisone prescribed to treat the rash and hives was unsuccessful.  The reporter consented to follow up.
This spontaneous report as received from a physician's nurse (also reported as physician's assistant) via a Company Representative referring to a 20 year old female patient. On 29-SEP-2014 the patient was vaccinated with the first dose of GARDASIL (Lot# was reported as K00163) (dose, frequency and route unspecified). On 02-OCT-2014, the patient called her physician reporting that she had bumps on the side of the face and all under her chin. The physician prescribed a metronidazole (manufacturer unknown) 500 mg tablet 4 tablet but the bumps were already present on the patient before she took the first tablet. (The tablet was additional medicine that was ordered along with the GARDASIL). The patient explained the bumps are not itchy, there was no swelling and she did not experience shortness of breath. The patient reported there were no other symptoms except the bumps. The patient had sought medical attention via calling physician's office. The outcome of "bumps on the side of the face and all under her chin" was reported as not recovered/not resolved. The reporter would like a call back on how to continue therapy and whether or not to continue on with the following scheduled shots of GARDASIL. Additional information has been requested.
The same evening the infants temp elevated to 103. She was seen in the ER and admitted to the hospital. She slept for 6 hours. Vomited and developed hives. Hospitalized 6 days, sent home on Ceclor and a nebulizer.  Diagnosed with bronchitis and respiratory distress.
ADVERSE EVENT NOS; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced adverse event nos. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of adverse event nos was not reported. This report was non-serious. This case, from the same reporter is linked.
Pt. was on phone saying had runny nose, sneezing, sore throat and headache which started after the next day of the meningitis shot; suggested - CLARITIN, TYLENOL.
Within 5 minutes of PNEUMOVAX, patient stated that she felt hot/burning sensation and difficulty breathing, back pain, dizziness. VSS with elevated BP which resolved in 5 minutes.  Lungs clear. 10:14 a.m. BP=178/120, map=139, pulse=92. 10:15 a.m., BP=140/91, map=107, pulse=88 patient placed in Trendelenburg, symptoms resolved within 5 minutes. 11: 03 a.m., BP=121/80, map=94, pulse=82, temp=97.1, lips feel numbs but no visible CLARITIN 10 mg given. No symptoms of numbness. Lungs clear.
One week after shot, the injection site is swollen, hard, red and itches.  I also have fatigue comparable to the day after the injection where I couldn't keep my eyes open and would fall asleep.
12cm boil, diarrhea, achy, multiple clinic visits and outpatient IV antibiotics.
body aches; Fever; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (body aches) and PYREXIA (Fever) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047b11a and 046a21a) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included GABAPENTIN for an unknown indication.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced MYALGIA (body aches) and PYREXIA (Fever). At the time of the report, MYALGIA (body aches) and PYREXIA (Fever) outcome was unknown.            Treatment information was unknown.   This case was linked to MOD-2022-454610 (Patient Link).
Lymph node soreness under left arm.  Puffy and tender feeling and can see difference in mirror between sides.
This spontaneous report as received from a Certified Medical Assistant refers to a 3 month old male patient. Medical history and concurrent conditions were not reported. On 22-DEC-2014, the patient was vaccinated with a first dose of ROTATEQ oral, 2 ml, (lot number and expiry date were not reported). There was not concomitant medication provided. On 22-DEC-2014, the patient vomited most of ROTATED dose right after dose was administered. The outcome of vomited most of ROTATEQ dose was unknown. Additional information is not expected because reporter refused additional contact.
this is 1 of 3 pt from this facility to develop an inj site rxn characterized by swelling & soreness p/vax;
This spontaneous report was received from a Community Nursing Services and refers to a patient of unknown age. On an unknown date the patient was vaccinated with a dose of PROQUAD lot # H021358, expiry date 29-MAY-2014. Dosing information and route of administration were not provided. On an unknown date, the PROQUAD had been stored improperly. Follow up information as received from the nurse who stated that the vaccine was exposed to unknown temperature for 5 hours during interoffice transport and the patient ws revaccinated and no symptoms reported. This is one of several reports received from the same source. Additional information is not expected.
irregular menstrual cycles, more frequent menstrual cycles, very heavy and unusually heavy menstrual periods
This spontaneous report was received from a health care professional refers to multiple unspecified patients of unknown demographics. On unspecified dates the patients were vaccinated with improperly stored GARDASIL injection (dosing regimen unspecified) (K011562, expiration 08-APR-2017). Excursion details are as follows: temperature: 32F, Time frame: 24 hours, it was back in range. There was no previous temperature excursion. It was a call because of a data logger. No adverse effect reported. Call disconnected before any additional information was obtained. No additional information was provided. This is one of the two reports from the same reporter. Additional information has been requested.
Information has been received from a physician and a pediatric patient's mother concerning an 18 month old female who was reported to have received two doses of varicella virus vaccine live by "accident". The first dose was administered on 11/02/2000. The second dose was administered on 01/09/2001. On 01/24/2001 the patient developed herpetic stomatitis. The child's mother sought medical attention for her child because she suspected that the additional dose of varicella virus vaccine live resulted in the herpetic stomatitis. The physician inquired as to the possibility of herpetic stomatitis due to the second varicella virus vaccine live immunization. Additional information has been requested.
Report A0370976A describes Lyme disease in a 61 year old female who received Lyme disease vaccine recombinant. This report was received from the vaccinee and has been verified by a physician. The medical history reportedly included Lyme disease, chronic sinusitis, a bleeding ulcer "from taking to many aspirins to get rid of sinus headaches" (1989), and hematuria beginning (1996). The vaccinee's concurrent medications included unspecified vitamins and PremPro. In October 1999, the vaccinee received her second injection of LYMErix. Subsequently, on an unspecified date in October 1999, she began to experience back pain that "continued intermittently." At an unspecified time, blood was found in the subject's urine. She stated that she was given a "complete exam" by a urologist and "everything was fine." On an unspecified date, the vaccinee reportedly received her third injection of LYMErix and still was experiencing "some" back pain. In 2001, the subject underwent a colonoscopy "to see if there was a problem which may be causing hte backaches." She stated that "everything was fine." For the past two years, the subject has been treated by a chiropractor. These treatments have "helped" but have not eliminated her back pain. Shehas used prescription and over the counter medications. They provided "no help." The subject stated that "even though I have pain I exercise twice a day and walk at least 3 to 4 miles three times per week." She stated that "recently," Lyme disease western blot analysis was positive and her physician made a diagnosis of Lyme disease. She reported that she was treated with "a series of antibiotics." While taking antibiotics, the back pain reportedly "got better." The subject's back pain persisted as of 9/17/02. On 10/22/02, the vaccine provider reported that the subject's medical history included presumed Lyme disease with back pain treated with doxycycline starting on 6/15/94. She had recurrent symptoms that were responsive to doxycycline. In 1999, her  Lyme disease symptoms had resolved and she requested LYMErix immunization. Post-immunization, on 10/14/99, she began to experience recurrent symptoms of Lyme disease, primarily back pain. The vaccine provider considered the Lyme disease symptoms, primarily back pain, to be possibly related to LYMErix administration. The back pain persisted as of 10/22/02. On 10/28/02, the subject's chiropractor reported that the subject began to experience Lyme disease and back pain on 4/7/01. The chiropractor considered the Lyme disease and back pain to be possibly related to LYMErix administration. As of 10/28/02, the Lyme disease and back pain had "improved." Follow up on 02/26/04: "The most recent information was received from the subject on 09/11/03.  The subject stated that "after many tests and seeing some specialists I am still suffering.  I have back pain and the symptoms of Lyme disease. I did have Lyme this summer which was much more severe than previous bouts." The subject also stated that she 'has to live with constant inflammation (sic). There are times I cannot even touch my skin without pain."
chest pain; dizziness; joint pain; muscle pain; bad headache; Extreme facial swelling began in areas of dermal filler, which was administered 10/2019 and progressed throughout face; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN6200, expiry date unknown) via an unspecified route of administration on 13Feb2021 13:15 in left arm at single dose for COVID-19 immunization. Medical history included migraine, joint pain and dermal filler in Oct2019; allergies to penicillin, mango, tree nuts, bees, shrimp. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medication received within 2 weeks of vaccination included estrogens conjugated (PREMARIN), celecoxib (CELEBREX), levothyroxine, colecalciferol (D3), cyanocobalamin (B12), ascorbic acid (C) and Mul. The patient previously received first dose of BNT162B2 (lot number EL9262), on 23Jan2021 09:30 AM at Left arm. At 4:30 am 14Feb2021, the patient woke with chest pain, dizziness, joint and muscle pain; and bad headache. Extreme facial swelling began in areas of dermal filler, which was administered Oct2019 and progressed throughout face. The events resulted in Doctor or other healthcare professional office/clinic visit. Treatment received for the adverse events included Benadryl and Tylenol (today 1 Celebrex). The outcome of the events was recovering. The events were reported as non-serious, did not result in death, life threatening, caused or prolonged hospitalization, disabling or incapacitating, congenital anomaly or birth defect
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old male patient received BNT162b2 (BNT162B2), on 10Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 60 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. Patient took medication within 2 weeks. The patient's relevant medical history included: "High cholesterol" (unspecified if ongoing); "blood pressure" (unspecified if ongoing). Concomitant medication(s) included: METOPROLOL, start date: 20Jun2021. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jun2022) Negative; (Jun2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
persistent strain of herpes zoster/severe herpes zoster; did not prevent shingles as intended; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient (pt) of an unknown age. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date in 2017, the pt was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) (exact dose, dose number, route and site of administration, lot# and expiration date were not reported) for routine adult health maintenance and for the prevention of shingles at a physician office. On an unknown date, the vaccine did not prevent shingles as intended and the pt subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On an unknown date, the pt was treated for a blistering vesicular outbreak that was diagnosed as severe herpes zoster. As a direct and proximate result of  zoster vaccine live (ZOSTAVAX) vaccine, and/or despite receiving  zoster vaccine live (ZOSTAVAX) for the long-term prevention of shingles, the pt suffered painful injuries and damages and required extensive medical care and treatment. As a direct and proximate result of these malfunctions the pt suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result the pt had suffered and would continue to suffer significant medical expenses, and pain and suffering and other damages. The outcome of events was not provided. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Pt.'s Mother states that after receiving the 2nd dose Meningococcal B 11/01/2021, started experiencing symptoms of dizziness, vomiting, fatigue, and fever. No noted Primary visit/communications.
First night I had fever and coughing. Coughing never stopped until today. Coughing is randon, short bursts, dry and no other symptoms. Is more annoying than anything but it does not stop.
Small, red bumps around both eyes, itching, some swelling and also rash on shoulders following Hep-A vaccination #1. Parent gave Benadryl with improvement of symptoms. Did not see MD.
After 11 hrs broke out in severe chills.fever , thirst , aches and pains all over . These symptoms lastest 14 hrs then fully recovers after 24 hrs