chrisvoncsefalvay/vaers-outcomes huggingface dataset:
extremely itchy palms; hives on arms, legs and back; Administered dose 1 and dose 2 Moderna and dose 3 BNT162B2; Administered dose 1 and dose 2 Moderna and dose 3 BNT162B2; Administered dose 1 and dose 2 Moderna and dose 3 BNT162B2; This is a spontaneous report from a contactable consumer (patient) reported for himself. A 73-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Lot number: Unknown) via an unspecified route of administration, administered in left arm on 22Oct2021 at 13:00 (at the age of 73-year-old) as dose 3 (booster), single for COVID-19 immunization. Facility where the most recent COVID-19 vaccine administered was pharmacy or drug store. The patient's medical history included asthma from an unknown date and unknown if ongoing. He had known allergies to Iodine and contrast Die. He previously took cefepime hydrochloride (CEFEPIME) and experienced allergy. Concomitant medications within 2 weeks of vaccination were fluticasone propionate, salmeterol xinafoate (ADVAIR) 260/50, doxycycline (DOXYCYCLINE) and lisinopril (LISINOPRIL), more; all were for an unspecified indication and from an unknown date to unknown if ongoing. The patient had not received any other vaccine within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Historical vaccine included Moderna (MODERNA COVID-19 VACCINE) administered in left arm on 12Jan2021 at 13:00 (Lot No: 011L20A) as dose 1, single and received Moderna (MODERNA COVID-19 VACCINE) administered in left arm on 09Feb2021 13:00 (Lot No: 010M20A) as dose 2, single; both doses via an unspecified route of administration, for COVID-19 immunization (at the age of 72-year-old). It was reported that on 24Oct2021 at 20:00, 2nd evening after injection, the patient experienced extremely itchy palms, then within hours, hives on arms, legs and back. Patient did not receive any treatment for the event extremely itchy palms and hives on arms, legs and back. Outcome of the events extremely itchy palms' and hives on arms, legs and back' was recovering.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
sick; felt like head was gonna explode; couldn't even open bottle of water so weak/stayed in bed all day until 9pm; could not move; did not feel her self all next day; headache so bad induced vomiting; chills; fever for 3 days; had 2 really bad head colds; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick), HEAD DISCOMFORT (felt like head was gonna explode), ASTHENIA (couldn't even open bottle of water so weak/stayed in bed all day until 9pm), HYPOKINESIA (could not move) and FEELING ABNORMAL (did not feel her self all next day) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in March 2021. Concurrent medical conditions included Allergy. Concomitant products included MELOXICAM for an unknown indication.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced NASOPHARYNGITIS (had 2 really bad head colds). On 17-Mar-2021, the patient experienced ILLNESS (sick), HEAD DISCOMFORT (felt like head was gonna explode), ASTHENIA (couldn't even open bottle of water so weak/stayed in bed all day until 9pm), HYPOKINESIA (could not move), FEELING ABNORMAL (did not feel her self all next day), HEADACHE (headache so bad induced vomiting), CHILLS (chills) and PYREXIA (fever for 3 days). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, ILLNESS (sick), HEAD DISCOMFORT (felt like head was gonna explode), ASTHENIA (couldn't even open bottle of water so weak/stayed in bed all day until 9pm), HYPOKINESIA (could not move), FEELING ABNORMAL (did not feel her self all next day), NASOPHARYNGITIS (had 2 really bad head colds), HEADACHE (headache so bad induced vomiting), CHILLS (chills) and PYREXIA (fever for 3 days) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Other concomitant medications include Allergy pills for an unknown indication.
The patient was administered an expired ACTHIB with no reported AE; Initial information regarding an unsolicited valid non-serious case was received from other health care professional via physician via Global Medical Information (Reference number- 00718353) and transmitted to Sanofi on 10-Aug-2020.  This case involves a 1-year-old patient (unknown gender) who was administered an expired HAEMOPHILUS TYPE B (HIB) VACCINE [ACT-HIB] (Expired product administered).  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID;PERTUSSIS VACCINE ACELLULAR;POLIO VACCINE INACT;TETANUS VACCINE TOXOID for prophylactic vaccination.  On 10-Aug-2021, the patient received a 0.5 ml fourth dose of suspect HIB (PRP/T) VACCINE (lot UJ3581AA, expiry date: 09-Aug-2021) via intramuscular route in left vastus lateralis for prophylactic vaccination.  It was a case of an actual medication error due to Expired vaccine used (latency same day).  It was reported "Caller reports that today she administered ACTHIB to a patient, ACTHIB expired yesterday, 09AUG2021. Caller asking if patient needs to have another dose of ACTHIB"  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 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.
Intestinal upset - diarrhea/constipation alternately.  Migraine headache, nausea, fatigue and injection site pain.
The pharmacy technician was administering vaccines. The pharmacist had prepared a batch of the Pfizer vaccine and left it out at room temperature. There was a batch from the night before that had expired 22 hours before. The technician by habit went to the fridge got the expired vaccine and administered it to the patient. Then after speaking to the pharmacist realized she had administered the expired vaccine. Then CDC and Pfizer were both contacted. Pfizer did not offer a recommendation, however CDC recommended patient receive a repeat dose as quickly as possible.
Alopecia areata  Developed after 2nd dose 3 bald spots so far
Sore throat; Some diarrhea; Tired; Pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant), OROPHARYNGEAL PAIN (Sore throat), DIARRHOEA (Some diarrhea) and FATIGUE (Tired) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 23-Mar-2021 and the estimated date of delivery was 01-Jan-2022. On 02-Sep-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant). On 03-Sep-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat), DIARRHOEA (Some diarrhea) and FATIGUE (Tired). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-third week of the pregnancy.  On 02-Sep-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) had resolved. At the time of the report, OROPHARYNGEAL PAIN (Sore throat), DIARRHOEA (Some diarrhea) and FATIGUE (Tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  After receiving the vaccine the patient had a sore throat, been tired, and had some diarrhea. She had been drinking water and resting to try and help with her symptoms.  This report refers to a case of maternal exposure during pregnancy for mRNA-1273 with associated AEs reported as oropharyngeal pain, diarrhoea and fatigue in a 28-year-old female patient. The patient experienced the events on the same day as mRNA-1273 administration. Based on the current available information and temporal association between the use of the product and the onset date of the events, a causal relationship cannot be excluded. Therefore, causality is assessed as possibly related.; Sender's Comments: This report refers to a case of maternal exposure during pregnancy for mRNA-1273 with associated AEs reported as oropharyngeal pain, diarrhoea and fatigue in a 28-year-old female patient. The patient experienced the events on the same day as mRNA-1273 administration. Based on the current available information and temporal association between the use of the product and the onset date of the events, a causal relationship cannot be excluded. Therefore, causality is assessed as possibly related.
eye feels hot; Dizziness; Arm feel not ok; Terrible nausea; Headache; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 16-Mar-2021 and was forwarded to Moderna on 16-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of OCULAR DISCOMFORT (eye feels hot), DIZZINESS (Dizziness), LIMB DISCOMFORT (Arm feel not ok), NAUSEA (Terrible nausea) and HEADACHE (Headache) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high.    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced OCULAR DISCOMFORT (eye feels hot), DIZZINESS (Dizziness), LIMB DISCOMFORT (Arm feel not ok), NAUSEA (Terrible nausea) and HEADACHE (Headache). At the time of the report, OCULAR DISCOMFORT (eye feels hot), DIZZINESS (Dizziness), LIMB DISCOMFORT (Arm feel not ok), NAUSEA (Terrible nausea) and HEADACHE (Headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient on concomitant medication for high blood pressure medication cholesterol medication
was lethargic for 2 days;pt fainted during administration of second immunization vax;mom reports pt was very quiet & sleepy for 2 days;MD was notified;
I had vaccination on 10/26/2022. I did have bumps around injections site and was warm to the touch for 48 hours. I tested COVID-19 positive on 12/20/2022. I was experiencing a headache; my nose was congested. I started to run a fever on 12/22/2022 which lasted for 3 days. I lost my taste buds and sense of smell. I went to the emergency room on 01/05/2023 because I was having a hard time breathing. Presently I feel ok on 01/30/2023. I do have a follow up with my physician on 01/31/2023.
Fever; headache; loss of taste; cold sweats; cough; dehydration; nausea; pain in left arm; weakness; shortness of breath, all of which occurred about 12 hours after the vaccine shot.  Symptoms are still present.
muscle pain, chest pain w/palpitations;muscle twitching;tx w/med;
Weak hands and feet and then a low grade fever for about 24 hours followed by fatigue for about 24 hours
Approximately 8 days after second dose of COVID vaccine, had redness  warmth (palm-sized) around area of injection site. Not painful.
Vaccination site initially red  and pruritic with macular rash.  Rash then generalized to involve all skin areas except face.  Arms, legs, chest, abdomen , skin behind ears, and scalp area all involved with macular, rash with peeling of the skin.  Very pruritic.  A few days later patient awoke with splotchy type macular  erythematous lesions.  Lesions particularly noted of soles of feet.   No SOB.    Evaluated by dermatology with biopsy x2 . Results pending.
CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 37 year old female. The patient's weight was 130 pounds, and height was 67 inches. The patient's pre-existing medical conditions included: The patient was not pregnant at the time of vaccination, had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 202A21A expiry: 21-SEP-2021), 1 total, dose was not reported, administered on 17-AUG-2021 for prophylactic vaccination on left arm. No concomitant medications were reported. On SEP-2021 about a month after vaccination, the patient started experiencing achy, exhausted (flu-like symptoms) for about 2 days along with fever of 101 F. On 22-SEP-2021, the patient was tested positive for covid (confirmed clinical vaccination failure) along with loss of taste and smell (confirmed covid-19 infection). The patient did not seek medical treatment and stayed home. Laboratory data included: COVID-19 virus test (NR: not provided) Positive and Body temperature (NR: not provided) 101 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from confirmed clinical vaccination failure, and confirmed covid-19 infection. This report was serious (Other Medically Important Condition). This case was associated with regulatory authority 90000197714.; Sender's Comments: V0: 20211031819-covid-19 vaccine ad26.cov2.s-Confirmed clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
I got my booster and my arm was extremely sore for several days, still is but is getting better. What was weird is that it?s splotchy red all around the injection site and runs a little down towards my armpit. It?s not burning or swollen just red.
Starting the evening after the vaccination, I experienced malaise, low grade fever (100.2),myalgias and arthralgias that lasted 3 days. The morning after the vaccination, I developed a mild rash on my chest  as well as a small ( approx 2 cm ) lymph node in my left axilla ( I received the injection into the left deltoid muscle ) that was tender to palpation.  The rash resolved in 2 days and the node resolved in 5 days. Over the following 2 weeks I experienced episodes intense sharp left sided chest pain. The episodes were sporadic and of acute onset usually lasting 3 - 5 seconds. I did not experience dyspnea but did feel dizzy. Two weeks post injection , i developed profound lethargy and weakness lasting 3-4 weeks. Always worse in the afternoon I felt the need to sleep  taking frequent naps
Developed pustules on arm that formed and burst; Have trouble raising arm; scratchy itchy red sore around arm; scratchy itchy red sore around arm; scratchy itchy red sore around arm; symptoms improved after receiving a booster dose; This spontaneous case was reported by a physician and describes the occurrence of PUSTULE (Developed pustules on arm that formed and burst), LIMB DISCOMFORT (Have trouble raising arm), ERYTHEMA (scratchy itchy red sore around arm), PRURITUS (scratchy itchy red sore around arm) and PAIN IN EXTREMITY (scratchy itchy red sore around arm) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 005C21A, 013M20A and 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19. Concomitant products included LOSARTAN and LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PUSTULE (Developed pustules on arm that formed and burst), LIMB DISCOMFORT (Have trouble raising arm), ERYTHEMA (scratchy itchy red sore around arm), PRURITUS (scratchy itchy red sore around arm), PAIN IN EXTREMITY (scratchy itchy red sore around arm) and THERAPEUTIC RESPONSE UNEXPECTED (symptoms improved after receiving a booster dose). At the time of the report, PUSTULE (Developed pustules on arm that formed and burst), LIMB DISCOMFORT (Have trouble raising arm), ERYTHEMA (scratchy itchy red sore around arm), PRURITUS (scratchy itchy red sore around arm) and PAIN IN EXTREMITY (scratchy itchy red sore around arm) was resolving and THERAPEUTIC RESPONSE UNEXPECTED (symptoms improved after receiving a booster dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication was provided.   This case was linked to MOD-2021-034126, MOD-2021-059296 (Patient Link).
Initial report received from another manufacturer on 11 August 2008.  A patient (initials, age, gender not reported) experienced a seizure after administration of a pertussis vaccine (trade name not reported, manufacturer unknown).  Date of vaccination and onset date of event were not reported.  No additional information was provided.
Several hours after vaccine. Got symptoms that lasted 2 days-aches, fever 101.5, chills. Patient took TYLENOL.
My son began having stomach pain about 8 hours after his second dose of the Pfizer vaccine.  He then vomited and had diarrhea throughout the night and into the next morning.  He last vomited about 2 hours ago. (It is 11:00 a.m. right now--roughly 19 hours since his shot.
5 days after vaccine, awoke with severe pelvic ic pain and pressure.  Felt like either a UTI or an IC flare.    Continue LS to get worse l. Became constipated over the week.  Never had a flare this bad.   Unable to get gyn or urology appt until OCT
My son has type 1 diabetes and had his first dose on Nov 3 and has had uncontrollably high blood sugars all day. Vaccine made his insulin resistant for 24 hours; My son has type 1 diabetes and had his first dose on Nov 3 and has had uncontrollably high blood sugars all day. Vaccine made his insulin resistant for 24 hours; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 8 year-old male patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) at the age of 8 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Type 1 diabetes" (unspecified if ongoing). Concomitant medication(s) included: INSULIN taken for type 1 diabetes mellitus. The following information was reported: BLOOD GLUCOSE INCREASED (non-serious), INSULIN RESISTANCE (non-serious), outcome "recovered" (2021) and all described as "My son has type 1 diabetes and had his first dose on Nov 3 and has had uncontrollably high blood sugars all day. Vaccine made his insulin resistant for 24 hours". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of blood glucose increased, insulin resistance.  Additional information: The patient had not COVID prior vaccination. The patient did not COVID tested post vaccination. No known allergies. The patient did not had other vaccine in four weeks. Other medications in two weeks was Insulin  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made.   Follow-up attempts completed. No further information is expected.
Night of imz, patient got a runny nose. Then in the morning around 4 AM patient had a headache and took tylenol. The tylenol did help. Symptoms continued to worsen to raspiness in the lungs. Patient went to see the doctor today and was prescribed ProAir inhaler.
Headache all day and into night, 11pm rigors(?) - extreme cold, extreme cold, continued headache. Duration was 45 minutes. Treated with electric bed warmer on high and under 3 thick comforters.
also has redness on her arm; arm swelled really bad the next day; lump in her arm; arm is very sore and hard to move; arm is very sore and hard to move; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program. A 46-year-old female patient received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13) with unknown lot number and expiration date, via an unspecified route of administration on the arm on 11Jul2019 at a single dose for prevention. The patient's medical history included rheumatoid arthritis, and post-traumatic stress disorder (PTSD) from 2011 and ongoing. Concomitant medication included vilazodone hydrochloride (VIIBRYD) from 2012 and ongoing for PTSD, and ascorbic acid, betacarotene, biotin, calcium, chloride, chromium, copper, folic acid, iodine, iron, magnesium, manganese, molybdenum, nickel, nicotinic acid, pantothenic acid, phosphorus, potassium, pyridoxine hydrochloride, riboflavin, selenium, silicon, thiamine, vanadium, vitamin b12 nos, vitamin d nos, vitamin e nos, vitamin k nos, xantofyl, zinc (CENTRUM SILVER WOMEN 50+) that the patient has taken since age 23 which she takes out of habit because was recommended by her mother, and adalimumab (HUMIRA) rheumatoid arthritis and it suppresses her immune system. The patient reported that she received a dose of pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein). Her arm swelled really bad the next day (12Jul2019). She still has a lump in her arm (started on 12Jul2019) and the doctor doesn't know what to do at this point. The patient was asking how long she should expect the lump to be in her arm. She also has redness on her arm  on 13Jul2019. Her arm was very sore and hard to move. She ended up going to the ER. The outcome of the events "arm swelled really bad the next day" and redness on her arm was recovering. The outcome of the event lump in her arm was not recovered. And the outcome of the event "arm is very sore and hard to move" was unknown.  Information on the batch number has been requested.
fever, delerious kept saying cant hear you & hitting head, fever, low grade 2 days, rash 2 wks later; hosp 24SEP93 dx viral meningitis;
pt recvd vax & devel fever 102.5; t rose to 104.5; several hrs later had mild tremors; given tepid bath; vomitted; was restless & looked washed out for 2 days;
7 Year old with severe redness (8x8cm), swelling, pain at injection site, concern for bacterial infection/cellulitis (vs local severe reaction).
Redness, swelling at injection site. Sought no treatment. Pt advised to use OTC NSAIDS, Benedryl, cold compress. Contact physician if effects persist.
1 day p/vax pt devel a 7cm by 6cm area of blotchy erythema @ the site of vax;the area was also tender & itchy;
Per vaccinator,  while administering vaccine she attempted to push the dose , the needle separated from the syringe and vaccine sprayed out.  A replacement dose was administered by Syringe and needle.