chrisvoncsefalvay/vaers-outcomes huggingface dataset:
tenderness under both armpits; Headache; Nausea; Diarrhea; felt like she had a fever that would come and go; felt like she had Covid again; She got hot; chills; really sick last night; This is a spontaneous report from a contactable consumer, the patient.  A 66-years-old female patient  received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EL9261),   via an unspecified route of administration in the left arm on 27Jan2021 at 11:10 (at the age of 66-years-old)  as a single dose for covid-19 immunisation .  Medical history included diabetes mellitus from 1995 and ongoing , ongoing hypertension , covid-19 from an unknown date and unknown if ongoing (Had Covid at Christmas).  The facility in which the vaccine was received was a Workplace Clinic There were no concomitant medications. No other vaccines were given within 4 weeks.  On 27Jan2021 The patient reported she was sick last night,  tenderness under her arm pits, headache, nausea, diarrhea and she felt like she had a fever that would come and go. She got hot and then had chills. She felt like she had Covid again. Treatment included Zofran and it helped with the nausea. There was  No physician office visit and No emergency room visit as a result of the events The clinical outcome of the events Nausea, diarrhea, was recovered on 27Jan2021, tenderness under both armpits recovered on 28Jan2021, Headache non recovered, Fever  was recovering, while felt like she had Covid again, Feeling hot Chills and Sick unknown.
Immune system down; COVID with HUMIRA (ADALIMUMAB); COVID with HUMIRA (ADALIMUMAB); This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4518942-00 (Agency).  A 30-year-old female patient received BNT162b2 (BNT162B2), on 03Sep2021 as dose 1, single (Batch/Lot number: unknown) and on 24Sep2021 as dose 2, single (Batch/Lot number: unknown) at the age of 29 years, all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown), subcutaneous. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: IMMUNODEFICIENCY (medically significant), outcome "recovered", described as "Immune system down"; DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID with HUMIRA (ADALIMUMAB)". The action taken for adalimumab was dosage permanently withdrawn.  Clinical course: On unknown dates, the patient experienced immune system down and COVID. On an unknown date, immune system down resolved. Pfizer BioNTech COVID-19 vaccine (Tozinameran) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter considered "immune system down" and "covid with humira (adalimumab)" related to BNT162b2.  The reporter's causality for the event(s) of immune system down with Humira (Adalimumab) was a reasonable possibility. The reporter's causality for the event(s) of COVID was not provided.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the events and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Acute anaphylactic reaction approx. 2-3 minutes after injection. Airway began to swell with difficulty in breathing.  Heart beat tachycardic in the 160's with BP of 117/90. Epipen administered EMS called.  Oxygen placed on and I.V. Benadryl 50 mg. given.  Transported to E.R.. Hands and fingers began to draw from hyperventilating and unable to visualize or open eyes. I.V. Solu-Medrol given in E.R. along with Zantac.  Finally became alert and orientated.  Reaction lasted about 90-120 min.
soreness of the muscles in her arm; going towards her chest area; on the right side of her jaw she noticed a bump that looks like it has blood in it; This is a spontaneous report from a contactable consumer or other non hcp (patient). A female patient of an unspecified age received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date at dose number unknown, single for covid-19 immunisation. Medical history and concomitant medications were not reported. On an unspecified date the patient experienced soreness of the muscles in her arm going towards her chest area, on the right side of her jaw she noticed a bump that looks like it has blood in it. Patient is calling about the Pfizer COVID-19 vaccine. She wants to know if the side effects of soreness of the muscles in her arm going towards her chest area and on the right side of her jaw she noticed a bump that looks like it has blood in it and she just wants to make sure that is from the vaccine. Outcome of the events was unknown.   Information on the lot/batch number has been requested.
Not adverse!! Advantageous!!! All my post COVID symptoms went away! Headaches diarrhea. Tiredness and fatigue/aches. All left after the FIRST vaccine. Then all my eczema on my feet and psoriasis on my scalp wentaway after vaccine 2!; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration in the arm left on 26Mar2021 at 14:30 (at the age of 52-years-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER9729) via an unspecified route of administration in the arm left on 16Apr2021 at 15:00 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history reported as nothing related. Prior to the vaccination it was unknown whether the patient was diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 27Mar2021 at 08:00, the patient reported not adverse!!  but advantageous!!!  all her post COVID symptoms went away, headaches diarrhea, tiredness and fatigue/aches, all left after the first vaccine. Then all her eczema on her feet and psoriasis on her scalp went away after vaccine 2!!! she feels amazing!! Great effects! she wasn't sure how to let this know and said this was the only way and asked to please ensure someone follows up on this and told it's a miracle of science!!. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event, not adverse!!  Advantageous!!! all her post COVID symptoms went away!  headaches diarrhea, tiredness and fatigue/aches, all left after the first vaccine, then all her eczema on her feet and psoriasis on her scalp went away after vaccine 2 was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
1-2 days after acell DPT vaccine the patient developed swelling, redness and tenderness at site. Irregular maculo papular rash at site. Irregular maculo papular rash at site. Seen at Med check and KEFLEX started. Pt rash better 8/25
c/o of nausea after taking the vaccine.  Denies past medical history and allergic reaction.  pt. verbalized feeling better prior to leaving the parking lot.
severe itching on left toe; Rash on left toe; excessive Swatting; swelling of arm; Pain in arm; This spontaneous case was reported by a patient and describes the occurrence of PRURITUS (severe itching on left toe), RASH (Rash on left toe), HYPERHIDROSIS (excessive Swatting), PERIPHERAL SWELLING (swelling of arm) and PAIN IN EXTREMITY (Pain in arm) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, the patient experienced PRURITUS (severe itching on left toe), RASH (Rash on left toe), HYPERHIDROSIS (excessive Swatting), PERIPHERAL SWELLING (swelling of arm) and PAIN IN EXTREMITY (Pain in arm). At the time of the report, PRURITUS (severe itching on left toe), RASH (Rash on left toe), HYPERHIDROSIS (excessive Swatting), PERIPHERAL SWELLING (swelling of arm) and PAIN IN EXTREMITY (Pain in arm) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by investigator o No treatment medications provided by the reporter.    Reporter did not allow further contact
passed out twice; Intense, rapid and irregular heartbeat (prolonged); intense pain in various organs and muscles (some short and some long duration); rash; cold; night sweat; no energy; intense dreams first night; This is a spontaneous report received from a contactable consumer (patient). A 62-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot Number: EP6955) via an unspecified route of administration, administered in arm left on 30Mar2021 13:30 at single dose for COVID-19 immunisation. The patient medical history was not reported. Concomitant medications included zolpidem tartrate (AMBIEN). The patient was healthy. No known allergies. 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 had not been tested for COVID-19 since the vaccination. The patient received the first dose of BNT162B2 (Lot number: EN6199) in the left arm on 11Mar2021 11:00 AM at the age of 62-year-old for COVID-19 immunisation. The patient experienced passed out twice, intense, rapid and irregular heartbeat (prolonged), intense pain in various organs and muscles (some short and some long duration), rash, cold, night sweat, no energy, intense dreams first night; all on 30Mar2021 with outcome of not recovered. Doctor appointment was scheduled. The events resulted in doctor or other healthcare professional office/clinic visit. It was unknown whether treatment received for the events.
Feeling of hopelessness, felt like death was upon her; Immense fatigue; This spontaneous case was reported by a pharmacist and describes the occurrence of FEELING OF DESPAIR (Feeling of hopelessness, felt like death was upon her) and FATIGUE (Immense fatigue) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Bipolar disorder and Anxiety. Concomitant products included LITHIUM for an unknown indication.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FEELING OF DESPAIR (Feeling of hopelessness, felt like death was upon her) and FATIGUE (Immense fatigue). At the time of the report, FEELING OF DESPAIR (Feeling of hopelessness, felt like death was upon her) and FATIGUE (Immense fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient concomitant medication include  Antipsychotic medication.  No treatment drugs were reported
Information was received on 10-MAR-2017 from a pharmacist regarding a male and female patient (age not provided) (this case refers to the male patient- see MARRS # 1703USA005786 for female patient case). Medical history, concurrent conditions and concomitant medications were not reported. On an unspecified date the patient received a dose of ZOSTAVAX for prophylaxis (dose, duration, and lot number not specified). On an unknown date, six months later, the patient received another dose of ZOSTAVAX (dose, duration, and lot number not specified). No adverse effects were reported. No other information was available. Additional information has been requested. Sender's Comments: US-009507513-1703USA005786.
One of four pt's who were immun fr the same vial developed local rxn, size of a quarter or fifty cent coin; Site of inject was red, hot to touch & pt c/o of tenderness;
Extreme Sexual arousal with intense blood rush feeling to genitals lasting 4 days. Very uncomfortable even after intercourse.
This spontaneous report as received from a 73 years old female consumer refers to herself. The patient was vaccinated with ZOSTAVAX (lot number, dose, route not reported) on an unknown date. No other co-suspects were reported. no concomitant medications were reported. On an unknown date the patient developed smallpox like rash in her arm and small round blisters. It was unspecified if the patient had sought medical attention. No treatment information was reported. The outcome of small round blisters and smallpox like rash was unknown. Additional information has been requested.
PNEUMOVAX at 0830. Itchy & red at injection site with tender axillary lymph node approx 9 hr. after admin. Rx with BENADRYL, ice, ibu. Progressed to myalgias, chills, feverish that evening. Improved during day so stopped Rx. Symptoms recurred next night & injection site more swollen & red with return of myalgias.
Influenza vaccine dose #3 in same 2022-2023 season erroneously administered. This was done without an MD order, though was ordered in electronic medical record for co-sign. Staff member who administered it reported it was given accidentally. Previous flu dose#1 administered 9/30/22 and flu#2 on 11/11/22. Spoke with mother via phone today 12/30/22 who reported pt had no fever or increase in fussiness. Appeared normal today
?Moderna COVID-19 Vaccine EUA Started to experience headache, fatigue, muscle aches, and nausea the day after the vaccine
Violently Ill, bodyaches, brain fog, rash in the left groin to knee area. Raised D-dimer test.  Muscle aches and weakness.  Joint pain and frequent headaches. Bladder leakage and her blood pressure has been elevated since vaccine.
7.5 x 11 cm area of erythema and warmth with smaller area of induration - on (L) upper arm/(L) deltoid, mildly tender, occurred w/in 24 hrs of vaccine administration.
Severe pain in arm of injection for one week.  Difficulty using the arm. Taking ibuprofen over the counter round the clock.
The pt received the vaccines on 7/14/00. Later that evening, she developed a red rash that covered her face, hands, feet. The next day, the rash spread to her trunk. As of 7/17/00, the infant was recovering.
constipation; Severe lower right side pain, felt like burning and stabbing, thought my appendix was rupturing; felt like burning and stabbing; appendix was rupturing; This is a spontaneous report from a contactable consumer (reported for herself). A 53-year-old female non pregnant received second dose of BNT162B2 (Pfizer Covid-19 vaccine, lot number ER2613, expiry date: unknown) via an unspecified route of administration at left arm at a single dose on 19MAR2021, for covid-19 immunization. Medical history included Gastrooesophageal reflux disease, diverticulitis, Graves Disease in left eye, full hysterectomy, high bp, high cholesterol, depression, hypothyroidism, Gastric bypass and heart ablation. Concomitant medications included an unspecified 5 different medications and daily vitamins. Historical vaccine includes first dose of BNT162B2 (Pfizer Covid-19 vaccine, lot number EN6203, expiry date: unknown) via an unspecified route of administration at left arm at a single dose on 25FEB2021 06:00 PM, for covid-19 immunization. She did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, she was not diagnosed with COVID-19. Neither was she tested for it since the vaccination. On 24Mar2021 19.00, she experienced severe lower right sided pain, felt like burning and stabbing, thought her appendix was rupturing. On an unknown date, she went to an emergency room (ER), had a computerized tomography scan that showed constipation. Her pain was at a level 9, was doubled over for 6 hours while seeking care. She had complete sudden onset of pain, with no warning. She was treated with Fentanyl shot that took almost an hour to provide minimal pain relief. Had continuing pain for three days after the initial onset. No real treatment other than pain medication were given at ER. She was told to get collace and mirilax. The outcome of the events of severe lower right sided pain, felt like burning and stabbing, thought her appendix was rupturing was recovering.   No follow-up attempts are needed. No further information is expected.
In today 9/16/02 with twenty vesicular lesions-generalized. Rash began yesterday. Received Varivax given on 6/5/02.
Patient received Janssen COVID19 vaccine on 3/18/21. The week of 4/12/21, patient noted right calf pain. No swelling or redness noted. Patient was seen in MD office on 4/21/21 and mentioned pain in right calf and that it was improving. MD ordered venous US and D-dimer and both tests were completed and resulted on 4/21/21. D-dimer is positive and venous US is positive for DVT in right gastrocnemius vein. Patient will start on Eliquis 10mg twice a day for 7 days, then Eliquis 5mg twice a day for 6 months. Will have Chest CT to rule out PE on 4/22/21.
PATIENT WAS GIVIN THE BIVALENT AS WAS SUPPOSE TO RECEIVE THE MONOVALENT AS SECOND DOSE
Local site reaction- raised red, itchy area approximately 2 inches high by 4 inches wide at site of injection.
sudden on set of fever / spiked a fever; Chills; headaches/mild headache; feeling very unwell; congestion/stuffy nose; respiratory symptoms; upper respiratory infection type (URI); mild sore throat; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 62-year-old male patient received bnt162b2 (BNT162B2), administration date 23Mar2021 (Lot number: EP6955) at the age of 61 years as dose 2, single for covid-19 immunization. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE: 01, Lot number: EL3247, Anatomical Location: Arm left), administration date: 01Mar2021, when the patient was 61 years old, for COVID-19 Immunization, reaction(s): "No reaction on previous exposure to vaccine". The patient experienced PYREXIA  with onset 02Aug2021 16:00, outcome "recovered", described as "sudden onset of fever / spiked a fever"; CHILLS  with onset 02Aug2021, outcome "recovered", described as "Chills"; HEADACHE with onset 02Aug2021, outcome "recovered", described as "headaches/mild headache"; MALAISE with onset 02Aug2021, outcome "recovered", described as "feeling very unwell"; NASAL CONGESTION  with onset 02Aug2021, outcome "recovering", described as "congestion/stuffy nose"; RESPIRATORY SYMPTOM  and UPPER RESPIRATORY TRACT with onset Aug2021, outcome "recovering", OROPHARYNGEAL PAIN with onset Aug2021, outcome "recovering", described as "mild sore throat". Therapeutic measures were taken as a result of pyrexia.  No follow-up attempts are possible. No further information is expected.
This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (isn't feeling better and it's been about a week) and PYREXIA (she may be running a low-grade temperature) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (isn't feeling better and it's been about a week) and PYREXIA (she may be running a low-grade temperature). At the time of the report, FEELING ABNORMAL (isn't feeling better and it's been about a week) and PYREXIA (she may be running a low-grade temperature) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 96 (normal) 96 and low grade temperature (abnormal) low grade temperature. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No relevant concomitant medications were reported. No treatment information was provided. Reporter did not allow further contact
When I woke up on December 10 at 8 am, 31 hours hours after receiving my first dose of moderna covid 19 vaccine, I had developed flu-like symptoms including body aches, tiredness, a low-grade fever that came and went, and general malaise. The lymph node(s) in my left armpit near the injection site was tender and somewhat swollen. My flu-like symptoms resolved by the end of December 12 but my armpit continued to become more accutely tender over two additional days which made sleeping and moving my affected arm uncomfortable. On the evening of December 14 the discomfort in my armpit had significantly decreased.
ALMOST PASSED OUT; BODY ACHE; REALLY TIRED; CHILLS; FEVER; This spontaneous report received from a patient concerned a 35 year old female. The patient's weight was 145 pounds, and height was 157.48 centimeters. The patient's past medical history included back issue, and covid-19 infection, and other pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802068 and expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-MAR-2021, the subject experienced almost passed out. On 13-MAR-2021, the subject experienced body ache. On 13-MAR-2021, the subject experienced really tired. On 13-MAR-2021, the subject experienced chills. On 13-MAR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 102 F. On 14-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 101.7 F. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from almost passed out on 13-MAR-2021, body ache, and chills on 14-MAR-2021, and fever on MAR-2021, and had not recovered from really tired. This report was non-serious.  Additional information was received from patient on 24-03-2021 following information was updated and incorporated into case narrative: Patient demographic details (height, weight,  patient age and age group), pre-existing condition, event outcome and end date (fever), medical history added (covid-19 infection, back issues); Sender's Comments: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
This spontaneous report as received from a other health professional refers to a 4 year old patient. On 09-AUG-2014 the patient was vaccinated with M-M-R II HSA (lot # H011885, expiration date: 25-JUN-2014) 0.5 ml, subcutaneously, which was expired. This is one of several reports received from the same source. Additional information has been requested.
From nasal discharge c/o flu-like symptoms general non well ness occurring w/ 12 hr after vax. Cont for 1 mo.
Information has been received from a licensed practical nurse concerning a 4 months old patient of unknown gender who on 22-OCT-2014 was vaccinated with ROTATEQ (lot # J014868 expiration date 13-OCT-2015), oral (dose not reported). The vaccine was reported to have temperature excursions from 10-SEP-2014 to 12-SEP-2014. No adverse reports. This is one of several reports from the same source. Additional information is not expected because all follow ups requested to complete the case were received.