chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Menstrual period has been delayed; Menstrual period has been missed; This is a spontaneous report from a non-contactable consumer, the patient. A 13-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 13May2021 (at the age of 12-years-old) as a single dose for COVID-19 immunisation and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 03Jun2021 (at the age of 13-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously took polymyxin (MANUFACTURER UNKNOWN) and experienced drug allergy. On an unknown date in 2021, the patient experienced menstrual period has been delayed/missed. The 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 events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events menstrual period has been delayed/missed was not resolved at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Unilateral tingling/pain "nerve pain" on left side starting from sternum to finger tops.
Pt pale per mom gave APAP; no fever per mom pt screaming @ times high pitched since immun (approx 2 hrs); refused to nurse or take bottle; Seen by MD 25OCT91 recommended APAP pt had sz on 26OCT91 seen @ clinic;
numbness and tingling of lips Narrative:  Patient reported upper lip tingling without swelling ~20 min after first vaccine dose. No urticaria, hives, or sweilling, SOB, or wheezing noted. BP was 170/82, 178/89, 184/86, 190/86; patient states his SBP is usually 140's in the morning. Patients was administered cetrizine and was transported to the ED for observation. Symptoms were resolved upon arrival to ED. In ED BP was 154/70 P79, o2 sats 100%. Patient stated that he had been running around all day and was running late for his vacation which could've caused the elevated BP.
Pulmonary coccidioides; Rheumatoid arthritis flare up; condition aggravated; Patient was on the continuous positive airway pressure machine; arm was sore; weight gain; urinary tract infection; stomach upset; abdominal pain; chills; vomiting; This spontaneous case was reported by a physician and describes the occurrence of COCCIDIOIDOMYCOSIS (Pulmonary coccidioides) and RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced COCCIDIOIDOMYCOSIS (Pulmonary coccidioides) (seriousness criterion medically significant), RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) (seriousness criterion medically significant), CONDITION AGGRAVATED (condition aggravated), CONTINUOUS POSITIVE AIRWAY PRESSURE (Patient was on the continuous positive airway pressure machine), PAIN IN EXTREMITY (arm was sore), WEIGHT INCREASED (weight gain), URINARY TRACT INFECTION (urinary tract infection), ABDOMINAL DISCOMFORT (stomach upset), ABDOMINAL PAIN (abdominal pain), CHILLS (chills) and VOMITING (vomiting). At the time of the report, COCCIDIOIDOMYCOSIS (Pulmonary coccidioides), RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up), CONDITION AGGRAVATED (condition aggravated), CONTINUOUS POSITIVE AIRWAY PRESSURE (Patient was on the continuous positive airway pressure machine), PAIN IN EXTREMITY (arm was sore), WEIGHT INCREASED (weight gain), ABDOMINAL DISCOMFORT (stomach upset), ABDOMINAL PAIN (abdominal pain), CHILLS (chills) and VOMITING (vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medications was not provided.  Company Comment  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Patient developed swollen arm. NP at healthcare clinic called said arm swollen, treated as cellulitis, hot to the touch. Pt reported no fever.
a 17 year old male patient received a dose of Flublok Quadrivalent in error/no AE; Initial information received on 31-Oct-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 17 years old male patient who received a 0.5 ml dose QUADRIVALENT RECOMBINANT INFLUENZA VACCINE (flu Blok quadrivalent) in error lot number and expiry date not reported via intramuscular route in unknown administration site on 13-Oct-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error due to inappropriate age at vaccine administration.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 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.  Information on the batch number was requested.
Headache tingling hands and lips, tongue felt thick/swollen Narrative:  12/30 given vaccine in the ED due to a shellfish allergy for which she carries an epipen. Pt experienced mild symptoms c/w allergic reaction after receiving Pfizer COVID vaccine #1. Symptoms included tingling lips and sensation of swollen tongue. She was given Diphenhydramine 50mg PO. Condition did not progress and her symptoms resolved within about one hour of oral Diphenhydramine. She was observed for 3 hours and discharged to home with prescriptions for an epipen and benadryl. Employee states - "15 min after the vaccination my hands got tingly on the palms. 5-10 min after that the front of my lips were tingly then my tongue felt thick. I also got a headache They gave me benadryl pills in the ED and within 10 min tingling on my lips went away and my tongue felt normal. My headache also went away." She was discharged from the ED back to work and reports no other symptoms.
Received flu shot twice and both Times patient was sicker with the flu; Received flu shot twice and both Times patient was sicker with the flu; Initial information was received on 08-Dec-2020 regarding an unsolicited valid non-serious case received via media from a consumer (patient).  This case involved an unknown age patient who reported received flu shot (INFLUENZA VACCINE) twice and both times patient was sicker with the flu (Influenza and Illness).  Relevant medical history, concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient reported that received flu shot twice and both times patient was sicker with the flu (Influenza and Illness).  Relevant laboratory test was not reported.   It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome was unknown for the reported event.  There would be no information available on batch number for this case.
Arm is painful after the injection; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm is painful after the injection) 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 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm is painful after the injection). At the time of the report, PAIN IN EXTREMITY (Arm is painful after the injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. Treatment details was not provided.   Reporter did not allow further contact
pt recvd vax; approx 30 min p/ vax; pt began c/o HA; sl nausea, itching, throat swelling & chest pain;
Large local swelling of R arm from upper bicep to elbow. Transient urticarial-like lesion on inner of R arm. All resolved with in 10 days after vaccination.
Temperature of 102; body aches; chills; headache; This is a spontaneous report from a contactable nurse (patient herself).  A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 19Jan2021 at a SINGLE DOSE for covid-19 immunization. The patient's medical history was not reported.  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 hasn't been tested for COVID-19. the patient was not pregnant. Concomitant medication included celecoxib (CELEXA) and vitamin D.  The patient previously took stadol and experienced allergies. Patient previously received the first dose of bnt162b2 (lot number: EJI1686) on 29Dec2020 via intramuscular in the right arm for covid-19 immunization and experienced Right sided supraclavicular lymph node enlargement and pain.  On 20Jan2021 01:00, 24 hours after the vaccine administration, the patient had a temperature of 102 body aches, chills and headache. The outcome of events was reported as "recovering". The patient did not receive any treatment for the events. the events were considered as non-serious.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
Hot hands, knees, legs and feet... swelling in feet and ankles, swelling over knees and swelling in right hand and fingers..achy right shoulder( old shoulder injury and surgery here 8 years ago).  Shot was given in left arm. Started last evening prior to 8 pm and continues today.
This spontaneous report as received from a physician refers to an unspecified number of patients (demographics unknown). Pertinent medical history, drug reactions or allergies were not reported. On unknown dates, the patients were vaccinated with VAQTA (dose, route and lot numbers were not provided). The physician stated that approximately 4 or 5 doses of VAQTA were administered to patients after improper storage. No adverse effects were noted. This is one of two reports from the same reporter (MARRS# 1408USA011485). Additional information has been requested.
Started to have typical flu symptoms night of 2nd vaccine, also followed with dizziness, nausea, and lastly small bumps of a rash developed over chest, neck and back.
After took the vaccine on 10/12, my arm felt swelling and pain. On 10/14 when I woke up around 8am, I found my right face was swelling so big and my left face was swelling too at night around 10pm.
Due to having to change the patient schedules for the state due to allocations, this patient's second dose was moved back and she received her second dose at 23 days which was one day to early using the 4 day rule.  She did not have any adverse reactions to the vaccine
Breakthrough COVID-19 case with symptom onset 9/5/2021:  New loss of taste or smell,  Runny nose/Congestion,  Cough (new onset or worsening of chronic cough),  Shortness of breath or difficulty breathing,  Fatigue or tiredness. Hospitalized for 1 day 9/5/2021-9/6/2021
Generalized erythematous rash beginning in hands on post vaccination day 8 evolving to a confluent rised urticarial rash on day 9 over buttocks and underarms bilateral as well as patchy over chest, back and abdomen.  Intensely pruritic.  Not well controlled by benadryl, topical steroids, or Calmine lotion.  Moderate relief with ice packs for short periods.  Short term relief with Kenalog.  Oral medrol dose pack of very little benefit.  Eventually used Loratadine 20 mg. bid and hydroxyzine 25 mg. q.d. on day 5.  Lesions were much improved by dy 6 but still had some pruritis and rare lesion through day 7  and pruritis through day 9
The first time I noticed the symptoms were on November 25 of 2021. I had severe uncontrollable diarrhea which was more fluid than anything. I had a fever of 104 and swollen legs. A week later I still had the same symptoms. The fever was not all day long, but the diarrhea and the swollen legs kept getting bigger and bigger. I went to the immediate care, and she requested a stool sample. My temperature was lox grade at about 100 but would spike at night. She insisted that I make an appointment to see my doctor immediately. She gave me 3 days of CIPRO and I saw my primary care doctor around the 3rd or 4th day after. I went in and he reviewed the report from the stool sample which indicated inflammation in stool was high in my body. I prescribed furosemide due to retaining water. By that time, I had developed open sores or ulcers on my legs. I was prescribed a stronger antibiotic. I also spoke with a gastroenterologist off the record. He did not know what it was but gave suggestions about taking IMODIUM over the counter. I was also prescribed another antibiotic. Around the end of May, my doctor sent me to an infectious disease specialist who referred me to another gastroenterologist for an endoscopy procedure on July 11, 2022. I also had a colonoscopy on the same date which confirmed the diagnosis. I was then diagnosed with Crohn's. The gastroenterologist spoke with my rheumatologist, and I was provided an infusion REMICADE to address both the Rheumatoid Arthritis symptoms and chrome symptoms. I was also placed on budesonide for 90 days. I am scheduled to have it done every 6 weeks. It's sort of helping but it's not terrific so they are considering changing it. They are running several different blood panels to see why the medicine is not helping the Crohn's symptoms. I am still getting an infusion and continuing to receive treatment. I do know that I am recovering.
large lump at injection site; injection site is warm to the touch; injection site is itchy; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 15-Mar-2021 and was forwarded to Moderna on 16-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE MASS (large lump at injection site), INJECTION SITE WARMTH (injection site is warm to the touch) and INJECTION SITE PRURITUS (injection site is itchy) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, the patient experienced INJECTION SITE MASS (large lump at injection site), INJECTION SITE WARMTH (injection site is warm to the touch) and INJECTION SITE PRURITUS (injection site is itchy). At the time of the report, INJECTION SITE MASS (large lump at injection site), INJECTION SITE WARMTH (injection site is warm to the touch) and INJECTION SITE PRURITUS (injection site is itchy) outcome was unknown.            No concomitant medications were reported. Action taken with mRNA-1273 in response to the drug was not applicable.  No treatment medications were reported.
Fever, chills, myalgias, headache, fatigue, neck pain, and right arm pain.
Information has been received from an office manager concerning a 71 year old female with thyroid disorder who was a vaccinated intramuscularly into the left deltoid with a 0.5 ml dose of the PNEUMOVAX 23 (lot # 655152/0889F). Concomitant therapy included aspirin and SYNTHROID. Post vaccination, the patient experienced pain at the injection site, arm swelling and she was hot to touch. The patient sought unspecified medical attention. The office staff is requesting a lot check. A standard lot check investigator was performed. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. This is one of two reports from the same source. Additional information has been requested.
severe chills fever upto 102 F+ fever lasting more than 15 hours nausea vomiting 1x severe body aches severe headache injection site pain
On Jan 2, 2022, which was 2 months after receiving the booster (3rd) dose of Pfizer COVID-19 vaccine, patient noticed a red bump on hand.  Each week the skin condition became worse and worse.  On April 11, 2022, the patient's PCP diagnosed the condition as psoriasis.  It is quite a bad case, with psoriatic patches on a large portion of patient's torso, and down the legs and arms.
Patient work with bilateral ear pain 3/10 and no hearing out of left ear.  Patient also had vertigo.
I received the first dose of the vaccine a month prior to the second one. I didn't have any side effects to the first one, despite my doctor suspecting that I'd have worse side effects than someone who doesn't have EDS. But I didn't have a single problem, no bruising, no aching or pain, nothing. I received the second one and had to wait at the pharmacy for 15 minutes (the pharmacy's protocol) Within about 10 minutes I had a sharp pain from the left of my neck and straight up to the temple of my head. It was very sharp, but it was early in the morning, I'd been up late and had to get up very early and I'd been working a lot so I was tired, hungry, and wanted caffeine. I mentioned it to my mom, who received her first dose that same day. I drove us to the store for 30 minutes, and then home, and we currently reside in a hotel. I parked in front of our hotel room, got out of the car, said hello to my dogs and my dad, and went for left over pizza because I was so hungry, I didn't care about anything else. The last thing I remember was telling my dad to scoot over so I could get the pizza and after that, I woke up on the floor. I felt like I was in a dream, a scary one. So I wanted to get out of it, but my dad wouldn't let me get up because 911 advised them not to let me get up. It was a terrifying experience because nothing felt normal and it took several minutes for parts of the picture around me to register as real. My mom was getting off the phone with 911 and that's when I got really scared. My parents tried to calm me down but said I had a seizure. I didn't know how this was real, as I have no personal nor familial history of seizures at all. During the seizure, my parents report that I stopped breathing and turned blue with my eyes rolled into the back of my head, while my entire body convulsed violently. I was completely unconscious for the entire thing which lasted about 7 minutes. Within a minute of coming back to consciousness, the EMTs had arrived and were putting me in the back of an ambulance. They checked my blood sugar three times en route to the hospital and it was fine. They ran multiple EKGs, as the first several came back very concerning. So within an hour of the vaccine, I had a tonic clonic seizure for the first time in my life.
Gave a Covid Moderna booster shot and patient is only 17 years old. Patient should have received Pfizer because she is not yet 18.  Patient has not had any reaction to the shot but this is not the shot she should have received.
From telephone contact received on 11/5/02, it was reported that a 15 year old male was vaccinated with TD ADS ADULT (lot number U0820AA) on 11/4/02. The next morning, the patient presented with fever of 100.9 F, myalgia, headache, and numbness in his right foot. The patient was sent to the emergency room for evaluation. It is not reported whether the patient recovered.
CHIEF COMPLAINT:   Difficulty breathing x a few days. Edema in all extremities. Hx of kidney disease. Of note, bed bugs found in house and pt with many scabs on skin from bugs.   HISTORY OF PRESENT ILLNESS:     7-year-old female with diabetes and lymphedema presenting for shortness of breath.  Patient reports 4 days of progressively worsening shortness of breath.  She states that she feels short of breath at rest.  She denies chest pain or chest pressure.  Denies fevers.  Reports a cough that is resolved.  Reports baseline leg swelling.
Information has been received from a physician assistant concerning an 18 year old female patient who on an unspecified dates was vaccinated with all three doses of GARDASIL (Lot # and route were not reported). Subsequently the patient had a positive HPV test rest at unspecified time. At the time of the report the patient's outcome was unknown. It was unspecified if the patient sought medical attention. Follow-up information was received from a physician assistant who stated that the patient did not have an adverse reaction. The physician assistant had a question regarding whether the vaccine would show up as antibodies on an HPV test - not that the vaccine caused HPV. No further information is available.
Bruises; Dizziness / light headedness; Feeling of ringing ears; ringing in ears; Little soreness; A spontaneous report was received from a consumer concerning a 72-year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced little soreness / pain.  The patient's medical history and concomitant medications were not provided by the reporter.  On 14 Feb 2021, approximately one day prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) for prophylaxis of COVID-19 infection. The route of administration and anatomical location of vaccine administration was not provided.  On 15 Feb 2021, the patient experienced little soreness.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not reported.  The event, little soreness was resolved on 15 Feb 2021.
when i woke up sunday i had a headache and little sore on right arm. nothing to worry about. when i woke up  monday april 5th to say i was mean is a big understatement! i wouldn't leave the house i was scare of what i might do. cause a wreak , run someone down. my husband couldn't do anything right. tuesday april 6th was the same way. scared to leave apt. i could see me being mean .... and believe me i was way worse than mean. i had NO control over it. come wednesday i was so so .  was mean but not as bad. come thursady april 8th i was fine.. like nothing had happen. something had messed with my bipolar and i had no control of it. it scared me terribly!! you have to be careful with people with mental disorders. i talk to my aunt who's a nurse and she said i should report it. please be careful with people with mental disorders.
Sore Arm. Aches, chills and a throbbing headache X 5 days. Vomiting on one occasion and then horrible stomach pain for 4 days.