chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Lost control of urine; Diarrhea; Nausea; Vomited all night; Chills; This spontaneous case was reported by a consumer and describes the occurrence of URINARY INCONTINENCE (Lost control of urine), DIARRHOEA (Diarrhea), NAUSEA (Nausea), VOMITING (Vomited all night) and CHILLS (Chills) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     Concomitant products included FOLIC ACID for an unknown indication.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 09-Feb-2021, the patient experienced URINARY INCONTINENCE (Lost control of urine), DIARRHOEA (Diarrhea), NAUSEA (Nausea), VOMITING (Vomited all night) and CHILLS (Chills). At the time of the report, URINARY INCONTINENCE (Lost control of urine), DIARRHOEA (Diarrhea), NAUSEA (Nausea), VOMITING (Vomited all night) and CHILLS (Chills) was resolving. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Other concomitant medications include cholesterol medications. Reporter has not provided details regarding cholesterol medication.
Right buttock and right leg (upper and lower) shingles lesions onset after 5 days of vaccine, condition remains.
Drug ineffective; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), in Apr2021 as dose 1, single (Batch/Lot number: unknown), in left arm, in Apr2021 as dose 2, single (Batch/Lot number: unknown), in right arm and in Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "not recovered"; COVID-19 (medically significant), outcome "not recovered". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: having 4 days of negative tests; Positive, notes: just the positive test results; negative, notes: having 4 days of negative tests; positive, notes: just the positive test results. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient took 'Paxlovid' for treatment of COVID-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300130564 Same patient, different drug, different event;
This spontaneous prospective pregnancy report as received from a 23 year old female patient with no pertinent medical history or drug allergies/reactions refers to herself. On 03-JUL-2014 the patient was accidentally vaccinated with a dose of GARDASIL (dose and routed unspecified) (lot # J009788, expired date 17-MAR-2016). There is no concomitant therapy. The patient was 7 month pregnant. LMP was on approximately 03-DEC-2013 and EDD was on 09-SEP-2014. The vaccine the patient scheduled to received was ADACEL. No adverse event reported. No treatment was given. No lab diagnostic studies performed. The patient did not seek any medical attention. Additional information has been requested.
Golf ball size lump in armpit of injection arm; This is a spontaneous report from a contactable nurse. A 49-year-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration on left arm on 19Dec2020 18:15 at SINGLE DOSE for COVID-19 immunization. There was no medical history reported. Concomitant medication included estradiol (ESTROGEN), and meloxicam. On 26Dec2020 08:00, the patient experienced golf ball size lump in armpit of injection arm. The patient did not receive treatment for the adverse event. The outcome of the event was not recovered.   Information on the lot/batch number has been requested.
Patient came in to pick up prescription and requested third Covid Pfizer dose. Stated he has not previous reaction to any vaccine, nor does he have seizure disorder. He originally requested that vaccine be given on stomach or thigh. Immunizing technician refused and reiterated vaccine should be given in arm muscle. Vaccine was given to the patient, who said he was fine. Patient stood up, then leaned against the wall, then laid down on the floor, saying he was shaking. Immunizing technician asked me for Epi-pen. I went to the patient, noticed patient was shaking and licking his lips. I asked if he had a seizure disorder, he stated no. I asked if his throat was closing up, he hesitated, then said it's anaphylaxis. Ambulance was called, and Epipen was administered in left thigh. Patient was becoming increasingly agitated. He began crying and stating he wanted to leave the pharmacy. Both myself and the store manager insisted he wait until ambulance arrived to be checked over, patient refused, and ran out the door. As ambulance arrived, patient was across the parking lot, and apparently ducked into the bushed to hide.   EMS stated since patient left property, there was nothing else that could be done for him.
no  adverse event.  Vaccine expired on 8/31/2022,  administered 9/1/2022  Parent being contacted and recommended to be revaccinated.  booster vaccine   Previous doses 2/11/2022  and 3/4/2022
Overall soreness in the body; Fatigue; Some respiratory issues / shortness of breath and labored breathing; A shingles rash developed at the injection site; Rash / left some scarring; This case was reported by a consumer via call center representative and described the occurrence of rash zosteriform in a 63-year-old female patient who received Hepatitis B vaccine for prophylaxis.   On an unknown date, the patient received the 1st dose of Hepatitis B vaccine. On an unknown date, unknown after receiving Hepatitis B vaccine, the patient experienced rash zosteriform, scar, general body pain, shortness of breath and fatigue. On an unknown date, the outcome of the rash zosteriform, scar, general body pain and shortness of breath were recovered/resolved and the outcome of the fatigue was unknown.   It was unknown if the reporter considered the rash zosteriform, scar, general body pain, shortness of breath and fatigue to be related to Hepatitis B vaccine.  Additional details were provided as follows: The case was reported by the patient's husband. The age at vaccination was not reported. The patient received Hepatitis B vaccine in the 1990's, the manufacturer was unknown. The patient developed shingles rash at the injection site and travelled up to the armpit area following the administration. The rash lasted for 4 to 5 weeks and left some scarring. The patient also felt an overall soreness in the body and some respiratory issues described as shortness of breath and labored breathing that lasted approximately a month. The patient also experienced fatigue. The reporter did not consent to follow up.
14JUN t102 APAP given would not bring down; AM 15JUN took to ER 0200 t103.4 & rash; ER MD drew blood & put on Advil 6-8hr;8JUN nausea & vomiting x 24 hr;
Gradually developing ascending weakness culminating in admission to hospital and diagnosis of Guillain-Barre syndrome on 10-30-09.  11/23/09 Discharge summary, ED, hospital records received. Service dates 10/31/09 to 11/02/09. Assessment: Guillain-Barre syndrome.  Child has been sick 2 weeks. complained of right hip pain the day prior to admission. Now complains of weakness in legs and arms, wide gait. Absent ankle / knee jerks. Tired, irritable, stumbling and falling. IVIG administration. Dehydration. Decreased weakness, improved ambulation. Discharged.  ICD-9 Codes: 357.0, 276.51, V13.61, V45.89, V15.86.
This spontaneous report was received from a pharmacist regarding a patient of unknown age and gender. Information on the concurrent condition, medical history and pertinent drug allergies of the patient were not reported. On 19-NOV-2015 at time- 14:47, the patient was vaccinated with improperly stored RECOMBIVAX HB lot # L016427 (expiry date, dose #, route, dose units and anatomical location were not specified). Concomitant medication was not reported. No adverse events were reported. The high temperature and low temperature at which the product was stored were 3.3 and 2,5 (units unspecified) respectively. There were no Product Quality Complaint (PQC) involved. This is one of several reports received from same reporter. Additional information has been requested.
Within an hour of the shot, elevated heart rate recorded on smart watch and continued for 24 hours.  Resting heart rate is usually 85; after shot it was sustained at 120 bpm, spiking as high as 145 bpm at times.  No physical activity was recorded after the shot.  Occasionally, heart rate increases to 120 at rest, even 96 hours later.  Extreme thirst noted at 1am, woke up from sleep.  Dehydration continues 96 hours later.  Also, bad taste in mouth has been noted since the shot.  Nothing has helped.  Headache, migraine like, began at 2am, continued for 72 hours.  Anacin used but did not help much.  Elevated temperature 100.2 noted at 8pm, continued for 24 hours.
Pt is 37 yo female, s/p full COVID Pfizer vaccination: dose 1 on 1/20 and dose 2 on 2/10. Patient presents to ED on 8/7 with complaint of sore throat, headache, chills and dizziness. Exposed to daugther with positive COVID diagnosis. Rapid test resulted positive on 8/7.
ACUTE HYPOXEMIC RESPIRATORY FAILURE 8/20/2021 ACUTE HYPOXEMIC RESPIRATORY FAILURE
Fever, headache, chills, body aches, nausea, vomiting and injection site swelling and pain.
Patient had extreme night sweats, lightheaded, bad headache, Swollen armpit/peck area. Unable to lift arm In severe pain in the arm area.. Armpit and pain still persists after 48 hours. Some nausea.
I got lightheaded and a headache within seconds of receiving the dose. Very shortly after, within a minute or two, my throat felt dry and itchy. Nausea followed quickly after that. I thought maybe I was just dehydrated as I had worked out earlier in the day, so did not mention it to the pharmacist. I grabbed a Gatorade on my way out and assumed that would help. Shortly after, within 20-30 minutes my palms became very itchy. Within an hour pain at the injection site developed and got worse quickly.  My face, the area near and around my mouth and neck, and feet started to get itchy, maybe about two hours after getting the dose - palms were still itchy and throat still itchy and dry. Around 4 am I woke up, itchiness continuing, especially in the palms and throat. Feet were a little swollen. Nausea and headache continued. It?s now 8:30, so a little over 24 hours since my vaccine - itchiness is mostly better, throat still dry, massive headache, body aches, and nausea. Mostly reporting because the itching in my throat, palms, feet, and face happened so quickly, understand some of the other side effects are common.
About 15 mins of receiving flu vaccine patient was noted to be irritable then later developed generalized hives.  No respiratory distress/lethargy/vomiting noted. Patient was initially given Zyrtec 1.25 ml po but he vomited more than 1/2 of it, was given another 1ml after 7 minutes and was able to keep it down
Itchy back / Itchy stomach /  itchy chest / itch arms; sick to stomach; Sore arm; Joint Pain; Muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchy back / Itchy stomach /  itchy chest / itch arms), ABDOMINAL DISCOMFORT (sick to stomach), PAIN IN EXTREMITY (Sore arm), ARTHRALGIA (Joint Pain) and MYALGIA (Muscle pain) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     Concomitant products included TIMOLOL, lantoprost, CENTRUM SILVER +50, SERTRALINE, ATORVASTATIN CALCIUM (LIPITOR), LEVOTHYROXINE SODIUM (LEVOXYL), GABAPENTIN, SUMATRIPTAN, ONDANSETRON HCL, FISH OIL, MAGNESIUM, CALCIUM, ASCORBIC ACID (VIT C) and VITAMIN D3 for an unknown indication.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, the patient experienced PRURITUS (Itchy back / Itchy stomach /  itchy chest / itch arms), ABDOMINAL DISCOMFORT (sick to stomach), PAIN IN EXTREMITY (Sore arm), ARTHRALGIA (Joint Pain) and MYALGIA (Muscle pain). The patient was treated with CORTISONE at an unspecified dose and frequency. On 06-Mar-2021, ABDOMINAL DISCOMFORT (sick to stomach), ARTHRALGIA (Joint Pain) and MYALGIA (Muscle pain) had resolved. At the time of the report, PRURITUS (Itchy back / Itchy stomach /  itchy chest / itch arms) and PAIN IN EXTREMITY (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
pain in her thighs/pain in her hands; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in her thighs/pain in her hands) and PYREXIA (Fever) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038AZIA) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, the patient experienced PYREXIA (Fever). On 17-Mar-2021, the patient experienced PAIN IN EXTREMITY (pain in her thighs/pain in her hands). On 16-Mar-2021, PYREXIA (Fever) had resolved. At the time of the report, PAIN IN EXTREMITY (pain in her thighs/pain in her hands) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not applicable. No concomitant medications information was reported. No treatment medications were provided.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
School Nurse Volunteer at Public Health, School-based clinic administered Pfizer Gray Cap, rather than the appropriate age-based Orange Cap.  There were no immediate adverse reactions and 3 weeks post vaccination no further adverse reaction detected.  Mother of child and Child's PCP, MD were advised of the incorrect vaccine administration.  No further actions were taken place.  Mother was informed to follow up with Dr. if any symptoms developed.
Small Hives on forearms.  Provided one chewable children's Benadryl.  Hives seemed to recede a bit but still noticable 24 hours later.
right arm and hand intermittently tingles; right arm and hand feels very weak; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 14Apr2021 at 05:15 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history included hypertension, Raynauds syndrome and spondylolisthesis. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included lisinopril dihydrate (LISINOPRIL), amlodipine besilate (AMLOR), ascorbic acid, levoglutamide, biotin, folic acid, tyrosine, cyanocobalamin, choline bitartrate, acetylcarnitine, docosahexaenoic acid, panax ginseng root, phosphatidyl choline, phosphatidyl serine, resveratrol, ginkgo biloba leaf, bacopa monnieri herb (PROVASIL), cod-liver oil (FISH OIL) and acetylsalicylic acid (SPRIN); all taken for unknown indication on unknown date, unknown if ongoing. The patient previously took hydrocodone (MANUFACTURER UNKNOWN) and tramadol (MANUFACTURER UNKNOWN) and experienced drug allergy as itch. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 24Mar2021 at 05:15 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. On 15Apr2021, at 06:00, 1day after receiving the vaccine and subsequent days afterwards, the patient experienced right arm and hand intermittently tingles and right arm and hand feels very weak. 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 adverse events right arm and hand intermittently tingles and right arm and hand feels very weak. The clinical outcome of the event right arm and hand intermittently tingles were not recovered at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
third Shingrix; This case was reported by a consumer via interactive digital media and described the occurrence of extra dose administered in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st and 2nd dose on an unknown date).   In October 2021, the patient received the 3rd dose of Shingrix. In October 2021, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details provided were as follows: The case was self-reported by patient. The age at vaccination was not reported. The patient received 3rd dose of Shingrix because patient forget that he/she already received first and second dose, which led to extra dose administered. Follow-up would not be possible as no contact details available.
This spontaneous report as received from a physician refers to an unspecified number of patients of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On unknown dates, the patients were vaccinated orally with unknown doses of ROTATEQ (lot # K009181, expiry date 24-APR-2016), which were improperly stored. No adverse effects were reported. This is one  of two reports received from the same reporter. Additional information has been requested.
Pain in left calf started 2 days after vaccine. Pain progressed. Went to ER on 4th day. DVT in left leg noted. No history of DVT or clotting issues in past.
Shot was placed too high on arm. Shot was given too high/too deep. Experience immediate intense injection pain. Likely pierced bursa. Improper and poor technique. Reported to administrator of shot and emt on site. 3 days later having shoulder pain.
I started to feel sick on Sept 7, 2021. I was tested for COVID-19 on Sept 9, 2021, and received a positive PCR test result on Sept 11, 2021. I quarantined until Sept 20, 2021.   My symptoms were congestion, headache, loss of taste and smell, and tiredness. The congestion and headaches lasted about 4 days. Tiredness lasted about 14 days. I still have a loss of taste and smell today, which is about 3 weeks from the start.
Large localized rxn L upper arm-entire lateral upper arm indurated, red, hot to touch 24 hrs after immunizations.
Report of left shoulder, arm and neck pain began 20 minutes post vaccination. Treatment: Ibuprofen. Outcome: no improvement.
MUCUS IN NOSE/RUNNY NOSE; STUFFINESS/CONGESTION; SORE THROAT; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 11-JUN-2021, the subject experienced sore throat. On 14-JUN-2021, Laboratory data included: COVID-19 virus test (NR: not provided) Negative. On an unspecified date, the subject experienced mucus in nose/runny nose, and stuffiness/congestion. Treatment medications (dates unspecified) included: chlorphenamine maleate/dextromethorphan hydrobromide/paracetamol/pseudoephedrine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sore throat, mucus in nose/runny nose and stuffiness/congestion was not reported. This report was non-serious.
12 minutes post vaccination pt stated she felt "lightheaded " and face "flushed" vitals taken at 1534 BP 140/80 HR 91bpm spO2 97% , at 1545 161/71  HR 89 spO2 98% Temp 97.4. Provided water and encouraged deep breathing. Pt called husband to inform him of the situation. She stated she was feeling a little better. Vitals repeated. At 1540 BP 126/65 HR 83 spO2 98% , husband arrived at 1607 and pt left with him and encouraged to check with PCP prior to second vaccination.
Shoulder aches; This is a spontaneous report received from a contactable consumer (Patient) as part of Pfizer-sponsored program. A female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via unspecified route on 08Feb2021 as a single dose for COVID-19 immunization. Patient's medical history and concomitant medications were not reported. On an unspecified date, next day of vaccination, the patient experienced shoulder aches and wanted to take Ibuprofen. The Outcome of event was unknown.   Information on the lot/batch number has been requested.
Hospitalized 05/11/2022-05/22/2022; COVID-19 positive 05/11/2022; fully vaccinated plus booster  ASSESSMENT / PLAN:   COVID-19 virus infection - Not hypoxic - Pt is immunized with Pfizer 4/20/21, 5/17/21, 11/19/21 - CXR negative for acute changes - did not qualify for remdesivir or Decadron   Acute kidney injury, Resolved -Cr 1.85 on admission. Resolved with IVF GIVEN  -renal dose medications, avoid nephrotoxins   Frequent falls -BLE 5/5 strength on exam, BUE 3/5 strength on exam, suspect BUE weakness resulting in difficulty controlling walker leading to falls -PT/OT -> SAR   Hx of pituitary adenoma s/p resection with secondary hypopituitarism and hypothyroidism -continue home Cortef and Synthroid   HTN - Noted previous decrease in steroids which helped. Started Amlodipine 5mg daily   Parkinsonism Dysphagia -chronic dysphagia and urine incontinence at baseline -continue home dysphagia diet with thickened liquids   Gout -no evidence of acute gout flare -continue home allopurinol  Plan Discharge Coordination/Progress: Pt out of isolation today. Authorization obtained by facility. Plan: transfer today at 1445
Patient developed right facial zoster following her first dose of the Moderna Covid-19 vaccine. She was placed on valacyclovir and gabapentin. She was seen by Ophthalmology due to eyelid involvement and double vision. She was immunized 20 JAN and developed zoster 06FEB.
Was dizzy, B/P started (R) = 70/40 - 1:15 PM. Given ammonia at 1:15 PM. At 1:27 PM, BP = 110/68; 1:35 PM = 118/70 - "I feel great."Nurse recommended to the patient was to seek physician't care if necessary.