chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a pharmacist, and via a company representative, concerning a patient (age and gender unknown), with unknown medical history, who "within the last six weeks" was vaccinated (route unknown) with a 0.5 ml dose of pneumococcal 23v polysaccharide vaccine (Lot# unknown).  It was reported that the patient experienced a severe local reaction just after receiving the shot.  The pharmacist reported that "within the last six weeks" the patient developed a cellulitis reaction.  It was reported that the patient may have received the vaccine from a multi dose vial or from single dose vial.  The outcome was not reported.  No product quality complaint was involved.  Additional information has been requested.
Eye swelling; Eye pain; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of EYE SWELLING (Eye swelling ), EYE PAIN (Eye pain) and NAUSEA (Nausea ) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 054C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Jul-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 28-Jul-2021, the patient experienced EYE SWELLING (Eye swelling ), EYE PAIN (Eye pain) and NAUSEA (Nausea ). At the time of the report, EYE SWELLING (Eye swelling ), EYE PAIN (Eye pain) and NAUSEA (Nausea ) outcome was unknown.            No concomitant medications reported. No treatment medications reported.
admitted for 8/23/2021 to Hospital for low blood pressure and found to have COVID.
Headache, lack of appetite, rib-pain, rash on rib cage.  Diagnosed with Shingles on 10/15/2014.
Low fever; chills; arm pain; nausea; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right (Lot number: ff5841) as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Ff5841), for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown), for Covid-19 immunization.  The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "Low fever"; CHILLS (non-serious), outcome "unknown", described as "chills"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm pain"; NAUSEA (non-serious), outcome "unknown", described as "nausea". Therapeutic measures were not taken as a result of pyrexia, chills, pain in extremity, nausea.  Additional information: Patient's age was unknown. The patient was not pregnant at the time of vaccination. Facility type Vaccine was Pharmacy or Drug Store. No known allergies. No other medical history. No other vaccine in four weeks. No other medications in two weeks. No covid prior vaccination. Not tested for covid post vaccination.    No follow-up attempts are possible. No further information is expected.
This spontaneous report was received from a registered pharmacist via company representative refers to a couple of unknown age and gender patients (number unspecified). On an unspecified date the patients started therapy with ZOSTAVAX (lot # unspecified) (formulation, route, dose and frequency unspecified) for vaccination. On an unspecified date, the patients who was taking ZOSTAVAX developed a shingles like rash, not at the injection site. Action taken of therapy with ZOSTAVAX was unknown. At the time of report, the outcome of the event was unknown. Additional information has been requested.
Information has been received from a physician concerning a 26 year old female who on 22-AUG-2007 was vaccinated intramuscularly with the first 0.5 mL dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) (lot # 653650/0696F). There was no concomitant medication. On 22-AUG-2007 the patient experienced redness, swelling, numbness at the injection site, some fever and chills. Subsequently, on 23-AUG-2007 the patient recovered. There was no product quality complaint involved. Additional information has been requested.
Patient presented to clinic for COVID19 booster. Full-dose Moderna was administered by mistake.  RN notified patient of dosing error via phone.
Full body hives; This is a spontaneous report from a contactable consumer, the patient. A 29-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0164) via an unspecified route of administration in the left arm on 07May2021 at 14:00 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included paracetamol (TYLENOL) for unknown indication on an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the left arm on 16Apr2021 at 14:00 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. On 10May2021, 3 days after second dose, the patient experienced full body hives. Since the vaccination, the patient had been tested for COVID-19. Therapeutic measures were not taken as a result of the reported event. The clinical outcome of the event full body hives was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Headache on front lobe of head; This is a spontaneous report from a contactable consumer (reporting for herself).  A 79-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization.  Medical history included high blood pressure and breathing problem.  Concomitant medication included salbutamol (ALBUTEROL) taken for breathing problem and unspecified high blood pressure medications and blood thinners.  The patient experienced headache on front lobe of head on 09Jan2021. The outcome of headache on front lobe of head was unknown.    The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
Fever chills Narrative:  for 3 days after #1 dose 12/30/20 had pain and after #2 dose had chills fever pain for 3 d
FEELING ACHY; FEVER; This spontaneous report received from a consumer concerned a 59 year old male. The patient's weight was 350 pounds, and height was 80 inches. The patient's concurrent conditions included: non smoker, alcohol use, blood pressure, and atrial fibrillation, and other pre-existing medical conditions included: The patient had no known allergies and did not have any drug abuse/illicit drug use. The patient had no past medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, and expiry: UNKNOWN) dose was not reported, administered on 24-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 25-AUG-2021, the patient experienced feeling achy. On 25-AUG-2021, the patient experienced fever. Laboratory data included: Body temperature (NR: not provided) 104.1 F. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from feeling achy, and fever. This report was non-serious.
One week after receiving the vaccine dose 1, the arm I received the vaccine on is red with hives and swollen.
CHIEF COMPLAINT:   SOB prior dx of covid with treatment, loose stools   HISTORY OF PRESENT ILLNESS:    PT is a 69 Years old Male with PMH of HTN, HLD, DM II, CAD s/p AICD, AFib on Eliquis s/p PPM, CHF, CKD, COPD not on home oxygen, nicotine dependence, and obesity who presents to the ED with progressive dyspnea and continued diarrhea in the setting of known COVID-19. Patient tested positive for COVID-19 on 11/12/2021. Patient is approximately on day 9 of symptoms.  Initially, he had upper respiratory symptoms with rhinorrhea, cough, congestion, and fevers, but these have resolved.  He states that he had has continued dyspnea.  No chest pain.  He has profuse diarrhea.  No abdominal pain, nausea, or vomiting.  Patient is vaccinated for COVID-19.  He received monoclonal antibodies 2 days ago.  He is not on oxygen at baseline.  He has a pulse oximetry device at home.
One hour after awaking on 9/10, left eye became blurry, right eye painful, then left side of face felt numb, lasted 5-6 minutes. Then left hand felt numb and heavy for 50 minutes. Headache developed over right side of head, could not see out of left eye. Headache through the day; Tx:Advil  9/17/08 MR received from PCP. Returned to office 1 day after HPV #3 with c/o tingling to L side of face and L hand.  Loss of sensation began near the mouth and spread toward the L side of face. Developed blurry vision eye which lasted ~5 minutes. L hand numbness lasted 30 minutes- unable to grab things. Developed severe R sided H/A and vomited 5x. Has become photopobic. PE WNL. Assessment:  Migraine headache. No further f/u at this time.
Two weeks post vax, the pt experienced marked arthralgia, arthritis, fatigue, and insomnia. The vaccinee was seen in the office by another physician in the medical group on 6/8/00. There were no objective signs of swelling, as reported by vaccinee. The vaccinee complained of joint pain in her hands, knees, toes, and neck. No treatment was given. The vaccinee's joint complaints were evaluated by a physician, who reported that no swelling or warmth was noted. The most recent information received on 9/26/00, reports the outcome of the events as unknown.
Approx. 30 minutes after vaccination the joints in my left shoulder froze up and felt like a lump of concrete for 20-30 minutes total. Approx 3 hours after vaccination intense waves of nausea set in and have been coming and going since and currently is still active. Very shortly after the nausea began my left arm began experiencing, excruciating muscle spasms and cramps those are also still active and come and go. Approx. 4 and a half hours after vaccination I began feeling extremely fatigued and started experiencing chills and the sensation of being cold despite my apartment being at the typical temperature I keep it at.
This spontaneous report was received from a registered nurse regarding an unspecified number of patients of unknown demographics. There was no information about concurrent condition and historical medication. Since 11-FEB-2015, the patients were vaccinated with PROQUAD (Merck) lot # L031602, expiration date- 18-FEB-2017, which was exposed to temperatures outside of the recommended range (incorrect product storage). No adverse event was reported. The outcome of event was unknown. Temperature was 9F, time frame- less than 1 hour and there was temperature excursion earlier also. This is one of several reports received from the same reporter. Additional information has been requested.
Patient woke the morning after vaccine with a headache and then had an episode where she was unresponsive, while her eyes were open she was humming and moaning and husband shaking her no response, episode lasted about 1-1,5 min , patient was tired after episode and went to sleep and did recall what had happened. everything was back to normal at visit 4/6/2021
This is my fifth pregnancy, 1 miscarriage, followed by 3 live term births, with current pregnancy at 33 weeks (34 weeks on Sunday). This is an IVF pregnancy, with myself acting as a gestational surrogate. Estimated due date is 11/28/2021.  Around 6:30pm on 10/12/2021, I started experiencing hives on my head and face. By 7pm, my upper lip was swollen and my face became warn and flushed. I took a 25 mg Benadryl and took my temperature, 99.1.  At 10pm, I started experiencing a persistent cough and throat irritation. At 11pm, I took another 25 mg Benadryl and went to bed.  The next day, 10/13/2021, my lip started swelling again, and slight hives reappeared at 10am, with sneezing and some coughing. I took another Benadryl at 11am, and made an appointment with the Walk-In Clinic for 1pm. Pulse was elevated but blood pressure and temperature was normal. Hives returned to face around 3pm, but went away without treatment.  10/14/2021- Hives again appeared covering my back at 9am. I took a Benadryl at 9:30am, and they were gone shortly after. 11:30am, they appeared on my face for a short time. By 6pm, there was hives on my lower neck, along with sniffles and congestion. By 7pm, the hives were on my neck and breast area, along with flushing in my ears and face. I took another Benadryl at 7:30pm and went to bed at 9pm.  10/15/2021- Woke up at 12am with significant pain in right ear, took 2 500 mg acetaminophen caplets. At 4am, I woke up again to slightly reduced pain in my right ear, took 1 500 mg acetaminophen caplets. Woke up with pain in right ear and shoulder at 7:30am + tiny raised itchy bumps on wrists and  hands Went away by 8am, but congested and pressure in ear.  1pm itchy on right side of chin/neck and white bumps with red rash on right breast.
Delayed skin sensitivity reaction that appeared on Day 8 after the first dose was given. Large red, swollen spot at injection site that was itchy, warm, and raised (almost hive like). Matches what others were calling Covid arm. Gradually  disappeared over the next 7-8 days. Itchiness, swelling, and warmth went away after 24/48 hours. Redness went down a lot in the first 48 hours as well.
NON-MOTOR ABSCENCE SEIZURE, NON-POSTICAL SP02: 96% BP: 138/82 ALERT X4
2 days after the vaccine, her right wrist began to hurt. diagnosed with De Quervain's (radial tenosynovitis) of the right wrist. she was sleeping on right side because left shoulder hurt after vaccine. sleep position does not cause tenosynovitis.  she had been doing light weight workouts regularly prior.
6 by 7 centimeter wide, erythema, induration, 0.5 centimeter around area appearing in 24 hours after vaccination.  Intramuscularly ROCEPHIN given, placed on oral OMNICEF.
Female pt 2y/o was given TDAP+IPV dose appropriate for 4-6 years old. No signs of symptoms.
Urticaria on trunk, arms, face, legs, signif itch. Temp to 103 F x 24 hours. Mild periorbital edema, all beginning about 6 hours after vaccine administration.
Patient started to itch on left arm and showed slight redness. Gave 25mg of diphenhydramine liquid for 1 dose
After several days, I had the sensation I was looking through water in both of my eyes. My vision was very blurry. This was primarily sensed in the bottom half of both eyes. It seemed as if they were filled with water, although doctors confirmed they are not.
Fever began around 99.7 and ranged from 99.7 to 102 in the following days. Fever never exceeded 102.  Pink/red spots (raised and flat) rash appeared on 09/13/2013 morning around 7:30am and remains throughout the day as this report being filed.  The rash began on chest and torso, then spread to lower back and arms. Few on thighs, legs and fingers and palms. Infant Tylenol was initially given on the first 2 days to patient to reduce fever. It seemed to reduce the fever at first but never came back down to normal.  Then, physician suggested to switch to infant ibuprofen. It was given to patient approximately 3 times total in one day but it did not reduce the fever.  Since the patient was otherwise behaving normal and had good energy and did not show other symptoms besides rash and fever, ibuprofen was then only given at bedtime to help the patient sleep better, therefore, it was not given during the day.  The patient continues to eat, play and sleep normally.  No abnormality has been observed in stool or urine.  Patient's physician has requested the patient to be brought into the practice if her fever persists by Sunday, 09/15/2013. Physician has not personally seen the patient since the adverse reaction was observed.
Subacute Thyroiditis: classic clinical presentation and clinical course.; This is a spontaneous report from a contactable physician. A 64-year-old male patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number ER7832) intramuscular on 26Mar2021 at 13:00 (at the age of 64-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included hyperlipidemia and osteoarthritis. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. Prior to the vaccine the patient was not diagnosed with COVID-19. Concomitant medications included atorvastatin from an unknown date for an unknown indication. The patient previously received tetanus vaccine on an unspecified date and experienced allergy. On 29Mar2021 at 13:00 the patient experienced subacute thyroiditis with classic clinical presentation and clinical course. The event was reported as serious. The patient was not hospitalized for the event. The patient visited a doctor or other healthcare professional/clinic as a result of the event. The patient underwent lab tests and procedures which included  2 RNA QLRRT-PCR (nasal swab) on 22Apr2021 with a result of negative. The patient received treatment with supportive steroids and beta blockers. The outcome of subacute thyroiditis was recovering.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event subacute thyroiditis and the suspect drug.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Patient presented with red blotches and complaint of feeling "really warm." I gave her 10ml of diphenhydramine elixir and One Epinephrine 0.3mg shot. Took her blood pressure until returned back to what patient stated as normal.
At the beginning of Jan I started feeling inflammation in my hands. I had some blood work done and it showed high white blood cell count. More recent testing is showing inflamed red blood cell count. I started seeing a rheumatologist and we aren't at the point of being diagnosed for rheumatoid arthritis. In October I did have a stomach flu and It may have triggered something. I am just unsure.
Patient was given Pfizer COVID Bivalent 12+ instead of the Pfizer 5-11yr, patient showed no reaction or illness after the fact.
After getting vaccinated on 3/3/21 and 3/24/21, I missed a menstrual period.  I had my doctor complete a whole bunch of tests and nothing came back to explain the missed menstrual cycle.  I am not pregnant, my blood and urine samples confirmed.  There is no other changes to my health that would affect my menstrual cycle.
2 day post vax developed red rash around diaper line on abd & thighs in afternoon mom noticed reddened areas bilaterally ax area & on rt cheek; rash not raised mom described as sunburn appearance; diaper area appeared poss yeast infect;
Tetanus booster administration on 1/21/00. Starting afternoon of 1/22/00, developed body aches and weakness. Still present on 1/24/00.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Nov2021 as dose 1, single (Lot number: FG3527), in left arm, on 21Nov2021 as dose 2, single (Lot number: FG3527), in left arm and on 01Feb2022 as dose 3 (booster), single (Lot number: FM9698) at the age of 44 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Sickle Cell" (unspecified if ongoing); "diabetes" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Dilaudid for Allergy. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of covid-19 which included a Anti-viral and treatment stop date: 15Sep2022, Lot number=1918535A. Clinical course: The patient received other medication in 2 weeks.
patient "saw black"and nearly passed out was grey, sweaty HR 39, BP 96/60  after a few minutes his color came back after vomiting x2 observed in tent, BP 136/78, HR 69
Case fully Covid-19 vaccinated at the end of February. On 07/16/2021 patient tested positive with Covid-19. Patient admitted on 07/27/2021 ICU with shortness of breath, productive cough and O2 % on 86%. CXR on 07/27/2021 shows bilateral infiltrate's. patient was hypoxic and tachypneic.  07/31/2021 patient become more shortness of breath and was put on CPAP high flow and CT of the chest was done showing PE. Patient was put on Heparin drip. Patient decompensated  on 08/02/2021, was connected to MV and went to cardiac arrest, patient pass at 09:57 on 08/02/2021.
Mild Bells Palsy: Numbness in lower left chin and jaw. Extreme teeth pain and swelling (multiple).
Her arm felt hot and was swollen for 5 days. She did not seek additional care. Happened to stop by pharmacy and mentioned se to us.
This spontaneous report was received from a healthcare worker and refers to unspecified number of patients of unknown age and gender. No information about the patient's pertinent medical history, concurrent conditions, drug reactions or allergies was provided. On unspecified dates, the patients received two improperly stored doses of RECOMBICAX HB lot # K021444, expiration date 17-SEP-2016 (dose and route of administration were not reported). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Information has been received from a medical assistant referring to a 16 year old female patient. The patient's concurrent condition, medical history and concomitant therapy were not reported. On 06-AUG-2018, the patient was vaccinated with improperly stored GARDASIL 9 (dosing details unknown, lot# R001262, expiry date: unknown) in the left deltoid for prophylaxis in a public health clinic/hospital using public funds (Incorrect product storage). The patient had one dose of GARDASIL 9 previously. No prescription drug treatment was required for the experience. The patient did not receive any reverse reactions to the vaccine. The vaccine was stored at a temperature of 0 Celsius (C) degree to 1 C degree for 41 hours, below 0 C degree (-0.01) for 27 hours and between 9 C degree to 25 C degree (16.4) for 12 hours 30 minutes. Previous temperature excursion were 0 C degree to 1 C degree for 27 hours. Data logger was involved. No adverse effect reported. No product quality complaint (PQC) was involved.  This is one of two reports from the same reporter. Sender's Comments: US-009507513-1808USA003706.
2 circular areas 1 inch in diameter and induration.  Erythema.   Treated w/ ice compresses.