chrisvoncsefalvay/vaers-outcomes huggingface dataset:
For both the first dose and the second, I experienced belching that tasted very bad, watery diarrhea, gas, bloating, and abdominal cramps.
Recurrence of left side facial Bells Palsy. tingling of left lower and upper lip and slight droop of left side of mouth.
VAGINAL SPOTTING; VACCINE EXPOSURE DURING PREGNANCY; YEAST INFECTION; FATIGUE; This spontaneous pregnancy report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included alcoholic, and concurrent conditions included diabetes (gestational), and nonsmoker, and other pre-existing medical conditions included the patient had no known allergies. the patient had no drug abuse or illicit drug use. It was not reported whether the patient had been pregnant before. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802072, and expiry: UNKNOWN) dose was not reported, 1 total, administered on 09-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced yeast infection. On MAR-2021, the subject experienced fatigue. Laboratory data included: Laboratory test (NR: not provided) NEGATIVE. On 09-MAR-2021, the subject experienced vaccine exposure during pregnancy. The date of the subject's last menstrual period and expected delivery date were not reported. On 14-MAR-2021, the subject experienced vaginal spotting.  The pregnancy was continuing. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vaginal spotting on 22-MAR-2021, had not recovered from vaccine exposure during pregnancy, and the outcome of fatigue and yeast infection was not reported. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard operating procedure as the case assessed as non-serious.
Symtoms: left upper arm swollen, arm & fingers numbness and tingling, pain to the touch; Lasting 3 days. Treatment: applied ice ibuprofen 3xday.
headache; Dizziness; have not been able to drive since; This is a spontaneous report from a contactable consumer (patient). A 31-years-old non pregnant female patient received first dose of bnt162b2 (Solution injection; Batch/Lot Number: Er8729), via an unspecified route of administration, administered in Arm Right on 14Apr2021 as single dose and received second dose of bnt162b2 (Solution injection; Batch/Lot Number: Batch/Lot Number: Ew0171) via an unspecified route of administration, administered in Arm Right on 05May2021 as single dose for covid-19 immunisation. The patient medical history was not reported. Concomitant medications included iron. Patient was not diagnosed with covid prior vaccination. Patient was not tested for covid post vaccination. Patient did not receive any other vaccine in four weeks. The patient experienced severe dizziness and headache that started 5 days after dose 1 on 19Apr2021. She went to the ER due to severity. She had not been able to drive since. It started to get better before dose 2, but now it was back. The outcome of all the events was not recovered.  No follow up attempts are possible. No further information is expected.
Patient was here for her 2nd dose vaccine and during her wait time her tongue started to feel funny and swell slightly. Staff was notified as they were talking with her that  her voice sounded a little funny and thick. She also started to cough on a regular interval. As staff continued talking with her she stated her throat started to feel funny and tight. Staff notified other healthcare personal and moved her to the private  treatment area. She continued to complain of thick tongue and continued to speak different then her baseline. We elected to give 50 mg Benadryl IM. She was also placed on the ECG showing sinus rhythm with O2 stats of 100 % and her blood pressure was 149/61, After the Benadryl, she stated she started to fell somewhat better. After about 10 minutes her tongue started to swell again and when she turned her head to speak to a staff member her airway shut off due to swelling. Staff quickly turned her head back to forward she was able to breath again.  She advised that she needed to be transported and was going to get 0.3 epi IM in her left arm. She did state prior to Epi being given she was now also having trouble focusing visually. Dr arrive to assess her and agreed that she needed transported. EMS arrived and care was turned over to Huntertown EMS to transport the patient to Medical Center.
Shooting pains from injection site distally with numbness in fingertips.  Stiffness in digits and elbow/wrist.  Pain is not constant, but comes and goes in "waves" every 2-3 minutes.  Patient describes the pain as a "burning" sensation.  Rated the pain a 10/10 when active, 5/10 when inactive.
Pt had hives for 3 days 5 mo ago. Moved from another state. Had flu shot on 9/28/07. Five hours later had hives. Continues with breakouts through today 10/3/07. Not sure of environmental or from immunization.
Trouble sleeping; It hurts when he walks; Losing weight/ Weight loss; Short term memory loss; Suffers mental health; Depression; Loss of hair; Non-stop headaches; Got sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team and legal division. The reporter is the parent.  A 15-year-old male patient received bnt162b2 (BNT162B2), on 31Aug2021 as dose 2, single (Lot number: FD8448) at the age of 15 years for covid-19 immunisation. The patient's relevant medical history included: "disabled" (unspecified if ongoing), notes: We are disabled. The patient's concomitant medications were not reported. Vaccination history included: bnt162b2 (DOSE 1, SINGLE, Lot number: FA7485), administration date: 10Aug2021, for COVID-19 immunisation. The following information was reported: ILLNESS (non-serious) with onset 2021, outcome "unknown", described as "Got sick"; INSOMNIA (non-serious), outcome "unknown", described as "Trouble sleeping"; PAIN (non-serious), outcome "unknown", described as "It hurts when he walks"; WEIGHT DECREASED (non-serious), outcome "unknown", described as "Losing weight/ Weight loss"; AMNESIA (non-serious), outcome "unknown", described as "Short term memory loss"; MENTAL DISORDER (non-serious), outcome "unknown", described as "Suffers mental health"; DEPRESSION (non-serious), outcome "unknown"; ALOPECIA (non-serious), outcome "unknown", described as "Loss of hair"; HEADACHE (non-serious), outcome "unknown", described as "Non-stop headaches". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Reporter and her son had a sickness, weight loss, Loss of hair, depression, pain when walking and non-stop headaches.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300304578 same reporter/product, different event/patient;
Fever, chills and vomiting for ~12 hours. Treated with Motrin and Tylenol.
24 hours after vaccine (2nd dose): headache, soreness, fatigue, heart racing feeling (like the flu) 48 hours after vaccine (" "): malaise, fatigue 4 days after vaccine (Sunday evening): mild itchiness all over body (stomach, arms, thighs, neck, chest, back). No rash, bumps, discolored skin.  6 days after vaccine (Tuesday afternoon): intense/nonstop itchiness all over body (stomach, arms, thighs, neck, chest, back). I've been taking Zyrtec for about a month for seasonal allergies, but Zyrtec does not seem to help with the itching. No rash, bumps, discolored skin.
Approximately 10 minutes after immunizations pt RTC with SOB, coughing, red face. Examined by physician - RR 22, faint expiratory wheeze, HR 90, no retractions, no grunting. Red rash to face - Dad was instructed to go directly to ER.
About 6 hours after PPV shot was administered, rt (injection) arm became very painful. 10 on a 10 scale. Patient was up all night because pain was so intense. Sometimes shooting to other body parts. Feet, shins, knees, head and neck were affected. Some pain 48 hrs later, but worst was from 6 to 32 hours after injection.
Dark urine then turned bright red Fever Body ache Blood in urine Elevated Liver Enzymes Fatigue Voice comes and goes
Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 15-Jul-2022; No adverse event; The patient administered the vaccine after the 30 days by used; This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The patient administered the vaccine after the 30 days by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 15-Jul-2022) and NO ADVERSE EVENT (No adverse event) in a 64-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 15-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (The patient administered the vaccine after the 30 days by used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 15-Jul-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The patient administered the vaccine after the 30 days by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 15-Jul-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (The patient administered the vaccine after the 30 days by used) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 15-Jul-2022).    No concomitant product use was reported. The patient received half dose. The vial had not undergone any temperature excursions. No treatment information was provided.
itchy; rash on her arm; swelling on her arm; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swelling on her arm), RASH PRURITIC (itchy) and RASH (rash on her arm) in a 97-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041620A) for COVID-19 vaccination.     Concomitant products included LISINOPRIL for an unknown indication.    On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, the patient experienced PERIPHERAL SWELLING (swelling on her arm). On 26-Feb-2021, the patient experienced RASH PRURITIC (itchy) and RASH (rash on her arm). At the time of the report, PERIPHERAL SWELLING (swelling on her arm), RASH PRURITIC (itchy) and RASH (rash on her arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Treatment information was not provided.
Fever X 4 days of 101-103, irritability, decrease in appetite and sleep activity, rhinorrhea, knot on leg at injection site.
The Moderna COVID bivalent vaccine given on 5/22/2023 had an expiration date of 5/20/2023. The baby is fine. He had no adverse reactions or any other issues.  Per the manufacturer- "The vaccine administered on May 22, 2023 from lot number AS7162B maintained the activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration. "
SWOLLEN UPPER GUM, LEFT SIDE OF MOUTH; PATIENT WENT TO DR. WHO CHECKED FOR INFECTION AND PRESCRIBED ANTIBIOTICS
Frequent urination; Dry mouth; Disrupting her sleep; Injections 21 days apart; This spontaneous case was reported by a consumer and describes the occurrence of POLLAKIURIA (Frequent urination), DRY MOUTH (Dry mouth), INSOMNIA (Disrupting her sleep) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Injections 21 days apart) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017E21A and 011D21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Injections 21 days apart). On an unknown date, the patient experienced POLLAKIURIA (Frequent urination), DRY MOUTH (Dry mouth) and INSOMNIA (Disrupting her sleep). On 21-Aug-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Injections 21 days apart) had resolved. At the time of the report, POLLAKIURIA (Frequent urination), DRY MOUTH (Dry mouth) and INSOMNIA (Disrupting her sleep) outcome was unknown.            The patient developed side effects of frequent urination and dry mouth that were actually disrupting her sleep she can not go anywhere without water.  No concomitant medications were reported. No treatment information was reported.   This case was linked to MOD-2021-319687 (Patient Link).
PATIENT CAME  TO THE PHARMACY REPORTING THAT HE HAS EXPERIENCING SEVERE BODY ACHE SPECIFICALLY UPPER BODY, HE ALSO STATED THAT INJECTION SITE SORENESS WAS OFF AFTER A DAY. HE INDICATED THAT HIS LYMPH NODES SWOLLEN AS HIS ARMPIT GOT PAINFUL. THE PAIENT DOES NOT HAVE ANY OTHER ADVER REACTIONS AND OVERALL SEVERE BODY ACHE AND PAINFUL ARMPIT  WERE THE MOST CONCERN. I CONSULTED  THE PATIENT THESE ADVERSE REACTIONS  ARE ACTURLLY PART OF ADVERSE REACTIONS  REPORTED SO FAR.
a 11 years old patient has erroneously received a second dose of MENACTRA within a 7 month timeframe with no adverse event; Initial information received on 25-Jun-2021 regarding an unsolicited valid non-serious case received from an other health care professional.  This case involves a 11 years old female patient has erroneously received a 0.5 ml first dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] Injection batch number: U6827BA, expiry date: 18-FEB-2022 via intramuscular route in the left deltoid on 09-Nov-2020 and a 0.5 ml second dose batch number not reported, expiry date: 09-JAN-2022 via intramuscular route in the right deltoid on 22-Jun-2021 within a 7 month time frame for prophylactic vaccination (inappropriate schedule of product administration).  The patient's medical history, medical treatments, vaccinations and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP VACCINE) batch number: U6827BA on 09-Nov-2020 for Prophylactic vaccination.  It was an actual medication error due to drug dose administration interval too short (latency: same day).  It was reported that "The caller stated that an 11 years old patient has erroneously received a second dose of MENACTRA within a 7 months timeframe. Please see the Event Information, additional description of event for further details. Nurse asks if there are adverse effects that they should monitor for and should the child still receive a booster dose at 16 or so. On 09-Nov-2020, the patient received a dose of Menactra. On 22-Jun-2021, the patient reported to the doctor office for a routine annual exam where she was administered Menactra again in error. The caller would like to know if there will be any adverse events as a result of this error. The caller also wants to know if the patient should still receive another dose of Menactra at 16 year of age. Dosage Information Frequency: once, Strength: standard. No adverse events reported. Product used: Used".  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Between 5 and 10 minutes after the immunization, patient sat down with his father and starting feeling ill with a headache.  Head was shaking a bit and the patient vomited.  He was given some water while the paramedics were on their way.  Patient was coherent and talking fine sitting in the chair.  He was asked if he gets seizures ever and he both him and his dad said no.  Dad said he just doesn't like needles.  No issues giving the shot at all. He didn't look and said he hardly felt it.  Paramedics arrived, patient still had a bit of headache. He vomited a small amount before he left with his father.
shingles. started 72 hours after vaccine. treated with valcyclovir and gabapentin
Diarrhea, NauseaVomiting,  redness/soreness, nausea, vomit, diarrhea Narrative:  Day 1 - redness to inj site; Day 2 and 3 - red/sore to inj site, nausea, vomiting, diarrhea; Day 4 - sore to inj site, nausea and diarrhea; Day 5 - some soreness to inj site; no further symptoms
Heart palpitations and feeling flushed/ hot.  Happened over throughout the day of first vaccine and symptoms first began within three hours. I went home and tried to rest and relax. Symptoms subsided by the next day.
Warm to the touch around injection site; Itchy around injection site; Red around injection site; Fatigue; Little soreness on arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Little soreness on arm), VACCINATION SITE WARMTH (Warm to the touch around injection site), VACCINATION SITE PRURITUS (Itchy around injection site), VACCINATION SITE ERYTHEMA (Red around injection site) and FATIGUE (Fatigue) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     The patient's past medical history included Breast operation (Breast surgery last year to take out a sentinel node on her left side) in 2020.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, the patient experienced PAIN IN EXTREMITY (Little soreness on arm) and FATIGUE (Fatigue). On 25-Mar-2021, the patient experienced VACCINATION SITE WARMTH (Warm to the touch around injection site), VACCINATION SITE PRURITUS (Itchy around injection site) and VACCINATION SITE ERYTHEMA (Red around injection site). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Little soreness on arm), VACCINATION SITE WARMTH (Warm to the touch around injection site), VACCINATION SITE PRURITUS (Itchy around injection site), VACCINATION SITE ERYTHEMA (Red around injection site) and FATIGUE (Fatigue) outcome was unknown. Not Provided      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. No concomitant medications were reported.; Sender's Comments: Based on the current available information which includes a temporal association between the use of the product and the start date of the reported events, a causal relationship with the event cannot be excluded. Vaccination site erythema, vaccination site pruritus and fatigue are consistent with the known safety profile of the vaccine.
Right Lung Pulmonary Embolism - Shortness of Breath - Chest Pain. Currently on Oxygen and Anti-Coagulation Therapy (Lovenox Injections and Pradaxa Oral)
Heart attack (complete blockage in LAD artery). Symptoms began Wednesday 5/12 with elevated heart rate/chest tightness. Went to ER on Friday 5/14 and received two stents via cardiac catheterization.
Narrative:  .61 y/o male with relatively benign PMH (ONLY HTN and arthritis), had 2nd COVID vaccine (Moderna) on 4/10/2021 and developed Bilateral PE AND DVT left leg 4/14/2021 (no prior history of clotting, or report of family hisotry clotting)
VACCINE WAS ADMINISTERED.  AFTER APPROXIMATELY 5 MINUTES OF TALKING WITH THE PATIENT HE STATED HE FELT LIKE HIS MUSCLES WERE TIGHTENING AND HE WAS GOING TO FAINT.  PATIENT FAINTED.  EMS WAS CALLED AND ARRIVED IN APPROXIMATELY 4-5 MINUTES.  HE WAS CHECKED, AND DENIED AN EMERGENCY ROOM VISIT AND WAS RELEASED.
Patient experienced right arm soreness the day following vaccination. That has persisted to this date. So far patient has tried ice, but NSAIDs were just started as part of treatment.
42yo F px with no PMH, here to receive the Pfizer booster after receiving Johnson & Johnson as a primary vaccine. Approx. 7min after the shot she felt pain in the right arm (Injection site) that was radiating to the right side of her chest, sharp, 7/10, exacerbated by arm movement and alleviated by leaving the arm still. Denied any other symptom. Patient was evaluated by on-site EMS and MD. On PE AAO x 3; Initial VS: HR 82, RR 18, SpO2 99%, BP 118/74. RRR, lungs CTA, normal ROM on the affected limb. EKG (normal sinus rhythm); After 30min observation she felt better, pain now 2/10. Repeated set of VS WNL. Advised to go to the hospital to get a complete evaluation, but she refused. She was d/c home.
Started menstrual cycle by noon of vaccination day. She has a very regular cycle and should not have started for 10 more days.; This is a spontaneous report from a contactable consumer, the parent. A 14-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206) via an unspecified route of administration in the left arm on 21May2021 at 08:45 (at the age of 14-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. Concomitant medication was not reported. The patient did not have a history of allergies to medications, food, or other products. 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 vaccination. On 21May2021 at 12:00, the patient started experiencing menstrual cycle by noon of vaccination day. The patient had a very regular cycle and should not had periods started for 10 more days. Therapeutic measures were not taken as a result of the event. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the event irregular periods was unknown at the time of the report.   No follow-up attempts are needed. No further information is expected.
Patient had extreme redness, swelling, blood under the skin, petechiae, tenderness from shoulder all the way to the elbow.
Wrong dose given.  0.25ml given instead of 0.5ml of recommended dose.
AERS completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose:1/2/2021.pfizer Lot#EL0142 2nd dose:01/23/21.pfizerLot#EL9262 Diagnosed covid positive: 03/25/21 Exposure:Community Exposure Symptoms:Cough, Fatigue, Runny Nose, Muscle Aches
1:35 pm Mom called stating patient Left upper arm chest and Left side of neck was swollen and red dots on chest.
Tdap given, pain in left arm for 2 weeks after administration, patient has asymmetric deltoid.