chrisvoncsefalvay/vaers-outcomes huggingface dataset:
urinary problem; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the parent.  A male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administration date 01Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MICTURITION DISORDER (non-serious) with onset 04Apr2021, outcome "unknown", described as "urinary problem".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
The spot of the injection is raised, itchy, and red, it looks like I may have a slight red ring around the actual injection site. I am a week out from getting it and this is the first time it has felt itchy and red again.
Red raised rash and bumps at injection site; itches and feels raw. Tx with OTC hydrocortisone and Rx triamcinolone 0.5% ointments.
Patient found on floor in hallway after completion and exiting of the  COVID vaccine. Assessed by physican. Symtoms resolved.
inflammation caused electricity to drop to the heart; electricity to drop to the heart; arm  and armpit became swollen; muscle pain ran to the back,muscle pain to the heart; arm pain; This spontaneous case was reported by a consumer and describes the occurrence of INFLAMMATION (inflammation caused electricity to drop to the heart), CARDIAC DISORDER (electricity to drop to the heart), PERIPHERAL SWELLING (arm  and armpit became swollen), MYALGIA (muscle pain ran to the back,muscle pain to the heart) and PAIN IN EXTREMITY (arm pain) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 013A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Feb-2021, the patient experienced PAIN IN EXTREMITY (arm pain). On 15-Feb-2021, the patient experienced INFLAMMATION (inflammation caused electricity to drop to the heart), CARDIAC DISORDER (electricity to drop to the heart), PERIPHERAL SWELLING (arm  and armpit became swollen) and MYALGIA (muscle pain ran to the back,muscle pain to the heart). The patient was treated with PARACETAMOL (TYLENOL) for Pain, at a dose of UNK dosage form and AMOXICILLIN for Pain, at a dose of UNK dosage form. At the time of the report, INFLAMMATION (inflammation caused electricity to drop to the heart), CARDIAC DISORDER (electricity to drop to the heart), PERIPHERAL SWELLING (arm  and armpit became swollen), MYALGIA (muscle pain ran to the back,muscle pain to the heart) and PAIN IN EXTREMITY (arm pain) outcome was unknown.            No Concomitant medications were reported.  Patient received second dose on 04mar2021,reported did not have any AE.
No other AE details available at this time; Caller reported temperature excursion. / Temperature -13.3C; This spontaneous report was received from a registered nurse concerning to a 12-month-old patient of unknown gender. The patient's medical history, historical drugs, allergies, concurrent conditions and concomitant therapies were not provided.  On 17-NOV-2020, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX), 0.5 milliliter (ml) for prophylaxis, lot number reported as T017688 and expiration date as 21-MAY-2022 (vaccination scheme, route of administration and anatomical site of vaccination were not provided). No additional adverse events were reported.  The administered vaccine had a temperature excursion of -13.3°C (degrees Celsius) for a time frame of 4 hours and 15 minutes, and the data was recorded by a digital data logger. It was also reported there was not a previous temperature excursion.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2012USA013095:
Red rash, itching, warm to the touch, swelling and hardness of muscle in an area approx 5" in diameter 16 hours after first symptoms presented/ at time of reporting.
Site of shot was hard and swollen. Area was very red and hot. Drew a line around border of swelling and was about the size of a quarter. At noon on 8/23/2014 area was checked again and had some more swelling. Marked another border line around the swelling. Had ice pack applied to area for 15 mins. Appeared to have some decrease in swelling. Checked again at 9pm and saw no change. At noon on 8/24/2014 site was checked again. Swelling had increased again and was found to be 3 inches in diameter. Site was extremely hot, red and hard. Administered 200mg ibuprofen and 25mg of Benadryl. Checked for fever and was at 100.2 orally. Had ice applied for 15 mins. Rechecked at 3:30 PM and found swelling had decreased and fever had come down to 99.2. Continued to monitor. Appeared to be getting better still at 9 PM.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 18-DEC-2015 at 08:25, the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L025738, expiry date: unspecified (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. The high and low temperatures were 8.6 (for a duration of 9 hours 20 minutes) and 6.2 (units unspecified) respectively. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Pt complained of redness and swelling on inner right arm (not on injection site), both ears, nose, upper eyelids and under eyes x 8 days. Pt did not seek treatment after reaction.
Painful L arm; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of   in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for an unknown indication.    No Medical History information was reported.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (unknown route) dosage form. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not reported. Treatment medication was not reported.
Nosebleeds; This spontaneous case was reported by a consumer and describes the occurrence of EPISTAXIS (Nosebleeds) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis.    On 13-Apr-2021 at 12:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, the patient experienced EPISTAXIS (Nosebleeds). At the time of the report, EPISTAXIS (Nosebleeds) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Apr-2021, Blood pressure measurement: high (High) blood pressure has been high.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments.  It was reported that after the vaccine patient's blood pressure had been high and  experienced nosebleeds every day.  Concomitant medication including arthritis medication (name not provided) was reported. No treatment medication was reported
Headache, itching of injection site, redness/rash/swelling from injection site down to elbow
Sleeplessness on the night of 8/21, fever of 100.2 by around 4am 8/22, body aches and fatigue as of 14:08 on 8/22.
Fluzone ID given in right arm; Zostavax given in Left arm; 11/16/12, both arms hurt and left arm appeared red and left arm is still currently red; 11/17/12 pt had whole body aches and ate very little; 11/18/12 patient has been on couch all day with whole body aches and been sleepy and not eating; patient's wife says he feels warm but fever is unknown; patient wife said she has given him aleve (all per wife on 11/18/12 at 3:25pm); told wife that if she felt this was an emergency to take him to the ER and then to follow up with primary MD.
Patient returned to pharmacy on 10/12/17 stating on the evening of 10/11/17 she began to have pain in Left hand and swelling. Reports loss of feeling and pain today with visual swelling.
SOB, acute stabbing heart/ chest pain extreme enough to limit ability to walk or care for oneself (bedridden) for 48 hours, chest pain and SOB continued for 8 days.
72 hour fever 103-100.  Prolonged fatigue, shortness of breath with minimal exertion, Brain fog, difficulty with math calculations, word finding., continued to worsen rather than diminish over these last  12 months.
08:55am (8/15/17), Dr at hospital called to report swelling, redness, and itching of (L) arm. MD states this is the second time this child presented to the ER with these complaints since getting the shot on Saturday. "Upon chart review, patient received shot on 8/12/17.
Redness; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Redness) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Mar-2021, the patient experienced ERYTHEMA (Redness). At the time of the report, ERYTHEMA (Redness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported.  No treatment medication was reported.
Patient was waiting his 15 minutes and about 10 minutes after vaccination patient became light headed and passed out.  Pt did pass out 2 times and then I put him on the floor with his feet elevated.  Patient was also given an Ice pack to apply to back of the neck.  After the patient was feeling well enough to sit up again he was given water to drink.   He was resting and filling out an incident report for the store when he felt hot again so I brought the ice pack back, took his blood pressure which was 99/56 and offered a small snack of peanut butter crackers because he said he had not eaten yet that day and was feeling hungry.  I took his blood pressure 2 other times before he went home 117/82 and 108/79.  He left the pharmacy on his own with his wife to drive him home.  I did a follow up in the afternoon, he said he felt off for about another hour but was feeling well by 5:00pm.
pt recv vax 1996 & pt devel a mild fever & a small rash;
Terrible headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Terrible headache) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concurrent medical conditions included Hypertension and Eye disorder NOS. Concomitant products included VITAMINS NOS for an unknown indication.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Apr-2021, the patient experienced HEADACHE (Terrible headache). At the time of the report, HEADACHE (Terrible headache) had not resolved. Not Provided          Concomitant medications included blood pressure medicine and eye medicine. .  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not applicable.
About one week after the second vaccine for COVID-19 buzzing sound began in head, neurologist states due to vaccine and wait it out. As of today 9 months later the buzzing sound remains constant in head, currently now taking medications to help reduce the sound, but it still exists.
gave Menveo with sterile diluent; gave Menveo with sterile diluent; This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On 12th May 2022, the patient received Menveo. On 12th May 2022, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.       Additional Information: GSK Receipt Date: 12-May-2022 Reporter's Comments: It was stated that practice manager gave Menveo powder with a sterile diluent. The health care professional unable to provide any other adverse event details at the time of reporting. The reporter consented to follow up.  Additional Supportive Information: The patient received Menveo powder with a sterile diluent which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.
About 2 hours after receiving a flu vaccine from a multidose vial (Sanofi lot #UJ998AE, exp June 30 2019) early in the am at work on 9/22, she developed pinpoint itchy red spots on her arms. About 15 minutes later, she developed generalized hives, SOB, wheezing, chest heaviness and partial throat closing. Her BP was 180/110.
Patient given Pneumovax and Fluvirin, said could not move her arm, and was paralyzed waist down. She saw her Dr and given ibuprofen and methocarbamol.
First night was really bad with itching all over my body/itching all over; covid arm; Swelling of throat; headache; fatigue; weakness; This is a spontaneous report from a contactable consumer (patient). A 30-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EW0169, Expiry date: not reported), via an unspecified route of administration in right arm on 02Jun2021 11:30 (at age of 30-year-old) as dose 1, single for COVID-19 immunization in Health Clinic/facility. Medical history included asthma, attention deficit hyperactivity disorder, depression, anxiety, post-traumatic stress disorder. Concomitant medication(s) included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) taken for an unspecified indication, start and stop date were not reported. The patient previously took dextromethorphan. The patient had not received any other vaccine within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not tested for COVID-19. On 19Jun2021 at 12:00, the patient experienced first night was really bad with itching all over my body/itching all over, covid arm, swelling of throat, headache, fatigue, weakness. First night was really bad with itching all over his body took hydroxyzine 25mg. Now two weeks in the patient had covid arm and the same side effects. Swelling of throat, itching all over with headache/fatigue/weakness. The patient had taken hydroxyzine again currently. The patient had dose 2 scheduled in 4 days. Therapeutic measures were taken as a result of the events which included hydroxyzine. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
This spontaneous report as received from a medical assistant refers to a 4 year old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 22-MAR-2016, the patient was vaccinated with a third dose of M-M-R II, lot # L026553, expiry date 16-JUL-2017 (route and site of administration were not reported) and a third dose of VARIVAX (Merck), lot # L043619, expiry date 02-NOV-2017. The patient received them in error because provider believed that the patient did not receive the second doses. The error was due to an oversight of the date on which the second doses of vaccine were previously administered. The patient received the vaccines previously on 21-JUL-2014 and 21-SEP-2015. No adverse experience has been reported. Additional information has been requested.
Red swollen arm. Hot to touch. Pain from should all the way down arm to wrist.
No additional AEs reported; She reported that 0.1ml of VARlVAX was left in the syringe that the patient did not receive; This spontaneous report was received from a nurse and refers to a child patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 20-OCT-2021, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) lot # U016064, expiration date not provided but after internal validation determined as 20-MAY-2023 (dose, route of administration and anatomical location were not provided) for prophylaxis. During vaccination, the patient jumped, and the needle came out during the injection. Reporter stated that 0.1 mL of varicella virus vaccine live (Oka/Merck) (VARIVAX) was left in the syringe that the patient did not received (incomplete dose administered). No additional adverse event was reported.
chest pain; heart burn; congestion of the lungs; bivascular atelectasis with mild plural thickening; bivascular atelectasis with mild plural thickening; difficulty breathing; rib pain; lung pain; This case was reported by a consumer via call center representative and described the occurrence of lung congestion in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included allergy to animal (allergic to Hamsters).   On 25th May 2022 09:00, the patient received the 1st dose of Shingrix. On 25th May 2022 19:00, 10 hrs after receiving Shingrix, the patient experienced lung congestion (serious criteria GSK medically significant), atelectasis, pleural thickening, difficulty breathing, rib pain and pulmonary pain. On 27th May 2022, the patient experienced chest pain and heartburn. On an unknown date, the outcome of the lung congestion and difficulty breathing were not recovered/not resolved and the outcome of the atelectasis, pleural thickening, rib pain, pulmonary pain, chest pain and heartburn were unknown.   It was unknown if the reporter considered the lung congestion, atelectasis, pleural thickening, difficulty breathing, rib pain, pulmonary pain, chest pain and heartburn to be related to Shingrix.     Additional Information: GSK Receipt Date: 01-Jun-2022 Reporter's Comments: The patient stated that by 19.00 that evening, she experienced congestion of the lungs, lung pain, rib pain and difficulty breathing. Two days after vaccination, she also began to experience heart burn and chest pain. The patient stated at that time, she was seen by her primary care physician (PCP) who then sent her to the emergency department (ED).  The PCP was associated with this ED.  While in the ED she received a CT angiogram which resulted in a diagnosis of bivascular atelectasis with mild plural thickening. The patient stated that she was allergic to hamsters. The reporter consented to follow up.
NONE Covid 19 vaccine EXPIRED 2/8/2023 GIVEN 3/20/2023
Pain in Legs; Pain in Arms; Soreness; Headache; Fatigue; Lightheadedness; Pain in Neck; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Lightheadedness), NECK PAIN (Pain in Neck), PAIN IN EXTREMITY (Pain in Legs), PAIN IN EXTREMITY (Pain in Arms) and MYALGIA (Soreness) in a 78-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.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), CANDESARTAN, METOPROLOL, FAMOTIDINE (PEPCID AC), ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) and ERGOCALCIFEROL, RETINOL PALMITATE (VITAMINS A & D) for an unknown indication.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced DIZZINESS (Lightheadedness), NECK PAIN (Pain in Neck), PAIN IN EXTREMITY (Pain in Arms), MYALGIA (Soreness), HEADACHE (Headache) and FATIGUE (Fatigue). On an unknown date, the patient experienced PAIN IN EXTREMITY (Pain in Legs). At the time of the report, DIZZINESS (Lightheadedness), NECK PAIN (Pain in Neck), PAIN IN EXTREMITY (Pain in Legs), PAIN IN EXTREMITY (Pain in Arms), MYALGIA (Soreness), HEADACHE (Headache) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Patient immediately began feeling lightheaded and nauseated.  Then patient became dizzy and fainted.  Patient was revived.  Upon awakening, patient remained dizzy and had trouble talking.  BENADRYL was administered.  Patient slept off the symptoms and was fine next day.
Developed rash in diaper area on Friday afternoon on 9/14/01. By Saturday 9/15/01 rash covered entire body and was running a fever that got up to 103. Reported to ER and physician instructed Mom to give Tylenol and Motrin. Report back to ER if symptoms and rash increase and follow up with PCP in 3-5 days if no improvement.
A spontaneous report was received from a Consumer concerning a 22 years old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced cellulitis, skin felt hot/feeling hot, arm was red/redness generalized, arm was swollen/peripheral swelling. The patient's medical history was not provided. No relevant concomitant medications were reported. On 14 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 012L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 15 Jan 2021, the patient experienced the events as cellulitis, skin felt hot, arm was red, arm was swollen. Treatment information was provided as patient has taken antibiotic Cephalexin 1 capsule four times a day for a week. Action taken with mRNA-1273 in response to the events was unknown. The seriousness criteria of event cellulitis was assessed as serious as per EMA list. The outcome of the event swollen arm was resolved. The outcome of the events cellulitis, skin felt hot, arm was red was unknown.; Reporter'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.
I had a fever, chills, sweating, and headaches for about 10 days. It felt like I was on a roller coaster. I went to the doctor about this on April 11th. They tested me for COVID-19, Flu, RSV, and lime, negative results on all of them. They did bloodwork, showed my WBC was low. They also did a urine sample, normal results.
Syncopal episode and bronchospasm within 1 hour of immunizations.  Improved with epinephrine, steroids, benadryl  7/4/08 Reviewed PCP & urgent care medical records of 6/24-25/2008. FINAL DX: anaphylactic reaction to immunizations; syncope & collapse. Records reveal patient seen in PCP office for well child vs & routine vaccinations. Was filling prescriptions for allergy meds when suddenly fell over backwards & hit his head.  Tx in Urgent Care w/epi, benadryl & steroids for respiratory distress.  Stabilized & d/c to home.  Referred to Allergist.