chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Chest pain; Rash on his back; Pain in armpit; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Rash on his back), VACCINATION SITE PAIN (Pain in armpit) and CHEST PAIN (Chest pain) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K202A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE RASH (Rash on his back), VACCINATION SITE PAIN (Pain in armpit) and CHEST PAIN (Chest pain). At the time of the report, VACCINATION SITE RASH (Rash on his back), VACCINATION SITE PAIN (Pain in armpit) and CHEST PAIN (Chest pain) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Information has been received from a physician concerning an infant who was vaccinated with a second dose PO of ROTATEQ. The infant had blood in their stool within one week of receiving the second dose of ROTATEQ. The patient recovered, and subsequently completed the series of ROTATEQ. There was no product quality complaint. Upon internal review the event of blood in stool (hematochezia) was considered a other medically important event (OME). Additional information has been requested.
during supper, pt clenched teeth, became stiff & shook; this occurred 3 times between eating food & was observed by pts father;
sweating; chills; fever; major fatigue; Major hair loss starting 1.5 days following the vaccination; This is a spontaneous report from a contactable other health care professional. A 27-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number: EL0142), intramuscular on 12Jan2021 16:30 at SINGLE DOSE at Arm Left for covid-19 immunisation. Medical history included covid-19; covid prior vaccination: yes. Concomitant medication included escitalopram oxalate (LEXAPRO). Major hair loss starting 1.5 days following the vaccination on an unspecified date in Jan2021, in addition to sweating, chills, fever, and major fatigue on 13Jan2021 22:30. The patient did not receive treatment for the events. The outcome of the events was not recovered.
Pt developed dyspnea, significant voice changes and pruritus.  Symptoms almost completely resolved.0
administered a patient both Kinrix and Pediarix on 16/05/2023; Extra dose administered; patient received kinrix as 2nd dose; This non-serious case was reported by a physician via call center representative and described the occurrence of overdose in a 4-year-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number M7HL3) for prophylaxis.   Co-suspect products included DTPa-IPV (Kinrix) (batch number N7HL3) for prophylaxis.   Previously administered products included hepatitis B vaccine (the patient receive at birth), hepatitis B vaccine (received at 25 months of age), IPV (received at 25 months of age) and DTAP (received at 25 months of age).   On 16-MAY-2023, the patient received the 2nd dose of Pediarix and the 2nd dose of Kinrix. On 16-MAY-2023, an unknown time after receiving Pediarix and Kinrix, the patient experienced overdose (Verbatim: administered a patient both Kinrix and Pediarix on 16/05/2023), extra dose administered (Verbatim: Extra dose administered) and inappropriate schedule of vaccine administered (Verbatim: patient received kinrix as 2nd dose). The outcome of the overdose, extra dose administered and inappropriate schedule of vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 16-MAY-2023 The vaccine, patient and event information was provided. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up. The reporter called and stated that a nurse administered a patient both Kinrix and Pediarix at the time of reporting, which led to overdose and inappropriate schedule of vaccine administered. The patient 2nd dose of Kinrix, which led to extra dose administered.
left side of his lower lip inflated, Lip was big - triple the size; Lip was numb; "sometimes he forgets where he put his keys, but this will keep happening"; gets woken up by pain where the injection was made - in that circle,It "bothers the hell out of him",Pain at a 4/10,; This spontaneous case was reported by an other health care professional and describes the occurrence of LIP SWELLING (left side of his lower lip inflated, Lip was big - triple the size), HYPOAESTHESIA ORAL (Lip was numb), MEMORY IMPAIRMENT ("sometimes he forgets where he put his keys, but this will keep happening") and VACCINATION SITE PAIN (gets woken up by pain where the injection was made - in that circle,It "bothers the hell out of him",Pain at a 4/10,) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032B21A and 028A21A) for COVID-19 vaccination.     The patient's past medical history included Hepatitis C (Hepatitis C from the 80s until 2015 - never had any symptoms.). Concomitant products included TRAZODONE, ACETYLSALICYLIC ACID, DIPHENHYDRAMINE CITRATE (ALKA-SELTZER PM) and IBUPROFEN (MOTRIN [IBUPROFEN]) for an unknown indication.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Apr-2021, the patient experienced LIP SWELLING (left side of his lower lip inflated, Lip was big - triple the size), HYPOAESTHESIA ORAL (Lip was numb), MEMORY IMPAIRMENT ("sometimes he forgets where he put his keys, but this will keep happening") and VACCINATION SITE PAIN (gets woken up by pain where the injection was made - in that circle,It "bothers the hell out of him",Pain at a 4/10,). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Lip swelling, at a dose of 1 dosage form. On 02-May-2021, LIP SWELLING (left side of his lower lip inflated, Lip was big - triple the size) and HYPOAESTHESIA ORAL (Lip was numb) had resolved. At the time of the report, MEMORY IMPAIRMENT ("sometimes he forgets where he put his keys, but this will keep happening") and VACCINATION SITE PAIN (gets woken up by pain where the injection was made - in that circle,It "bothers the hell out of him",Pain at a 4/10,) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Pain assessment: 4/10 (High) Pain at a 4/10.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Now, the patient is concerned because of the booster - his workplace is requesting for everyone to get vaccinated, but he doesn't know if he will get it.
pt says he developed a severe headache and back pain.  He took ibuprofen for his symptoms which seemed to help.  He says the headache and back pain will come and go.. He says the pain is moderate.  When he takes ibuprofen medicine for this the pain will subside but then come right back after a couple of hours.  Pt will contact his PCP.
Patient states she woke up at 4am this morning with uncontrolled muscle movements and chest pain.  She took a tylenol and xanax, and the symptoms resolved. She has not had any issues since.  I instructed her to contact her doctor's office for guidance, and I instructed her to go to the hospital if the symptoms come back before she hears back from her doctor.
Tenderness at shot site. Fever the highest known at 100.6. Chills. Burning/tingling sensation on skin on arms and legs. Lasted 24 hours then totally fine.
Fever of around 99.5 (normal temp is 97.1), chills and severe muscle pain first night, extreme fatigue
This spontaneous report as received from a other health professional refers to 5 patients of unknown age. the patients were vaccinated with a dose of lot # (665425/1017Y: exp date 15-JUL-2011) MMR II (dose and route not reported) on unspecified dates. No other co-suspects and no concomitant medications were reported. The reporter stated that the patients were vaccinated with expired vaccines. The reporter did not have exact dates of vaccination but thought the patients were vaccinated within the last couple of months. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available.
Took Benadryl prior to 2nd shot and symptoms limited to swelling around eyes; This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date of 2021 as dose 2, single for covid-19 immunization. Medical history included peg allergy from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. Historically the patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date of 2021 as dose 1, single for covid-19 immunisation and experienced numbness around mouth, swelling of eyes / swelling around eyes and delayed hypersensitivity reaction after first covid immunization. On an unspecified date of 2021, the patient took benadryl prior to second shot and symptoms limited to swelling around eyes. It was reported that the patient experienced delayed hypersensitivity reaction after first covid immunization. The patient had swelling of eyes, numbness mouth 40 minutes after vaccine. It was reported that the patient had appointment with allergist and peg allergy was confirmed. The patient took Benadryl prior second shot and symptoms limited to swelling around eyes. Therapeutic measures were taken as a result of took benadryl prior to second shot and symptoms limited to swelling around eyes. The outcome of the event was unknown.   No follow-up attempts are possible;information about lot/batch number cannot be obtained. No further information is expected
lost 95% of the vision in one eye; This case was reported by a consumer via  interactive digital media and described the occurrence of unqualified visual loss, one eye in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced unqualified visual loss, one eye (serious criteria GSK medically significant). On an unknown date, the outcome of the unqualified visual loss, one eye was unknown.   The reporter considered the unqualified visual loss, one eye to be related to Shingrix.  Additional details were reported as follows: The case was reported by patient's best high school friend. The age at vaccination was not reported. The patient lost 95 percent of the vision in one eye because of the Shingrix vaccine. The follow-up would not possible as no contact details were available.
This spontaneous report was received from a office manager referring to a 12 month old patient of unknown gender. The patient's medical history and concurrent conditions were not reported. On 07-MAY-2018, the patient was vaccinated with an improperly stored M-M-R II, lot # N001532, expiration date 13-JAN-2019 (anatomical location and administration route were not reported) for prophylaxis (Incorrect product storage). Concomitant medications included properly stored Sterile Diluent. No adverse effects were reported. The vaccine was stored at 47 degrees Fahrenheit to 77 degrees F (61.7 degrees F) for 2 hours 30 minutes and 32 degrees F to 35 degrees F (33F) for 6 hours 51 minutes. The  previous temperature excursion was reported as 47 degrees F to 77 degrees F (52F) for 1 hour 30 minutes. The call was due to digital data logger. This is one of several reports received from same reporter. Sender's Comments: US-009507513-1803USA010116; US-009507513-1808USA007353; US-009507513-1808USA007351; US-009507513-1808USA007352; US-009507513-1808USA007355.
Patient reports right hand severe swelling starting one week after Johnson and Johnson covid vaccine with pain in the hand. She went to ER and US showed a DVT in forearm. Patient was placed on aspirin and states the swelling has improved some but still has some swelling and pain.
Patient with facial flushing and itching after vaccination. Patient self administered her own home Benadryl 50mg PO. With close monitoring, the patient returned to baseline and was returned home with a friend as a driver.
crying > 1/2hr, inconsolable, blue hands & feet, t100 ax, BP 84/42, P164, R56;no shock;responsive;gave Ibuprofen-calmed w/bottle;went home w/mom;f/u TC 16AUG97 doing well no s/s x/sl irritability;
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 78-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Mar2021 as dose 1, single (Lot number: ER8727), in left arm, on 13Apr2021 as dose 2, single (Lot number: EW0162), in left arm, on 16Oct2021 as dose 3 (booster), single (Lot number: FE3590), in left arm and on 23May2022 as dose 4 (booster), single (Lot number: WM3144) at the age of 77 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LISINOPRIL. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 18Aug2022, 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; Positive, notes: Then I went into rebound Covid. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: Patient received other medications in two weeks. Anti viral treatment for COVID 19 with Paxlovid (Lot Number: 6D5273) from 18Aug2022 to 23Aug2022. After the first day of Paxlovid patient said that it had helped and was improving. However, a few days after the last dose that seemed to reverse. Then patient went into rebound Covid. Patient think that would not be happened if she had a day or two more of medicine. Patient still have some lung congestion and fatigue. Patient had allergies and other medical history many.  Follow-up attempts are completed. No further information is expected.
pt recv vax 6JAN99 & 2 days later pt exp a loss of appetite;10JAN99 pt devel a fever of 99.9;pt recovered by 11JAN99;
patient received the QUADRACEL vaccine instead of the PENTACEL vaccine by accident with no reported adverse event; Initial information received on 22-Jun-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 2 months old male patient received the diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (MRC5) vaccine [Quadracel] instead of the Pentacel vaccine by accident with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) for Prophylactic vaccination; and PNEUMOCOCCAL VACCINE CONJ (PNEUMOCOCCAL CONJUGATE VACCINE) for Prophylactic vaccination.  On 02-Jun-2022, the patient received 0.5ml dose of suspect diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (MRC5) vaccine, suspension for injection (lot C5862BA; expiry date; 01-Apr-2023; strength and not reported) via intramuscular route in the right thigh for prophylactic vaccination.  On 02-JUN-2022, it was reported that patient received the quadracel vaccine instead of the pentacel vaccine by accident with no reported adverse event (wrong product administered) (latency same day).  It was asked "if the child should get a separate HIB injection and what would the proper diluent be"  Action taken : Not applicable.  At time of reporting, the outcome was Unknown for the event patient received the quadracel vaccine instead of the pentacel vaccine by accident with no reported adverse event.   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 guidelines. 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.
It's been a while since this started but my oxygen level started dropping into the 80s and I start gasping for breath bringing it up into the 90s again. It happens for sometimes just a few minutes and sometimes for hours. I went to urgent care and the doctor assumed it was asthma though it wasn't happening anymore when I got there and put me on prednizone for maybe 10 days. It stopped after about 4 days on medication and started up again a couple days after it was gone so my doctor gave me about 3 weeks of prednizone but it didn't help. The whole time I was having albuterol via nebulizer which didn't help either. About a month after the loss of breath started I had palpitations and my pulse got as high as 176 while my bp got as low as 78/50 so I went to the er only it stopped before I got there. Since then I've been to the er 4 more times. I had an angiogram and have clear arteries, I had a sleep study with no results yet, I had a pulmonary function test which I passed. They just don't know what is happening still.
Patient experienced itching. Patient was given dihenhydramine 25mg oral solution. Patient left after observation period
Mild erythema and swelling of right thigh warm to touch, no bruising, no fever.
1.)  Rash with blisters in center of chest. 2.)  Fever/shaking 3.)  Headache 4.)  Abdominal Pain / Diarrhea 5.)  Burning sensation (skin)
08-29-2022 at 1320: Immediately after giving the vaccine ID, skin around the vaccination site turned pink. Patient was not reporting any side effects. Patient was sent to monitoring and was supervised under an RN. At 15 minutes, myself (RN, PHN) and RN who was monitoring the patient noticed 3 welts on the arm, and redness had spread locally around the forearm. Patient did not report any itchiness, difficulty breathing, pain. Redness and welts were not identified  on other parts of the body, only remained localized on the forearm.  I brought in another RN for guidance and this RN confirmed patient did not have a history of allergies, advised patient to take benadryl, and contact the facility advice line since this individual was a facility patient. RN provided Facility advice phone number.  08-31-2022 at 1038 I called the patient to follow up with the vaccination site on the left arm. It was unclear if the patient had taken benadryl. Patient reported that the welts  and swelling had gone down when the patient went home. Patient reported they did not contact the Facility advice number. Patient reported they did not have any new side effects  and only reported redness at the time of the phone call.
A nurse reported that a pt received an injection of Flu Shield on 11/16/2000 and subsequently developed an injection site reaction characterized by a reddened area.
Swelling of face Rash Itching From initial information received on 11/17/2003 from a health care professional regarding an adverse event occurring in the U.S.A., it was reported that a 46 year old male patient received a dose of FLUZONE SV '2003-'2004 USP, lot number U1095AA, administered intra-muscularly in the right deltoid on 10/11/2003. Within one hour of vaccination, the patient developed facial swelling, itching and rash on the upper trunk and face. Reportedly, the patient did not recover from these events. It was reported that the patient is allergic to the flu vaccine. From additional information received on 02/25/2004 from the initial reporter, it was reported that the patient did not receive any other vaccines within four weeks of receiving FLUZONE SV '2003-"2004 USP. Reportedly, the patient recovered from these events. No further information is anticipated, this case is considered closed.
Mini-POD at Mall.  While in waiting area post-vaccination became light headed, ears ringing, lost consciousness for 1-3 secs.  Lowered to mat on floor, legs elevated, cold pack to back of neck.  Regained consciousness, rested 20-30 minutes and left with parents.
WEAKNESS; FATIGUE; LOSS OF APPETITE; NAUSEA; This spontaneous report received from a patient concerned a 70 year old female. The patient's height, and weight were not reported. The patient's past medical history included Covid-19 infection, and concurrent conditions included floxacin allergy, non alcohol user, and non smoker, and other pre-existing medical conditions included the patient did not had history of any drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 07-APR-2021, the subject experienced loss of appetite. On 07-APR-2021, the subject experienced nausea. On 08-APR-2021, the subject experienced weakness. On 08-APR-2021, the subject experienced fatigue. On JAN-2021, Laboratory data included: COVID-19 virus test positive (NR: not provided) positive.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from loss of appetite, and nausea on 09-APR-2021, and had not recovered from fatigue, and weakness. This report was non-serious.
chronic pain all entire head; severe muscle ache and joint pain; severe muscle ache and joint pain; extreme fatigue; chest pain; Nausea; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  An adult male patient received bnt162b2 (BNT162B2), on 21Feb2021 as dose 1, single (Lot number: EN9581) at the age of 21 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Chronic depression" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "OCD" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN; FLUOXETINE; NORTRIPTILINA. The following information was reported: HEADACHE (non-serious), outcome "not recovered", described as "chronic pain all entire head"; MYALGIA (non-serious), ARTHRALGIA (non-serious), outcome "not recovered" and all described as "severe muscle ache and joint pain"; FATIGUE (non-serious), outcome "not recovered", described as "extreme fatigue"; CHEST PAIN (non-serious), outcome "not recovered"; NAUSEA (non-serious), outcome "not recovered". The events "chronic pain all entire head", "severe muscle ache and joint pain", "extreme fatigue", "chest pain" and "nausea" required physician office visit.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300400483 Same Reporter/Patient/Drug/AE, Different Vaccine Dose;US-PFIZER INC-202300400482 Same Reporter/Patient/Drug/AE, Different Vaccine Dose;US-PFIZER INC-202300397042 Same Reporter/Patient/Drug/AE, Different Vaccine Dose;
Fatigue, mild fever, joint ache, muscle ache, headache, eye pain (had underwent LASIK recently, date of vaccination was LASIK POD#18, but that eye pain had entirely resolved at least a week ago, now recurring), mild chills.  (Instructed by employer to include this in Item 18: Pfizer-BioNTech COVID-19 Vaccine EUA)
pt recv vax & exp place in throat that hurt & nose was clogged followed by a cold developing in chest; pt felt anxious & weak; pt seen for episode of sinusitis;