chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient is experiencing a sore arm; headaches; This spontaneous case was reported by a non-health professional and describes the occurrence of PAIN IN EXTREMITY (Patient is experiencing a sore arm) and HEADACHE (headaches) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, the patient experienced PAIN IN EXTREMITY (Patient is experiencing a sore arm) and HEADACHE (headaches). At the time of the report, PAIN IN EXTREMITY (Patient is experiencing a sore arm) and HEADACHE (headaches) outcome was unknown.        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.   Patient received Tetanus vaccine and Moderna COVID-19 vaccine at same time.
muscle aches in her legs; headache; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (muscle aches in her legs) and HEADACHE (headache) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039A21A and 027A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In June 2021, the patient experienced MYALGIA (muscle aches in her legs) and HEADACHE (headache). At the time of the report, MYALGIA (muscle aches in her legs) and HEADACHE (headache) had not resolved.            No concomitant medication was reported.  No treatment medication was reported.
Pt recv vax on 7/8/98; on same day pt exp pain &swollen vax site w/ hard lump; dx=abscess; tx=incision &drainage, daily visits from nurse to pack & dress incision area
This case was reported by a pharmacist and described the occurrence of Guillain-Barre syndrome in an 83-year-old female subject who was vaccinated with FLULAVAL, (GlaxoSmithKline).  Concurrent medical conditions included neuropathy.  On 15 September 2009 the subject received 1st dose of FLULAVAL (.5 ml, unknown, left arm).  On 14 October 2009, 29 days after vaccination with FLULAVAL, the subject experienced Guillain-Barre syndrome.  On an unspecified date, at an unspecified time after vaccination with FLULAVAL, the subject experienced progressive neuropathy with demyelination.  The subject was hospitalised and the pharmacist considered the events were disabling, life threatening and clinically significant (or requiring intervention).  At the time of reporting the outcome of the progressing neuropathy with demyelination was unspecified.  Guillain-Barre syndrome was unresolved at the time of reporting.  On 15 October 2009, a health care professional (pharmacist) reported that a patient was vaccinated for seasonal influenza with FLULAVAL on 15 September 2009 at a private doctor's office.  The patient was admitted to the hospital on 14 October 2009 with progressing neuropathy with demyelination.  The neurologist diagnosed the patient with Guillain-Barre syndrome.  Any information on the progression of illness prior to the hospitalization is not known at time of report.  10/22/2009 received DC summary for hospital stay 10/14-10/21/2009. DC DX: Demyelinating inflammatory acute polyneuropathy, GBS   Patient presents with hx of c/o's numbness/tingling and weakness in all extremities that was progressive in nature. Seen by neurologist, evaluated with EMG which was abnormal. PE: noted decreased sensation to pinprick fingertips and toes, DTR's absent. Tx: IV IGG, po Neurontin   ICD-9 codes: 357.0, 276.1, 492.8, 401.9, 250.00, 272.4, 427.31, v12.54, 414.00, v45.81, v58.61, v58.63, 305.1, 412
No additional AE details; Customer calling for TE evaluation on frozen products states that 7 vaccines stored outside of recommended range were administered to patients.; inappropriate age at vaccine administration; This spontaneous report was received from an administrator and referred to a 7-week-old male patient. Pertinent medical history and drug reactions/allergies were not reported. Concomitant medication included sterile diluent.  On 12-APR-2022, the patient was vaccinated with the improperly stored (stored outside of recommended range) measles, mumps, rubella and varicella (oka-merck) virus vaccine (live recombinant human albumin (rHA)) (PROQUAD) (lot #U039258, expiration date: 09-JUN-2023) for prophylaxis (strength, dose, and route of administration were not provided) (product storage error and product administered to patient of inappropriate age).  It was reported that the suspect vaccine was exposed to a temperature of 6 Fahrenheit (F) up to 14 F (7.9 F) for a time frame of 4 hours, 8 minutes, and 0 second. There were no previous temperature excursions. No digital data logger was reported.  No additional adverse event (AE) details was provided (no adverse event).   This is one of the several cases reported by the same reporter.; Sender's Comments:  US-009507513-2205USA001205: US-009507513-2205USA001061: US-009507513-2205USA000973:02158490 US-009507513-2205USA001043: US-009507513-205USA001272: US-009507513-2205USA001271:
Mom called in stating patient has a red bump where patient received the vaccine, stated it was itching. mom treated her with Tylenol at the time.
Patient is fully vaccinated and boosted. 70y.o. female that presents shortness of breath.  She was found to have COVID 19.  She has a history of diabetes and asthma.  Patient is requiring 3 L of O2.  Patient also has a history of CKD and creatinine appeared worse today than baseline. No chest pain.  Chest x-ray shows bilateral infiltrates. Labs Cr 2.09, D dimer 592.  Treatments:  IV Dexamethasone,  Anticoagulation per protocol. Incentive spirometry and flutter valve encouraged. Proning encouraged. Wean oxygen as able. Discharged home.
Individual complained of feeling warm and faint Became flushed Placed on cot and subsequently complained of "generalized heaviness". experienced difficulty moving lower extremities against resistance. Required assistance holding glass of juice administered  BP 170/94 pulse 64 / min -0xygen  2 sat normal
This spontaneous report as received from a pharmacy technician refers to a 1 year old patient of unknown gender. Patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 19-MAR-2018, the patient was vaccinated with improperly stored dose of VARIVAX (lot # N022979, expiry 23-AUG-2019) for prophylaxis. No adverse effect was reported. The VARIVAX temperature excursion occurred on 14-DEC-2017 and 30-DEC-2017. On 14-DEC-2017, the vaccine was exposed to the temperature of 16.9 degree Fahrenheit (F) for 30 minutes. On 30-DEC-2017, the vaccine was exposed to the temperature of 6 degree Fahrenheit (F) to 14 degree F for 30 minutes. It was reported that the event was because of data logger. No product quality complaint was involved. This is one of the several reports received from the same reporter source. Sender's Comments: US-009507513-1802USA001558.
Patient had immediate blistering at the site of injection (R) deltoid area.  After couple of hours the blisters went away, then reappeared 10 days later and was brought back into the office with 4-5 erythematous vesicles.
had a reaction to it; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (had a reaction to it) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced ADVERSE REACTION (had a reaction to it). At the time of the report, ADVERSE REACTION (had a reaction to it) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medications were reported.  No treatment medications were reported.    Reporter did not allow further contact
Swollen lymph node under arm pit on left vaccinated arm, received vaccination on 12/29/21, still swollen on 01/21/2022
Vaccine was administered 7 days after vial expiration date. Parent notified by provider. Provider chosen not to revaccinate. Parent agreed, child doing well.
VARIVAX given 2/6/17. On 2/7/17 evening-local redness, swelling and warmth at site. Approx 2"x3". Swelling of glands (L) axilla.
This spontaneous report was received from an approximately 71 year old female patient, regarding herself. The patient's pertinent medical history and drug reactions/allergies were reported as none. Concomitant therapies included levothyroxine sodium(manufacturer unknown). In 2015 (about a year ago), the patient was vaccinated with ZOSTAVAX, 1 dose, (therapy route and lot#/expiry date were unknown). The patient reported that about a day after receiving ZOSTAVAX, she developed a hard lump, as big as an egg, on the under side of the right arm where she received the vaccine. Shortly after developing the lump, she also had muscle pain, like a stinging sensation, at the injection site. The patient stated that it was not painful however it was distracting. No treatment was given for the adverse events. Routine unspecific blood work up was performed. About 6 months ago the lump, decreased and was no longer there (recovered), however the muscle pain was still there (not recovered). Causality assessment was not provided. Patient sought medical attention (spoke with pharmacist). No product quality complaint (PQC) was involved. No Further adverse event information was provided. Additional information has been requested.
Patient received the primary vaccine instead of the Pfizer bivalent 5-11 vaccine.
The grandmother refers that his mother told her that the boy was scratching his hand and at night a rash appear in all his body and redness in the injection area and ears.
Sleepiness, confusion, shaking, left eye blood vessel rupture, Muscle weakness - head droops to left side and cannot get up or down without assistance, can barely walk with a walker, doesn't speak unless asked a question and delayed response, right arm jerking constantly, incontinence, itchy skin, easily distracted and forgets what she is doing
Short of breath day one, chills but hot to the touch, rapid heart Day two chest pain radiated from the left side Of the heart / chest area .  The first vaccine dose I had chest pain that also happened on the second day but radiated from Mid heart . This was discussed with doctor after it happened in Feb after the first dose via video appointment.
This spontaneous report as received from a pharmacist refers to an approximately 58 year old female patient. Concomitant medications included FOSAMAX and aspirin. No information about medical history concurrent conditions was reported. On 09-APR-2014 the patient was vaccinated with ZOSTAVAX lot # J011338 expiration date 19-DEC-2014, route subcutaneous in the back of arm and the patient developed big re area, swelling and white bumps around the injection site on 09-APR-2014. No lab investigations were performed. The outcome of big red area, swelling and white bumps around the injection site was reported as not recovered/not resolved. The patient sought medical attention. No product quality complaint was involved. Additional information has been requested.
Patient had a cardiac arrest.  There were no symptoms prior to, no history of heart issues, no high blood pressure, or any known cause for the cardiac arrest.  He passed his routine physical exam a week before the event.  During the event, patient's heart stopped.  He was gasping for air for a few seconds, then collapsed.  CPR and shock treatment with an AED were performed to restart his heart.  When paramedics arrived, they continued treatment.  Since the event, he has developed heart atrial fibrillation and cardiomyopathy.    Patient is on a number of new medications, has installed a defibrillator, and has been recommended for shock treatment to restore normal heart rhythm.  He will have 12 weeks of cardiac rehab.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 26-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), on 30Apr2021 as dose 1, single (Lot number: EW01705), in left arm, on 05May2021 as dose 2, single (Lot number: EW0187), in left arm and on 09Feb2022 as dose 3 (booster), single (Lot number: FK9729) at the age of 24 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures included Paxlovid from 15Oct2023 to 19Oct2023 were taken as a result of drug ineffective, covid-19.
After my first shot on Day 8, my left arm began to itch then swelled again and was hard/red.  I used benedryl and it went away the next day. Today, 2 days after my second shot, my arm is VERY sore and hard/red is getting bigger rather than smaller. I will use ice.  It's not itchy as of now.
Vaccine administered on 10/17/07. Patient had fever & chills on Thursday PM. States she went home and went to bed.  On Friday 10/19/07 was achey with fever & chills and stayed in bed all day.  Started feeling better Saturday PM.
COVID hit/ Can I get second shot now; This case was reported by a consumer via (Shingrix GSK Chatbot) interactive digital media and described the occurrence of social problem in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in November 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.  Additional details provided were as follows: The case was reported by patient himself/herself. Age at vaccination was not applicable for this report. The patient did not received the 2nd dose till the time of reporting due to covid which led to social problem. The patient enquired if he/she could get the 2nd dose now or have to start over again. Follow-up would not be possible as no contact details available.
Patient presented with redness on the arm where the vaccine was injected reported swelling and itching.
hours after vaccination arm soreness, stiffness in hands, two days after vaccination fatigue, breathing difficulty-feeling of tightness around rib cage, heart felt tight, headache, body aches, sinus trouble
Supposed to receive the last dose of the Kinrix vaccine but was given Boostrix by mistake; Boostrix on 6/7/2021 to a four year old; This case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 4-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number BR352, expiry date 27th August 2022) for prophylaxis.   On 7th June 2021, the patient received Boostrix. On 7th June 2021, unknown after receiving Boostrix, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.  Additional details were provided as follows: The patient was supposed to receive the last dose of the Kinrix vaccine but was given Boostrix by mistake at the age of 4 years which led to wrong vaccine administered and inappropriate age at vaccine administration. No further events were reported.  The reporter consented to follow up.
Patient received ZOSTAVAX SQ injection on 4-22-14. Patient's arm at injection site and beyond has been painful and swollen since injection. She saw her M.D. on 4-24-14 and was given cefadroxil in case of secondary infection. Pharmacy will follow-up with patient.
3/22/2021, 2:00am - Fever of 102.9 that lasted until 7:00am even after taking 400mg Tylenol. Sweats, chills, muscle and body aches continued through the night into the morning. 03/22/2021, 7:00pm - Fever of 101.2. Went away after Tylenol 400mg. Nursing child had temperature of 99.9 3/23/2021, 9:00am - large bruise over injection site
Diarrhea; Cannot talk; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 90-year-old female patient received BNT162b2 (BNT162B2), on 31Aug2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "IBS" (unspecified if ongoing), notes: Has had IBS for many years. Has been over 2 hours going to the bathroom. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 3: MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: SPEECH DISORDER (non-serious) with onset 2022, outcome "unknown", described as "Cannot talk"; DIARRHOEA (non-serious) with onset 2022, outcome "unknown", described as "Diarrhea".  Additional Information: It was stated that she had a shot yesterday and said that it could cause diarrhea effects with certain people. Has had IBS for many years. Had been over 2 hours going to the bathroom. Thought it would better to have the shot to be safe. Wanted to know if was there anything to do. Had stopped a great deal. Caller rambling on; unable to clarify details. Mentioned that she might as well go back to the doctor. Thought that she might had to go into the hospital anyway. This was unbelievable. Was for the Pfizer Bio vaccine. Cannot talk. Was kind of out of it. Had the other three shots. Was told that if she was going to have this it would be good to had it now. Had been in the bathroom for the past several hours. Wanted them to know to warn people that ever had a bowel problems. Gets to the point that she dare stand up and it runs out of her. Had never reacted to anything like this time.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Husband had COVID-19 Vaccine last 2021; Now her husband had a quadruple surgery in February; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID.  A male patient received BNT162b2 (BNT162B2), in 2021 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]), (Batch/Lot number: unknown) at 81 mg daily (81 mg, daily [per day]). The patient's relevant medical history included: "blood thinner" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: CORONARY ARTERY BYPASS (hospitalization, medically significant) with onset Feb2022, outcome "unknown", described as "Husband had COVID-19 Vaccine last 2021; Now her husband had a quadruple surgery in February". The action taken for aspirin [acetylsalicylic acid] was unknown.  Additional information: Reporter called on behalf of her husband. She mentioned that they both had COVID-19 vaccine last 2021 and at the time of report, patient had a quadruple surgery in February. She asked if it would be safe for him to take booster because they had an appointment for the Bivalent booster shot (Confirmed as Pfizer COVID-19 Vaccine) and also she mentioned that patient was taking Aspirin per day and that was 81 milligrams (Further clarification unknown, hence aspirin captured as suspect conservatively) also her husband had a blood thinner.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
A nurse reported that a male physician received an injection of Flu Shield (2001-2002 formula) and subsequently developed a fever and felt sick. No further information was available at the date of this report. This is 1 of 4 pts from this facility who had an adverse experience following receipt of Flu Shield (2001-2002 formula) lot 4018032. See MCN: HQ0185226JAN2002, HQ0408401FEB2002 and HQ0408501FEB2002.
Sore hand; little bit of a mild fever of 99F for only a couple of hours with first shot; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore hand) and PYREXIA (little bit of a mild fever of 99F for only a couple of hours with first shot) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, the patient experienced PAIN IN EXTREMITY (Sore hand) and PYREXIA (little bit of a mild fever of 99F for only a couple of hours with first shot). On 10-Apr-2021, PYREXIA (little bit of a mild fever of 99F for only a couple of hours with first shot) had resolved. At the time of the report, PAIN IN EXTREMITY (Sore hand) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Apr-2021, Body temperature: 99.0 (Borderline) Mild fever of 99.0 F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   No treatment was reported for these events.  Reporter reports that after the first shot her husband had a sore hand and a little bit  of a mild fever  of 99F for only a couple of hours   This case was linked to MOD-2021-128369 (Patient Link).
Swelling by the Jaw; This is a spontaneous report from a non-contactable healthcare professional. A 31-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER7835), via an unspecified route of administration in the left arm on 31Mar2021 at 16:45 (at the age of 31-years-old), as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient did not have any known allergies to medications, food or other products. Concomitant medications included vitamin D (MANUFACTURER UNKNOWN) started on an unknown date for unspecified indication and fish oil capsule (MANUFACTURER UNKNOWN) started on an unknown date for unspecified indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 02Apr2021, the patient experienced swelling by the jaw. No therapeutic measures were taken as a result of the reported event. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event swelling by the jaw was not recovered at the time of this report.   No follow-up attempts are possible. No further information is expected.
pt recv vax 25OCT96 & 29OCT fell & fractured hip, requiring surgery;p/surgery devel a urinary tract infect  & treated w/floxin;d/c from hosp on 1NOV;3NOV exp chest pain & rehosp;