chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Administered vaccine after 33 days in the refrigerator; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator) in a 67-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator). On 18-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant products were reported. No Treatment medication were reported.
On 04/09/2021, I began having a headache and diarrhea for 3 weeks. I went to the doctor and labs and blood test were normal.
He is admitted at this for Covid 19, mentioned shortness of breath; He is admitted at this for Covid 19, mentioned shortness of breath; This is a spontaneous report from a Pfizer-sponsored program . A contactable healthcare professional (specialty: pulmonary critical care) reported that a male patient of an unspecified age received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunisation.  The patient medical history was not reported. Concomitant medication included prednisone and an unspecified other medication that was 20 mg or something else; both taken for an unspecified indication, start and stop date were not reported. It was reported that patient received the first dose of COVID vaccine already and he was admitted at the hospital for COVID-19, mentioned shortness of breath, scheduled for the second dose on the 30th and she wants to further discuss providing if it is safer for him to take the vaccine, he is on different medication as well she mentioned prednisone and other that a 20 mg or something else. It was reported that patient was admitted at this for COVID-19 mentioned shortness of breath on unspecified dates. The outcome of the events was unknown.   Follow-up attempts are completed. Information about lot/batch cannot be obtained. No further information is expected..; Sender's Comments: A contributory role of BNT162B2 to event he was admitted at the hospital for COVID-19, mentioned shortness of breath cannot be excluded based on limit information.
Hearing loss and ringing in left ear.   Hearing is only about 10%.  Shortly after getting 1st shot, my household also get colds.  I went to doctor and was prescribed Amoxacilin.   I thought hearing loss could have been from minor infection.  Once antibiotics were complete and I still could not hear (& tinnitus) I went to primary doctor and he prescribed Methylprednisolone (a steroid).  That treatment has now completed and hearing loss & tinnitus still persist.
Received 2nd Hepatitis B immunization 12/11/2008 at approximately 10 A.M.  Patient began experiencing an itching sensation mainly on the facial area at about 11 A.M.  Reported to the vaccine administrator at 2:45pm.  At that time the itching also affected jaw/neck.  She also had developed red blotchy patches (mild) and hives on the face/jaw/neck.  This was reported to the on-call physician who advised patient to take diphenhydramine and counselled regarding potential outcomes and guidelines for outcomes.  Patient took the Benadryl, had two episodes of vomiting in the PM.  By the next day the itching, blotchy areas, and hives had resolved.  Patient recovered without further treatment.  Physician also advised patient receive no further Hepatitis B vaccination.
Chills; Sweats; Muscle pain; Joint pain; Slight less taste sensations; This is a spontaneous report from a contactable consumer or other non hcp.  A 59-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number and expiration date: unknown) dose 1 via an unspecified route of administration on 20Jan2021 (at the age of A 59-years-old),  as single for covid-19 immunization. The patient medical history was not reported. The patient concomitant medications were not reported. On 27Jan2021, the patient had experienced some chills, sweats, muscle pain, joint pain, and slight less taste sensations.  The patient asked it would that still be from the first dose of the vaccine. Patient mentioned that he will call his doctor first then report online. No treatment was reported. The outcome of events was unknown.   Information about batch/lot number has been requested.  Follow-up attempts are completed. No further information is expected.
Patient had vasovagal reaction: lightheadedness, low blood pressure, tachycardia. Was taken to ED, and had resolution of symptoms with laying supine. Was given 1L NS, and EKG, CBC, Chem 8, and UA normal. Patient was discharged from ED.
had redness & swelling in lt extremity from shoulder to elbow & itching 4 hrs p/vax
Pt developed swelling, redness, and warmth at the injection site. Area was noted to be approximately 3"x3". Relieved over several days after Benadryl, Ibuprofen.
dose administered to patient after more than 1 temperature excursion; dose administered to patient after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003B21A and 031L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Feb-2021 at 2:37 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 21-Mar-2021 at 2:51 PM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On an unknown date, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment and concomitant medications were reported. Age of patient was reported as 28.48 for dose administered on 14-Feb-2021 and 28.57 for dose administered on 21-Mar-2021. Batch number 031L20A underwent temperature excursion on 14-Feb-2021 with temperature 32 degrees Fahrenheit and 35 degrees Fahrenheit from 9:00 AM to 02:00 PM. This vial was moved to fridge on 09-Feb-2021 and beyond use date for the vial was reported as 10-Mar-2021. Product moved to clinic on 13-Jan-2021. Batch number 003B21A underwent temperature excursion on 21-Mar-2021 with temperature 32 degrees Fahrenheit and 34 degrees Fahrenheit from 9:00 AM to 11:00 AM. This vial was moved to fridge on 16-Mar-2021 and beyond use date for the vial was reported as 15-Apr-2021. Product moved to clinic on 21-Mar-2021. Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.   This case was linked to MOD-2022-566976 (Patient Link).
Received varivax vaccine on 8/7/01 in the office. A few minutes, post vax, a hive developed near the injection site. Ice pack applied and 1/2 tsp Benadryl given. Waited in office for 30 minutes with no further adverse reactions noted.
Deep Vein Thrombosis; Superficial Thrombophlebitis. Treatment: Xarelto. Outcome: Resolved
Heart racing, noticed hearts beats going to 131 max. Sustained high heart beats. Heart racings observed 3 times from 10 AM - till 3 PM.
Pt was given J&J vaccine while lying down. patient passed out in waiting area 15 min after COVID vaccine was administered. wife was with patient in waiting area. Patient was sitting in chair when passed out. wife lowered him to floor. no injury sustained. pt was attended to by clinic staff. patient transferred to cot and recovered in separate room. vitals were taken, pt monitored in clinic for approx. 1 hour. pt discharged in wife's company after he was awake, alert, had eaten some crackers and drank some juice. pt did report he has a history of passing out when giving blood in past.
feel exhausted; have chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid 19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 Immunization; Comirnaty (DOSE 3 (BOOSTER), SINGLE), for COVID-19 Immunization. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "feel exhausted"; CHILLS (non-serious), outcome "unknown", described as "have chills". The events "feel exhausted" and "have chills" required physician office visit.  Additional information: Reporter also mentioned that he and his wife were at the doctor's office all day. He was told by the doctor that people can feel like they have COVID after receiving the vaccine. He stated that after receiving their second Pfizer Covid-19 booster, they have chills and feel exhausted. He is not happy with Pfizer right now.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200826818 same reporter, vaccine, event with different patients;
Pt had HPV #1 done 9/9/15 - had seizure on 10/11/15. There is no specific correlation b/w (2) however neurology can also not explain the sudden seizure.
This is a spontaneous report received from a contactable reporter (Pharmacist). The reporter is the patient. A 30-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm right, administration date 03Feb2021 16:30 (Lot number: EL9262) at the age of 30 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Known allergies:Cantaloupe" (unspecified if ongoing), notes: Known allergies:Cantaloupe. Concomitant medications included: AIRBORNE; ADVIL [IBUPROFEN], and "MULTIVITA".The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 03Feb2021 18:30, outcome "recovered", described as "Sore arm for 2-3 days". Therapeutic measures were not taken as a result of pain in extremity. The patient did not receive treatment for the event. The patient did not receive other vaccines in four weeks. The patient was not diagnosed with Covid prior vaccination and was not tested post vaccination. No follow-up attempts are possible. No further information is expected. Sender's Comments: Linked Report(s) : US-PFIZER INC-2021219722 same patient/vaccine, different dose/event.
pt felt faint p/entering hallway following vax;brother reported legs wobbled & began to faint;color pale;staring blankly;responded to verbal & tactile stimulation;episode of nausea;no vomiting;color & responsiveness faded & improved x3;
7-8-10 mother returned to office after she had called 911 and child was examined by paramedics for imz rxn. Child crying with red legs and spots on his legs. Eyes rolled back. No LOC. At OV child consolable with few blue/red macules on lower extremities. Sent home after reevaluated.
Some pain in the arm where the vaccine was injected; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Some pain in the arm where the vaccine was injected) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) 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 VACCINATION SITE PAIN (Some pain in the arm where the vaccine was injected). At the time of the report, VACCINATION SITE PAIN (Some pain in the arm where the vaccine was injected) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information were not provided.   No concomitant medications were reported.
patient was extremely nervous to get the vaccination and finally was able to receive the FLUMIST product without any issues.  The patient then proceeded to leave the area after about 10 minutes of remaining in the vaccine room with her family.  When the family was near the check out of the store the patient reported severe drowsiness and felt very lethargic.  Patient returned to the pharmacy and continued to report severe drowsiness and "just wanted to go home".  Patient was provided a cool cloth on the rear of her neck, cool water to sip and a couple pieces of candy to suck on when she was more calm.  paramedics did evaluate her for heart arrhythmias, none detected, they then tested her blood sugars and she came in at 133.  Patient began feeling a lot better and left without further medical care.  Mom of patient reports that patient ate her full dinner and drank and had no further issues for the evening.
Mom refer PT; started w/high fever 39.5 C p/vax; appr .5 hr p/vax started w/high-pitch crying that last about 5 hrs; shake develops; induration @ both thighs;
18 days p/vax given pt devel very, red, hard lump the size of fifty cent piece to rt leg;has a very fine rash around bump & blister looking areas on top bump;examined by MD
PATIENT REPORTS RASH AND SWOLLEN AT SITE ON INJECTION AND ITCHY.
The client passed out losing consciousness for approximately 30 seconds after receiving vaccine. After rest and juice she fully recovered .
Patient states 3 days after receiving the vaccine his left arm went numb causing him to drop a cup he was holding.  Also had numbness in left lower extremity  as well as persistently elevated heart rate, dizziness, and weakness.  Presented to his primary care physician on 4/12/21 with the above complaints (records obtained and reviewed to get details of symptoms).
Noticed itching of the injection site area on 1/7, the next morning it looked like a local reaction with redness, warm and sore to touch.
Stevens-Johnson Syndrome; A spontaneous report was received from a health care provider regarding a 71-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Stevens Johnson Syndrome, which results in blisters and rashes all over the body.  The patient's medical history not included. No Concomitant medication was provided.  On 02 Feb 2021, prior to the onset of the events, the patient received one of two planned doses of mRNA-1273 (Lot number: 025L20A) for prophylaxis of COVID-19 infection.    On 03 Feb 2021, the day after the mRNA-1273 vaccine was given, the patient experienced Stevens Johnson Syndrome, causing rashes and blisters all over her body.  Treatment information was not reported.   Action taken with mRNA-1273 was not reported.  The outcome of the events, Stevens Johnson Syndrome, causing rashes and blisters all over the patient's body, was not reported.; Reporter's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
Was very sick last night with chills, fever and muscle soreness. Today I have chest pain and nausea.
Could hardly walk; Sty in eye; Body ached terribly; Body ached terribly, especially her legs,feet; Body ached terribly, especially her legs,feet and back; Tired; Didn't feel good; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Didn't feel good), PAIN (Body ached terribly), PAIN IN EXTREMITY (Body ached terribly, especially her legs,feet), BACK PAIN (Body ached terribly, especially her legs,feet and back) and GAIT DISTURBANCE (Could hardly walk) in a 75-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 ACHILLEA MILLEFOLIUM, CRATAEGUS MONOGYNA, OLEA EUROPAEA, VALERIANA OFFICINALIS, VISCUM ALBUM (BP (BLOOD PRESSURE)) and THYROID for an unknown indication.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, the patient experienced MALAISE (Didn't feel good). On 05-Feb-2021, the patient experienced FATIGUE (Tired). On 06-Feb-2021, the patient experienced PAIN (Body ached terribly), PAIN IN EXTREMITY (Body ached terribly, especially her legs,feet) and BACK PAIN (Body ached terribly, especially her legs,feet and back). On an unknown date, the patient experienced GAIT DISTURBANCE (Could hardly walk) and HORDEOLUM (Sty in eye). The patient was treated with IBUPROFEN at an unspecified dose and frequency; PARACETAMOL (TYLENOL) at an unspecified dose and frequency and NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency. At the time of the report, MALAISE (Didn't feel good), PAIN (Body ached terribly), PAIN IN EXTREMITY (Body ached terribly, especially her legs,feet), BACK PAIN (Body ached terribly, especially her legs,feet and back), GAIT DISTURBANCE (Could hardly walk), HORDEOLUM (Sty in eye) and FATIGUE (Tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-086842 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2021: Follow up received on 22/4/2021 :TCR: AE updated, will not complete ADR form.
Pt reported that 1 day post vax she developed an injection site reaction characterized by a red, hot, flaming area extending from elbow to shoulder and arm pit. On 10/18/00 she developed a fever of 102F. As of 10/19/00, her symptoms were resolving. This is 1 of 2 pts from this facility who had an adverse experience following receipt of Pnu-Imune-23, lot 468-136. Follow-up info recvd from MD on 3/12/01 indicated that the pt was seen twice by MD. She recovered.
This non-serious spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 16-Aug-2018 by Seqirus from VAERS (VAERS ID: 719522), concerns an adult female patient of unspecified age. On an unspecified date in 2016, the patient was administered influenza vaccine (dose, anatomical location, batch number, route of administration, expiry date, trade name, manufacturer: not reported). On an unspecified date in 2016, after vaccination, the patient developed redness and swelling at injection site. At the time of this report, the outcome of the events was not reported. This case was cross linked to case 201803418 due to same patient.
pt immediately felt warm and started having severe back pain to the point where he agreed to call an ambulance, pain intensified. Then was starting to have same feeling in both legs. Paramedics arrived and symptoms started to subside. They took his vitals and everything was ok. Said he still felt off but didn't want to go to hospital since the intense pain had gone away. Still sat in pharmacy for a bit and then I offered to call someone to get him. He just asked that i follow him as he walks to front door. I called twice this evening and he said he is feeling better
Site: Redness at Injection Site-Mild, Systemic: Headache-Mild, Additional Details: Rash presented at injection site to top of shoulder, the size of a deck of cards.
patient called today (11/1) and said she has had severe sore arm with severe redness and swelling on arm where she had injection. Patient has been managing side effect with cold pack, tylenol, ibuprofen, and benadryl OTC since symptom onset on 10/29/21, but symptoms have not resolved yet so she would be scheduling an appointment to see physician at clinic.
lymph nodes on supraclavicular region were swollen; lymph nodes on supraclavicular region were tender; This is a spontaneous report from a contactable consumer (patient). A 32-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Lot Number: EN6205; Expiration date was not reported), via an unspecified route of administration, administered in the left arm on 07Mar2021 01:00 PM (at the age of 32-years-old) as dose 2, single for COVID-19 immunisation at a Clinic/facility. Medical history included cashews allergy and nickel allergy, both from an unknown date and unknown if ongoing. Concomitant medications included testosterone cipionate, glycyrrhiza glabra (LICORICE), adrenal gland, aminobenzoic acid, calcium pantothenate, pyridoxine hydrochloride, riboflavin (ADRENOGEN); all taken for an unspecified indication, start and stop dates were not reported. The patient was previously vaccinated with BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Lot Number: EL9267; Expiration date was not reported), via an unspecified route of administration, administered in the right arm on 13Feb2021 (at the age of 32-years-old) as dose 1, single for COVID-19 immunisation. No other vaccine was received by the patient in four weeks. The patient had no COVID prior vaccination and was not tested for COVID post vaccination. On 08Mar2021, patient experienced that the lymph nodes on supraclavicular region were swollen and tender. First area was within 24 hrs, second area was within 48 hours. No treatment was taken for the events. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Child awoke at night with arm pain, no visible abnormalities at that time.  24 hours after shot, erythema and calor developed in a 5" diameter area around shot site in Left Deltoid (as of this writing at 11:45 AM 12/29/11).
headache, occasional productive cough, body aches, wheezing d/t congestion,nose bleeds. starting 10/9/21
Bilateral skin rash dx as herpes zoster. Hx of varicella at age 10 years. No underlying medical conditions reported except skin cancer removed previously.
Arrived by ambulance from an independent facility. She stated she went to the bathroom and does not remember what happened. She was found on the ground. She has a laceration to the right-side of her scalp.