chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient had change in hearing and tinnitus after first dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional and describes the occurrence of TINNITUS (Patient had change in hearing and tinnitus after first dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hearing loss (Pre-existing hearing loss).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TINNITUS (Patient had change in hearing and tinnitus after first dose). At the time of the report, TINNITUS (Patient had change in hearing and tinnitus after first dose) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-080311 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-080311:crosslinked
Patient presented in office due to small red bump on left thigh over injection site that was hard to the touch. Per mother she explains that it was present since date vaccine was administered. Provider ruled outcome as Serum reaction due to vaccination. Patient did not present with discomfort and was able to ambulate without problems. Patient will follow up in about 2 weeks.
Overall leg soreness; basically both of my legs have a lot of extra soreness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65 year-old female patient received bnt162b2 (BNT162B2) (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: PAIN IN EXTREMITY (non-serious), outcome "not recovered", described as "Overall leg soreness; basically both of my legs have a lot of extra soreness".  Additional information: Well she just had some overall leg soreness since she had the 1st shot, it started couple of days after she had the 1st shot which was not on past Thursday but she guess on 22nd this is when she had the shot and then she had a overall soreness in her leg since the 24th and she don't know if its related or not but it was been persistent enough. When confirmed the shot as Pfizer Covid 19 vaccine, patient stated, Yes it was on 22nd it was just after the 1st shot. When paraphrased the concern, patient stated, Yes, it was primarily, basically both of her legs had a lot of extra soreness that had not been going away and she don't know for sure if its related to the vaccine. When asked if wanted to report or wanted to know why it was happening, consumer stated, Yes, of Couse she don't know if its the common thing and she queried for what could be the cause if any suggestion or this was a common thing.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Red, hot temp 102 degrees, (L) arm 5-6 inches in diameter. On 3/31/10 - called to check on pt & stated almost back to normal.
she administered a one-day old expired PENTACEL vaccine to a patient with no reported adverse event; Initial information received on 19-Oct-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 9 months old female patient who was administered a one-day old expired Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel (Vero)] vaccine with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine Suspension for injection (lot number: UJ794AB) (Expiry date: 08-Oct-2023) (with an unknown strength) via unknown route in unknown administration site for immunization.  On an unknown date, the patient was administered a one-day old expired Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) vaccine with no reported adverse event (expired product administered) (latency: same day).  It was reported, Medical assistant called stating that she administered a one-day old expired PENTACEL vaccine to a patient. She is calling to inquire if she needs to revaccinate.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
1st and 2nd doses in 2006, now wants 3rd dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 58-year-old male patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (1st dose received on 14th July 2006) and Twinrix (2nd dose received on 14th August 2006).   On an unknown date, the patient did not receive the 3rd dose of Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced incomplete course of vaccination (Verbatim: 1st and 2nd doses in 2006, now wants 3rd dose). The outcome of the incomplete course of vaccination was 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: 01-MAY-2023 A pharmacist reported that a patient would like to get the 3rd dose. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up via email. Till the time of reporting, the patient did not receive 3nd dose of Twinrix, which led to incomplete course of vaccination. Details pertains to 1st dose of Twinrix in product tab
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Pharmacist).  A 59-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of covid-19, drug ineffective.  No Follow-up attempts are Possible. No further information is expected.; Sender's Comments: Based on available information a contributory role of BNT162B2 to the reported events Covid-19 and Drug ineffective cannot be totally excluded as efficacy of a drug varies from individual to individual depending upon the immune status. As with any vaccine, vaccination with BNT162B2 may not protect all vaccine recipients, so the expectedness of covid-19 and drug ineffective is : expected. The case will be reassessed further upon receipt of additional information.
8/19/02 c/o legs hurting. 8/22/02 could not walk. Evaluated at health care. Spinal tap done in ER diagnosed with Guillain Barré syndrome. Transferred to hospital. 9/22/02 discharged from hospital. Receiving physical therapy and starting to walk again. The discharge summary states behavior abnormal.
Pink papular rash started in left hand, belly buttom, neck, scalp and back. Discreet pink papules, vesicles,pruritic consistent with varicella.
Three swollen lymphs in the left side spread between armpit, chest, clavicle; Body aches; First day after vaccination experienced extreme fatigue; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: PFIZER ER8734) via an unspecified route of administration in the left arm on 07Apr2021 at 17:15 (at the age of 33-year-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. The patient did not receive any other medications within two weeks of vaccination. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 08Apr2021 at 12:00, first day after vaccination, the patient experienced extreme fatigue and body aches. On 09Apr2021 Second day after vaccination, the patient developed three swollen lymphs in the left side spreaded between armpit, chest and clavicle. No therapeutic measures were taken as a result of reported events. The clinical outcome of the events body ache, extreme fatigue and swollen lymphs were not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Parents report a 5 day period, immediately following the day on which the pt received his vaccinations, during which he had decreased activity and was not acting like himself.
Around 6 pm on the ninth, I started to feel lethargic; really lethargic. 8:30 pm - 100.5 fever. 09:00 pm I had chills that shook my body. Very intense. Extreme body aches and especially legs which prompted me to use a weighted blanket. That was all overnight and excessive sweating overnight. That may have been from the fever. I had nausea that started around midnight. That was mild. I did notice a little bit of a headache at that time as well which was mild. Saturday, fever all day, fatigue. Overnight that night - a little achy; but the chills had gone away. Tuesday night the body aches had gone away - they had diminished Saturday- Monday. I had body aches until about 6 or 7 pm on Monday. The fatigue -all this week I've still been dragging - I'm still tired. The fever would go up and down with Tylenol but I needed it until Sunday night. Headache - the first one was gone Saturday morning. I had a headache  Sunday evening and Monday morning. It was gone about lunch time.  The injection site was tender with the delivery of the shot until Sunday when I went to bed. It was not pain but just tender to the touch. Usually that happens with any shot for me but usually it doesn't stay tender for that long. April 13th - Televisit with a Physician's Asst in my doctor's office.
I woke up about 11PM the same day of vaccination with 103 fever, that stuck around till 11AM the next day, I also had body ache, joint pain and a terrible headache. For a week I had tension migraines and in the ten following days of the vaccine I got hives that were really itchy. It was spreading so quickly that I decided to go into an urgent care. I got the hives on my face as well. Doctor diagnosed as urticaria and she basically said that was a reaction to the booster vaccine. I was prescribed hydroxyzine 25MG every 4 hours for 7 days. This medication I started on 12/23/2021 and I still have hives all over my body, my skin is very sensitive so it is still not gone completely.
Error: Bivalent vaccine administered instead of the 2023-2024 formulation.
Developed A-Fib 2 weeks after getting 2nd vaccine and an exacerbation of Fibromyalgia.  The Fibromyalgia improved for the most part after about 2 months.  The A-Fib episodes started about 6 weeks apart and became more frequent (3-4 weeks) apart over the course of a year.   I went to the ER about 5 times in 2021/early 2022.  One of the times they had to jump start my heart to get it back onto sinus rhythm.   I had an ablation in early April.  It so far has been successful but I was reluctant to get the 3rd dose.  I finally went ahead and got the 3rd dose about 3 weeks ago, but changed to Pfizer.  I then had 2 weeks of episodic tachycardia for periods of time lasting anywhere from 10 min to 3 hours.  It has since settled down without any intervention.  Exacerbation of fibromyalgia symptoms was minimal.
Got covid; Got covid; 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 25 year-old male patient received bnt162b2 (BNT162B2), administration date 26Apr2021 (Lot number: EW0172) at the age of 25 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "All nuts allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1 , Batch/Lot No: ER8737), administration date: 02Apr2021, for Covid-19 immunisation. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 26Dec2021, outcome "recovering" and all described as "Got covid". The patient underwent the following laboratory tests and procedures: sars-cov-2 antibody test: (30Dec2021) positive. Therapeutic measures were not taken as a result of vaccination failure, covid-19.  Additional information: The patient got covid with the following symptoms: cough, sore throat, fatigue, stuffy nose. There was no prolonged hospitalization. No treatment was received. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination the patient has been tested for COVID-19.
Administration after a below temperature excursion; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Boostrix and Boostrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was 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: 30-SEP-2022 Reporter's Comments: The health care provider called on 30th Sep 2022 to report a below temperature excursion where Boostrix and Shingrix were exposed to 27 degree F from the period of 27th July 2022 until 22nd Sep 2022, due to a malfunction of their fridge. The HCP reported that during that period a total of 20 patients might had received these vaccines,15 patients received Boostrix and 5 patients received Shingrix. The expiration dates or any patients information was handy at the time was asked. The lot number was not provided. The vaccine administration facility was the same as primary reporter. The reporter consent to follow up. Additional supportive information: The patient received Boostrix vaccine for which there was temperature excursion to 27 degree F which led to incorrect storage of drug. This case is 1 of 20 cases reported by same reporter.
10 by 10 cm redness, swelling warmth of deltoid Left. similar reaction with previous, but each vaccination size of swelling redness increases.
Patient says that the day after his vaccination, the area around the injection site was red, itchy and had a "hard lump."  this persisted for 4 days, then subsided.
My son went from talking at 12 months old saying one syllable words to after getting the above injections he only would grunt and point to things.
Chills, fatgiue, major achiness in all bones, joints . . . slept 11 hours felt rotten . . . expect to be fine except for injection-site muscular soreness by tomorrow.
First Day arm sore, fatigued and cough.  Second day Chills and Fever, Body Aches, Headache, Nausous, couldn't eat or drink,  Arm sore and swollen, very fatigued, slept all day.    Third day a little better, Fourth day fine.
PATIENT HAD SLIGHT SWELLING, REDNESS AND WARMTH IN VACCINE AREA
Non Stop High piteched screaming, stiff body, refused to eat or sleep and crying lasted for 5 hours non stop when he was sleeping every 3 hours at that time.  His whole sleep schedule was thrown off after that and he had more trouble sleeping and eating than usual.
first dose of Twinrix in December 2022 and did not come back for the second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 66-year-old female patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (received 1st dose in December 2022).   On an unknown date, the patient did not receive the 2nd dose of Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced incomplete course of vaccination (Verbatim: first dose of Twinrix in December 2022 and did not come back for the second dose). The outcome of the incomplete course of vaccination was 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: 13-JUL-2023 The reporter asked if the patient had to restart the series. The reporter did not provide patient´s initials, nor the lot number and expiry date of the first Twinrix dose. The reporter consented to follow up. Till the time of reporting the patient did not receive the 2nd dose of Twinrix, which led to incomplete course of vaccination.
Right arm developed an extreme pain; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP 7534), via an unspecified route of administration in the left arm on 19Mar2021 at 14:00 (at the age of 34-years-old), as a single dose for COVID-19 immunisation. Medical history included polycystic ovarian syndrome. The patient had no allergies to medications, food, or other products. The patient did not receive any medications within 2 weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccination. On 20Mar2021, the patient developed an extreme pain in right arm. The patient received vaccine on left arm, however, the next day right arm developed an extreme pain that disabled the patient from using the whole right arm. The pain had lasted for one week. On an unspecified date in Mar2021 (reported as for the past two days), the pain had slowly been wearing off however the patient still had difficulty using the right arm at 100%. This event resulted in doctor or other healthcare professional office/clinic visit. The patient received ibuprofen (MANUFACTURER UNKNOWN) as treatment for the event. The clinical outcome of the event extreme pain in right arm was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
12 hrs later woke up with fever, nausea, migraine lasted 24 hrs, took ibprofen every 6 hrs for 24 hr period once symptoms began. Did not fully recover until 72 hrs later full appetite back, headache gone
I began running a fever of 101F which lasted approx. 36 hours.  Also lethargy and slight headache.
Drug ineffective; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27Sep2022 as dose 5 (booster), single (Lot number: 027L21A) at the age of 77 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Sulpha drugs" (unspecified if ongoing). Concomitant medication(s) included: ROSUVASTATIN, start date: 01Aug2021, stop date: 31May2023; LISINOPRIL, start date: 01Aug2021. The following information was reported: COVID-19 (medically significant) with onset 2023, outcome "unknown"; DRUG INEFFECTIVE (medically significant) with onset 2023, outcome "unknown". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included treatment with Paxlovid from 31May2023 to 05Jun2023.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300219453 Same reporter/patient, different product/AE.;
9 years old received a Havrix adult dose; 9 years old received a Havrix adult dose; This case was reported by a nurse via call center representative and described the occurrence of overdose in a 9-year-old patient who received HAV (Havrix adult) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Havrix adult and Havrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Havrix adult and Havrix Pre-Filled Syringe Device, the patient experienced overdose and adult product administered to child. On an unknown date, the outcome of the overdose and adult product administered to child 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 details were provided as follows: The age at vaccination was not reported. The 9 years old had been administered with a Havrix adult dose, which led to overdose and adult product administered to child. The reporter consented to follow up.
- First COVID shot on April 22. No immediate symptoms  - On May 2 morning, woke up with very strange chest/heart pain that I've never felt before in my life. Few hours later felt strange sensations in chest area, almost sharp/stabbing. I had to stop working to walk around for several minutes before I started feeling better. Entire day felt light headed with chest pain  - May 3, felt the same thing. - May 4, same thing, so called my doctor. She said to come back if lasted more than 2 weeks - For the next few days (total about a week) I continued to experience strange heart symptoms: strange chest pain/sensation, heart palpitations, feelings of weakness, shortness of breath, light headedness. Overall, my heart felt "weak"