chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial information received on 08-Nov-2018 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional. This case involves a 13 months and 27 days old patient who received second dose of 0.25 ml of FLUZONE QUADRIVALENT one week early. The patient's past medical history, medical treatment(s), and family history were not provided. No other vaccines were given. On 17-Oct-2018, the patient received first dose of 0.25 ml suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number: UT6262NA and expiry date: 30-Jun-2020) via unknown route in the right thigh and on 07-Nov-2018, received second dose of the same vaccine. It was a case of actual medication error due to Inappropriate schedule of vaccine administered. It was unknown if the patient had any 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 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. List of documents held by sender: none.
RASH ON CHEST. FEVER 99.1. IRRITABLE BEGAN 10/23/2011. SEEN IN OUR OFFICE 10/25/2011 BECAUSE RASH CONTINUES TO SPREAD. NOW ON FACE, ARMS, AND LEGS. PATIENT WITH PAPULAR LESIONS OVER BODY. MORE CONCENTRATED TO CHEST AND ABDOMEN. 0 PUSTULES. 0 VESICLES.
Nausea starting approximately 1 hr after vaccination.  Local tenderness.  Heart pounding, somewhat short of breath and Shakey.  Was seen by Dr the following day.   Had just very slight swelling over injection site, but throat non erythemitious , neck supple, lungs CTA, Heart with regular rate and rhythem without any click murmur or rubs.  No JVD, Neg HJR.
tired; headachy; hurting; sore jaw/jaw hurts; This is a spontaneous report from a contactable nurse. A female patient of an unspecified age (reported as age: 46; unit: unknown) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were unknown), via an unspecified route of administration on 07Jan2021 at 10:00 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the vaccine on Thursday (07Jan2021) at 10am from work then experienced a hurting and sore jaw later that evening. On Friday (08Jan2021), she became tired, headachy, had no motivation, and mentioned that her jaw still hurts. She reported the AEs on 09Jan2021, and mentioned that she was feeling better but her jaw hurts. The patient has not recovered from the event 'sore jaw/jaw hurts'. Outcome of the rest of the events was unknown.  Information on the lot/batch number has been requested.
High pitched cry Persistent 830AM 23AUG91 to 12 noon, t102, 26AUG91 seen by MD treatment for sore throat;
Vial was stored in refrigerator on 26-May-2022 and administered on 29-Jun-2022; Vaccine administered 3 days after beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered 3 days after beyond use date) and PRODUCT STORAGE ERROR (Vial was stored in refrigerator on 26-May-2022 and administered on 29-Jun-2022) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059A22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 29-Jun-2022 at 10:30 AM, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 29-Jun-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered 3 days after beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was stored in refrigerator on 26-May-2022 and administered on 29-Jun-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine administered 3 days after beyond use date) and PRODUCT STORAGE ERROR (Vial was stored in refrigerator on 26-May-2022 and administered on 29-Jun-2022) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient had never been diagnosed with or tested positive for COVID 19. Acute illness at the time of vaccination and up to one month before was reported as none. No concomitant medications were reported. The number of doses or vails were reported as 7. The vial was initially stored in the refrigerator on 26-May-2022. The vial had not undergone any temperature excursion. The patient had reported no side effects. Treatment details were not reported by the reporter.   This case was linked to MOD-2022-601207 (E2B Linked Report).; Sender's Comments:  MOD-2022-601207:Master case
Suspect vaccination failure; Shingles; Sore/Painful; Large patch on my mid back; rash on vaginal area; Touching it painful; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 2 years after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspect vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles), pain (Verbatim: Sore/Painful), patchy rash (Verbatim: Large patch on my mid back), genital rash (Verbatim: rash on vaginal area) and tenderness (Verbatim: Touching it painful). The outcome of the vaccination failure was unknown and the outcome of the shingles, genital rash and tenderness were not reported and the outcome of the pain and patchy rash were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, pain, patchy rash, genital rash and tenderness to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles, pain, patchy rash, genital rash and tenderness to be related to Shingles vaccine.   Additional Information: GSK receipt date: 03-MAR-2023 The case was received from the patient via interactive digital media. The patient already had Shingles shot, but about 2 years later he/she got Shingles.  It was what would be considered a mild case. The patient thought that he/she correctly self-diagnosed it at once and saw his/her physician promptly thereafter, he/she was given an injection which eases the effects of said virus.  The patient stated that he/she still had a fairly large patch on my mid back. The patient stated that the most sore was, the rash on his/her vaginal area too and with every movement or clothing touching it was painful. The patient thanked good ness that he/she was immunized.  The patient stated that a friend of mine inspired me to move in that direction, after she got Shingles on her face and she lost vision in one eye because of it. The patient requested to do get the shot anyone who had not done so. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
First day was just soreness at and around the injection site. The next day on the other hand. I woke up from what felt like hitting the exhaustion wall. Along the lines of being so worn out you can't even sleep. Along with heavy lethargy, soreness, a mental fuzziness, and a general feeling of unwell. To the point of forgoing water and food while famished as it meant having to move and stand in front of the stove. By about 1700ish I started to notice chill's/fever (I think, I did not grab a thermometer and check)  As of the time of writing this some of the lethargy has subsided. Though the rest has stuck around. Given that the second dose is more known to cause adverse effects. I am not looking forward to it. Which is to no way state that i won't go back and get my second dose. Just that at least for me are pretty rough.
Information has been received from a company representative concerning a female who approximately in February 2007 (3 months ago), was vaccinated with the first dose of Gardasil and she experienced severe genital warts. Unspecified medical attention was sought. No other information was provided. Additional information has been requested.
Early next morning noted to have difficulty with lisp which progressed over several hours to full left sided facial paralysis including eye, cheek, and lip.  Also swelling and pain from top of head all the way to neck on left side.  Still unable to drive or use left eye.
6/8/06 Telephone call from pt's mother who expressed concerns of pt having chills and weak legs with difficulty walking. To MD for evaluation.
WITHIN AN HOUR PATIENT HAD A SEIZURE, AND HAD 2 ADDITIONAL SEIZURES ABOUT 15 MINUTES AFTER THAT.  STATED THAT ARM AND LEGS WERE ALSO HURTING.  USED A HEATING PAD FOR THE PAIN.
One hour after flu vaccine was given the sign and symptoms listed started escalating in intensity: generalized body redness, feeling warmth, temp 99.5 oral, itchy around mouth, swelling left arm.
Above individual called the health center and said had a reaction after vaccinated with FLUZONE. C/O flushed face tingling and itching, coughing wheezing stridor. Onset 3 hrs after shot rec'd sx lasted 12 hours she did not seek medical attn. She took 2 puffs of a cumavent inhaler x 3 that belonged to her "client". Sx improved but still coughing. Health center consulted pt advised to go to ER for eva. and follow up with MD. Pt ate at BD party at 1pm. 11/1/08.
No treatment - Very sore arm - red streak below injection 2 in" wide and 4 in" long Spent next day (Friday) after shot in bed most of the day.  Didn't eat all day - wasn't hungry. Felt all washed out, no energy - much like COVIT that I contacted 1st week of August 2020 - but not as bad The next day (Saturday)I felt much better with some energy.  Ate a good breakfast
It?s been a week since receiving my vaccination and yesterday mid afternoon my arm began to itch. I began scratching and when I realized it was my shot I immediately stopped. I then researched to see if this was a symptom and from what I saw it was. I didn?t feel comfortable taking any medication so I just put ice on the  shot spot. The strength of the itch would vary and at times the spot would get very hot. Towards the end of the night, my whole body began to get hot so I took a shower. The shower extremely helped. I was also able to sleep without the need to itch. It?s now the next morning and the itch is slightly there, but not completely
Area where the injection is, started to get red and itchy; The area where the injection is, started to get red and itchy; cold with chills; cold with chills; sore throat; she woke up this morning all sweaty; The initial case was missing the following minimum criteria: unspecified product. Upon receipt of follow-up information on 27Feb2020, this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13) via an unspecified route of administration on an unspecified date at an unknown dose and frequency for immunization. The patient's medical history and concomitant medications were not reported. The patient previously got pneumonia vaccine three years ago with no complications, lisinopril and experienced severe adverse reaction. The patient was administered pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13) prescribed by her cardiologist who recommended to get a dose this year and one more dose one year later. The patient reported that the area where the injection is, started to get red and itchy. She stated that she had been taking diphenhydramine (BENADRYL) for the itchiness and redness that started 12 days after she got the Prevnar13. These symptoms are now gone. She mentioned she is feeling now like she is going to get a cold with chills and sore throat. She also mentioned she woke up this morning all sweaty. She asked if pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13) had similar components to lisinopril as she had a severe adverse reaction to lisinopril in the past. The outcome of the events 'area where the injection is, started to get red and itchy' was recovered, and of the remaining events was unknown.   Information on the lot/batch number has been requested.
shingles; pain from shingles/pain from them was much worst.; This is a spontaneous report from a contactable consumer or other non HCP (Patient). A 89-year-old male patient received bnt162b2 (BNT162B2, formulation; Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Right on 20Feb2021 (Batch/Lot Number: EN6ZCI) as DOSE 2, SINGLE (at the age of 88-year-old) for covid-19 immunisation. Medical history included breast cancer from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient did not receive other products. Historical vaccine included first dose of bnt162b2 on 30Jan2021 (Batch/lot number: ELGZ65, Unknown dosage shot to her right arm) for covid-19 immunisation. The patient experienced shingles and pain from shingles/pain from them was much worst on an unknown date of 2021. The patient stated that they shingles killing her and the pain was really bad. Stated that it has been one month since she was told that she had the shingles. Stated that she went to emergency room on 30Jul2021 due to shingles. The reporter stated that nurse stated that the shingles were lighter. The pain from them was much worst. The patient prescribed with prednisone twice and a low dose of Gabapentin. The patient not taken Gabapentin yet as she stated that if the other dose of prednisone helps her then she will not take Gabapentin. The doctor gave her some creamy stuff and she was doing that too. Therapeutic measures were taken as a result of the events. The outcome of events reported as not recovered.  Follow-up attempts are completed. No further information is expected.
Vaccine administration error. Patient given flu shot on 10/29/21. Patient had already had a dose on 10/02/21. This made 2 doses of flu shot for this season when only needed 1 dose. No reaction to vaccine.
Patient received ZOSTAVAX in 2008. Had shingles outbreak 2012. Eye swelled & was painful May 28th, 2012 shingles appeared 6-3-2012 5 on eyelid 1, on side of forehead, lesions crusted now.
new leucopenia in labs 01/12/2021 at Quest 2 days after vaccine.  Currently asymptomatic
4 hrs after receiving immunizations, was sent home from preschool for 100.1 temp. Today noted circumoral facial redness with fine papules, also on back. Decreased appetite X 2 days.
No additional AE; Caller reporter improperly stored and administered vaccines for MMR-II, PROQUAD, and VARIVAX to multiple patients since May 2023 (TE occurred 5/9/2023). No symptoms reported. Caller did not have specific AE information available regarding patient inf; This spontaneous report was received from other and refers to a 14-year-old patient of unknown gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 23-JUN-2023, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, lot #W001518, expiration date: 13-JAN-2024, administered for prophylaxis (strength, and route of administration were not provided); and  varicella virus vaccine live (oka/merck) (VARIVAX) injection, lot #W020540, expiration date: 28-JUN-2024, administered for prophylaxis (strength, and route of administration were not provided). This vaccine underwent temperature excursion before administration in 58.65 degree Farenheit (F) for 25 hours 45 minutes (Product storage error). No additional adverse event was reported.
Refridgeration excursions identified; No adverse event; Poor quality vaccine administered; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) and NO ADVERSE EVENT (No adverse event) in a 48-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 19-Sep-2022 at 12:46 PM, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 19-Sep-2022 at 12:46 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified) and POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered).    No concomitant products were reported.  Anatomical location for vaccine administration was reported as deltoid. It was reported that refrigeration excursions identified, state vaccine was housed in these units. There were excursions noted. Manufactures were notified and the state department and made aware of the situation.The Nurse called for a clinic that she was assisting. The clinic had a similar issue with vaccines stored in their freezer. Vaccines stored in the refrigerator that underwent several temperature excursions going back to August 2022. Date vial moved from freezer to refrigerator was 07 Sep 2022. The vial underwent temperature excursion. No adverse reactions reported for the patient.  No treatment products were reported.
She had swelling in the lymph nodes of both armpits; She got her second COVID-19 Vaccine dose on 12Apr2021, and had swelling in her arm; She got her second COVID-19 Vaccine dose on 12Apr2021, and had a little feeling of being tired for 2 days.; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 56-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number and Expiration date was unknown) via an unspecified route of administration on 12Apr2021 (at the age of 56-year-old) as a single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: unknown) via an unspecified route of administration on unspecified date in 2021 as a single dose for COVID-19 immunization. Patient got her second COVID-19 Vaccine dose on 12Apr2021, and had no big things happened/did not experienced any big reaction, except swelling in her arm (arm swelling), and a little feeling of being tired for 2 days on an unspecified date in Apr2021. She said after those 2 days she had been feeling well. She said the day before yesterday (29Jun2021), she had swelling in the lymph nodes of both armpits. She said she was going to see her doctor (about the swollen lymph nodes) but wanted to doublecheck with Pfizer to see if having the swollen lymph nodes in both armpits so long after her second COVID-19 Vaccine dose was normal. She said she knew of other people who had swollen lymph nodes in their armpit the day after getting their COVID-19 Vaccine shot. She said the swelling in the lymph nodes of both armpits was strange for her, and she wanted to contact Pfizer to see what to do to prepare for her doctor's appointment. She took tylenol and she was feeling better. She did not feel it anymore on left arm, but still feels on right arm. She stated that her husband said that patients had been reporting this effect days after, but it was been weeks after the vaccine. The outcome of the event she had swelling in the lymph nodes of both armpits was not recovered and the rest of the events was recovered on an unspecified date in Apr2021.  Follow-up attempts are needed. Further information is requested.
VOMITING; HIGH FEVER; RIGORS; MUSCLE ACHES AND PAINS; UNUSUAL PAIN AT INJECTION SITE; HEADACHE; WEAKNESS; DIZZINESS.
pt recvd Engerix-B vax on 31MAR92 & exp chills, dyspepsia & dry mouth; pale & sick to stomach;
Diagnosed with Alpha Gal Syndrome/allergy from a tick bite; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), in Nov2021 as dose 3 (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: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 Immunization; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 Immunization. The following information was reported: FOOD ALLERGY (non-serious) with onset Apr2022, outcome "unknown", described as "Diagnosed with Alpha Gal Syndrome/allergy from a tick bite ".  Additional information: Patient stated that, she has previously received 3 total doses of the Pfizer-BioNTech COVID-19 Vaccine. Patient was diagnosed with Alpha Gal Syndrome in Apr2022, following a tick bite. Patient wanted to know if they were animal byproduct on the Bivalent Vaccine because she had alpha gal syndrome and acquired the redneck allergy from a tick bite.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Salivary gland to abscess; swollen lymph nodes around my jaw; It is swollen and sore; they are on my jaw more so then my neck/ Jaw was swollen, sore and tender; Jaw was swollen; couldn't eat; The initial safety information received was reporting only non-serious adverse drug reaction(s), Upon receipt of follow-up information on 20Oct2021, this case now contains serious adverse reaction(s). Information processed together. This is a spontaneous report from a contactable consumer (reporting or self).   A patient of unspecified age and gender received BNT162b2 (COMIRNATY), dose 2 via an unspecified route of administration in Oct2021 (Batch/Lot Number: FF8839) as a single dose for COVID-19 immunisation.  The patient's medical history and concomitant medications were not reported.  The patient previously received dose 1 of BNT162b2 (COMIRNATY), Lot # FF2588, on an unspecified date for COVID-19 immunization and experienced foggy brain. The patient reported having had their second COVID vaccine "on this last Wednesday" (Oct2021). The patient reported swollen lymph nodes, which seem to be around the patient's jaw. It was swollen and sore. The reporter clarified they were on the patient's jaw moreso than neck. Jaw was swollen, sore and tender. Salivary gland to abscess. There was a lot of swelling and pain, and she couldn't eat. When it burst, it all went down. Swelling and pain 6 hours after her shot. Following Monday, around five days. The patient received ibuprofen for treatment. The patient recovered from the events on an unspecified date in Oct2021.