chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. No Medical History information was reported. On 12-Jan-2021 at 10:37 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 12-Jan-2021 at 10:37 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Age of patient was reported as 71.20 for dose administered on 12-Jan-2021. No concomitant medications were reported. Batch number 041L20A underwent temperature excursion on 12-Jan-2021 with temperature 34 degrees Fahrenheit from 08:00 AM to 09:00 AM. This vial was moved to fridge on 08-Jan-2021 and beyond use date for the vial was reported as 27-Jan-2021. Product moved to clinic on 07-Jan-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 Fisherbrand traceable temperature monitor at every hour. No treatment medications were reported. This case was linked to MOD-2022-566976 (Patient Link).
Felt brain fatigue; Felt very hungry before dinner; On 07Jan, after breakfast I suddenly felt tired, so took a nap; During the whole day I took three naps; Had sore arm; Between 15-30 min after injection, I felt light arrhythmia twice and I tried to do deeper breath to control it. About 1.5 hours after injection, in between my pull-up exercises I felt light arrhythmia; his legs were shaking which had never happened before; This is a spontaneous report from a  contactable consumer reporting for himself.  A 56-years-old male patient  received the first dose of bnt162b2 (BNT162B2; Lot # EL0140) vaccine , in the right arm on 05Jan2021 16:00 at single dose for Covid-19 immunisation .  The patient medical history and concomitant medications were not reported.  The patient experienced light arrhythmia  on 05Jan2021 16:30 with outcome of recovered , his legs were shaking which had never happened before on 05Jan2021 with outcome of unknown, had sore arm  on 06Jan2021 with outcome of recovered; felt brain fatigue  on 07Jan2021 with outcome of recovered ,  , felt very hungry before dinner  on 07Jan2021 with outcome of recovered , on 07Jan, after breakfast  felt tired, so took a nap  on 07Jan2021 with outcome of recovered , during the whole day i took three naps  on 07Jan2021 with outcome of recovered.   Course of the event: Between 15-30 min after injection, the patient felt light arrhythmia twice and  tried to do deeper breath to control it. About 1.5 hours after injection, in between his pull-up exercises he felt light arrhythmia 2-3 times, and after doing the third set of pull-ups his legs were shaking which had never happened before.  Next morning the patient  woke up a couple hours later than his normal time. Noting that the night before he went to bed one hour earlier for no reason. When semi-waking up, he had a strong arrhythmia, followed by a couple more light ones. In the past arrhythmia did occur to him when he was very stressed or very tired, but had not have it for a few years.  The patient had sore arm but tolerable. On 07Jan2021, after breakfast the patient suddenly felt tired, so took a nap. During the whole day he took three naps, which he had never done before. No arrhythmia though. The patient felt brain fatigue, but physically no problem. He felt very hungry before dinner, same as the day before, but not in other days.
The following vaccination, the patient found their right arm to be swollen and in pain (the left arm was fine).
This spontaneous report was received from a registered pharmacist referring to a patient of unknown age and gender. No concurrent or historical conditions were reported. On 08-SEP-2014, the patient was vaccinated with the first dose of ZOSTAVAX (lot number, expiration date not reported) dose, route and anatomical location were not specified and on 17-NOV-2015 the patient received the second dose of ZOSTAVAX (lot number, expiration date not reported) dose, route and anatomical location were not specified. No concomitant medication was reported. No adverse effect was reported. No product quality complaint was involved. It was unknown if the patient sought medical attention. Additional information has been requested.
Site: Bruising at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Additional Details: Immediately after administering vaccine, patient bled quite a lot. I wiped the area 2 times times and applied pressure for ~1 minutes. Applied a cotton ball under a band-aid. Within 1 min of the vaccine, the pt developed a pump that appeared to be filled with blood under the surface. She stated that the site felt like "when you initially get poked with a needle". I recommended to take ibuprofen 200-400mg q4-6 hours until the swelling decreases, to apply a cold compress, and call md if worsens.
Patient reporting that she had hives 24 hours after receiving vaccination. Hives were all over body, and in opposite arm. Fatigue, and sore arm.
I received the Pfizer booster for COVID-19 on 9/8/2022. On 12/3/2022, I developed a scratchy throat. It persisted into 12/4/2022. I then developed fever, sneezing, cough, and runny nose that evening. I had fever and chills overnight and into 12/5/2022. I took two home antigen tests and both yielded positive results. I contacted my clinician, who prescribed PAXLOVID. I took the PAXLOVID and gradually got better. I am due to take my last dose on 12/10/2022. I was a little better on 12/08/2022 and markedly better on 12/9/2022.
The vaccine was initially moved from the freezer to the refrigerator on 10-May-2022 and was administered on 14-Jun-2022; Moderna COVID-19 vaccine was administered after the 30 day beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna COVID-19 vaccine was administered after the 30 day beyond use date) and PRODUCT STORAGE ERROR (The vaccine was initially moved from the freezer to the refrigerator on 10-May-2022 and was administered on 14-Jun-2022) in an 89-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 004M21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Jun-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 14-Jun-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna COVID-19 vaccine was administered after the 30 day beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vaccine was initially moved from the freezer to the refrigerator on 10-May-2022 and was administered on 14-Jun-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna COVID-19 vaccine was administered after the 30 day beyond use date) and PRODUCT STORAGE ERROR (The vaccine was initially moved from the freezer to the refrigerator on 10-May-2022 and was administered on 14-Jun-2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  The vaccine manufacture date was 13-Dec-2021.  This patient had not experienced any symptoms after receiving this dose of the vaccine. No additional doses, medications, or treatments had been administered in response to this error.
During the midnight of April 2, 2021, I started with chills and body aches. I took two acetaminophen and was able to rest. At 7:25 AM on the same I fainted and was unconscious for few minutes. I also had a lot of nausea. During the whole day I have been having headaches and body aches with fever. I also have pain on the injection area, I am still taking acetaminophen every six hours.
nausea and vomiting; nausea and vomiting; having issues; diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (nausea and vomiting), NAUSEA (nausea and vomiting), MALAISE (having issues) and DIARRHOEA (diarrhea) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History Information was reported.    On 15-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, the patient experienced VOMITING (nausea and vomiting), NAUSEA (nausea and vomiting), MALAISE (having issues) and DIARRHOEA (diarrhea). At the time of the report, VOMITING (nausea and vomiting), NAUSEA (nausea and vomiting), MALAISE (having issues) and DIARRHOEA (diarrhea) had not resolved.            No relevant Concomitant medications were reported.   No Treatment information for the event was provided. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 22-Feb-2021 and was forwarded to Moderna on 22-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (nausea and vomiting), NAUSEA (nausea and vomiting), MALAISE (having issues) and DIARRHOEA (diarrhea) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History Information was reported.    On 15-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, the patient experienced VOMITING (nausea and vomiting), NAUSEA (nausea and vomiting), MALAISE (having issues) and DIARRHOEA (diarrhea). At the time of the report, VOMITING (nausea and vomiting), NAUSEA (nausea and vomiting), MALAISE (having issues) and DIARRHOEA (diarrhea) had not resolved.            No relevant Concomitant medications were reported.   No Treatment information for the event was provided.
Headache; my back was hurting; going on the second week my back still hurt; was very tired so I just  stayed like that for 3 days; right behind my ear;  where your lymph nodes are its swollen; This is a spontaneous report from a contactable other hcp. A 56-years-old patient of an unspecified gender received bnt162b2 (BNT162B2) formulation solution for injection, dose 1 (Lot number was not reported) via an unspecified route of administration at arm on 12Jul2021 (at the age of 56-years-old) as a single dose for covid-19 immunisation. Medical history included from an unknown date and unknown if ongoing. There were no concomitant medications. On 12Jul2021 got my first dose of the Pfizer Covid vaccine and that night nurse had a horrible headache, nurse back was hurting, and nurse was very tired so nurse just stayed like that for 3 days now then this was going on the second week nurse back still hurt patient still had a headache and had right behind patient ear you know where your lymph nodes are its swollen, should patient be concern about the second shot.   Information on lot/batch number has been requested.
8/17 I woke up to a kidney infection. I got antibiotics prescribed and took the full dose feeling better after 3 days. At the same time I started to feel exhausted every moment of the day. When I wasn?t working, I was sleeping.  About 8/23 or so I started getting fevers daily. Ranging from 101.5-101.9. I had chills that I couldn?t get rid of for hours, daily. 2 of my toes turned reddish purple and ached like they were thawing from getting too cold.  My breathing was bad. I couldn?t talk without being out of breath. My lips are  both swollen right now. My legs developed a hive like rash. I have a scar on my knee that is red now and itching along with my sides and hips.  I got a covid test that came back negative today
sicker than a dog for over a week with Moderna; injection site is also very hot; injection site has a red spot; injection site is also very hot, very red, and itches; swollen like a super man arm" and the injection site has a red spot; fatigue; headaches; joint pain; nausea.; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sicker than a dog for over a week with Moderna), VACCINATION SITE WARMTH (injection site is also very hot), VACCINATION SITE ERYTHEMA (injection site has a red spot), VACCINATION SITE PRURITUS (injection site is also very hot, very red, and itches) and VACCINATION SITE SWELLING (swollen like a super man arm" and the injection site has a red spot) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018B21A and 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS (sicker than a dog for over a week with Moderna), VACCINATION SITE WARMTH (injection site is also very hot), VACCINATION SITE ERYTHEMA (injection site has a red spot), VACCINATION SITE PRURITUS (injection site is also very hot, very red, and itches), VACCINATION SITE SWELLING (swollen like a super man arm" and the injection site has a red spot), FATIGUE (fatigue), HEADACHE (headaches), ARTHRALGIA (joint pain) and NAUSEA (nausea.). The patient was treated with DIPHENHYDRAMINE, PARACETAMOL, PHENYLPROPANOLAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE;PARACETAMOL;PHENYLPROPANOLAMINE HYDROCHLORIDE]) for Itching, at an unspecified dose and frequency. At the time of the report, ILLNESS (sicker than a dog for over a week with Moderna), VACCINATION SITE WARMTH (injection site is also very hot), VACCINATION SITE ERYTHEMA (injection site has a red spot), VACCINATION SITE PRURITUS (injection site is also very hot, very red, and itches), VACCINATION SITE SWELLING (swollen like a super man arm" and the injection site has a red spot), FATIGUE (fatigue), HEADACHE (headaches), ARTHRALGIA (joint pain) and NAUSEA (nausea.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information not provided.    Most recent FOLLOW-UP information incorporated above includes: On 05-Aug-2021: Follow up report received on 05-Aug-2021, Added event (sicker than a dog with Moderna).
6-7 hours post injection an abnormal feeling, with chest discomfort/tightening, general malaise, fatigue, and pain at injection site. Took Tylenol twice throughout night and woke up feeling slightly better, but some chest discomfort persists.
Information has been received from a registered nurse concerning a female with torn knee cartilage and no drug reactions/allergies who on an unspecified date was vaccinated with the first dose of GARDASIL. Concomitant therapy included birth control pills. The patient had a panic attack a few hours after receiving the vaccine. The patient did not sought medical attention. The patient has not received any additional dose of GARDASIL yet. The patient said she never had a panic attack prior to receiving GARDASIL. As of 25-AUG-2009, the patient had recovered. Additional information has been requested.
Pt was mistakenly given 40 mcg of vaccine instead of 20 mcg
Pt received MMR and Varivax on 7/12/02. Mother reports pt developed wheezing, fussiness 1 1/2 hrs after shots. Pt had no vomiting or rash. He was treated at urgent care same day for the wheezing with Albuterol, Benadryl and Prolone.
Patient recevied both varicella and HPV on 7/9/08. The mother called our clinic on 7/18/08 with the note documented below.Nurse Comments: Placed call back to mom. Mom states patient had reported to mom last night that her throat felt swollen. Mom gave Benadryl. Mom states today she has her voice back. Questioned if patient had hives yesterday or just itching. Mom states patient did have hives and she gave Benadryl yesterday. States right now patient is reporting that her tongue feels thick and her throat feels swollen. Mom states patient says she aches all over. Patient recently just went off of her Florinef that she had been on x 2 years and wondered if that could be contributing. Recommended mom give Benadryl again now. Discussed with Dr. here in the office who states patient should go to ER at this time. Mom informed of this and states understanding. Completed by Nurse: July 18, 2008 11:52 AM Patient was taken to clinic by mother. The physician form there called and discussed the case with Dr. She ordered a referral to an allergist. The patient has an appointment with an allergist on 9/17/08 for this and other past allergic reactions.
This spontaneous report as received from a registered nurse refers to a patient(s) of unknown age and gender. It was unknown if the patient(s) were vaccinated with RECOMBIVAX HB (dose, concentration and lot number not reported) that had gone through a temperature excursion of 31 F. No adverse effect reported. This is one of several reports from the same source. Additional information has been requested.
This spontaneous report as received from a physician refers to a 2 year old male patient. On 02-JUL-2015 the patient was vaccinated with first dose of VARIVAX (Merck) (dose, strength, route unspecified). No concomitant therapy was reported. On 03-JUL-2015, the patient experienced hives treated with BENADRYL. The outcome of hives was reported as recovering/resolving. The patient sought medical attention. No product quality complaint was involved. The causality was not provided by the reporter. Additional information has been requested,
This spontaneous report was received from a nurse referring to a 22-year-old female patient. The patient's concurrent conditions included penicillin and erythromycin allergy, while the patient had not medical history and her concomitant medications included ORTHO TRI-CYCLEN. On 06-MAR-2019, the patient was vaccinated with GARDASIL 9 lot # 1581027 (expiration date: 03-JUN-2021) (dose and frequency not provided), intramuscular for immunization. On 07-MAR-2019, the patient developed itchy red bumps on her hands (rash popular) and her hands became swollen (peripheral swelling). Then, in the same day, one area of unspecified size and location appeared to have formed a blister. The patient did not see medical attention, no laboratory tests were performed and she did not received any treatment. The outcome for the events was reported as recovered in March 2019. The causal relationship between the events and GARDASIL 9 was not reported.
immed swelling @ inj site rt thigh in 5min noted 4.5cm in diameter;beef red color;DPH /Ibuprofen;
Breakthrough case admission after 5 vaccines Pfizer 1/21/21 Lot# EL9261;  Pfizer 2/11/21 Lot# Em9810;  Pfizer 10/12/21 Lot# EW0183;  Pfizer 4/18/22 Lot# FK9894;  Pfizer 10/27/22 Lot# GJ6665
Pt reports muscle pain all over his body that developed 2 days after receiving his first dose of Shingrix. He notes that his pain was most severe in his legs and hips, pain lasted for 1 month but is now resolved. He reports taking OTC ibuprofen to relieve the pain but it was not effective.
Initial unsolicited report received from a consumer (patient herself) on 18-Jan-2018. This case involves a 47-year-old female patient who was vaccinated with a 0.5 ml single dose of FLU SHOT (Batch number, expiry date and dose in series were not reported) via intramuscular route in the right deltoid on 26-Sep-2017 for immunization and also vaccinated with a dose of PNEUMOCOCCAL VACCINE (PNEUMONIA VACCINE) (Batch number, expiry date, dose, dose in series, route and site of administration were not reported) on an unspecified date. The patient's medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient developed symptoms of right arm pain, limited range of motion (ROM) and numbness of fingers of right hand which continued to persist. It was reported that the patient was being evaluated by a neurologist in February. Laboratory investigations and corrective treatment were not reported. The outcome of all the events was reported as not recovered. List of documents held by sender: none.
Report 2001003522-1 describes joint pain in a 54 year old female who received Lymerix. This report was received from a lawyer and has not been verified by a physician or other health professional. In the summer of 1998, the vaccinee was treated for Lyme disease. On 03/29/99, she was reported to be 100% better, except for some stiffness of the left hand. On that date she was given a prescription for Celebrex for her continued hand stiffness, and received the first injection of Lymerix. The hand stiffness reportedly continued, without changes, until the vaccinee received her second injection of  Lymerix on 04/03/99. Following a dose of Lymerix, the vaccinee experienced joint pain, vision impairment, palpitations, chills and a bull's eye rash over the injection site. As of 02/01/01, the vaccinee continued to experience "significant joint pain, stiffness, fatigue, swelling of her hands and an impaired vision field in her left eye." The adverse events of "joint pain" and "stiffness" do not meet ICH serious criteria, but are being submitted as an expedited report by special FDA request per the June 28, 2000 letter.