chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and unknown gender. The patient pertinent medical history was not reported. On 22-NOV-2013, the patient was vaccinated with ZOSTAVAX (dose strength and route was not reported) (lot # J006831 and expiry date: 14-SEP-2014) which was improperly stored. Primary reporter was reporting excursion of 6 F since 01-JUN-2013 (confirmed date) affecting ZOSTAVAX, nurse also reported that products were not stored in an overall average support range of -58 degree F and 5 degree. No adverse effects reported. No product quality complaint (PQC) was reported for ZOSTAVAX. This is one of the several reports from the same reporter. Additional information has been requested.
Injection was administered to a 16 year old, even though it is only approved for ages 18+.
Diarrhea; virus; Initial information was received on 30-Nov-2022 regarding an unsolicited valid  non-serious case received from a physician.  This case is linked to case 2022SA344363(CLUSTER).  This case involves a 80 years old female patient who experienced diarrhea and virus after being vaccinated with Influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 29-Nov-2022, the patient received a dose of suspect Influenza vaccine (produced by unknown manufacturer) (with unknown strength, dose, route, administration site, lot number and expiration date) for immunization.  On an unknown date the patient had diarrhea (diarrhoea) and virus (viral infection) (unknown latency) following the administration of Influenza vaccine.  Action taken: Not applicable.  Corrective treatment: Not reported for the events (Diarrhea, virus).  Outcome: Recovering / Resolving for the events.
6FEB92 pt recvd 1st dose of Engerix-B & 30 minutes p/recvd dose epx acute SOB, heavy feeling in chest, hypertension BP 148/92, pain, dizziness, lightheadedness, sweaty palms, paleness & nausea; also felt like ants crawling under skin;
Information has been received from a medical assistant referring to an adolescent patient of unknown age and gender. Concurrent conditions, medical history and concomitant medications were not reported. On 06-NOV-2015, the patient was vaccinated with second dose of improperly stored VAQTA, lot # L028666; expiry date 04-NOV-2016 (dose, route and frequency unspecified). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Diaherria which persisted for 48+ hours. Vomiting which persisted for 24 hours. Joints hurt. Low-grade fever. Sweats.
Information has been received from a non healthcare professional, who was informed by a nurse from the physician's office, concerning a patient who on 01-SEP-2009 was vaccinated with a dose of PNEUMOVAX 23 (Lot # 662905/1162X) injection, and on 02-SEP-2009 experienced fever, hard knot under the injection site, cellulitis, chills and severe pain. The patient's outcome was not reported. The patient sought unspecified medical attention. Follow-up information was received from a non-health care professional. It was reported that the AE was closed and no further investigation was pending. No additional information about the adverse event was provided. This is one of two reports received from the same source. Additional information is not expected.
? Intussusception w/successful reduction by air enema 8/22/08. 9/3/08-records received for DOS 8/21/08-DX:Intussusception with successful reduction by air enema of US revealed ileocolic intussusception at level of hepatic flexure.  Presented to ED with C/O bloody diarrhea with blood and mucus noted in diaper. Fever 103 and decreased appetite. Lethargy. Abdominal cramping. Just returned 2 days prior from another country.
Patient is unsure they received the required dose. After the injection, patient witnessed visible stream of liquid coming from needle while still in vaccinators hand. After  learning in the next week the full Pfizer does is only 0.3 mls, that amount could have easily been discharged from the needle onto the floor. Patient has tried unsuccessfully to contact the vaccination center, Pfizer, the CDC, health authority to find out what should occur since learning this would not be a normal scenario. Patient also watched spouse get both doses of same vaccine, this did not occur with either one.
Nauseous; Night sweats; Chills / more of the chills; Headache; Aching all over; Off balance/ head felt like it was swimming off balance; Throwing up; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the left arm on 30Mar2021 at 15:30 (at the age of 60-year-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. Concomitant medications included simvastatin (MANUFACTURER UNKNOWN), buspirone (MANUFACTURER UNKNOWN), bupropion (MANUFACTURER UNKNOWN) and fluoxetine (MANUFACTURER UNKNOWN) all for unknown indications from  an unknown dates. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 31Mar2021 at 15:00, the patient started experiencing chills and headache. By the night, the patient experienced aching all over, throwing up and off balance. On 01Apr2021, the patient experienced more of the chills, nauseous and head felt like it was swimming off balance. On an unknown date in Apr2021, the patient experienced night sweats. The patient experienced headache the whole time. The patient did not receive any treatment for the events. The clinical outcome of the events chills, headache, loss of balance, night sweats and nauseous was  resolved on an unknown date in Apr2021.The clinical outcome of the events general body pain and vomiting resolved on an unknown date in 2021.  No follow-up attempts are needed. No further information is expected.
Pt received PREVNAR 13, Hib, MMR, & varicella on 6/20/11. Pt returned on 6/24/11 with itching papular rash on all 4 injection sites - localized.
Anxiety; lost 20 punds; Severe distress; Depression; Tinnitus; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Tinnitus), ANXIETY (Anxiety), WEIGHT DECREASED (lost 20 punds), STRESS (Severe distress) and DEPRESSION (Depression) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LORAZEPAM (ATIVAN) for an unknown indication.    On 11-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced TINNITUS (Tinnitus). On an unknown date, the patient experienced ANXIETY (Anxiety), WEIGHT DECREASED (lost 20 punds), STRESS (Severe distress) and DEPRESSION (Depression). At the time of the report, TINNITUS (Tinnitus), ANXIETY (Anxiety), WEIGHT DECREASED (lost 20 punds), STRESS (Severe distress) and DEPRESSION (Depression) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information provided.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: fallow up received and concomitant medication added. new events were added.
Approximately 10 minutes after vaccination, per patients mother, pt fell upon getting up from exam table but she didn't see how he fell. Pt was already on the floor dizzy & pale. ERT was called & transported pt to Urgent Care. From UC pt was transferred to ER.
My nose started moderately bleeding for about 3 to 5 min while I was doing my evening face washing routine. I haven't had a nosebleed in over 15 years.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 38-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroid" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 24May2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (24May2022) Positive, notes: Sx of Covid 19 started 24May and tested positive; (02Jun2022) Negative, notes: Negative on 02Jun; (06Jun2022) Positive, notes: Positive PCR 06Jun. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: No other medication in 2 weeks. It was reported that patient received anti-viral product "Paxlovid" for Covid-19 treatment as treatment start date on 25May2022 and treatment stop date was on 29May2022 via oral route. It was also reported that Sx of covid 19 started 24May2022 and tested positive. Started paxlovid 25May2022-29May2022. Improved sx from 29May2022 onwards. Negative on 02Jun2022. Recurrence of sx 05Jun2022. Positive PCR 06Jun2022. Covid rebound.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events and the suspect drug BNT162B2.
I got the vaccination too. But I still got shingles/Suspected vaccination failure; I got the vaccination too. But I still got shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: I got the vaccination too. But I still got shingles/Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: I got the vaccination too. But I still got shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date 23 Jul 2023 This case was reported by a consumer via interactive digital media. The patient got the vaccination too. But he/she still got shingles. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles not reported.
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not provided. On 31-MAR-2016, the patient was vaccinated with an improperly stored dose of M-M-R II 0.5 ml injection, lot# L026553, expiration date: 16-JUL-2017, (route and site of administration were not reported). According to the reporter, the vaccine was stored at a temperature of 11.1 degrees Celsius for 1 hour and 36 minutes and also at a temperature of -12.3 degrees Celsius for 1 hour and 33 minutes (excursion dates were not reported). No adverse symptoms were reported. No product quality complain (PQC) was involved. This is one of several reports received from the same source. Additional information has been requested.
I experienced a knot in my arm which spread to a large section. My speech became blurry and I passed out at work along with a lot of shaking, twitching, and head numbness. I was rushed to the ER and I was transferred to another hospital that placed me on Prednisone and a Muscle relaxer for 5-days and finally was able to get a doctor's appointment. My doctor put me on Meclizine and Clonazepam to help with anxiety and dizzy spells. I am taking Tylenol to help with the headaches until I can see the Neurologist on 08/10/2021.
Information has been received from a medical assistant referring to a 4 years old female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 22-JUN-2015, the patient was vaccinated with an improperly stored dose of M-M-R II (lot # K021151 with expiration date 02-NOV-2016; dose and route of administration were not reported)(Incorrect product storage). No adverse effects were reported. This is one of several cases received from the same source. Additional information has been requested.
He had the vaccination on 09/02/2022. On 09/03/2022 his symptoms were lethargy, low energy unsure of temperature but he was warm. He complained of stomachache vomited a few times and loss of appetite. We called the doctor who said it was normal and we gave him TYLENOL that day which didn't make much of a difference. 09/04/2022 the lethargy continued and was worse. He slept a lot of the day the nausea went away and still loss of appetite with mild temperature. He would say his foot hurts his hands hurt and he seemed in physical discomfort with possible joint pain. On Monday 09/05/2022 he seemed to get his appetite back and the symptoms cleared up a lot. He still complained of stomachache. On Tuesday 09/06/2022 I took him to the doctors because he had a rash on his hand and face was splotchy with hives. Doctor said he was processing a viral infection or that it could be from vaccine. I gave him ZYRTEC and sent to day care. They called as the hives spread. I took him back to doctors but they stated it was not allergic reaction. Today 09/07/2022 he seems to be doing much better and rash has cleared up.
AT 530PM ON 1/19/21, DEVELOPED BODY ACHES, FEVER, CHILLS, FATIGUE, EXCRUTIATING ARM PAIN AT INJECTION SITE
Severe, debilitating abdominal pain lasting 5+ hours; General weakness; Chills; Pain centered around navel and radiated to lower abdomen; This is a spontaneous report from a contactable consumer, the patient. A 69-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 26Feb2021 at 15:00 (at the age of 69-year-old) as a single dose for COVID-19 immunisation. Medical history included obsessive-compulsive disorder, hernia hiatal and gallstones. The patient was allergic to peanuts. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included clonazepam (MANUFACTURER UNKNOWN), from an unknown date and for an unknown indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 05Feb2021 at 15:00 (at the age of 69-years-old) as a single dose for COVID-19 immunisation. On 27Feb2021 at 23:00, the patient experienced severe, debilitating abdominal pain lasting 5+ hours accompanied by general weakness and chills. Abdominal pain necessitated response by local paramedics. The pain centered around navel and radiated to lower abdomen. The patient did not have vomiting. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken for abdominal pain by local paramedics. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events severe, debilitating abdominal pain lasting 5+ hours accompanied by general weakness and chills, the pain centered around navel and radiated to lower abdomen was resolving at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Patient presented to the ED on 11/24/2021 for Shortness of breath and pleurisy. Patient presented to the ED and was subsequently hospitalized on 12/10/2021 for shortness of breath, acute kidney injury,
Woke up to bloody nose. Stopped by blowing nose (blood plus heavy, dark red mucus), pinching nose, and leaning forward.  Issue built up/recurred every 2 to 3 hours throughout the day. Also, had sinus pressure on left side and maybe post nasal drip (felt it and had the vague taste of iron in my mouth). Issue resolved itself overnight. After clearing my nose  in the morning on 04/26, I was good.  Also, I had a sore arm around the injection site, starting about 6 hours or so after injection, lasting about 2 days
Pt received 3rd Anthrax Vaccine in left upper arm. Pt complained of discomfort with atypical parasthesia in 4th and 5th digits for 2 days post vax. The pt also experienced left upper arm redness, and warmth. No swelling at injection site. Follow up on 04/18/2000: "Patient did not receive any further shots since reported event.  Patient full recovery."
Lightheaded,dizziness, nausea. seen by onsite EMT. pt. released at 13:00.  B/P 122/74. O2:100% ARA HR:86 Recorded by RN
Rash, hives, bumps all over chest, arms, legs. Peaked after about 2 days from beginning symptoms.
The patient misrepresented her vaccine status to the pharmacist completing her request for a covid-19 vaccine. The pharmacist asked her if she had ever received a covid-19 vaccine before in which she replied "no, this is my first dose". Later on that evening, the pharmacist realized what happened when she tried to log the dose in the state-wide database. She had already received pfizer dose 1 and 2 on 6/17/21 and 7/8/21, respectively by a different pharmacy.
Localized redness and nodule s/p vaccine administration. Pt A/Ox4, Skins normal for ethnicity. Resp unlab and even. NAD. Denies any other s/sx at this time. Ice pack applied to site.
No adverse event; 3 previous Moderna monovalent received a Monovalent booster instead of a Bivalent Booster.; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (3 previous Moderna monovalent received a Monovalent booster instead of a Bivalent Booster.) and NO ADVERSE EVENT (No adverse event) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044C224) for COVID-19 prophylaxis.     Patient never diagnosed with COVID-19 and had no known allergies.  Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 Vaccine (Dose 1) on 11-Aug-2021, Moderna COVID-19 Vaccine (Dose 2) on 08-Sep-2021, Moderna COVID-19 Vaccine (Dose 3 and Lot: 033K21-2A) on 05-Apr-2022. Past adverse reactions to the above products included No adverse event with Moderna COVID-19 Vaccine, Moderna COVID-19 Vaccine and Moderna COVID-19 Vaccine. Concurrent medical conditions included Type 2 diabetes mellitus, Chronic kidney disease, Vitamin D deficiency and Hyperlipidemia.    On 27-Dec-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Dec-2022, the patient experienced WRONG PRODUCT ADMINISTERED (3 previous Moderna monovalent received a Monovalent booster instead of a Bivalent Booster.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (3 previous Moderna monovalent received a Monovalent booster instead of a Bivalent Booster.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (3 previous Moderna monovalent received a Monovalent booster instead of a Bivalent Booster.).    No concomitant medications were reported.  It was reported that, patient received a monovalent booster dose instead of a Bivalent Booster.  No treatment medications were reported.
One week after administration of vaccine pt. complained of pain in the right deltoid area that radiated into right lateral and frontal neck area. She described it as a sharp, intermittent pain. She also stated that she has been unable to sleep on the right side. Has not had treatment, advised to see private provider.
Breakthrough case admission after 2 vaccines Pfizer 1/28/21 lot# EL9265; Pfizer 2/18/21 lot# EN6200
I still have a big bruise after 2 weeks; I think a little bit of it came out the injection site and ran down my arm; that side of my arm has a little bumpier like solution has ran down from; This is a spontaneous report from a contactable Nurse. A patient of unspecified age and gender received first dose of bnt162b2 (COVID 19 Vaccine Pfizer, Solution for injection, Batch/lot number: EL9269, Expiration date: Unknown), via an unspecified route on an unspecified date as a single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date, when patient received covid shot, patient think a little bit of it came out the injection site where the needle was, think that some of it came down the arm because he put the cotton of about 4 inches below the injection site and ran it up and then held it. Patient understand how this is normal but can feel afterwards that, that side of the arm has a little bumpier like solution has ran down the arm. Was that going to be a problem in the effectiveness? Patient want to know that because some it ran out, if it was still effective because patient still have a big bruise after 2 weeks and also, can see where the needle went in still. The clinical outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
11-6-12 Gave influenza injection. 11-7-12 4pm (L) upper arm has red, swollen area of injection site and approx. 2 inches around site, warm to touch, not painful, no fever. Informed mom to give BENADRYL and started on Cephalexin. 11-8-12 Looks better today, swelling down.