chrisvoncsefalvay/vaers-outcomes huggingface dataset:
PATIENT CAME IN TO GET FLU SHOT AND WAS ACCIDENTLY GIVEN PFIZER COVID SHOT AFTER SHE HAD ALREADY RECEIVED 3 MODERNA DOSES. WE INFORMED PATIENT IMMEDIATELY AS WE REALIZED THERE WAS A MISTAKE IMMEDIATELY. FOLLOW UP WITH MD REVEALED THAT SHE SUFFERED HEADACHE, FUZZY HEADED, SORE ARM AND FATIGUE AFTER BEING GIVEN INCORRECT VACCINE.
This initial spontaneous report was received from a registered medical assistant referring to an unspecified number of patients of unknown ages and genders. There was no pertinent medical history, concomitant medication, concurrent conditions or drug allergies/drug reactions described. On unspecified dates, the patients were vaccinated with improperly stored doses of ROTATEQ oral solution (lot# L013202 with expiration date 27-JAN-2017; dose was not provided). No adverse effect was reported. It was unknown if the patients sought medical attention. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Telephone call from client Thursday 9-14 reporting on Tuesday 9-12 pm right arm "red and sore".  Wednesday 9-13 "warm to touch".  Thursday 9-14 "redness spread".  Saw private medical doctor Thursday 9-14 confirmed it was a reaction to Td.  Suggested she use BENADRYL.  On Friday 9-15 3:20 pm I observed injection site to be slightly red in color with swelling size of silver dollar.
Pediatric dose was given to adults mistakenly; Moderna COVID-19 vaccine administered to patients post temperature excursion; Poor quality vaccine administered; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patients post temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR5186C) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patients post temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patients post temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patients post temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered).    Concomitant product use was not provided by the reporter.  It was reported there was a temperature excursion between 26 May 2022 to 30 Sep 2022 and lot AR5186C was affected between 08 Sep 2022 to 27 Sep 2022. AR5186C was previously reported. Pediatric dose was given to adults mistakenly and were reported to CDPH, VAERS, CAIR and each patient that received the error dose, with instructions to re-vaccinate 2 months from the initial error dose. 051B22A was kept in the freezer upon receipt of shipment on 01-Aug-2022 and individual vials were put in the refrigerator on the day of use.  No treatment information was provided.  This case contains information for the 33rd of 104 adult patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-669791 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-669791:Master Case
Red, painful, raised area - warm to the touch for 3 days - went to walkin clinic on 12/14/15 - diagnosis was cellulitis secondary to injection - prescribed Keflex 500mg 1tid x10d.
Left arm numbness; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 38 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in deltoid left, administration date 31Dec2020 07:30 (Lot number: EK9231) at the age of 37 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Known allergies: Sulfa" (unspecified if ongoing); "Known allergies: latex" (unspecified if ongoing); "Depression" (unspecified if ongoing); "thyroid disease" (unspecified if ongoing); "dermatology condition" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID; ZOLOFT; ACYLOVIR. The following information was reported: HYPOAESTHESIA (non-serious) with onset 05Jan2021, outcome "not recovered", described as "Left arm numbness". Therapeutic measures were not taken as a result of hypoaesthesia.  Additional Information: Left arm numbness, it comes and goes but persistent since first vaccinated. Patient had almost daily numbness of left arm, tingling-goes away and returns (ongoing). Patient did not receive other vaccine in four weeks of vaccination. Patient received other medications in two weeks of vaccinations were synthroid, zoloft and acyclovir. Patient was not diagnosed with COVID, prior vaccination. Patient has not been tested for COVID, since the vaccination. Patient received dose 2 (Batch/ Lot number: EL8982) in left deltoid on 21Jan2021 at 08:00. Patient received dose 3 (Batch/ Lot number: FC3183) in left deltoid on 30Aug2021 at 19:45, due to weakened immune system (occasional use of high dose steroids). No specific relevant test for thromboembolic events with thrombocytopenia.  No follow-up attempts are possible. No further information is expected.
Employee reports she received her flu vaccine in her left deltoid on 9/8/20 from an immunization liaison. States she noticed some redness, swelling, and pain at the site a few hours later that continued to get worse. Reports she also developed a low grade fever of 99.6. Reports she went to urgent care today to be evaluated and was diagnosed with cellulitis.  States she was prescribed Cephalexin.
Pfizer-BioN Tech MONOVALENT given instead of Pfizer-BioN Tech BIVALENT vaccine, for 12yrs+
Patient went to local Pharmacy for first varicella vaccination to her right posterior arm. Since, has been complaining of intermittent hives localized to the injection site.
Some 6 hours after receiving the 4th dose of the Covid vaccine, I experienced Right arm weakness and was not able to grab things with my hand. My speech was slurred to the point that my wife could not understand what I was telling her.  This lasted less than 2 minutes. Later, as I was being triaged at the hospital, I experienced an incident when all of a sudden I was not able to utter words. This lasted a few seconds. An MRI was performed and this was the finding.  BRAIN PARENCHYMA: Small acute infarction is present whithin the posterior left frontal lobe subcortical white matter.   Extensive heart tests and ultrasound to detect plaque were negative.
Body aches, chills, fatigue, nausea, starting at 3:00 am the following morning. Throbbing headache. Fever of 101.8 by noon the next day. Extreme fatigue, slept on and off all day, approximately 18 of the following 24 hours. Almost too tired to walk. Fever broke the next morning at 6:00 am. The following day was much better with a headache and mild fatigue.
Admitted to hospital from Emergency Dept visit with acute exacerbation of COPD; test (+) for COVID-19 infection.
Starting 12/28/2022, I developed aches and a fever. I developed congestion and exhaustion. I ended up sleeping for about 6 days. I contacted the doctor yesterday, 1/2/2023. They gave me some medicine. I am feeling better today.
Moderna administered to the patient. She is under 18 years old. She should have been administered Pfizer. We have notified the mother of the incident. She said the patient is fine. Just a little tired. No other issues since.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2022 at 1:44 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 15-Apr-2021 at 1:44 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). In 2021, 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, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 48.47 for dose administered on 15-Apr-2021  No concomitant medications were reported.  Batch number 044B21A underwent temperature excursion on 15-Apr-2021 with temperature 34 to 44 degrees Fahrenheit from 09:00 AM to 2:00 PM. This vial was moved to fridge on 6-Apr-2021 and beyond use date for the vial was reported as 9-May-2021. Product moved to clinic on 15-Apr-2021  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour. No treatment medications were reported.
Acute onset of vertigo approximately 1 week post vaccination. Have never experienced vertigo prior. Symptoms worsened throughout day and I sought emergency care approximately 6 hours post first onset of symptoms. No diagnosis provided but physician suspected peripheral vestibular problem. Treated with meclizine for vertigo and migraine medication and discharged. Symptoms persisted for 1.5 weeks. Vertigo has mostly resolved
Pt reported after her 1st dose 3 weeks prior, approximately 40 minutes after leaving the clinic she felt her tongue swell and throat thick. Reports taking a Benadryl and contacted PCP. Pt presented to clinic on 4/5/21 with paperwork from PCP stating patient to receive 2nd dose of vaccine "benefits outweigh risks." PCP did not recommend premedicating for 2nd dose.  After receiving 2nd dose approx 15 minutes later, patient reported  feeling of tongue swelling. Patient took her own Benadryl 50mg PO. At 2:28PM, pt reports feeling full throat. Placed on monitor, Pulse Ox 96%, HR 90's, BP 189/119. Pt transported to Emergency Room. Was able to speak clearly on arrival in ED,  Dexamethasone 10mg IV push and famotidine 20mg IV Push administered. Patient symptoms resolved, diagnosed with minor vaccine reaction and discharged to home with instructions to f/u with PCP.
This case was reported by a healthcare professional (physician assistant), via another manufacturer (Merck), and described the occurrence of injection site pain in a female subject of unspecified age who was vaccinated with FLUARIX (GlaxoSmithKline). Concurrent vaccination included influenza virus vaccine; GlaxoSmithKline; unknown, unknown given on an unspecified date. On an unspecified date the subject received 2nd dose of FLUARIX (details unknown). At an unspecified time after vaccination with FLUARIX, the subject experienced injection site pain and swelling injection site. The subject was administered one dose of FLUARIX and then 3 months later administered another dose. The subject experienced pain and swelling at the injection site only after the second dose. The healthcare professional reported this to a Merck Field employee. At the time of reporting the events were resolved.
product=COVID 19 Treatment, brand=Paxlovid/vaccine brand=Pfizer / BioNTech; product=COVID 19 Treatment, brand=Paxlovid/vaccine brand=Pfizer / BioNTech; 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 41-year-old male patient received BNT162b2 (BNT162B2), on 07Oct2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 41 years, 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 was not reported. Concomitant medication(s) included: KEPPRA [LEVETIRACETAM]. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 05Jun2022, outcome "unknown" and all described as "product=COVID 19 Treatment, brand=Paxlovid/vaccine brand=Pfizer / BioNTech". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative; Positive. Therapeutic measures were taken as a result of covid-19.  Clinical course: Re-lapse Covid. After testing negative for 5 days, on the 6th day, I started to test positive again. The complaint for lot FF2589 was investigated.  A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact to product quality. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.
About 8 hours after receiving the Shingrix injection on Oct 8, I noticed a discomforting soreness on the right side of my abdomen. Over the next two days I had right flank pain that I thought might be a kidney infection. By Oct 11 I had more pain and my skin was becoming increasingly sensitive and uncomfortable, as if my clothing was made of sandpaper. I did not think the flank pain and the skin soreness were related when I saw a Nurse Practitioner from the flank pain on Tues, the 12 where I had a urinalysis done(neg) which then was sent  for culture. Today when I woke up I had very sore lesions on my right abdomen along the waist line. I saw my primary physician and he diagnosed shingles and prescribed me Valacyclovir.
This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No Concomitant product use was reported. It was reported that there had been no power outages that would have impacted the Moderna vaccine. However, the reporter reiterated that because their facility was unable to download the digital data logger, they would need to treat the issue as a temperature excursion. The data logger that caller was unable to download were for the months of Dec-2021, Jan-2022, and Feb-2022. It was also reported that no adverse reactions were reported by patient. No treatment information was provided. This case was linked to MOD-2022-501575 (Patient Link).
Developed  symptoms of Covid on 10/18/2021 and tested positive on 10/23/2021.
Headache since 30 minutes after vaccine given. Feels pressure in head, behind eyes. Also had body aches, fever and red eyes.
Breakthrough Case. Tested positive on 04/24/2021, 64 days after vaccination.  Hospitalized 04/24/2021, Discharge Date: 05/12/2021.  Died 06/10/2021
drug use in unapproved population; Fever and sore arm where vaccine was taken; Fever and sore arm where vaccine was taken; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 11 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date Aug2021 (Lot number: FA6780) as dose 1, single for covid-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing), notes: covid prior vaccination: Yes. There were no concomitant medications. The following information was reported: PRODUCT USE ISSUE (non-serious) with onset Aug2021, outcome "unknown", described as "drug use in unapproved population"; VACCINATION SITE PAIN (non-serious), PYREXIA (non-serious) all with onset Aug2021, outcome "recovering" and all described as "Fever and sore arm where vaccine was taken". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of product use issue, vaccination site pain, pyrexia.  Additional information: Patient did not receive other vaccine in four weeks or other medications in two weeks.  No follow-up attempts are possible. No further information is expected.
He received  3 shots of Pfizer vaccine (agent was not able to clarify if that was covid vaccine ) but stated he still got covid.; He received  3 shots of Pfizer vaccine (agent was not able to clarify if that was covid vaccine ) but stated he still got covid.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 72-year-old male patient received BNT162b2 (BNT162B2), 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 covid-19 immunisation. The patient's relevant medical history included: "stage 3 lung Cancer/stage 3B lung", start date: 1995 (unspecified if ongoing); "trachea cancer/trachea cancer necrosis", start date: 1995 (unspecified if ongoing), notes: inoperable; "no muscle mass", start date: 1999 (unspecified if ongoing); "could not walk", start date: 1999 (unspecified if ongoing); "skin cancer/skin necrosis" (unspecified if ongoing); "skin necrosis" (unspecified if ongoing); "voice was not clear/does not have "a lot of voice"" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 20May2022, outcome "unknown" and all described as "He received  3 shots of Pfizer vaccine (agent was not able to clarify if that was covid vaccine ) but stated he still got covid.". The patient underwent the following laboratory tests and procedures: Blood test: (unspecified date) Unknown results; Body temperature: (unspecified date) 99; (unspecified date) 104; (unspecified date) 102; (May2022) 102; (May2022) 97-98; Magnetic resonance imaging: (unspecified date) Unknown results; SARS-CoV-2 test positive: (20May2022) Positive; Ultrasound scan: (unspecified date) Unknown results; Urine analysis: (unspecified date) Unknown results; X-ray: (unspecified date) Unknown results. Therapeutic measures were taken as a result of covid-19 included Paxlovid tablet from 20May2022 to 24May2022 3 in the morning and 3 at night, 1 white tablet and 2 light pink with each dose.  Clinical course: Patient received 3 shots of the Pfizer Covid vaccine and he still got Covid. He took PAXLOVID for covid and his last dose was last night. PAXLOVID helped with fever from 102 to now its 97-98 degrees but he still had body aches, shoulder pain and neck  pain across the base of the neck, his fever gotten better but he had no energy. He still did not feel 100% better yet. He stated PAXLOVID did not help with the aches and pain in the body, shoulder and neck, he has that form covid time," part of the covid". Patient was coughing a lot during the conversation. He felt somewhat better but not a lot. Patient was a veteran and a cosmetologist.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
I accidentally gave Proquad and Varivax. instead of MMR and Varivax.
Intermittent vibrations in foot following same path each time. MD noticed blotches on arms and legs. Pt taking BENADRYL for red areas on body.
Received vaccines in left arm 10/19/9 at 6:30 pm. At 3 AM pt woke- with extreme pain in arm, redness, swelling and numbness. Went to work and had chills all day. Went to ER 10/20. Said Staph infection. Started LEVAQUIN, then changed to IV Clindamycin and Doxycycline x 3days inpatient. Then after 3days discharged w/ 2wk course of Doxycycline and clindamycin by mouth. No residual besides slight tenderness and dryness.