chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient sat for about 5 minutes in the room prior to getting up, however started feeling dizzy once he stepped out of the room. Patient was taken back into the room and given water, he then stated he was also having hearing loss. Patient had an icepack placed on the back of his neck and waited 5 minutes before leaving. Patient stated he felt fine, but seemed a little pale. Patient never lost consciousness and eventually got his color back.  After patient left room and went to waiting room the front office staff came and stated he didn't feel good. Went out to waiting room and he stated that he felt dizzy, gave him some water and applied ice pack to back of neck. Patient alert and stated he started to feel better. Vital signs were obtained and were within normal limits. Had patient sit for another 5 minutes. Patient was able to stand without becoming dizzy. Informed him and legal guardian to monitor for any new s/s and to drink plenty of water. Let her know she could call the clinic if she needed anything she stated understanding. Provider made aware of this.
nausea/vomiting, flushing, chills-1 hr post inj;
erythema at injection site with swelling, pain and enlarging area of involvement from time of vaccine to present (3/2/2021)
body aches; exhaustion; chills; This case was reported by a consumer and described the occurrence of chills in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   On 3rd December 2020, the patient received the 2nd dose of Shingrix. On 4th December 2020, 1 days after receiving Shingrix, the patient experienced general body pain and exhaustion. In December 2020, the patient experienced chills. On an unknown date, the outcome of the chills, general body pain and exhaustion were unknown.   It was unknown if the reporter considered the chills, general body pain and exhaustion to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but was selected as an adult as per vaccine indication. A day before reporting the patient received 2nd dose of Shingrix and had chills at night. On the day of reporting, the patient went to work and had to leave early because of body aches and exhaustion. The patient asked was that a normal side effect.
Caught Covid_19 after receiving all the shots required.; Caught Covid_19 after receiving all the shots required.; This is a spontaneous report from a contactable consumer (patient). A 44-year-old male patient received two doses of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), both via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced caught covid_19 after receiving all the shots required on an unspecified date with outcome of unknown. Took all vaccines and still caught Covid_19.   Information on the Lot/Batch number has been requested.
17 year old patient was given DAPTACEL with no adverse event; 17 year old patient was supposed to be given TENIVAC but was given DAPTACEL instead with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from a other health professional  (physician assistant) via Medical Information (Reference number- 00428721) and transmitted to Sanofi on 13-Jan-2021.  The case involves a 17 year old patient who received DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination (product administered to patient of inappropriate age) instead of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] (wrong product administered).  Relevant medical history, past medical treatment, vaccination, concomitant medications and family history were not provided.  It was an actual medication error case due to wrong vaccine administered and inappropriate age at vaccine administration (latency same day).  At the time of reporting, no adverse event was reported.  The reporter wanted to know if patient should be revaccinated. The reporter stated that the patient had left the office and was doing fine.   This suspected adverse reaction report was 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 was 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 had contributed to or was to be held liable for the occurrence of this medication error.  There would be no information available on batch number for this case.
Redness; Pain in legs/Couldn't lay on arm because it hurt, if she tried to reach for something it hurt; Swelling; Lump under the skin; Dizzy; Joint pains; Muscle pain down in legs; Chills; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Swelling), ERYTHEMA (Redness), PAIN IN EXTREMITY (Pain in legs/Couldn't lay on arm because it hurt, if she tried to reach for something it hurt), SKIN MASS (Lump under the skin) and DIZZINESS (Dizzy) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Skin disorder NOS.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced SWELLING (Swelling) and PAIN IN EXTREMITY (Pain in legs/Couldn't lay on arm because it hurt, if she tried to reach for something it hurt). On 08-Jan-2021, the patient experienced ERYTHEMA (Redness). In January 2021, the patient experienced SKIN MASS (Lump under the skin), DIZZINESS (Dizzy), ARTHRALGIA (Joint pains), MYALGIA (Muscle pain down in legs) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, SWELLING (Swelling), PAIN IN EXTREMITY (Pain in legs/Couldn't lay on arm because it hurt, if she tried to reach for something it hurt), SKIN MASS (Lump under the skin), DIZZINESS (Dizzy), ARTHRALGIA (Joint pains), MYALGIA (Muscle pain down in legs) and CHILLS (Chills) outcome was unknown and ERYTHEMA (Redness) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
On 3 Oct my arm had a rash about 2" wide all around the injection site- it itched like crazy and was hot. I used LANACANE to stop the itch for 4 days.
03/28/2021 @ 01:30PM vaccination. 03/31/2021 @01:55PM Noticed itching upper L arm. Baseball size, red, hot to touch, itchy. Took pictures, drew circle around circumference to monitor growth. 03/31/2021 Telehealth appt; Dr. said to take Benadryl, ice; 'COVID ARM'.
Hot to touch; Lump at the injection site; Redness at injection site; Rash on neck, chest and shoulder; Lw grade fever; Flamed arm; Feels the area is flamed/pain at injection site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site burning in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site mass (1st dose received on 30th October 2019, refer linked case US2020213909).   On 6th March 2020, the patient received the 2nd dose of Shingrix. In 2020, less than 9 months after receiving Shingrix, the patient experienced injection site burning. On an unknown date, the patient experienced injection site warmth, injection site lump, injection site erythema, rash, low grade fever and burning sensation. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site burning and injection site erythema were not recovered/not resolved and the outcome of the injection site warmth, injection site lump, rash, low grade fever and burning sensation were unknown.   It was unknown if the reporter considered the injection site burning, injection site warmth, injection site lump, injection site erythema, rash, low grade fever and burning sensation to be related to Shingrix.  Additional details were provided as follows: The patient experienced adverse reactions after receiving 2nd dose of Shingrix. Health care professional explained that both 1st and 2nd dose were administered on the same arm (not sure which arm as patient had received the vaccinations on different facility). Less than 9 months after vaccination, the patient felt the area was flamed, hot to touch, lump at the injection site, rash on neck, chest and shoulder and low grade fever and flamed arm. Pharmacist also reported that patient experienced redness and pain at injection site. The patient was still experiencing these symptoms, coming and going till the time of reporting. No batch number or expiration date was known as the patient had received the shots on different facility. The reporter consented to follow-up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020213909:1st dose, same patient
5pm Temp 99.4, Tylenol given by parents. 9pm T 99. Tylenol given. 1am (8-9-07) T 98.7, restless, coughing - Tylenol given. 8-9-07 11am increased "quiet". Tylenol 2pm. ER 1525 - T 101.8, cough, fussy. Chest x-ray - WNL. UA WNL. CBC results below (#12). 2235 Rocephin given. Discharged from ER at 2350 with instructions for how to treat a fever.
Fever 101.5, Chils, Rigors, Headache, body ache, much pain at site of injection Treated with tylenol, benadryl Next day at time of report, symptoms had not resolved.
"I received the first Pfizer dose of the COVID-19 Vaccine today  and developed hives on my lower legs"  Called in the report  approx 1 hour after shot.    PCP Rx'd Benadryl, stroids, and EPIPEN (if needed).  Patient took Bendryl with plans to follow-up with allergist.  She declined need for ER.
Fully vaccinated with Moderna. Admitted to local Medical Center on 12/07/2021. Tested positive for COVID-19 on 11/21/2021. Expired on 12/17/2021 while still hospitalized.
This spontaneous report was received from a health care worker regarding an unspecified number of patients of unknown age and gender. Patient demographics were not provided. Information on the concurrent conditions, medical history and drug allergies of the patients were not reported. On unknown date, unspecified number of patients were administered unspecified number of improperly stored doses of PROQAUD (Merck) lot # L045675, expiry date 09-MAY-2017 (dose number, dose, frequency, route and anatomical location were not specified). Concomitant medication were not specified There were no adverse effects reported. There was no product quality complaint (PQC) involved. Vaccine was stored at temperature of -0.1 degree centigrade for 11 hours, 45 minutes. There was no previous temperature excursion performed. Also GARDASIL 9 appeared in the product list as it was involved in the excursion, however no improperly stored doses of it were administered. This is one of several reports received from the same reporter. Additional information has be been requested.
minor joint pain; minor muscle pain; This spontaneous case was reported by a nurse and describes the occurrence of ARTHRALGIA (minor joint pain) and MYALGIA (minor muscle pain) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     Concomitant products included NADOLOL (CORGARD) and HYDROCHLOROTHIAZIDE for Blood pressure high, LOSARTAN for Blood pressure low, PAROXETINE HYDROCHLORIDE (PAXIL CR) for Depression and Anxiety, OMEPRAZOLE MAGNESIUM (PRILOSEC [OMEPRAZOLE MAGNESIUM]) for GERD, IBUPROFEN (ADVIL 12 HOUR) for Pain, POTASSIUM for Potassium low.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced ARTHRALGIA (minor joint pain) and MYALGIA (minor muscle pain). On 06-Mar-2021, ARTHRALGIA (minor joint pain) and MYALGIA (minor muscle pain) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient was treated with Advil (Unknown strength and amount).
sick; 101F temperature/temperature of 101.5; aching; she's really flu-like; This is a spontaneous report from a contactable consumer. A 59-years-old female patient received bnt162b2 (Formulation: Solution for injection; Batch/Lot number was not reported), dose 2 via an unspecified route of administration on 17Aug2021 as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 on an unspecified date for covid-19 immunisation. Caller is a consumer reporting adverse event symptom for his wife after receiving her second dose of the Pfizer-Biontech Covid19 vaccine yesterday (17Aug2021). He reports my wife has a 101F temperature, she got her second shot yesterday. She's aching, she's really flu-like, she's very very sick. Caller reports that he has been trying to get in touch with someone at Pfizer since midnight last night and that he's so concerned about his wife, I want to take her to the hospital, but they don't want us to bring her, that's how sick she is. Reporter stated, It was too ridiculous. Pfizer should be ashamed of itself when someone is sick and they must fill out all of that stuff, that is baloney. How dare them. So, my wife is very sick right now. She said she feels beyond the flu. Last night when this developed at about 12 o'clock, she was at a 10 and now she is at a 9. We just took the temperature, and she is a 101.5. The patient underwent lab tests and procedures which included body temperature: 101 fahrenheit on an unspecified date, body temperature: 101.5 fahrenheit on an unspecified date. The outcome of the events was unknown.  The action taken in response to the events for bnt162b2 was not applicable.
Two grand mail seizures 22 days after booster vaccine. Been on anti seizure meds since. Experiencing dizziness, bright light and strobe lights now make me dizzy and I have to wear sunglasses all the time now and remove myself whenever I see strobe lights.
Information has been received from a nurse referring to unspecified patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant therapy were not provided. The patients were vaccinated with the following improperly stored doses of PROQUAD (dose and route unknown) for prophylaxis: on 30-JAN-2017, 3 doses with lot# M031565 and expiration date 24-DEC-2017; on 31-JAN-2017, 1 dose with lot# M031568 and expiration date 24-DEC-2017; on 01-FEB-2017, 1 dose with lot# M001152 and expiration date 05-JUL-2017; on 02-FEB-2017, 2 doses with lot# M031565 and expiration date 24-DEC-2017, 2 doses with lot# M031568 and expiration date 24-DEC-2017, on 03-FEB-2017, 2 doses with M031565 and expiration date 24-DEC-2017, 1 dose with M031568 and expiration date 24-DEC-2017, 1 dose with M018638 with expiration date 11-OCT-2017; on 06-FEB-2017, 3 doses with M031565 with expiration date 24-DEC-2017, 1 dose with M031568 with expiration date 24-DEC-2017; on 07-FEB-2017, 1 dose with M031568 with expiration date 24-DEC-2017, 1 dose with M031568 with expiration date 24-DEC-2017, 2 dose with M035145 with expiration date 30-JAN-2018; on 08-FEB-2017, 3 doses with M035145 with expiration date 30-JAN-2018; on 10-FEB-2017, 1 dose with M031568 with expiration date 24-DEC-2017, 1 dose with M035145 with expiration date 30-JAN-2018; on 14-FEB-2017, 2 doses of M035145 with expiration date 30-JAN-2018; on 15-FEB-2017, 3 doses of M035145 with expiration date 30-JAN-2018; on 16-FEB-2017, 1 doses of M035145 with expiration date 30-JAN-2018; on 17-FEB-2017, 2 doses of M035145 with expiration date 30-JAN-2018. The temperature excursions that PROQUAD experienced were as follows: lot# M031565 with expiration date 24-DEC-2017, lot# M031568 with expiration date 24-DEC-2017 and lot# M001152 with expiration date 05-JUL-2017 at -3 to 61 degrees Fahrenheit (F) for 27.5 hours on 28-JAN-2017; lot# M035145 with expiration date 30-JAN-2018 and lot# M018638 with expiration date 11-OCT-2017 at -3 to 61 degrees F for 27.5 hours on 28-JAN-2017 and at -11 to 48 degrees F for 4 hours on 17-FEB-2017. It was also reported that the vaccine also experienced the following temperature excursion previously: > 14 but < 46 degrees F (>-10 but < 8 degrees centigrade (C)) for 23 hours 30 minutes; also: >46 but < 77 degrees F (>8 but < 25 degrees C) for 12 hours 45 minutes. This is one of two reports received from the same reporter. Additional information is not expected as there is no consent to contact the reporter.; Sender's Comments: US-009507513-1703USA003861:
Patient was administered MMR instead of MMR-. Patient did not receive the Varicella portion as ordered/scheduled. Varicella was administered on 8/28/19 as a catch up dose. There was no Varicella outbreak.
This was a vaccination administration error. Patient received a Moderna COVID vaccine  2/3/2021. Pt came to a Pfizer only clinic and in error received a Pfizer vaccine instead of Moderna #2.
This case was reported by a consumer via call center representative and described the occurrence of injection site rash in a 74-year-old female patient who received Shingrix for prophylaxis. On 21st August 2018, the patient received the 1st dose of Shingrix (intramuscular). On 21st August 2018, less than a day after receiving Shingrix, the patient experienced injection site rash. On an unknown date, the outcome of the injection site rash was recovered/resolved. It was unknown if the reporter considered the injection site rash to be related to Shingrix. Additional details were provided as follows: The patient experienced a rash around the injection site, which spread over several days before it started starting to resolve. The rash reached about 5 by 7 cm at its largest and resolved after 8 days.
Reports that he had a temperature of 101.3 for 24 hours starting in the evening of 2/3/2021 along with chills, body aches, diarrhea and headache.  His fever ended on 2/4/2021 in evening but he continues to have the chills, diarrhea, heachache and body aches as of 2/5/2021.
12hours after 2 dose of vaccine I woke up with a headache and some muscle soreness. 18 hours I had a low grade fever of 99.6 and felt extremely fatigued. I noticed a large, halved lime sized, lump under my injection site after 36 hours. It has now been 45 hours all my symptoms remain he same, constant headache even with Tylenol, fever reduced with Tylenol, very tired, mild muscle aches.
The day after being given the flu shot (11/4), he developed a papular rash approximately 3" long and 1.5" wide, next to the injection site. He reports no itching, burning, pain, warmth.
Information has been received from a physician concerning a male who was vaccinated with a dose of Pneumococcal 23v polysaccharide vaccine (lot 650648/0967P). Subsequently the pt experienced a severe local reaction. It was noted that the physician did not feel comfortable using the remaining doses in the vial and would like an investigation into Pneumococcal 23v polysaccharide vaccine (lot 650648/0967P). The records of testing prior to release of this lot have been checked and found to be satisfactory. The lot complies with the standards and was released. Additional information has been requested.
Tenderness at the site of injection; Swelling at the site of injection; Pateint felt it went not deep enought in the muscle; This is a spontaneous case, reported by other health professional to Med Communications (case ID: SEQ19-04349) and initially received on 09-Oct-2019, concerning a 45-years-old female patient.  The patient had no relevant medical history and concomitant medications were not provided.  On 03-Oct-2019, the patient was administered Flucelvax QIV [Influenza vaccine, subunit influenza virus vaccine polyvalent, dose: 0.5 ml, anatomical location: deltoid, route of administration: intramuscular, batch number: 261217 expiration date: 30-Jun-2020] for influenza prophylaxis.  On 06-Oct-2019, 3 days after vaccination, the patient developed tenderness and swelling at the site of injection. The patient stated that she felt that it did not go deep enough in the muscle (explicitly coded as ' Inappropriate route of administration'), and she was questioning whether she should receive a second dose.  The outcome of the event was resolved.  The reporter assessed the case as non-serious and did not provide causality criteria.; Sender's Comments: The patient experienced injection site pain and vaccination site swelling after incorrect route of administration with the suspect product Flucelvax QIV. Chronology is plausible. No diagnostic findings and concomitant medications were reported. Incorrect route of product administration is assessed as not related per company conventions. For all other events, causal role of the suspect product is assessed as related.
This is a spontaneous report from a contactable consumer who reported for herself. This 67-year-old female patient received PREVNAR 13, via an unspecified route of administration at 0.5 ml single in the arm (unsure if it was given in the right or left arm) on 07Apr2017 for immunisation. Medical history included ongoing osteoporosis (diagnosed in early 2000 and may before in late 90s), she had surgery on that hand a while ago in 2011, underactive thyroid. Concomitant medication included levothyroxine sodium (SYNTHROID) 75mcL, daily for underactive thyroid (she has been taking for years; maybe started around 2009), sertraline 25 mg daily from 2013 and ongoing for antidepressant, denosumab (PROLIA) injection twice a year for osteoporosis. The patient experienced lost ability to bend right thumb on 08Apr2017 with outcome of not recovered, certain muscle was effected on an unspecified date with outcome of unknown, was neuropathy of a particular nerve on an unspecified date with outcome of unknown. The events were described as follows: she lost the ability to bend her right thumb. She could bend it with her other finger but it does not bend on its own. Her doctor ended up sending her to a Neurologist who she saw two weeks ago and went thru all the shock tests and the pins and they said that a certain muscle was effected. The neurological tests on 27Apr2017, the results said that it was neuropathy of a particular nerve. That there was electrodiagnostic evidence of right anterior interosseous neuropathy. She looked it up and that was the name of the nerve and the name of the muscle that was effected was flexor pollicis longus. The little muscle at the base of the joint that bends it and that muscle is the muscle that controls the upper joint.
Presents to the ED c/o N/V/D, onset 1 week ago. Recently exposed to her granddaughter, who is infected with COVID-19.Pneumonia due to COVID-19 virus.Azithromycin, Ceftriaxone  Decadron. Completed COVID vaccination 02/10/2021.Disposition:Home health and home O2
A report has been received from a Health Professional concerning a 5 years 8 months old, male subject, who had been receiving FLUMIST, 0.2 millilitres, once/single administration. FLUMIST started on an unknown date. HCP gave FLUMIST 0.2 mL February 3, 2016 then realized 20 minutes later that it had expired on January 4, 2016. FLUMIST was continued. The outcome of the event of took expired med is unknown. The report was considered to be non-serious.