chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a registered medical assistant concerning a 16 month patient of unknown gender. The patient's concurrent conditions, medical histories and concomitant medications were not reported. On 28-APR-2017, the patient was vaccinated with PEDVAXHIB (lot number N000236, expiration date 24-OCT-2019), intramuscularly for prophylaxis during or after a temperature excursion occurred. The vaccine was exposed to a temperature excursion of 52 degrees Fahrenheit for 2 hours. A data logger involved. There was no previous temperature excursion. No adverse events were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected as all scheduled correspondence has been received. Sender's Comments: US-009507513-1704USA001797: US-009507513-1706USA004370: US-009507513-1706USA004380: US-009507513-1706USA004381: US-009507513-1706USA004383.
Hives over entire body that itches.  Zyrtec 1/2 tsp q12hrs. given to treat symptoms as needed to help with itching.
Several hours after getting 2nd dose, left arm very painful. The next morning she woke up and had increase in arm pain, not able to move it, body aches, chills, nausea, and fatigue. symptoms remain today.
chronic hives/full of hives; some aches; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (chronic hives/full of hives) and MYALGIA (some aches) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination.     Concurrent medical conditions included Egg allergy (because he ate a lot of eggs).    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, the patient experienced MYALGIA (some aches). On an unknown date, the patient experienced URTICARIA (chronic hives/full of hives). At the time of the report, URTICARIA (chronic hives/full of hives) and MYALGIA (some aches) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.   This case was linked to MOD-2021-335299 (Patient Link).
Pt called the office reporting injection site pain, headache, and right eye redness.  Started with the red eye then injection site arm hurting/pain, and headache. Pt was told to go to her PCP and/or the emergency room to be seen and treatment.
got the shots!,then three repeats/suspected vaccination failure; have had three repeats./ on my behind/Since then then I have had had three repeats; it is very painful sitting!!; This 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.   The patient's past medical history included shingles (The patient got shingles around waist) and pain (it was really painful).   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional Information: GSK Receipt Date: 21-SEP-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient later got the shingles shots. Since then he/she had three repeats of shingles.  The reporter stated that, not as bad, but on his/her behind and it was very painful sitting. The reporter further stated that, hate to feel how it be if he/she had not gotten the shots. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.
Red Rash full body on 1/8/21. Some Relief 1/9/21. Full Recovery 1/10/21 Benadryl dose for treatment of rash
Blood clots both lungs; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: not reported) via an unspecified route of administration, administered in right arm on 30Mar2021 12:00, as DOSE 2, SINGLE for COVID-19 immunisation in pharmacy. Medical history included sulphate drugs allergy. The patient's concomitant medications were not reported. 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 COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: not reported), administered in right arm on 09Mar2021 02:00, as DOSE 1, SINGLE for COVID-19 immunisation. On 22Jun2021, the patient had blood clots both lungs. The event reported as serious. The event resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care hospitalization. Therapeutic measures were taken as a result of blood clots both lungs and treatment with heparin. Outcome of the event was not resolved.  Information about lot/batch number has been requested.
About 45 minutes after the vaccine patient felt ill (really hot and started sweating). We recommended she had some juice and water and we took her to a cool room. She felt really "out of it" afterwards and had to call for a family member to drive her home.  Het symptoms were described as fatigue, depressed, and felling  cloudy. Two days later the patient reported that she had hives from the vaccine. PEr her supervisor she is doing well now and all symptoms resolved.
second vaccine, she chose to have it in her buttocks; Off label use; Welts; Red Streaks; Swelling on her injection site arm from her left shoulder to her left fingertips; Swelling on her injection site arm from her left shoulder; This case was reported by a other health professional via sales rep and described the occurrence of welts in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular) and the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced welts, red rash, swelling arm, swollen joints, vaccine administered at inappropriate site and off label use. On an unknown date, the outcome of the welts, red rash, swelling arm and swollen joints were recovered/resolved and the outcome of the vaccine administered at inappropriate site and off label use were unknown.   It was unknown if the reporter considered the welts, red rash, swelling arm and swollen joints to be related to Shingrix.  Additional details were provided as follows: The patient was an office manager and was vaccine representative. The age at vaccination was not reported. The patient experienced welts, red streaks and swelling on her injection site arm from her left shoulder to her left fingertips. These symptoms were from her first vaccine and lasted seven days. To avoid having the same reaction from her second vaccine, the patient chose to have it in her buttocks, which led vaccine administered at inappropriate site and off label use. The reporter did not consent to follow-up.
Ringing in both my ears, predominant in right ear; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: ER8727) via an unspecified route of administration in left arm on 21Mar2021 at 14:15 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. Medical history included migraine. Concomitant medications included topiramate (MANUFACTURER UNKNOWN) 100mg twice daily and propranolol (MANUFACTURER UNKNOWN) 25mg twice daily for an unknown indication from an unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6203) via an unspecified route of administration in left arm on 28Feb2021 at 16:15 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. The patient past drug history included codeine and was allergic to it. The patient was not diagnosed with COVID-19, prior to vaccination. The patient had not tested for COVID-19, since the vaccination. On 22Mar2021 at 12:00, the patient experienced ringing in both ears, right ear more prominent beginning day after second dose and continued with intensity each day after and it had been 6 days. The patient did not receive any treatment for the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of ringing in ears was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
This spontaneous report was received from a registered nurse, concerning a patient of an unknown age and gender. There were no concurrent conditions, medical history, drug reactions or allergies or concomitant medications reported. On 14-APR-2017 and 21-APR-2017, the patient was orally vaccinated with the first and second dose of ROTATEQ (dose, frequency, strength, lot # and expiration date were not reported), respectively, for prophylaxis; this vaccination schedule was outside the recommendations per ROTATEQ prescribing information. No adverse effects were reported. Additional information has been requested.
while taking shower 6DEC approx 24hr p/vax lt arm devel pain/burning in lt axillary region;palpable tenderness w/o specific lt axillary lymphadenopathy;
I got pregnant less than 1 month after the vaccine.  Since conception I had a Subchorionic Hemotomia.  The hemotomia did not get smaller as pregnancy progressed and ended in a missed miscarriage at 10.5 weeks
Patient reported a mild rash near injection site two days after immunization (12/06/17). Patient starting taking BENADRYL 25 mg and rash improved by 12/8/17.
I63.512 ACUTE STROKE DUE TO OCCLUSION OF LEFT MIDDLE CEREBRAL ARTERY 4/26/2022 ACUTE STROKE DUE TO ISCHEMIA, UNSPECIFIED TYPE AND ARTERY J96.11 CHRONIC HYPOXEMIC RESPIRATORY FAILURE 7/12/2022 ACUTE STROKE DUE TO ISCHEMIA, UNSPECIFIED TYPE AND ARTERY R09.02 HYPOXIA 5/1/2022 ACUTE STROKE DUE TO ISCHEMIA, UNSPECIFIED TYPE AND ARTERY
PATIENT RECEIVED A PFIZER BIVALENT BOOSTER ON 9/21/2022.  PATIENT RECEIVED ANOTHER MODERNA BIVALENT BOOSTER ON 12/14/2022.
itching on the injection site; red blotch on the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PRURITUS (itching on the injection site) and INJECTION SITE ERYTHEMA (red blotch on the injection site) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension (High Blood pressure). Concomitant products included LISINOPRIL for an unknown indication.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, the patient experienced INJECTION SITE PRURITUS (itching on the injection site) and INJECTION SITE ERYTHEMA (red blotch on the injection site). At the time of the report, INJECTION SITE PRURITUS (itching on the injection site) and INJECTION SITE ERYTHEMA (red blotch on the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 64-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Sep2022 as dose 5 (booster), single (Lot number: GJ5342) at the age of 62 years for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). No Known allergies. Concomitant medication(s) included: FAMOTIDINE; SYNTHROID. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 13Sep2023 to 18Sep2023.; Sender's Comments: Vaccine efficacy varies from person to person. The association between the event lack of effect (COVID-19) with BNT162B2, BNT162B2 OMI BA.4-5 can not be fully excluded.
Thursday afternoon, was the first symptom - this was extremely sore arm. Right up in shoulder area- I had a nodule. It hurt really bad. I woke up Friday and it was bigger. I went to Hospital ER - they did an Ultrasound. They believed it was from vaccine. After a week, it went down. Not a steady thing  but on a week after the vaccine- but on and off- I never had it before. I have dizzy spells here and there. They go away and then a week later I will get a dizzy spell. It comes out of nowhere, lasts for a few minutes and then it's gone.  And the last had a dizzy spell four or five days ago. I haven't gone to the doctor yet.
A non-serious spontaneous report of administration of expired FLUMIST was received from a health professional concerning an 11-year-old female. Neither the patient's medical history nor concomitant medications were reported. The product expired on 25-Feb-2012. On 27-Feb-2012, the patient received expired product. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.
8JUL98 hlth dept states baby had high pitch cry that lasted 3hr;the ER advised to use motrin (took to ER 7JUL98) swelling about the size of silver dollar @ that time;
Fever - headache - pain, back and legs, weakness 4 plus days - dizziness. Shot on Monday - symptoms Tues, Wed, Thurs, Fri and Sat.
No additional AE; temperature excursion in which PROQUAD and V ARlV AX may have been administered to patient(s).; This spontaneous report as received from a nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 25-MAR-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # T021639, expiration date: 21-DEC-2021, dose 1 (formulation, strength, exact dose, frequency, route of administration were not reported) for prophylaxis. On an unknown date, the dose of the vaccine was exposed to temperature excursion at 17.32 Fahrenheit degrees (F) for 1 hour 22 minutes. There was no previous temperature excursion reported. The call was due to digital data logger. No additional adverse event was reported.
First dose / almost a year ago and has not received the second dose yet; This case was reported by a physician via call center representative and described the occurrence of incomplete course of vaccination in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (received 1st dose almost a year ago of batch number MT7C9 and expiry date was 15th April 2022).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination. VAERS details of 1st dose was reported. The reporter consented to follow-up.
02/13/2021: sore left arm, extreme fatigue started in afternoon 02/14/2021 - 02/15/2021: muscular pain, headache,  exhaustion, slight nausea, joint pain 02/16/2021 - 02/17/2021: extreme fatigue, joint pain 02/18/2021 - 02/24/2021: fatigue, joint pain (7 on a scale of 1-10)
Oct 13, 2010 a flu shot clinic was done at apartments in conjunction with the Health Dept. Tenant received a flu shot at approximately 1:00 pm, no problem noted at the time and she returned independently to her apartment. At approximately 1:30 pm patient returned to the area where the flu shot clinic was being held complaining that she didn't feel well, was very lightheaded and felt "wheezy". She walked to the clinic room on her own. Color was pale compared to her usual. The lower eyelids bilaterally were bright red (she had been seen by me earlier in the day and eyelids were normal color), lung sounds were clear throughout, BP 130/76, HR 122 and irregularly irregular apically and pulse conducted through to radial at rate of approximately 80. RR 18 and without distress. No history of cardiac disease except one episode of pericarditis approximately 4-5 years ago. Skin warm and dry. Denied itching or difficulty breathing, just felt "wheezy". No markings of any kind seen at the injection site; no abnormality palpable at the site. Emergency rescue called. Remained in attendance with patient until they arrived. BP 5 min later was 130/80 with HR 100 and remaining irregularly irregular apically. Care was turned over to rescue squad and she was transported to hospital emergency room. Suspected flu shot reaction or coincidental onset of atrial fibrillation. 10-14-10 Phone call to patient regarding outcome. She was kept in ER for several hours, given an IV injection of drug unknown to her to regulate the heart rhythm, then sent home with a 48 hour Holter monitor on. Has experienced no further symptoms.
dizziness with horizontal nystagmus, improving the next day.  No fatigue, no weakness, no headache, no fever, no aches or pains at any time, no other symptoms.
Pt developed a rash that started on both legs and migrated to upper arms it lasted for 4 days & resolved.
Shoulder and neck soreness; Shoulder and neck soreness; Dominant arm very painful; Flexibility in range/can't move arm; This is a spontaneous report received from a contactable consumer or other non hcp. A 61-years-old female patient received 1st dose of bnt162b2 (Pfizer covid19 vaccine,Batch/Lot Number: EN6207),via an unspecified route of administration, administered in Arm Right on 13Mar2021 12:30,at the age of 61 years old,as Dose 1,single for covid-19 immunization.Medical history included ongoing overweight Structured information(Patient episode name,Patient Medical comments: Verbatim: Overweight,ongoing hypertension and ongoing asthma.Concomitant medications included hydrochlorothiazide, Irbesartan( HCTZ) taken for hypertension from an unspecified start date and ongoing; montelukast taken for asthma from an unspecified start date and ongoing and naproxen taken for inflammation,start and stop date were not reported.The patient experienced shoulder and neck soreness, dominant arm very painful and flexibility in range/can't move arm on 14Mar2021.Therapeutic measures were taken as a result of shoulder and neck soreness ,dominant arm very painful,flexibility in range/can't move arm.Patient can not raise her arm above her head. It is her dominant arm and it is very painful. It was not bothering her like it is now.Yesterday was 24 hrs ago.The patient was taking advil for the adverse event.The adverse events didn't result in hospital emergency room visit or physician clinic visit.The patient had no prior vaccination within 4 weeks.The outcome of the events was not recovered. Follow-up (15Mar2021): This is a follow-up spontaneous report from a contactable consumer. This consumer reported that Caller stated daughter filed her own adverse event report through Pfizer Safety Reporting online.  No follow-up attempts are possible. No further information is expected.
her doctor stated to wait an additional week before receiving her second dose; headache; tiredness; fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of OFF LABEL USE (her doctor stated to wait an additional week before receiving her second dose), HEADACHE (headache), FATIGUE (tiredness), PYREXIA (fever) and CHILLS (chills) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 030B21A) for COVID-19 vaccination.     No medical history was provided by the repor.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In March 2021, the patient experienced OFF LABEL USE (her doctor stated to wait an additional week before receiving her second dose), HEADACHE (headache), FATIGUE (tiredness), PYREXIA (fever) and CHILLS (chills). In March 2021, OFF LABEL USE (her doctor stated to wait an additional week before receiving her second dose), HEADACHE (headache), FATIGUE (tiredness), PYREXIA (fever) and CHILLS (chills) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No relevant concomitant medication was reported. Treatment information was not provided.
severe allergic reaction.  arm swelled up immediatly following shot then after 30 minutes my face lips  & tongue swelled up bad and I felt very weak,  I had a fever and my arm was very hot hurting and swollen for many days. I still do ot feel back to my normal self.  I had to take prednisone as well as benadryl for over a week.  use ice packs on my arm which hurt me very much to use..
splitting headache; inability to sleep; This case was reported by a consumer via call center representative and described the occurrence of headache in a 80-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th February 2020, the patient received the 2nd dose of Shingrix. In February 2020, less than a day after receiving Shingrix, the patient experienced insomnia. On 18th February 2020, the patient experienced headache. The patient was treated with ibuprofen (Advil). On an unknown date, the outcome of the headache was not recovered/not resolved and the outcome of the insomnia was unknown.   It was unknown if the reporter considered the headache and insomnia to be related to Shingrix.  Additional details were received as follows: The patient received 2nd dose of Shingrix in left arm at her doctor's office. The patient experienced   splitting headache that evening causing an inability to sleep. The patient had taken 2 Advil approximately 30 minutes and it has not helped. The reporter consented to follow up.
This spontaneous report was received from a pharmacist refers to 2 patients of unknown age and gender. No concurrent condition or medical history was reported. On 24-OCT-2015, the patients were vaccinated with ZOSTAVAX (lot # L025000, dose and route of administration not provided) which were exposed to temperatures outside of the recommended range. No concomitant therapy was reported. No adverse effect were reported. The outcome of the event was unknown. No product quality issue was involved. Additional information has been requested.