chrisvoncsefalvay/vaers-outcomes huggingface dataset:
tiredness; This is a spontaneous report from a contactable Consumer.   An unspecified age male Consumer (Age: 68; Unit: Unknown) reported that he received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: Unknown, and Expiration date: Unknown), via an unspecified route of administration on 29Jan2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient received the first dose of the COVID vaccine on 29Jan2021. The patient stated that he was reading the Fact Sheet, in which he wanted to verify the information that was on the Fact Sheet. Caller asked how long after the second dose will 95% efficacy occur. The patient stated that he had efficacy reports from Pfizer that read if you experience tiredness, the vaccine is working. The patient reported experiencing tiredness after the vaccine on an unspecified date. He read on the fact sheet about the benefits of the vaccine. The information showed it prevents the virus following two doses plus seven days. Then you are good after getting the vaccine doses three weeks apart. The patient wanted to know was there any additional information that goes with it. He did not believe some of the idiots on the news. "Some people think it is 65% effective, but they don't explain it". No other details were provided. The patient was curious that how long after the second dose you were fully protected. His next dose was due scheduled for 19Feb2021. The outcome of the event was unknown.  Information about lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Red, hard and swollen arm, warm to touch.  Cellulitis to site treated with cephalexin.
I got the vaccine on Saturday. I went to the gym for a spin after the vaccination. It was less than a half an hour. I was short of breath and couldn't complete the ride, very weak. I felt pain on the sides of my ribs...pleuritic pain. I went home and was tired. My resting heart rate on my watch which is typically between 55 and 64 went to 85-90 and did not go down until 10 days later but is still elevated. Achy low grade fever on Sunday. Went to work on Monday, tired, got an appointment Tuesday PM. EKG was abnormal and sent to ER. Cat scan multiple pulmonary embolisms both lobes and peripheral arterties. Hospitalized lots of pleuritic pain. Ulrasound of right leg DVT. Echo the next day...EF less than 30%. Hear Heart Failure in left ventricle. Started on blood thinner Lovenox 5 days. Prodaxa 2 tabs daily. Significant pleuritic pain persisted post hospitalization. Treatment for HF, Lisinopril 20 mgs, eventually on Beta blocker, Metropol Succinate started yesterday. I can do light exercise, heart rate still an issue, elevated. A little fatigued after exercise. The tx team at hospital including hematology  concluded that my pulmonary embolisms and HF is due to the vaccine. I am warned not to take another MRNA vaccine. The hope is that my condition will resolve in time. I was fit, 155 lbs, cycled about 2000-2500 miles a year. Road to work 8 months a year and on weekends. Exercised 6-7 times a week. Ski  in winter, rafted in summer. At this point I'm a little weaker, careful with exercise, need more layers to stay warm. Heart rate doesn't recover as quickly. My resting heart rate is elevated relative to baseline.
Two patients received a booster dose of Moderna Covid-19 vaccine on day 32 of being in the refrigerator; Two patients received a booster dose of Moderna Covid-19 vaccine on day 32 of being in the refrigerator; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Two patients received a booster dose of Moderna Covid-19 vaccine on day 32 of being in the refrigerator) and PRODUCT STORAGE ERROR (Two patients received a booster dose of Moderna Covid-19 vaccine on day 32 of being in the refrigerator) in an 82-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 068H21A) for COVID-19 vaccination.     No Medical History information was reported.  On 18-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Two patients received a booster dose of Moderna Covid-19 vaccine on day 32 of being in the refrigerator) and PRODUCT STORAGE ERROR (Two patients received a booster dose of Moderna Covid-19 vaccine on day 32 of being in the refrigerator). On 18-Jan-2022, EXPIRED PRODUCT ADMINISTERED (Two patients received a booster dose of Moderna Covid-19 vaccine on day 32 of being in the refrigerator) and PRODUCT STORAGE ERROR (Two patients received a booster dose of Moderna Covid-19 vaccine on day 32 of being in the refrigerator) had resolved.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.  The vial was initially stored in refrigerator on 17-Dec-2021 and the vial did not undergo any temperature excursions.   This case was linked to MOD-2022-456307 (Patient Link).
4/18 received COVID vaccine 4/20 developed rash 4/22 was seen in office - full body rash, hives on face
right hand drying up like a prune when it touches water; barely being able to move his right hand; This spontaneous case was reported by a consumer and describes the occurrence of DRY SKIN (right hand drying up like a prune when it touches water) and HYPOKINESIA (barely being able to move his right hand) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced DRY SKIN (right hand drying up like a prune when it touches water) and HYPOKINESIA (barely being able to move his right hand). At the time of the report, DRY SKIN (right hand drying up like a prune when it touches water) and HYPOKINESIA (barely being able to move his right hand) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication not provided. Treatment medication not provided.
On 11/22/21 mother requested a covid  vaccine for her son  Pfizer vaccine,  after consent signed and  identified the patient as patient and gave him the adult pfizer vaccine dose of 0.2ml to the left deltoid, patient tolerated the vaccine well  and mom and patient waited minutes in the car no reactions noted and  left. Patient was seven years old and should have received the pediatric formula dose.  On 11/23/21  the patient mother was contacted and informed of error at which time mother confirmed he  did to her his arm was a little sore  but today it feels better and he was feeling just fine
Warmth, edema began, redness 1/26/11, pain began, parent called reporting 1/27/11. Left arm larger than right. 1/28/11 pain decreased, less edema, less redness.
Information has been received from a health professional concerning a 6 year old female with an amoxicillin allergy who on 12/04/1996 was vaccinated with the first dose of varicella vaccine. There was no concomitant medication. On 12/10/2001, the pt developed chicken pox. The pt sought unspecified medical attention. On an unspecified date, the pt recovered. No further info is available.
Acute headache, joint aches and pains, fever (100.8), fatigue, dizziness, weakness
patient was inadvertently given a dose of Havrix after it was involved in a temperature excursion; This non-serious case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a patient who received HAV (Havrix) (batch number T9TL9, expiry date 05-DEC-2025) for prophylaxis.   On 25-SEP-2023, the patient received Havrix. On an unknown date, an unknown time after receiving Havrix, the patient experienced incorrect storage of drug (Verbatim: patient was inadvertently given a dose of Havrix after it was involved in a temperature excursion).  The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK Receipt Date: 26-SEP-2023 The nurse reported a patient was inadvertently given a dose of Havrix after it was involved in a temperature excursion that rendered the product unstable, which led to incorrect storage of drug. The reporter consented to follow up.
Headache, Myalgia, c/o fatigue,sob, ear pain,back pain,injection site sore. Told to visit primary care physician if no improvement. Narrative:
pt recvd vax & 15mins post vax pt exp numbness,warmth,& tingling around mouth;ER MD was required;tx w/DPH;sx subsided in 45mins;
The next morning I woke up with a head cold and headache, which today on Saturday I still have.
Fever, Headache, sore throat, chills, sweats. Basically the same issues I had when I had Covid in Jan 2021 except it lasted only 24 hours instead of 10 days.
This case was reported by a consumer via call center representative and described the occurrence of fever in a 74-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included influenza. On 10th July 2018 16:00, the patient received the 1st dose of SHINGRIX. In July 2018, 10 hrs after receiving SHINGRIX, the patient experienced fever, pain, thirst and shivering. In July 2018, the outcome of the fever, pain, thirst and shivering were recovered/resolved. It was unknown if the reporter considered the fever, pain, thirst and shivering to be related to SHINGRIX. Additional details were received as follows: This case was previously reported to the physician. On 10th July 2018, at 4 pm or 5pm the patient was vaccinated with a dose of SHINGRIX. On 11th July 2018, at 2 am, the patient went to bed experienced shivering with a fever. The fever was recorded as 99.9 Degree F. The patient was experienced aching like she did the last time she had flu. On 11th July 2018, at 9:00am after 17 hours she woke up experienced very thirsty. All symptoms were resolved by later that afternoon.
Approx one day after the injection, L arm became inflamed at the injection site and moved to lower arm.  The arm remained dark red (similar to a severe sunburn), was warm to the touch, and itchy.  After a couple days, it went away.  However, it occasionally reappears.  Most recently 9/22/21 (four months after the second vaccine); arm again was red, warm, inflamed and itchy.
3 patients did not receive actual vaccine; There were a few vaccines that went in easy; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (3 patients did not receive actual vaccine) and SYRINGE ISSUE (There were a few vaccines that went in easy) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 014M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (3 patients did not receive actual vaccine) and SYRINGE ISSUE (There were a few vaccines that went in easy). On 16-Apr-2021, PRODUCT DOSE OMISSION ISSUE (3 patients did not receive actual vaccine) and SYRINGE ISSUE (There were a few vaccines that went in easy) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   An pharmacist reports that 20 patient received the Moderna vaccine, where mixed patient received 1st and 2nd dose, but there were 3 remaining syringes containing vaccine at the end of Vaccination clinic. HCP feels that 3 patient didn't received the vaccine and the administrator felt that few Vaccine went in too easy.   Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2021: The follow up received on 20-APR-2021, with information on Batch/lot number and expiration date
7 days status post first dose of Moderna vaccine experiencing itchy rash located axillary, back, abdomen, chest, and bilateral upper and lower extremities.
Pt stated "I feel dizzy" was not making eye contact. B/P 160/111, 144/104, 133/81, numbness to legs / face / fingers and poor tone.
One week after injection, woke to swelling, redness, intermittent itching at injection site, no pain or tenderness.  It is now day three with no worsening or improvement.
Administered expired vaccine to patient after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to patient after the manufacture date of expiration) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 25-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to patient after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to patient after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.   Date the vial was initially stored in the refrigerator was unknown.  The vial did not undergo any temperature excursions.  Vaccine expiration date was reported as 24-Oct-2021.  No treatment details were reported.   This case was linked to MOD-2022-581986 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow-up received included non significant information: reporter details.
MYSTERY "STROKE":  The patient remembers receiving the MODERNA COVID vaccination and feeling nothing immediately after shot, took off work a few days later and then on following Monday remembered getting up and preparing for day with shave and shower.  Remembers blood sugar being in normal range.  Went to dress and collapsed.  Could not move left side of body or cry out for help.  Was found by a neighbor after two days of being face down on floor unable to reach phone drifting in an out of consciousness.  Transported by EMT to hospital.  MRI brain scan, ultrasound of legs including Doppler velocimetry conducted.  Now at healthcare facility.  Continued weakness left side.
Initial spontaneous report received on 07 November 2013 from a pharmacist. A female patients whose age, medical history and concomitant medications were not reported, received a dose of ADACEL (route was intramuscular, lot # C4247AA and site of vaccination was not reported) on 07-Nov-2013. Patient is pregnant and drug exposed during pregnancy. List of documents held by sender: none.
This spontaneous report was received from a nurse practitioner via a company representative referring to a 11 year old female patient. The patient's concurrent conditions and medical history were not reported. On an unknown date, the patient was vaccinated with a dose of GARDASIL 9 0.5 ml (concentration, dose number, anatomical site of vaccination, lot # and expiration date were not reported) for routine vaccination. Concomitant therapies included TDAP and MENACTRA. On an unknown date (reported as "within the last couple of days") and after the vaccination with GARDASIL 9, the patient "almost passed out". The patient was attended to at the office and was kept there for 45 minutes before she was allowed to leave. She was "fine" at the time she left. There was no cancer, the patient did not die, there was no significant disability or hospitalization and the event was not life-threatening. No product quality complaint was involved. Subsequently (also reported as "within the last couple of days"), the patient recovered of the loss of consciousness. The reporter did not provide a causality assessment between GARDASIL 9. Additional information has been requested.
patient was given a High Dose Flu vaccine by mistake. Patient tolerated ok and no adverse reaction to receiving this vaccine
Face turned red, and then numb, hard to breathe, and felt like heart beat quicken, and felt like passing out. Lasted for about 3 minutes.
Case number PHEH2012US016274 is a spontaneous report initially received from a nurse on 16 Aug 2012 with a follow-up received on 27 Aug 2012 and 17 Sep 2012: This report refers to a 16-years-old female patient. Her medical history included allergy to penicillin and cephalosporin. She was given only the MenA lyophilized conjugate vaccine component of MENVEO (batch number: A11046 and expiry date: 20 Apr 2014) reconstituted with sterile water, intramuscularly on 14 Aug 2012. She did not receive the MenCYW-135 liquid conjugate vaccine component. She experienced slight itching at the vaccination site on 14 Aug 2012 and completely recovered from the event on 17 Aug 2012. It was reported that vaccination with correctly reconstituted MENVEO would be repeated later. No further information was provided. Follow-up information received from the nurse on 27 Aug 2012: Updated patient demographic and medical history. Follow-up received from the nurse on 17 Sep 2012: Updated expiry date of MENVEO, start date of itching and information on revaccination with MENVEO.
On an unspecified date, the pt received her third dose of Lymerix. Subsequently, the pt experienced arthritis versus arthralgia, reportedly. As of 1/31/01 the outcome of the event is unknown.
Swelling and pain in left armpit; Swelling and pain in left armpit; Dose received: 3; This is a spontaneous report from a contactable reporter (consumer or other non HCP). The reporter is the patient.   A 34-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in left arm, administration date 10Jan2022 (Lot number: 33025BD) at the age of 34 years as dose 3 (booster), single for COVID-19 immunisation. The patient had no relevant medical history. The patient had received unspecified concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot Number: EW0158, Anatomical Location: Left arm), administration date: 15Apr2021, when the patient was 33 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE, Lot Number: EW0172, Anatomical Location: Left arm), administration date: 06May2021, when the patient was 33 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 10Jan2022, outcome "unknown", described as "Dose received: 3"; SWELLING (non-serious), AXILLARY PAIN (non-serious) all with onset 11Jan2022, outcome "unknown", and all described as "Swelling and pain in left armpit". Therapeutic measures were not taken as a result of swelling and axillary pain.  Additional Information: The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care.
patient was administered an expired booster dose; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient was administered an expired booster dose) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient was administered an expired booster dose). On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (patient was administered an expired booster dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter. Treatment information was not provided by the reporter.   This case was linked to MOD-2021-369020 (Patient Link).
neck pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient. A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NECK PAIN (non-serious), outcome "unknown", described as "neck pain". Therapeutic measures were taken as a result of neck pain. Additional information: Event was reported as follows: The patient got the last dose of the vaccine last 04Feb2021 and can't remember the day of his first dose. The patient took Ibuprofen (for neck pain) 3-4 hours prior to his second dose. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a registered nurse (RN) concerning a 18-week-old patient who on 02-MAY-2006 was vaccinated PO with the first dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human-bovine). It was unknown if medical attention was sought and no symptoms were reported. Additional information has been requested.
erythema and swelling at injection site, low grade fever, myalgia and malaise x 3 d after injection
Felt like punched in arm; Some soreness and some stiffness at the injection site; stiffness at injection site; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on 24Mar2021 at 16:30 (at the age of 63-year-old), as a single dose for COVID-19 immunisation. Medical history included mild obstructive sleep apnea. Concomitant medication included pravastatin (MANUFACTURER UNKNOWN) 40 mg and omeprazole (MANUFACTURER UNKNOWN) 20 mg daily; both for an unknown indication from unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. On 24Mar2021 at 19:00, the patient experienced like punched in arm, some soreness and some stiffness at injection site. The patient used an ice pack and once taken 800 mg ibuprofen helped reduce this no worse than mild pain or soreness. Moving left arm overhead with a back-and-forth motion also provided relief. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events felt like punched in arm, sore injection site and injection site stiffness were recovering at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.