chrisvoncsefalvay/vaers-outcomes huggingface dataset:
received dose 1 18-22 months ago; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received between 18 to 20 months ago of reporting date).   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 were reported as follows: The age at vaccination was not applicable for this report. The HCP (health care professional) reported that patient received first dose of Shingrix between 18-22 months ago.  No reactions reported. Till the time of reporting, the patient did not receive the second dose of Shingrix, which led to incomplete course of vaccination. The reporter consented to follow up by email. GSK note- considering worst case approach, this case kept valid even though reporter did not commented for 2nd dose.
Pt. felt fine but later went to ER, notified by family member 9/27/12 about ER visit.
Got shot Monday 11/11/2013; Tuesday had muscle pain from arm to neck on one side and headache - told us Thurs 11/14/13.
Narrative:  69yo male pt died on 9/14/2021 at home in home hospice care due to end stage cirrhosis of liver. Pt received one covid vaccine on 3/22/2021. Pt's death is not related to vaccine.
Initial report was received 30 September 2010 from a health care professional. An adult pregnant female patient (age and date of birth to be confirmed), had received a first dose intramuscular injection of ADACEL, lot number C3476AA on 09 September 2010. The patient's last menstrual period occurred on 06 August 2010 and her expected date of delivery was 13 May 2010. It was unclear at the time of the report if the patient's date of birth was 10 April 1983 or 04 October 1983. The patient had no risk factors, and at the time of the report, she had not experienced any adverse events since receiving ADACEL. Follow-up information was received from a health care professional on 03 June 2011. The patient's last name was corrected as per the reporter. Follow-up information was received from a health care professional on 11 July 2011 reported that the patient had a history of irregular menses and test negative for pregnancy prior to administration of ADACEL. The reporter has no further contact with patient and no further information to provide. The outcome remained unknown. Follow-up information received from a health care professional on 15 July 2011. The patient has history of 2 prior pregnancies that resulted in 2 live births. The patient had no concurrent illnesses, and was diagnosed with irregular menses and dysmenorrhea at time of ADACEL vaccination. She had not received any other vaccinations within 4 weeks of 09 September 2010. The patient had no adverse events following prior vaccinations. The patient had a negative urine pregnancy test on 09 September 2010. Health during pregnancy included nausea and vomiting, and a UTI (urinary tract infection) that was treated with oral CEPHALEXIN from 07-14 October 2010. Obstetrical ultrasound performed on 28 October 2010 revealed a single 7.3 week gestation with negative fetal heart sound determined to be fetal demise. The patient underwent "abortion" (date not provided). Recovery status not reported. Documents held by sender: None.
This spontaneous report received from a medical assistant refers to a unspecified number of patients of unknown age and unknown gender. The patients medical history and current conditions were not reported. Since 03-JUN-2014, the unspecified number of patients were vaccinated with improperly stored RECOMBIVAX HB (dose/frequency, route of administration were not reported). Concomitant medications were not reported. No adverse effects were reported. No product quality complaint (PQC) was reported for RECOMBIVAX HB. This case is linked to 1407USA009063, 1407USA012207, 1407USA012206 and 1407USA012205 (same reporter link). Additional information has been requested.
Pt recvd APAP per MD recommendation; c/o h/a, discomfort about 8PM became feverish to 105F @ 10PM put in cold bath per advise of MD; pt vomited x 1 & slept rest of night;
No additional AE; patient received an improperly stored PROQUAD vaccine; This spontaneous report was received from a licensed practical nurse and refers to a patient of unknown gender or age. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 16-JUN-2023, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant human albumin (rHA) (PROQUAD) injection, product quantity: 1, lot #W039841, expiration date: 12-JUN-2024, administered for prophylaxis (anatomical location, and route of administration were not provided) (product storage error). There were no adverse events reported (no adverse event).  This is one of the two reports received from the same reporter.; Sender's Comments:  US-009507513-2306USA009685:009507513
The symptoms of this adverse event were noticeable tiredness and weakness continue beyond a week after the second vaccine dose. Went to primary doctor who then sent me to physical therapy. During my first visit, the physical therapist found that the was significant weakness on the left side of my body. The therapist suspects the vaccine shot  temporarily enhanced a previously unknown issue enough where it became noticeable.  The therapist says this 'enhancement' effect would go away in time.
Received MMR, Varicella, and PedvaxHIB on 4/25/06. TC from mom reports rash x1 week. Feels warm, teething also, eating, and sleeping normal - normal activities. Note 4 pox - forehead, right chin, mid back, and left upper buttock. All intact.
Patient was given Fluzone High Dose vaccination that was already expired, no AE; Initial information received on 03-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to case 2019SA278105 (same reporter).  This case involves 70 years male patient who received 0.5 ml dose (4th dose) of expired vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (lot UI995AB, expiry date: 01-Apr-2019) via intramuscular route in the left arm on 02-Oct-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of actual medication error due to expired vaccine used.  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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 is 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 has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
This is a spontaneous report received from a contactable reporter (consumer or other non-HCP). The reporter is the patient.A 20-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in left arm, administration date 03Jan2022 at 12:00 (Lot number: unknown) at the age of 20 years as dose 3 (booster), single for COVID-19 immunisation. The patient had no relevant medical history and no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot number: UNKNOWN, Route of administration: Left arm, Vaccine administration time: 12:00), administration date: 05Jun2021, when the patient was 20 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE, Lot number: UNKNOWN, Route of administration: Left arm, Vaccine administration time: 12:00), administration date: 26Jun2021, when the patient was 20 years old, for COVID-19 immunisation. The following information was reported: IMMUNISATION (non-serious) with onset 03Jan2022 at 12:00, outcome "unknown", described as "Dose number: 3"; MENSTRUATION DELAYED (non-serious) with onset 04Jan2022 at 12:00, outcome "unknown", described as "Menstural Cycle delayed by 7 days". Therapeutic measures were not taken as a result of menstruation delayed.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.The lot number for BNT162b2 was not provided and will be requested during follow up.
This spontaneous report was received from a physician assistant, 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 19-APR-2017, the patient was vaccinated with an expired dose of VARIVAX injection (dose, frequency and route were not reported) lot # L013395 with expiration date of 16-APR-2017, for prophylaxis. No adverse effects were reported. There was no product quality complaint involved. Additional information has been requested.
the patient was administered her first dose of GARDASIL 9 before the age of 14 and then received her second dose at the age of 22.; no additional AE's were reported; This spontaneous report has been received from a nurse, regarding a 22-year-old female patient. The patient's medical history, concurrent conditions, concomitant therapies and drugs reactions or allergies were not reported.  On an unknown date (reported as before the age of 14 years old), the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (dose, vaccination scheme, frequency, lot number, expiration date, and route of administration were not provided) administered for prophylaxis and on an unknown date (reported at age of 22 years old), the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (dose, vaccination scheme, frequency, lot number, expiration date, and route of administration were not provided) administered for prophylaxis (inappropriate schedule of product administration).  No additional adverse events (AE's) were reported.
Could not stand off legs; Felt week in his knees; Light headed; Pain to touch or pressed on the injection site; This spontaneous case was reported by a consumer and describes the occurrence of DYSSTASIA (Could not stand off legs), ASTHENIA (Felt week in his knees), DIZZINESS (Light headed) and VACCINATION SITE PAIN (Pain to touch or pressed on the injection site) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Meniscus tear, Sinusitis and Obesity.    On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Mar-2021, the patient experienced DYSSTASIA (Could not stand off legs), ASTHENIA (Felt week in his knees), DIZZINESS (Light headed) and VACCINATION SITE PAIN (Pain to touch or pressed on the injection site). At the time of the report, DYSSTASIA (Could not stand off legs), ASTHENIA (Felt week in his knees), DIZZINESS (Light headed) and VACCINATION SITE PAIN (Pain to touch or pressed on the injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication provided include supplements for knees and allergic pill for sinuses. Treatment information was not provided.
Starting the following evening around 6 pm, upon waking up from a nap, spiked a fever of 103 degrees. Experienced significant muscle weakness with gross motor coordination compromised.  Could not sit up.  Had to rock back and forth to try to sit up.  Difficulty walking. Difficulty speaking and altered mental status.  Speech not clear. Took Tylenol on advice of GP administered by husband. Temperature fell to 101, then 99 degrees by 10 pm.  By 4 am Sunday morning, temperature was 99 degrees, speech had returned to normal.  Sunday 8 am, sleeping normally.  Sunday during the day, felt shaky and weak, still slight fever of 99 degrees but normal mental status and speech.  Continued taking Tylenol periodically.  By Sunday evening, felt mostly back to normal, but have continued to feel somewhat weak/shaky for the last week.
A week of positional vertigo.; Second shot...day of felt like cloud lifted. 20 after shot...almost blacked out,; Dizzy; Diarrhea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 20Mar2021 14:00 (Lot number: EN6208) at the age of 64 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Past drug history included: Known allergies: compazine for vomiting, reaction(s): "Known Allergies: Compazine", notes: Known Allergies: Compazine; Known allergies: tyramine, reaction(s): "Known Allergies: Tyramine", notes: Known Allergies: Tyramine. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6200, Location of injection: Arm Left, Vaccine Administration Time: 10:00 AM), administration date: 26Feb2021, when the patient was 64 years old, for COVID-19 immunization. The following information was reported: VERTIGO POSITIONAL (non-serious) with onset 20Mar2021, outcome "unknown", described as "A week of positional vertigo."; PRESYNCOPE (non-serious) with onset 20Mar2021, outcome "unknown", described as "Second shot...day of felt like cloud lifted. 20 after shot...almost blacked out,"; DIZZINESS (non-serious) with onset 20Mar2021, outcome "unknown", described as "Dizzy"; DIARRHOEA (non-serious) with onset 20Mar2021, outcome "unknown", described as "Diarrhea". The events "a week of positional vertigo.", "second shot...day of felt like cloud lifted. 20 after shot...almost blacked out,", "dizzy" and "diarrhea" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of vertigo positional, presyncope, dizziness, diarrhoea.  Additional information included: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not received other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Moderna COVID-19 Vaccine  As of 5/29/2021: Redness, rash, small bumps similar to hives, aching shoulder muscle. 1:05 PM, 5/30/2021: Symptoms/ signs still present.
COVID; COVID; This spontaneous case was reported by a consumer and describes the occurrence of the first episode of COVID-19 (COVID) and the second episode of COVID-19 (COVID) in an 88-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced the first episode of COVID-19 (COVID). On 08-Mar-2021, the patient experienced the second episode of COVID-19 (COVID). On 09-Mar-2021, last episode of COVID-19 (COVID) 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.
This spontaneous report as received from a pharmacist refers to a 74 year old female patient with hypertension. Drug reactions/allergies were not reported. On approximately May 2011, (two years ago), the patient was vaccinated with ZOSTAVAX (lot number, dose, route and expiration date were not reported) at unspecified clinic. Concomitant therapies included NEXIUM and unspecified medication for hypertension. In April 2013, (about one month), the patient was diagnosed with shingles. The patient had "tingles" in her fingers. The patient was treated with acyclovir. The patient sought medical attention, by an office visit to unspecified physician. The outcome of shingles and "tingles" in her fingers was reported as recovering. Additional information has been requested.
Two to three days following I ran a low temp, was nauseaus and felt achy. Day three I developed a rash on my left arm that itched. A week after the shot I had swelling in the upper back left top of my mouth. Though I had an absessed tooth. After seeing my dentist I was told my tooth was fine, but that the swelling and blisters were herpes. I was given Valacylovir HCL 1 gram to take once per day for 14 days.
Tingling and numbness in lower legs. Started in toes and within about 1 - 1 1/2 months had moved up to my knees. Went to chiropractor, with no relief. Went to my PCP (Devareaux) who referred me to a neurologist and prescribed Gabapentin. Did nerve testing. Still experiencing symptoms.
Patient started bleeding from nipple of left breast 3 weeks after vaccine.  Ultrasound of breast determined that there was no tumor/mass, just an increase in breast density tissue.  Doctors are unable to explain why the nipple is bleeding. Patient is still bleeding.
Information has been received from a female patient who on 15-MAR-2011 was vaccinated with a dose of ZOSTAVAX (Merck) (lot number not provided). The patient reported that she experienced swelling and pain at the injection site. It was unspecified if the patient sought medical attention, received any treatment of if any lab diagnostic studies were performed. At the time of the report, the patient's outcome was unknown. No further information is available.
pt stated that several days later she started having trouble with her left leg, hip and foot.  Pt went to her PCP  after she got these symptoms and they did xrays on her leg which showed no breakage.  He prescribed her anti-inflammatory and pain pills.  She has been applying ice to affected areas.  She has been referred to an orthopedic doctor but is waiting for them to contact her.  She has also been to a message therapist and a Chiropractor with no help for the pain.  Pt states that the pain is not getting any better.
This spontaneous report was received from a registered nurse referring to a 13 year old female patient. The patient's concomitant medication, pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On 15-SEP-2017, the patient was vaccinated with either GARDASIL lot # N000326, expiration date 14-OCT-2019 or GARDASIL 9 lot # N000326, expiration date: not reported (strength, dose, dose number and route of administration were not provided) for prophylaxis which were improperly stored (incorrect product storage). This is one of several reports received from the same source.; Sender's Comments: US-009507513-1709USA008666:
from 13NOV thru 18NOV or + knot in stomach caused food to go both up & down;BM & vomit;then a fainting-to be all day & noc w/some vomiting;no appetite, unsteady on feet;pains in upper GI;BM liquid only for 2-3 days;day 4 very painful
Hand swelling on 3/17/14 and swelling to mid-arm. Painful and itching.
Some component in the vaccine actually took away the pain and the weaknessfrom peripheral artery disease in legs; This is a spontaneous report from a contactable consumer or other non-hcp (Patient). A 71-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection; Lot Number: ER2613) via an unspecified route of administration (age at vaccination 71-year) on 23Apr2021 13:00 as dose 2, single for COVID-19 immunization. The medical history includes Peripheral artery disease in legs, pain, weakness from peripheral artery disease in legs, all from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Historical vaccine includes first dose of BNT162B2 (lot number was Either EN or FN followed by either 208 or Z08) administered on 19Mar2021 for COVID-19 immunization. On 23Apr2021 the patient experienced some component in the vaccine actually took away the pain and the weakness from peripheral artery disease in legs. The caller is a consumer reporting she did not have any bad effects from the Pfizer Covid Vaccine. The caller states she literally had no bad effects from the Pfizer Covid Vaccine, but the caller had a positive effect. The caller states she can't seem to find a place to report this positive effect. Some component in the vaccine actually took away the pain and the weakness from peripheral artery disease in legs: The caller states some component in the Pfizer Covid Vaccine took away the pain and weakness from the peripheral artery disease in the caller's legs. The caller states this pain removal lasted for about 3 weeks. Caller states it began within; well, the caller received the second dose Pfizer Covid Vaccine around 1300. The caller states she did not have any bad side effects from either dose Pfizer Covid Vaccine, had things set up in the event that the caller did, but the caller did not have any bad side effects. The caller clarifies the pain removal began within hours of receiving the second dose Pfizer Covid Vaccine. The clinical outcome of the event was unknown.  Description of product complaint: The caller states some component in the Pfizer Covid Vaccine took away the pain and weakness from the peripheral artery disease in the caller's legs. Caller states this began after receiving second dose Pfizer Covid Vaccine. Product strength and count size dispensed: N/A. Additional lot numbers: First dose: The caller states the lot number is kind of covered up with a sticker from the second dose on the vaccine card. Either EN or FN followed by either 208 or Z08. Second dose: ER2613. The sample of the product available to be returned was not requested.  A final statement is not entered.
2 days after receiving the first dose of the Pfizer-Biotech vaccine- started having chest pain, shortness of breath, and rapid heart rate. Went to the ER after symptoms worsened (on 3rd day after). I was treated in the hospital for the pain and low potassium, referred to a cardiologist. Still have chest pain after 4 days of getting the first dose of vaccine.
1. rash below the vaccine site covering lower upper arm , erythematous and mild elevated  2. petechial spots  over left 4th and 5th finger
Mother stated on phone,"Upper arm swelled to elbow and warm to touch. Had fever but did not know how high.  Did not take to ER but gave him Benadryl all weekend every 4-6 hours and Tylenol for fever. Was better by Monday but had Husband take him to Dr. to be checked on Monday and nothing else done."