chrisvoncsefalvay/vaers-outcomes huggingface dataset:
achey head; achey  jaw; neck leadingto migraine; Tired; achey neck; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: er8732) via unspecified route of administration in the left arm on 24Mar2021 at 15:45 (at the age 51 -years-old), as a single dose for COVID-19 immunisation. Medical history included migraine. Concomitant medications included Ibuprofen (ADVIL), loratadine;pseudoephedrine sulfate (CLARITIN-D) and women's daily vitamins (MANUFACTURER UNKNOWN), from unknown date for unknown indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 24Mar2021 at 19:30, the patient experienced tired, achey head, jaw, neck leading to migraine which lasted 3 days. The adverse 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 patient receive treatment with IMITREX for the adverse event migraine. The clinical outcome of the events tired, headache, neck pain and jaw pain were resolving while neck leading to migraine recovered on 27Mar2021 (third day) at the time of report.    No follow-up attempts are needed. No further information is expected.
Moderna Bivalent booster and flu vaccine were given, one in each arm. Immediately after the second vaccine patient lost consciousness, experienced shaking of arms and legs, rigidity, and turned pale. The patient screamed approximately 20-30 seconds later and regained consciousness and was able to speak and drink. 911 was called. Paramedics assessed the patient who refused to be transported. The patient was advised to follow up with PCP asap.  Called the patient to follow up on 10/9.  She did not return the call.
Information has been received from an investigator concerning a 67-year-old male with an unknown medical history who entered a study, titled as stated above. On 07-JAN-2008 the patient was randomized and received a one time subcutaneous dose of 0.65 mL of Zostavax (Oka/Merck). Concomitant therapy was unknown. On 19-Feb-2008 the subject was hospitalized for a GI bleed as described as melana. The subject was discharged from the hospital on 21-Feb-2008. At this time, relationship of GI bleed to study therapy is unknown. Additional information has been requested.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date in 2014, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 20-AUG-2016, the patient was treated for a severe vesicular outbreak, which was diagnosed as herpes zoster or shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
I have the sensation that I am leaning forward and I feel like I have to hold my balance backwards in order to stand up straight; This is a spontaneous report from a contactable other healthcare professional, the patient. A 50-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ep7533) via an unspecified route of administration in the left arm on 30Mar2021 at 12:30 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Medical history included obesity, neuropathy, borderline diabetes and asthma. The patient did not receive any concomitant medications. The patient previously took clindamycin (MANUFACTURER UNKNOWN) on an unknown date for an unspecified indication and experienced drug allergy. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 31Mar2021 at 09:00, the patient experienced sensation that she was leaning forward and she felt like she had to hold her balance backwards in order to stand up straight (balance difficulty). No therapeutic measures were taken as a result of the reported events. The clinical outcome of balance difficulty was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
someone my husband knowns got sick a couple days after getting the vaccine; This is a spontaneous report from a non-contactable consumer or other non hcp. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration on an unspecified date as unknown, single dose for COVID-19 immunisation. Medical history included she has allergies to: sulfa drugs/sulfate, MRI contrast/dye "Blue dye different numbers, hives, difficulty breathing. The patient's concomitant medications were not reported. The patient previously took metoprolol for drug hypersensitivity. It reporter, reported that 'someone my husband knowns got sick a couple days after getting the vaccine'. Reporter wants to know there was a certain population that has allergies that increase risk of allergy to vaccine. she does not have allergy to eggs but uses egg allergy as an example. The outcome of event was unknown.  No follow up attempts are possible. Information about Lot/batch number cannot be obtained
This is a spontaneous report from a contactable consumer reported similar events for himself and his wife. This is for himself. This 78-years-old male patient received PREVNAR 13 (Lot number S35324), at 0.5 ml, single in the right arm on 31Aug2017 for immunisation. The patient medical history was not reported. Concomitant medication included metoprolol succinate at 100 mg, 1x/day, in the evening from an unpecified date and ongoing for heart rhythm, acetylsalicylic acid (ASPIRIN ) at 81 mg, 1x/day from an unpecified date and ongoing  for thin blood, colecalciferol (VITAMIN D3) at 5000 IU, alternate day from an unpecified date and ongoing for vitamin D deficiency. The patient experienced lung congestion on Sep2017 with outcome of recovering, sore throat on 31Aug2017 with outcome of recovering, nose running on 01Sep2017 with outcome of recovering, pounding headache on 01Sep2017 with outcome of recovering, blood pressure high on 05Sep2017 with outcome of recovering, coughing on an unspecified date with outcome of unknown. No reaction around the injection site. The patient underwent lab tests and procedures which included blood pressure measurement: 190/100 on 05Sep2017, blood pressure measurement: 180/100 on 07Sep2017. Therapeutic measures were taken as a result of sore throat included gargles with salt water.
Pt developed headache 20 min after receiving GARDASIL 9 HPV vaccine. Rated pain 5/10 on pain scale. Saw MD - gave Toradol 30mg IM.
Period after the shot came one week early; Heavy bleeding; Heavy cramping; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 29Apr2021 at 15:00 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history was 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 vaccination. Concomitant medications were not reported. On 04May2021, the patient experienced period after the shot came one week early, heavy bleeding and heavy cramping. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event period after the shot came one week early, heavy bleeding and heavy cramping was not recovered at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
1st dose on march and missed the second dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (The patient was administered the first dose of Twinrix in march).   On an unknown date, the patient did not receive the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 07-JUN-2022 Reporter's Comment: The patient missed the second dose of Twinrix.  The reporter consented to follow up. Additional Supportive Information: Till the time of reporting, the patient did not receive the 2nd dose of Twinrix, which led to incomplete course of vaccination.
A few hours past immunization on 4/20/04, he developed fever 100.8 , very pale, lethargic x 3 days. 3 days past immunization, had high pitched shrill crying x 10 days. Also had "hives" on torso. Pediatrician recommended ped. dt from now on. Also wants immunization given once at a time.
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a adult female patient who received DTPA vaccine. On 21st September 2016, the patient received DTPA (intramuscular). In September, less than a week after receiving DTPA vaccine the patient experienced pain in arm, injection site redness, injection site swelling, injection site induration, injection site itching, injection site warmth, headache and influenza-like symptoms. The patient was treated with hydrocortisone and medication unknown (Ice Pack (Nos)). On an unknown date, the outcome of the pain in arm, injection site redness, injection site swelling, injection site induration, injection site itching, injection site warmth, headache and influenza-like symptoms were not recovered/not resolved. It was unknown if the reporter considered the pain in arm, injection site redness, injection site swelling, injection site induration, injection site itching, injection site warmth, headache and influenza-like symptoms to be related to DTPA vaccine. Additional details were provided as follows: The age at vaccination was not reported. The patient received a dose of TDAP vaccine (not specified) in her right deltoid through my employer. The injection site was very painful, but now it was very red, swollen (7 cm in circumference), hard, very hot and it itches tremendously. Her entire right arm hurts. She also had headache and flu like symptoms. The next day of the reporting date, it was going to be 7 days since the vaccination. On the night before reporting, the patient had applied ice, but it did not help. She has also applied hydrocortisone cream for the itchiness. The patient was asking whether this was normal or she should go to her primary physician.
Information has been received from a registered nurse (also reported as a medical assistant) and a nurse practioner respectively concerning a 73 year old white male with a penicillin allergy who on an 22-MAY-2007  was vaccinated in the left arm with a first dose of Zostavax (Oka/Merck) (Lot #657625/06180).  Two days later he had a red rash all over his body.  The rash consisted of erythematous petchea at his left upper extremity, back, and bilateral lower extremeties.  He returned to the office and they did made the determination it "may be" due to the Zostavax.  No further information was provided. Additional information has been requested.
Headache, neck stiffness, vertigo. 11/30/09 Adm. to hosp. 19d intermittent vertigo. LP done because of symptoms - confusion ? Viral meningitis. Empiric Vancomycin &  Rocephin and Acyclovir.
Swelling from shoulder to elbow on arm that received seasonal flu vaccine. Not given at our office. Pt put on antibiotic treatment. Dx: cellulitis vs. allergic Rxn.
itchy eyes; watery eyes; frontal headache; This is a spontaneous report from a contactable consumer, the patient. A 67-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6207), via an unspecified route of administration in the left arm on 19Mar2021 at 12:30 (at the age of 67-year-old) as a single dose for COVID-19 immunisation. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EL266), via an unspecified route of administration in left arm on 26Feb2021 at 13:00 (at the age of 67 years old) as a single dose for COVID-19 immunisation. Medical history included insulin resistant and asthma. The patient was allergic to Sulfa drugs, ramipril, peanut and shellfish. Concomitant medications included metformin (MANUFACTURER UNKNOWN) for unknown indication on an unknown date, levothyroxine (MANUFACTURER UNKNOWN) for an unknown indication on an unknown date, multivitamins/D2 and fish oil received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient had not received any other vaccine within four weeks prior to vaccination. On 24March2021, the patient experienced watery itching eyes and frontal headache which had started after 5 days. Therapeutic measures were taken as result of watery and itchy eyes that included treatment with over the counter (OTC) eye drops. The clinical outcome of watery itching eyes and frontal headache was not recovered.   No follow up attempts are needed. No further information is expected.
I have had the vaccine but I have shingles/ Suspected vaccination failure; I have had the vaccine but I have shingles; itch; numb skin; knocked me off my feet; headache; This serious 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.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: I have had the vaccine but I have shingles/ Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: I have had the vaccine but I have shingles), headache (Verbatim: headache), pruritus (Verbatim: itch), numbness (Verbatim: numb skin) and feeling abnormal (Verbatim: knocked me off my feet). The outcome of the vaccination failure was unknown and the outcome of the shingles, pruritus, numbness and feeling abnormal were not reported and the outcome of the headache was resolved (duration 4 days).   It was unknown if the reporter considered the vaccination failure, shingles, headache, pruritus, numbness and feeling abnormal to be related to Shingles vaccine.   It was unknown if the company considered the vaccination failure, shingles, headache, pruritus, numbness and feeling abnormal to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 14-JUL-2023 This case was reported by a patient via interactive digital media. The patient had the Shingles vaccine but he/she had shingles. The patient's case was less severe than those without the vaccine but still knocked him/her off his/her feet.  The headache that lasted for 4 days was worse than the itch in numb skin that you could not scratch. 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.
Lump in throat, short of breath, dizzy, lightheaded, nausea.
No additional AE information provided; Nurse reported the patient was administered an improperly stored dose of ROTATEQ on 5/19/2020.; This spontaneous report was received from a registered nurse, referring to patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent condition, concomitant therapy, drug reaction, and allergies was not provided.  On 19-MAY-2020, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) vial, administered by oral route (dose, and vaccination scheme were not reported; lot number S013890, which has been verified to be valid, expiration date reported and validated as 14-FEB-2021) as prophylaxis (product storage error).  The administered dose of the vaccine rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was stored in a temperature of 12.1 degrees Celsius for 16 hours and 11 minutes, as recorded by a data logger. There was no previous temperature excursion reported. No additional adverse events were reported.
Received vaccine while pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Received vaccine while pregnant) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21a) for COVID-19 vaccination.     The patient's past medical history included Alcohol use (Not used during pregnancy or while breastfeeding  when not pregnant 4 drinks a week) from 01-Jan-2006 to 19-Aug-2020. Concurrent medical conditions included Anxiety since 06-Jul-2017, Asthma (Improved during pregnancy) and Penicillin allergy. Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Allergy, BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT) and SALBUTAMOL (VENTOLIN [SALBUTAMOL]) for Asthma, MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for Pregnancy, ZINC for an unknown indication.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 19-Aug-2020 and the estimated date of delivery was 26-May-2021. On 24-Mar-2021, the patient experienced EXPOSURE DURING PREGNANCY (Received vaccine while pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirty-first week of the pregnancy. The cesarean delivery occurred on 04-Jun-2021, which was reported as Full-term. For neonate 1, the birth weight was 4000 grams (8lbs 13oz) with an APGAR score of 9 and 9 at (1, 5 minutes). The outcome was reported as Term Birth NOS. Delivered in June 2021 but the due date was meant to be 26th of May 2021. It was a long labor (30 hours) that resulted in an emergency Caesarean due to babies position, size and stress to baby causing issues with his heart rate during the labor. Apgar score at 1 minute was 9 Apgar score at 5 minute was 9 Baby just hitting 3 weeks. At the time of the report, EXPOSURE DURING PREGNANCY (Received vaccine while pregnant) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Sep-2020, Pregnancy test: positive (Positive) Positive. On 04-Nov-2020, Ultrasound foetal: abnormal (abnormal) border line irregular. On 11-Nov-2020, Ultrasound foetal: normal (normal) normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       On 08-Jan-2021 the patient had Ultrasound scan which was inconclusive (Inconclusive) Inconclusive. On 01-Apr-2021 the patient had Ultrasound scan which was  inconclusive (Inconclusive) Inconclusive. In April 2021 the patient had Blood glucose test which was inconclusive (Inconclusive) inconclusive.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 25-Jun-2021: pregnancy outcome, weight of the newborn, lab data, concomitant medications were updated.
Large local reaction began 1 day after varicella vaccine given.  10cm ring of erythema with darker center L arm.
pt devel redness 915 x 10cm), induration (3cm larger) & pain approx 12 hrs p/inject of Typhoid vax;
This spontaneous report as received from a physician assistant via a company representative refers to a non-pregnant female patient of unknown age. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with a dose of GARDASIL (dose, frequency, route of administration, lot# and expiry date were not reported). On an unknown date, the patient had several seizures. The patient was still seizure-prone at the time of the report. The patient was not able to obtain a driver's license or drive a car. The patient did not seek medical attention. The outcome of the event was reported as not recovered. The causality between the event and GARDASIL was not reported. Upon internal review, the event of seizure was considered to be medically significant. Additional information has been requested.
I had no symptoms until over 24 hours after the shot.  I woke up in the night with an excruciating headache, which did not go away with my normal migraine medication Zomig, or Motrin, or Tylenol.  I had nausea and probably would have vomited had I not taken Ondansetron (that I had on hand for when I get severe migraines).  I would say the headache was a 10 on a scale of 1-10.  It subsided slightly (down to a 7) for awhile after I took a Motrin, but returned to a 10 (Motrin didn't help when I took it again). I also had a low grade fever and some aches around 48 hours after the shot for about 24 hours..
Flu-like symptoms; This is a spontaneous report from a contactable consumer via Pfizer-sponsored program.  A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as SINGLE DOSE for covid-19 immunization. The patient medical history and concomitant medications were not reported. Reporter stated that the patient who experienced 'cold' like symptoms after receiving first CoVax dose, running a home COVID-19 test and asked if there's potential to see positive results due to receiving first CoVax.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Day after vaccine:  Severe flu like symptoms, achy, vomiting, exhaustion, weak 3 days after vaccine: Kidney stone 4mm
Received 1st shot August 26,2021 and on September 13th noticed my right ear hurting and can't hear very good. Had my second shot on September 16,2021. Company made it mandatory for employees to get the shots to keep their jobs. I saw a E.N.T on September 24,2021 and told me I have nerve damage in my right ear. Dr. said the vaccine can't make you lose your hearing. I have had hearing test at work for 17 years and had excellent results until getting this vaccine. Ear pain,ringing,  and feel swelling in right ear.