chrisvoncsefalvay/vaers-outcomes huggingface dataset:
12/26/22 My feet became very sensitive and started hurting.  I am used to that, but generally recover quickly. While I was on a trip, I had issues with walking. Eventually, I could not stand.  I treated it as if it was plantar fasciitis. I continued self-treating. I went to my PCP who sent me to a podiatrist. The podiatrist said it was my Achilles tendon.  I have been wearing a boot for over a month. I was prescribed a lidocaine, meloxicam and baclofen cream.
Started getting upset and complained of severe back neck pain, pain in sternum, headache, and nausea. Tylenol. Felt better after 3 hours, then all symptoms returned more severe at 8:20 pm.
Information has been received from a nurse concerning a 32 week old patient who was vaccinated with a third dose of Rotateq at 32.5 weeks instead of at 32 weeks. It was unknown whether medical attention was sought. There was no product quality complaint. Additional information is not expected.
On Monday, March 29, 2021 at 2 pm, I was given the Moderna COVID?19 Vaccine EUA as an injection into my right arm.  I had no immediate problems or reactions.  On Thursday, April 1, 2021 at about 4 pm, an itchy rash developed on my right arm.  I applied cortisone anti-itch cream.  The itchy rash spread up the inside of my arm, and has continued to spread up and around that arm last night and this morning (I am reporting this on April 2, 2021 at 10:35 am).  The rash consists of small red and white bumps, and is both itchy and causes a burning sensation.  As of the time of this report, I have not seen a doctor, but if it persists, I will do so over the weekend.
A HBP called to report a TE for GARDASIL 9 that had also been administered post excursion.  The GARDASIL 9 TE and administration occurred today, 07/27/2023, and no adverse issues or side effects are reported.  The HCP declined to provide full demogra; No additional AE information was provided.; This spontaneous report was received from Other Health Professional and refers to a 15-year-old male patient.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 27-JUL-2023, the patient started therapy with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5ml via injection in the left deltoid, lot #W015894, expiration date: 20-JAN-2025, administered for prophylaxis (strength, and route of administration were not provided).  On 27-JUL-2023, a HBP called to report a TE for GARDASIL 9 that had also been administered post excursion. On the same day, the GARDASIL 9 TE and administration occurred, and no adverse issues or side effects are reported. The HCP declined to provide full demographic information for the patient that received the improperly stored vaccine. The GARDASIL 9 was administered by a new MA and the product is not available for retrieval as it had already been discarded. The TE for the GARDASIL 9 was supported - please reference TE case 02437748 for more details. No additional AE information was provided. No PQC.  Lot Number W015894 is valid for V503 formulation prefilled syringe.
Patient was observed post Covid-19 immunization for 15 minutes .  During the observation period, she experienced an adverse reaction with the following symptoms:  difficulty breathing and chest tightness, right arm tingling.   Assessment : Time of assessment 1508. Alert and oriented, no apparent distress noted.   Actions taken: After 15 minutes observation, she reported the symptoms above. She was transported via w/c by EMS to the triage area. 1513: BP 131/56, P 73, 99% sat RA; 1522: BP 120/56, P 73 99% sat RA. She reports feeling better. She says on a scale of 1-10, her SOB/chest tightness was a 5 and now it's down to 1 with no SOB. Last VS at 1528 BP 124/64, P 72, 100% sat RA. She was cleared to go home by EMS on site.   Medications administered:None   Disposition:Instructed to call 911 for trouble breathing, rapid heart rate, dizziness, swelling of tongue or throat. Ambulatory out.
Initial and follow up information has been received from a physician concerning a 65 year old female, enrolled in the VZV Identification program, with allergic reaction to tetracycline, iodine allergy and hypersensitivity to AVELOX, hyperthyroidism, hyperlipidemia, and hypertension who on 14-APR-2008 was vaccinated subcutaneously into the left arm with 0.65 mL if zoster vaccine live (Oka/Merck) (Lot # 659762/1874U). Concomitant therapy included atenolol, ZETIA, TRICOR, MICARDIS HCT and ATACAND. On 16-APR-2008, at 3:00, the patient developed a superficial local reaction/ rash 3 cm in diameter at the injection site, that was also described as a red area around the site 1" by 2" and bright red. It was noted that there were no recent exposures to chickenpox or shingles. Unspecified medical attention was sought. There was no product quality complaint. There were no lab diagnostic studies performed. At the time of reporting the patient had recovered (date unspecified). Additional information is not expected.
REDNESS AND SWELLING OF INJECTION SITE. PAIN IN UPPER SHOULDER - LEFT SIDE.
Blue bruising after shot was administered. Stayed bruised for 3 weeks. Starting to go down a little. Just resolved it. No pain.
Son came up to my room states he said that his chest was hurting and had a hard time breathing. Feeling heart palpitations. GI Cocktail given to him for heart palpitations. Dr. stated that he had a heart event but did not know what it was. He was transferred to Hospital via ambulance. Diagnosed with Myocarditis
Had inj at 5pm 21/12/2020. At 5am the next morning I was woken up as I was shaking so violently. Extreme nausea, severe headache, ear ache, ringing in ears, aching all over body, could barely walk, severe chills, dripping in sweat, food and drink taste awful. Severe pain up the back of my neck into my head and across both shoulders and dizzy. Day 5 my left arm became very painful at inj site plus all round the top of my arm and in axila .  Still exhausted. Still nauseous, still not eating. Today 4th Jan spoken to my GP as still absolutely exhausted, still barely eating, have now lost 12lbs! Food still tastes awful, still have pain in neck back of head and shoulders, still dizzy, still have earache. Just do not seem to be getting any better.
Recieved Pfizer dose #2 on 2/4/23 and recieved another monovalent on 2/14/23.
was looking at the card and the card says it expired on 31 Jul 21; It looks like that''s the expiry on the sticker on card; right arm still sore; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. Other Case identifier(s): US-PFIZER INC-202101751980 (Pfizer).  A 66 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 12Oct2021 10:00 (Lot number: ER8734, Expiration Date: 31Jul2021) at the age of 66 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "carpel surgery", start date: Oct2021 (ongoing), notes: carpel surgery on left wrist; "Type 2 Diabetes" (unspecified if ongoing); "Allergy" (unspecified if ongoing); "obesity" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE: 1), administration date: 16Mar2021, when the patient was 66 years old, for COVID-19 immunization; Bnt162b2 (DOSE: 2), administration date: 06Apr2021, when the patient was 66 years old, for COVID-19 immunization. The following information was reported: EXPIRED PRODUCT ADMINISTERED (non-serious) with onset 12Oct2021, outcome "not recovered", described as "was looking at the card and the card says it expired on 31 Jul 21; It looks like that''s the expiry on the sticker on card"; PAIN IN EXTREMITY (non-serious) with onset Oct2021, outcome "unknown", described as "right arm still sore".  Additional information:No other vaccines given the same day and no problems with vaccines in the past. States he did get the high dose flu shot in either Sept or early Oct 2021, but unable to provide the NDC, Lot, or expiry. No further details provided. No Emergency Room and Physician Office visit. Patient's Medical History (including any illness at time of vaccination)? Type 2 Diabetes. Provide other relevant medical history including but not limited to these conditions: diagnosed allergies, compromised immune status, respiratory illness, genetic/chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity: Type 2 diabetes  Follow-up attempts are completed. No further information is expected.
Pt recvd 1 dose of Engerix-B on 24JUN92 @ 4PM; the same day @ approx 730PM devel hives on legs & stomach; primarily on the legs; the hives resolved by the morning 25JUN92;
Adjuvant quadrivalent HPV vaccine series was also adminstered /  ESOPHAGEAL SQUAMOUS PAPILLOMA in the pediatric population; Adjuvant quadrivalent HPV vaccine series was also adminstered / 3 year old female;  This literature marketed report was received from the authors of a published article, and concerns to a 3 year old female patient.      On an unknown date, the 3 year-old female presented with respiratory symptoms, vomiting and abdominal pain. On an unknown date, laryngoscopy plus bronchoscopy plus upper endoscopy revealed laryngeal and diffuse esophageal papillomatoses as well as Helicobacter-pylori gastritis; following, in the immunohistochemistry of papillomatous lesions was confirmed Human Papillomavirus-subtype 6/11. The patient had Esophageal Squamous Papilloma.  Therefore, on an unknown date, the patient's laryngeal lesions were treated with laser ablation, the Helicobacter pylori gastritis was treated with an unspecified proton pump inhibitors (PPI) and antibiotics.   On an unknown date, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL), dose reported as "series", (strength, frequency, route, anatomical location, lot number, and expired date were not reported), as adjuvant therapy for the Esophageal Squamous Papilloma (product administered to patient of inappropriate age and drug use for unapproved indication). No other suspect or concomitant therapies were administered.     On successive endoscopies, on an unknown dates, there was resolution of laryngeal and esophageal lesions.  This is one of two reports from the same literature article (CASE # 1908USA006182).    A copy of the published article is attached as further documentation of the patient's experience.; Sender's Comments:  US-009507513-1908USA006182:
Soreness at injection site; fatigue; general malaise; This is a spontaneous report from a non-contactable consumer, the patient. A 34-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EL3247) via an unspecified route of administration on 02Mar2021 (at the age of 34-Year-old), as a single dose for COVID-19 immunisation. The medical history included allergy to penicillin and the concomitant medications within 2 weeks of vaccination included omeprazole (MANUFACTURER UNKNOWN) and famotidine (MANUFACTURER UNKNOWN). The patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EL3247) via an unspecified route of administration in left arm on 23Mar2021 (at the age of 34-Year-old) as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On an unspecified date, the patient experienced injection site pain (vaccination site pain), fatigue and general malaise. No therapeutic measures were taken for adverse 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 injection site pain, fatigue, general malaise was recovering at the time of report.   No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: Amended Patient's initials updated as UNKNOWN since no name provided.
Received Td vaccine on 06/07/07 at approximately 3:30 pm. Patient reports feeling uneasy the following morning with slight dizziness.  Feelings of uneasiness continued and worsened by 1:00 pm on 06/08/07 at which time he reported to employee health to report symptoms.  Patient sent to ER for evaluation.  Patient seen and released from ER on 06/08/07.  No treatment indicated.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Apr-2021 at 11:24 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 28-Apr-2021 at 11:24 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 20.23 years.  No concomitant medications were reported.  Batch number 007C21A  underwent temperature excursion with temperature 33 degrees Fahrenheit at 09:00 AM. The vial was initially moved to the fridge on 19-Apr-2021 and proposed beyond use date was 19-May-2021. Product moved to clinic on 28-Apr-2021. 4 vials were sent to clinic.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  No treatment medications were reported.
The injection itself was unusually painful and deeper than I've experienced before with flu shots. Left arm was predictably sore but the pain has continued well past a week and feels deep in my muscle and bone. Any range of motion of my left arm is painful. Pain radiates from left arm muscle to elbow. It does not radiate to the shoulder. Standard NSAID does help relieve pain, but pain persists if I don't take this.
Initial report received on 06 November 2009 from a healthcare professional. An unidentified patient, whose medical history was not reported, received a dose of FLUZONE (lot number not reported) in one arm and a dose of PNEUMOVAX (manufacturer and lot number not reported) in the other arm on 04 November 2009. Within four hours of vaccination, the patient developed double vision and dropping eyelid. The patient was sent to an eye doctor and an internist. The symptoms spontaneously resolved while the patient was at the physician's office. The physician thought that the vaccine possibly caused the "MS like onset" and was scheduling the patient for an MRI. No other information was provided. Follow-up information was received on 28 December 2009 from a healthcare professional. The patient, a 62-year-old female, had a medical history of hypertension. Other medications were reported as LIPITOR, NORVASC and aspirin (81mg). The  lot number for the intramuscular dose of FLUZONE administered on 04 November 2009 was reported as UP010AA; this lot number, however, corresponds to H1N1. PNEUMOVAX 23 (manufacturer Merck), administered intramuscularly on that same date, had a lot number of 0527Y. No additional details were provided. Documents held by sender: None.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Feb2021 as dose 1, single (Lot number: 001M21A), in left arm, on 22Feb2021 as dose 2, single (Lot number: FC3181), in left arm and on 04Oct2021 as dose 3 (booster), single (Lot number: EN6198) at the age of 68 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 18Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "High Blood Pressure (BP)" (unspecified if ongoing); "Known allergies: Yes" (unspecified if ongoing), notes: Known allergies: Yes. Concomitant medication(s) included: HYDROCHLOROTHIAZIDE. The following information was reported: VACCINATION FAILURE (medically significant) with onset Jul2022, outcome "unknown", COVID-19 (medically significant) with onset Jul2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: After COVID positive rapid and PCR tests,; (02Aug2022) Negative, notes: Negative rapid tests on 02Aug and 03Aug; (03Aug2022) Negative, notes: Negative rapid tests on 02Aug and 03Aug; (unspecified date) Positive, notes: After COVID positive rapid and PCR tests,; (04Aug2022) Positive, notes: I have tested positive again on 04Aug. Therapeutic measures were taken as a result of covid-19.  Clinical Course: No Results in death, Life threatening: No, Caused/prolonged hospitalization, Disabling/Incapacitating and Congenital anomaly/birth defect: No Other medication in 2 weeks: Yes. Anti-viral details: Product: COVID 19 Treatment, Brand: Paxlovid Treatment start date :25Jul2022 Treatment stop date :30Jul2022, Indication: Treatment of COVID-19. Other medication details: Other medication in 2 weeks product: Hydrochlorothiazide. Adverse event: After COVID positive rapid and PCR tests, I completed Paxlovid course, felt better and had neg rapid tests on -2Aug and 03Aug. I have tested positive again on 04Aug with runny nose and head congestion Adverse event start date: 04Aug2022 AE resulted in: None of the above. If Patient recovered: Not recovered. If treatment AE: No. Device Date : 04Aug2022
local rxn w/redness @ site;29NOV94 f/u w/in 24hrs of vax pt had very large approx 2" x 4" rxn;area was warm to touch;there was no pain;no other sign noted;applied ice & cold compresses to area for 24hrs;area stayed red for @ least 5 days
fever & vomiting beginning day p/vax w/MMR/HIB; was seen in ER x 2; t100.5; treated w/APAP only;
left arm swelled up; left arm hurt; headache; left gland swollen; A spontaneous report was received from a health care professional concerning a patient of age 63 years old, female who received Moderna's COVID-19 vaccine and experienced multiple events of left arm hurt (Pain in extremity), left arm swelled up (Peripheral swelling), left gland swollen (Lymphadenopathy) and headache.  The patient's medical history was not provided. No concomitant medications were reported.  On 28-Dec-2020, the patient received their second of two planned doses of mRNA-1273 (Lot number was unknown) intramuscularly for prophylaxis of COVID-19 infection. After receiving the vaccine, the patient experienced left arm hurt, left arm swelled up, left gland swollen and headache. Treatment for the events included Tylenol. The patient took Tylenol and her headache subsided. The patient's arm still hurts and is swollen but is starting to go down and the left gland is still swollen but is also starting to go down.  The Action taken with mRNA-1273 in response to the events was not reported.   The outcome for the events, left arm hurt (Pain in extremity), left arm swelled up (Peripheral swelling) and left gland swollen (Lymphadenopathy) was considered as recovering/resolving and for headache its considered as recovered on 28-Dec-2020.; Reporter's Comments: This case concerns a 63-year-old, female patient. The patient's medical history was not provided. The patient experienced a non serious event of lymphadenopathy, headache, pain and swelling of arm. The event occurred after the administration of the first dose of mRNA-1273. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Left arm soreness lasted 24hrs; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 28 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 11Mar2021 (Lot number: EL3247) at the age of 28 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: JUNEL FE. Past drug history included: Augmentin for Allergy to Augmentin. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "recovered", described as "Left arm soreness lasted 24hrs". Therapeutic measures were not taken as a result of vaccination site pain.  Additional information: Patient had no other vaccine in four weeks. Patient had received Junel Fe (birth control pill) other medications in two weeks. Patient had not covid prior vaccination. Patient had not covid tested post vaccination.  No follow-up attempts are possible. No further information is expected.
After my first dose of the Moderna vaccine on 12/31/2020 I had symptoms of a urinary tract infection, which I did not think was related at the time and considered it a fluke.  Today, however, after the second dose the symptoms are worse (more pain while urinating, lots of blood in urine, frequent urgency).  I have an appointment in the morning to see a doctor about the cause but this happened after both vaccine doses.
Dizziness started 1 hr after, shaking/chills started 5 hours after. 103 degree fever for 3 days (even while taking ibuprofen and tylenol), headache, body aches, swollen lymph nodes, rash, extreme nausea and vomiting.