chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Extreme persistent full body joint paint - Still going to this day. (Three and a half months later and counting). Tingling/burning scalp for a month after vaccine shots.
Had vaccine in 2008 and had reaction.; This spontaneous report was received from an other reporter type via Pfizer, referring to a female patient of unknown age. The patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies and concomitant medications were not provided.   The patient reported that, she could not remember if on an unknown date in 2008 she was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), administered as prophylaxis or if she received pneumococcal 13v conj vaccine (crm197)(PREVNAR 13) (formulations, concentrations, doses, vaccination scheme frequencies, anatomical sites of vaccination, lot numbers and expiration dates were not reported), but she had a reaction (adverse reaction). The outcome of adverse reaction was not provided. The causality assessment between both suspect vaccines was not reported.
Patient received first dose of Moderna on 4/23/21, first dose of Pfizer on 12/3/21, and second dose of Moderna today on 3/15/22. Patient wasn't supposed to get the first dose of Pfizer and she didn't have the Pfizer administration documented on the vaccine card. She scheduled herself for the 2nd dose of Moderna today and the vaccinator gave the dose to her after checking the vaccine card (only Moderna dose documented). The patient left the facility having no adverse reactions and after checking in with the patient 4 hours after the administration, she states that she is feeling fine without any symptoms.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a adult patient who received FLULAVAL QUADRIVALENT 2018-2019 season (batch number 4MA57, expiry date 11th June 2019) for prophylaxis. This case was associated with a product complaint. On 11th October 2018, the patient received FLULAVAL QUADRIVALENT 2018-2019 season. On 11th October 2018, immediately after receiving FLULAVAL QUADRIVALENT 2018-2019 season, the patient experienced injection site pain. On an unknown date, the patient experienced syringe issue and pharmaceutical product complaint. On an unknown date, the outcome of the injection site pain, syringe issue and pharmaceutical product complaint were unknown. It was unknown if the reporter considered the injection site pain to be related to FLULAVAL QUADRIVALENT 2018-2019 season. Additional details were provided as follows: This case was reported by the pharmacist for her colleague. The age at vaccination was not reported. The patient noted the unusual amount of air in syringe, as well as, experienced pain during the vaccination and could feel the vaccine being injected. The reporter did not provide more information about colleague at the time of reporting. This case has been linked with the case US2018185671 and US2018185712, reported by same reporter.
Unexplainable ecchymosis on bilateral lower extremities; This is a spontaneous report from a contactable healthcare professional, the patient. A 39-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3249) via an unspecified route of administration in the left arm on 26Jan2021 at 10:00 (at the age of 39-year-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19.  Concomitant medications included bupropion hydrochloride (WELLBUTRIN), escitalopram (MANUFACTURER UNKNOWN) and colecalciferol (vitamin D3) (MANUFACTURER UNKNOWN), all from unknown date, for unknown indication and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9261) via an unspecified route of administration in the left arm on 26Jan2021 at 10:00 (at the age of 39-year-old) as a single dose for COVID-19 immunisation. On 20Mar2021, the patient experienced unexplainable ecchymosis on bilateral lower extremities. The events resulted in doctor or other healthcare professional office/clinic visit. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had been tested for COVID-19. On 27Jan2021, the patient underwent SARS-CoV2-PCR test and the result was negative. The clinical outcome of the event unexplainable ecchymosis on bilateral lower extremities was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Mom reports pt cried uncontrollably for about 24 hrs; reported pt "burned up" w/fever through the noc & only slept 10-15 min @ a time;
Second toe on right foot swelled up and toenail turned black.  Five persons in our party went together.  One other person had the same reaction on the same toe on the same foot.  The swelling subsided within a day and the toenail grew out in a few months.
A red raised rash developed at the site of injection on the 3 third day of administration rash grew to twice the size of quarter and was not to touch. Pt went to the MD who sent her to ER.
Patient received  covid vaccine #1 Jan 7, 2021. On Jan 14th started having severe red rash? with petechiae and ecchymosis with some capillary oozing of blood on bilateral arms and lower extremities.    Was seen by oncologist and had blood work done with no major abnormalities. Rash and bruising continued to spread and  employee visited clinic on Jan 20th and she was instructed to contact oncologist ASAP for reevaluation.   Patient had surgery for rt breast cancer few months ago currently finishing up radiation therapy to rt chest. To start po chemotherapy next week.   Patient returned to clinic today January 26th to report that physician had meeting with other physicians and feels that the episode is related to the Covid vaccine and recommends employee not receive dose #2.
Cos tongue tingling and possible rash. was taken to ED by  RRT. She stated having flushing neck and cheeks, elevated blood pressure 138/115 to 140/73
extra dose of FLUZONE HD QIV administered to a patient with no adverse event; Initial information received on 12-Sep-2023 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a patient of unknown age and demographics who was administered an extra dose of Influenza Quadrival A-B High Dose HV vaccine [Fluzone high-dose quadrivalent] with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received an extra, unknown dose of suspect Influenza Quadrival A-B High dose HV vaccine (strength, formulation, lot number and expiry: not reported) via unknown route in unknown administration site for influenza (extra dose administered) (latency: same day). Information on the batch number was requested.  No lab data was provided.  Action taken was not applicable.  At time of reporting, the outcome was Unknown.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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.
24AUg93 enlarged gland; 30AUG93 c/o pain when mom touched-swelling; 30AUG93 PM mom phoned MD dx cat scratch fever;
Pt reported onset of red, blotching, itchy rash on side of torso - adjacent to vaccinated arm, approx 24 hrs after vaccine admin. Advised pt to use Benadryl 1 tabs/cream and call MD. Pt called MD but did not require visit. Since symptoms resolved within next 24 hrs (48 hrs after vaccine admin.).
Paralysis experienced on November 20 2018. Attempted to get out of car and could not. Had to call ambulance and has been in hospital since Nov 20 until current 12/11. Patient is out of network. Arms and legs affected.
Diagnosed with COVID-19 on 8/23/2021 and experienced shortness of breath, pneumonia.
Severe ringing in ears was followed by burning sensation starting in abdomen, then to legs and then to upper body. This happens every night about one hour after sleep. I have no fever.   But I feel like I am in an oven.  Subsides about one hour later but extreme tinnitus continues.  During the day I feel hot but not the same intensity of the nightly attacks. Never had this before. I had a second shot on 2/26 and on that night it was very severe.  Still suffering to this date. Primary doctor does not know what I have.  Blood work negative except for two positive Ana antibody tests.
pt says her she has swelling in the crease of her left elbow, her bicep and her arm pit.  When she holds her arm up it causes her pain but does not have any pain at the injection site.  Pt will see her PCP for her symptoms when she can get in to him.
VISITED SCHOOL NURSE SHORTLY AFTER RECEIVING VACCINE WITH COMPLAINT OF "ITCHY" THROAT, NEED TO CLEAR THROAT AND FLUSHED CHEEKS.  NO RASH NOTED TO FACE/TRUNK/EXTREMITIES.  EVEN RESP., NO WHEEZING/RALES.  NO REDNESS/EDEMA NOTED TO TONGUE/ORAL MUCOSA/TONSILS.  NO DYSPHAGIA REPORTED.  NO COMPLAINT OF STOMACH ACHE/NAUSEA.  ALERT, ORIENTED X3.  NO HEADACHE/DIZZINESS.  GIVEN BENADRYL 50 MG AT 12:08 PM PER STANDING ORDER. (DID NOT TAKE SCHEDULED ALLEGRA BEFORE SCHOOL) PARENT PICKED UP, TOOK HOME TO REST.
This spontaneous report as received from a medical assistant refers to a patient of an unknown age and gender who on 31-MAR-2015 was vaccinated with a dose of, oral, ROTATEQ (lot # K016313) (expiration date, dose and route not reported) that was 12 hours in temperature excursion. No adverse effects had been observed or reported. This is one of several reports received from the same source. Additional information is not expected as all correspondence was received.
no additional AE; patient received GARDASIL 9 series outside of the recommended dosing schedule / 2nd dose 10/27/17 / 3rd dose 1/8/18; This spontaneous report was received from a physician and refers to an approximately 11-year-old (11 years old when starting suspect vaccine's series) patient of unknown gender. No information about the patient's pertinent medical history, concomitant medications and drug reactions or allergies was provided.  On 05-JUL-2017, 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) for prophylaxis (dose, route of administration, anatomical location, lot #, and expiration date were not provided).  On 27-OCT-2017, 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) for prophylaxis (dose, route of administration, anatomical location, lot #, and expiration date were not provided).  On 08-JAN-2018, the patient was vaccinated with the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for prophylaxis (dose, route of administration, anatomical location, lot #, and expiration date were not provided) (inappropriate schedule of vaccine administered, reported as patient received suspect vaccine's series outside of the recommended dosing schedule). There was no additional adverse event (AE). At the time of report, physician was unwilling to provide additional patient information as she had not talked to the patient's mother at that time.
06/24/2013 - Call to states L arm was sore on 6/21 and on 6/22 L arm was sore and shoulder and neck and between shoulder blades. States dime size swelling at injection site. States headache for 24 hrs post injection has resolved. No fever. 6/27/13- States a lot better- still a little tenderness.
VIBRATING PULSE IN GROIN FOR 3 DAYS; SORE ARM; CHILLS; FEVER; FATIGUE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced vibrating pulse in groin for 3 days, sore arm, chills, fever, and fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vibrating pulse in groin for 3 days, sore arm, fever, fatigue and chills was not reported. This report was non-serious.
This spontaneous report was received from a pharmacist refers to a patient of unknown age. The patient was vaccinated with ZOSTAVAX (lot, dose and route not reported) on 31-AUG-2012 that expired on 26-JUL-2012. No other co-suspects reported. No concomitant medications were reported. Additional information has been requested.
Expired Vaccine administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired Vaccine administered) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 068H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 06-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Vaccine administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired Vaccine administered) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The vial was initially stored in the refrigerator on 14-Mar-2022.  The vial did not undergo any temperature excursions.  No concomitant medication reported.  No treatment medication details reported.
bleed heavily again; a feeling of pins and needles in their face/tingling sensation in face; A spontaneous report  was received from a consumer who was also a 64-year old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced heavy bleeding/ postmenopausal bleeding, a feeling of pins and needles that began on the left side of the face and radiated down to the bottom of the chin with sensitivity on the nose and lips/ paraesthesia oral.  The patient's medical history was not reported by the reporter. Concomitant medications taken by the patient were not provided.   The patient received the first of two planned doses of mRNA-1273 (Lot number: 031M20A) intramuscularly in the left arm on 14 Feb 2021.   On 13 Mar 2021, prior to the onset of the event, the patient received their second of two planned doses of mRNA-1273 (Lot number: 026A21A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 18 Feb 2021 four days after the first dose of vaccination, patient began to bleed as if their menstrual cycle began. Patient reported that she was at a menopausal phase in life to typically do not bleed not or if they do there was a light pink blood excreted, the last time this had occurred was in November. Patient had a bleeding that was very heavy and contained large blood clots. The event heavy bleeding/ post menopausal bleeding was a medically significant event.  Patient stated that this bleeding lasted 7 consecutive days until 25 Feb 2021. The bleeding then stopped 26 Feb 2021 for 2 days, and then heavy bleeding episode came back again on 28 Feb 2021 for 2 days lasting until 02 March 2021.  On 03 March 2021, patient reported that she had a fever of 102F which lasted for 24 hours. Patient also reported that she had very sore gums and swelling inside of mouth. Patient reported that she was not sure if these evets were due to the vaccination.  On 13 Mar 2021, after the 2nd dose patient had begun to bleed heavily again. Patient also reported that after the first and second dose immediately afterwards there was a feeling of pins and needles in their face. This tingling sensation began on the left side of face down to the bottom of the chin with the most sensitivity on the nose and lips. This tingling sensation was far more pronounced after the second dose than the feeling of the first dose. Patient reported that the heavy bleeding and feeling pins and needles in face were present on 15 March 2021. Treatment activities for event was not provided.  The patient received both scheduled doses of mRNA-1273; therefore, action taken with the drug in response to the events is not applicable.  The outcome of events, heavy bleeding and tingling sensation that began on the left side of face down radiating to the bottom of the chin with the most sensitivity on the nose and lips were not recovered/not resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Shingles on right breast; Trouble focusing eyes; Headache; This spontaneous case was reported by a nurse and describes the occurrence of HERPES ZOSTER (Shingles on right breast), VISION BLURRED (Trouble focusing eyes) and HEADACHE (Headache) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L20A and 010M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  The patient's past medical history included No Adverse Event.   On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HERPES ZOSTER (Shingles on right breast), VISION BLURRED (Trouble focusing eyes) and HEADACHE (Headache). The patient was treated with VALACICLOVIR HYDROCHLORIDE (VALACYCLOVIR HCL) at a dose of 1 g three times a day. At the time of the report, HERPES ZOSTER (Shingles on right breast), VISION BLURRED (Trouble focusing eyes) and HEADACHE (Headache) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided.   This case was linked to MOD-2021-089205 (Patient Link).
10  hours after receiving vaccines patient awoke with moderate to severe chills and shivering. Over next 6 hours woken several times due to chills , drifting in and out of sleep. At 6:15 patient got out of bed, and dressed for the day. Lingering chills, but shivering has stopped.
Initially started as abdominal pain, by 10/13/12 patient had fever of 104F. Went to Emergency Room on 10/15/12.  Admitted to hospital on 10/16/12 with high fever and neurological symptoms.  Diagnosed with postinfectious or parainfectious myoclonus and aseptic meningitis.
5 days following Tdap to (L) deltoid developed lymphadenopathy under the (L) clavicle - 2 small rubbery firm nodes. Today is 9 days post Tdap and nodes still present.
Pt presented with fever, nausea and vomiting 12 hours after the shot. Advised pt to contact MD.
Redness at vaccination site; itch at vaccination site.  Itch at vaccination site happened at some point, at the time I ignored it and did not associate it with anything.  Vaccination site was pink. My daughter had drawn a circle with a pen around the pink vaccination site on Wednesday  6 January, to see if the pink area grew.  Yesterday 11 Jan when I went to shower I noticed it was still pink and somewhat itchy, and the pink area had extended beyond the circle about 1 mm.  Today 12 Jan it has not itched, but it is still pink and extends about 3 mm. It is not hot to the touch, it is not tender to the touch. It has finally begun to slowly fade, but it is still ongoing.
1 hr after vaccine: Headache, neck and shoulder pain at noon - chills at temp 101.7 at 1:00 o'clock associated to stomach discomfort. No chest pain or tightness, SOB, nausea or vomiting. No dizziness no headache.
Information has been received from a registered nurse concerning a 21 year old female patient with a history of hyperthyroidism and no drug reactions or allergies who on 10-SEP-2009 was vaccinated via the IM route with a dose of ZOSTAVAX (Merck) (lot# 664319/0562Y). This medication was given accidentally. The intended medication was to be MENACTRA. The patient experienced a localized irritation at the site of injection about the size of a quarter. The injection site was the left deltoid. The patient did not seek any medical attention. On an unspecified date, the patient recovered. Follow up information has been received which reported that the patient received a dose of ZOSTAVAX (Merck) instead of MENACTRA by mistake. The patient developed redness at the site with discomfort. At the time of this report, the patient had recovered without treatment. This is an amended report. Redness at injection site and discomfort at injection site were added as adverse events. Additional information is not expected.
10:00 AMPatient stated throat felt funny. Gave Benadryl 25 mg  PO.  10:07 AM voice became hoarse, 10:10 AM  excessive phlegm,  10:14 wheezing, hives and SOB. 10:16 Gave 0.3 mL of Epi IM. 10:17 Started O2 on 3L.  At 10:21 Gave Kenalog IM, 10:22 Albuterol Neb TX. Ambulance arrived around 10:27 AM. Patient was feeling some relief. Transported to  Hospital.
FEEL SICK; SHIVERS; FEVER; HEADACHE; INJECTION SITE PAIN; BODY ACHE; This spontaneous report received from a patient concerned a 31 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1802068 expiry: UNKNOWN) dose was not reported, administered on 24-MAR-2021, 09:00 at left arm for prophylactic vaccination. No concomitant medications were reported. On 24-MAR-2021, the subject experienced body ache. On 24-MAR-2021, the subject experienced shivers. On 24-MAR-2021, the subject experienced fever. On 24-MAR-2021, the subject experienced headache. On 24-MAR-2021, the subject experienced injection site pain. On 24-MAR-2021 15:00, the subject experienced feel sick. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body ache, and shivers, had not recovered from fever, headache, and injection site pain, and the outcome of feel sick was not reported. This report was non-serious.