chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial unsolicited report received from a healthcare professional via other company (Pfizer) (Manufacturer Report Number: 2014051489) on 31-Jan-2017. This case involves a female patient (onset age not reported) who was vaccinated with a dose of TETANUS TOXOID (batch number, expiration date, dose, dose in series, route and site of administration were not reported) on an unspecified date. Patient's medical history and concomitant medications were not reported. On an unspecified date, following vaccination the patient experienced Allergic to Tetanus Shot (Allergy to vaccine). Laboratory investigations and corrective treatment were not reported. The outcome of the event was not reported. List of documents held by sender: none.
Pt recvd Hep B vax in APR92 & devel localized swelling of the arm @ the inject; swelling lasted appropx 15 mins then subsided; No further details were provided;
7-23-10 Workup in morning orange size.  Skin hot to touch.  Injection site.  Patient took allergy medication.  Saturday site less swelled and last red and hot, Sunday decreased size, redness, heat.  07-30-10 called patient this morning patient has no redness, heat and site is only the size of a quarter.
numbing of the tongue; Case reference number MOD-2021-012274 is a spontaneous case report sent by a Non-Health Professional on 22-JAN-2021 00:00:00 , which refers to a Female aged 52 Years .  The patients past medical history included: No adverse event   . .  On   the patient started taking Moderna COVID-19 Vaccine for COVID-19 vaccination. Some  1 day later,  the patient developed numbing of the tongue. Over a period of the next <ENTER DURATION OF EVENT> days, the patient also developed  . Relevant laboratory results included   and relevant physical signs were <LIST PHYSICAL SYMPTOMS>. The patient experienced the following serious criteria:. The eventual diagnosis made on was Hypoaesthesia oral . .  The patient was treated for the event with   . <ENTER ANY PROCEDURES> The action taken for Moderna COVID-19 Vaccine was  Unknown on  . An autopsy was performed on  . The Non-Health Professional did not declare any relatedness between numbing of the tongue and Moderna COVID-19 Vaccine In their opinion, other possible etiological factors included  <STATE OTHER FACTORS> and the patients age/ history or other factors <LIST OTHER RELEVANT  FACTORS> .  The company believes the following facts are also relevant in this case: <LIST OTHER RELEVANT FACTORS HERE> OR  <THERE IS NO KNOWN PLAUSIBLE MECHANISM BY WHICH THE DRUG WOULD CAUSE THE PRIMARY EVENT>.  The medical reviewer may provide a case evaluation statement, including other possible etiological and confounding factors, e.g. (only limited information has been obtained so far, it is difficult to assess the cause and effect relationship; the co-medications y and x should also be considered causative as the reported event is labeled for both drugs; the company's view is the event is not due to the drug for the following reasons  (probably due to pre existing disease); there is no plausible mechanism to implicate the drug.  .   Terse Narrative (for PSUR narratives and signal review) Brief 3 line summary of above for CIOMS listing: Report Source- Non-Health Professional,  Age- 52 Years,  Sex- Female,  Suspect Drug- Moderna COVID-19 Vaccine,  Treatment-    Diagnosis\Outcome- numbing of the tongue - Not Recovered/Not Resolved.
10:00 Varicella/KINRIX administered (L) arm, MMR administered (R) arm. Client immediately complained of itching/pain. (R) arm reddened around insertion site. 10:02 client's face reddened, hives present on (L) side, continues to complain of itching. 10:07 sent to ER via private vehicle, as client was leaving, he stated that "it is getting harder to breathe".
hsv outbreak; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 67-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, Batch/Lot Number: EN5318, expiration date not reported), dose 1 via an unspecified route of administration, administered in arm right on 29Jan2021 09:45 (age at the time of vaccination was 67 years) as 1st dose, single dose for COVID-19 immunization. The patient medical history included allergy to Penicillin, there was no other medical history. Concomitant medications in two weeks included aciclovir sodium (ACYCLOVIR [ACICLOVIR SODIUM]); Vitamins [Ascorbic Acid;Ergocalciferol;Nicotinamide;Retinol;Riboflavin;Thiamine Hydrochloride] (ASCORBIC ACID; ERGOCALCIFEROL; NICOTINAMIDE; RETINOL; RIBOFLAVIN; THIAMINE HYDROCHLORIDE) and Lysine-Monolaurin. The patient did not receive any other vaccine prior to COVID-19 Vaccine in four weeks. The patient did not have COVID-19 prior to vaccination. The patient had not been tested for COVID-19 post vaccination. On 31Jan2021, the patient experienced HSV outbreak. No treatment was received for the event. Outcome of the event was reported as recovering.  Follow-up attempts are completed. No further information is expected.
This spontaneous report as received from a medical assistant refers to a 16 year old patient of unknown gender. On 21-JAN-2016, the patient was vaccinated with an improperly stored dose of the GARDASIL 9 (dose, anatomical location and route of administration were not provided, lot # L016429 with expiration date 09-AUG-2017). The vaccine underwent temperature excursion of either +1 or -1 degree Celsius for 255.5 total cumulative hours, which was detected by a data logger. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
A report has been received from a Health Professional concerning a 2 year old, Female subject, who has been receiving nasal FLUMIST. FLUMIST started on an unknown date. Med Assist reported that we have a patient who received expired FLUMIST on 07-Feb-2013. The outcome of the event of RECEIVED EXPIRED FLUMIST is unknown. The report was considered to be non-serious.
Warmth throughout body, flushed feeling, dizziness and felt like fainting. Injection site swollen, hard to touch and red. Heart palpatations for only the day of injection.
4 days after vaccination patient developed high fever. Abdominal. Nausea. diarrhea, headache, cough up sputum. Body ache. malaise and fatigue, most symptoms has not resolved since then.
pt developed fevers on night of vaccine 2days later developed diarrhea. the diarrhea imrpoved bur fevers continued. he was seen on november 8.  due to high fevers had extensive work up showed elevated crp and sed rate. then developed pain and swelling left knee and right ankle, saw orhto and had knee tapped no gout or infection identified, then pt developed anterior uveitis, treated with steroids and appeared to improve. still has arthritis of knee, jaw and has floaters in eye, was diagnosed with reactive arthritis after vaccine
dry mouth & metallic taste in mouth starting 1/2hr post vax;reported back to med dept @ 4PM;exam no abnormal findings;
Patient is fully vaccinated.  COVID positive 12/31/2021 at admission to hospital. 51-year-old female who presented to the hospital with headaches, in the setting of an arachnoid cyst history.  Arachnoid cyst was seen once again on CT of the head without contrast.  She was evaluated by neurology, who deemed her stable for discharge with outpatient follow-up with neurosurgery.  She had a normal neurological exam and a stable CT of the head, and her headaches seem to be controlled with Tylenol. She also had some slight hypoxia, and was found to be covid positive with covid 19 pneumonia. Positive for chest pain.  She did exhibit a left lower lobe patchy infiltrate on the CT of the chest.  D dimer elevated. Lovenox given.  Negative for PE.  Normocytic anemia. She was given some breathing treatmentsand decadron, and remained on room air for the rest of her admission.  Stable for discharge.  Will follow up with neurosurgery.
Right thigh, red bump. Use cool compress to area TID for 3-4 days. Prednisolone syrup, 15mg/5mg 7.5 ml, orally once a day, 3 days 22.5 ml 0 refills.
Pfizer vaccine was dilueted with 0.8ml, rather than the reccomended 1.8ml, resulting in double dose of vaccine. Mother called by provider and informed of medical error.
pt got vaccine that was 6 days past BUD but still refrigerated. MOderna suggested that  there is no safety data for another dose.
30SEP91 Pt recd shot @ 330PM; 1OCT91 @ 130AM Pt suffered severe aches all over body & in bones; nauseated but didn't vomit; Pt took Motrin; MD's ofc advised Pt to continue w/Motrin & rest, also to report back to ofc if symptoms persist;
Information has been received from a currently 63 year old female patient referring to herself. The patient had no concomitant medication, pertinent medical history or drug reactions/allergies. In 2012, the patient was vaccinated with a dose of ZOSTAVAX (subcutaneous, dose, lot# and expiration date were unknown)for prevention of shingles.    The patient stated since she had the ZOSTAVAX injection, she had experienced multiple episodes of unspecified rashes and itching, on her neck, arms, and thighs. The patient stated she also developed sores on her skin. The consumer stated that she was presently experiencing the same symptoms. The consumer stated she had various unspecified tests done to help determine the cause of her symptoms, but no positive determination had ever been made. No specific treatment was provided. There was no lab diagnostics studies performed or treatment given for the events. The patient sought medical attention by seeing physician. The consumer stated she had inquired as to whether her symptoms were a result of the ZOSTAVAX injection, but it was not determined. The outcome of the events was reported as not recovered.  Additional information has been requested.
Left arm red, swollen and warm - augmentin 400 mg 8 hrs x 10 days.
Severe arm pain  near injection site ans ahouls/ shoulder blade on and off since injection. Arm still sore now.   The pain seems to go away for a while and I resume normal activity and then comes back again.
CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient concerned a patient of unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: allergy. The patient received covid-19 vaccine ad26.cov2.s (dose number in series: 1) (suspension for injection, route of admin, batch number, and expiry were not reported) dose was not reported, 1 total administered to left arm on an unspecified date in MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. The patient received, non-company suspect vaccine: tozinameran (Pfizer) (dose number in series:2) (form of admin, route of admin, batch number, and expiry were not reported) dose was not reported, administered to left arm on an unspecified date in OCT-2021 for prophylactic vaccination. On an unspecified date, the patient reported tested negative after 5 days of symptoms. After 5 days of no symptoms, tested positive for covid-19 (dose number in series:2) which was confirmed covid-19 infection (dose number in series:2) and confirmed clinical vaccination failure (dose number in series:1) The patient received treatment with non company suspect (Pfizer) (form of admin, route of admin, batch number, and expiry were not reported) dose was not reported, administered from on an unspecified date in May-2022 for Covid-19 treatment. On 01-JUL-2022, Laboratory test: Covid-19 positive (rebound test device). The action taken with covid-19 vaccine ad26.cov2.s, and tozinameran was not applicable. The outcome of the confirmed covid-19 infection and confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint and reference number requested.; Sender's Comments: V0:20220721911-covid-19 vaccine ad26.cov2.s-Confirmed clinical vaccination failure. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Sore arm, can't even lift my arm, feels worse than tetanus shot/arm is painful; A spontaneous report  was received from a 38 year old female patient (Nures) concerning herself who received Moderna's COVID-19 vaccine (mRNA-1273) and developed pain in arm.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 28 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot: 025J20A) intramuscularly in left arm for prophylaxis of COVID-19.  On 28 Dec 2020, a few hours after administration, the patient stated that her arm was "pretty painful", that she can't even lift her arm. She stated that there was no redness and it's not swollen. She mentioned that it "feels worse than tetanus, it is past soreness". She also mentions that the pain was not "excruciating". Treatment included ibuprofen, which she mentioned taking around the clock.   Action taken with mRNA-1273 in response to the event was not reported.   The outcome for the event was unknown.; Reporter's Comments: This case concerns a 38-Year-old female who experienced NS unexpected event of pain of extremity.  Event onset occurred a few hours after the first dose of mRNA-1273. Treatment included ibuprofen. Event outcome known. Based on 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.
Shingles 5 weeks later after 2nd dose of Moderna COVID-19 Vaccine; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HERPES ZOSTER (Shingles 5 weeks later after 2nd dose of Moderna COVID-19 Vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021D21A and 036A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-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 5 weeks later after 2nd dose of Moderna COVID-19 Vaccine). The patient was treated with VALACYCLOVIR HYDROCHLORIDE for Shingles, at a dose of 1 gram three times a day. At the time of the report, HERPES ZOSTER (Shingles 5 weeks later after 2nd dose of Moderna COVID-19 Vaccine) outcome was unknown. Not Provided          No relevant concomitant medications were reported.  The expiration date for second dose was provided as 9/26 (not sure if it was month and date). The patient got treated with Valacyclovir hydrochloride 1 gram tablet 3 times a day for 10 days.
Pt got the Pfizer vaccine and passed out at the consultation window. I saw she was not feeling well with her head rested on the glass divider. When out to her and she was out for 5 secs. She woke up shaking and was very dizzy. She felt mostly better within 10 mins after the event.
PATIENT PASSED OUT AFTER RECEIVING MODERNA VACCINE, SAID SHE FELT HOT AND WEAK, PARAMEDICS CAME AND DETERMINED THAT HER BLOOD PRESSURE WAS LOW
entire right arm aches from injection site to tips of her fingers; entire right arm aches from injection site to tips of her fingers; All over aches that didn't go away stronger at the joints; All over aches that didn't go away stronger at the joints; This is a spontaneous report received from a contactable reporter (Nurse). The reporter is the patient.  A 36-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11Oct2022 at 10:00 as dose 4 (booster), single (Lot number: GJ2524) at the age of 36 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Gastroesophageal reflux disease (Gerd)" (unspecified if ongoing); "Attention-deficit/hyperactivity disorder (ADHD)" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "Supraventricular (SVT) arrhythmia" (unspecified if ongoing); "arthritis" (unspecified if ongoing); "thrombocytosis" (unspecified if ongoing); "hemochromatosis" (unspecified if ongoing); "iron deficiency anemia" (unspecified if ongoing). Concomitant medications included: IRON; PROBIOTICS; ASPIRIN [ACETYLSALICYLIC ACID]; ADDERALL; DEXILANT. Past drug history included: Augmentin, reaction: "allergy", notes: known allergies. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 3; MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: PAIN (non-serious), ARTHRALGIA (non-serious) all with onset 12Oct2022 at 12:00, outcome "not recovered" and all described as "All over aches that didn't go away stronger at the joints"; PAIN IN EXTREMITY (non-serious), VACCINATION SITE PAIN (non-serious) all with onset 12Oct2022 at 12:00, outcome "not recovered" and all described as "entire right arm aches from injection site to tips of her fingers". The events "entire right arm aches from injection site to tips of her fingers" and "all over aches that didn't go away stronger at the joints" required physician office visit. Therapeutic measures were taken as a result of pain in extremity, vaccination site pain, pain, arthralgia, which included unspecified pain relievers.  Additional information: The vaccination facility was a hospital. The patient had no other vaccine in four weeks. The patient had no covid prior vaccination. The patient was not tested for covid post vaccination.  Follow-up attempts are completed. No further information is expected.
received the 1 dose / on 12/10/2020 / 1, 6-month doses were not administered yet; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 57-year-old male patient who received HBV (Engerix B) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Engerix B (received 1st dose on 10th December 2020 from batch number P4DJ5).   On an unknown date, the patient received the 2nd dose of Engerix B and Engerix B Pre-Filled Syringe Device. On an unknown date, unknown after receiving Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. The action taken with Engerix B Pre-Filled Syringe Device was unknown. 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 details provided were as follows: Age at vaccination was not applicable for this report. Health care professional was called to report that the patient received 1st dose of Engerix B and did not receive the 2nd dose, till the time of reporting. VAERS details was provided for the 1st dose of Engerix. The reporter consented to follow-up. This case is linked with case US2021164835, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021164835:Same reporter
first dose/administrated more than a year ago/No 2nd dose/administrated; 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 with an associated reaction of no adverse event (1st dose of Shingrix received more than a year ago).   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 provided as follows: The age at vaccination was not applicable to this report. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination. No patient's identifiers, lot number and expiration date was provided.  No vaccination date provided for the first dose. No further information was reported. The reporter consented to follow up.
began restlessness @ 1AM-@ 6AM c/o n/v, h/a & threw up;APAP given @ that time;t102 @ 6AM down to 101 @ 10AM;c/o h/a, sore throat @ 1130AM;to see MD
PATIENT RECEIVED VACCINE PAST BUD, CONSIDERED AS AN INVALID DOSE AND WILL COME BY NEXT WEEK FOR RE-VACCINATING
Patient presented on 19JUL08 (day 11 post vaccination) with chest pain worse with supination and improved with leaning forward.  T 101 and other VS wnl. WBC elevated at 13. EKG with ST depression in lead III. Cardiac enzymes negative.  Patient was given motrin and SIQ for trt of presumed pericarditis. Pain improved over following 36hrs. The following night, 20JUL08 at 2330, patient presented with unrelenting retrosternal chest pain and SOB. T 99.2, BP 108/62, HR 67. EKG with ST elevation in leads I and aVL and ST depression in leads III and aVF. Cardiac enzymes (trop, myo, CK-MB) positive. Patient was given 325mg ASA chewed and O2 NC at 3L. (2)lg bore IVs with LR at 60ml/hr in each. Patient was medevac-ed via helo to Hospital where he was admitted to ICU. ECHO on admission showed nl EF.  Patient remains in ICU, is stable, but is pending a cardiac catheterization procedure.  Will likely be transferred to outside facility for cath. 9/3/08-records received for DOS 7/21/08 and 8/7/08-DX: Acute pericarditis. Adverse drug effect of vaccines smallpox. Began to have diaphoresis and headache on 7/16/08 and substernal chest pain worse in supine position on 7/17/08. Could feel heart pounding. Shortness of breath while lying down with chest pressure. On 7/19/08 temperature 100.5.
Caller stated she was told the 6 month old had a fever 101F on 6/14/2023 and 100F 6/15/2023.; Caller stated she was told the 6 month old had a fever 101F on 6/14/2023 and 100F 6/15/2023.; Caller also stated the patient has not pooped since received the GARDASIL 9; Pharmacist called stating a friend asked her about recommendations for a 6 month old who received a dose of GARDASIL 9; This spontaneous report was received from pharmacist and refers to a 6-month-old patient of unknown gender. Information regarding the patient's medical history, historical drug, current conditions and concomitant therapies was not provided.  On 12-JUN-2023, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 1 dose, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided).  It was reported that the patient had not pooped (constipation) since received the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). Patient had fever on 14-JUN-2023, when the body Temperature was 38.3 degree Celsius (101F) and on 15-JUN-2023, body Temperature was 37.7 degree Celsius (100F).   At the time of reporting, the outcome of the fever events was not provided, patient had not recovered from the constipation. The causal relationship the fever events, constipation and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not reported.
Patient called on Saturday 5/15/21 and stated that the vaccine was given 1 inch from the top of her shoulder.  She says she was in a tremendous amount of pain overnight.  She "has to carry her left arm with her right arm".  Patient was advised by Dr. and myself to ice and take Ibuprofen or Naproxen.  on Sunday 5/16/21, I do not have an update on patient's condition.