chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Case number PHEH2014US017378 is an initial spontaneous report received from a nurse on 27 Aug 2014. This report refers to a 17 year old female patient. Past medical history and concomitant medications was not reported. She received only Men A lyophilized conjugate component of MENVEO (batch number: M14024), intramuscularly reconstituted with a sterile diluent instead of MenCYW-135 liquid component on 07 Aug 2014. Reporter stated that, they have scheduled patient for revaccination tomorrow. No adverse reaction was reported following this administration error.
This spontaneous report as received from a pharmacy intern refers to a patient of unknown demographics. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapy were not reported. On an unknown date the patient was vaccinated with VARIVAX injection (dose and frequency were not reported) (lot # R018141, expiry date: 25-JUN-2020) intramuscularly instead of subcutaneous (incorrect route of product administration) for prophylaxis. No adverse effects were reported. No product quality compliant was involved. Lot number [R018141] has been verified to be a valid lot number for VARIVAX.
FEELING ACHEY; TROUBLE SLEEPING; FLU LIKE SYMPTOMS; MILD HEADACHE; LOW GRADE FEVER; FELT NAUSEOUS; This spontaneous report received from a patient via a company representative 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: 1805031) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced feeling achey, trouble sleeping, flu like symptoms, mild headache, low grade fever, and felt nauseous. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu like symptoms, and was recovering from feeling achey, mild headache, low grade fever, trouble sleeping, and felt nauseous. This report was non-serious.
Ringing in ears since 2nd injection; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9267) via an unspecified route of administration in the right arm on 13Mar2021 at 11:00 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Medical history included HIV (human immunodeficiency virus) infection. The patient had no known allergies to medications, food or other products. 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 included HIV medication (unspecified) from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9267) via an unspecified route of administration in the right arm on 18Feb2021 at 17:00 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. On 14Mar2021 at 08:00, the patient experienced ringing in ears since 2nd injection. The event 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 reported event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event ringing in ears since 2nd injection was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration) in a 57-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 070H21A) for COVID-19 prophylaxis. No Medical History information was reported. On 08-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 08-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration). At the time of the report,  EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration) outcome was unknown. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. No concomitant medication were reported. It was reported that vials had not undergone any temperature excursion. Total of 173 doses were given from LOT 070H21A. No treatment medication were reported. Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: follow-up received includes   reporter address updates.
Was a little queasy; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Was a little queasy) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021B21A and 036A21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension. Concomitant products included AMLODIPINE BESILATE (NORVASC) for Hypertension, ACETYLSALICYLIC ACID (BABY ASPIRIN) and ROSUVASTATIN CALCIUM (CRESTOR) for an unknown indication.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced NAUSEA (Was a little queasy). At the time of the report, NAUSEA (Was a little queasy) had resolved.            Treatment information was not provided.   This case was linked to MOD-2021-407182, MOD-2021-407326 (Patient Link).
Extreme prolonged fatigue; This spontaneous case was reported by a physician and describes the occurrence of FATIGUE (Extreme prolonged fatigue) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter once. On 04-Dec-2021, the patient experienced FATIGUE (Extreme prolonged fatigue). On 09-Dec-2021, FATIGUE (Extreme prolonged fatigue) had resolved.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medicines were reported. It was reported that, fatigue during day and night, needing rest sleep, unable to accomplish chores, not affecting ADL. No treatment information was provided by the reporter.
Stated immediately experienced pain left upper arm after receiving flu vaccine. Describes throbbing & burning. Difficulty sleeping. Seen on occ Health Rx: FLEXERIL & tramadol for pain.
Monthly Period during normal scheduled time was only 1 day and very small.  2 weeks later it is a normal flow and massive pain/cramps.  This is above normal.  I have a Paraguard IUD to help control flow and was not off until after this shot.  According to my tracker between dose 1 and dose 2, my period was normal.  I did not mark pain as above normal.  I am day 2 in an off cycle period and the pain is way above normal.
urinary Infection; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported for a female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: unknown), via an unspecified route of administration on 11Feb2021, as SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medication were not reported. On an unspecified date, the patient experienced urinary Infection. Patient was taking antibiotics. He wanted to confirm if his wife can take the vaccine on the scheduled appointment on 07Mar2021, which is over 21 days interval. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
4/5/21 vaccinated  4/7/21 numbed face.,right side from nose to ear and from upper lip to top of scalp. painful face and scalp like a severe burn.
3/31/2022, RN spoke to legal guardian of Patient, regarding the adult dosage being given. No adverse reactions, side effects, or unwanted symptoms. Guardian stated that Patient is a "larger 11-year-old." Guardian was advised to follow up with her PCP should she have concerns. Guardian verbalized understanding and did not have any concerns at the time of the conversation.
12/4/02 inconsolable irritability x several hours. 12/5/02 baby doing well-no fussiness.
This case was reported by a consumer (subject's son) and described the occurrence of chronic inflammatory demyelinating polyneuropathy in an adult male subject who was vaccinated with Hepatitis a + b vaccine (manufacturer unspecified). A physician or other health care professional has not verified this report. On unspecified date the subjects received unspecified dose of Hepatitis a + b vaccine (details unknown). The subject's son was unsure if the subject had received TWINRIX. Within years of vaccination with Hepatitis a + b vaccine, the subject experienced chronic inflammatory demyelinating polyneuropathy (CIDP). The subject's son reported that his father developed CIDP after what he "believes was TWINRIX vaccination about 10 years previous". It was "unknown if that was 10 years previous to current date or 10 years previous from the caller's TWINRIX vaccination". This happened in the "late 1990s and cannot be sure it was TWINRIX vaccination". This case was assessed as medically serious by GSK. At the time of reporting the outcome of the event was unspecified. The subject's son reported events for himself with TWINRIX. See case A0984817A for details.
Started feeling itchy later after getting the vaccine, have been breaking out in hives every other since then
The following day and since I have had continued huge increase in my peripheral neuropathy and trigeminal neuralgia  symptoms. I have pins and needles neuropathy in almost whole body and facial pain (TN). This has been a huge increase of pain and I am VERY scared this is a permanent effect that this vaccine has caused.
Ipol exposed to a temperature excursion was administered to the patient with no reported adverse event; Initial information was received on 21-Jul-2023 regarding an unsolicited valid non-serious case received from a physician.  This case involves a poliomyelitis vaccine (inactivated) (IPV) (vero) [Ipol] which was exposed to a temperature excursion was administered to a 4 years old male patient with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included measles vaccine, mumps vaccine, rubella vaccine (MMR) for Prophylactic vaccination (immunisation).  On 05-Jun-2023, the patient received a dose of suspect poliomyelitis vaccine (inactivated) (IPV) (vero) Suspension for injection (strength: standard) at dose of 0.5 ml once (lot number: V1A021M, expiration date: 27-Feb-2023, administration site: unknown) via intramuscular route for Immunization (immunisation) which was exposed to a temperature excursion with no reported adverse event (poor quality product administered) (latency: same day).  It was reported that "Products involved: IPOL opened Reason of the excursion: accidentally left the refrigerator door open too long. Did excursion occur due to a human error: Yes Conditions of the excursion: 3 separate excursions with the same vaccines. Total: low of 1.85C for 30 minutes and a high of 8.74C for 60 minutes."  No lab data reported.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event ipol exposed to a temperature excursion was administered to the patient with no reported adverse event
Initial information received on 29-Nov-2018 regarding an unsolicited valid non-serious case received from a physician. This case involves a 57 years old female patient who experienced numbness in her left foot- it spread to both hands and feet and is worse in the morning/tingling, while she received vaccine FLUZONE QUADRIVALENT. The patient's past medical history included Five or six years ago she had the Hypoaesthesia but it resolved in a week. The patient's past medical treatment(s), vaccination(s) and family history were not provided. On 15-Nov-2018, the patient received a 0.5 mL dose of suspect Influenza Quadrival A-B Vaccine, lot UJ070AA, expiry date: 30-Jun-2019 via unknown route in the left deltoid. On an unknown date, 12 hours later the patient developed a non-serious numbness in her left foot- it spread to both hands and feet and is worse in the morning/tingling (hypoaesthesia) following the administration of Influenza Quadrival A-B Vaccine. It was reported that the patient came back to see her doctor two days ago, her reflexes were good, no sensory defect with light touch. Her left arm was a little weaker but it could be because she was right handed. Other relevant tests included no lab data. Final diagnosis was numbness in her left foot- it spread to both hands and feet and is worse in the morning. It was not reported if the patient received a corrective treatment. The outcome of the event was not reported.
Soreness in left shoulder; Shoulder blade flare up of arthritics.History of arthritis in left shoulder. However, pain intensified and was completely gone within 48 hours.; pain intensified; This is a spontaneous report from a contactable consumer, the patient.  A 75-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EK9231), via an unspecified route of administration in the left arm on 15Jan2021 at 12:30 (at the age of 75-years-old) as a single dose for COVID-19 immunization.  Medical history included diabetes mellitus, high blood pressure, heart valve replacement, and history of arthritis in left shoulder.  Prior to the vaccination, the patient was not diagnosed with COVID-19.  Since the vaccination, the patient had not been tested for COVID-19.  Concomitant medications included unspecified medications taken within 2 weeks. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took warfarin (MANUFACTURER UNKNOWN) on unknown dates for an unknown indication and experienced drug allergy.  On 15Jan2021 at 18:00, the patient experienced soreness in left shoulder and shoulder blade flare up of arthritis in left shoulder. The pain intensified in Jan2021. The patient went to the urgent care (physician's office) for the events. The patient took gabapentin (MANUFACTURER UNKNOWN) 300 mg for treatment and to get some sleep. The clinical outcome of the soreness in left shoulder, shoulder blade flare up of arthritis in left shoulder, and pain intensified were recovered on 17Jan2021 after approximately 48 hours.     No follow-up attempts are possible. No further information is expected.
The patient had an episode of hypoglycemia in the early morning hours prompting a voluntary visit to the Emergency Department. He describes waking up feeling weak, that he could not walk, disoriented. It lasted about 30 minutes and resolved after eating a sandwich. He and his wife decided to go to the Emergency Department that morning to get "check out." The evaluation was negative. Notably, the patient had reduced PO intake in the 2 days prior, just because he was not feeling well. He does not have diabetes (has history of pre-diabetes, not on any medications for this).
PT stated she had tongue swelling and a "tight" throat after 1st dose of vaccine. Pt given 25mg Benadryl prior to being given 2nd dose. Approximately 10mins later Pt stated she had "Tingling" under and at Tip on Tongue. Pt given 25mg of Benadryl. Pt stated she still wasn't feel well and asked to stay longer. Pt. monitored for a full 1.5hrs. Pt stated she now felt better and we released w/advice to call 911 if needed.
HEART RACING; BODY ACHES; CHILLS; FEVER; FATIGUE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's past medical history included covid-19. The patient received covid-19 vaccine ad26.cov2.s (form of admin and route of admin were not reported, batch number: Unk) dose was not reported, administered on 31-MAR-2021 08:30 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 31-MAR-2021, the subject experienced heart racing. On 31-MAR-2021, the subject experienced body aches. On 31-MAR-2021, the subject experienced chills. On 31-MAR-2021, the subject experienced fever. On 31-MAR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, and fatigue on 01-APR-2021, and chills, and fever on 31-MAR-2021, and was recovering from heart racing. This report was non-serious.
This spontaneous report was received from a register nurse concerning a 25 year old patient of an unknown gender. Medical history and concurrent conditions were not reported. On 05-MAR-2014, the patient was vaccinated with M-M-R II (route was not reported) lot J006954, expiration date 07-JUN-2015. Co-suspect and concomitant therapies were not reported. The register nurse reported that M-M-R II went through a unsupported temperature excursion; however 10 doses of M-M-R II were overlooked because they were stored in the fridge. These doses were administered to 10 patients, this case pertain to one of them who had not received repeat dose to date. This case is linked to 1404USA001099, 1404USA001100, 1404USA001101, 1404USA001102, 1403USA010165, 1404USA014293, 1404USA014294, 1404USA014295, 1404USA014296, 1404USA014297, 1404USA014298, 1404USA01430 and 1404USA014301. Additional information has been requested.
Arm sore, head "spinning", headache, upset stomach, stomach "gurgling".  Denies diarrhea.  Vomited once. Fever. Lasted through the next day but was able to attend school.  Denies seizure activity.
one prefilled syringe of PNEUMOVAX 23 which was leaking during administration; No adverse effects; one prefilled syringe of PNEUMOVAX 23 which was leaking during administration; one prefilled syringe of PNEUMOVAX 23 which was leaking during administration; This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, historical drugs, drug reactions/ allergies and concomitant medications were not reported. On 12-NOV-2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection (1 DS X 10 SYRINGES) prefilled syringe, lot # S012247 and expiration date 10-FEB-2021 (dose, route and anatomical location not reported) for prophylaxis. It was reported that one prefilled syringe of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) which was leaking during administration (product quality issue), (circumstance or information capable of leading to medication error) and (incorrect dose administered). The leaking occurred between the syringe hub /Luer lock and syringe needle, while the plunger rod was being pushed forward. No adverse effects reported.
Presented to ED on 09-07-21 with confusion after being discharged from hospital on Sept 1 (for COVID19). Patient had a very complex past medical history and was admitted to hospital on 09-07-21. Family says patient started getting confused after taking steriods (Decadron).
The vaccinator volunteer, administered a half dose (.25mL) of the Moderna vaccine formulation in error. A second dose of .25mL was administered immediately per agency guidance. The vaccinator volunteer administered the second dose.
This spontaneous report was received from a 52 year old male consumer reporting on himself. The patient's medical history included chickenpox twice. On 18-SEP-2013the patient was vaccinated with ZOSTAVAX (dose, route and lot number were not provided) "one time shot" injection, for prevention of shingles. Concomitant therapies included ibuprofen. On 20-SEP-2013, patient developed a welt of the size of a lemon that turned red and itched badly; he also developed hives, felt nauseous, and had extreme pain in his lower back, hips, and neck. The patient also stated he gets nauseous after taking some unspecified pain pills. Patient was treated with Benadryl (manufacturer unknown) and an unspecified cortisone cream. The outcome of welt the size of a lemon that turned red and itched badly, hives, extreme pain in neck, hips and lower back, and felt nauseous was reported as recovering/ resolving. The relationship between ZOSTAVAX and the events was not reported. No lab diagnostics studies were performed. Patient contacted physician by phone. Additional information has been requested.
On Saturday, November 3rd my temperature fluctuated between 100.7 and 102.2 degrees.  I was extremely sore at the injection site, achy, flu-ish and extremely weak. As of today, Sunday, November 4th, my temperature is below 100 degrees, but I still feel very, very weak and I have a 4-6" diameter spot that looks like a sunburn at the site of the injection.  It is very hot and sensitive to the touch. I have been on 500 mg of Azithromycin and 750 mg Levofloxacin since Friday, October 26th, 2012 so I don't think it is an infection.
Infant received PEDIARIX on 5/4/2016 and Hemophilus and pneumococcal vaccines on 5/5/2016. On 5/6/2016 at 0045, infant was noted by the nurse caring for her, to have periodic breathing accompanied by decreased oxygen levels, period breathing continued for about 1 hour. At 0145, infant was noted to be lethargic with an elevated temp of 37.7C. Infant had another desaturation to 14% with bottle feeding requiring oxygen to be administered to the infant. The neonatologist was notified and lab testing was ordered. The infant remained lethargic for many hours and did not take her usual amounts of milk. At 0556, infant had another 5-6 minutes of periodic breathing with desaturations to 60%.
Within 8 hrs of vaccine pt developed fever 103.5F, fever lasted 2 days, developed little rhinorrhea, was fussy, had somewhat puffy eyes - all by parent report. Not examined. Treated with antipyretic. Not examined.
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old male patient received BNT162b2 (BNT162B2), on 27Apr2021 as dose 1, single (Lot number: EW0170), in left arm and on 18May2021 as dose 2, single (Lot number: EW0185) at the age of 41 years, in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 30Dec2021 as dose 3 (booster), single (Lot number: 084J21A), in left arm for covid-19 immunisation; ornithine aspartate (DETOX [ORNITHINE ASPARTATE]), (Lot number: 20003813). The patient had no relevant medical history. Concomitant medication(s) included: VITAMIN D3; ZINC. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative; Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient had other medication in 2 weeks. No known allergies. The patient was treated for COVID-19 with Paxlovid (lot number FY6859) from 09Jun2022 to 14Jun2022. Eight days after initial covid infection and treatment with Paxlovid, symptoms disappeared, and tested negative on at-home antigen test. 1.5 days after negative test, symptoms returned and tested positive again on at-home antigen test.