chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 71-year-old female patient who received SHINGRIX for prophylaxis. On 2nd May 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain in arm and injection site erythema. On an unknown date, the outcome of the pain in arm and injection site erythema were recovered/resolved. It was unknown if the reporter considered the pain in arm and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the right deltoid. The patient stated that, she had very little effects from the 1st dose of SHINGRIX, mostly a very sore arm, which took about a week to resolve. There was a large red circle on the patient's arm at the injection site which gradually disappeared. The patient read various reports about the adverse affects of SHINGRIX and wanted to know if there had been cases of optical neuropathy, as she was due for the 2nd shot very soon.
Pt received 2 Pfizer covid 19 vaccines in March and April of 2021. Pt returned for another vaccine, claiming it was his first vaccine, on 12 July 2021. Pt was given the pfizer vaccine and a vaccine card. Today, pt returned for his "second" shot, which was really his 4th shot. Pt presented the card he received on 12 July and was given a 4th dose of pfizer covid 19 vaccine.
On evening of vaccine pt developed fever of 100, tenderness of vaccine site with myalgia, fatigue and headache.
Pfizer-BioNTech COVID-19 Vaccine EUA: During observation, vaccine recipient complained of lip numbness. She was monitored by EMS. No further intervention.
Severe soarness in vaccinated arm, vomiting, stomach cramps, fever sleepiness, dizziness. The symptoms all resolved on day 4.
Rash that lasted 5 days; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash that lasted 5 days) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, 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 RASH (Rash that lasted 5 days). At the time of the report, RASH (Rash that lasted 5 days) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment medications were reported.   This case was linked to MOD-2021-262976 (Patient Link).
Chills; Fever; Headache; Nausea; Muscle ache; Chest pain; Shortness of breath; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Chest pain), DYSPNOEA (Shortness of breath), CHILLS (Chills), PYREXIA (Fever) and HEADACHE (Headache) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced CHEST PAIN (Chest pain) and DYSPNOEA (Shortness of breath). On an unknown date, the patient experienced CHILLS (Chills), PYREXIA (Fever), HEADACHE (Headache), NAUSEA (Nausea) and MYALGIA (Muscle ache). On 10-Mar-2021, CHEST PAIN (Chest pain) had resolved. At the time of the report, DYSPNOEA (Shortness of breath) had not resolved and CHILLS (Chills), PYREXIA (Fever), HEADACHE (Headache), NAUSEA (Nausea) and MYALGIA (Muscle ache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided. After the investigation of doctors, it was ruled out everything is fine.
possible irritation at the injection site; VAQTA that was adrninistered Subcutaneous as opposed to Intramuscular; This spontaneous report as received from a pharmacist refers to a 23 years old female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported.      On 08-NOV-2019, the patient was inadvertently vaccinated with hepatitis a vaccine, inactivated(VAQTA) Intramuscular Injection, at a dose of 0.5 milliliter once, subcutaneously (Lot # and expiry date was not reported) for prophylaxis (incorrect route of product administration). The pharmacist reported that the patient may have experienced "possible irritation at the injection site" (injection site irritation). The outcome of injection site irritation was unknown (it was reported as "no harm"). The relatedness between the event and the suspect therapy was not provided.
tired feeling, 2-3 dizzy/light headedness feeling, weakness, voice is lower, feels like she has been up all night with a new born.  shoulder soreness radiating to neck, achy feeling when she moves her head. donor took ibuprofen for achy feeling & sat down when she felt dizzy/light headed.   she feel like it is getting better today, but she still feels weak, has not taken any ibuprofen today.
11/16/2022 at 1000 Shoulder Surgery (Rotator cuff) Dr. MD
Fever 101.8, chills, body aches, nausea, light-headedness, headaches, injection site pain and hardness
This spontaneous report as received from a nurse reporting that unspecified number of patients (no patient demographics unknown) were most likely vaccinated with GARDASIL which went out of temperature range and were exposed to temperature condition not supported by their in house stability data. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report was received from a registered nurse and refers to a 4 years old patient of unknown gender. No medical history, concurrent conditions and concomitant therapies were reported. On 12-MAY-2015, the patient was vaccinated with an improperly stored dose of (Oka/Merck) VARIVAX lot # K021933, expiration date 10-NOV-2016, dose 0.5 ml, subcutaneously (anatomical location was not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is note expected, as all required information has been received.
Maternal exposure timing unspecified; This spontaneous prospective pregnancy report was received from a physician refers to a female patient of unknown age.   The patient had a history of 1 previous pregnancy and 1 live birth(s) and she was second gravida. It was mentioned that in the previous pregnancy  was not reported birth defects. Pertinent  medical history, current conditions and concomitant medications were reported as none.  The patient became pregnant with last menstrual period (LMP) reported as  on 14-APR-2020 and estimated date of delivery (EDD)  reported as on 19-JAN-2021.   On 10-AUG-2020 a maternal serum alpha-fetoprotein was performed, and the result showed was normal; On 11-SEP-2020, an ultrasound was performed, and the results was reported as normal anatomy.   On 11-NOV-2020,  the patient was vaccinated with a first  dose of  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) prefilled syringe lot # R030453, expiration date not reported, but upon internal validation established as: 23-JUL-2021 for prophylaxis (dose, and  route of administration, were not reported).   The patient became pregnant with last menstrual period (LMP) reported as  on 14-APR-2020 and estimated date of delivery (EDD)  reported as on 19-JAN-2021.   The therapy was taken during the third trimester of pregnancy (maternal exposure during pregnancy). The pregnancy outcome was unknown. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. devicelotnumber: R030453; expirationdate: 23-JUL-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
pt recvd vax & 45 days later 16AUG94 exp painful swelling in finger joints of both hands,& arthralgia;sx subsided 15 days later (31AUG94);
No adverse event; Patient received a 0.2ml dose of a pink cap vial Moderna COVID19 vaccine bivalent as a second dose; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient received a 0.2ml dose of a pink cap vial Moderna COVID19 vaccine bivalent as a second dose) and NO ADVERSE EVENT (No adverse event) in a 6-month-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 216K22A) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 Vaccine (First dose AS1417b) on 11-Apr-2023. Past adverse reactions to the above products included No adverse event with Moderna COVID-19 Vaccine.    On 09-May-2023, the patient received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .2 milliliter. On 09-May-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced WRONG PRODUCT ADMINISTERED (Patient received a 0.2ml dose of a pink cap vial Moderna COVID19 vaccine bivalent as a second dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient received a 0.2ml dose of a pink cap vial Moderna COVID19 vaccine bivalent as a second dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Patient received a 0.2ml dose of a pink cap vial Moderna COVID19 vaccine bivalent as a second dose).    No concomitant medication was reported.  No treatment information was reported.
inc redness/swelling lt deltoid minimally tender started 24hr p/vax;seen 4JUL w/lt tricep entire area bright red;
about 2 days after the 1st dose of the moderna vaccine, felt very tired and unwell for several days. He felt okay for about 2 weeks then on January 29, 2021 he felt intense chest pain. Concerned it was a heart attack, he was brought to the hospital. He stayed one night and the hospital ran several tests like EKG, stress test and others. Found his results to be normal and was released on January 20, 2021. Even the moment he was released, he felt very dizzy but hospital was not concerned and thought maybe side effect of medication. He continued to feel dizzy, fuzzy brain and hard time staying awake during the day and sleeping through the night for the rest of the week. He passed sometime in the early hours of February 6, 2021. Doctor's suspicion is a blood clot. He has no history of blood clots, heart problems or any health issues.
Hives, swelling eyelids, nose, mouth, ears 30-45 min after doses given. No hx of egg allergy or allergy to known component. We administered BENADRYL and SOLU-MEDROL.
Hives on my face, skin itching, temperature increase in face neck and ears. Happens mainly in the evening or night time.
Patient was given expired medication. No adverse reaction noted. Left several messages for parent to call office and a letter was sent to families home asking for parent to contact office with no response as of yet. Dr. was going to give pt option as to whether they want to redo vaccine at this time or hold off for now. Pt is up to date on all of his vaccines so far.
Pt claims "Hives, stiff neck, pain on left side, including arms. Never felt anything like that before and I had the flu shot multiple times in my life".
The booster dose was given one month too early. Notified patient and she is having no problems.
Initial and follow-up information has been received from a nurse and a office employee concerning a 9 year old female (granddaughter of the office employee) experienced a seizure after her first vaccination with RECOMBIVAX HB (manufacturer unknown).  At the time of the report, the patient's outcome was unknown.  Upon internal review, seizure was determined to be an other important medical event.  Subsequently, she was vaccinated with a first dose of GARDASIL concomitantly with a second dose of hepatitis A virus vaccine inactivated (manufacturer unspecified) and a second dose of RECOMBIVAX HB (manufacturer unknown) and experienced a "small seizure."  (MSD WAES# 0705USA02215).  Additional information has been requested.
This spontaneous report as received from Medical Assistant refers to a unspecified number of patients of unknown age and gender. On an unknown date in 2014 the patients were vaccinated with VARIVAX (dose, route of administration and indication were not provided). It was reported that the patients received doses of VARIVAX that underwent supported temperature excursions. Doses were administered between the dates of 26-AUG-2014 through 29-OCT-2014. No adverse experiences reported. This is one of several reports received from the same source. Additional information has been requested.
Patient developed swelling in the left arm the morning after receiving Tdap vaccine and Varivax vaccine.
day p/vax pt seen @ clinic w/swelling redness,  warmth to palpation on rt leg. area of redness on near site of inject. some surrounding induration. APAP or Ibuprofen susp ordered by MD for discomfort;
Client came into clinic requesting 2nd Pfizer vaccine.  His vaccination card stated he was due his 2nd vaccine.  He was asked if he had had any other vaccine and signed paper stating he had only received Pfizer.  After administration, was noted when entering into state immunization registry, he had had both Moderna vaccines as well as his first Pfizer.  No acute event noted at the time of administration.
Event occurred AFTER the 2nd dose...3 months later... A complex of symptoms started in May, including extreme exhaustion and rib pain.  Subsequently discovered to be profoundly Iron deficient anemic with a ferritin level of 3 and a hemoglobin of 10.5 (never had any anemia prior to this time).  Still later, in September, have now discovered to have profound hypothyroidism.  (TSH 4 times normal high and T4 low. ).  So this is a question of which came first, the anemia and iron supplements, or a sudden worsening of my Hashimoto's hypothyroidism - which up to this point for 10 years had never required any adjustments and had been stable).  The question is : did my autoimmune hashimotos react to the mRNA vaccine?
Immunization given on 3/31/2009.  Child had tactile fever for one day on 4/9/2009 with onset of generalized body rash which is still present at time of reporting.
This case was reported by a consumer via call center representative and described the occurrence of weakness in a 71-year-old female patient who received SHINGRIX for prophylaxis. In September 2018, the patient received the 1st dose of SHINGRIX. In September 2018, less than a day after receiving SHINGRIX, the patient experienced weakness, fatigue and pain of skin. On an unknown date, the outcome of the weakness, fatigue and pain of skin were recovered/resolved. It was unknown if the reporter considered the weakness, fatigue and pain of skin to be related to SHINGRIX. Additional details were reported as follows: The patient's husband also received 1st a dose of SHINGRIX. After vaccination, the patient experienced fatigue, weakness and no energy. The patient also experienced that her skin hurt all over. The symptoms began around the same day as the injection and lasted for about 2 days. The reporter did not consent to follow up.
A little cough; Some aches; A spontaneous report was received from a consumer concerning himself a male patient of unknown age who received Moderna's COVID-19 vaccine and experienced a little cough and some aches.   The patient's medical history or concomitant medication was not provided.  On 04 Jan 2021, prior to the onset of the events, the patient received their dose of two planned doses of mRNA-1273 (Lot number: unknown) for prophylaxis of COVID-19 infection.    On 05 Jan 2021 , after he received the mRNA-1273 vaccination, the patient experienced a little cough and some aches. Treatment information was not provided. Patient reports a negative Covid-19 test from 04 Jan 2021.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.    The outcome of the event, a little cough and some aches, was considered unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.
This literature report concerns a case of a 9-year-old patient (further identification not available) from a series (16 cases) among patients treated for narcolepsy in three major centers of reference for narcolepsy. All cases were HLA DQB1*0602 positive with severe sleepiness and definite/severe cataplexy. The most striking features of the sample were the abrupt onset and the unusual severity of both sleepiness and cataplexy. Rapid weight gain was frequently noted, as is typical with abrupt onset cases. This case potentially involved CSL product (unbranded H1N1 / no adjuvant (injectable)). Date of vaccination was 12-Sep-2009. Date of EDS (excessive daytime somnolence) was 01-Oct-2009. Date of cataplexy was 01-Oct-2009. Time between H1N1 exposure to cataplexy onset was 2 weeks. All cases were examined for past H1N1 exposure or vaccination. The event outcome was not reported. Reporters comment: Cases reported here with their temporal link between vaccination and disease onset and unusual clinical presentation, with rapid development and severity of both excessive daytime somnolence and cataplexy, suggest that H1N1 vaccination or exposure may trigger narcolepsy. However, there are several limitations and potential confounding factors, such as increased awareness of narcolepsy and more efficient diagnostic processes leading to faster diagnosis and increased identification of recent-onset cases. Another limitation is that a large portion of the population was either vaccinated or had H1N1 infection, including many unrecognized instances of infection, increasing the difficulty to document a specific association between narcolepsy onset and H1N1 infection or vaccination.
Cellulitis left arm, redness, warm to the touch and tenderness at injection site.  Was prescribed Keflex 250mg/5ml 15cc BID.
1-2 weeks after mom states - got sick: runny nose, cough, fever, traveled with grandmother for 1 mo. For 1 week had runny nose without cough or fever. Then they came back and she was still sick for another week or two. Got better. Was not sick enough to see a doctor. #2 stomach eczema spread to buttocks.
Fatigue; Extreme nausea; Fever; Body aches; This is a spontaneous report from a contactable other health care professional, the patient. A 32-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6204) via unspecified route of administration in the left arm on 04Mar2021 at 18:30 (at the age of 32-year-old) as a single dose for COVID-19 immunisation. Medical history included PCOS (polycystic ovary syndrome). Concomitant medications included norethisterone acetate, ethinylestradioal and ferrous fumarate(HAILEY FE 1.5/30), spironolactone (MANUFACTURER UNKNOWN) and valacyclovir (MANUFACTURER UNKNOWN) from unknown date for unspecified indication. The Patient did not have any allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown if the patient was diagnosed with COVID-19 prior to vaccination. The Patient had not tested for COVID-19 since the vaccination. On 07Mar2021 at 13:00, the patient experienced fatigue, extreme nausea, fever and body aches. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported events. The clinical outcome of the events fatigue, extreme nausea, fever and body aches was recovered on unknown date.   No follow-up attempts are needed. No further information is expected.
Systemic: Joint Pain-Mild, Systemic: Numbness (specify: facial area, extremities)-Mild, Additional Details: hand/knuckle pain on left side of hand and numbness to fingers after vaccine, spoke with her pcp and sx self resolved, they advised she was okay to get next dose
71-year-old male with history of Ménière's disease states he woke up 4/9/2021 with ringing in both ears, fullness in the left, and intermittent episodes of vertigo, described as very similar to prior, no headache fever cough pain or ear discharge, no numbness tingling or weakness, negative rashes or swelling. Patient felt mild nausea but no actual vomiting earlier that day. No medications taken. Patient denies syncope or palpitations. No changes otherwise in sensorium except mild ringing in the ears. No difficulty thinking or concentrating. No chest pain or shortness of breath. Patient also describes mild nasal and sinus congestion with dry cough, possibly related to "pollen. "No specific history of allergies however. Patient also within the last 4-6 weeks, had shots for COVID 19 and shingles. Vital signs stable, no acute distress on exam.
sore arm; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) and FATIGUE (fatigue) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and 038K20A) for COVID-19 vaccination.     Concurrent medical conditions included Breast cancer (diagnosed in late 2005 and underwent unspecified surgery in Feb-2006) since 2005 and Emphysema. Concomitant products included LANSOPRAZOLE, THEOPHYLLINE, PRAVASTATIN and FLUTICASONE FUROATE, UMECLIDINIUM BROMIDE, VILANTEROL TRIFENATATE (TRELEGY) for an unknown indication.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-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 PAIN IN EXTREMITY (sore arm) and FATIGUE (fatigue). At the time of the report, PAIN IN EXTREMITY (sore arm) and FATIGUE (fatigue) was resolving.            Patient's height was 5.3 (160.02 cm). It was reported that the patient had no allergies and COVID-19 in the past.  The patient experienced sore arm  and fatigue after vaccination, however felt better in 24.  Treatment information was not provided.   This case was linked to MOD-2022-528604, MOD-2022-528619, MOD-2022-528626 (Patient Link).
Patient was accidently given Moderna monovalent Covid-19 vaccine as a booster dose instead of Moderna bivalent Covid-19 vaccine. Patient has received Moderna covid-19 vaccines as his primary series and original booster dose in 2021, tolerated all doses well. Patient reported mild discomfort overnight as side effects from receiving both flu and covid vaccine, but stated that symptoms had resolved and that he now feels well. Patient was informed that he may receive bivalent booster dose in 2 months if he wishes.