chrisvoncsefalvay/vaers-outcomes huggingface dataset:
worst case of the flu; Shakes; aches; headache; muscle pain; Still had a mild temperature; This is a spontaneous report from a contactable consumer, the patient. The A 63-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6225) solution for injection, administered on the arm left on 15Mar2021 19:00 (at the age of 63 years) as a single dose for COVID-19 immunisation. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6203) solution for injection, administered on the arm left on Feb2021 14:00 as a single dose for COVID-19 immunisation. Patients medical history included blood pressure, prostate and cholesterol medications. Concomitant medications were not reported. The patient does not had any allergies to medications, food, or other products. At other facility the most recent COVID-19 vaccine was administered to the patient. The patient does not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination the patient has not been tested for COVID-19. The lab test includes body temperature and the result was max 100.2 degrees. On 15Mar2021 at 22:00, he experienced worst case of the flu. First 24 hours, he felt like the worst case of the flu he has had in decades. Shakes, aches, headache, muscle pain and hard to concentrate. Absolutely miserable. Still had a mild temperature. The patient does not receive any treatment for the adverse event. The clinical outcome of worst case of the flu was resolving. No follow-up attempts are needed. No further information is expected.
This spontaneous report as received from a medical assistant refers to a 77 years old patient. The patient was vaccinated with, .65 ml ZOSTAVAX on 19-NOV-2012. No other co-suspects were reported. No concomitant medications were reported. On 19-NOV-2012 the patient received a dose of ZOSTAVAX (lot # 1268AA) 11/19/2012 that expired on 11/05/2012. The patient experienced no adverse event. No treatment information was reported. Additional information has been requested.
my heart rate went up; rapid deep breaths; tingling and numbness in my lips; tingling and numbness in my lips; mild stomach weakness; This is a spontaneous report from a contactable consumer (patient). A 42-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, solution for injection, Lot Number: ER8730), dose 1 via an unspecified route of administration, administered in Arm Left on 24Mar2021 08:30 (age at the time of vaccination was 42-year-old) as DOSE 1, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took aspirin (E.C.) and experienced hypersensitivity. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient was not pregnant at time of vaccination. Patient did not receive other medications within 2 weeks of vaccination. On 24-MAR-2021 08:30, "approximately 3-5 minutes after 1st dose of covid vaccine, my heart rate went up, I began to have rapid deep breaths, tingling and numbness in my lips and mild stomach weakness. I had two more episodes of these symptoms within 1 hour after receiving the shot. The fire rescue on site took my heart rate and blood pressure during the first episode of my symptoms. I am scheduled to take the second shot on 15Apr and I would like to know if after experiencing these symptoms I should still take the second dose". The patient did not receive any treatment for AEs. Prior to vaccination patient was not diagnosed with COVID-19. Since the vaccination the patient had not tested for COVID-19. The outcome of events was recovered on an unspecified date in 2021.  No follow-up attempts are needed. No further information is expected.
Day of injection- I had a sore arm.  )n the day following the injection;  started experiencing the following s/s including arm soreness, body aches, headache, extreme fatigue, and fever (  my normal temperature is 96.4-97.4 F ) My temperature began to increase throughout the day until it reached 99.5 F about 7:30 pm .  The most serious adverse reaction was the 18 hour spike in my blood glucose level which was elevated to the high glucose level .  I ended up taking over 200 units of insulin in a 30+ hour period (normally would use this amount of insulin in a 36 hour period.  I was unable to lower my blood glucose level from the range (200-300mmg) despite repeated doses of insulin during the time period of reaction (8:00am- 4:00 am).
I am not sure if it is at all related.  I started feeling sick after dinner with flu-like symptoms. I felt tired the next couple of days and then again felt sick two nights later.  I continued t feel sick with body aches, headaches, fatigue, achy joints for a few days. I called the doctor and she sent me to get some bloodwork.  Everything she checked for seemed ok, except my white blood cells were low.  A week later after doing a follow-up blood work and getting an antibiotic injection for what appeared like an infection on my arm, my white blood cells-neutrophils, were at cero. I developed a throat infection with a fever and was admitted to the hospital for two days. I received intravenous antibiotics and felt much better after the next day.   I also had a bone marrow exam done and it came out normal and an appointment with a rheumatologist to discuss some autoimmune markers that were a little abnormal in one of the exams.  She diagnosed me with an autoimmune disorder- Limited Scleroderma.
Left arm red from shoulder to wrist, swollen at immunization site, raised red at immunization site, night sweats, dizziness
Case number PHEH2014US020345 is an initial spontaneous report received from a pharmacist on 07 OCT 2014 with a follow-up received on 14 OCT 2014. This report refers to a 63-year-old female patient. Her medical history and concomitant medication were not reported. She was vaccinated with FLUVIRIN 2014/2015 (batch number: 146401) intramuscularly at a dose of 0.5 ml on 06 OCT 2014. It was reported that before vaccination, the FLUVIRIN prefilled syringe reached 35.54 degree Fahrenheit for 1.5 hours. It was further reported that the total excursion was 1.5 hours and the vaccine was administered within that total duration. No adverse event was reported following this administration error (incorrect syringe of drug).   Follow-up received on 14 OCT  2014: Narrative updated with total excursion time and vaccination time (total excursion was 1.5 hours and the vaccine was administered within the total duration).
Around 3pm, felt fatigued, mildly sore right arm at injection site. Around 11pm, felt more severe arm pain, sharp pain in the right side of my neck (around the trapezius), fatigue. Middle of the night, had cold sweats.
Patient has had no reported side effects at this time; an expired dose of V ARlV AX was accidentlyadministered to a patient; This spontaneous report was received from an office Manager referring to a 20-month-old patient. No information was provided regarding the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant medication.  On 20-APR-2021, in the morning, the patient was accidently administered with an expired dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot number S012036, and expiration date of 17-APR-2021, at a dose of 0.5mL x 1 dose, subcutaneously for prophylaxis (anatomical location was not reported). The varicella virus vaccine live (oka/merck)(VARIVAX) administered had no temperature excursions. The patient had no reported side effects at this time.
COVID arm.  Felt perfect for seven days then on day eight I started having itching and swelling at the injection site. Tonight it is about one inch in diameter and medium hard. No pain and I otherwise still feel great.
chills, body aches, headaches. lasting about 24 hours. improved with tylenol. Symptoms similar to those experienced with covid infection 2 weeks prior, but felt 10x worse.
Woke up on 2/21 with a Migraine; then by 2:00 pm had nausea, chills, fever, tiredness.  Did not feel good rest of day; did not sleep well and headache again this morning, 2/22/21.
No adverse event; Inbound call from HBP who stated PNEUMOVAX 23 was inadvertently administered after a non-supported temp excursion. No additional AE details or PQC.; This spontaneous report was received from a office manager, referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concomitant therapies were not provided.     On 13-APR-2022, the patient was inadvertently administered pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (lot# U022819, expiration date 14-JAN-2023; formulation, strength, dose, frequency and route were not provided) for prophylaxis after a non-supported temperature excursion (product storage error). The storage temperature of the vaccine was 70 degrees Fahrenheit for a time frame of 96 hours. There was no previous temperature excursions. No additional adverse events (AEs) or product quality complaint (PQC) reported.
all over her abdomen, she was covered in hives, about size of quarter, bumpy, red and itchy; lips became swollen; Injection site became hard; Injection site grew in size to about 3x4 inches; Injection site became red; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (all over her abdomen, she was covered in hives, about size of quarter, bumpy, red and itchy), LIP SWELLING (lips became swollen), VACCINATION SITE INDURATION (Injection site became hard), VACCINATION SITE SWELLING (Injection site grew in size to about 3x4 inches) and VACCINATION SITE ERYTHEMA (Injection site became red) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy, Drug allergy, Blood pressure high and High cholesterol. Concomitant products included SPIRONOLACTONE, METOPROLOL and METFORMIN for an unknown indication.    On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced URTICARIA (all over her abdomen, she was covered in hives, about size of quarter, bumpy, red and itchy), LIP SWELLING (lips became swollen), VACCINATION SITE INDURATION (Injection site became hard), VACCINATION SITE SWELLING (Injection site grew in size to about 3x4 inches) and VACCINATION SITE ERYTHEMA (Injection site became red). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, URTICARIA (all over her abdomen, she was covered in hives, about size of quarter, bumpy, red and itchy), LIP SWELLING (lips became swollen), VACCINATION SITE INDURATION (Injection site became hard), VACCINATION SITE SWELLING (Injection site grew in size to about 3x4 inches) and VACCINATION SITE ERYTHEMA (Injection site became red) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Pain in arms; Feling sick; Chills; Headache; Body ache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in arms), MALAISE (Feling sick), CHILLS (Chills), HEADACHE (Headache) and MYALGIA (Body ache) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No prior medical history was reported).   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Apr-2021, the patient experienced PAIN IN EXTREMITY (Pain in arms), MALAISE (Feling sick), CHILLS (Chills), HEADACHE (Headache) and MYALGIA (Body ache). The patient was treated with PARACETAMOL (TYLENOL) for Headache, Myalgia and Pain in arm, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Pain in arms), MALAISE (Feling sick), CHILLS (Chills), HEADACHE (Headache) and MYALGIA (Body ache) outcome was unknown.            The patient reports that he had taken concomitant medication but no further information was provided. Action taken was not applicable as the patient has taken both the doses of vaccine.
Subsequent to receiving varicella virus vaccine live the pt experienced breakthrough chickenpox with several lesions which cleared and not the pt has broken out again with a case of chickenpox at the time of this report.
This spontaneous report as received from a Licensed Practical Nurse refers to a patient of unknown age and gender. On 22-AUG-2013 the patient was vaccinated with expired dose of GARDASIL (lot # unspecified, expiration 13-AUG-2013), injection. It was unspecified whether the patient had any adverse reactions to the expired dose being administered. Additional information has been requested.
DRUG EXPOSURE VIA BREAST MILK; This spontaneous report received from a patient concerned a 3 day old of unspecified sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported .The patient's parent (mother) received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1808609 expiry: UNKNOWN) dose was not reported, administered on 31-MAY-2021 13:00 for prophylactic vaccination. No concomitant medications were reported. On 31-MAY-2021, the subject experienced drug exposure via breast milk. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from drug exposure via breast milk. This report was non-serious. This parent/child case is linked to another report.
About 6 weeks after taking Hepatitis A and B vaccines in December 1995, he had a severe right-sided headache and was feverish and fatigued. These symptoms continued intermittently for 1 year, between early 1996 and early 1997, and then resolved. During that year, he also noted some visual changes. Between March 1997 and August 1998, pt experienced several upper respiratory and sinus infections. In January 1999 pt sought evaluation after not feeling well for 3 weeks. His complaints at that time included headache and visual problems, along with dizziness and feeling faint.  In September 2000 pt experienced a sharp pain on the right side of his head, followed by a recurrence of headaches, fatigue and visual problems. He continued to experience these symptoms intermittently, with varying degrees of intensity and frequency. In February 2001 pt developed an upper respiratory infection, which seemed to trigger another severe episode of right-sided headaches, fatigue and vision problems. During 2002 pt experienced 4-5 respiratory infections, which each lasted 4-5 weeks. Extensive diagnostic work-ups and evaluations completed have revealed some evidence of autoimmune disease.
Arm swelled after 48 hr after Dtap possible cellulitis. RX Keflex 500g TIX X 7d Medrol dose pak
Right axilla painful Lymphadenopathy noted 12/27, Sore right arm at injection site improved after 72 hours, no other symptoms reported Narrative: No treatment necessary at this time. Will continue to monitor. Advise to seek care/call occupational health if concerns arise or anything worsens. Reports right arm injection site soreness improved after 72 hours, no other symptoms reported.
SWOLLEN ARM, TENDERNESS AND 3 INCH BAND AROUND LEFT ARM IS STILL SWOLLEN FOR MORE THAN 4 WEEKS
Infant given Prevnar and DTaP on 05/08/2005 @ 12:30PM. Pt was on a nasal cannula on full feedings. Numerous A & B's after immunization. NPO and intubated within 12 hours. Infant febrile 15 hours later.
Hives (generalized) began 2-3 hrs. after vaccines given. Responded to BENADRYL.
At 10pm pain was level 5 on a scale of 1-10. At 1 am arm was in unbearable pain (level 8 pain) and patient could hardly move it. Took pain reliever and was able to get some sleep. In the morning 1/12/16 9:56 AM pain is at level 6.
Patient received a vaccine that was stored beyond the 30 days recommended in the refrigerated state. This event was reported to the manufacturer. The manufacturer tested the lot number in question. Data revealed that the vaccine administered did not maintain activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration. We consulted with the Public Health and recommended repeating this dose in question. Patient was sent a letter to inform them of the need to repeat the dose in question. Healthcare is working with the RA on a compliance improvement plan and has been reinstated vaccination privileges.
This spontaneous report as received from a medical assistant refers to a 4 year old male patient. On 13-APR-2018 the patient was vaccinated with improperly stored dose of PROQUAD (lot#N031929, expiry date 12-MAY-2019) for prophylaxis. The vaccine was reconstituted with a properly stored Merck sterile diluent (lot# N021030, expiry date 19-NOV-2019). No adverse effect was reported. The vaccine was exposed to the temperature of 6 degree Fahrenheit to 14 degree Fahrenheit for 41 hours and 17 minutes. No previous temperature excursion was involved. A data logger was present. No product quality complaint was present. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1804USA010458.
HYPOXIA 3/2/2022 &  8/10/2022  --  RECURRENCE OF SAME SYMPTOMS
swollen hands; sore left arm injection site; achiness; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swollen hands), VACCINATION SITE PAIN (sore left arm injection site) and MYALGIA (achiness) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     Concurrent medical conditions included Neutrophil count decreased.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced VACCINATION SITE PAIN (sore left arm injection site) and MYALGIA (achiness). On 24-Jan-2021, the patient experienced PERIPHERAL SWELLING (swollen hands). On 21-Jan-2021, VACCINATION SITE PAIN (sore left arm injection site) and MYALGIA (achiness) had resolved. On 25-Jan-2021, PERIPHERAL SWELLING (swollen hands) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Jan-2021, Blood test: normal (normal) Blood work came normal for everything..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-290967 (Patient Link).
numbness for an hour; burning sensation; joint pain; This is a spontaneous report from a non-contactable consumer reporting on behalf of the patient. A 49-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, unknown lot number and expiration), via an unspecified route of administration on 19Dec2020 at a single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced numbness for an hour, and subsequently burning sensation and joint pain which subsided with Tylenol use. The patient was recovering from the events burning sensation and joint pain, while unknown outcome for the remaining event.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
I developed shingles around the outside of my left eye; painful stiffness in the injection site arm; felt a little tired; joint pain in the injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of OPHTHALMIC HERPES ZOSTER (I developed shingles around the outside of my left eye) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Cataract (cataract surgery, left eye) on 26-Mar-2021. Previously administered products included for an unreported indication: SHINGRIX in 2020.    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Mar-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (painful stiffness in the injection site arm), FATIGUE (felt a little tired) and ARTHRALGIA (joint pain in the injection site arm). On 01-Apr-2021, the patient experienced OPHTHALMIC HERPES ZOSTER (I developed shingles around the outside of my left eye) (seriousness criterion medically significant). At the time of the report, OPHTHALMIC HERPES ZOSTER (I developed shingles around the outside of my left eye) had not resolved and MUSCULOSKELETAL STIFFNESS (painful stiffness in the injection site arm), FATIGUE (felt a little tired) and ARTHRALGIA (joint pain in the injection site arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment for the ophthalmic herpes zoster include sulfamethoxazole 160mg BID and valacyclovir 500mg 2 tablets TID. Company comment: Based on reporter's causality and recent history of cataract surgery the event eye herpes zoster is assessed as unlikely related to mRNA-1273. For the other events the causality cannot be excluded.   On 05Apr2021, his eye Dr assessed the area with shingles and thought that the shingles was most likely due to the trauma to the eye from the surgery.
5 days after receiving vaccine, arm  became swollen, red and hot and then large red blotches similar to the one at injection site appeared all over body.  They were extremely swollen, red and itchy. Took oral Benadryl for 2 days before seeking medical attention where I received a Benadryl shot and a steroid shot followed by an oral steroid for 5 days.
This spontaneous report as received from a pharmacist refers to a patient of age and gender unknown. Medical history and drug reactions were not reported. On an unknown recently, in 2013, the patient was vaccinated with PNEUMOVAX 23 1 dose, lot number J007786 Expiration date 25-SEP-2015, (dose, indication, concentration were not reported). Concomitant therapy was not reported. On an unknown date in the past week in September 2013, the patient experienced some itching, edema at injection site swelled to the size of a silver dollar, whole arm swelled like balloon. Laboratory data was unknown. The outcome of edema at injection site, whole arm swelled like balloon, some itching and the site swelled to the size of a silver dollar was unknown. This is one report of several reports from the same source. Additional information has been requested.
syncope in middle of the night on 4/10/21; felt weak and tired earlier that day
This immunocompromised 53 year old patient incorrectly received Fluad, which is intended for 65 years and older, instead of Flublok by the CMA. No harms occurred however.