chrisvoncsefalvay/vaers-outcomes huggingface dataset:
body ache; headache; This is a spontaneous report from a non-contactable consumer, the patient. A 57-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on an 20Jul2021 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. Medical history included penn allergy (allergy nos). Concomitant medication was not reported. 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. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 22Jun2021 at 17:00 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. On 21Jul2021, the patient experienced headache (6-12 hours after second injection). On 21Jul2021 at 17:00, the patient experienced body ache (24 hours after the injection). The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event body ache and headache was recovered on unknown date in Jul2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient has noticed a sudden onset of numbness and tingly sensations that began on this right thigh. Over the past week these symptoms have become more spread out.
Injection 1 caused itching at the injection site within 5min of administration, then to entire body with 60min. Relieved with Benadryl and Pepcid.  Injection 2 caused a reddened area at injection site within 5-10min of injection. With an hour, a red circular raised spot approx 2-3 inches in diameter was hot, painful and swollen. 24hrs after the injection, the red area was 3-4 inches in diameters, still swollen, red, raised, painful. 36hrs after the injection, the area was no longer raised, but remained red, swollen and started itching. Seems to be slowly dissipating.
right arm started to fell very warm  and itchy where the injection site was.  Then I noticed under my arm was a  size of a  ball like a baseball. I did see my primary and gave me antibiotics  for the next 2 weeks.  I still have a red like rash of injection site and ball under my arm.  Im really concern and worried about this. Im not getting my second moderna Vaccine due to this reaction.  What if this gets worst I do have a heart condition. I was told my body is fighting an infection but where?  What can be done for me now.
Patient passed out, woke up minutes later and conscious. Emergency number called, and patient taken to hospital. Nauseous and vomited.
Dizziness, Horrible Pain in Arm for 5 days, Mast Cell Activation that lasted for 3 months, could hardly get out of bed for 3 weeks sleeping 14 hours a night and napping 4 hours during the day, slowly improved, extremely week, slowly recovering strength
Day 9 I have developed a huge red swollen lump on my arm where I received the injection. lump measures 4 1/2" by 2". Painful and itching. swollen throat and dizziness.
As soon as the vaccine was administered and up to this date one or two blisters will appear on the skin.
S/S OF SYNCOPE: NAUSEA, LIGHT-HEADEDNESS, INCREASED HEART RATE, HOT/FLUSHED FEELING, ANXIOUS.  S/S STARTED RIGHT AFTER ADMINISTERING.  TX: KEPT HER SEATED AND GAVE HER WATER TO DRINK PRN. ALSO GAVE HER ICE PACK TO APPLY TO HER NECK/CHEST AREA TO COOL DOWN. HAD HER STAY SEATED IN PHARMACY AREA FOR 45 MINUTES AND SOMEONE SAT WITH HER THE ENTIRE TIME TO MONITOR. HER SYMPTOMS LESSENED WITHOUT FURTHER NEED OF INTERVENTION AND SHE HAD A FAMILY MEMBER PICK HER UP TO TAKE HER HOME TO REST.
This spontaneous report was received from a medical assistant referring to a 1 year old female patient. The patient's pertinent medical history included asthma. There was no concomitant therapy, or drug reactions/allergies. On 12-MAY-2018, the patient was vaccinated with VARIVAX, (lot # N029628, expiration date 23-OCT-2019) subcutaneous in the left thigh  as part of a routine vaccination (strength, dose and frequency were not provided). The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT), (lot # N030572, expiry date 20-APR-2020). On an unspecified date in May 2018,  the patient developed redness and tenderness at the injection site. The patient was seen in the emergency department on 23-MAY-2018 and was prescribed an unspecified dose of cephalexin upon discharge from the emergency department. The outcome of injection site erythema and injection site pain was reported as not recovered. The causal assessment between the redness and tenderness at the injection site and the suspect therapies  was not reported. This is 1 of 2 reports from the same reporter, concerning patients who experienced a reaction to this lot number of VARIVAX, a lot check was requested.; Sender's Comments: US-009507513-1805USA012458:
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No pertinent medical history, drug reactions/allergies or concurrent conditions were reported. On 02-MAY-2016, the patient was vaccinated with improperly stored VARIVAX (Merck) (which had a lot # of L042265 and an expiration date of 26-OCT-2017; however, dose, dosage number, route of administration and anatomical location were not reported). Information regarding concomitant therapies was not provided. The vaccines experienced a temperature excursion of 10 F for a time frame of 3 hours and 16 minutes. Reportedly, no previous temperature excursions had occurred and the aforementioned one was called out due to a data logger. Despite being vaccinated with such an improperly stored vaccine, no adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Had three shots, had them (shingles)/Suspected vaccination failure; Shingles/ Had three shots, had them (shingles); Pain is not as bad; Had three shots; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis and Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had shingles three times in the same place) and pain.   On an unknown date, the patient received the 3rd dose of Shingles vaccine, the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, pain and extra dose administered. On an unknown date, the outcome of the vaccination failure, shingles, pain and extra dose administered were unknown.   The reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine, Shingles vaccine and Shingles vaccine.     Additional Information: GSK receipt date: 17-Dec-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient had shingles three times in the same place.  The first time, did not knew what it was but it was very painful, had three shots, had them in the same place every time, but the pain was not as bad. Additional supportive information: The patient received 3 shots, which led to extra dose administered. This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
This spontaneous report was received from a health professional refers to a patient of unknown age and gender. The patient's medical history and concomitant medications were not reported. On 15-JUL-2016 and 13-APR-2017, the patient was vaccinated with VARIVAX (lot # L035124, expiry date: 14-SEP-2017) for prophylaxis (dose and route was not reported), which was stored improperly.
patient mother stated patient was here for her third vaccine as she had 2 doses before and she did not have her card after administering the vaccine  it was discovered that there were 3 doses already recorded
Discomfort in groin area; Testicles were swelling / Testicles were enlarged; Testicles were painful; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL DISCOMFORT (Discomfort in groin area), TESTICULAR SWELLING (Testicles were swelling / Testicles were enlarged) and TESTICULAR PAIN (Testicles were painful) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     The patient's past medical history included Vasectomy (few years ago). Concomitant products included FISH OIL (FISH OIL OMEGA 3), ROSUVASTATIN, NIACIN, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), CYANOCOBALAMIN (B12 [CYANOCOBALAMIN]) and COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) for an unknown indication.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced MUSCULOSKELETAL DISCOMFORT (Discomfort in groin area), TESTICULAR SWELLING (Testicles were swelling / Testicles were enlarged) and TESTICULAR PAIN (Testicles were painful). The patient was treated with IBUPROFEN for Groin discomfort, Testicular swelling and Testicular pain, at a dose of 800 milligram. On 15-Feb-2021, MUSCULOSKELETAL DISCOMFORT (Discomfort in groin area), TESTICULAR SWELLING (Testicles were swelling / Testicles were enlarged) and TESTICULAR PAIN (Testicles were painful) had resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Cold compress and Ibuprofen 800mg used as treatment   This case was linked to MOD-2021-323864 (Patient Link).
Irregular pattern of bruising noted on left upper arm. TD booster administered left deltoid 09/12/2005.
Flu-like symptoms, temperature of 102.1, headache, fatigue, nausea, weakness when standing, stomach cramps, diarrhea, frequent urination.
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX, subcutaneously, lot # N008828, expiration date 16-MAR-2019 (dose was not reported) for prophylaxis; administered along with a properly stored sterile diluent, subcutaneously, lot # L028663, expiration date 29-MAR-2018. (dose was not reported) for prophylaxis. It was reported that the vaccine was exposed to temperature of -9 degrees Celsius to 8 degrees Celsius, for a time frame of 4 hours and 4 minutes. The temperature excursion was recorded by a data logger and no previous excursions were reported for the vaccines. No adverse effects were reported. There was no product quality complaint (PQC) involved. This is one of several reports received form the same reporter (MARRS # 1712USA008050, 1712USA008780, 1712USA008781, 1712USA008782, 1712USA008783, 1712USA008784, 1712USA008785, 1712USA008786, 1712USA008787.); Sender's Comments: US-009507513-1712USA008050:
Felt sick/so sick she had to be assisted; lethargic; This is a spontaneous report from a contactable consumer (Patient) via Medical Information Team. A female patient of an unspecified age (mid 50s-70s) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, patient experienced felt sick/so sick she had to be assisted, lethargic. It was reported that the patient was shopping at the time of event. Patient experienced side effects earlier, but she had a severe episode while she was out. The patient went to her doctor and was advised to wait until 2 weeks for the symptoms to go away. The outcome of the events was unknown.  No Follow-up attempts are needed. No further information is expected.
Information has been received from a RN concerning a 12 month old female with no relevant medical history reported who at 10:10 am on 07-JUL-2004 was vaccinated SC in the left arm with a first dose of MMR II (lot number 644845/0138N). On 07-JUL-2004, immediately post vaccination, the pt developed a raised wheal/hives above the injection site. Unspecified medical attention was sought. The pt was treated with oral Benadryl, and ice was applied to hives. Subsequently, the pt recovered. No additional information is expected.
Fatigue, body aches, headache, injection site pain  (day 2)  Rash around injection site, warm, itchy, painful (day 3) Rash grew larger (day 4) Rash began to go away (days 5-6) Rash returned bigger and itchy (day 7)
Some pain in chest (lungs) with deep inhalation followed immediately by cough. Feels like smoke/smog inhalation. Woke up with condition on 04/10/2021. Symptoms continue as of today.
Received vaccine and developed painful joints and some facial swelling.  He self-medicated and felt fine.
Vaccine was expired on 29 Apr 2022 and was stored in refrigerator on 10 May 2022 was administered on 10 May 2022; Vaccine was expired on 29 Apr 2022 and was administered on 10 May 2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 29 Apr 2022 and was administered on 10 May 2022) and PRODUCT STORAGE ERROR (Vaccine was expired on 29 Apr 2022 and was stored in refrigerator on 10 May 2022 was administered on 10 May 2022) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042J21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Johnson & Johnson COVID-19 Vaccine on 07-Apr-2021. Past adverse reactions to the above products included No adverse reaction with Johnson & Johnson COVID-19 Vaccine.   On 15-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-May-2022, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 10-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 29 Apr 2022 and was administered on 10 May 2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was expired on 29 Apr 2022 and was stored in refrigerator on 10 May 2022 was administered on 10 May 2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 29 Apr 2022 and was administered on 10 May 2022) and PRODUCT STORAGE ERROR (Vaccine was expired on 29 Apr 2022 and was stored in refrigerator on 10 May 2022 was administered on 10 May 2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Pharmacist did not realize that it expired 29Apr2022, so she administered it to 8 patients. They were all given the second booster of 0.25 ml. These doses came from different vials, but from the same carton with lot number 042J21A. The expired doses were administered on 4May2022, 10May2022, 16May2022, and 17May2022. The pharmacist stated that she thought the expiration date was 2069, like it was printed on the vial.  The vial did not undergo any temperature excursions. Patient received first Moderna booster on 15 NOV 2021 and second Moderna booster on 10 MAY 2022.   No treatment medication was reported.
TRANSIENT CEREBRAL ISCHEMIA ACUTE NON ST ELEVATION MI 2/15/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Patient inner arm swollen, painful, and red. She is taking ibuprofen and BENADRYL and using cold compresses.
On Friday, July 16,2021, Patient was wrongly administered 0.5ml of Pfizer Vaccine instead of 0.3ml by a nurse.  Incident was reported to Management, Patients will be notified by medical staff.
Systemic: blurred vision-Medium, Additional Details: pt had blurred vision after shot, no other adverse reactions, checked blood pressure 126/93, called advice nurse at clinic where pt goes, she was advised to go to emergency room
t101 4 hrs p/DT/HIB; about 25 hrs p/shots pt had 1 sz-staring & jerking lasting about 1 minute; extremely irritable; mom used APAP prior to inject;
when the patient got really bad the patient died; This is a spontaneous report from a contactable consumer. A 92-year-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced when the patient got really bad the patient died. The patient died on an unspecified date.  It was not reported if an autopsy was performed.  Information on the lot/batch number has been requested.; Reported Cause(s) of Death: when the patient got really bad the patient died
Fever x 2 days, extreme irritability x 2 days. Rash, Emesis
Ringing in left ear; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old male patient received BNT162b2 (BNT162B2), on 04Jan2022 at 12:00 as dose 1, single (Batch/Lot number: unknown) at the age of 50 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "If covid prior vaccination: Yes" (unspecified if ongoing), notes: If covid prior vaccination: Yes. There were no concomitant medications. The following information was reported: TINNITUS (non-serious) with onset Jan2022, outcome "not recovered", described as "Ringing in left ear". The event "ringing in left ear" required physician office visit. Therapeutic measures were taken as a result of tinnitus.  Additional information: Ae treatment was reported as various allergy medicines and steroids. It was reported that patient had ringing in left ear started shortly after getting the vaccine. It had not stopped and was constant in his left ear only. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Since the vaccination, the patient had not been tested for COVID-19.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Thrombosis; Vericose veins; Swollen, bulged nerves around left hand palm and fingers/The same symptoms noticed on right foot; Nerves are in black darkened color and the palm fingers, knuckle areas; the palm, fingers, knuckle areas had moderate pain. The same symptoms noticed on right foot.; the palm, fingers, knuckle areas had moderate pain; sensitive to touch; This is a spontaneous report from a contactable consumer(patient). The 36-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 24Apr2021 14:45 (Lot Number: EN6205) as first dose, single for covid-19 immunization. Medical history included none. He had not known allergies to food or medications, no illlness history. Concomitant medications included minerals nos, vitamins nos (CENTRUM A TO ZINC) adutls vitamin, miconazole nitrate (LOTRIMIN AF ANTIFUNGAL) topical cream.  The patient experienced one hour after first dose of vaccine shot at left arm shoulder, he saw swollen, bulged nerves around left hand palm and fingers. Nerves were in black darkened color and the palm, fingers, knuckle areas had moderate pain. The same symptoms noticed on right foot. The affected areas on both palm, fingers, foot area have dark patch areas with moderate pain. After 32 hours, he saw swollen nerve back of left leg thigh area with deep pain. It was sensitive to touch. It looked like thrombosis or vericose veins not sure about it. He reached out to doctor office and they said to wait for another day to see if he can recover. whereas he still have the darkened black nerve with pain in the affected areas. Events occurred on 24Apr2021 16:00 which was resulted in doctor or other healthcare professional office/clinic visit. There was unknown if treatment received. Outcome of events was not recovered. There was no covid prior vaccination and post vaccination.
Hives over torso, legs, arms, neck and face for four weeks; extensive itching. Also, in turn, caused fungal infection of the skin; dark red, very large areas. Tried/used hydrocortisone, Benadryl, fluconazole, Clotrimazole cream, prednisone, hydrogen peroxide, Calendula cream, and triamcinolone cream.
Pt vomited immed p/vax given; Given APAP; w/in 1 min became very pale, sl circumoral cyanosis, dec activity not totally flaccid; Color improved in 15-20min; regurgitation x 3 small amts;
A report has been received from a registered nurse via medical representative concerning a female child. Her medical history was not reported. There was no information on her concomitant medication. On 13-NOV-2012 the child received FLUMIST. On 07-DEC-2012 she was tested positive for the flu after receiving FLUMIST. The outcome of the event was unknown. The report was considered to be non-serious. Corrected report 04-MAR-2013: event coding changed.
Pt returned to our office 20-25 mins after receiving vaccines with urticaria on head/face, legs and slightly on torso. Stuffy nose. Pt was given Benadryl orally and Orapred orally. Initial O2 sat 94%. Within 10 mins, O2 sat 98-100% on RA. Pt remained stable in office for 40 mins.
Information was received on 25-JUL-2017 from a lawyer regarding a case in litigation concerning a male patient of unknown age. The patient was inoculated with a dose of ZOSTAVAX vaccine on or about 19-FEB-2009 at a medical facility as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended but rather caused the patient to contract a persistent and chronic strain of herpes zoster. On or about 31-JAN-2017, the patient was treated by a registered nurse  for a blistering vesicular outbreak which has spread to the eyes and was then diagnosed as herpes zoster. On or about 08-FEB-2017, the patient was treated by the registered nurse for ongoing and worsening symptoms of shingles. On or about 08-FEB-2017, the patient was treated at an emergency clinic for unbearable shingles pain and was prescribed pain medication. On or about 13-FEB-2017, the patient sought subsequent treatment from a nurse practitioner for treatment of his recurrent and painful symptoms. The patient has been prescribed valacyclovir (VALTREX), gabapentin (manufacturer unknown), and hydrocodone (+) acetaminophen (VICODIN) (manufacturer unknown) to help manage his recurrent symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. Upon internal review, blistering vesicular outbreak which has spread to the eyes and diagnosed as herpes zoster was considered medically significant. Additional information has been requested.
fever, chills, muscle aches, fatigue starting around 11 PM and lasting through the next day