chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Some sort of blood formation in his ankle/Like a blood clot; Not feeling well; Rash on his arm; Felt tired; Bleeding at the back of his neck at his cervical area of his spine; Back of his neck at his cervical area of spine has laceration; Dizzy; Flu like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Some sort of blood formation in his ankle/Like a blood clot) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's medical history was not provided.  Concomitant products included LORAZEPAM and MIRTAZAPINE for an unknown indication.   On 18-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, the patient experienced SKIN HAEMORRHAGE (Bleeding at the back of his neck at his cervical area of his spine), SKIN LACERATION (Back of his neck at his cervical area of spine has laceration), DIZZINESS (Dizzy), INFLUENZA LIKE ILLNESS (Flu like symptoms), RASH (Rash on his arm) and FATIGUE (Felt tired). On an unknown date, the patient experienced THROMBOSIS (Some sort of blood formation in his ankle/Like a blood clot) (seriousness criterion medically significant) and MALAISE (Not feeling well). The patient was treated with Wound care (Bandage) for Skin haemorrhage and Wound care (Bandage) for Skin laceration. At the time of the report, THROMBOSIS (Some sort of blood formation in his ankle/Like a blood clot), SKIN HAEMORRHAGE (Bleeding at the back of his neck at his cervical area of his spine), SKIN LACERATION (Back of his neck at his cervical area of spine has laceration), DIZZINESS (Dizzy), INFLUENZA LIKE ILLNESS (Flu like symptoms), MALAISE (Not feeling well), RASH (Rash on his arm) and FATIGUE (Felt tired) outcome was unknown.            Concomitant product use was not provided by the reporter. Treatment information was not provided.  81-year-old male patient who experienced a serious, unlisted event of THROMBOSIS among other non-serious events. Very limited information regarding this event has been provided at this time. Details including the exact diagnosis, treatment received, outcome are required for further assessment.   Most recent FOLLOW-UP information incorporated above includes: On 28-Jul-2021: Follow up received include the new adverse events (Not feeling well and blood clot).; Sender's Comments: 81-year-old male patient who experienced a serious, unlisted event of THROMBOSIS among other non-serious events. Very limited information regarding this event has been provided at this time. Details including the exact diagnosis, treatment received, outcome are required for further assessment.
Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation. 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 FATIGUE (Fatigue). At the time of the report, FATIGUE (Fatigue) outcome was unknown. No concomitant medication reported.No treatment medication reported.This case concerns a male patient, unknown age, with no known medical history, who experienced the non-serious, expected event of fatigue. The event occurred  on unknown date after the two doses of mRNA 1273 vaccine. The patient states he had episodes of fatigue with various causes after receiving two Moderna vaccines but did not specify which dose. The patient stating that there are various causes to his fatigue remains as a confounder to the event. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.Reporter did not allow further contact; Sender's Comments: This case concerns a male patient, unknown age, with no known medical history, who experienced the non-serious, expected event of fatigue. The event occurred  on unknown date after the two doses of mRNA 1273 vaccine. The patient states he had episodes of fatigue with various causes after receiving two Moderna vaccines but did not specify which dose. The patient stating that there are various causes to his fatigue remains as a confounder to the event. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.
Mom called office and let RN know about reaction. Stated child's leg " blew up like a balloon" and noticed red bumps on his leg. Mom took child to ER and they administered Benadryl. Mom stated swelling today 1/9 has improved. Complaints of red bumps and itching currently but has improved.
On 4/2/15 3 months old infant male was vaccinated by PCV, HBV, PENTACEL, oral ROTATEQ-and 45 minute after # shot in office, by parent reported on 4/6/15 when, later had chest, abdomen macular rash.
Not ovulating; Sex drive has depleted; Gained 20 pounds; Feet started to feel numb; Had more appetite; "not normal period"/not as heavy as usual/not having period for 3 months/period is gone; This spontaneous case was reported by a consumer and describes the occurrence of AMENORRHOEA ("not normal period"/not as heavy as usual/not having period for 3 months/period is gone), OVULATION DISORDER (Not ovulating), LIBIDO DECREASED (Sex drive has depleted), WEIGHT INCREASED (Gained 20 pounds) and HYPOAESTHESIA (Feet started to feel numb) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included IBUPROFEN for Headache.   On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-May-2021, the patient experienced AMENORRHOEA ("not normal period"/not as heavy as usual/not having period for 3 months/period is gone). On an unknown date, the patient experienced OVULATION DISORDER (Not ovulating), LIBIDO DECREASED (Sex drive has depleted), WEIGHT INCREASED (Gained 20 pounds), HYPOAESTHESIA (Feet started to feel numb) and INCREASED APPETITE (Had more appetite). At the time of the report, AMENORRHOEA ("not normal period"/not as heavy as usual/not having period for 3 months/period is gone), OVULATION DISORDER (Not ovulating), LIBIDO DECREASED (Sex drive has depleted), WEIGHT INCREASED (Gained 20 pounds), HYPOAESTHESIA (Feet started to feel numb) and INCREASED APPETITE (Had more appetite) outcome was unknown.            No treatment medications were reported.  The patient stated that before vaccination as the patient "was on a weight lost thing" and also stated she was very concerned and upset.
Felt feverish, temperature high of 100.4. Treatment include hydrating and resting. Ended after about 24 hours from onset.
plaque psoriasis flare up on torso with Skyrizi; This spontaneous case was reported by a physician and describes the occurrence of PSORIASIS (plaque psoriasis flare up on torso with Skyrizi) in a 46-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    No Medical History information was reported.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) 1 dosage form. On 11-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PSORIASIS (plaque psoriasis flare up on torso with Skyrizi). At the time of the report, PSORIASIS (plaque psoriasis flare up on torso with Skyrizi) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
This spontaneous report as received from a licensed practical nurse referring to unspecified number of patients of unknown age and gender. The patients' concurrent condition and medical history were not provided. On unknown dates, the patients were vaccinated with the improperly stored doses of (Merck) VARIVAX (lot # L025207, expiration date on 07-JUL-2017 and lot #: L041207, expiration date on 20-OCT-2017) (dose and anatomical location were not reported). No concomitant medication was reported. The vaccines were stored in a temperature of 9F during 20 minutes. No previous temperature excursion was reported. No adverse events were reported. Additional information has been requested.
Patient received Pfizer COVID vaccine on 4/2/21 (lot # ER8732), 5/2/21 (lot # EW0171), and 12/30/21 (lot # 33025BD). On 12/26/22, patient admitted to our inpatient facility (med/surg unit) with acute hypoxic respiratory failure secondary to COVID-19 infection and hypervolemia /pleural effusion with atelectasis, prominent ascites, cirrhosis with portal hypertension related to alcohol use, symptomatic ascites, and alcohol use disorder with history of delirium tremens/hospitalization. Patient was discharged home on 12/29/22.
Pt reported feeling hot, sick and swelling in her arm from deltoid to elbow. She slept all day on 9/14/16. Patient gets swelling every in her deltoid for 2-4 days. She thought this was normal after a flu shot.
Flu; sick; Initial information was received on 08-Oct-2020 regarding an unsolicited valid non-serious case from a consumer (patient) via  (social media) .     This case involves a patient with unknown demographics who experienced flu (influenza) and sick (malaise), while patient received INFLUENZA VACCINE.  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.   On an unknown date in 2007, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious flu (influenza) and sick (malaise), unknown latency following the administration of INFLUENZA VACCINE.  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, the event outcome reported as unknown for flu and sick.  There will be no information available on the batch number for this case.
After the second shot that was given on 1/28/2021 I experienced body aches and fatigue starting the day after the shot and lasting about 8 hours.  This began on 1/29/2021 at 8 am.  Three days after the 2nd shot on 1/31/2021 I woke up with a rash, swelling and itching at the site of the injection.
little soreness; This is a spontaneous report from a Pfizer-sponsored program. A non-contactable consumer reported that a patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry date not reported), via an unspecified route of administration on 29Dec2020 at a single dose as Covid Vaccine. The patient's medical history and concomitant medications were not reported. Patient got the vaccine on 29Dec2020. Patient stated that so far so good just a little soreness since an unknown date. The patient was feeling good and happy. The outcome of the event little soreness was unknown.   No follow-up attempts are possible. Information about Lot/Batch could not be obtained. No further information is expected.
I had a terrible bladder flare following this third injection. It felt like I was peeing through broken glass, I couldn't hold my urine, and my cystitis with this disease was increased ten fold. I did a urine culture to rule out UTI and it came back negative. So then I knew that I was having a horrible flare and not a UTI.
The patient was administered Shingrix on 3/5/2020. The patient felt "warm, wet and Puff" at the site of injection. The patient ended up going to urgent care and was then diagnosed with cellulitis and prescribed Doxycycline. The patient also mentioned that her temperature was 99 Degree F. After getting her antibiotic, the patient said she started to feel better.
GLS, resembling cellulitis on right arm. Lesion is about 10cm x 6cm.
Headaches and a feeling of fluid in my head.  It feels like fluid pressure when I bend or lay forward or if I arch my back a certain way.  Still working on getting treatment.  I was seeing a pain specialist about other issues  and told her about this.  But she said it was out of her scope of expertise . S o I been on the wait list to see a Neurologist for two months . I should finally see a Neurology PA in two weeks.   But I have also received steroidal injections in my neck since.   Injections were in July 2021.
Information has been received from a pharmacist referring to a patient of unknown age and gender. On 17-AUG-2015 the patient was vaccinated with VAQTA (dose, strength and frequency were not reported, lot # J005680, expiration date: 02-AUG-2015) (expired product administered). No adverse effects were reported. Additional information has been requested.
2nd dose - tightening on my abdomen heaving and could not breathe it affected my breathing- severely gastritis and flare up of arthritis. Joint pains even worse. Went to ER because breathing.
Case number PHEH2016US023435, is an initial spontaneous report received from a nurse on 13 Sep 2016. This report refers to a 39 year old patient of unknown gender. Medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1515701) at a dose of 0.5 ml intramuscularly in the left arm on 12 Feb 2016. On 12 Feb 2016, FLUVIRIN MDV that had been exposed to 8 to 10 temperature excursions was administered to patient. The nurse stated that, no adverse event was reported following this administration error (incorrect product storage). The case was assessed as non serious by the nurse.
Patient reported developing itchy hives and rash all over body. Reported to pharmacy on day 3 but still having symptoms. Reporting to Dr tomorrow.
Administered above vaccine past the 75- days of storage in the fridge to 25 days past BUD. I'm calling all 55 patients to let them know their options.
Chills, nausea, aches, abdominal pain, horrible cough which resulted in hoarseness and LOSS OF VOICE.
Diarrhea; Extra Dose administered; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), EXTRA DOSE ADMINISTERED (Extra Dose administered) and PAIN IN EXTREMITY (Sore arm) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (Diarrhea), EXTRA DOSE ADMINISTERED (Extra Dose administered) and PAIN IN EXTREMITY (Sore arm). At the time of the report, DIARRHOEA (Diarrhea), EXTRA DOSE ADMINISTERED (Extra Dose administered) and PAIN IN EXTREMITY (Sore arm) outcome was unknown.            No relevant concomitant medications were reported. No treatment information was provided
I experienced purpura, bleeding under the skin, and was diagnosed with Capillaritis. My capillaries are inflamed and leaking. I experienced red dots all over my legs, arms, and they began to merge with one another. I also had what looked like scratches, but were dots in lines, from this on my legs, stomach, and thighs. This occurred around 2 weeks after my dose. I had no itching, pain, rash, or raised blotches. I experienced 2 days of the spreading, darkening, and this gradually got lighter, but I have scattered remnants that has remained. My legs have a mottled appearance due to this.
No known adverse effects.; a patient received an expired dose of M-M-R II; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. Concomitant therapy included sterile diluent. Information about medical history and concurrent conditions was not provided.  On 10-JAN-2020, the patient received an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (lot # N034002, expiration date 04-DEC-2019; dose and route were not provided) for prophylaxis (expired product administered). No known adverse effects.
Patient received vaccine after beyond use date of  07/29/2022 (30 day freezer to fridge dating). Patient contacted via voicemail - haven't been able to speak to the patient at this time.
It was reported that a 51-year old male patient received a Fluzone SV '00-'01 vaccination on 16 Oct 2000 at 10 am. At 2 pm the patient developed pain in arm, extremities and pelvic area along with fatigue. At 6 pm the pt developed shaking, chills, malaise and was achy. Pt slept from 9pm to morning the symptoms were gone. The pt recovered from the experience. No additional information was provided from correspondence received on 7 Feb 2001. No further information is expected. This case is closed.
This spontaneous report was received from a healthcare worker and refers to an unspecified number of patients of unknown age and gender. On an unknown date an unspecified number of patients were vaccinated with unspecified number of improperly stored (Oka/Merck) VARIVAX (dose, route of administration, lot number and expiration date were not reported). No adverse effect was reported. This is one of several reports from the same reporter. Additional information has been requested.
The first day - nothing much just slight sore injection site.  No need to take any meds.  Then good for a week.  One week later woke up with a sore itchy arm at injection site. .  I did take Ibuprofen.
Patient reported fever and chills lasting about 3-4 days and bright red, swollen, itchy, painful, hot to the touch area around injection site lasting about 5 days.
Patient complained of light-headedness, generalized chills, warmth to body, and palpitations at 10:04 immediately after receiving vaccination. She did not eat breakfast. States she had similar reaction after receiving the first dose, which self-resolved after a minute.  At 10:05, she was hypertensive and given water. At 10:25, patient verbalized feeling better and was able to ambulate without dizziness. At 10:33, she developed chills, mild rigors, and throat tightness. Blood sugar on low end of normal, tachycardic, and hypertensive, so patient was given an oatmeal bar and transferred to ED. Upon evaluation in ED at 10:49, patient stated symptoms had resolved. Patient was discharged at 12:22.
He got his vaccine while at work.  He worked on the shot team that day, and was giving shots all day and went home and woke up the next morning and woke up that his hands were paralyzed until he went to the bathroom and he could not hold his penis to go to the bathroom.  He tried to dress himself as he could not as they were all buttons, and he got dressed with minimal control and drove to work with his wrist as he could not use his hands.  He went to the Aide station right away and he told them that his hands were paralyzed and put him on quarters for 2 days in bed.  He then was able to regain motor control and feeling after that.  He was a medic.  About 25-30 years ago he started to get neu neuropathy in his feets, and now it's in his hands, and has loss of sensation to hot/cold.  His left leg is worse than the right, it goes almost up to his knee now.  He has seen many doctors and tell them that he has neuropathy and ask if he is a diabetic which he is not, and he tells them about the swine flu vaccine he got in 1976 and that's where it ends, they don't know anything about that.    I have been told that he was not supposed to have a flu shot as he had Guillaine Barre symptoms due to the flu shot, but has had the flu shots and COVID shots with no problems or similar symptoms with the swine flu vaccine.    There were 800 people in the group that were out on sick call out of 1000 the next day after the vaccine that they were give.
This spontaneous report was received from a nurse practitioner referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 06-SEP-2016, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot # M007764, expiry date: 30-JAN-2018 (strength, dose number, route and anatomical location were not provided). Concomitant therapies were not provided. This is one of the several reports received from the same reporter. Additional information has been requested.
Information has been received from a health professional concerning a 21 month old male with peanut allergy who on 12-JUN-1997 was vaccinated with varicella virus vaccine live (Oka/Merck). On 31-OCT-1997, the patient experienced approximately 50 lesions. On 13-Nov-1997, the patient recovered from lesions. Additional information has been requested.
Diffuse maculopapular erythematous raised rash on torso, back, buttocks, dorsal aspect of feet. Sparing legs. Face with erythema, hives. Low grade fever to 100C. Started 10/23 & worse when seen 10/24. Treated with benadryl, tylenol, prednisolone 10mg QD x3 d.
A pediatric dose of the vaccine was administered instead of a 12 year old and up dose.
Got the vaccine, he was fine while he was there, the following day his arm starting itching, and then had a big rash about 3" x 3" immediately after the vaccine.  The swelling did not go down, he went to see his doctor and she gave him a steroid shot and some Pepcid, Zybek OTC to take.   These  are still itchy as of 4/7/21, but trying to dry up and scaly.  He has been putting ointment and peroxide on the area.
Just a few hours after the vaccine was administered, my upper arm became swollen. I gradually became more fatigued, lost my appetite for food, and the left armpit lymph nodes began swelling.  Then I started having chills and sweats.  This lasted for approximately 2 and a half days.  On day three, the fever broke, and all adverse side effects slowly began to reverse.  On day four, theupper arm and  lymph nodes were still slightly swollen, but no longer bothered me.
Slight arm soreness; Headache; This spontaneous case was reported by a patient and describes the occurrence of   in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A and 008B21-2A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Opioids), Type 1 diabetes mellitus since 30-May-1999 and Blood pressure high since 31-Jan-2015. Concomitant products included LISINOPRIL for BP raised, INSULIN GLARGINE (LANTUS), INSULIN LISPRO (HUMALOG) and DULOXETINE HYDROCHLORIDE (CYMBALTA) for Diabetes, TOPIRAMATE (TOPAMAX) for Migraine.   On 03-Mar-2021 at 4:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency.            Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to MOD-2021-084083 (Patient Link).
Soreness and aching started day after took shot. Also had rash on legs and arms and patches on abdomen. States rash has almost disappeared. Used hydrocortisone cream 1%. Had cortisone injection, BENADRYL and MEDROL dose pak from physician.