chrisvoncsefalvay/vaers-outcomes huggingface dataset:
intense pain on his stomach; felt like he had food poisoning; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (intense pain on his stomach) and FOOD POISONING (felt like he had food poisoning) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030A21A and 031L20A) for COVID-19 vaccination.     No medical history was reported.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Mar-2021, the patient experienced ABDOMINAL PAIN UPPER (intense pain on his stomach) and FOOD POISONING (felt like he had food poisoning). At the time of the report, ABDOMINAL PAIN UPPER (intense pain on his stomach) and FOOD POISONING (felt like he had food poisoning) outcome was unknown.            Concomitant product use was provided by the reporter Statin for cholesterol and unknown for blood pressure. Treatment information was not provided.
Fever, chills, arm soreness, arm itching, swelling at injection site,  diarrhea, headache, fatigue, nausea . Symptoms maintained for 36 hours.
Pt received Fluzone HD on 9/23/2015. The site of injection still sore, inflammed with flakes. Advised pt to apply ice on site and call her physician.
Started crying on 6/27/14 at 1:00 am, had fever 20 min later had first seizure. They continued into morning. Admitted into hospital. Treated with TYLENOL and MOTRIN. Testing performed. He recovered and was discharged from hospital.
Pt complained of pain/stiffness left side neck 1-2 days after immunization.
This spontaneous case was reported by a consumer and describes the occurrence of SKIN BURNING SENSATION (Patient rash burns), RASH PRURITIC (Patient rash itches) and RASH (rash inside of her arm/rash has intensified and grown now to the point where it stretches from patient armpit to wrist) in a female patient of an unknown age 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SKIN BURNING SENSATION (Patient rash burns), RASH PRURITIC (Patient rash itches) and RASH (rash inside of her arm/rash has intensified and grown now to the point where it stretches from patient armpit to wrist). At the time of the report, SKIN BURNING SENSATION (Patient rash burns), RASH PRURITIC (Patient rash itches) and RASH (rash inside of her arm/rash has intensified and grown now to the point where it stretches from patient armpit to wrist) outcome was unknown.            No treatment information reported.   This case was linked to MOD-2021-049994 (Patient Link).
subacute hyperthyroidism/fatigue; neck pain; achiness; Fatigue; This is a spontaneous report from a contactable consumer (patient) via COVAES. This non-pregnant 55-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration in Mar2021 (at 55-years-old) as a single dose for COVID-19 immunisation. Medical history included mild hypertension which was treated from an unknown date. Concomitant medications included losartan from an unknown date for an unknown indication. The patient previously received the first dose of BNT162B2 (lot number EI9264) in the left arm on 05Feb2021 at 09:45 (at 55-years-old) for COVID-19 immunisation. Prior to vaccination the patient had not received any other vaccines in four weeks, was not diagnosed with COVID-19 and had no allergies. On 22Mar2021, two weeks after the second dose, the patient developed neck pain, achiness, and fatigue, and was diagnosed with subacute hyperthyroidism. The event resulted in a doctor's office visit; no treatment was provided for the event. The clinical outcomes of the events were recovering. Since vaccination, the patient had not been tested for COVID-19.
Intense full body itching and hives that are still on going. Being treated with antihistamines and itching cream.
Pt was resting in the pharmacy area post vaccination and experienced a seizure. His companion immediately called out, and as he continued to seize he slumped down to the floor. The seizure subsided and pt continued to rest on the floor as we called 911 and had medics come to the pharmacy. Pt companion states pt has no ongoing health concerns; has never had a reaction to a previous vaccine and has no history of stroke or heart disease. Administering intern states pt was very anxious prior to vaccine, but seemed fine as he left the vaccination room. Pt was transported via private vehicle to hospital in city.
This spontaneous report was received from a registered nurse, referring to multiple unspecified patients of unknown ages and genders. The patient's medical history or concurrent conditions were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of PNEUMOVAX23 (which has the lot number of L040178, expiration date 15-AUG-2017)(dose and route were not provided). There were no adverse effects reported. The vaccines experienced a temperature of 13.2 C in a time frame of 1 hour and 20 minutes, there had been no previous temperature excursion. Furthermore no product quality complaint was involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Arm pain; Slight headache; Muscles pain; Tiredness; Unexpected pain has been in ear.; Sharp shooting pains.; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0164) via an unspecified route of administration in the arm left on 14Apr2021 at 10:15 (at the age of 57-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included estradiol (MANUFACTURER UNKNOWN) from unknown date for unknown indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 15Apr2021 at 17:30 the patient experienced some of the common effects but not bad, arm pain, slight headache, muscles pain, tiredness, unexpected pain has been in her ear and sharp shooting pains. 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 event. The clinical outcome of the events arm pain, slight headache, muscles pain, tiredness, unexpected pain has been in her ear and sharp shooting pains were not recovered.  No follow-up attempts are needed. No further information is expected.
Her throat started to feel dry and she stated she was having trouble swallowing. She was given 20 mg liquid Benadryl at 2:16 PM and vital signs were stable.  She left the Health Center at 2:30 PM in good condition.  She stated that she had this after her first dose but she didn't report it as it was after she had returned to work and she was at her desk.  At that time she had gotten the first doses of Hep A and B vaccines.
Information has been received from a registered nurse concerning a 60 year old female with hypothyroidism, sulfa drug allergy and environmental allergies, who "two years ago" was vaccinated with a dose of Pneumovax 23. Concomitant therapy included an unspecified hormone replacement, unspecified thyroid medication, unspecified medication for environmental allergies. It was reported that "now" the patient "has titers for 4 of the covered pneumococcal strains that are below a protective level." The patient has not suffered any illness related to this event. Unspecified medical attention was sought. Additional information has been requested.
mild occasional dry cough, nasal congestion, runny nose, headache, feverish (but no fever), chills, loose stools. starting 12/18/21
My arm just bothered me; Nausea; Chills; This is a spontaneous report from a contactable consumer (patient). This patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient stated "I got the Covid vaccine on Friday afternoon. Yesterday morning my arm just bothered me. Today 4 O'clock in the morning I started getting nausea and chills." Outcome of the events was unknown.  Information on the lot/batch number has been requested.
After receiving a booster vaccine,  I developed Tinnitus in my right ear.  I've been tested for other possibilities that would cause it and there is nothing else that coincides with the onset of Tinnitus.
arm sore; faint headache; mild nausea; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm sore), HEADACHE (faint headache) and NAUSEA (mild nausea) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 03M20A) for COVID-19 vaccination.     The patient's past medical history included Chickenpox (youngest of 5, aged 4), Rash (treated with benadryl) and Arm fracture (23 years ago broke arm). Concurrent medical conditions included Drug allergy.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced PAIN IN EXTREMITY (arm sore), HEADACHE (faint headache) and NAUSEA (mild nausea). At the time of the report, PAIN IN EXTREMITY (arm sore), HEADACHE (faint headache) and NAUSEA (mild nausea) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No treatment related information has been reported.   This case was linked to MOD-2021-053856 (Patient Link).
190 patients (9 different lot numbers) received a vaccine past the beyond; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      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 EXPIRED PRODUCT ADMINISTERED (Expired vaccine used).    No concomitant medication was reported.  190 patients (9 different lot numbers) received a vaccine past the beyond used by date.  It was unknown if patient received any other vaccines in the 4 weeks prior to the COVID-19 vaccine administration.  No treatment medication was reported.  This case pertains to the 140 patient of the total 190 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-704335 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704335:Master case
I95.9 HYPOTENSION 4/22/2023 DM 2 W RENAL MANIFESTATION
Chills, wheezing, swell like grapefruit, pain all the way to neck and under arm.
Headache,  nausea, vomiting, fever, chills, shortness of breath ER visit with IV fluids, Zofran
PATIENT RECIEVED THE VACCINE ON SATURDAY SHOWED NO SYMPTOMS. CAME IN MONDAY 2/17 STATING THAT HER ARM HAD MORE REDDNESS THAN USUAL. UPON EVALUATION. I COULD NOT TELL WHETHER IT WAS AN ALLERGIC REACTION OR CELLULITIS I SUGGESTED CONTACTING HER PROVIDER AND DREW A LINE AROUND THE AFFECTED AREA. MD SAW PHOTOS AND SUBMITTED FOR KEFLEX 500MG. PATIENT IS IN NO DISCOMFORT.
SWELLING; LOCALIZED PAIN AT SITE OF INJECTION; This spontaneous report received from a patient concerned a 60 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure, and other pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802068, and expiry: UNKNOWN) dose was not reported, administered on 15-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 18-MAR-2021, the subject experienced swelling. On 18-MAR-2021, the subject experienced localized pain at site of injection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from swelling on 19-MAR-2021, and had not recovered from localized pain at site of injection. This report was non-serious.
After MMR: Severe headache, followed by discovery of highly enlarged Lymphatic Nodes behind the ears.
pt recv vax 13JUL94 & later that day became very sleepy & slept for 10-12hr periods for several days; The inj site was tender & painful & temp fluctuated as high as 100.5 for several days; 16AUG94 recv 3rd dose;
Redness et swelling at injection site, began day after injection. TX: Acetaminophen PRN, pain; cook most cloth to area.
Reportedly woke up in the night with headache. Went to school in the morning-school nurse took temp of >101 "almost 102" per mother. No other allergic type symptoms, no nausea or vomiting. Taking Tylenol for headache and fever
Stated on 10-26-12 that the ZOSTAVAX injection made his arm stiff and he could not lift his arm. Blue spot at injection site.
Knot softball size; Some discomfort; Softball size knot turned to a reddish; Softball size knot turned to a reddish scar; This non-serious case was reported by a consumer and described the occurrence of skin nodule in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced skin nodule (Verbatim: Knot softball size), discomfort (Verbatim: Some discomfort), erythema (Verbatim: Softball size knot turned to a reddish) and scar (Verbatim: Softball size knot turned to a reddish scar).  The outcome of the skin nodule and discomfort were resolved and the outcome of the erythema and scar were not reported.   It was unknown if the reporter considered the skin nodule, discomfort, erythema and scar to be related to Shingles vaccine.     It was unknown if the company considered the skin nodule, discomfort, erythema and scar to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 03-SEP-2023 The patient reported that he or she received Shingles vaccine and initially experienced softball size and some discomfort. After a week, softball size turned into a reddish scar with no pain. The patient stated that the knot and discomfort gone. Follow-up would not possible as no contact details were available.
Pt got both Flu/Pneumo vaccine in same arm on 10/7/12 flu shot on front Pneumo 2 inches behind. Pt felt feverish and arm tenderness for 2 days after vaccination. Has taken TYLENOL/MOTRIN and iced arm. Fever has improved but redness on flu site lingers MD prescribed BACTRIM said had a skin infection.
Localized hives, swelling, redness - we gave him a Benadryl and put some Benadryl cream on it.  The onset might have been earlier - that is when he told us about it.
Information has been received from a registered nurse reporting on a 4 year old female patient. There was no information about the patient's concurrent conditions, drug reactions/allergies, pertinent medical history or concomitant medication. On 16-NOV-2017, the patient received inadvertently a partial dose of VARIVAX, subcutaneous, in an unspecified arm for prophylaxis (dose, lot number and expiration date were not reported) with sterile diluent; the reporter indicated that the patient did not receive a complete dose, as the patient's arm moved during the administration. No adverse effects reported.
I had a sore throat, congestion, and a headache. I contacted my doctor and was prescribed amoxicillin. I also took ibuprofen. I decided to take a COVID-19 test because I had a dentist appointment and I ended up testing positive. I contacted my doctor but was not prescribed medication. I took another COVID-19 test on day 10 and tested negative.
CHILLS , FEVER, MUSCLE ACHES, SEVERE HEADACHE BEGINNING IN THE MIDDLE OF THE NIGHT AFTER THE VACCINE AND ONGOING THE ENTIRE NEXT DAY.  I COULD NOT GET OUT OF BED ALL DAY  HARD TO WALK.
Pharmacist forgot to dilute the pediatric Pfizer and gave 0.2mL concentrated. At this point I have been unable to reach the parent to see if the child is having an adverse event. The parent has not called the pharmacy to report an adverse event.
Pharmaceutical product complaint; Only liquid diluent portion of Menveo used; Only the liquid diluent administered; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 11-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA722Z, expiry date 31st August 2023) for prophylaxis. This case was associated with a product complaint.   On 29th September 2022, the patient received Menveo. On 29th September 2022, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the patient experienced pharmaceutical product complaint. On an unknown date, the outcome of the inappropriate preparation of medication, inappropriate dose of vaccine administered and pharmaceutical product complaint were unknown.   Additional Information: GSK Receipt Date: 29-SEP-2022 Reporter's Comment: The reporter reporting a possible 7 patients having received only the liquid diluent portion of Menveo. The reporter consented to follow up. Additional Supportive Information: The reporter reporting a possible seven patients having received only the liquid diluent portion of Menveo, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. This was 1 of 7 cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2022140220:Same reporter- Patient 1 US-GSK-US2022140222:Same reporter- Patient 2 US-GSK-US2022140225:Same reporter- Patient 4 US-GSK-US2022140223:Same reporter- Patient 3 US-GSK-US2022140233:Same reporter- Patient 6 US-GSK-US2022140243:Same reporter- Patient 7
chills, hot flashes, swollen injection site, painful injection site/entire Left arm, body aches, fatigue
This spontaneous report as received from a licensed practical nurse (also reported as registered nurse), refers to a 32 year old patient of unknown gender. No pertinent medical history or drug reactions/allergies were provided. On 23-OCT-2013, the patient was vaccinated with M-M-R II (Lot number reported as J008882; expiry date, does and route not provided). No co-suspect or concomitant therapies were reported. It was reported that the M-M-R II administered to the patient was exposed to temperatures above 8 degrees C (between 8.09 and 22.73 degrees C) during 42.78 hours, from 05-OCT-2013 until 09-OCT-2013. No adverse effect had been reported. This is one of several reports from the same reporter. Additional information has been requested.
Her skin is itchy; The injection site is sore; Her arm is swollen; The injection site is sore. It's red; but there seems to be a bump underneath the skin where it was injected; This spontaneous case was reported by a patient and describes the occurrence of PRURITUS (Her skin is itchy), VACCINATION SITE PAIN (The injection site is sore), VACCINATION SITE SWELLING (Her arm is swollen), VACCINATION SITE ERYTHEMA (The injection site is sore. It's red) and VACCINATION SITE INDURATION (but there seems to be a bump underneath the skin where it was injected) in a 51-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     Previously administered products included for Drug use for unknown indication: Pfizer (She states all her other vaccines were Pfizer. When she had the Pfizer, the arm hurt for two days. Other than being sore and there was no redness and there was nothing that she could feel underneath her skin). Past adverse reactions to the above products included Vaccination site pain with Pfizer.    On 14-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRURITUS (Her skin is itchy), VACCINATION SITE PAIN (The injection site is sore), VACCINATION SITE SWELLING (Her arm is swollen), VACCINATION SITE ERYTHEMA (The injection site is sore. It's red) and VACCINATION SITE INDURATION (but there seems to be a bump underneath the skin where it was injected). At the time of the report, PRURITUS (Her skin is itchy), VACCINATION SITE PAIN (The injection site is sore), VACCINATION SITE SWELLING (Her arm is swollen), VACCINATION SITE ERYTHEMA (The injection site is sore. It's red) and VACCINATION SITE INDURATION (but there seems to be a bump underneath the skin where it was injected) had not resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   She states all her other vaccines were Pfizer. She never had Moderna before. She had on 14Oct2023. Her arm was swollen. The injection site was sore. It was red.  She didn't have this with Pfizer, but there seems to be a bump underneath the skin where it was injected. Her skin was itchy. It had been a few days. It was still itchy and sore. She received the Spikevax. It had been a year since she had a COVID vaccine. She does not had her COVID19 vaccine history on hand. She thought the bump reduced in size. When she had the Pfizer, the arm hurt for two days. Other than being sore, there was no redness and there was nothing that she could feel underneath her skin. She does not remember it having an itch either. Concomitant medications were not reported.  No treatment information was provided by the reporter.
Difficulty breathing; This case was reported by a consumer via call center representative and described the occurrence of difficulty breathing in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 30th August 2022, the patient received the 2nd dose of Shingles vaccine. In August 2022, less than a week after receiving Shingles vaccine, the patient experienced difficulty breathing. On an unknown date, the outcome of the difficulty breathing was not recovered/not resolved.   It was unknown if the reporter considered the difficulty breathing to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 31-AUG-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The reporter reported that the patient received Shingles vaccine. The reporter stated that after received Shingles vaccine the patient experienced difficulty breathing. The patient asked to the agent that how long the difficulty breathing last. The agent advised to patient if you are having difficulty breathing then contact your health care provider. Additional supportive information: Follow-up would not possible as no contact details were available.