chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Shingles rash; red rash was all over the front of her right breast and under the breast, under her arm pit, and out onto the right side of her back, below the shoulder blade,rash was getting redder and redder; Blisters/More blisters were forming; Pain; temperature of 100.6; Pain in her right breast; left arm (injection site), did hurt; Tired; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 5th August 2022, the patient received the 1st dose of Shingrix. On 6th August 2022, 1 days after receiving Shingrix, the patient experienced breast pain. On 7th August 2022, the patient experienced shingles, red rash, blister, pain and fever. In August 2022, the patient experienced injection site pain and tiredness. The patient was treated with paracetamol (Tylenol). On 8th August 2022, the outcome of the fever was recovered/resolved. On an unknown date, the outcome of the injection site pain was recovered/resolved and the outcome of the breast pain, red rash, blister and tiredness were unknown and the outcome of the shingles and pain were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, breast pain, shingles, red rash, blister, pain, fever and tiredness to be related to Shingrix.     Additional Information: GSK Receipt Date: 17-AUG-2022 Reporter's Comment: The reporter stated the after received vaccine on next day the patient experienced pain in her right breast. On 7 August 2022, 2 days after received Shingrix vaccine patient experienced Shingles rash, blisters, pain and a temperature of 100.6 degree F. The patient had red rash was all over the front of her right breast and under the breast, under her arm pit and out onto the right side of her back, below the shoulder blade. Patient was also began to see blisters form.  Patient was also tired.  The patient temperature went away the next day, but her rash was getting redder and redder and more blisters were forming.  The patient was admitted that her left arm at injection site did hurt and lasted for couple of days. The patient had been taking Tylenol around the clock to control the pain and using calamine spray. The reporter consented to follow up.  Note- The treatment product was not getting coded in product tab with encode button, however it was mention in narrative.
Swelling at the injection site; Body ache; subsided later that day and ran away; This is a spontaneous report received from contactable reporter(s) (Other HCP) from a sales representative. The reporter is the patient.  A 37-year-old female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE SWELLING (non-serious), outcome "recovered", described as "Swelling at the injection site"; PAIN (non-serious), outcome "recovered", described as "Body ache; subsided later that day and ran away".  Additional information: The patient was a nurse practitioner and got our Comirnaty vaccine first and had a side effect (reported as Unspecified Bivalent Vaccine). It was reported that "The side effect are from the COVID Comirnaty vaccine. She said she had swelling at the injection site and then 24 hour later she had body ache, and they did subsided later that day and ran away." She reported herself when she got the Bivalent shot (suspect captured as unspecified Bivalent shot) because she said it was side effect of the Bivalent. The date of the shot was unknown.   The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.
I was informed from the doctor's office that patient was given an expired vaccine. I called and spoke to County Health Department on 10/23/17 and she informed me I should report the incident via the VAERS website.
Slight Fever; Body Aches; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Slight Fever), MYALGIA (Body Aches) and HEADACHE (Headache) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 010A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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. On 31-Mar-2021, the patient experienced PYREXIA (Slight Fever), MYALGIA (Body Aches) and HEADACHE (Headache). At the time of the report, PYREXIA (Slight Fever), MYALGIA (Body Aches) and HEADACHE (Headache) had resolved.            No Concomitant medications were provided  No treatment medications were provided.   This case was linked to MOD-2021-271879 (Patient Link).
chills; body ache; headache; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), MYALGIA (body ache) and HEADACHE (headache) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007M20A and 038K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CHILLS (chills), MYALGIA (body ache) and HEADACHE (headache). At the time of the report, CHILLS (chills), MYALGIA (body ache) and HEADACHE (headache) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2021-369478.
Information has been received from a 60 year old female patient with type 1 diabetes mellitus, egg allergy and poultry allergy who in December 2008 was vaccinated with a dose of PNEUMOVAX. Concomitant therapy included insulin. It was reported that she began "burping eggs" and could not stop 15 minutes after administration of PNEUMOVAX. The patient then experienced gas, massive diarrhea and swelling. The patient reported the physician administered oxygen and "shots". The patient reported the physician said that she nearly died, however, she recovered in an hour (December 2008). There were no laboratory diagnostic tests performed. The patient was not hospitalized. No further information is available.
Itching and Rash/hives appeared on all over approx 4hrs after the vaccination. No other abnormal symptom appeared. The patient ate well and played as usual. The Patient was given only one 25mg of Benadryl at 6.15PM. The itching and rash/hives disappeared before the night and the next day no itching or rash.
Caller states that her son got COVID for the second time; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (Caller states that her son got COVID for the second time) in a male patient of an unknown age 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)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Caller states that her son got COVID for the second time). At the time of the report, COVID-19 (Caller states that her son got COVID for the second time) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided. Patient took some medicine to help with symptoms.
Significant painful recurring intermittently muscle spasm on chest wall that continued until 3/15/2021. It was so strong that I initially thought I was having a heart attack. However, other symptoms associated with such an event did not occur, that is no profuse sweating, rapdid heart beat, etc. On Monday, I visted my doctor who listened to my heart and took an EKG. The EKG was normal and she felt that the spasm was associated with the Moderna shot.  I have had no further such events
Severe body ache the entire night; Severe headache; Initial information was received on 15-Oct-2021 regarding an unsolicited valid non-serious case from a physician and non-healthcare professional via Regulatory authority (under reference: 00814214).  This case involves a 65 years old female patient who experienced severe headache (headache) and severe body ache the entire night (pain) when received vaccines COVID-19 VACCINE and INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  On 14-Oct-2021, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (injection, 0.7 mL, once, total, lot number and expiry date not reported) via an unknown route in the left arm for prophylactic vaccination.  On an unknown date, the patient received a dose of suspect COVID-19 VACCINE not produced by Sanofi Pasteur (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On 15-OCT-2021 the patient developed a non-serious severe headache (headache), severe body ache the entire night (pain) 1 day following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE and (unknown latency) following the administration of COVID-19 VACCINE.  It was reported "The caller's wife turned 65 within this past year and yesterday received FLUZONE HIGH DOSE QUADRIVALENT for the first time in her life. When the caller woke up this morning, his wife informed that she had a severe headache and severe body ache the entire night. She seems to be improving, as she had an appointment this morning and was able to leave the home to keep her appointment. The caller was unsure of which arm his wife received the injection, but believes it is likely that it was the left arm. He mentions that he and his wife both received Covid-19 vaccinations with the same brand. He had no side effects from the Covid-19 vaccine, but his wife had similar side effects that she is now having with after Fluzone High-Dose Quadrivalent."  Laboratory details were not reported.  It was not reported if the patient received a corrective treatment for the events.  The patient was recovering from the events (headache, pain) at the time of reporting.  There will be no information available on the batch number for this case.
Feels numbness in her left left from her ankle to her thigh, she loses strength in her leg and is unable to walk.
Vaccine given prematurely per age. Patient monitored by nurse for 1 hour. No adverse reactions noted. No swelling, hives, or rash noted to patient. Respirations even and non-labored. Patient remained awake and alert. Injection site with no redness noted. Patient's mother present with the child at time of vaccination and during monitoring.
Patient Developed a fever of 103 post Prevnar 13 administration; This is a spontaneous report received from contactable reporter(s) (Other HCP) from a sales representative.  A 3-month-old patient received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "Patient Developed a fever of 103 post Prevnar 13 administration". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Patient Developed a fever of 103 post Prevnar 13 administration, event took place after use of product.  Follow-up attempts are completed. No further information is expected.
G62.0 CHEMOTHERAPY INDUCED PERIPHERAL NEUROPATHY, SEQUELA 3/11/2022 CARDIOGENIC SHOCK R57.0 CARDIOGENIC SHOCK 8/5/2022 CARDIOGENIC SHOCK G62.0 CHEMOTHERAPY INDUCED PERIPHERAL NEUROPATHY, SEQUELA 3/11/2022 COVID-19 DISEASE R57.0 CARDIOGENIC SHOCK 8/5/2022 COVID-19 DISEASE
The left arm where the shot was given hurt and that was expected.  My right arm between the shoulder and elbow was also very sore, more sore than the right arm.  It had not been that sore prior to the shot.   I wonder if that had something to do with the replacement surgery I had when I fell 2 and a half years ago.   The pain was relieved with Tylenol but did last longer than the pain in the arm where the shot was given.
Headache; Muscle pain; Shaking; Tiredness; Nausea; Fever; This case was reported by a consumer and described the occurrence of headache in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th August 2019, the patient received the 1st dose of Shingrix. On 27th August 2019, less than a day after receiving Shingrix, the patient experienced headache, muscle pain, tremor, tiredness, nausea and fever. On an unknown date, the outcome of the headache, muscle pain, tremor, tiredness, nausea and fever were not recovered/not resolved.   It was unknown if the reporter considered the headache, muscle pain, tremor, tiredness, nausea and fever to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. On the day before reporting date, the patient received the 1st of two doses of Shingrix.  The patient had muscle pain, headache, tiredness, nausea, fever and was shaking. These reactions were very extreme that, these not resolved even 24 hours later and the patient was not sure about taking a 2nd shot due to the severity of reactions.
Feeling tired; A spontaneous report was received from a consumer concerning a 72 year-old male patient who was administered Moderna's COVID-19 vaccine (mRNA-1273) and developed fatigue.  The patient's medical history included COVID-19 infection. Concomitant product use was not provided.   On 05-JAN-2021, the patient received his first of two planned doses of mRNA-1273 (lot#: unknown) intramuscularly for the prophylaxis of COVID-19 infection.   The patient's wife called to report that he was fine the day of vaccination but started feeling tired the next day; 06-JAN-2021. Treatment information was not provided.   Action taken with mRNA-1273 in response to the event was not provided.  The outcome of the event, fatigue, was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Was normal for 10 min after vaccine, sitting down and waiting. Was about to leave and get on my motorcycle but a wave of dizziness hit, couldn't see (as if I had stood up too fast), started sweating profusely. Lasted for about 3 minutes. Man working brought me a bottle of water which I chugged, symptoms mostly passed a couple minutes later.  Was still dizzy for another 20 min but after that it passed.
red rash all over his face; rash on part of his neck and chest area; face itching all night long; swollen eyes, cheeks, lips; swollen eyes, cheeks, lips; swollen eyes, cheeks, lips; This is a spontaneous report from a contactable other health professional (HCP). A 14-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: 301308A), via an unspecified route of administration, administered in arm right on 23Sep2021 at 19:30 (at the age of 14-years-old) as dose number unknown, single for COVID-19 immunisation. Medical history included mild seasonal allergies. The patient's concomitant medications were not reported. The patient experienced red rash all over his face, rash on part of his neck and chest area, face itching all night long, swollen eyes, cheeks, lips on 25Sep2021 at 09:00. Events took place after use of product. The events resulted in emergency room visit. The clinical course was as follows: Woke up on 25Sep2021 at 9:00am with swollen eyes, cheeks, lips and red rash all over his face. Complained of face itching all night long. Also has rash on part of his neck and chest area. The patient has no underlying conditions. Patient does not take any prescribed medications. Patient took diphenhydramine (BENADRYL) every 4 hours since rash developed. No history of food allergy. Patient does have mild seasonal allergies. Patient has never had a rash like this before. Patient is going to urgent care today to see a physician. Therapeutic measures were taken as a result of all events. The events red rash all over his face and rash on part of his neck and chest area were assessed as serious and medically significant by the regulatory authority. The outcome of the events was not recovered.; Sender's Comments: Based on the information provided in the narrative, a causal association between the suspect drug and the events cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
This spontaneous report was received from a medical assistant via company representative and refers to a 14-year-old female patient. The patient had no pre-existing physician diagnosed allergies, birth defects, medical conditions or illness at the time of vaccination. On 19-JUL-2018, the patient was vaccinated with the first dose of PNEUMOVAX 23 one intramuscular injection in the deltoid muscle of right arm, lot # R002354 and expiration date 17-DEC-2019 (indication was not reported). Concomitantly on 19-JUL-2018, the patient was vaccinated with the second dose of VAQTA (reported as Hep A) intramuscular injection in the left arm. The PNEUMOVAX 23 was given in error, because patient should have been vaccinated with GARDASIL 9. The reporter stated that the label on the vaccine bottle was not checked before given to the patient. There were no any other vaccinations within 4 weeks prior to the 19-JUL-2018. The medical assistant stated that there was no harm to the patient. There were no side effects or reactions and there was no prescription drug treatment given.
redness; Arm was red; Arm discomfort/uncomfortable; Itchy; Hot to the touch; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchy), FEELING HOT (Hot to the touch), ERYTHEMA (redness), VACCINATION SITE ERYTHEMA (Arm was red) and VACCINATION SITE PAIN (Arm discomfort/uncomfortable) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, the patient experienced PRURITUS (Itchy), FEELING HOT (Hot to the touch), VACCINATION SITE ERYTHEMA (Arm was red) and VACCINATION SITE PAIN (Arm discomfort/uncomfortable). On 11-Feb-2021, the patient experienced ERYTHEMA (redness). At the time of the report, PRURITUS (Itchy), FEELING HOT (Hot to the touch), ERYTHEMA (redness), VACCINATION SITE ERYTHEMA (Arm was red) and VACCINATION SITE PAIN (Arm discomfort/uncomfortable) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient stated that she felt fine. Patient used ice on the arm as a treatment.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: Follow up document received on 06 Jul 2021 included outcome of the events and an update that patient declined Further Follow-up. The event coding for arm discomfort and arm was red changed to vaccination site pain and vaccination site erythema respectively.
Raised red area at site of injection radiating outward down arm about 5-6 inches, itching.
Lost of taste on Day 6 after the first vaccination and already lasted 6 days and still has not resolved the symptom yet.
received the first dose of the Pfizer covid vaccine on 23Jul2021 and tested positive on 28Jul2021; This is a spontaneous report from a contactable pharmacist. The pharmacist reported for a female patient. A patient of an unspecified age received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 23Jul2021 (Batch/Lot number was not reported; Expiry date: Unknown) as DOSE 1, SINGLE for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient received the first dose of the PFIZER COVID vaccine on 23Jul2021 and tested positive on 28Jul2021 (covid-19) (non-serious) on 28Jul2021 with outcome of unknown. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 28Jul2021. The clinical outcome of the event was unknown. The patient completed quarantine. The patient wanted to know if it was ok to proceed with 2nd dose tomorrow as it would be 21 days by tomorrow. The patient was asking if should go ahead with the 21 day scheduled second dose Pfizer Covid Vaccine. Should the patient delay receiving the second dose Pfizer Covid Vaccine based on the positive Covid test and if so, how long should the patient delay receiving the second dose Pfizer Covid Vaccine.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
On 4/29/00, the infant was seen in the ER, due to febrile seizures and probable UTI. The infant was hospitalized. The infant was discharged from the hospital with a dx of UTI. The infant was seen in the clinic on 5/20/00. The clinic physician made dx of UTI and URI. The infant recovered fully. Both the investigator and the medical monitor agree that the febrile seizure and UTI are not reasonably related to Prevnar administration.
This spontaneous case reported by a consumer, describes the occurrence of nasopharyngitis (bad head cold) and nasal congestion in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. March 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced nasopharyngitis (bad head cold) and nasal congestion. At the time of the report, nasopharyngitis (bad head cold) and nasal congestion outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No concomitant production use or treatment medications provided. Reporter did not allow further contact.