chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse effects were reported; doses of improperly stored given PROQUAD and VARIVAX were administrated; This spontaneous report was received from a nurse regarding a 4-year patient of an unknown gender. The patient's concurrent conditions and medical history were not provided.  On 14-JAN-2019, the patient was vaccinated with an improperly stored dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (rHA) (PROQUAD) (route of administration and dose were not reported) for prophylaxis (lots # and expiration dates: R020676, 15-JAN-2020; R020816, 16-JAN-2020; R020677, 15-JAN-2020; R020814, 16-JAN-2020), however, it was unknown which specific lots the patient received. A sterile diluent was used to reconstitute the vaccines was properly stored.   No adverse effects were reported. The vaccines were exposure to a temperature excursion of 9°C to 25°C (9.2°C) during 2 hours which was called by a data logger. There was not previous temperature excursion.  This is one of the several reports received from the same reporter.; Sender's Comments:  009507513-1901USA005742: 009507513-1901USA005741: 009507513-1901USA005740: 009507513-1901USA005743: 009507513-1901USA005739:
This spontaneous report as received from a physician via a company representative refers to a 10 year old male patient. The patient's pertinent medical history, current conditions and concomitant medications were not reported. On an unknown date when the patient was an infant he was vaccinated with ROTATEQ full series 1 DF (one shot/3 dose series). On an unknown date the patient experienced diarrhea which eventually resulted in the patient being admitted to the hospital and sought medical attention for at least four days due to the dehydration. The patient was tested for and diagnosed with rotavirus in the hospital. The reporter stated that the vaccine was ineffective or if there was a strain of the virus that the vaccine does not work against. The physician stated that the patient was "ok" (recovering/resolving). The reporter did not provide the causality assessment between the events and the suspect therapy. There was no product quality complaint involved. Additional information has been requested.
This spontaneous report as received from a pharmacy technician refers to a 4 year old patient of unknown gender. Patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 28-FEB-2018, the patient was vaccinated with improperly stored dose of VARIVAX (lot # N022979, expiry 23-AUG-2019) for prophylaxis. No adverse effect was reported. The VARIVAX temperature excursion occurred on 14-DEC-2017 and 30-DEC-2017. On 14-DEC-2017, the vaccine was exposed to the temperature of 16.9 degree Fahrenheit (F) for 30 minutes. On 30-DEC-2017, the vaccine was exposed to the temperature of 6 degree Fahrenheit (F) to 14 degree F for 30 minutes. It was reported that the event was because of data logger. No product quality complaint was involved. This is one of the several reports received from the same reporter source. Sender's Comments: US-009507513-1802USA001558.
still very sick; was losing breathing while trying to talk on the phone; Chest pain, mostly sharp pains on her right breast; Could hardly move around; Muscles felt very sore and muscle pain; Swollen lymph nodes under her arm; Arm was sore; Was fatigued; Arm hurt real bad; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BREAST PAIN (Chest pain, mostly sharp pains on her right breast), HYPOKINESIA (Could hardly move around), ILLNESS (still very sick), DYSPNOEA (was losing breathing while trying to talk on the phone) and VACCINATION SITE PAIN (Arm hurt real bad) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history reported.).    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, the patient experienced VACCINATION SITE PAIN (Arm hurt real bad). On 20-Mar-2021, the patient experienced FATIGUE (Was fatigued). On 21-Mar-2021, the patient experienced VACCINATION SITE PAIN (Arm was sore). On 22-Mar-2021, the patient experienced BREAST PAIN (Chest pain, mostly sharp pains on her right breast), HYPOKINESIA (Could hardly move around), MYALGIA (Muscles felt very sore and muscle pain) and VACCINATION SITE LYMPHADENOPATHY (Swollen lymph nodes under her arm). On 02-Apr-2021, the patient experienced DYSPNOEA (was losing breathing while trying to talk on the phone). On an unknown date, the patient experienced ILLNESS (still very sick). At the time of the report, BREAST PAIN (Chest pain, mostly sharp pains on her right breast), HYPOKINESIA (Could hardly move around), ILLNESS (still very sick), DYSPNOEA (was losing breathing while trying to talk on the phone), VACCINATION SITE PAIN (Arm hurt real bad), FATIGUE (Was fatigued), MYALGIA (Muscles felt very sore and muscle pain), VACCINATION SITE PAIN (Arm was sore) and VACCINATION SITE LYMPHADENOPATHY (Swollen lymph nodes under her arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medicines were reported. No treatment information were reported.
arm around the site of injection was red, swollen, itchy, sore, and hot to the touch; arm around the site of injection was red, swollen, itchy, sore, and hot to the touch; arm around the site of injection was red, swollen, itchy, sore, and hot to the touch; arm around the site of injection was red, swollen, itchy, sore, and hot to the touch; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (arm around the site of injection was red, swollen, itchy, sore, and hot to the touch), VACCINATION SITE SWELLING (arm around the site of injection was red, swollen, itchy, sore, and hot to the touch), VACCINATION SITE PRURITUS (arm around the site of injection was red, swollen, itchy, sore, and hot to the touch) and VACCINATION SITE WARMTH (arm around the site of injection was red, swollen, itchy, sore, and hot to the touch) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (arm around the site of injection was red, swollen, itchy, sore, and hot to the touch), VACCINATION SITE SWELLING (arm around the site of injection was red, swollen, itchy, sore, and hot to the touch), VACCINATION SITE PRURITUS (arm around the site of injection was red, swollen, itchy, sore, and hot to the touch) and VACCINATION SITE WARMTH (arm around the site of injection was red, swollen, itchy, sore, and hot to the touch). At the time of the report, VACCINATION SITE ERYTHEMA (arm around the site of injection was red, swollen, itchy, sore, and hot to the touch), VACCINATION SITE SWELLING (arm around the site of injection was red, swollen, itchy, sore, and hot to the touch), VACCINATION SITE PRURITUS (arm around the site of injection was red, swollen, itchy, sore, and hot to the touch) and VACCINATION SITE WARMTH (arm around the site of injection was red, swollen, itchy, sore, and hot to the touch) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.  No treatment medication was reported.
Patient received first dose of Pfizer at an unknown location and presented to the ED at  with lip swelling and tingling.  States the symptoms started 30 mins after the vaccine. Given treatment with steroids and discharged home.  Patient returned to the ED on 5/15 complaining of nausea and throat tightening with a rash on her back and arms. Zofran, Benadryl, Pepcid and steroids administered.  Pt was discharged home.
Patient felt clammy, lightheaded, dizzy, and had a headache  about 10 minutes after vaccination. Had patient lie down, drink water/orange juice. Checked vitals BP 78/63 and Temp 96.3. Monitored patient for an additional 15 minutes. Felt better vital check BP 111/68 and Temp 97.3. He will follow up with primary care provider.
On  Friday April 23, I was filing papers in my office when I suddenly experienced an extremely elevated heart rate. According to my watch, my heart rate increased to 210 bpm. It remained elevated for about 5 minutes. My other symptoms were chest pounding, throat tightening followed by sweating and malaise.  I went to urgent care after and they performed an EKG on me. The Nurse Practitioner advised i go to the ER since I Was still not feeling well. I wen to the emergency room later and they performed multiple lab tests and more EKGs on me. They did not observe signs of a heart attack.  The following Tuesday, I went to see a cardiologist. He placed me on a heart monitor for 30 days. Results did not indicate any abnormal heart rhythms. I later received an ecocardiogram. I am still pending results.
UNBEARABLE  JOINT PAIN   FROM  THE JAWS TO THE  FEET. SWOLLEN  HAND  FEET.
Pt. c/o numbness to L arm after H1N1 vaccine admin. Went to ER 6 days after shot given, numbness began 6 hours after shot given. Still has numbness is 30% better, pt still has pain, Dr. notified has appt. 1/8/10 @ 8:30AM.
Got shingles after the shot/Suspected vaccination failure; Got shingles after the shot; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 18-Feb-2023 Reporter's Comments: The case was received from the consumer via interactive digital media. The reporter reported that his/her brother had the patient (neighbor) got the shot and got shingles after the shot. Additional supportive information: This case was considered as suspected vaccination failure, since the details regarding primary schedule, time to onset for event and laboratory confirmation of shingles were not provided. The follow-up could not be possible as no contact details were available. This 1 of 4 linked cases reported by same reporter for different patients.; Sender's Comments:  US-GSK-US2023AMR028529:Same reporter US-GSK-US2023AMR028532:Same reporter US-GSK-US2023AMR028534:Same reporter
This spontaneous report as received from a healthcare worker via a company representative refers to an unspecified number of female patients of unknown age. Concurrent conditions and medical history were not reported. The reporter reported that he read on an unspecified web site on the internet that GARDASIL 9 or GARDASIL (route, dose, frequency, lot# and expiration date were not reported) impacted females' menstrual cycles. Outcome of the event was not reported. Additional information is not expected as there was no consent to contact the physician.
This spontaneous report as received from a registered nurse refers to a 9 week old patient of unknown gender. The patient's concurrent conditions, medical history and drug allergies were not reported. On 21-NOV-2016, the patient was vaccinated with improperly stored PEDVAXHIB (dose and route not reported) from lot # M025192, expiry date: 21-MAR-2019 for prophylaxis. Concomitant medications were not reported. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous temperature excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1610USA014705: US-009507513-1610USA014706: US-009507513-1610USA008140.
Customer arrived at Appointment for COVID vaccine around 4:15 pm on 03/26/2021. After filling out VAR, customer was then brought into vaccinating room and vaccinated around 4:30pm. Vaccinating technician asked me to come in and look at his arm as he had a knot come up on the area that he was vaccinated immediately after his vaccination. I had seen this reaction before and told him not to worry and to put ice on it later when he went home. About 5 min later as we were talking customer became pale, he was a little nauseous, he did not feel right and became diaphoretic, but was breathing fine. Technician asked me to get him a cold cloth, and I brought 2, she placed one on his neck and I placed one on his head. I instructed patient to put his head between his knees as he was sitting, but he was concentrating on his breathing as we were talking to him. Customer did not lose consciousnessand his breathing remained stable. I stepped back into the pharmacy to continue work while the tecnician stayed with him to continue to monitor him. After a little bit I stepped back into the vaccination room and relieved the technician so that she could continue to vaccinate. His temperature was 98 and his color was looking better. He began to talk to me more, so we carried on a conversation as I continued to place cold compresses on his head and neck. After about another 15 or 20 min another tecnician came in with a fan to circulate air and  relieved me as I needed to check another prescription. The FE manager was talking to him and checking his BP the technician said that the customer told her that he had not been feeling well for the past 2 weeks and that he had seen a doctor and they were running some tests to figure out why he was feeling the way he was. The customer did not state any of this on his VAR nor tell us before his vaccine. He also told the technician checking him in that he had a little to eat that day as he was on site with his job most of the day. The FE manager opened the door from the vaccination room and advised us the he called EMS to pick up Patient as his BP was 80/40 and his pulse was 42. EMS came soon after and transported Patient at around 5:30pm. No medications were administered to the customer at the pharmacy by any Pharmacy employee. When I arrived at work this am (03/27/21) there was a voicemail from 9:39 pm the previous night and it was Patient's wife stating that her husband was in the hospital and that they would be here at some point to pick up the truck. She wanted to let us know so that the truck would not be towed.
Chronic, feverless, severe rigors (full body shaking), accompanied by stage 2 hypertension and tachycardia (resting HR of 130+ BPM) that commenced in early September 2021 and continue to this day. Swollen and painful lymph nodes in areas both armpits and neck that commenced in early September and continue. Enlarged spleen (splenomegaly) as determined by a CT angiogram of the abdomen and pelvis on November 10, 2021.
Approx. 2 min after injections, became pale, nauseated, dizzy, + felt "hot".  Vital signs stable.  After 15" up to chair.  Denied nausea or dizziness, color improved, skin warm & dry.
Light headache; Light Body pain; Light fever; This is a spontaneous report from a non-contactable consumer, the patient. A 29-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN), via an unspecified route of administration in the right arm on 12Apr2021 at 09:45 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to 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 first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: UNKNOWN), via an unspecified route of administration in the left arm on 22Mar2021 at 09:45 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. On 13Apr2021 at 01:00, the patient experienced light headache, light body pain and light fever. No therapeutic measures were taken as the result of adverse events. The adverse event did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not tested for COVID-19. The clinical outcomes of the events, light headache, light body pain and light fever was recovering at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pain at injection site; fatigue; 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 (intramuscular) .5 ml. On 5th August 2022, several minutes after receiving Shingrix, the patient experienced injection site pain and fatigue. On an unknown date, the outcome of the injection site pain was recovered/resolved and the outcome of the fatigue was not recovered/not resolved.   It was unknown if the reporter considered the injection site pain and fatigue to be related to Shingrix.     Additional Information: GSK Receipt Date: 18-AUG-2022 Reporter's Comments: The reporter was the patient.  The patient received dose of Shingrix and minutes after experienced pain at injection site and fatigue. No other information provided. The patient did not want to give her demographics. The patient did not want to give her demographics, nor did she give consent for HCP follow up. The reporter did not consent to follow up.
Pt received vaccines on 04/21/2003. Developed rash 04/22/2003. Erythematous circular rash on the arm, hand, leg , face. Tender to touch. + X Ray
Patient called and said that he felt - after receiving the 2nd Shingrix shot, very tired and achy all over and had to leave work, He said that he had a similar reaction to the first Shingrix shot.
Feeling hot, flushed, burning arms/legs/head, tachycardia (125), fluttering heart, couldn't catch breath, feeling faint, tasted medicine in mouth, breathless
Information has been received from a pharmacist referring to a 67 year old female patient. The patient was allergic to macrolides, ketolides, salicylates. On 16-MAR-2015, the patient was vaccinated with a dose of ZOSTAVAX, lot number: K020802, expiry date: 31-JAN-2016, 0.65 ml, once, subcutaneously. Concomitant therapies included losartan (manufacturer unknown), glipizide, amlodipine, lovastatin (manufacturer unknown) and metformin (manufacturer unknown). Subsequently, on an unspecified date in March 2015, the patient developed redness, swelling, and a "bump" (clarified as related to swelling and not any type of rash or lesion) at the injection site. The patient sought medical attention by called the pharmacist. No treatment was given for the event and none lab diagnostics studies were performed. The outcome of the event was reported as not recovered. Additional information has been requested.
Severe abdominal cramping, nausea, vomiting and diarrhea.
Numbness in hands and feet Intermittent; This is a spontaneous report from a contactable other health care professional reported for herself. A 51-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot unknown) via unspecified route of administration in left arm on 19Feb2021 12:30 AM at age of 51 years old at single dose for COVID-19 Immunization. Patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. No known allergies reported. Other medications the patient received within 2 weeks of vaccination included Natasia (as reported). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient previous received the first dose of BNT162B2 in left arm on 22Jan2021 12:30 AM at age of 51 years old for Covid-19 Immunization. Patient experienced numbness in hands and feet intermittent on 22Feb2021. Since the vaccination, the patient had not been tested for COVID-19. The report was reported as non-serious, no results in death, no life threatening, no caused/prolonged hospitalization, no disabling/incapacitating, no congenital anomaly/birth defect. Patient was not received treatment for the adverse event. Outcome of events was not recovered.  Information on the lot/batch number has been requested.
Immediately after receiving  her shot, pt reported feeling light headed and dizzy. Transported via wheelchair to cot. Laid down with feet elevated. After 5 minutes-patient sat upright to drink juice. VS 130/86, HR 84, SPO2 98%. After 20 minutes-patient reported feeling better-left with husband. Instructed to follow up with provider and notify vaccine clinic at next dose of how they felt after first.
Report received on 24.May.2012 from a nurse and forwarded, ref. no. CVAE-021-2012. This case concerns a 21-year-old female patient who received VIVOTIF (batch number 3000009). The patient's medical history and concomitant medications were not reported. On 22.May.2012, the patient took the first oral dose of VIVOTIF. On the same day, she experienced diarrhea. The event regressed on the interval day. On 24.May.2012, the patient took the second dose of VIVOIF, with further onset of diarrhea. The patient discontinued VIVOTIF. At the time of the report, the patient's event was resolving. The event was considered non-serious.
Headache; Aches/pains,aches/pains, especially of back,; Aches/pains,aches/pains, especially of back,; Nausea; Cramps; Fatigue; Felt worse next day with arm pain; This is a spontaneous report received from a contactable consumer or other non hcp. A 60-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported, Pfizer NTEC), via an unspecified route of administration in Arm Left on 03Mar2021 10:30 (at age of 60-year-old) as a single dose for covid-19 immunisation. Medical history included high cholesterol, High blood pressure and General anxiety from an unknown date and unknown if ongoing. Concomitant medications included atorvastatin, losartan, alprazolam and xanax only as needed. The patient had no allergies to medications, food, or other products. The patient experienced headache, aches/pains, especially of back, nausea, cramps, fatigue; felt worse next day with arm pain on 03Mar2021. The events assessed as non-serious. No treatment was received for the events. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, was the patient did not diagnosed with COVID-19. Since the vaccination, did not patient been tested for COVID-19. In pharmacy or drug store most recent COVID-19 vaccine was administered. The outcome of the events was reported as recovered on unknown date.  Follow up: This is a follow-up spontaneous report received in response to the mail trail sent regarding the confirmation of below mentioned query. The response included: The patient told reporter about the event on 3Mar2021 (day of vaccination) and PRD for initial report updated to 03Mar2021 accordingly.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
on 1/28/2022 -1/30/2022 normal pain at injection site.  2/2/2022 pain underneath armpit,  upper shoulder pain, could not extend arm over my head