chrisvoncsefalvay/vaers-outcomes huggingface dataset:
dizziness; weakness; not being able to walk. He had to crawl to the door to let her in. He has been this way all day.; feeling nauseous; This is a spontaneous report from a contactable consumer reported for a male patient on behalf of her uncle. A 61-years-old male patient received a dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via unspecified route, on unspecified date as unknown dose, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. After vaccination, the patient experienced dizziness, weakness to the point of not been able to walk (He had to crawl to the door to let her in. He was this way all day. He felt 'really winded' after attempting to remove the snow a day after they got snow), he had nothing to eat all day and feeling nauseous. The outcome of the event was unknown.  Information on the lot/batch number has been requested.  No follow-up attempts possible. No further information expected.
Shingles right leg; chickenpox; little tired; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HERPES ZOSTER (Shingles right leg), FATIGUE (little tired) and VARICELLA (chickenpox) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003A21A and 007M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Mar-2021, the patient experienced FATIGUE (little tired) and VARICELLA (chickenpox). On an unknown date, the patient experienced HERPES ZOSTER (Shingles right leg). At the time of the report, HERPES ZOSTER (Shingles right leg) had not resolved and FATIGUE (little tired) and VARICELLA (chickenpox) outcome was unknown.            No Concomitant medications were reported. Treatment included shingles medications.  Pain in right leg ,continuing to be painful shooting down thigh area to knee/severe late nerve pain on her right leg/rash on her right leg were considered as symptoms and are subsumed under Event "Herpes zoster".   Most recent FOLLOW-UP information incorporated above includes: On 30-Mar-2021: Additional  information included significant Events
pain; redness; swelling at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a elderly patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced injection site pain, injection site erythema and injection site swelling. On an unknown date, the outcome of the injection site pain, injection site erythema and injection site swelling were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, injection site erythema and injection site swelling to be related to Shingrix.  Additional details were received as follows: The patient was not a healthcare professional. The age vaccination was not reported. The age group was not reported but was selected as an adult per the vaccine indication. The patient asked about how long and how large of an area are Pain, redness, and swelling at the injection site after vaccination.
At approximately 12:15 pm the resident had a brief unresponsive episode that resolved quickly. Her Vital signs were stable and her mentation was at baseline.  Later that evening approximately 10 pm she had labored respirations, shortness of breath, lethargy with bilateral crackles,  Oxygen desaturated to 76% on room air, tachycardia and hypotension. She expired at 6:30 a.m. the following day.
Arm pain; Fatigue; Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm pain), FATIGUE (Fatigue) and ARTHRALGIA (Joint pain) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029K20A and 013C20A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm pain), FATIGUE (Fatigue) and ARTHRALGIA (Joint pain). At the time of the report, PAIN IN EXTREMITY (Arm pain), FATIGUE (Fatigue) and ARTHRALGIA (Joint pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 28-Jun-2021: TCR information received on 28-JUN-2021 contains non-significant information.
pt recv vax 21AUG96 & 12FEB98 pt devel a total of 15 vesicles described as small red spots w/blisters, scattered all over body;
PT WAITING IN WAITING ROOM FOR 15 MIN, PATIENT STARTED TO FEEL DIZZY AND VOMITTING
started with chills and body ache, had momentary hearing loss (about 1-2-minutes), fever 101 degrees, headache and neck ache, vomiting, third day rash on left arm at shot site.
This spontaneous report as received from a pharmacist refers to a 79 year old patient. The patient's medical history included weight loss in 2013 (exact date unspecified) which was discovered to be related to low testosterone level and had been corrected since. Patient's historical medication included AFLURIA on 14-OCT-2014. The patient had none drug reactions or allergies. On 11-NOV-2014 the patient was vaccinated with a dose of ZOSTAVAX (0.65 ml once, subcutaneous, lot # K012921, expiry date: 29-NOV-2015, in the arm). Concomitant therapies included fluoxetine, fentanyl, zolpidem tartrate, methimazole and metoprolol XL. On 04-DEC-2014 the patient showed pharmacist his arm, where injection was administered: arm was swollen, red, sore, hurt, looked like infection like shingles but no blisters or pustules showing. On 13-NOV-2014 the patient received cortisone injection for unspecified reason. The reporter stated, that on an unknown date, the patient underwent screening for ZOSTAVAX administration and never had serious reaction to vaccines. The outcome of events was reported as not recovered. The patient sought medical attention via contacting the pharmacist. The relatedness between events and ZOSTAVAX was not reported. Additional information has been requested.
flu; Initial information received on 23-Jan-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves patient with unknown demographics who had flu while receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site.  On an unknown date the patient had flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  Action taken:not applicable  It was not reported if the patient received a corrective treatment for the event (flu).  At time of reporting, the outcome was Unknown for the event flu.
Extremely painful legs; abdomen spasms; abdomen spasms and cramps; severe chills; This is a spontaneous report from a contactable nurse (patient). A 52-year-old female patient (not pregnant at the time of vaccination) received her 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose on 17Dec2020 04:00 PM Intramuscular in Right arm (also reported Arm Left) for Covid-19 immunization. Prior to vaccination, patient was not diagnosed with COVID-19. Medical history included hypothyroidism, hypotension, obesity, and allergies to onions. There were no other vaccines received in four weeks; however other medications received in two weeks. Patient experienced extremely painful legs and abdomen spasms and cramps, severe chills on 17Dec2020 09:00 PM. Patient applied arnica 35% on the affected area and it helped. Since the vaccination, patient had not been tested for COVID-19. Outcome of the events was resolving.  The events were reported as non-serious.       Information on lot/batch number has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events of extremely painful legs, abdomen spasms and cramps, and severe chills cannot be excluded.  The case will be reassessed if additional information becomes available.  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.
Left parotid gland swelling (parotitis) 18 days after MMR vaccine. No fever. Oil/water asymptomatic vaccine 9/12/02. Onset of parotid swelling 9/30/02. Resolved within 9 days.
Cold sore formed on lip; Body ache; Developed chills; Fever (up to 102.8 degrees F); A very bad headache; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0164), via an unspecified route of administration in the left arm on 25Apr2021 at 15:15 (at the age of 45-years-old) as DOSE 2, SINGLE for COVID-19 immunization. The patient had no medical history. Concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733), via an unspecified route of administration in left arm on 04Apr2021 at 15:00 (at the age of 45-years-old) as a single dose for COVID-19 immunization. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 26Apr2021 at 04:00, about 12 hours after the second vaccination, the patient experienced chills, followed by fever (up to 102.8 Fahrenheit), a very bad headache and body ache which lasted for about 30 hours. On 27Apr2021, the patient experienced a cold sore formed on her lip which was almost healed by 04May2021, and later another cold sore appeared. Therapeutic measure was taken as the result of chills, fever, headache, general body pain and cold sore lip which included paracetamol (MANUFACTURER UNKNOWN). The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcomes of chills, fever, headache, general body pain were recovered on 27Apr2021 at 10:00 and cold sore lip was recovering.  No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information included: Fahrenheit captured as unite for Body temperature. The patient experienced cold sores lip updated to the patient experienced a cold sore formed on her lip in narrative. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care added in narrative.
This spontaneous report as received from a pharmacist refers to a newborn male patient of unknown age. On 07-OCT-2012 00:33, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. two lot # were involved and the lot # were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot # the patient was administered. the outcome of the event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Case was fully vaccinated against Covid19, and became infected with Covid-19 on 7/12/2021. She died on 7/15/2021 with Covid Pneumonia listed as a secondary diagnosis contributing to her death.
Received Janssen vaccine on 3/4, 11/12/21 COVID-19 positive by PCR on  1/22/22 admitted to hospital on 1/30/22 for COVID pneumonia underlying Type 1 DM
patient had stroke; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  An adult female patient (not pregnant) received bnt162b2 (BNT162B2), administration date Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose number=2), for COVID-19 immunization; Bnt162b2 (dose number=1), for COVID-19 immunization. The following information was reported: CEREBROVASCULAR ACCIDENT (death, hospitalization) with onset 03Feb2022, outcome "fatal", described as "patient had stroke". It was unknown if therapeutic measures were taken as a result of cerebrovascular accident. The patient date of death was 08Feb2022. The reported cause of death was cerebrovascular accident. It was not reported if an autopsy was performed.  Course of the event: The patient had stroke on 03Feb2022 after getting Pfizer booster in December2021. She was hospitalized and passed on 08Feb2022. Additional details are unknown  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on limited information in the case , a possible causal association between   the reported  event cerebro vascular accident and the suspect drug BNT162B2 cannot be 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; Reported Cause(s) of Death: Cerebrovascular accident
Pt reports fever, chills, and achy feeling 10 or so hours after receiving vaccine. She also stated the soreness was much greater than the first dose (received 5/1/18). She also reported being very "thirsty" after the shot. There was no rash reported. The patient states the symptoms lasted less than 12 hours and she did not take any medication or call her physician.
Patient became light headed and after administration of immunization by MA. Provider entered room to find patient on the floor unresponsive. Was unresponsive for less than 10 seconds. He was immediately oriented x 3. Diffuse bleeding from right nare and 5mm laceration noted to bridge of nose. Contusion present to forehead between eyebrows. Patient remained supine on floor with legs elevated x 10 minutes. He was then able to assist with transfer to exam table but did become light headed. Head of table lowered. No LOC occurred. Ice applied to forehead contusion. Laceration cleansed and Dermabond applied along with steri strip. Diffuse tenderness with palpation of bridge of nose. No tenderness over forehead or eyebrow areas. Bleeding from right nare was controlled with pressure and was minimal. Blood pressure on dismissal 110/60. His wife was called to take him home. He was able to ambulate from clinic without assist. He was observed in clinic for 1 1/2 hours post incident.
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient. A 51 year-old male patient received bnt162b2 (BNT162B2), administration date Apr2021 (Batch/Lot number: unknown) as dose 2, single for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1 Lot # unknown, Location of injection: Arm, shoulder), administration date: 03Apr2021, when the patient was 50 years old, for Covid-19 Immunization, reaction(s): "cognitive issues". The following information was reported: MULTIPLE SCLEROSIS (hospitalization, medically significant), outcome "unknown", described as "after 2nd dose started developing physical issues that landed me in the hospital for 6 days and a diagnosis of multiple sclerosis."; DEMYELINATION (medically significant), outcome "unknown", described as "demyelination on my spinal cord and brain/demyelination of caller's spinal cord and brain"; CONTUSION (non-serious) with onset Apr2021, outcome "unknown", described as "sort of like bruises"; PAIN (non-serious) with onset Apr2021, outcome "unknown", described as "Caller is right handed and knows had soreness". The patient was hospitalized for multiple sclerosis (hospitalization duration: 6 day(s)). Clinical Course: Patient had concern that the Covid vaccine From company triggered demyelination on his spinal cord and brain. He had no issues prior to the vaccine in Apr2021. Patient read studies showing a possible link and would like to speak with someone at your company about this. Multiple sclerosis was not listed as something that was reported during the clinical trials for the vaccine. Post-authorization experience these reactions are reported voluntarily, Reason for no lot number: of Pfizer Covid-19 Vaccine: Patient does not have vaccine card available to provide this information. Patient was taking Pfizer Covid-19 Vaccine Required for his employer and just seemed like the right thing to do based on Covid. Patient does not want to provide address or email. HCP states the information was for his primary doctor, not a neurologist. Patient unable to provide NDC/lot/expiration first and second dose. He doesn't know exact date for sure. Unable to recall left or right arm, shoulder. He knows soreness is a side effect when went for the Pfizer Covid-19 Vaccine. The soreness began the day after receiving the second dose Pfizer Covid-19 Vaccine. The lot number for bnt162b2 was not provided and will be requested during follow up.
Doses administered past the published expiry date; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry date) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry date). On 26-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported No treatment medications were reported
Severe pain, unable to sleep on left side for 3 day. Allergic reaction, severe redness and swelling of most of left arm pt took prednisone for symptom relief and symptom tx.
On the second day on 12/29/2020 in the afternoon I started feeling fatigue, I hade nose bleeding, fevers & headaches. On the third day on 12/30/2020 I had hives I had them in my face they were the size of a dime they are lumping I had them on my eyebrows & on my right cheek, & continued nose bleeding, fever continued, fatigue continued, headaches continued, pain on my arm & I felt with no energy. I had a lot of nose bleeding. On 12/30/2020 I called the doctor and they gave me an appointment for 12/31/2020 & they gave me a zoom meeting. The doctor said every symptom I had was a normal reaction to  the covid vaccine except the nose bleeding. The symptoms continued but the nose bleeding is the only thing it has stopped.
Large red swollen area from shoulder to slightly above elbow. On 10/06/2009 area became more swollen and itching with hives. Took 50 mg of Benadryl. it is still swollen and red and somewhat itchy.
About 5 hours after shot, I started feeling weak, tired, and nauseas with a slight headache.  I had discomfort trying to fall asleep. I woke up at 12:43AM with a throbbing headache. I was hospitalized at 18 for viral meningitis, and this was a similar, intense pain. It felt like I had a crown on,  and that crown on my head caused a very intense, throbbing, debilitating pain. I also had chattering teeth, shaking with a freezing fever. I eventually fell asleep and woke up again at 2-something. My fever and headache still intense, but now I was drenched in sweat and burning up. I wanted to get up and find my thermometer--I remember digging through my drawers and closets around my apartment,  I remember speaking but no recollection what I was trying to say (I live alone), and I remember seeing my reflection looking glazed over. I don't remember getting back in bed but woke up again after 5AM. I still had a bad headache, though less severe, and felt my body was alternating very hot sweating and very cold freezing--like it was mix and matching. I eventually fell asleep again and woke up around 7:45AM. I was fatigued with a fever and chills all day.  I found my thermometer and went to sleep with a 100.3 fever that night. I was much better next day, just slight fatigue.
Seizure began hours after this round of vaccines, lasting 10 to 15 minutes. Stopped by EMT with VERSED. One additional seizure occurred between this vaccination and the 3rd doses. After 3rd dose, a cluster of seizures occurred, and patient has been diagnosed with a seizure condition. Patient still has seizures as recently as last week.
Pinpoint eyes, sweating, clamy, skin discoloration, vomiting, fainting occurred within 10 min. of vaccination
Client vaccinated, said it was good then slumped in chair, eyes rolled back. Responded to verbal commands, opened eyes ,pupils dilated, diaphoretic, took a minute for her eyes to come into focus. Paramedic to cubicle, client transported to treatment area. Observed by paramedic for 45 minutes, departed for home with Mom and brother.
This spontaneous report as received from a nurse refers to multiple unspecified patients of unknown ages and genders. On multiple unspecified dates, the patients were inadvertently administered with improperly stored RECOMBIVAX HB, (lots and expirations were unspecified) (route: intramuscular) (incorrect product storage). The vaccine was stored at a temperature of 33 F for a time frame of 84 hours. There was no previous temperature excursion and data logger was not involved. No adverse effect reported. This is one of the four reports received form the same reporter. Additional information has been requested.