chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient was sitting in a chair during monitoring period. Patient fell out of chair onto the floor on their face. He had lost consciousness. Monitoring personnel reported the event to the pharmacy. The pharmacist grabbed the first aid kit and blood pressure machine to assess the patient. The patient was no conscious and speaking. Color was pale. Pharmacist assessed client and gave them water to drink and snacks to eat. Client said they were looking at their phone and then were all of a sudden looking at the carpet. Pharmacy called EMS during this assessment. Patient had stated he was feeling warm. A nurse with the clinic in the building came to assist. The nurse took the clients blood pressure and it was 115/74, pulse 62 and oxygen was 99%. Client stated they hadn't eaten for over 12 hours and had consumed large amounts of THC the night previously. The Fire Department/EMT personnel arrived and performed their assessment of the patient. They found him to be similar blood pressure and advised him if he wasn't feeling well that they could bring him to the hospital. Patient decided to stay until feeling better and then leave to home. They asked him to go to the hospital if it occurs again. Pharmacist gave client a card to call with any other events and asked the patient to not drive home and stay until they felt much better. Patient agreed and left with a friend when better.
Pain at site redness that progress in size around insertion site to tennis ball sized area that resolved after 3 days with hardness to area.
When the vaccine was injected I had immediate severe pain in my left shoulder joint. The pain was not in the site of the injection, it was in my actual shoulder joint. It was immediately extremely painful. It continued to get worse over the next month and I even had my second dose put in my opposite arm as the pain was still so bad in my left arm. The pain continued to get worse until I had very limited range of motion and no over the counter anti-inflammatories would work. I visited my primary care doctor 2 times, went to the Emergency Room once, and went to an Orthopedic Surgeon. I was given oral steroids, prescription anti-inflammatory medicine, and a muscle relaxer from my Primary doctor. The ER gave me a narcotic pain reliver and a topical ibuprofen since my stomach could not handle anymore oral. I have missed many days of work and still cannot perform daily duties
No adverse event; Received 0.5 ml  Bivalent booster dose instead of first primary Monovalent dose; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Received 0.5 ml  Bivalent booster dose instead of first primary Monovalent dose) and NO ADVERSE EVENT (No adverse event) in a 67-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7164B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 27-Sep-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 27-Sep-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Received 0.5 ml  Bivalent booster dose instead of first primary Monovalent dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Received 0.5 ml  Bivalent booster dose instead of first primary Monovalent dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        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 WRONG PRODUCT ADMINISTERED (Received 0.5 ml  Bivalent booster dose instead of first primary Monovalent dose).    Concomitant medication was not provided.  Treatment information was not provided.
injection site feels sore; I feel chilly and numb; I feel chilly and numb; This is a spontaneous report from a contactable consumer or other non hcp (patient) from a Pfizer-sponsored program  Support. A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 12Feb2021 at dose 2, single for covid-19 immunisation. Medical history and concomitant medications were not reported. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date at dose 1, single for covid-19 immunisation. On an unspecified date in 2021 the patient experienced injection site feels sore, i feel chilly and numb. Verbatim and Event Description: Took a second shot yesterday, the injection site feels sore and I feel chilly and numb. Can I take Tylenol. Outcome of the events was unknown.  Information about lot/batch number has been requested.  Follow-up (11May2021): Follow-up attempts completed. No further information expected.
had two strokes; This is a spontaneous report from a Pfizer sponsored program. Received from a non-contactable consumer (patient's husband). A female patient of an unspecified age received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), at dose 1, single for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient had first vaccine and had two strokes and had to go to the hospital. Patient had stroke after first vaccine. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pts shoulder and hand are slightly swollen. Pt reports moderate shoulder pain but otherwise no pain, just swelling. Pt still has full function of right hand.
I have  intense sensation of pins and needles with body temperature changes.  For example, when I start exercising the pins and needle sensation begins about 5 min into exercise.  If I get into a warm car after being outside this is another time I feel a strong pins and needle sensation.  The feeling is primarily in my trunk, but at times I feel them on my face and head as well.
vomiting by 9PM fell asleep; breast fed 1 hr later; labored or noisy breathing during noc; no APAP given according to mom; fever 102 11AM; described as pale & lethargic;
Moderna COVID?19 Vaccine EUA  Patient received her first dose of Moderna on 2/10/2021. On 2/11/2021 she developed chills and fever of 104. She was sent to Hospital. Was admitted and chest Xray showed patchy spots suspicious of pneumonia. She remained inpatient for two days with antibiotic treatment. Was discharged home on 2/13/2021 with oral antibiotic and follow up appointment with pulmonary.  PCR and rapid COVID testing while inpatient was nagative for COVID-19
Diagnosis of Myocarditis by cardiologist following 3rd injection. Symptoms of spiking hypertension after 1st vaccination,
Arm sore for a few days, then about a month later, the arm started to hurt and itch, a hard knot was at sight. Then I started to notice that I had a rash under my breast, stomach, and in my private area as if I have been burned and the skin is fragile and easy to scratch.  One day while taking a shower, I accidentally scratch my inner thigh, and it turned into a second-degree burn formation that took a while to heal, and the area is still very tender.
Rash Narrative:  Developed ~1x1 inch well circumscribed rash at injection site within 4 hours of vaccination, lasted for another day. Described as warm to touch, indurated, and erythematous. No other adverse effects noted, no therapies tried or applied.
After receiving the vaccine, I woke up the next morning with swollen lips and swollen and extremely itchy vagina around the labia. My labia and vaginal area was so swollen that I had weeping edema for the next 2 weeks.  When I got COVID in January I again woke up with swollen lips and face that was not relieved by Benadryl.
11/07/2021-11/09/2021 Severe dizziness with upper and lower extremity numbness causing ER visit, severe fatigue slept for two days straight, sore throat, headache, neck and shoulder pain, lower extremity joint pain and kidney pain
Systemic: Flushed / Sweating-Medium, Additional Details: at 12:25pm had extreme sweating, BP at 12:31pm was 137/87 pulse of 82, turned fan on for patient and had her elevate legs. Patient felt better at 12:40pm and left, advised no to drive until felt better.
This spontaneous report as received from a physician via company representative refers to a baby of less than 10 days old. The patient was born with many congenital heart anomalies. Drug reactions/allergies were unspecified by the reported. No demographics were provided for the baby. On an unknown date, the patient was vaccinated with Hepatitis B vaccine (manufacturer unknown) (lot#, route, dosage not reported) (routine immunization) shortly after birth. It is unknown whether the baby was given RECOMBIVAX HB or another company's Hepatitis B product. It is also not known when or where the baby received this vaccine. No concomitant medications were reported. It was reported that the baby was born at one unspecified hospital, had heart surgery (fatal, medically significant and hospitalization at another unspecified hospital and then went to a third unspecified hospital, where the baby died (dates unspecified) (fatal and hospitalization. It is not known how long the baby stayed at any of the hospitals. After death, the parents of the baby wanted the organs of this baby to be donated. When tissues from this baby's organs were tested, it was discovered that tissues from the baby's liver were found to be positive for Hepatitis B surface antigens (fatal and hospitalization). The mother of this baby tested as not positive for surface antigens, so they determined that the surface antigens of the baby's liver must have come from the vaccine itself. The liver was rejected as an organ for donation. The physician queried and would like to have phone conversation regarding how it was possible that tissue in an infant's liver could be positive for Hepatitis B surface antigens when infants mother does not have Hepatitis B. Hepatitis B surface antigens were discovered in liver when testing to see if infant could be an organ donor. The company representative states that the infant had multiple health issues requiring surgery and it is assumed that infant had blood transfusions (fatal and hospitalization) but she was not positive (infants antibody were not positive). The outcomes of the reported events were reported as fatal. All the reported events were considered to be serious due to death and hospitalization except the event of heart surgery. The event baby had heart surgery was considered to be medically significant as per internal review in addition to hospitalization and being fatal. Additional information has been requested.
Five to ten flat, round, red, crusty patches on back of neck, both shoulders and arms, but more on left side. Most are the size of a fingertip but some are thumbprint size. They slightly itch when showering, otherwise no itching. They appear to be slowly resolving on their own, but more have developed since first noticing the effect.
Pt. came to pharmacy, 3 days after receiving vaccine w/an area approx 4" long on her arm that was still very red, inflamed warm, and she said beginning to itch. Advised pt to apply ice and possibly take BENADRYL. Pt stated the reaction had gotten a little better. Advised pt. to call Dr. if rxn got any worse.
No adverse outcomes have occurred thus far, however, patient was given .3 mL of Pfizer BioNTech vaccine straight (undiluted).  The dose was drawn up without being reconstituted and was given to patient.  We informed patient and had PCM monitoring x45 minutes.  Consulted with Immunologist on next steps. Discussed red flag symptoms such as chest pain, racing heart, severe pain, etc. and when patient should go to the ER. Will follow up with patient in the morning to see how he feels.
102 degree fever starting about 10 hours after vaccination. The fever lasted the night of the injection, and the next two days. I was unable to sit up in bed without getting dizzy, had a headache, after walking 25 steps in my house I had to sit down due to shortness of breath and rapid heartbeat. Now, two weeks after vaccination I am experiencing a cough, syncope and occasional irregular heartbeat.
Pt contracted case of chicken pox after receiving vax. Pt was tired and had fever of 102 prior to breaking out in pox. Pt placed on acyclovir by MD.
patients's last 2 Imovax vaccinations were given in the gluteous/ no AE; Initial information received on 04-Jun-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 27 years old male patient who received vaccine RABIES (HDC) VACCINE [IMOVAX RABIES] in gluteous region.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 21-May-2019 the patient received a first dose of the suspect RABIES (HDC) VACCINE (formulation: unknown) via intramuscular route in unknown administration site. On 24-May-2019 he also received a second dose and on 28-May-2019, the patient received a third dose of the same vaccine (formulation: unknown, lot: N1G4O/M0308) via intramuscular route in Gluteus. On 04-Jun-2019, the patient received a fourth dose of (formulation: unknown) via intramuscular route in the upper arm.  It was an actual medication error due to vaccine administered at inappropriate site (last 2 Imovax vaccinations were given in the gluteous).  The patient had no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested for 1st and 4th dose.  List of document held by sender: none.
On 7/30/00, post vax, pt reported he felt ill all weekend with general malaise and fever of 101F at the highest for which he took Tylenol. On exam, 7/31/00, the area of the injection site was firm but not red, no longer reports fever. He was given ice pack to area and will alternate Tylenol and Advil for the next 2 days. On 8/3/00, he feels well now, left arm no longer sore and took only 1 dose of Advil on 7/31/00. No return of fever.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient was vaccinated with dose 1 RECOMBIVAX HB (lot # not reported) dose and route not reported on 18-SEP-2012. No concomitant medications were reported. On 25-SEP-2012 was vaccinated with dose 2 RECOMBIVAX HB (lot # not reported) dose and routes not reported and on 09-0CT-2012 was vaccinated with dose 3 RECOMBIVAX HB (lot # not reported) dose and route not reported. No adverse symptoms reported. No further information provided. Additional information is not expected.
This spontaneous report as received from a healthcare worker refers to patients of unknown ages. It was reported that VARIVAX (Merck) was exposed to temperatures below -15 C multiple times. On unknown dates, doses of the vaccines (lot # not reported) (strength and total daily dose not reported) had been administered to patients. At the time of this call, the healthcare worker did not know the exact length of time that the vaccine doses were exposed to the temperatures out of range, nor was there adequate documentation of the administration of these doses to the practice's patients. It ws unspecified whether the patients sought for medical attention. The outcome was unknown. This is one of several reports received from the same source.  Additional information has been requested.
Hospitalization: 1/13/2023 - 1/19/2023 (6 days) Presentation to the ED: generalized weakness, loss of appetite x2 weeks.  Recently hospitalized for Norovirus infection, has not fully recovered.  COVID + date: 1/13/2023 Treatment: Patient was not candidate to receive Remdesivir due to kidney function.  Discharge to: deceased 1/29/2023  EN6205 3/10/2021  FC3184 9/30/2021 FK9893 5/2/2022
Client was injected with Moderna 0.5ml LD. Incorrect dose was given. Based on client's medical condition, client was thought to be immunocompromised. Based on CDC Guidance for immunocompromised, client did not meet criteria and should have received Moderna 0.25ml as a 1st booster dose. Instead client received an Additional Dose (primary 3rd dose). At this time client has not reported any adverse events.
Narrative: Pt was a 92 YO male seen by palliative care service with a PMH of tricuspid valve regurg, diastolic HF, pulmonary HTN, CKD, hypothyroidism, anemia, BPH, arrhythmia, HTN, and HLD. Per record system, agency was notified of pt's death by NOK.
huge lump the size of a baseball; the lump is red.; She had a headache. This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (huge lump the size of a baseball), ERYTHEMA (the lump is red.) and HEADACHE (She had a headache.) 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 fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SWELLING (huge lump the size of a baseball), ERYTHEMA (the lump is red.) and HEADACHE (She had a headache.). At the time of the report, SWELLING (huge lump the size of a baseball), ERYTHEMA (the lump is red.) and HEADACHE (She had a headache.) outcome was unknown.            Concomitant medications was not provided by the reporter. Treatment information was not provided.   Reporter did not allow further contact
8 days following MMR patient required ER visit for febrile seizure patient had evidence of upper respiratory infection and otitis media on exam.
Shortness of breath, dizziness, nausea occurred between the hours of 2:30am-10am
Swelling at injection site which got worse on 9/16/09 then better on 9/17/09. Also itching around the injection site.
Employee states that after receiving her Zoster on Thursday morning, that afternoon her arm became hot, red with big red splotches at the injection site. States on Sat. and Sun. she experienced numbness. States called her Dr. on Sat. and reported it and was given inst. for comfort measures and reporting.
5 yo pt received 4-6 yo shots on 5/18/06. Dad brought her in on 05/22/06 with slight swelling and redness to right thigh. Vital sign wnl. No difficulty breathing. Dr notified. Prescribed prednisolone and Triamanolone cream. Pt Dc'd in no distress.
I had a colposcopy on June 25. Then that's went the did EKG and said that my heart was out of rhythm. I went to see my cardiologist. He put me on two medicines. One a blood thinner. He scheduled me a cardio vision on this past Friday, August 27. I will see my cardiologist tomorrow, August 31 at 11 am to see what the next step is.
Day after shot was horrible. Thought I was getting better. Muscle and joint pain not gone away. Muscles burn and weak just walking and doing regular daily activities.
16 year-old Pt given Moderna booster rather than Pfizer booster on 12/21/2021. Contacted CDC for recommendations and waiting further instruction.
Asymptomatic. Tested Covid Positive 4/17/21 due to required Covid test before colonscopy
swollen lymph node in left shoulder; swollen lymph node in left shoulder that moves and was painful first couple days; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in the left arm on 26Mar2021 at 14:45 (at the age of 60-year-old) as a single dose for COVID-19 immunisation. The patient medical history included GERD, blood pressure high, clot blood and the patient was allergic to albuterol. Concomitant medications included xerolto (MANUFACTURER UNKNOWN), bystolic (MANUFACTURER UNKNOWN) and pantoprazole (MANUFACTURER UNKNOWN) taken with in two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6203) via an unspecified route of administration in the left arm on 05Mar2021 at 14:45 (at the age of 60-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any vaccination within four weeks prior to the COVID-19 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 27Mar2021, the patient experienced lymphadenopathy and lymph node pain. The patient reported that she had swollen lymph node in left shoulder that move and was painful first couple days but subsided, still swollen but less so one week later. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events lymphadenopathy and lymph node pain were resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Adverse Effects- Muscle pain, Arm Pain, LICHEN PLANUS upper thigh area and other areas, stomach pain, tinnitus, headache, insomina, fever, cough, cold sweats, chills, runny nose, sneezing, sore throat, sleep apnea, bradypnea, strained eyes, itching, confusion, loss of appetite, flank pain, neck pain, neck spasms, upper leg spasms
Severe migraine. Stuffy nose. I have experienced only one migraine before in my life, 34 years ago. This one included flashing lights, smell and sound aversion and upset stomach. This was in addition to body aches, fever. Well beyond a headache that the CDC lists as a possibility.  I also experienced a stabbing sensation in my shoulder blade after the first injection.  This lasted for 3 weeks. I currently have one after this second dose. It is manageable, but not indicated on the CDC list.  It is not an "ache" - it's a stabbing sensation. My mother also received the Moderna vaccine and I just found out she too had a migraine in addition to other symptoms.  I don't mind the aches and pain and fever and potential headache.  But this was a terrible migraine in a person not prone to migraines.
Patient stated he was extremely tired.  Spouse stated he was not responding normally. Has a pituitary glad issue and has emergency steroids, but did not have with him or use in advance. Spouse was uncomfortable with how he was not acting normal. EMS was called  at 12:00 pm due to history and at request of spouse.  EMS arrived at 12:10 pm and transported at 12:26 pm. Vitals: 164/90 HR 40 blood glucose 137 170/92 HR 42 Ox sat 97%