chrisvoncsefalvay/vaers-outcomes huggingface dataset:
At 3:20pm, the patient received his Janssen Covid shot and sat in the post vaccination area afterwards. At 3:23pm, another patient witnessed the patient moving strangely and noticed something was wrong with the patient, so she called out for assistance. Pharmacy technician heard the other patient and responded by asking a Pharmacist to assist a patient who is having an adverse reaction. I was the Pharmacist that responded to the incident. I grabbed the immunization caddy that contained the epi=pen and ran over to the patient. I witnessed the patient eyes rolling  back, his body jerking, and the patient was foaming in the month. I asked the technician to call 911 and the other Pharmacist on duty to call code white. As I was talking to the Pharmacist and Technician, the patient began jerking violently and the other patient tried to help the patient down on the floor because she thought he patient was having a seizure. Once the patient was on the floor, I immediately tried to assess whether he was having a true allergic reaction but his symptoms seem similar to fainting therefore, a epi pen was not necessary. A few moments later the patient came to it and sat up. He was sweating and flushed but he was responsive. We gave the patient water and an ice pack, and waited for the ambulance to arrive. The ambulance arrived 30 mins later and checked the patient's vitals. All vitals were normal and that patient refused to be taken to the hospital. The Paramedic thought the patient had Vago down symptoms which is similar to fainting but can present like a seizure. The patient left shortly after he was checked by the paramedics. The patient does not have any medical conditions or a history of allergies to  medications. The patient needed the covid shot for work. The patient was nervous about receiving his Covid shot which may have resulted in the adverse reaction he had to the vaccine.
Patient report pain in the elbow and shoulder. Has informed us that her doctor said it is because shot was given in wrong location and nerve was damaged.
The afternoon after the vaccine, pt had fever, fussiness and diarrhea. Diarrhea lasted 1 week. Follow up visit for diarrhea on 09/14/2001. Pt presented with symptoms ear infection, visited Lumberton Family Health Clinic on 09/22/2001, was given Amoxil 3 times a day for 10 days.
having elevated heart rate; dizzy/Lightheaded; blood pressure being elevated/blood pressure a little elevated; Episodes of spike in heart rate; This is a spontaneous report from a contactable consumer (patient). A female consumer of unknown age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 03Sep2021 at single dose for COVID-19 immunisation. Medical history and concomitant medications were unknown. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on unknown date for covid-19 immunisation. On 04Sep2021, the day after the vaccine, the patient started having elevated heart rate, resting 123 beat per minute (BPM); since then, the patient was having episodes elevated heart rate, blood pressure being elevated and dizzy. The patient had been trying to get in and of course no one was taking walk-ins, most appointments were booked. Pharmacist indicated because they are more like episodes rather than it being elevated consistently and uncontrollable, not thinking medical emergency. In 04Sep2021, blood pressure was little elevated, and heart rate was 123 (resting heart rate). The outcome of the events was unknown. Follow-up attempts are completed. The batch/lot number is not available despite the follow-up attempts made. No further information is expected.
Immunocompromised patient received half dose for 3rd dose; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Immunocompromised patient received half dose for 3rd dose) in a  patient of an unknown age and gender 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (Immunocompromised patient received half dose for 3rd dose). At the time of the report, ACCIDENTAL UNDERDOSE (Immunocompromised patient received half dose for 3rd dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided.  No treatment medication information was provided.  It was reported that patient received a 0.25 mL dose for their 3rd dose, instead of a full dose   Reporter did not allow further contact
pt recv vax 7 started crying in loud screaming manner;unable to calm;crying cont until 14SEP98 PM;both legs was sl swollen & pink but not painful;would vomit;sl ear infect;12-24hr of rhinorrhea, head congestion, cough, fussy, dec appetite;
This case was reported by a healthcare professional (office manager) and described the occurrence of injection site pain in a 28-year-old female subject who was vaccinated with BOOSTRIX. Concurrent medications included Cabergoline and Ortho-cept (Orthocept). On 4 April 2013 the subject received a dose of BOOSTRIX (.5 ml, unknown route, left deltoid). On 4 April 2013, less than one day after vaccination with BOOSTRIX, the subject experienced injection site pain (described as "pain under the left arm and left upper breast"). This case was associated with a product quality complaint. At the time of reporting the events were unresolved. The healthcare professional considered the events were probably related to vaccination with BOOSTRIX. The reporter documented 2 other cases with BOOSTRIX. See cases A1021182A and A1021183A for details on the other cases. Quality Assurance (QA) follow up was received on 23 May 2013. Based on the currently available safety information and the nature of the complaint. It can be concluded that there is no evidence for a safety signal concern for the batch AC52B100CA of BOOSTRIX vaccine and its similar batches. The QC investigation performed on the received sample shows that the complaint samples are conform to the specification for the description. GlaxoSmithKline Biologicals considers this complaint to be unsubstantiated.
This spontaneous report was received from a pharmacist referring to a female patient of unknown age. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On an unknown date, the patient was vaccinated with M-M-R II subcutaneously lot # M045393 with expiration date 14-NOV-2018, for prevention of measles, mumps, and rubella (dose and dosage schedule were not provided). Other suspect therapies included sterile diluent. The reporting pharmacist stated that, after having performed a post vaccination serologic test on an unspecified date, the patient had a negative immune response. At the time of the report, the outcome of the event was unknown. The causality assessment between the event and M-M-R II was not reported.
Initial information received on 06-Mar-2019 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 54 years old male patient who was vaccinated with a 0.5 ml booster dose of ADACEL (lot number: U6217AA, expiry date, route of administration were not reported) in Arm on 01-Mar-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported. It was a case of actual medication error due to incorrect product storage and deteriorated drug administered because the vaccine was delayed delivery, delayed Transit vaccine stability. No reported reactions. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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. Documents held by the sender: none.
Rash - Around Injection Site; Itchy Sensation - Around Injection Site; Diarrhea; Fever; Chills; Nausea; Muscle Aches; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), PYREXIA (Fever), CHILLS (Chills), NAUSEA (Nausea) and MYALGIA (Muscle Aches) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Jan-2021, the patient experienced DIARRHOEA (Diarrhea), PYREXIA (Fever), CHILLS (Chills), NAUSEA (Nausea) and MYALGIA (Muscle Aches). On 01-Feb-2021, the patient experienced VACCINATION SITE RASH (Rash - Around Injection Site) and VACCINATION SITE PRURITUS (Itchy Sensation - Around Injection Site). On 31-Jan-2021, DIARRHOEA (Diarrhea), PYREXIA (Fever), CHILLS (Chills), NAUSEA (Nausea) and MYALGIA (Muscle Aches) had resolved. At the time of the report, VACCINATION SITE RASH (Rash - Around Injection Site) and VACCINATION SITE PRURITUS (Itchy Sensation - Around Injection Site) outcome was unknown.
shortly after receiving the 2nd covid shot I broke out in a rash on my stomach and back. It was mostly on the the left side . I was given prednisone and it helped until the dose was reduced and then it came back.  I have used all kinds of creams and nothing helps. I never had a problem with my skin until I got the vaccine.
Information has been received from a nurse practitioner concerning a 24 year old female with no medical history or allergies reported, who on 19-FEB-2008 was vaccinated intramuscularly with the first 0.5 ml dose of GARDASIL (Lot #659657/1487U). Concomitant therapy included TRI-CYCLEN LO. On 20-FEB-2008 the patient developed a rash described as itchy, diffuse plaque on her neck, back and lower abdomen. The patient was seen at the clinic and treated with BENADRYL. No diagnostic studies were performed. At the time of the report the patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested.
She fell on the ground minutes after the two vaccinations but did not sustain any fall injuries. She appeared cohorent and conscious throughout. I immediately elevated her lower legs. Her hands felt cold. Her BP was 123/101 and HR 101. She felt dizzy, fainty and experienced shallow breathing. Her husband and her both informed me that she had previous post-vaccination episodes in the past years but did not experience the same with the TDap she received last week. Medics arrived, cleared her and escorted her to her car in 15 minutes.
Some side effects of the second shot; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Some side effects of the second shot) in a patient of an unknown age and gender 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced VACCINATION COMPLICATION (Some side effects of the second shot). At the time of the report, VACCINATION COMPLICATION (Some side effects of the second shot) outcome was unknown.            No Concomitant medications was provided by the reporter.  No Treatment medications was provided by the reporter.
The patient had fever, body aches and neuropathy.  Initially in the same arm at eh vaccine with numbness and decreased mobility.  subsequently, she developed significant eosinophilia and had more lower extremity weakness and numbness.  She needed a wheelchair to get around.  She had significant medical workup, without a diagnosis.  eosinophilia has improved slowly, as have symptoms over a period of months, but has not returned to completely normal.
Administration error: Patient receives 0.25ml dose of the Moderna vaccine, instead of receiving 0.5ml according to the guidelines established by the regulatory authority, due to the conditions and medications that he presents at vaccination day. The dose is completed with an additional 0.25 ml minutes after the administration error.
Drug effect decreased; COVID-19; COVID-19; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4431075-00 (Agency).  A 42-year-old female patient received BNT162b2 (BNT162B2), on 12Aug2021 as dose 1, single (Batch/Lot number: unknown) at the age of 42 years intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown) till Oct2021 at citrate free, subcutaneous for ankylosing spondylitis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset Dec2021, outcome "unknown", SUSPECTED COVID-19 (medically significant) with onset Dec2021, outcome "recovered" and all described as "COVID-19"; THERAPEUTIC PRODUCT EFFECT DECREASED (non-serious), outcome "unknown", described as "Drug effect decreased". The action taken for adalimumab was unknown.  The reporter considered "covid-19" and "drug effect decreased" related to BNT162b2.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the known safety profile of the vaccine  BNT162b2, a causal relation between the reported events Suspected Covid-19, Drug ineffective, Drug effect decreased and the administration of the vaccine cannot be excluded.
She began having itching/her scalp was itching so bad she thought it may be lice.; welts; Rash; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (She began having itching/her scalp was itching so bad she thought it may be lice.), URTICARIA (welts) and RASH (Rash) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012H21B, 023M20A and 030L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Dec-2021, the patient experienced PRURITUS (She began having itching/her scalp was itching so bad she thought it may be lice.), URTICARIA (welts) and RASH (Rash). The patient was treated with OATMEAL at a dose of Oatmeal baths. At the time of the report, PRURITUS (She began having itching/her scalp was itching so bad she thought it may be lice.), URTICARIA (welts) and RASH (Rash) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant information was not provided.  Treatment information was antihistamines and anti-itch creams. But the patient reported that nothing was working.   This case was linked to MOD-2022-440551.
1 week after vaccination- onset of erythematous, swollen, warm, itchy, firm rash around injection site- left upper arm
Patient experienced a seizure resulting in cardiac arrest. Witnesses described patient "began convulsing and then tipped over". AED applied with no shock advised. Unknown down time prior to initiation of CPR. Rhythm PEA upon arrival of EMS. 7 mins CPR before ROSC obtained. Initial troponin 12. 12 lead EKG without ischemic changes, arrhythmia, etc. Transthoracic echo without regional wall abnormalities or significant findings. CT of head negative for acute intracranial process. No history of seizure, cardiac issues, drug use, etc.
Patient inadvertently received vaccine after published expiration date. Moderna Company analyzed vaccine and advised  lot  007B21A maintained activity needed to protect against covid 19 on date of administration. Also patient did not call in and complain of adverse event.  This is administrative error without adverse event.
temp to 103, h/a, neck pain & back pain, knee & ankle swelling 22SEP98;
Two months since first dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Two months since first dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Two months since first dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Two months since first dose) had resolved.            The concomitant medications were not reported. The treatment information was not provided.
feels like crawling on the caller's skin, similar to neuropathy; pins and needles on her skin; feels like crawling on the caller's skin, similar to neuropathy; very slight elevation of inflammation; This is a spontaneous report from a contactable consumer (patient).  A female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection; Lot number & Expiry date not reported), via unspecified route of administration on 05Apr2021 as Single dose for COVID-19 Immunization. Patient medical history and concomitant medications were not reported.   The patient doesn't know if it is considered an adverse event but she has experienced what feels like pins and needles on her skin on an unspecoified date. It feels like crawling on the patient's skin, similar to neuropathy. The patient went to her doctor and he did blood work and she had a very slight elevation of inflammation and the doctor didn't seem too concerned, the doctor thought it was an effect of the vaccine. Patient inquired if Pfizer heard of any of this. The Patient doesn't want to get the second dose until these symptoms go away. The outcome of the reported events were unknown.  Communication: The Patient declines to file a safety report as she is heading into a doctor's appointment at this time, no further information or details were captured at this time. The Patient  would like for Pfizer to email her the contact information as she would like to talk to an agent about her questions but does not have the time to do so today. In response to it mention no information found on "pins and needles" possible AE, and refer to HCP for guidance.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Information has been received from a nurse referring to four patients of unknown age and gender. The patients concurrent conditions and medical history were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ (lot # K010222, expiration date: 12-MAY-2016 or lot K019370, expiration date: 16-JUL-2016, dose and route were unknown). No adverse effect reported. Additional information has been requested.
Redness, at injection site that is d veloping into a larger rash. Very itchy, warm and hard lump. Had a fever of 100 last night.
Patient was given a booster dose at a clinic where he works.  The patient began complaining of tingling sensation and numbness on the left side of his face.  We told him we will continue to observe him and urged him to contact his doctor.  He called his doctor while still being observed by us.  about 30 minutes after his injection, he began to cough and gag and told me he felt swelling in his throat and was having difficulty breathing.  We then called 911 and took out an epipen to use.  He refused the epipen and kept telling us to please not inject it, that he was fine.  about 10 minutes later the EMT came and took over.  His doctor also was on the phone during this entire process and told him to go to the emergency department
Flu vaccine given to employee during her shift at work. Employee reported, 1 week later, that she noticed lip swelling and lymph node enlargement in her neck area approx. 16 hours after she received her flu vaccine. She had gone home from work, went to sleep and noticed when she woke up. No breathing difficulties noted. Symptoms resolved within 24 hours with no treatment. Was not evaluated medically. History of anaphylaxis to bees and hair dye.
Covid Arm-- sore arm, redness around injection site, starting about 9 days after vaccine received
Nausea, vomiting, muscle aches, headache, low-grade fever, exhaustion
a rash started on my other arm and spread down to the elbow; got a rash by the injection sight; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (got a rash by the injection sight) and RASH (a rash started on my other arm and spread down to the elbow) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination.     Concomitant products included LISINOPRIL, METFORMIN, AMOXICILLIN TRIHYDRATE, CLARITHROMYCIN, ESOMEPRAZOLE MAGNESIUM (NEXIUM 1-2-3), CITALOPRAM and TRAZODONE for an unknown indication.    On 14-Apr-2021 at 11:00 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021 at 8:00 AM, the patient experienced VACCINATION SITE RASH (got a rash by the injection sight). On an unknown date, the patient experienced RASH (a rash started on my other arm and spread down to the elbow). On 05-May-2021, VACCINATION SITE RASH (got a rash by the injection sight) had resolved. At the time of the report, RASH (a rash started on my other arm and spread down to the elbow) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient started using Benadryl Allergy medicine twice a day and bought Cortizone 10 to both arms.   This case was linked to MOD-2021-051681 (Patient Link).
TAKEN TO HOSPITAL ER WITH BREATHING PROBLEMS LATER IN THE DAY AFTER HAVING A FLU VACCINE AND AFTER TAKING A DOSE OF NITROFURANTOIN MACROCRYSTALS 100 MG. UNSURE IF PT TOOK PYRIDIUM SHE WAS PRESCRIBED.
Patient woke up day after receiving a vaccine with a red, itchy, localized reaction. It was also painful to the touch and has an approximate size of 3 in x 2 in. She is self treating with diphenhydramine, ibuprofen, and ice.
Headache, Myalgia, HYPERtension, swelling & tingling in face& lips, trouble breathing Narrative: Right after injection, Pain from left middle finger all the way her arm, BP was high 177/110, HA, right side of face started to swell this was on 1/25/21 later that evening her lips started tingling & swelling and right side of face and head, trouble breathing . Pt did not seek medical treatment as she was afraid. EE went to EOH, swelling still there and advised to see pcp, has appointment set up. EE verbalized understanding.