chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report has been received from a medical assistant and a nurse referring to a 14 years old patient. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 28-MAY-2015, the patient was vaccinated with a dose GARDASIL (dose, route, lot # and expiration date not reported) for prophylaxis. Then the patient was vaccinated with GARDASIL 9 (dose, route, lot # and expiration date not reported) for prophylaxis on 22-JUL-2016 (interchange of vaccine products and inappropriate schedule of vaccine administered). No adverse effect was reported. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1707USA009952.
His arm where he got it has a nagging annoying pain that comes and goes and won't go away; He experienced a "rotating cup (shoulder)" on the same extremity; This is a spontaneous report from a contactable consumer (patient) via medical information team. A male patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 10Mar2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took first dose of BNT162B2 for COVID-19 immunization. Patient stated that his arm where he got it has "nagging and annoying pain" on the extremity that got the vaccine shot and that comes and goes and won't go away in Mar2021. He also stated that he experienced a "rotating cup (shoulder)" on the same extremity that received the vaccine shot in 2021. The outcome of vaccination site pain was not recovered and for shoulder discomfort was unknown.  Information on lot/batch number has been requested.
Patient was given vaccines around 2:30pm. Roughly 5 minutes later mom brought him out of the room to the nurses station and said "Something is wrong he almost passed out". He was pale in appearance. We took him back to the room and set him on the table.  He was in no respiratory distress and had no rash on his body. We offered him apple juice and before he took a sip he began to vomit. He vomited 3 times. After he vomited the Dr. came in the room and did a manual blood pressure, palpated a pule and listened to his heart and lungs. All were normal. Around 2:40 he began to get his color back and feel more like himself. Overall, his main reaction was light headed, pale appearance and vomiting.
Client received Moderna vaccines for Covid on 2/22 and 3/22/2021 at Valley Hospital, Ridgewood NJ.  Client symptomatic with sore throat, headache, cough on 8/27 and tested positive with PCR on that date.  Reported as a case of breakthrough Covid illness in a fully vaccinated person.
Tender and sore arm at vaccination site; Tender and sore arm at vaccination site; feeling of coldness that abated after a hot shower; Bad headache; Off label use; Booster dose administered; This is a spontaneous report from a contactable other healthcare professional. A 22-year-old male patient received third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0217) via an intramuscular route of administration in the right arm on 06Oct2021 at 11:00 (at the age of 22-years-old) as a single dose for COVID-19 immunisation. The patient's medical history was reported as not applicable. Prior to the 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 did not receive any concomitant medications. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an intramuscular route of administration in the right arm on 19Jan2021 at 13:00 (at the age of 22-years-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an intramuscular route of administration in the right arm on 09Feb2021 at 13:00 (at the age of 22-years-old) as a single dose for COVID-19 immunisation. The patient previously took amoxicillin (MANUFACTURER UNKNOWN) on an unknown date and experienced allergy. On 06Oct2021 at 15:00, the patient experienced tender and sore arm at vaccination site and a  feeling of coldness that abated after a hot shower. On  06Oct2021 morning, after the third dose, the patient had a bad headache. The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were taken as a result of the reported events included treatment with ibuprofen (MANUFACTURER UNKNOWN) of 400mg on an unknown date. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events tender and sore arm at vaccination site, feeling of coldness that abated after a hot shower and bad headache were resolving at the time of this report.    No follow-up attempts are possible. No further information is expected.
Injection site rt arm inflamed/tender. Resolved without medical interaction. Tylenol/cool compresses only.
Fever of over 100 degrees fahrenheit; intense chills; joint pain; arm pain at injection site; nausea; unable to concentrate/brain fog; unable to concentrate/brain fog; This is a spontaneous report from a contactable consumer, the patient.   A 28-years-old male patient received second dose of bnt162b2 (PFIZER BIONTECH COVID 19 VACCINE, formulation: solution for injection, lot number: EN6202) via an unspecified route of administration, administered in arm left on 15Mar2021 08:00 as dose 2, single (age at the time of vaccination 28 years) for covid-19 immunisation. Medical history included ADHD. The patient did not have any known allergies. Concomitant medication(s) included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL); fluticasone propionate (FLONASE); ibuprofen and sunflower lecithin. The patient experienced fever of over 100 degrees fahrenheit, intense chills, joint pain, arm pain at injection site, nausea, unable to concentrate/brain fog on 15Mar2021. The patient received first dose of bnt162b2 (PFIZER BIONTECH COVID 19 VACCINE, formulation: solution for injection, lot number: EL9266) via an unspecified route of administration, administered in arm left on 22Feb2021 19:45 as dose 1, single (age at the time of vaccination 28 years) for covid-19 immunisation. The patient did not take any other vaccine in 4 weeks. The patient did not have covid prior to the vaccination. The patient's lab data included fever of over 100 degrees Fahrenheit. The patient was not tested for covid post vaccination. The patient did not undergo any therapeutic treatment for events. The outcome of all the events was not recovered.  No follow-up attempts are possible. No further information is expected
mom reported 10APR97 10AM stated pt was running high fever of over 103, very fussy & didn't really respond;suggested to be seen by MD;inj site was observed & looked very good no redness or swelling;lethargic;poss viral infect;dx w/BOM in ER
vaccine came out on their arm; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL UNDERDOSE (vaccine came out on their arm) 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 14-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Mar-2021, the patient experienced ACCIDENTAL UNDERDOSE (vaccine came out on their arm). On 14-Mar-2021, ACCIDENTAL UNDERDOSE (vaccine came out on their arm) had resolved. Not Provided          No concomitant medications reported by reporter. Treatment medication was not reported. Action taken with mRNA-1273 was not applicable.   Reporter did not allow further contact
Information has been received from a physician concerning a 15 month old female who on approximately 08Dec2003, was vaccinated with a dose of measles virus vaccine live  (Moraten) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) . Subsequently, in Dec 2003, the pt developed fever of 102 F. Unspecified medical attention was sought. No further information is available.
Two days, post vax, complained of flu-like symtoms, fatigue, nausea, low grade fever and on 5/19/2000 pt experienced chest discomfort substernal and radiating to jaw. Rated 4/10. Dx Myocarditis.
General irritability and swelling and erythema of injection site. Area was warm to touch and resolved in 2-3 days. This swelling started on day 7 after vaccine. After the swelling resolved I developed another pruritic  irregular Erythema multiforme type rash which is now fading.
The patient was brought in to the clinic by her mother on 2/13/2020, two days after she received her 6 month immunizations. Mom reports that the patient was a little fussy the day of her vaccinations, and this was not unexpected based on her previous experience with her 2 month and 4 month immunizations. However, mom was surprised to find the patient's left thigh swollen and red on 2/12/2020, the day after she received her Pentacel and Hep B in the left thigh. Mom says she could feel hard "knots" under the skin at the injection sites on the left thigh. The right thigh appeared normal. Mom also reported that the patient has had a decrease in urine output. She reports that she typically has 2-3 wet diapers over the course of the morning, but the patient only had 1 wet diaper that morning. She reports that the patient has not had a decrease in appetite/feeding. The patient gets both breast milk and formula, and has had normal feeding behaviors. Overnight, the patient awoke in the middle of the night and was screaming/crying and this is not typical. It was hard for mom to console her but she eventually went back to sleep. The day of her examination, 2/13/2020, mom reports her urine output is still not normal, and the left thigh is looking a little better than the day before.
Initial information received on 03-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves patient who experienced projectile vomiting, fever of 101.4 and shipment of Pentacel that came in and it took greater than 2 days, while he/she received vaccine PENTACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 02-Oct-2018, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot C5590AA via intramuscular route in the right arm. The patient developed a non-serious projectile vomiting following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE. The patient developed a non-serious fever of 101.4 following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE. It was also a case of actual medication error due to incorrect product storage. (Other relevant tests included No lab test.) Final diagnosis was shipment of pentacel that came in and it took greater than 2 days, fever of 101.4 and projectile vomiting. The patient was treated with TYLENOL ER. The patient outcome is reported as Unknown for projectile vomiting, as Unknown for fever of 101.4 and as Not Applicable for shipment of pentacel that came in and it took greater than 2 days. 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.
Persistent increased level of pain and soreness to Left arm/shoulder, not relieved by over the counter Tylenol.
None- vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 041L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment information was not provided. The patient experienced no adverse events.   This case was linked to MOD-2021-395985 (Patient Link).
This spontaneous report as received from a pharmacist refers to a 60 year old female patient with Diabetes and "Epstein Barre". On 13-JAN-2015 the patient was vaccinated with a dose of ZOSTAVAX, dose of 0.65 ml, subcutaneous, lot # K016326 and expiration date of 24-DEC-2015. On 14-JAN-2015, the patient experienced pain in extremity, his arm was sore. She also experienced injection site erythema, injection site inflammation referred as "raised", and injection site warmth about the size of a half dollar. The patient sought medical attention by calling the pharmacist. No treatment was given and no lab diagnostics were performed. At the time of the report the outcome of the events was unknown. Additional information has been requested.
This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Upper arm is sore), VACCINATION SITE PAIN (Pain reached the point is now painful) and VACCINATION SITE DISCOMFORT (At the site of the injection 2 inches between elbow and shoulder in the muscle there was a normal sense of discomfort) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0BF21A, 039K20A and 013L20A) for COVID-19 vaccination. No Medical History information was reported. On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Upper arm is sore), VACCINATION SITE PAIN (Pain reached the point is now painful) and VACCINATION SITE DISCOMFORT (At the site of the injection 2 inches between elbow and shoulder in the muscle there was a normal sense of discomfort). At the time of the report, PAIN IN EXTREMITY (Upper arm is sore) and VACCINATION SITE PAIN (Pain reached the point is now painful) had not resolved and VACCINATION SITE DISCOMFORT (At the site of the injection 2 inches between elbow and shoulder in the muscle there was a normal sense of discomfort) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments. No concomitant medications were reported. Patient experienced no other symptoms, no bleeding scab or swelling. It was reported that the patient felt as if something was going on. Upper arm was sore. On a scale of 1 to 10 the patient reported that the level of pain was 3. Patient stated that it has not let up it has moved from a 2 to 4. No treatment medications were reported. This case was linked to MOD-2022-497428 (Patient Link).
This spontaneous report was received from a registered nurse concerning to an unspecified patient of unknown age or gender. The patient's concurrent conditions, medical history or concomitant medication were not reported. On 15-APR-2017, the patient was vaccinated with GARDASIL 9, intramuscular, (strength, dose, lot number and expiration date were not reported) for prophylaxis. On 19-APR-2017, four days after the patient was vaccinated, the patient went to the doctor's office with flu like symptoms, and a low grade fever. At the time of reporting the outcome for the events was not reported. The causal relationship between the events and the suspect vaccine was not provided. Additional information has been requested.
Heart rate on 5/20 of 204 until now still higher than normal between 97-116, when usually is around 80; diarrhea; cough; cold symptoms; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 14-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 19May2021 12:45 (Batch/Lot Number: EW0186) as 1ST DOSE, SINGLE for covid-19 immunization at the age at vaccination of 14 years old.  Patient was not pregnant. Medical history included prior to vaccination, the patient was diagnosed with COVID-19. Past drug reported as none. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  The patient experienced heart rate on 5/20 of 204 until now still higher than normal between 97-116, when usually is around 80 (medically significant) on 20May2021 09:45 with outcome of not recovered; diarrhea, cough and cold symptoms (non-serious) on 20May2021 09:45 with outcome of not recovered. Reported as: Heart rate on 5/20 of 204 then we took her to the urgent care was given fluid and ekg and blood work, after that HR when down to 106, and until now still higher than normal between 97-116, when usually is around 80, also she had diarrhea on 5/20, and also cough from 5/20 until now like cold symptoms. The patient underwent lab tests which included blood test: unknown on 20May2021, electrocardiogram: unknown on 20May2021, heart rate: 204 on 20May2021, heart rate: 106 on 20May2021, heart rate: 97-116 on 20May2021 (still higher than normal, when usually is around 80), sars-cov-2 test: negative on 22May2021 (Nasal Swab; Test: Pcr). The events induced Emergency room/department or urgent care. The treatment received for the adverse event included: Fluids thru IV.  Information on Lot/Batch number was available. Additional information has been requested.
Headache, Fever & NauseaVomiting Narrative:  Other Relevant History:
About one minute after receiving the injection, ( approximately 9 AM) I felt my heart rate increase to about 100 bpm, and I just did not feel right.  I told the nurses I didn't feel right, and I sat down for about 10 minutes and drank 3 glasses of water.  Initially I felt better, but then I felt weak and "not right",  so I lay down on a cot for approximately 40 minutes.  My B/P was elevated (165/95), which is very high for me.  I did not have any trouble breathing.  I continued to drink water, and eventually my B/P lowered, and I felt better.  I took an antihistamine (10 mg Zyrtec) when I arrived home at 11:00 AM, and felt very tired until about 3:30 PM,  when I felt just about back to normal.  I was assessed by an ER physician at the clinic site.
Sporadic random hives throughout body. Some mild and some severe. Finger joints sore. Inflamed red nodules on left index finger. Looks like nodules developing on other finger.
Pt presented to ER with erythema of right upper extremity including discomfort (pain=8/10) and what appeared to be cellulitis on exam. She had a syncopal episode at home and was found on the floor with no pulse (PEA) and CPR was administered briefly before the pt regained consciousness.
1st event: December 9th, 2021 seizure in the afternoon during a workout in the weight room. Lasted a few minutes. There were no signs leading up to it. Was taken in an ambulance to Emergency Room.  2nd event: January 31, 2022 seizure while sitting at desk in dorm room. Felt like he was going to pass out. Lasted a few minutes. Was taken in a ambulance to Hospital.
I was feverish, achy joints, horrible headache ,and cough. I took a at home COVID-19 test and it was positive. When I took my temperature and it was 101. My headache, body aches, fatigue ,and fever lasted for 2-3 days. My doctor prescribed me Paxlovid. I took a tylenol for the  headache. It took me 10 days to test negative.
An intern used the incorrect size needle to administer the Covid vaccine. The needle size used was a 5/8 inch needle, when the correct size that should have been used was a 1 inch needle. The correct dose was given to all patients. Based on CDC recommendations, there is no need to revaccinate any patient that was administered the dose in the wrong location; in this case the vaccine was given SubQ rather than intramuscular, based on the length of the needle. All patients were notified of this error and were given advise on what to expect. All patients were informed that no harm was done, the vaccine was still effective, and no additional dose is required based on CDC guidelines. As a result of these errors, reeducation was given to the pharmacy student, and the area within the pharmacy that contains all vaccination related supplied were relabeled to make it more clear for everyone administering vaccines.
pt recvd vax 26JUL95, had ear infect but afeb @ that time;31JUL95 saw MD for 2nd ear infect was restarted on ATB, that evening had grand mal sz;mom phoned MD that evening pt was not evaluated;
Common variable immunodeficiency presenting as lymphonodular hyperplasia pernicious anemia and breast cancer. Journal of Allergy and Clinical Immunology 2006:S110-S110. Information has been received from a published literature abstract concerning a 56 year old female with a history of treated right breast cancer 7 years prior, now in remission, presented with weight loss, anorexia, and loose stools. She was previously well, without fevers. She was a nonsmoker, had no history of recurrent infections and had no significant family or environmental history. Initial workup revealed a macrocytosis and she was found to have pernicious anemia. Chest x-ray was negative. EGD showed diffuse, circumferential, nodular thickening of the entire duodenum. Biopsies showed non-specific inflammation. Colonoscopy was normal. Small bowel series and abdominal CT with contrast showed similar appearance of entire small bowel without lymphadenopathy. Jejunal biopsies showed lymphonodular hyperplasia. IgA was <15 mg/dL, IgM was 19 mg/dL, and IgG was 687 mg/dL. She was protected to tetanus but had no protection to pneumococcus, despite vaccination attempts with both conjugated and unconjugated vaccines (manufacturers unknown). Sinus CT showed mild pan-sinusitis. Chest CT showed right upper lobe ground glass infiltrate. Lung biopsy revealed metastatic breast cancer. The patient was diagnosed with pernicious anemia, lymphonodular hyperplasia, CVID, and metastatic breast cancer, CVID has been associated with all of these conditions. The patient never experienced the infections so commonly seen with CVID. The workup leading to the final diagnosis stemmed primarily from the discovery of lymphonodular hyperplasia. Upon internal review, the patient's breast cancer metastatic was considered an other medical event (OMIC). No further information is available. A copy of the published literature abstract has been attach as further documentation of the patient's experience.
Pt reports that deltoid is still swollen and sore. It is not red, however.