chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Ongoing headache and light sensitivity. Began day 3. Gets progressively worse as the day goes on. Tylenol alone is ineffective. Tylenol  3 works.   The left side of my neck - the node under my chin/ear area was tender to the touch for 5-6 days. Very uncomfortable to turn my head and the pain interrupted sleep at night.  The tenderness is still noticeable still today but not painful or causing sleep interruptions. Tenderness at the injection site for the first couple of days has subsided but the redness, swelling, and now "hot" to the touch (Temp 102.5 at the injection site) continues still 3.10.21,  which is 10 days after injection.
Initial unsolicited report received from a consumer via other company (Pfizer) on 03-Oct-2016. Manufacturer Report Number: 2016444837. This case involves a female patient (age not reported) who was vaccinated with FLU SHOT (manufacturer: unknown) (batch number, expiry date reported as unknown, dose, dose in series, route and site of administration were not reported) on an unknown date. The patient's medical history and Concomitant medications were not reported (reported as none provided). On an unknown date, following the vaccination, the patient got a touch of the flu and lung cancer. The patient's laboratory data (reported as none provided) and corrective treatment was not reported. The outcome of event: flu was not reported. It was reported that patient died 11-year ago and cause of death was lung cancer. List of documents held by sender: none. Sender's Comments: This is poorly documented consumer case where influenza was reported after administration of influenza vaccine and patient died due to lung cancer. However detail autopsy report, date of death, onset of lung cancer and administration date would be helpful to assess this case further. According to provided information no conclusion can be drawn. Reported Cause(s) of Death: lung cancer.
Approximately 8 hours after vaccine administration baby developed dumplings, coughing and difficulty breathing. Was taken to hospital by ambulance and admitted for 24 hours for observation. Discharged home with diagnosis ALTE.
This spontaneous report as received from a pharmacist refers to a newborn female patient of unknown age. On 17-OCT-2012 22:29, 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 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.
7FEB91 experienced neuralgia lt forearm & lower back area; 13FEB91 severe headache progressing to OD pain dx'd as optic neuritis;
20 mins after injection, pt had sensation of tongue & lip edema. No visible swelling noted. 50 mg Benadryl given with relief of symptoms about 45 mins later. No other complications or side effects.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in a 84-year-old female patient who received BOOSTRIX (batch number B4SD9, expiry date 24th September 2017). Concomitant products included FLUZONE. On 20th October 2015, the patient received the 1st dose of BOOSTRIX (intramuscular) .5 ml. On 20th October 2015, immediately after receiving BOOSTRIX, the patient experienced injection site swelling. On an unknown date, the outcome of the injection site swelling was recovering/resolving. It was unknown if the reporter considered the injection site swelling to be related to BOOSTRIX. Additional details provided were as follows: The healthcare professional reported that, the patient has received a dose of BOOSTRIX and experienced an injection site reaction. The healthcare professional reported that, this occurred right away after vaccination. According to the reporter the vaccine was given in the left deltoid and the site swelled and appeared to have a large bubble or a non-fluid filled nodule. At the time of reporting, the event appeared to be improving.
This spontaneous report as received from a medical assistant refers to a 13 years old female patient. On 20-JUL-2012, the patient was vaccinated with the first dose of GARDASIL (lot # 672721/0101AE, expiration date: 10-OCT-2014 00:00). No other co-suspects were reported. No concomitant medications were reported. On the same day the patient had an episode of syncope following the vaccination. The medical assistant reported that about 3 to 5 minutes after receiving the first dose of GARDASIL the patient became dizzy and fainted. The patient was laid dose and about 30 seconds later the patient's eyes rolled back into her head and the patient's body became stiff (The eyes rolling back into the head and body stiffness lasted for about 30 seconds total). The patient sought medical attention at office and was recovering at the office at the time of the call. Additional information has been requested.
joint side effects; This spontaneous case was reported by a consumer and describes the occurrence of ARTHROPATHY (joint side effects) in a male 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ARTHROPATHY (joint side effects). At the time of the report, ARTHROPATHY (joint side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.   No treatment and laboratory information was provided.
Really weak after the 1st dose; Fever of upto 101 F after the 1st dose; Chills after the 1st dose; Arm pain at injection site after the 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Really weak after the 1st dose), PYREXIA (Fever of upto 101 F after the 1st dose), CHILLS (Chills after the 1st dose) and VACCINATION SITE PAIN (Arm pain at injection site after the 1st dose) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037a21b) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Mar-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 ASTHENIA (Really weak after the 1st dose), PYREXIA (Fever of upto 101 F after the 1st dose), CHILLS (Chills after the 1st dose) and VACCINATION SITE PAIN (Arm pain at injection site after the 1st dose). The patient was treated with PARACETAMOL (TYLENOL) for Symptomatic treatment, at an unspecified dose and frequency. At the time of the report, ASTHENIA (Really weak after the 1st dose), PYREXIA (Fever of upto 101 F after the 1st dose), CHILLS (Chills after the 1st dose) and VACCINATION SITE PAIN (Arm pain at injection site after the 1st dose) 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.
pt recvd vax & 24JUL92 devel hives on palms & chest; No further details were provided;
Arm swollen and discolored (bruise coloration) from below shoulder to elbow. Mild discomfort
Information has been received from a registered nurse concerning a 65 year old female patient with no known drug reactions/allergies or pertinent medical history who on 15-SEP-2009 was vaccinated with PNEUMOVAX 23 (Lot # 665423/1295Y a varicella virus vaccine live (Merck) number. The information was provided to the registered nurse by a patient's friend. There was no concomitant medication. The nurse reported that in September 2009, the patient developed swelling in the injection arm and was "really sick". No lab tests were performed to this patient. It was noted that the patient refused to go to the emergency room. At the time of the report the patient had not recovered. Additional information has been requested. This is one of two reports received from the same source.
COVID positive test; COVID positive test; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group.  An 11-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12Nov2021 as dose 1, single (Lot number: FK5618), on 03Dec2021 as dose 2, single (Lot number: FK5618) and on 11Jun2022 as dose 3 (booster), single (Lot number: FL8094) at the age of 10 years, all intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 05Sep2022, outcome "not recovered" and all described as "COVID positive test". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (05Sep2022) Positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19. Clinical course: Patient did not have covid prior vaccination. Patient covid tested post vaccination.
PATIENT RECEIVED 0.2 ML PFIZER (MAROON CAP) AGE 6M TO 4 YEARS UNDILUTED ADMINISTERED. CONTACT PFIZER CASE #EFD1P2YN. PATIENT CONTACTED @10:30 AM NO ISSUES WILL F/U BY NURSING FOR 24 H (GO TO ER IF ISSUES). 08/08/2022 No Issues- Patient is doing well.
High temperature for 12 hours, extreme fatigue, sweats, chills, severe headache. All symptoms lasting 12
p/vax returning home from getting vax pt screamed for 5-6hr-ok since
This spontaneous report was received from a physician, via company representative, and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant therapies, drug reactions or allergies were not reported. On 12-MAY-2016, the patient was vaccinated with an improperly stored PNEUMOVAX 23 10 PK, lot # L002310, expiration date 08-JUL-2016, at a dose of 0.5 ml (route and anatomical location of administration were unspecified). The vaccine underwent a total temperature excursion, of 48 hours. The highest recorded temperature was 47 Fahrenheit degrees (8.333333333 Celsius). The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator(R)". No adverse effects were reported. No Product Quality Complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
FLASH PULMUNARY EDEMA, HYPOXIA (O2 SAT IN 60S)
on Tuesday 05/18/2021 i take my 2th dose of Vaccine and on 05/19/2021 at around 2100 pm i start to develop high fever at 103-104 with abdominal cramps, same way i was on the 05/20/2021 and on Friday morning 05/21/2021 i start bleeding with large clots and wasn't able to get from the bed, and around noon my waters broke following with a lot of blood and clots,i had to deliver my baby girl at home at 15 weeks, 911 was called, because the placenta didn't come out, so i was rushed to the ER Baby was Delivered at 13:30pm
Fever, chills, rashes, CP, fatigue, diarrhea, congestion, pain at injection site and numbness to left arm
Pt. had fever 100.4 degrees (Ax) and was very fussy since 7 PM on day of vaccination. Pt. was seen in the office on 4/5/12 noon, pt. referred to E.R. for further evaluation. Pt. had a full sepsis work-up.
The Moderna vaccine was administered in an "off-label" status, the patient is 17 years old. She has not any adverse reaction to the vaccine within 24 hours of the administration. Per the CDC recommendations, we will administer the 2nd Moderna vaccine in 4 weeks on April 26, 2021.
Vial left in refrigerator for more than 30 days; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vial left in refrigerator for more than 30 days) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048C21A and 036A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vial left in refrigerator for more than 30 days). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vial left in refrigerator for more than 30 days) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications or treatment details were reported.   This case was linked to MOD-2021-355908, MOD-2021-355908 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 18-Oct-2021: Patient demographics and second dose details were updated
I have symptoms of stiffness in my left thumb and swelling and it was a rheumatoid arthritis perhaps. So my doctor did some blood tests at the time and the ANA came up positive. I'm not sure if it was positive last year either just because I haven't had any blood work done. I didn't have any treatments done for it and I did have an x-ray done for my hand. I do have an appointment in February to follow up with a rheumatologist. I did have an ANA test done in 2017 that was negative, so this is new for me.
This spontaneous report as received from a licensed vocational nurse (LVN) refers to a 4 month old male patient. Patient's medical history included vaccination on 11-JUN-2014 with the first dose of ROTATEQ (2 ml, orally, lot # J022342), first dose of DTAP HBIP (default manufacturer GlaxoSmithKline reported as "GSK") (0.5 ml, right thigh, lot #2G437), first dose of HIB (default manufacturer: Sanofi reported as "AVP") (0.5 ml, left thigh, lot # U1045AA) and with first dose of PCV 13 (default manufacturer: Pfizer reported as "PFI") (0.5 ml, left thigh, lot # H08094). Patient had no history of chickenpox. On 11-AUG-2014 the patient was vaccinated with second dose of ROTATEQ (dose: 2 ml, orally, lot # J011342) which was improperly stored. Concomitant therapies included DTAPHBIP, HIB and PCV13. On 30-OCT-2014, the patient experienced patient received third dose of ROTATEQ (dose: 2 ml. orally, lot # J013589, expiration date: 06-JUN-2015) which was improperly stored. Concomitant therapies included DTAP HBIP, HIB and PCV 13. No adverse symptoms were reported. No product complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
A report has been received from a Health Professional concerning a 3 year old, Female subject, who had been receiving Nasal FLUNIST. FLUMIST started on 26-Dec-2012. The reporter reported that patient was administered expired FLUMIST on 26-Dec-2012. The outcome of the event of ADMINISTERED SIX DOSES OF EXPIRED FLUMIST is unknown. The report was considered to be non-serious.
Swollen, red itchy arm at the visible injection site. itchy eyes and sinus drainage
nausea; vomiting; headaches; chills; fever; Pain; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (nausea), VOMITING (vomiting), HEADACHE (headaches), CHILLS (chills) and PYREXIA (fever) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included LOSARTAN POTASSIUM (LOSATAN), AMLODIPINE and ATORVASTATIN CALCIUM (LIPITOR) for an unknown indication.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced NAUSEA (nausea), VOMITING (vomiting), HEADACHE (headaches), CHILLS (chills), PYREXIA (fever) and PAIN (Pain). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form. At the time of the report, NAUSEA (nausea), VOMITING (vomiting), HEADACHE (headaches), CHILLS (chills), PYREXIA (fever) and PAIN (Pain) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 21-May-2021: Follow up was received on 21 may 2021  non significant case included no new information
Around 2am on 1/8/2021 I woke up having chills, nauseas, fever, dizzy felt like I was going to faint, foggy head, very fatigue, shaky weak legs & body aches. The chills, body aches, fevers & dizziness were under 48hrs. The other symptoms lasted till 2 days before I got my second dose.  Tight Chest going on but I think it might of been anxiety.  Phone consult with doctor and prescribe some steroids.
Psoriasis of scalp; NERVE PAIN WAS GENERATING FROM BACK TO LEFT LEG; ARTHRITIS; This spontaneous case was reported by a consumer and describes the occurrence of PSORIASIS (Psoriasis of scalp), NEURALGIA (NERVE PAIN WAS GENERATING FROM BACK TO LEFT LEG) and ARTHRITIS (ARTHRITIS) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    The patient's past medical history included COVID-19 in January 2021.   On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced PSORIASIS (Psoriasis of scalp), NEURALGIA (NERVE PAIN WAS GENERATING FROM BACK TO LEFT LEG) and ARTHRITIS (ARTHRITIS). At the time of the report, PSORIASIS (Psoriasis of scalp) and ARTHRITIS (ARTHRITIS) outcome was unknown and NEURALGIA (NERVE PAIN WAS GENERATING FROM BACK TO LEFT LEG) had not resolved.            No concomitant medication information provided.  The reporter's causality for the event(s) of COVID, PSORIASIS ON SCALP and NERVE PAIN WAS GENERATING FROM BACK TO LEFT LEG with SKYRIZI(RISANKIZUMAB) was no reasonable possibility. The reporter's causality for the event(s) of ARTHRITIS was not provided.  No treatment medication information provided.  Company Comment: This spontaneous case concerns a 60-year-old female patient with no relevant medical history reported, who experienced the non-serious of Arthritis and non-serious events of Psoriasis (Psoriasis of scalp) and Neuralgia (nerve pain was generating from back to left leg) unspecified days after receiving the third dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 60-year-old female patient with no relevant medical history reported, who experienced the non-serious of Arthritis and non-serious events of Psoriasis (Psoriasis of scalp) and Neuralgia (nerve pain was generating from back to left leg) unspecified days after receiving the third dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Get pneumonia; Get pneumonia; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A patient (no qualifiers provided) received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), on 13Nov2013 as dose number unknown, single (Batch/Lot number: unknown) for immunisation; for immunisation; pneumococcal vaccine (PNEUMOCOCCAL VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), PNEUMONIA (medically significant) all with onset Apr2023, outcome "unknown" and all described as "Get pneumonia". Clinical course: The patient had 2 pneumonia shots which the patient think would go back to about 10 years before. The patient had a Prevnar on 13Nov2013. Ironically back in April of this year (Apr2023) the patient did get pneumonia.  The information on the batch/lot number for pneumococcal 13-val conj vac (dipht crm197 protein), pneumococcal 13-val conj vac (dipht crm197 protein)  has been requested and will be submitted if and when received.
No adverse event; Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial(10 mcg) instead of blue cap vial(25 mcg), when blue cap was indicated; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial(10 mcg) instead of blue cap vial(25 mcg), when blue cap was indicated) and NO ADVERSE EVENT (No adverse event) in a 7-month-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 214K22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 20-Apr-2023, the patient received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 10 microgram. On 20-Apr-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced WRONG PRODUCT ADMINISTERED (Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial(10 mcg) instead of blue cap vial(25 mcg), when blue cap was indicated). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial(10 mcg) instead of blue cap vial(25 mcg), when blue cap was indicated) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      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 (Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial(10 mcg) instead of blue cap vial(25 mcg), when blue cap was indicated).    The route of administration of suspect Moderna bivalent was reported as BI. Patient had dose 1 Moderna Monovalent (25 mcg) on 23 Mar 2023 (Lot number AS1903B). Concomitant medications were not reported.  No treatment information was provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-730780 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-730780:Master case,
Vaccination Error. 10 year old patient received Pfizer BioNTech vaccine. Patient was observed for 30mins with no adverse reaction noted.