chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No further AE; temperature excursion involving multiple lot numbers for GARDASIL 9, MMR II, ROTATEQ, and RECOMBIV AX. Many of the vaccines have been administered to patients; This spontaneous report was received from a practice manager and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 17-SEP-2020, the patient was vaccinated with an improperly stored dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB), 1 injection, lot # S022584, expiration date: 31-OCT-2021 (injection site and route of administration were not provided) for prophylaxis.  On 04-AUG-2020, the administered dose experienced the temperature excursion of below 2 degrees Celsius (C) (1.1 C) for 27 hours and 45 minutes and above 9 degrees Celsius (9 C) for 1 hour and 15 minutes. The digital data logger was involved in recording the temperature excursion details. No previous temperature excursion had occurred. No further adverse events (AE) were reported.  This is one of multiple reports received from the same reporter. combinationproductreport: Yes; brandname: RECOMBIVAX HB SYRINGE (DEVICE); commondevicename: Hepatitis B Vaccine (Recombinant); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S022584; expirationdate: 31-OCT-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2010USA001083:Same Reporter
Patient was good when she got the vaccine and said feeling ok . she was directed to the sitting area. she sat there for 10 mins. while waiting she started to sit down on the floor bending like praying on the floor, she vomited saliva out. she did not ate her Breakfast. She was sweating and really anxious initially she said it was itchy but then she said no itching . Looks like panic attack. she was worried and embarrassed by the situation and started worrying about it. I put her some ice on the back, gave her some water and she was really weak and she want to ear some pretzel. gave her some pretzel to eat. she was ok. EMT came and observed her she had normal BP and heart rate. No allergic reaction she said she want to go home after 30 mins of observation. she walked out with  EMT. she was good just little embarrassed by the situation. More like Panic attack. I called and followed up with her she is just doing fine and happy. she actually doing great by 4:30 pm today.
Patient received influenza vaccine at 5PM and developed eye and hand itching at 8PM.  Patient awoke at 4 AM next morning with angioedema of the lip.  Took Claritin with eventual resolution.
About 6 months after vaccination I developed numbness & tingling in the L arm. This progressed to complete paralysis of the left arm and an eventual diagnosis of Parsonage Turner Syndrome/Brachial plexus neuritis. I was encouraged by a V-Safe representative to complete a VAERS.
I was sitting calmly as weekend classes were ending.   I experienced a rapid heart rate followed by numbness in hands, legs and eventually face.  I couldn't walk or breathe.   I was transported to the hospital by ambulance and was told by the paramedics that I was having a panic attack.
ecchymosis, flu synd, herpes simples, h/a; possibly due to the Thimerosal;
No adverse event; 2nd dose given 3 weeks after the 1st dose; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose given 3 weeks after the 1st dose) and NO ADVERSE EVENT (No adverse event) in a 4-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. AS1416B and AS1416B) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Jul-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 10-Aug-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 10-Aug-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose given 3 weeks after the 1st dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose given 3 weeks after the 1st dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose given 3 weeks after the 1st dose).    Concomitant medication details were not reported by the reporter. Treatment details was not reported by the reporter.
No additional AEs; HBP called in and reported that the improperly stored vaccine was administered.; This spontaneous report was received from a office manager referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications and previous drug reactions or allergies were not reported.   On 13-OCT-2022, the patient was vaccinated with a improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection (lot number W011622 was verified to be a valid number, expiration date reported and established as 06-APR-2024) (dose, strength, route of administration, anatomical injection site and vaccination scheme were not reported), administered for prophylaxis, that underwent a temperature excursion of -14 Celsius degrees up to -10 Celsius degrees (-11.9 Celsius degrees) for 42 minutes (product storage error). There was no previous temperature excursion. No additional adverse events were reported.; Sender's Comments:  US-009507513-2210USA005741: US-009507513-2210USA005648: US-009507513-2210USA005639:
Started evening of 10/5, swelling of arm. Woke up in morning w/swelling and redness. She said it felt like a bad sunburn. She called the pharmacy on 10/7, told her to ice and Ibuprofen. By 10/9, swelling and redness have gone down.
Patient broke out in a rash one hour after receiving injection - went to ER on 10/12 - received Rx for treatment. The morning before she got flu vaccine, she saw her PCP for questionable rash on face.
10 days after injection, I started having ringing in my ears. It is a high pitch ringing in both ears that is constant. I've never had this before and continue to have it to this day.
Pt was given pfizer monovalent Covid vaccine on 3-9-23. Diluent was not mixed with vaccine vial before administering to pt. Lot number FT1551. Medical assistant should have mixed 1.3Ml diluent to 1 vial of vaccine, then administer .2ML dose to pt. per cdc guidelines, pt does not need to repeat dose, look for adverse reactions. Diluent (Pfizer-BioNTech COVID-19 Vaccine formulation only [orange cap and maroon cap]), No diluent, resulting in higher than authorized dose ,Do not repeat dose.? Inform the recipient of the potential for local and systemic adverse events. per cdc guidelines, pt does not need to repeat dose, look for adverse reactions.
stiffness on back and neck; pain on back; arthritis-like; riddle with muscle pain; joint aches; fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (stiffness on back and neck), BACK PAIN (pain on back), ARTHRITIS (arthritis-like), MYALGIA (riddle with muscle pain) and ARTHRALGIA (joint aches) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. Q48A421A and 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Polymyalgia rheumatica. Concomitant products included AMLODIPINE BESYLATE, CARVEDILOL PHOSPHATE, ALLOPURINOL, EICOSAPENTAENOIC ACID ETHYL ESTER (VASCEPA) and LOSARTAN for an unknown indication.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced PYREXIA (fever) and CHILLS (chills). On 01-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MUSCULOSKELETAL STIFFNESS (stiffness on back and neck), BACK PAIN (pain on back), ARTHRITIS (arthritis-like), MYALGIA (riddle with muscle pain) and ARTHRALGIA (joint aches). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency and PREDNISONE for Adverse event, at an unspecified dose and frequency. At the time of the report, MUSCULOSKELETAL STIFFNESS (stiffness on back and neck), BACK PAIN (pain on back), ARTHRITIS (arthritis-like), MYALGIA (riddle with muscle pain) and ARTHRALGIA (joint aches) outcome was unknown and PYREXIA (fever) and CHILLS (chills) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Follow up received. Updated vaccine facility ,medical history. Updated  treatment drug .Dose 1  date and batch lot .Updated dose 2 date .
Very sore arm where flu shot was given. Spread up to neck and down arm. Took ALEVE 2 x 220mg with minimal relief. Painful to move.
Myalgias - Generalized (aggravated from usual fibromyalgia) Burning sensation with pain legs Hair Loss
Erythema multiforme; This is a spontaneous report from a contactable physician. A 42-year-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 11Mar2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. There were no medical history and concomitant medications. The physician reported that a patient had severe erythema multiforme on 12Mar2021, severe rash after getting the vaccine and firmly believe it's a reaction to the vaccine. There is no other reason for him to have it. And one of the patient's questions is should he get the second vaccine. And physician's inclination was - no. But that's the situation physician wanted to report it and find out what the recommendation is for the second dose. When paraphrased the concern, reporter stated, specific rash called erythema multiforme. It's a very specific rash and the phrase that physician used, Erythema multiforme, it should always be recorded as that because it is a very specific kind of rash. It's not just erythema. Event improving. The physician gave patient prednisone, 50 mg per day and he got an additional dose, another kind of a steroid which is Decadron, 10 mg. The patient was not hospitalized for the event. Relatedness of drug to reaction: related.  Information about Batch/Lot number has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Erythema multiforme cannot be excluded.  The case will be reassessed if additional information becomes available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
IMMEDIATE PALPITATIONS  RATE 140 TO 160, CHEST PAIN. TREATED WITH BENADRLY, GLUCOCROTICOIDS AND PEPCI
Information has been received from a physician concerning a 14 year old female patient who on unspecified date was vaccinated with the first dose of GARDASIL in her pediatrician's office.  Concomitant therapy included YAZ.  After vaccination, the patient experienced "a feeling of anxiety and being emotional".  As of 11-NOV-2008, the patient had not recovered.  Additional information has been requested.
Received immunizations 8/31/07. Next day (9/1/07) child was fussy, started with diarrhea, had blood and mucus in stool. Told by triage RN to go to ER, but mom did not. Seen in office 9/5/07, no blood in stool noticed again. All results negative.
Information has been received from an office manager at a physician's office concerning a 20 year old female who was vaccinated with a first dose of GARDASIL (lot number, route and site not reported) on an unspecified date.  The patient received a second dose of GARDASIL (lot number not reported) intramuscularly on an unspecified date.  The office manager reported that the patient fainted and hit her head on a railing while making an appointment for her third dose at the receptionist desk.  The patient also became hypertensive, began seizing, and throwing up.  The patient was admitted to the hospital where she received 7 stitches.  A computed axial tomography was performed (results not reported).  The patient was admitted on 09-APR-2008 and released on 10-APR-2008.  After being released the patient is still experiencing pain at the injection site, headaches, nausea and back pain.  At the time of reporting the patient had not recovered.  Additional information has been requested.
17-year-old patient was given the first dose of Moderna vaccine; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17-year-old patient was given the first dose of Moderna vaccine) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17-year-old patient was given the first dose of Moderna vaccine). On 23-Mar-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17-year-old patient was given the first dose of Moderna vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications No treatment related information has been reported.; Sender's Comments: This report refers to a case of product administered to patient of inappropriate age (17 year old female) for mRNA-1273 (lot number 006B21A) with no associated AEs reported.
Severe abdominal pain, leading to ER visit and diagnosed with Pancreatitis. Severe pain started 30 minutes after the vaccination.
Started complaining of flu like symptoms. Temp as high as 101.8  headache, malaise, nasal drainage, sore throat, sneezing, body aches.
I am still doing chemotherapy until they can go in and surgically remove all the cancer. I went for my annual checkup, and they discovered the cancer in my lungs.
patient was administered a dose of MENACTRA, today, from an expired MENACTRA vial with no reported adverse event; Initial information received on 12-Aug-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves a 16 years old male patient who was administered a dose of meningococcal A-C-Y-W135 (D conj) vaccine [Menactra], today, from an expired menactra vial with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 12-Aug-2022, the patient received 0.5 mL dose of suspect meningococcal A-C-Y-W135 (D conj) vaccine (formulation and strength not reported; lot U6877BC, expiry date: 28-Feb-2022) via intramuscular route in the left deltoid for immunization.  On 12-Aug-2022, the patient was administered a dose of meningococcal A-C-Y-W135 (D conj) vaccine [Menactra], today, from an expired menactra vial with no reported adverse event (expired product administered) (latency : same day).  It was reported, "stated a 16 year old male patient was administered a dose of MENACTRA, today, from an expired MENACTRA vial. Caller asked, about the efficacy the dose that was administered from an expired MENACTRA vial that was administered to the patient".  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the 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 the guidelines. 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.
3 hrs p/vax ran fever 104 ax 4-6 hrs; severe local react bruise, redness; screamed high pitched acream w/o stopping x 6 hrs then for additional 4-6 hrs if rolled over on vax site;
Pt stated that she noticed within 30 minutes of the shot, as she'd headed back to work, that the shot was higher up on her arm than what she was used to. It hurt for about 2 days (typical soreness), but then in the weeks that followed, she continued to notice pain in a specific spot near the shoulder that feels more localized to where the injection was...especially upon lifting arm at shoulder.
Pt states that arm where the injection was given became red and swollen a few hours following vaccine adminstration.  Pt reports that he is unable to move his arm and was unable to sleep as any the night before.  Pt states the arm where vaccination was given is swollen up twice as big as his other arm.  I instructed the patient to go to the emergency or his physician but he stated that he did not have time to go to this doctor or the money to go to his doctor.
mild headache after the second dose of her Moderna Covid-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (mild headache after the second dose of her Moderna Covid-19 vaccine) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006B21A and 011A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included METFORMIN, AMLODIPINE and ROSUVASTATIN for an unknown indication.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, 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 experienced HEADACHE (mild headache after the second dose of her Moderna Covid-19 vaccine). At the time of the report, HEADACHE (mild headache after the second dose of her Moderna Covid-19 vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   no treatment drug was reported
Mother reports noticing the L thigh being swollen 2x normal approx. 12 noon.  Leg is favored with walking & c/o pain knee area.  To clinic to be checked.  Lt leg visibly larger than Rt & warm to touch.  Measures 3.5cm larger directly above knee when knee flexed at right angle.  Same mottled area above knee along thigh.  No bruising.  C/O pain at medial proniscus area.  Ice pack applied and advised to call PMO.
MGM reports noticing blister with small white (left arm-back) head on 01/14/07.  On 01/16/07 the blister opened and "bled a little".  Area is red, warm to touch, firm knot.  Redness measures 30 x 25 mm. Has not been treating with any medicines or ointments.  Also reports 3 additional blisters on back of neck onset 1/13/07.
Reports about an hour after getting her vaccine she noticed raspiness in voice. Noticed at lunch she felt some mild difficulty swallowing. Voice became increasingly hoarse. Did not seek medical care. Did not take antihistamine. Sx lessened. Slight residual hoarseness today.
**15 weeks pregnant. Due date 8/2/21. Second child**  I had chills, fever (101), headache, body aches, nausea and diarrhea. My arm was soar, I felt like I got hit by a Mack truck, I couldn't lift my arm.  The next two days I still had all symptoms., by Monday I felt ok.
Patient went to see her physician due to pain in arm after immunization. Physician diganosed patient with bursitis due to injection location. Patient was given steroid injection per physician. Patient was also prescribed hydrocodone/APAP 5/325mg for pain.
A report has been received from a Health Professional concerning a 1 year old, Male subject, Height: 34.0 IN; Weight: 26.0 LB, who had been receiving FLUMIST quadrivalent (intranasal). Concomitant medications included DTaP and paracetamol. Concomitant disease(s) included acute gastroenteritis. FLUMIST quadrivalent (intranasal) started on 06-Oct-2013. It was reported that consumer was inadvertently gave FLUMIST quadrivalent to a 22 month old child, that is FLUMIST was given to a before recommended age on 06-Oct-2013. FLUMIST quadrivalent (intranasal) was discontinued on 06-Oct-2013. The outcome of the event of inadvertently gave FLUMIST quadrivalent to a 22 month old child/FLUMIST given before recommended age is unknown. The report was considered to be non-serious.
Patient called and stated that she received her 2nd dose in the morning and at approximately 9:30-10 pm she experienced a surge of pain up her arm  up to her brain. She described it as a strange sensation similar to a headache but not exactly like a headache. She stated it lasted less then an hour and then went away and she had been fine since then.
blood sugar increased; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from License Party. Other Case identifier(s): 20211002640.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation; semaglutide (OZEMPIC) (Batch/Lot number: unknown). The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 immunization. The following information was reported: BLOOD GLUCOSE INCREASED (non-serious), outcome "unknown", described as "blood sugar increased". Relevant laboratory tests and procedures are available in the appropriate section. The action taken for semaglutide was unknown. Therapeutic measures were taken as a result of blood glucose increased. Additional information: A patient receiving therapy with Ozempic and Pfizer Covid vaccine reported blood sugar increased after 2nd Covid vaccine and booster, treated with increased dose of Levemir Flex Touch. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
11 days after 1sr shot, ....chills, fatigue, muscle soreness, loss of appetite,  2 days
After second shot had numbness on the left side of face approximately ten minutes after shot, was less numbness than shot one. Approximately 3 hours after shot developed hives on same area of face that was number. Hives last about 2 hours and cleared up with OTC Benadryl. Face numbness stopped about 6.5 hours  after injection