chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Received 3rd shot, but not immunocompromised; This spontaneous case was reported by an other health care professional and describes the occurrence of OFF LABEL USE (Received 3rd shot, but not immunocompromised) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017E21A, 032M20A and 024M20A) for COVID-19 vaccination.     Concomitant products included MULTIVITAMINS [VITAMINS NOS] and VITAMIN D NOS for an unknown indication.   On 07-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Sep-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced OFF LABEL USE (Received 3rd shot, but not immunocompromised). On 24-Sep-2021, OFF LABEL USE (Received 3rd shot, but not immunocompromised) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient case is crosslinked to MOD21-152897 She discloses that they are both overweight. Her son has asthma, and she has COPD and has two small nodules in the base of her right lung. No treatment medication information was provided
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Physician).  A 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Oct2021 as dose 1, single (Lot number: FE3590) at the age of 54 years for covid-19 immunisation. The patient's relevant medical history included: "Mild intermittent asthma" (unspecified if ongoing), notes: Other medical history: Mild intermittent asthma; "Known allergies: Sulfa and tree nuts" (unspecified if ongoing), notes: Known allergies: sulfa and tree nuts; "Known allergies: Sulfa and tree nuts" (unspecified if ongoing), notes: Known allergies: sulfa and tree nuts. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 23Sep2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (23Sep2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient was prescribed Paxlovid yesterday for positive COVID-19 home test. was called in to pharmacy in the evening and she took the first dose in the evening. Experienced lip swelling overnight and itching. Denied throat itching, swelling, or increased hoarseness.; Sender's Comments: As per the available information the events drug ineffective and covid-19 are possibly related to the suspect BNT162b2.
Patients guardian falsified DOB when registering for vaccination, stating the minor's DOB was 11/25/2002. Guardian consented to the vaccination. Department of Health verified with statistical records that the patients actual DOB is 11/25/2003 which made the vaccine a contraindication.  No known adverse reactions noted.
This spontaneous report was received from a healthcare worker refers to a patient of unknown age and gender. On 01-NOV-2013, the patient received an expired dose of MMR II (lot # 671103/1025AA, expiry: 30-JUN-2013). No adverse effect reported. Additional information has been requested.
I started off by having body aches and a sore throat. I took ibuprofen and that helped with the body aches but not the sore throat. I tested and was positive for COVID-19 then contacted a doctor. I went through an online link, and they sent a prescription for PAXLOVID which did help. The one thing that was horrible more than anything was the overwhelming pain and discomfit of sore throat. I have had strep throat, and this was far worse than any strep that I have ever had but it did only last for 24 hours total.
A nurse reported the occurrence of an injection site reaction in a 5 year old male who was vaccinated with Infanrix for prophylaxis. The reporter submitted a report directly to VAERS. The subject had no medical history or concurrent conditions. Concurrent medications were not specified. The subject had not experienced any adverse events following previous vaccinations. On an unspecified date the subject received his 5th vaccination of Infanrix (566B2) administered with a 25 gauge 5/8 inch needle. Subsequently, on 8/16/02, he experienced an injection site reaction characterized by a red welt on the left leg measuring 2 3/4 inches, warmth, and itching. The subject did not develop a fever. However, Tylenol was administered. Follow up received stated that the events were possibly related to Infanrix administration and the outcomes of the events were unknown. This case is considered serious (OMIC) because the reporter stated that the events jeopardized the pt or required intervention.
I woke up 05/09/2021 after receiving shot on 05/07/2021 with horizontal red lines under all of my fingernails and an indented ridge above cuticle
Pt received vaccine on 11/16/16 and said she had a high fever about 101-102 and sore arm and body aches. Took MOTRIN and saw Dr next day and her primary care said she might have had a reaction to the vaccine. Spoke to her on 11/22/16.
Localized swelling, erythema, and tenderness. Instructed pt to continue with cool compresses, Tylenol/ibuprofen, start antihistamines, and RTC is worsening or no improvement within the next 24-48 hours.
This spontaneous report was received from a registered nurse refers to a 6 month old male patient. On 03-NOV-2014, the patient was vaccinated with a dose of improperly stored ROTATEQ lot # K001716, expiry date 25-FEB-2016. The outcome of the event was unknown. This is one of the several reports received from the same reproter. Additional information has been requested.
On 2/22/2008 15:20 HB/908228 was given in divided doses in UOQ, IM.  Approximately 5 minutes post injection patient complained of "tingling and not feeling well".  Patient placed on a gurney.  B/P 140/78, Resp. 20 Denied distress.  15:28 Complained of tightness in chest and shortness of breath.  O2 Sat 100%.  Stridor started.  Epi 0.3cc given SQ.  B/P 138/76 HR 113 Reports no change.  Benadryl 50mg IM given in left deltoid.  15:31 No change.  Stridor present.  Epi 0.3cc given SQ.  O2 @3L per nasa; cannula on.  EMS called.  B/P 129/72 HR 119 and increasing up to 130. 1538 EMS here and report given.  Patient transferred to ER.
Information was received from a physician via Pfizer (reference No. W2015222779 and 4CPYZGKQ) referring to a patient of unknown age and gender. Concurrent conditions or pertinent medical history were not reported. On an unknown date, the patient went to a retail store to get their unspecified influenza virus vaccine (lot#, dose, frequency and route of administration were unspecified) and they received at the same time, PREVNAR 13 (lot#, dose, frequency and route of administration were unspecified), as well as ZOSTAVAX (also reported as ZOSTERVAX) (lot#, dose, frequency and route of administration were unspecified). On an unknown date, the pharmacist gave all three vaccines together, and the patient ended up admitted in an unspecified hospital (dates and duration of the hospitalization were unknown) because of respiratory symptoms. At the time of the report, it was unknown if the patient was still hospitalized. The outcome of respiratory disorder was unknown. The relatedness of ZOSTAVAX with respiratory disorder was not reported. This is one of several cases from the same source. Additional information has been requested.
As of 04/2/21: headaches, fatigue, chills, sleepiness, mouth sores (a lot and difficult to eat)
Chest tightness, heart  palpitations, overall "sick" feeling as described by individual
No additional information provided. No AE/ PQC reported at this time; improperly stored temperature excursion; This spontaneous report was received from a physician referring to a 11 years old patient of unknown gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medication were not provided.  From 03-JUN-2021 to 04-JUN-2021, the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (lot # 1659422 has been verified to be valid, expiration date not reported, but upon internal validation established as 04-SEP-2022) was under temperature excursion.   The storage temperature of the vaccine was below 2 degree Celsius (-51.0 C) for a time frame of 14 hours 0 minutes and 0 seconds (product storage error). There was no previous temperature excursion. No data logger was involved. On 25-JUN-2021, the patient was vaccinated with the improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (dose detail and route were not reported) for prophylaxis.  No adverse event or product quality complaint was reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1659422; expirationdate: 04-SEP-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability; Sender's Comments:  US-009507513-2107USA002504: US-009507513-2106USA008011: US-009507513-2107USA003379: US-009507513-2107USA002967:
Pain,  swelling, urticaria right arm from shoulder to area 6 inches below elbow.
16 hours later 8/19 extreme chills , fatigue, body aches everywhere and fever up to 102.5 that would not reduce.  8/20 low grade fever .   and body aches  I went back to Pharmacy 8/20 at 11 am and talked to pharmacist who said this was normal.  Missed 1.5 days of work
Initial and follow-up information has been received from a healthcare worker and a physician concerning a 46 year old male software developer with diabetes and high blood pressure who on 13-JAN-2006 was vaccinated intramuscularly (previously reported as subcutaneous), into the right arm, with a 0.5 ml first dose of pneumococcal 23v polysaccharide vaccine (lot#651321/1036P).  Concomitant therapy included metformin HCL (GLUCOPHAGE), olmesartan medoxomil (BENICAR), rosiglitazone maleate (AVANDIA) and rosuvastin calcium (CRESTOR).  On 16-JAN-2006 the patient developed a knot and swelling at the injection site.  Unspecified medical attention was sought.  On 18-JAN-2006, the patient recovered from knot and swelling at the injection site.  Follow up information received from the physician reported that the patient called the doctors office on 13-JAN-2006 at 11:42 am. to report that his right arm was swollen at injection site of pneumococcal 23v polysaccharide vaccine.  It was reported that the patient did not seek medical attention.  Additional information is not expected.
This spontaneous report was received from a medical assistant 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 23-NOV-2021, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) lot # S037498, expiration date 20-NOV-2021, 0.5 milliliter (formulation, concentration, dose number, route of administration and anatomical location were not reported) for prophylaxis (expired product administered). No temperature excursion occurred. No additional adverse event was reported.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. There was no information about the patient's concurrent conditions, medical history or concomitant medication. On or about 11-FEB-2010, the patient was inoculated with ZOSTAVAX by a physician as recommended for routine adult health maintenance for the prevention of shingles (dose, frequency, route of administration, lot number and expiration date were not reported). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 04-AUG-2012, according to the report, the patient was treated in the hospital, for a persistent and severe vesicular rash, which was diagnosed as herpes zoster or shingles. The patient was prescribed with LORTAB and Acyclovir for management of the painful symptoms and chronic pain. According to the report, as a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient did suffer and was going to continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of vaccination failure, herpes zoster, emotional distress, injury and pain was unknown. The reporter considered vaccination failure, herpes zoster, emotional distress, injury and pain to be related to ZOSTAVAX. Additional information has been requested.
Pt had previous reaction to the flu vaccine, she is not allergic to eggs, > 45 min after vaccination she became faint, vital signs monitored and were stable.
This spontaneous report was received from a 71 years old male consumer reporting on himself with no pertinent medical history, drug reactions or allergies. The patient was vaccinated with ZOSTAVAX (lot #, dose and route not reported) on 11-JUL-2012. No other co-suspects were reported. Concomitant medications included atenolol and LIPITOR. The consumer reported experiencing an itching sensation after receiving ZOSTAVAX was administered on 11-JUL-2012. Within a few days, a rash developed on the right side of his face. The rash then spread all over his body and formed "lesions". He also developed welts on his hands. The reporter mentioned that the rash was on both sides of his body. He had been seen by his physician, on 14-SEP-2012. During this visit he was prescribed triamcinolone 0.1% cream. The physician also referred him to a dermatologist, who he saw on 22-OCT-2012. During this visit he was told to stop using the triamcinolone 0.1% cream and was prescribed betamethasone dipropionate ointment. A skin biopsy was also done on the 22-OCT-2012 office visit to dermatologist (results not provided). The patient saw the dermatologist a second time on 31-OCT-2012. During this visit he was prescribed a one-week regimen of prednisone (manufacturer unknown) 20 mg, two tablets once daily. The patient stated that since he started taking the prednisone (manufacturer unknown) on 31-OCT-2012, the symptoms seemed to be slightly more tolerable. He also stated he had been taking BENADRYL (unspecified strength and amount) at night to help him sleep. The outcome of the events was reported as not recovered. The relatedness for itching sensation for the reported events was not provided for ZOSTAVAX. Additional information has been requested.
Pain shoulder to elbow & erythema 48 hours. Pt requested an appointment to be evaluated and is being seen in her PCP office today.
Local reaction on right arm at site of vaccination.  Red, raised area.  On day of vaccination member ran a low grade temperature. No treatment was given.  Patient was evaluated by provider and was released.  Local reaction to flu vaccine.
expired dose administered; This spontaneous case was reported by another health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired dose administered) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired dose administered). On 10-Jan-2022, EXPIRED PRODUCT ADMINISTERED (expired dose administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   On 06-Dec-2021, the vials with lot number 012H21B were placed in a refrigerator. No concomitant medications were provided. No treatment information was provided.
patient was given the 5 - 11 year COVID 19 vaccine and should have received the 6 months - 4 years vaccine
FEVER 101.5, and EXTREME CHILLS,  and EXTREME FATIGUE. Was really hot.  Started not feel good before bed, then extreme chills, and then fever and was really fatigued.  Stayed in bed all day the next day, was thirsty and also felt sick to my stomach in the morning but did not get sick and that went away.  I started feeling better 24 hours later and was totally fine.
pt recvd 2nd dose of vax & devel severe abdominal cramps, lower back pain, fatigue, nausea, vomiting, diarrhea & a headache; pt seen by MD; MD felt that pt exp was due to GI systemic yeast infection;
on the 24, I got 4th dose, the second booster of Pfizer (Pfizer COVID-19 booster shot) I don't know if that anything has to do then on 28 I tested positive then I take the Paxlovid on; on the 24 I got 4th dose the second booster of Pfizer (Pfizer COVID-19 booster shot) I don't know if that anything has to do then on 28 I tested positive then I take the Paxlovid on/ minor cough; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), as dose 1, single (Lot number: E1685), as dose 2, single (Lot number: EP7534), as dose 3 (booster), single (Lot number: 3OT308A) and on 24Jun2022 as dose 4 (booster), single (Lot number: PF4554) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.The following information was reported: COVID-19 (medically significant) with onset 28Jun2022, outcome "not recovered", described as "on the 24 I got 4th dose the second booster of Pfizer (Pfizer COVID-19 booster shot) I don't know if that anything has to do then on 28 I tested positive then I take the Paxlovid on/ minor cough"; DRUG INEFFECTIVE (medically significant) with onset 28Jun2022, outcome "unknown", described as "on the 24, I got 4th dose, the second booster of Pfizer (Pfizer COVID-19 booster shot) I don't know if that anything has to do then on 28 I tested positive then I take the Paxlovid on". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (07Jul2022) Positive; (28Jun2022) Positive; (03Jul2022) Positive; (07Jul2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Consumer stated, I had been tested positive since 28Jun, I was at first two days it was bad so my doctor prescribed Paxlovid they want me take like pack of 30 4 to 5 days but the past 4 days I didn't have any symptoms, but the problem was like I kept testing positive, tested this morning and it was the home test, the instant but I didn't have any symptoms. It really, I had like it was minor cough, but it was not its minor cough like other wise I am good I didn't have any symptoms at all. It was already ten days I was still positive, and I want to know why because if you were taking and I did. I think on the 24, I got 4th dose, the second booster of Pfizer (Pfizer COVID-19 booster shot) I didn't know if that anything had to do then on 28, I tested positive then I take the Paxlovid on, I started taking the Paxlovid on 29 I finished it like on like 3. I don't have Paxlovid anymore.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on plausible dose -event relationship post vaccination and no other alternate explanation the causal role of BNT162B2 cannot be excluded for the reported events.
Patient called after leaving the office after only about an hour and half with swelling and induration at injection site.  Patient states that it was very hot to touch and painful.  The size of induration was about 3-4 cm round.   We advised patient to take Benadryl,, Tylenol.  Dr. also prescribed Doxycycline 100mg  BID for 7 days. Patient is coming back into the office today for re-evaluation
Patient complained of feeling nauseous after receiving the vaccines and immediately started vomiting. Stayed with the patient as he vomited, applied cold compress, gave him cold water after. He said he felt better. In post vac for 30 minutes. Advised mom to report any additional side effect if it happens.
The next morning she had a headache and felt like she was getting sick. Arm was swollen significantly and was red. This lasted 3-4 days. The swelling had gone down but the redness appeared to spread toward the inside of her arm at 7 days later. Still has warmth and redness.
Headache, Myalgia, fatigue, chills Narrative: x1 d pain at inj site after #1 dose x3days after #2 chill headache fatigue myalgia   Other Relevant History:
Rt arm began to tingle + ache 2 hours after injection. 6-7 hours after injection ache, chills, headache + fever 101.7 8-10 hr felt chest pressure and shortness of breath similar to pericarditis pain he had 7 yrs previous.
Local symptoms- pain-discomfort, swelling. General symptoms- chills, headaches, muscle pains, joint pain, fatigue, nausea. Narrative:
Patient received a second booster (3 total) of Janssen vaccine before it got approved. Patient experienced no AEs at the time of administration. Will follow up with patient 1 day after, 1 week after, and 1 month after the shot.
Extreme lethargy, muscle pain, headache, cough, running nose, sputum production, lasting over 10 days.
Seizure : generalized stiffening with starring that lasted about 7 minutes after which her mother gave her Diastat then was taken to the ED by EMS. In the ED was found to have a temperature of 102 F, although mom had given her Tylenol ~ 6h prior to the event.
Soreness from mild deltoid to elbow - feels flush (face) - red and hot to touch - swollen - patient has had similar but less severe reaction to previous flu shot.
Left arm had flu shot, mild and small soreness at injection site. Right arm had Shingrix at approx. 10AM. By 10PM right arm was sore and swollen from shoulder to elbow, fever hit 100° by midnight. At 2AM began to have chills and body nausea, at 3AM severe abdominal cramping and diarrhea, considered ER as pain was approaching 5/5. During this profuse sweating and uncontrollable shivering, dizziness, and intense headache. Took warm shower and waited it out, by 5AM most symptoms eased. Headache eased after consuming fluids, abdominal soreness, "aftershocks" of diarrhea, and body soreness lasted for a few days.
This spontaneous report was received from a medical assistant concerning a 15-year-old patient of an unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 28-JAN-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (lot number: L027282, expiration date: 21-SEP-2017, dose, dose number, anatomical location and route of administration were not provided). The vaccine underwent temperature excursion of either +1 or -1 degree Celsius for 255.5 total cumulative hours, which was detected by a data logger. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected as all the data was already obtained.
noted inj site pain starting 3 days p/vax by 4th day pain was severe;itching 1st symptom 1wk p/inj noted feeling weakness, pain less but still considerable;pain relieved by Ibuprofen;gen weakness w/sore muscles;c/o shaky 2FEB99;
Patient stated she was having some stiffening of the neck and felt like a migraine headache was coming on.  vital signs were taken and all with in normal limits.  no treatment given.  Patient was observed for 30 min and released to go home.