chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This literature marketed report as received from the authors of a published literature article. Refers to a 51-year-old male patient. The patient reported that he did not have varicella (chickenpox) as a child, and he did not recall previous vaccination against varicella. The patient's concurrent conditions included rheumatoid factor-negative spondyloarthropathy for which he received a weekly 10 mg dose of methotrexate (manufacturer unknown) for 10 months. On unknown dates, the patient was vaccinated with 2 doses of ZOSTAVAX injection, (dose, route of administration, injection site, lot number and expiration date were not provided) for prophylaxis. On postvaccination day 21, the patient was evaluated in an outpatient clinic at which time physical exam revealed a nonpainful, nonpruritic, mixed maculopapular and vesicular rash (approximately 50 total lesions) involving the patient's face, torso, groin, and arms (date unspecified). The patient reported he had no contact with persons known or suspected to have active varicella or zoster and had no cough or other constitutional symptoms. On an unknown date, valacyclovir hydrochloride, an oral antiviral medication, was prescribed, and the patient was instructed to remain at home and avoid outside contacts until the lesions crusted over. All household contacts of the patient had documented evidence of receipt of 2 doses of varicella vaccine. Direct immunofluorescence testing and culture of vesicular fluid were positive for varicella zoster virus (VZV) on postvaccination day 24 (date unspecified). The outcome of the adverse event was unknown at the time of the report. The authors considered disseminated varicella zoster vaccine virus infection to be related to therapy with ZOSTAVAX. Upon internal review, disseminated varicella zoster vaccine virus infection was considered to be medically significant. Additional information has been requested.
Patient ended up getting COVID-19 even after she got vaccinated 5 months beforehand. Symptoms were cough, headache, loss of taste and smell, congestion.
The patient fainted for about 6-7 seconds after the flu shot was given. He stated that he was feeling fine. Just feeling a little bit thirsty. Pt was requested to stay in the pharmacy for extra 15 minutes with his mother to monitor for further reaction.
Information has been received from a physician concerning a patient who "4-5 years ago " was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine.  Subsequently, the patient had a skin reaction, an abscess developed and the affected area was indurated and drained.  It was also reported that "staphylococcal was found at the site".  Additional information has been requested.
Patient was feeling a little dizzy and light-headed immediately after the vaccinations and sat down for around 10-15 minutes and had a piece of candy before she tried to head out of the store. Patient made it about 20 feet before she fell down from feeling faint. The patient never lost consciousness and did not hit her head during the fall do to her partner kind of holding her up breaking her fall. Patient was immediately attended to by one of the pharmacist's on duty. Patient's legs were elevated and an ice pack was placed on patient's head. After laying on the ground for about 30 seconds, patient was already saying she was feeling better. EMS was called immediately after she fell and paramedics came on scene to make sure she was okay and to check her blood pressure. Patient and paramedics determined that she did not need to be taken to the hospital and patient left under her own power with her significant other.
pt recv 2 doses of vax 5DEC95 & 7FEB96 & 10JUL96 pt exp failure to seroconvert;lab test IGMAB was 0.14;
This spontaneous report as received from a physician and from a support services director refers to a patient of unknown age and gender. No information regarding the patient's medical history or concurrent conditions was provided. On 22-JUL-2016, the patient was vaccinated with an improperly stored ROTATEQ 2 ml oral injection (lot # L008997, expiry date 04-DEC-2020; dose and route of administration were not reported). There were no concomitant therapies reported. The dose of the vaccine was exposed to two separate temperature excursion (dates unspecified): on lasting for 712 hours, with the lowest recorded temperature of 34 degrees Fahrenheit and the second one lasting for 168 hours, with the lowest recorded temperature of 32 degrees Fahrenheit (0 degrees Celsius). The vaccine was stored in a refrigerator. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report has been received from a nurse referring to a patient of unknown age and gender. Information regarding the patient's medical history, drug reactions or allergies and concurrent conditions werenot reported. The patient's concomitant medications included a sterile diluent (manufacturer unknown). It was reported that, on 21-MAY-2012, the patient was vaccinated with one dose of measles, mumps and rubella (MMR) (strength, dose, frequency, route of administration, lot #, and expiration date were not provided) for prophylaxis. Then, on 01-JUN-2015, the patient was vaccinated with a first dose of PROQUAD (strength, dose, route, lot number and expiration date were not reported) , and later, on 07-SEP-2017, was vaccinated with a second dose of PROQUAD lot number reported as M015479 with expiration date of 23-JUL-2019 (strength and route were not reported ); both for prophylaxis (extra dose administered). No adverse effects were reported. Lot number M015479 is an invalid lot number for PROQUAD.
I have been early stage Menopause with no monthly cycle for several months, 9 days after receiving vaccine I started spotting and cramping and began heavier bleeding on 4/17/21. I have read several articles stating this as a side effect of the J&J vaccine but not Moderna.  Just thought it should be noted as other female friends I know have noted changes in their cycles after receiving same vaccine.
Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Tingling (specify: facial area, extemities)-Mild
Headache, Myalgia, CoughWheeze, Syncope, Chills Narrative: Employee sent for Covid testing at Facility today
Visual Snow - April 14 Floaters - April 17 Slightly numb hands/feet - Mid April Moving hands motion blur - Mid April  Still ongoing
Headache, Myalgia, Fever, PAIN AT INJECTION SITE, CHILLS FATIGUE STATES FELT BACK TO NORMAL BY FRIDAY EVENING (2/5/2021)
Metallic taste in mouth lasted 4+ hours.  Fatigue, gas, joint pain lasted 3 days, joint pain has persisted intermittently for a week+.  Headache on day three.  Took advil on day 3.
Vaccine administered as ordered without complication.  Vitals checked after 15minutes of injection.  Elevated blood pressure and pulse rate reported to this nurse.  Rechecked vitals manually.  Blood pressure and pulse rate elevated, pt denied lightheadedness/chest pain/SOB.  Pt asked to sit in room and recheck vitals in 15mins d/t elevated readings.  Pt agreed.  Vitals rechecked 15mins later.  Manual BP was lower, however pulse rate was 188.  Reported to doctor at this time.  Pt assessed by physician in clinic, ice applied to patients head and neck per doctor request.  Pulse rate continued to be elevated.  Pt taken to ER for treatment per doctor request.  EKG and lab work ordered in ER.  Pt currently being treated and monitored by physician at this time.
Two hours after 2nd vaccination I had wheezing and coughing. Took two Sudafed and symptoms improved. Then I noticed swelling of face, especially around eyes.  Took two  Benadryl and went to bed. Woke up  today 1/12/22 with continued swelling around eyes.
headaches; fatigue; nausea; after first dose vaccination extreme soreness of injection sight; This is a spontaneous report from a contactable consumer (patient). A 30-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: not reported) via an unspecified route of administration, administered in left arm on 24Feb2021 15:15 (at the age of 30-year-old) as a dose 1, single for COVID-19 immunisation. The patient medical history included asthma. The patient had no known allergy. Concomitant medications included budesonide (PULMICORT) and salbutamol sulfate (VENTOLIN HFA) taken for an unspecified indication on an unspecified date in two weeks. The patient was not pregnant at the time of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not tested for COVID-19 after vaccination. On 24Feb2021 at 22:15 about 7 hours after first dose vaccination, the patient experienced headaches, fatigue, nausea, and extreme soreness of injection sight. The patient took Tylenol for treatment of headache. Outcome of the events was unknown.  The lot and batch number for the vaccine BNT162B2 was not provided and will be requested during follow up.
Red rash on trunk and arms, starting ~24 hours after receipt of vaccine. Not itchy or painful.
Information has been received from a physician referring to a 19 month old patient of unknown gender. The patients' pertinent medical histories and concomitant therapies were not reported. On 30-AUG-2016, the patient received a dose of improperly stored VAQTA (lot # M017982, expiration date: 13-SEP-2017) (dose and route of administration were not provided). No adverse symptoms were reported. No product quality complaint (PQC) was involved. This is one of 5 reports received from the same reporter. Additional information has been requested.
pt recv vax & 5 days later devel pain in joints,fatigue & fever;sx cont x 2 wk;tx w/pred x 1 wk;on 13DEC95 sx returned & have worsened;pt reported diff using hands & ambulating,fever,& fatigue;
This spontaneous report was received from a health care professional refers to a patient of unknown age and gender. On 15-MAY-2015 the patient was vaccinated with improperly stored PROQUAD (Merck) (lot # K008868; expiry: 19-DEC-2015) (dose, route and frequency unspecified). No concomitant medications were reported. No adverse effects reported. There was no product quality complaint involved. The outcome of incorrect product storage was unknown. No further information provided. This is one of several reports received from the same source. Additional information has been requested.
has a cold; disconfort in the nose; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (has a cold) and NASAL DISCOMFORT (disconfort in the nose) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     No medical history were reported.     On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-May-2021, the patient experienced NASOPHARYNGITIS (has a cold) and NASAL DISCOMFORT (disconfort in the nose). At the time of the report, NASOPHARYNGITIS (has a cold) and NASAL DISCOMFORT (disconfort in the nose) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications provided.  Treatment included Hot water with ginger.
First symptom was swollen and itching injection site. (08/02/2021) Next symptom was severe and constant sneezing and runny nose, heavy fatigue (08/02/2021 - 08/20/2021 except for fatigue which is ongoing) Next symptom Pulsatile Tinnitus upon rising from sleep, Tinnitus symptoms much worse and louder than before,  tingling on end of tongue and tingling,  numbness   in left arm, fingers  and face, dizziness and fullness of head(08/22-2021- present)
Injection site pain, pain radiating into the shoulder joint. Vaccine was administered in the mid part of the deltoid muscle (at least 3 fingers width from the shoulder joint). Not clear how the pain started and why it is continuing this long. Not clear why the patient took this long to report the symptoms. When asked, when the symptoms began, he indicated the symptoms began after the vaccination. He is going to see the provider in the near future and let us know the outcome.
No adverse effects; patients received improperly stored vaccines; This spontaneous report was received from a medical assistant regarding a patient of unknown demographics. The patient's concomitant medications, pertinent medical history and drug reactions/allergies were not reported. On 06-MAY-2019, the patient was vaccinated with improperly stored hepatitis A Vaccine, Inactivated (VAQTA) (strength, dose, frequency, route of administration and anatomical location were unknown) (lot # R034340 and expiry date 23-NOV-2019) for prophylaxis (product storage error). No adverse effects were reported. It was reported that the vaccine was exposed to a temperature of 35.72 Fahrenheit (F) for a time frame of 5 hours and 5 minutes on 06-MAY-2019. There was previous temperature excursion reported as 31.28 Fahrenheit (F) for a time frame of 5 hours and 7 minutes on 03-MAY-2019, 32.68 Fahrenheit (F) for a time frame of 2 hours and 5 minutes on 06-MAY-2019, 31.26 Fahrenheit (F) for a time frame of 2 hours and 5 minutes on 06-MAY-2019. Data logger was involved. No product quality complaint (PQC) was associated with this report.  This is one of the four reports received from the same reporter.; Sender's Comments:  US-009507513-1905USA004979: US-009507513-1905USA005068: US-009507513-1905USA005069:
fatigue, muscle aches, painful vaginal and oral ulceration, onset of Behcets syndrome following 7 years without incidence
dose #1 was given 3/28/21 lot#028A21A-  After getting 2nd dose of Moderna (4/25/21), pt's fingers and their joints have been swollen like sausages.  The right 5th finger PIP joint is painful with decreased range of mother.  Xrays worrisome for inflammatory arthritis. (? reactive arthritis from vaccine).
At 8:45am he said he didn't feel good and threw up.  No fever.  Said it was a yellow color.  Then said he felt fine.  As of 10:45am he seems totally normal again.
Pt describes itchy throat closing sensation feels not getting enough air in lungs BENADRYL 50 mg po administered. Pt to ER - rec'd Prednisone po & PEPCID improved & discharged.
Rash #1 HPV on leg - red spot at site of Varicella vacc. - lasted 1 week. Dev. rash on left leg spread to trunk - both legs.
This spontaneous report as received from a Licensed Practical Nurse refers to a patient of unknown age and gender. On 27-AUG-2015, the patient was vaccinated with a first dose of GARDASIL 9 (route, dose, lot # and expiration date were not provided). On 09-OCT-2015, the patient was vaccinated with a second dose of GARDASIL 9 which was considered as an inappropriate schedule of drug administration. No adverse effect reported. Additional information has been requested.
This spontaneous report as received from a Licensed Practical Nurse refers to a patient of unknown demographics. The patient's current conditions or medical history were not reported. On 19-MAY-2014, the patient was vaccinated with a dose of (Oka/Merck) VARIVAX and (Oka/Merck) PROQUAD both vaccines were given as 0.5 ml subcutaneous injection (lot numbers and expiration dates were not provided). No adverse effects reported. Additional information has been requested.
hyper pyrrhexia, t104.5, diarrhea onset 24JUN93 x 36 hrs;
Initial information received on 11-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 3 years old female (3 year 8 months old) patient who got the 0.25 ml dose, while she received vaccine FLUZONE QUADRIVALENT. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a 0.25 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot number not reported via unknown route. Nurse called to report that the patient got 0.25 mL dose and needs to see if second dose is indicated. It was a case of actual medication error due to vaccine under dose. 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. Documents held by sender: none.
I started having redness in my left eye and slight irritation on 10/18/21.  It felt like I had scratched my eye.  I scheduled an eye appointment, and they didn't see any abrasions or foreign bodies.  The optometrist diagnosed me with iritis.  Thankfully my symptoms weren't severe, but it's a serious condition nonetheless.  I have been on prednisone eye drops with a slow taper since the day of the appointment on 10/20/21.  At my follow up appointment on 11/10/21, I was told that the iritis was unchanged after the previous treatment.  Now I'm on a more aggressive regimen of prednisone eye drops for the next 5 weeks and have another follow up appointment on 12/7/21.  She also ordered an autoimmune lab panel at this past appointment.
2 days after had chills, cough, headache, nausea, wheezing, loss of appetite, achy back and calves.
PC from Med ctr; admitted via ER @ 11AM w/ c/o feeling weak; has past hx of brain tumor, sz & hypertension on Tegretol & BP meds; no sz activity noted toady;
I POL administered along with Kinrix. Double Dose administered. Administrator notified. PT mother contacted and notifed to watch for swelling in arm and adverse reactions. Mother stated " he is doing well now, thank you for letting me know." Denied other concerns.
Felt lumps in her throat, Tonsils closing up, started sweating, tightening of her throat, administered epi pen, gave oxygen, was able to converse and tell us what was going on, 911 was called and sent to the ER, spent several hours in the ER and then was sent home.
After the application of the second dose of the vaccine, effects such as arm pain, body pain, tiredness and cut body were perceived. In addition to these effects, there was a constant severe headache and pulsations were felt on the right side of the head. To control the symptoms, a 750 mg Paracetamol tablet was administered, which reduced the pain, but about 8 hours later the effect returned. Today the headache has become recurrent and with prolonged intensity.    Reaction classification  Not serious  Mild  Causality  Grade 2 Information  No concomitant medication  No concomitant disease No previous surgeries Allergies denied Drug use denied Occasional alcohol consumption
at the time of the second covid vaccine I did start having body aches, fever, joint aches and generally feeling unwell for about a week after.  Most things improved except the joint pain.  Sometimes it would be in my knee, or ankle and other times my shoulders or hands.  In May and June things progressively worsened.  I had lab work done and it was concerning so I was referred to a rheumatologist.  I was diagnosed with seropositive rheumatoid arthritis in August of 2021 and continue to have problems with joint pain and swelling.  My rheumatologist is trying to find a medication that will work for me.
I now have vertigo; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (I now have vertigo) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VERTIGO (I now have vertigo). At the time of the report, VERTIGO (I now have vertigo) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The treatment history was not reported. The concomitant medication was not reported.
This spontaneous report was received from a medical assistant refers to multiple unspecified patients of unknown age. No information about patient's medical history, concurrent condition and concomitant medications. On an unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9, from lot # N000326 with expiry: 14-OCT-2019 (dosing details not reported) for prophylaxis. No adverse effects reported. The vaccine lot exposed to a temperature of 47 degree Fahrenheit to 77 degree Fahrenheit for 2 hours 25 minutes. It also had previous temperature excursion of 47 degree Fahrenheit to 77 degree Fahrenheit for 7 hours 45 minutes. The call was due to data logger. This is one of three reports received from the same reporter.; Sender's Comments:  US-009507513-1708USA012162: US-009507513-1708USA012163: US-009507513-1708USA012162:
Pt recvd 3 doses of Engerix-B & titer test result was neg;
achy joints; can't lift arm straight up; severe left arm pain/body pain; injection site soreness; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (can't lift arm straight up), MYALGIA (severe left arm pain/body pain), VACCINATION SITE PAIN (injection site soreness) and ARTHRALGIA (achy joints) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023C21A and 042B21A) for COVID-19 vaccination.     Concomitant products included LORAZEPAM for an unknown indication.   On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 27-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-May-2021, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (can't lift arm straight up), MYALGIA (severe left arm pain/body pain) and VACCINATION SITE PAIN (injection site soreness). On 28-May-2021, the patient experienced ARTHRALGIA (achy joints). On 29-May-2021, VACCINATION SITE MOVEMENT IMPAIRMENT (can't lift arm straight up), MYALGIA (severe left arm pain/body pain), VACCINATION SITE PAIN (injection site soreness) and ARTHRALGIA (achy joints) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medication details were provided.
Expired vaccine given to patient; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine given to patient) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 500E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine given to patient). On 20-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine given to patient) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment medications were not provided by the reporter.
Pt recvd vax & 26JAN93 & devel generalized small red raised areas; 28JAN93 rash inc & devel itchy eyes & a flushed red look on entire body; pt was seen by MD; also devel inc blood pressure;
Patient Rec'd Moderna Booster shot 8/30/21 at 9:30am and reported side effects bt 4-5pm.  Those include: Wheezing Heavy Flushed chills brain fog / trouble thinking  ***