chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a registered nurse (R.N.) and a mother of a student concerning another child in elementary school who was vaccinated with a dose of Varivax. It was reported that the patient now has breakthrough chickenpox after an outbreak in the elementary school. Unspecified medical attention was sought. No product quality complaint was involved. Follow-up information from a health professional indicated that the that the index case was an unimmunized individual. Additional information is not expected.
pt recv vax & 1hr post vax pt exp n/v & fever;ER or MD visit was required;tx was symptomatic;pepto-bismol was given;
Pt presented for 2nd flu shot.  A few min after injection, she developed full body rash. No other sx, breathing normal, behaving normally. She was observed for over 30min and rash did not worsen and no other sx developed. recommended zyrtec and tylenol.  I am indicating she has not yet recovered b/c the rash is still present.
shingles; This spontaneous report was received from a lawyer regarding a case in litigation referring to a patient (pt) of unknown age and gender. Information regarding current condition, historical condition or concomitant medication was not provided. In or about May 2015, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose number, strength, route, batch/lot# and expiration date were unknown) by a healthcare provider at a physician's office for the long-term prevention of shingles and/or zoster-related conditions. On an unknown date, subsequent to zoster vaccine live (ZOSTAVAX) inoculation, the pt was treated by a nurse practitioner (NP) for shingles. As a direct and proximate result of the pt's use of the zoster vaccine live (ZOSTAVAX) vaccine, the pt had and would continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of shingles was unknown. The reporter considered shingles to be related to zoster vaccine live (ZOSTAVAX).
8 hours post vaccine started feeling weak and then HA chills fatigue myalgia and fever 102.2
Body aches when I woke up the morning after.  My arm was sore.  The second morning I woke up with a rash at the injection site and my arm is still sore.
He was found unresponsive 2 days later in pack-and -play. UNK if there were other symptoms.
Chest pain and pressure; fever of 101 degrees F; shallow rapid breathing; rapid heart rate (120); fatigue and tiredness;  feeling of being hot and unable to catch breath.
Pt right arm with area approx 2 1/2 inches wid that is swollen and slightly pink. Small knot noted in center. Arm is not warm to touch. Pt is afebrile. No tx given. Told family to moniter for s/s of infection. Fever, arm becomes red and warm to touch.  May use ice or warm compress for comfort.
I began having difficulty breathing. I would wake up at night unable to breathe. My inhaler did not stop my breathing difficulties. The breathing difficulties escalated with each passing day. I finally had to go to the emergency room because I could hardly breathe.
Enlarged lymph node and pain at collarbone after receiving first Dose 1 on 2/22/2021.  Pain and swelling had alleviated itself after 7 days. Then after Dose 2 on 3/15/2021 same incident occurred, but more severe.  Waiting to see if the pain and swelling goes away.
No adverse reaction, fourth COVID Dose Given of COVID Pfizer 5 year - 11 year
Case number PHHY2014US021476 is an initial literature report received on 15 Feb 2014. The author discussed about the high intensive care unit admission rate for 2013-2014 influenza associated with a low rate of vaccination. Thirteen of 55 (23.6%) patients were vaccinated against influenza at least 2 weeks prior to the onset of their acute illness. This report refers to a patient of an unknown age and gender, among the thirteen patients who received influenza vaccination. The patient's current condition included hepatitis C and alcohol abuse. The patient was vaccinated with Influenza vaccine (manufacturer and batch number: not reported) on an unknown date. On an unknown date, after vaccination the patient got admitted in the intensive care unit overnight due to alcohol withdrawal. The patient was tested positive for influenza virus. The outcome of the events was not reported. The author concluded that there observations support encouraging influenza vaccination for all individuals without a contraindication, as this might prevent severe lower respiratory tract complications requiring ICU level care.
Pt started to feel lightheaded with a tingling sensation in her arms 5-10 minutes after vaccination. Pt was given water and observed for 15 minutes. Pt was released in Good Health to her mother
diagnosed with ACIP; This spontaneous case was reported by a consumer and describes the occurrence of UNEVALUABLE EVENT (diagnosed with ACIP) in an 81-year-old male patient 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 UNEVALUABLE EVENT (diagnosed with ACIP). At the time of the report, UNEVALUABLE EVENT (diagnosed with ACIP) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment and concomitant medications were reported.; Sender's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
Headache (10/5 through 10/7) Fever 99.1 (10/6) Chills (10/6) Loss of appetite (10/6) Tiredness (10/^0 Injection site pain and swelling (10/5 and continues )
Admitted to the hospital in August 2021 with Covid pneumonia s/p fully vaccinated in April  2021.
GOT A CALL TODAY FROM THE NURSE AT A LOCAL NURSING HOME REPORTING THAT PATIENT HAD A HEART ATTACK ON 10/2/2021 A DAY AFTER GETTING THE COVID VACCINE
Stiff Neck; Fever 102.8F; Sore Arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore Arm), MUSCULOSKELETAL STIFFNESS (Stiff Neck) and PYREXIA (Fever 102.8F) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination.     Concurrent medical conditions included Rectal cancer (Atypical Rectal Cancer for 5 years now.). Concomitant products included INFLIXIMAB (REMICADE) for Rectal cancer.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced PAIN IN EXTREMITY (Sore Arm). On 16-Apr-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (Stiff Neck) and PYREXIA (Fever 102.8F). On 16-Apr-2021, PAIN IN EXTREMITY (Sore Arm) had resolved. On 17-Apr-2021, MUSCULOSKELETAL STIFFNESS (Stiff Neck) and PYREXIA (Fever 102.8F) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Apr-2021, Body temperature: 102.8 f (High) Fever 102.8F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Information has been received from a consumer concerning her 15 year old daughter with no pertinent medical history and no known drug allergies/drug reactions who on an unspecified date was vaccinated with the first 0.5 ml dose of GARDASIL (Lot # not reported). There was no concomitant medication reported. It was reported that the patient experienced alopecia after getting first dose of GARDASIL. It was reported that the patient's hair was thinning after getting the second dose of GARDASIL (Lot # was not reported). The patient did not seek medical attention. There were no laboratory diagnostic tests performed. It was reported that the patient had not recovered at the time of the report. No further information is available.
Within moments felt lightheaded, within 10 minutes become tachycardic 120,  feeling  warm and developed hives.
Patient reported immediate pain in her left upper arm during the vaccination. She felt the injection site was more posterior than her previous flu vaccinations. No skin reactions/edema/induration occurred. Patient has had pain in her left tricep/deltoid area ever since (15 days) and can't put on her shirt due to severe pain. Massaging the tricep/deltoid area makes it feel better temporarily until she tries to use her arm. Lifting her arm with elbow flexed at 90 degrees and hand dangling causes tremendous localized pain left upper lateral arm. She is able to do lift off test with her left arm.  Only able to abduct her left arm to about 120 degrees due to pain. No bicep, wrist or finger weakness.  No elbow tenderness.
Had four shots of the Moderna vaccine and got Covid; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (Had four shots of the Moderna vaccine and got Covid) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form, second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2022, the patient experienced COVID-19 (Had four shots of the Moderna vaccine and got Covid). At the time of the report, COVID-19 (Had four shots of the Moderna vaccine and got Covid) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2022, SARS-CoV-2 test: (Positive) Positive.         No concomitant medications were provided. Reporter stated that her mother had four shots of the Moderna vaccine and got Covid and got it confirmed. Reporter said it was mild. No treatment medications were reported.  Company Comment: This spontaneous case concerns a 79-year-old female with no medical history reported, who experienced the unexpected non-serious AESI of COVID-19 that occurred in the context of fourth dose of mRNA-1273 vaccination. Latency cannot be assessed since vaccination date was not disclosed. SARS-CoV-2 test was Positive on an unknown date in 2022. No further details on clinical course, other lab test results and treatment received were reported. The outcome of the event was reported as unknown. Current pandemic situation of COVID-19 may remain as confounder to the event Covid-19. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 79-year-old female with no medical history reported, who experienced the unexpected non-serious AESI of COVID-19 that occurred in the context of fourth dose of mRNA-1273 vaccination. Latency cannot be assessed since vaccination date was not disclosed. SARS-CoV-2 test was Positive on an unknown date in 2022. No further details on clinical course, other lab test results and treatment received were reported. The outcome of the event was reported as unknown. Current pandemic situation of COVID-19 may remain as confounder to the event Covid-19. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Fatigue, Myalgia, Headache, Shivering, fever so severe I had to take time off work.  Also, at the injection site, a lot of pain swelling, and site was warm to the touch.  Need to take Tylenol and NSAIDs foe pain relief.
Posterior Vitreous Detachment in the right eye diagnosed by retina specialist Dr on 10/6/2022. Started seeing flashes and floaters  on 10/5. Remained through 10/6. Went to emergency room and was referred to Dr. for diagnosis.
5/22/13 noticed large baseball sized area on left thigh red, hot to touch. Painful, treated with Clinda r/o cellulitis on 5/23/13 mom took her to hospital. Admitted for 23 hr obs. Sent home diagnosis - Normal reaction to vaccines. Stopped Clinda no cellulitis.
I DEVELOPED SHINGLES ON THE RIGHT SIDE OF MY FACE UNDER MY EYE , SPREADING DOWN MY FACE AND SURROUNDING THE EYE
itchiness; warmness; rash; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchiness), FEELING HOT (warmness) and RASH (rash) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced PRURITUS (itchiness), FEELING HOT (warmness) and RASH (rash). On 16-Feb-2021, PRURITUS (itchiness), FEELING HOT (warmness) and RASH (rash) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
10/13: Stomach Ache, Fever, Chills, Equilibrium Issues, Weakness; 10/14: Fever, Chills, Equilibrium Issues, Weakness, Aches  and Pains, No Appetite; 10/15: Fever Down Some, Equilibrium Improving, Less Weakness, Aches  and Pains Moderating, No Appetite; 10/16: Same Weakness, Still Some Aches and Pains, No Appetite, Constant Itching All Over; 10/17: Some Appetite, Still Itching but Not as Bad.
Bruise, scratch in left leg. I breastfeed my baby and after the vaccination, I noticed that she slept more than usual
Patient received Moderna vaccine on 3/27/21 and 4/26/21. COVID positive on 2/12/22. Presented to ER on 2/12/22. She was admitted through the emergency room with chest congestion, respiratory failure, and radiographic evidence of bilateral pneumonia with a COVID-positive screening study. She was seen in consultation by the Pulmonary Service. She was begun on the usual regimen of remdesivir and Decadron, as well as empiric coverage with Rocephin and azithromycin. She had basically a very rapid clinical improvement over the next several days. Her  oxygen requirements steadily improved and by the 4th hospital day, she was on room air. Remdesivir was eventually discontinued. Her steroids were discontinued after 5 days. There appeared to be no superimposed bacterial infection, so the IV antibiotics of Rocephin and azithromycin were discontinued as well. Because of her COVID-positive state, even though she remained clinically stable, she had to remain in the hospital for 14 days until the nursing facility would accept her in care. I talked to her husband who did not feel he could manage her at home in that he was also responsible for taking care of patient's elderly sister who is legally blind. The only other complication during her hospital stay was the development of perineal candidiasis, for which she was treated with Lotrisone, as well as  worsening blood pressure control, which required the addition of amlodipine to be added to her regimen. She remained obtunded at times; but toward the end of her hospital stay, she was more alert and responsive, although confused. She was still very weak, spending most of her time in bed. Discharged on 2/24/22.
suspected vaccination failure; got them a year ago; itching; pain along nerves; horribly painful; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.  On an unknown date, the patient received Shingles vaccine. On an unknown date, less than 2 years after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, pruritus, post herpetic neuralgia and pain. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles, pruritus, post herpetic neuralgia and pain were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, pruritus, post herpetic neuralgia and pain to be related to Shingles vaccine.  Additional details were provided as follows: The patient had reported for him/herself. The age at vaccination was not reported. The patient received Shingles vaccine a year ago from the date of reporting. After receiving Shingles vaccine, the patient got shingles and still had itching or pain at times along the nerves till the time of reporting. The patient stated that, it was not unbearable but annoying, it was horribly painful in the beginning. The patient had talked to others who had gotten it, got the shot and got it again, refer case US2022AMR015279. The patient pity them and stated that, everyone was different, no medications or creams had taken the pain totally away, just was a temporary fix. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization and laboratory confirmation of shingles were not provided.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR015279:Same reporter
Pt. had lower legs (knees down) bilaterally turn bright red and swell. Pt. was also not able to be comforted/eat bottle for 1 hour - constant crying. Then issues resolved.
Patient developed diarrhea within hour of receiving injection.  She developed shortness of breath requiring trip to ED approximately 12 hours later.   She had cardiac arrest in ED.
Patient left arm became red and itchy spreading to chest are after 1st injection of Pfizer approximately 5-10 minutes after. Denies difficulty in breathing. Patient given Diphendramine HCL 50 mg/1mL IM left arm to prevent further reaction. Patient then sent to Immediate Care in the building for further evaluation. Patient was sent home after being seen by APN and informed to take oral Benadryl for the next couple of days.
Eight  days after the  Covid vaccination, my left arm became red, hot and itchy at the injection site.  The area started out about 2 inches in size and increased in size each day.  It was about 5 inches in size before it subsided.  I saw the doctor on day 4 of the rash, and the rash ended on day 6.  I tried OTC cortisone cream, Benadryl cream and oral Benadryl.  I also used cool compress.
No additional AE; Caller reporter improperly stored and administered vaccines for MMR-II, PROQUAD, and VARIVAX to multiple patients since May 2023 (TE occurred 5/9/2023). No symptoms reported. Caller did not have specific AE information available regarding patient inf; This spontaneous report was received from other and refers to a 14-year-old patient of unknown gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 18-JUL-2023, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection, lot #W008712, expiration date: 14-MAR-2024, administered for prophylaxis (strength, and route of administration were not provided). This vaccine underwent temperature excursion before administration in 58.65 degree Farenheit (F) for 25 hours 45 minutes (Product storage error). No additional adverse event was reported.
After the first shot, within 1/2 hour, my legs felt weak. Within 2 hours, I did not feel myself. I took my pulse with my pulse-ox and my pulse was dropping and went in the low 50's. It was like this for 4-5 days. My pulse never goes below 70, usually always afg. between 70-80. After the 2nd shot, same thing-my legs felt weak and my pulse using my pulse-ox showed dropping down in the low 50's again and lasted for 1 1/2 days. Then my left arm with the 2nd dose (half way up my arm) was always itchy. It got a scab several times and left a noticeable scar. Also, I developed weird small white bumps on my body, some itchy and has left scars. Most importantly, after the 2nd shot, my hands became very sore-unable to open and close and they has been going numb ever since the 2nd shot. I have never had any issues with my hands going numb. Its mainly the right hand. Everyday its my right hand. I ahve been doing exercises and trying different therapy for my hands. It is causing me some disability to not be able to use my hands.
Prior to giving patient vaccines, she informed me that she "doesn't do well with shots sometimes." I gave patient her vaccines at 12:00 pm. At 12:02 pm, she reported feeling hot and dizzy. I had her lay down, turned on the fan, and put a cold wash cloth on her forehead. She reported feeling better immediately, and I got her a water bottle to drink. I had her lay down and rest for around 10 minutes. Patient's vital signs were stable during this time. After 10 minutes, she sat back up and stated she felt normal again. She declined EMS and me calling a family member or friend to drive her. I encouraged to continue drinking fluids and to rest for the rest of the day. Also, I instructed her to seek emergency care if she developed syncope, dyspnea, chest pain, or change in consciousness. She left the clinic in stable condition. I called her an hour and a half afterwards, and she stated she felt completely normal.
11-6-07 Extreme heaviness, felt and could see movements across (RO) trapesius and down arm-bilateral. Imm. believed approx 3 min, then disappeared. Started again AM 11/20. Took Motrin, 1 bid, Nyquil. Numbness and tingling bilat hands/fingers. (L) residual numbness/tingles
RASH AT SITE, SHORTNESS OF BREATH, DIZZINESS, INCREASED HEARTRATE, T-101, CHILLS
3 days after receiving the first dose of the vaccine on 12/21/2020, experienced flu-like symptoms that lasted 24 hours. About 17 hours after receiving the second does on 1/11/2021, flu-like symptoms reoccurred.  The following day (1/13/2021) severe chills, and difficulty breathing occurred. Patient was admitted to Medical Center, where blood work, EKG, and oxygen were given and ordered. After overnight observation, the patient was discharged and informed that he had a severe reaction due to the Pfizer vaccine for Covid-19. As of 1/17/2021, patient still recovering and feeling generally weak and tired without much appetite.
Information has been received from a pharmacy tech concerning a patient who on an unspecified date was vaccinated with a dose of PNEUMOVAX 23 (lot number 665903/1427Y) from a multi dose vial. After vaccination the patient experienced an injection site reaction. At the time of the report the patient's outcome was unknown. It was unspecified if the patient sought medical attention. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. This is one of several reports received from the same source. Additional information has been requested.
11/30/21 first symptom was metallic taste in mouth - this started shortly after the vaccine and lasted for 4 days - no pain involved at 8pm that night, I began to have a fever, chills, and achy muscles and joints.  12/1/21 fever escalated to 103 - consistently stayed at 103 for over 24 hours. Had severe dizziness and nausea, vomiting, headache, aches(joints and muscles), overall weakness, hallucinations, chills, chest pain, sweating for this entire day of 12/1/2021. and mild difficulty breathing.  12/2/21 - fever went down to a steady 101, able to keep tylenol down, no more vomiting.  Still had dizziness, nausea, weakness and chills.  12/3/21 - started day with fever down to 99, headache and general weakness. ended day with no more fever, temp was 98.1.  12/4/21 -  weakness, headache, and muscle aches remained.