chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by a physician and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Dose of Moderna booster to someone when the temperature was not in range) and POOR QUALITY PRODUCT ADMINISTERED (Dose of Moderna booster to someone when the temperature was not in range) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 083J21A) for COVID-19 vaccination. The patient had no allergies to medication, food, and other products. The patient had no Covid-19 positive test or diagnosis. The patient had no history relating to mentioned AE and both acute and chronic illnesses at the time of vaccination. The patient did not receive any other vaccine within 1 month prior to Moderna COVID-19 vaccine. On 18-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Apr-2022, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Dose of Moderna booster to someone when the temperature was not in range). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Dose of Moderna booster to someone when the temperature was not in range). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Dose of Moderna booster to someone when the temperature was not in range) and POOR QUALITY PRODUCT ADMINISTERED (Dose of Moderna booster to someone when the temperature was not in range) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. It was reported that, the vial underwent an excursion of potentially 5 days since the 13-Apr-2022, until 18-Apr-2022 at 65 Degree Fahrenheit. 2 vials of ten doses each were involved. The vial was initially stored in refrigerator on 10-Apr-2022. At the time of this report the vial was stored in refrigerator. There was no visual inspection noting any vaccine state change. The AE did not cause patient to seek medical care. The patient did not experience similar events in the past. No treatment details were reported.
Initial report received from a health care professional on 25 August 2011. A 41-year-old female patient received dose 1 of an intramuscular right deltoid injection of IMOVAX Rabies, sanofi pasteur SA lot number E1031-1, and dose 1 of an intramuscular injections (two in the left deltoid, one in the right hip and 1 in the left hip) of IMOGAM Rabies-HT, sanofi pasteur SA lot number not reported, on 23 August 2011. The patient's medical history and concomitant medications were not reported. The patient, a half hour after leaving the physician office, experienced "voice, throat" swollen, lips tingling, and side of face numb. The patient was seen and treated in the Emergency Room (ER) with epinephrine. The patient was observed and released after 3 hours. The outcome was not reported. No further information was available. Documents held by sender: None.
Vaccinated: 11:54AM Reaction: 12:10PM Pt reported slight headache and dizziness 16 minutes after vaccination 12:30: patient complains of nausea, no vomiting; remains lying down; observation continues 12:45: BP 108/63, 74, 18, O2 100%; resting quietly 12:50: patient complains of headache, ice applied to forehead and no further complaint of nausea at this time 12:55: patient asleep, vital signs remain stable 13:05: to bathroom via wheelchair, voided, stable 13:10: returned to observation room, stated "I feel much better now, requested to sit at edge of bed" 13:24: patient stated "I'm feeling good now and can go home" 13:30: patient is stable, educated on s/sx of vaccine, encouraged to drink more water and if still not feeling good, should follow up with her MD Vitals: 122/178, 85, 19, O2 100% Pt states she did not eat or drink before the vaccine and was given orange juice and crackers; patient stable and released from vaccination site at 13:30
Pt's mom called and said he has woke up with spots on arms, legs and some on trunk and face. Instructed mom on chickenpox treatment.
Moderna COVID-19 Vaccine EUA  Right below the injection site my skin was red, hard, swollen and hot. It also hurt to the touch. I noticed this at night the day that I received the vaccine. At this time the area where it was red was not very big, probably just a bit smaller than the diameter of a golf ball. The next day the redness did spread, it got about 2 to 3 times bigger and was a bit raised. The swelling and hardness was still present as well as it being hot and painful to touch. This was the only other reaction that I had that was not listed as one of the common side effect. I am currently on day 3 after my second dose, the redness has gone down a bit but the other symptoms are still present.
HIVES DEVELOPED ON LEFT ARM WITHIN 24 HOURS OF RECEIVING VACCINATION. DAY 2 DEVELOPED COLD SORE LEFT LOWER LIP AND SORES IN MOUTH AND ON TONGUE, BURNING PAIN.WAS TREATED WIH ACYCLOVIR PER PCP. WAS NOT GIVEN SECOND DOSE OF MODERNA.
numbness on face first day, weakness on second day, numbness to T zone area of face  Narrative:
After MMR injection quick onset localized swelling, redness, pain. No respiratory symptoms noted, given Benadryl and redness, swelling decreased while in office.  Advised to continue antihistamine for 2-3 days call if worsening symptoms.
contact urticaria; hives; typical reaction; rash at back of my head /spread to other parts; chills; fatigue; itch at back of my head; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itch at back of my head), URTICARIA CONTACT (contact urticaria), URTICARIA (hives), VACCINATION COMPLICATION (typical reaction) and RASH (rash at back of my head /spread to other parts) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    In December 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In December 2021, the patient experienced PRURITUS (itch at back of my head), VACCINATION COMPLICATION (typical reaction), RASH (rash at back of my head /spread to other parts), CHILLS (chills) and FATIGUE (fatigue). On an unknown date, the patient experienced URTICARIA CONTACT (contact urticaria) and URTICARIA (hives). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at a dose of 12.5 mg every six hours; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at a dose of 25 mg every four hours and PREDNISONE in December 2021 for Adverse event, at an unspecified dose and frequency. In December 2021, VACCINATION COMPLICATION (typical reaction), CHILLS (chills) and FATIGUE (fatigue) had resolved. At the time of the report, PRURITUS (itch at back of my head), URTICARIA CONTACT (contact urticaria) and URTICARIA (hives) outcome was unknown and RASH (rash at back of my head /spread to other parts) had not resolved.            Tried second generation antihistamine didn't work. No concomitant medications were reported.
This is a spontaneous report received from contactable reporter(s) (Other HCP and Consumer or other non HCP) for a Pfizer sponsored program.  A 50 year-old male patient received bnt162b2 (BNT162B2), administration date 28Sep2021 (Batch/Lot number: unknown) at the age of 50 years as dose 2, single and (Batch/Lot number: unknown) for 1 day as dose 1, single for covid-19 immunisation. Relevant medical history included: "feel discouraged", start date: 2001 (ongoing); "depressed", start date: 2001 (ongoing); "Rheumatoid arthritis" (ongoing). The patient's concomitant medications were not reported. The following information was reported: MALAISE (non-serious) with onset 2021, outcome "recovering", described as "under the weather"; PAIN (non-serious) with onset 2021, outcome "recovering", described as "aches". Therapeutic measures were taken as a result of malaise, pain.  Additional information: Patient reports about 2 weeks into taking medication, he noticed "i was feeling a bit better" (no specific details provided), "since then i'm at a stand still". Patient strongly agrees with statement its been hard to cope with rheumatoid arthritis, and sometimes he feel discouraged and or depressed. This is not new to patient reports feeling this way as far back as 2001. Patient reports he received second covid vaccine 28Sep2021, and he feels "under the weather, aches and such", much like he did when he received the first dose.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Myalgia, Arthralgia, Fever, Angioedema, NauseaVomiting, swelling, redness, pain, joint pain, nausea, fatigue, facial swelling Narrative:  Day 2 - pain, swelling, redness to injection site, hard to lift arm above shoulders; myalgia, body aches, joint pain, nausea, fatigue, swelling to face, neck and eyelids; Day 3 - still soreness to arm, still w some swelling to eyelids, fatigue and body aches; Day 4 - no swelling or body aches, still w fatigue and feeling of malaise; Day 5 - fatigue; Day 6 - fatigue; no further symptoms noted
Covid 3 times; Covid 3 times; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old male patient received BNT162b2 (COMIRNATY), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Covid 3 times". Additional information: the patient got Covid 3 times after using Pfizer product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient received vaccine on 3/18/2021, reports left arm being sore with a raised (knot) in the axillary of left arm beginning on 3/22/2021, area remains swollen on 3/26/2021
Around 6 I had a mild headache and started coughing.  I then developed a mild fever and sore muscles, which got worse over the next few hours.  By around 8 I was feeling dizzy and nauseous as well.  By around 9 I was very tired and couldn't stand up without getting extremely sick to my stomach and dizzy.  Around midnight I got up to get a drink, and became extremely dizzy and lost vision in my eyes for about 5 minutes and felt like I was going to faint.  I laid down immediately, and within a few minutes regained my vision.   I then had a ringing in my ears for a minute or two, which went away very quickly.  I fell asleep shortly after, and when I woke up a few hours later I just felt mildly sore - all other symptoms seem to have gone away.
The day after receiving the 2nd dose of her shingrix the patient started experiencing arm pain. Over the course of the next couple of days her left arm (the site of administration) began to swell. She also started experiencing nose bleeds from her left nostril and had left sided chest pain. Two weeks after receiving the immunization shes still experiencing visible whole arm swelling, left nostril nose bleeds and clots and chest pain. She went to the dr and was prescribed steroids.
Case number PHEH2013US020532 is an initial spontaneous report received from a nurse on 30 SEP 2013 with a follow up information received from a nurse on 14 JAN 2014. This report refers to a 58-years-old male patient. His medical history and concomitant medications were not reported. It was reported that FLUVIRIN was tolerated in the past. He was vaccinated with 0.5 ml intramuscular dose of FLUVIRIN 2013/2014 (batch number: 1308401, expiry date: MAR 2014) in the deltoid on 26 SEP 2013. The vaccine was placed room temperature. It was reported that the nurse was not there when the shipment arrived and it was placed on desk and  hence the vaccine in shipping container was placed in room temperature for less than 72 hours. No adverse event was reported following the medication error.  Follow up information received from a nurse on 14 JAN 2014: Vaccination history and site of vaccination updated.
Dose given past the 12 hour post puncture time; Patient aged 16 years took vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose given past the 12 hour post puncture time) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient aged 16 years took vaccine) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose given past the 12 hour post puncture time) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient aged 16 years took vaccine). On 15-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Dose given past the 12 hour post puncture time) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient aged 16 years took vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment information was not provided.   This case was linked to MOD-2021-327879 (Patient Link).
Patient recived first dose of Pfizer COVID vaccine on 3/18.  Patient admitted to hospital at later date.  Patient was complaining of difficulty breathing and exacerbation of ALS symptoms.  Patient tested positive for COVID in our ER.  Patient was also enrolled in trial evaluating experiment drug for ALS.  Medication is called Zilucoplan.  Patient did not qualify for any COVID specific treatments.  Patient did receive antibiotics.  Patient was discharged in stable condition with plans to follow up with his ALS treatment team.
Very fatigued; Insomnia; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Very fatigued) and INSOMNIA (Insomnia) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (Very fatigued) and INSOMNIA (Insomnia). At the time of the report, FATIGUE (Very fatigued) and INSOMNIA (Insomnia) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were provided. No treatment details were provided.
Patient that received his first dose of Pfizer vaccine on 2/1/2021  passed away on 2/2/2021.  No further information is available at this time.
This case was initially reported by a pharmacist with additional info subsequently provided by a registered nurse and described the occurrence of atrial fibrillation in a female of approximately 40 years of age who received Engerix B. Concurrent vaccines/medications and concurrent medical conditions were not reported. The patient had no adverse events following receipt of previous doses of the hepatitis B vaccine. The patient did not have a history of cardiac problems. On 10 October 2003 at approximately 15:00, the patient received the third dose of Engerix B in a deltoid muscle. Three days post-immunization, on 13 October 2003 at approximately 4:00, the patient was awoken from sleep with a heart rate of 160 beats per minute. She was taken via ambulance to the local emergency room, where a diagnosis of atrial fibrillation was made. The reporting nurse did not believe that the patient was cardioverted electrically, but rather that cardioversion was achieved through treatment with IV CARDIZEM. The atrial fibrillation resolved while the patient was in the emergency room. CARDIZEM therapy was initiated. The patient also began to experience sciatica on 13 October 2003. The outcome of the sciatica was unknown. The pharmacist, considered the atrial fibrillation to be life threatening and clinically significant (OMIC) (or requiring intervention). The nurse considered that the events were possibly related to vaccination with Engerix B.
Vaccine was expired on 07-Apr-2022 and administered on 08-Apr-2022/ expired vaccine was administered after the 30-day Use By Date or after manufacturer date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 07-Apr-2022 and administered on 08-Apr-2022/ expired vaccine was administered after the 30-day Use By Date or after manufacturer date of expiration) in an 80-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 070H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 08-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 07-Apr-2022 and administered on 08-Apr-2022/ expired vaccine was administered after the 30-day Use By Date or after manufacturer date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 07-Apr-2022 and administered on 08-Apr-2022/ expired vaccine was administered after the 30-day Use By Date or after manufacturer date of expiration) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant product use was reported.  Date the vial was initially stored in the refrigerator reported as unknown. Number of doses/vials was reported as 173 doses.  The vial did not undergo any temperature excursions.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow-up received, additional reporter was added.
Sore right arm after vaccine administration where Hep A vaccine given.  It progressively got worse with pain radiating down to forearm and to mid-scapula.  She described a history of rotator cuff issues in the same arm in the past (years ago).  She denied any fevers/chills.  Denied warmth at the site or redness or swelling at the injection site.  Because of the pain and inability to sleep on that shoulder, she sought treatment with her medical provider who prescribed NSAID and vicodin and diagnosed her with tendonitis.
Zoster out break along 2 T-11. Dermatome within 48hrs of receiving vaccine
Bilateral nonblanching petechial rash on lower extremities, elevated WBCs, platelets, ESR
Bad reaction; Swollen lymph node; High fever; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (Bad reaction), LYMPHADENOPATHY (Swollen lymph node) and PYREXIA (High fever) in a 30-year-old female 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT (Bad reaction), LYMPHADENOPATHY (Swollen lymph node) and PYREXIA (High fever). At the time of the report, ADVERSE EVENT (Bad reaction), LYMPHADENOPATHY (Swollen lymph node) and PYREXIA (High fever) outcome was unknown. Not Provided          No relevant concomitant medications were reported.  No treatment information was provided.  Reporter agreed for follow-up with safety via email.
Began noticing itching and redness on left had on 1/3 PM. When I woke up on 1/4 the itching in the had was persistent and the redness was about the same. I also noticed a raised, red patch of skin on my right anterior ribs. The rash on the ribs is less itchy than the hand.
The patient stated he's never gotten COVID vaccine and was administered Pfizer.  When researched on state registry, we found out that patient actually got a Johnson & Johnson vaccine in April 2021.
This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, and expiry: 21-SEP-2021) dose was not reported, administered on 17-NOV-2021 for prophylactic vaccination. No concomitant medications were reported. On 17-NOV-2021, the patient experienced administration of expired vaccine. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of expired vaccine was not reported. This report was non-serious.
Stiff neck; Swollen gland; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Stiff neck) and PARATRACHEAL LYMPHADENOPATHY (Swollen gland) in a 71-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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MUSCULOSKELETAL STIFFNESS (Stiff neck) and PARATRACHEAL LYMPHADENOPATHY (Swollen gland). At the time of the report, MUSCULOSKELETAL STIFFNESS (Stiff neck) and PARATRACHEAL LYMPHADENOPATHY (Swollen gland) outcome was unknown.        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.   This case was linked to MOD21-073326, MOD21-020046 (E2B Linked Report).; Sender's Comments:  MOD21-073326: MOD21-020046:
On April 23, 2021, 5 weeks after 2nd vaccination, I developed a fever of +2-3 degrees above normal. On May 1st, after 2 trips to urgent care where they only checked for COVID-19 (which both resulted in negative tests). My condition got worse: sweating, loss of appetite, etc. I went to the emergency room where I was diagnosed with bacterial pneumonia that also infected my heart causing A-Fib. I was immediately put into ICU for 5 days where I was placed on oxygen for a day, saline/electrolytes, antibiotics and other treatment before being sent home.
Child developed fever >103 then 3-5 min. generalized seizure, emesis x3 after seizure.
Itch; Red rash (bigger than the parm of my hand); Redness; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itch), RASH ERYTHEMATOUS (Red rash (bigger than the parm of my hand)) and ERYTHEMA (Redness) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced PRURITUS (Itch), RASH ERYTHEMATOUS (Red rash (bigger than the parm of my hand)) and ERYTHEMA (Redness). At the time of the report, PRURITUS (Itch), RASH ERYTHEMATOUS (Red rash (bigger than the parm of my hand)) and ERYTHEMA (Redness) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment taken for symptoms.