chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 019B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Feb-2021 at 11:45 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 27-Mar-2021 at 1:52 PM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 61.52 on 27-Feb-2021 and 61.60 on 27-Mar-2021. Concomitant products were not provided. For Lot no : 014M20A on 27-Feb-2021, excursion time was 9 AM, 11AM, 12PM, 1PM, 2PM, 3PM, 4PM and 5PM and temperature was 33, 35, 35, 35, 35, 34, 34, and 35 respectively, total doses given for the day was 199, condition of vaccine prior to vaccination was not frozen, vaccine was moved to fridge on 24-Feb-2021 was moved to clinic on 27-Feb-2021. 20 vial was sent to clinic. Vaccine BUD date was 26-Mar-2021. For Lot no : 019B21A on 27-Mar-2021, excursion time was 9 AM and 10 AM  and temperature was 35 and 35 respectively, total doses given for the day was 195, condition of vaccine prior to vaccination was not frozen, vaccine was moved to fridge on 23-Mar-2021 was moved to clinic on 27-Mar-2021, 20 vial was sent to clinic, Vaccine BUD date was 22-Apr-2021. The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. Temperature recordings were taken using a Fisherbrand traceable temperature monitor at every hour. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature. It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F. Treatment medications were not reported.
Chills/shakes; Chills/shakes; A mild fever at 100F; Tenderness at the injection site; Headache; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Chills/shakes), CHILLS (Chills/shakes), PYREXIA (A mild fever at 100F), VACCINATION SITE PAIN (Tenderness at the injection site) and HEADACHE (Headache) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced TREMOR (Chills/shakes), CHILLS (Chills/shakes), PYREXIA (A mild fever at 100F), VACCINATION SITE PAIN (Tenderness at the injection site) and HEADACHE (Headache). At the time of the report, TREMOR (Chills/shakes), CHILLS (Chills/shakes), PYREXIA (A mild fever at 100F), VACCINATION SITE PAIN (Tenderness at the injection site) and HEADACHE (Headache) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Mar-2021, Body temperature: 100 (High) 100F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment medication was not given.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
A nurse reported that a 7 month old female received her 3rd dose of Prevnar and 2nd dose of Comvax on 03/27/01. On 05/05/01, she developed meningitis and bacteremia. She was admitted to the hospital. The reporter indicated that she reported this event to Communicable Disease, Reportable Diseases in Kansas. A copy of this report has been forwarded to Merck, manufacturer of Comvax. Follow-up received from the nurse on 06/06/01 indicated that the infant recovered from the meningitis; however, the mother of the infant states that her daughter has significant hearing loss in her right ear. F/U states that information was received from a nurse concerning a 9 month old female who on 3/27/01 was vaccinated IM in the left leg with a 2nd dose of Hib vaccine (lot 637874/1524K). Concomitant therapy included a 3rd dose IM in the right leg of Prevnar (474726). There was no illness at the time of the vaccination. On 5/5/01, the pt developed meningitis and bacteremia and was hospitalized. It was reported that a blood culture was done and was (+). It was noted that on 11/22/00 and 1/16/00, the pt received a 1st dose IM in the right leg (lot 473342) and a 2nd dose IM in the left leg (lot 473450) respectively of Prevnar. It was also noted that on 11/22/01, the pt received a 2nd dose Im in the right leg of Hib-Titer (lot 560903A). Follow-up information has been received from a health care professional who reports the pt had residual hearing loss, but she could not report on which ear or any other details. Additional info has been requested. Additional F/U has been received from a healthcare professional who reports there was profound hearing loss on the right side. Additional information has been requested. Follow-up received from the nurse on 06/06/2001 indicated that the infant recovered from the meningitis; however, the mother of the infant states that her daughter has significant hearing loss in her right ear. Follow-up info was received from the infant's primary care physician on 01/29/2002. The physician indicated that the infant was seen in the office on 05/11/2001 for follow-up to the hospitalization for pneumococcal meningitis and streptococcal septicemia. The infant was noted to have "profound deafness" in her right ear. Laboratory results from blood collected on 05/11/2001 revealed no growth at day 7 and a platelet count increased. A neurologic exam revealed no meningeal sings. Treatment included continuation of intravenous cefotaxime and acetaminophen. The pt was to be see by county health dept in September 2001 for a hearing test but did not show up for scheduled appointment. The physician reported that the family had not been compliant with his recommendations. As of 01/29/2002, he was unaware of the pt's location and believes that the family has moved away. Reported on 02/04/2003: A nurse from the public health clinic reported on 01-22-2003 that the child recovered but is deaf in the right ear and her left leg lags when she tries to run.  According to the nurse, the mother stated that "the child's father and child are both carriers of Streptococcal meningitis."  A copy of this report has been forwarded to Merck, manufacturer of Comvax.
After the second dose I woke up on 1/18/21 at 7:30 AM with extreme body and joint pain, a 102°F fever, a migraine with sensitivity to light and sound, dizziness, weakness and ear pain.  Fever broke on 1/19/21 at approximately 11:30PM.  I had a low grade fever, migraine, some body and joint pain, ear pain, dizziness and weakness. By 1/20/21 I had no fever, little body and joint pain, slight headache and still intense weakness and dizziness, and very intense ear pain. After 1/20/21, only the ear pain, slight arm pain, weakness and dizziness remained until 1/25/21.  As of today 2/1/21 I have diagnosed auditory neuritis but no other symptoms
Employee reported redness and swelling at the injection site with minimal itching. This lasted about 2 days and went away completely. No issues since.
Lower back pain first appeared on bending over, in the morning, 40 hours after vaccination. No other apparent cause.  Condition worsened throughout the day. Could remain sitting and standing without discomfort, but difficulty getting up, sitting down, walking and negotiating steps. Sitting on rolling chair at a short distance from desk and grasping edge of desk, could not pull myself back to the desk. By end of work day, could not walk without support. Next day, had chiropractic treatment and began a 30-day course of daily meloxicam 7.5 mg. Condition resolved fully within a week.
seasonal allergies; runny nose (originally thought to be due to allergies but was excessive by 16May); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 14 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 13May2021 15:30 (Lot number: ew0169) at the age of 14 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: ALEVE; NAPROXEN; ZYRTEC ALLERGY.  The following information was reported: RHINORRHOEA (non-serious) with onset 14May2021, outcome "recovered", described as "runny nose (originally thought to be due to allergies but was excessive by 16May)"; SEASONAL ALLERGY (non-serious), outcome "unknown", described as "seasonal allergies ". Therapeutic measures were taken as a result of rhinorrhoea.  Additional information: The patient did not receive any other vaccines within four. Prior to the vaccination, the patient was not diagnosed with COVID-19. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had no Known allergies. The patient had runny nose on 14May2021 but as she has seasonal allergies did not attribute to anything beyond seasonal allergies which are occurring right now. Late in the day 16May2021, runny nose was excessive beyond seasonal allergies so deemed this should be reported. She did not need medical attention (Doctor's visit).   No follow-up attempts are possible. No further information is expected.
Pt states that 3 days after her Pfizer covid vaccine, she developed swelling and pain of left hand. Doctors notes state she was diagnosed with gout with a Uric acid of 8. The doctor states the covid vaccine could trigger gout and that she is taking HCTZ which can predispose. This was the pt's first episode of gout. She was treated with a medrol pak. Doctor's notes state that pt improved 1 day after taking steroids. she has not had any recurrence of gout.
Death 3/18/2021 Causes of death listed on patient's death certificate: 1) Acute cessation of cardiac function  Other: Severe symptomatic aortic stenosis, coronary artery disease status post percutaneous coronary intervention
This case was reported by a consumer via interactive digital media and described the occurrence of difficulty breathing in a infant male patient who received DTPa vaccine for prophylaxis. On an unknown date, the patient received DTPa vaccine at an unknown dose. On an unknown date, unknown after receiving DTPa vaccine, the patient experienced difficulty breathing. On an unknown date, the outcome of the difficulty breathing was unknown. It was unknown if the reporter considered the difficulty breathing to be related to DTPa vaccine. Additional details were reported as follows: This case was reported by a consumer via Interactive Digital Media. The reporter had whooping cough in 1948. The reporter was about 2 and half and was so sick. The reporter remember part of it and would take a step and cough. His grandfather was an old school barber with home remedies up his sleeve. He got a teaspoon of sugar and poured kerosene on it. He had him ate it. No more coughing that night at least. The reporter was forced by his boss to had a flu shot in about 1974. He was sick for nearly 2 weeks. The reporter had one since. The reporter's grandson had a DPT shot as a baby. P for Pertussis. He had breathing issues his whole life of 25 years. This case has been linked with US2018GSK205808, reported by same reporter.
Tenderness spread to involve back and abdomen has getting worsen on last days; Generalize itching; Itch started on injection site; Injection site tenderness; Chest on fire; Worse and worse; Rash all over back, side, legs; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CHEST PAIN (Chest on fire), CONDITION AGGRAVATED (Worse and worse), RASH (Rash all over back, side, legs), BACK PAIN (Tenderness spread to involve back and abdomen has getting worsen on last days) and PRURITUS (Generalize itching) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 13-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, the patient experienced CHEST PAIN (Chest on fire), CONDITION AGGRAVATED (Worse and worse) and RASH (Rash all over back, side, legs). On 21-Feb-2021, the patient experienced BACK PAIN (Tenderness spread to involve back and abdomen has getting worsen on last days), PRURITUS (Generalize itching), VACCINATION SITE PRURITUS (Itch started on injection site) and VACCINATION SITE PAIN (Injection site tenderness). The patient was treated with FEXOFENADINE HYDROCHLORIDE (ALLEGRA) at an unspecified dose and frequency. At the time of the report, CHEST PAIN (Chest on fire), CONDITION AGGRAVATED (Worse and worse), RASH (Rash all over back, side, legs), BACK PAIN (Tenderness spread to involve back and abdomen has getting worsen on last days), PRURITUS (Generalize itching), VACCINATION SITE PRURITUS (Itch started on injection site) and VACCINATION SITE PAIN (Injection site tenderness) had not resolved.            No Concomitant products were reported.  Treatment medications include Antihistamines, Steroid creams.   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Follow-up information received on 03-MAY-2021: Reporter details updated , Event Added and Outcome updated.
also tested positive for COVID; also tested positive for COVID; This is a spontaneous report from a Pfizer-sponsored programt. A contactable consumer (patient) reported that a female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in Feb2021 (reported as either last 05Feb2021 or 06Feb2021) as SINGLE DOSE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient mentioned that her next dose will be on 12Mar2021. That was more than 21 days already. Consequently, she also tested positive for COVID yesterday, on 07Mar2021. The outcome of the event was unknown.   Information on the lot/batch number has been requested.
5 minutes after vaccines were administered, pt appearing to faint. found in older sister's arms. Initially non responsive.. EMS called.  Pt responded about 1 minute later.  Assessed to be oriented x 3.  HR 86, BP was 90/60.  RR 16. Pt was pale . EMS responded to the scene about 5 minutes later.  EMT assessed pt.  obtained and found to have BP on 106/64,  Pulse ox was 99%. bld glucose was 115.  Pt was oriented x3.  Pallor resolved.  Pt was cleared by EMT but  offered to take to ER , pt and family declined.  Pt reports that she is afraid of needles.
Administrator gave bivalent moderna 6m-5y to patient whom had 2 dose of mono pfizer 6m-4y. No harm to patient at this time. Patient showed no sign effects after 15 minutes.
Patient vaccinated 8-13-18. Presented at the clinic today (8-17-18) with injection site being red, hot and swollen. She has a rash on her arm and torso and reported having a fever on and off. She said the symptoms started the evening after getting the injection. I advised the patient to go to Urgent Care   as Dr.is out of the office. Patient was treated at Urgent care with antibiotics and steroids.
This is a 74-year-old female brought from home for altered mental status per EMS on 2/14. Found to be COVID positive 2/14. Pt in no apparent distress, respirations even & non labored. Pt. awake, alert and oriented x2, external cath placed, gown/linens are clean & dry. IV site without redness or swelling, pt denies pain/discomfort at insertion site and denied any needs. States able to breathe easy. Tolerating very well. RA O2. No anti-COVID rx needed 2/15. Found to be drastically improved the morning after admission without any complaints and discharged to home 2/15.
This is a spontaneous report received from contactable consumer. A 78-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administered in the right arm, administration date Feb2021 (Lot number: EL9266) as dose 2, single for COVID-19 immunisation. Relevant medical history included: "Parkinson's disease", start date: 2014 (unspecified if ongoing), notes: moderate to advanced, diagnosed 6 years ago 2014 maybe; "extreme muscle weakness" (unspecified if ongoing), notes: usually. There were no concomitant medications. Vaccination history included: BNT162B2 (dose 1, Lot Number: EL9262), administered in the right arm, administration date: 04Feb2021, when the patient was 78 years old, for COVID-19 immunisation. The following information was reported: MUSCULAR WEAKNESS (non-serious) with onset 26Feb2021, outcome "unknown", described as "muscle weakness has been exacerbated".Additional information: The reporter (patient's wife) believed that the patient's muscle weakness has been exacerbated by the vaccine. The reporter was unsure if it was improving or worsening. She wanted to know if this was a side effect of the vaccine. No follow-up attempts are possible. No further information is expected.
Patient denied previous Covid vaccines during screening and consent review.  After dose administered, informed administering clinician that she had already received 2 doses of Moderna Covid vaccine.  After discussion with PCP and state epi, determine that patient does not meet guidelines for immunocompromised although is taking long-term corticosteroids.
Patient reported pain at injection site immediately after vaccine. Reported increased pain and developed redness evening of vaccination. Saw PCP - diagnosis vaccine reaction vs. cellulitis. Patient afebrile. Treatment with oral dicloxacillin.
Saturday evening, she had rash on lower belly from navel down and all the way across her stomach; The next day she had fever of 101.7; She also had fatigue; light headache next day; On same day after receiving 2nd dose, injection site was swollen about 2 inches in diameter; It was red; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RASH (Saturday evening, she had rash on lower belly from navel down and all the way across her stomach) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included LISINOPRIL for an unknown indication.   On 22-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, the patient experienced VACCINATION SITE SWELLING (On same day after receiving 2nd dose, injection site was swollen about 2 inches in diameter) and VACCINATION SITE ERYTHEMA (It was red). On 23-Apr-2021, the patient experienced PYREXIA (The next day she had fever of 101.7), FATIGUE (She also had fatigue) and HEADACHE (light headache next day). On 24-Apr-2021, the patient experienced RASH (Saturday evening, she had rash on lower belly from navel down and all the way across her stomach) (seriousness criterion medically significant). At the time of the report, RASH (Saturday evening, she had rash on lower belly from navel down and all the way across her stomach), VACCINATION SITE SWELLING (On same day after receiving 2nd dose, injection site was swollen about 2 inches in diameter), VACCINATION SITE ERYTHEMA (It was red), PYREXIA (The next day she had fever of 101.7), FATIGUE (She also had fatigue) and HEADACHE (light headache next day) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Apr-2021, Body temperature: 101.7.         Treatment included acetaminophen. The patient went to the emergency room on Saturday night because of rash on stomach and they put her on antibiotics.; Sender's Comments: Based on current available information and the temporal association between product and the start date of the events a causal relationship cannot be excluded.
Moderate swelling at injection site along with ?knots hard ball at injection site and warmth.  Swollen lymph nodes under arm same side at injection; swollen lymph nodes in neck and groin   Severe all over joint pain for 48 hrs  Itchiness at injection site and all over body, not helped by Benadryl  Tension headache
C/O onset of symptoms the day after PREVNAR 13 vaccination. Stated increased temp to 102, chills, generalized body aches; "confined to bed"; c/o (L) arm (upper) swollen and red; follow up with PMD on 5/26/2015.
Started with tinnitis in both ears. Right ear cleared up after a couple of weeks. Left ear developed an echo the sound deadening. Now have hearing loss and ringing in left ear. There were no problems before the vaccine.
Post vax, the pt developed a fever, chills, and redness at the injection site.
Patient was given the vaccine 12 days past the expiration date. The vaccine expired 6/4/2022. Patient did not have an adverse reaction
1st dose Mar2022, 2nd never; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 62-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (in March 2020 patient received 1st dose).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 08-FEB-2023 Reporter's Comment: The pharmacist called to ask for information regarding a patient who received the first dose of Shingrix in March 2020 but never got the second dose.  The reporter asked if the patient had to receive a second dose or start over with the vaccination. The reporter did not provide data about the lot number and expiry date of the first Shingrix dose The reporter consent to follow up. Additional supportive information: Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination.
Left shoulder upper arm soreness and swelling with axillary lymph node 1 cm, skin redness/pinkness in 6x4 cm area of axilla.