chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after expiration date), PRODUCT STORAGE ERROR (Vial was expired on 13-May-2022, placed in the refrigerator on the same day of administration (26-May-2022)) and NO ADVERSE EVENT (No adverse event) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003K21-2A, 045C21A, 040B21A and 037A21B) for COVID-19 prophylaxis. No Medical History information was reported. On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 16-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 26-May-2022 at 9:06 PM, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 26-May-2022 at 9:06 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was expired on 13-May-2022, placed in the refrigerator on the same day of administration (26-May-2022)) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after expiration date), PRODUCT STORAGE ERROR (Vial was expired on 13-May-2022, placed in the refrigerator on the same day of administration (26-May-2022)) and NO ADVERSE EVENT (No adverse event) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related and EXPIRED PRODUCT ADMINISTERED (Dose administered after expiration date) to have an unknown relationship. No further causality assessment was provided for PRODUCT STORAGE ERROR (Vial was expired on 13-May-2022, placed in the refrigerator on the same day of administration (26-May-2022)). It was unknown whether the patient had acute illnesses at the time of vaccination and up to one month before. It was unknown whether the patient had chronic or long-standing health conditions. It was unknown whether prescriptions, over-the-counter medications, dietary supplements, or herbal remedies being taken at time of vaccination and/or at the time of the adverse event. Concomitant product use was not provided by the reporter. The event did not cause the patient to seek medical care. It was unknown if there was any other potential causes. It was unknown if the patient experienced a similar event in the past. The vial did not undergo any temperature excursions. Treatment information was not provided. This case was linked to PR-MODERNATX, INC.-MOD-2022-585601 (E2B Linked Report). Sender's Comments: PR-MODERNATX, INC.-MOD-2022-585601: Master case (same reporter).
pressure from eyebrow between eyes, and cheekbone; headache-left side; swollen lymph nodes in neck /behind ear left side; This spontaneous case was reported by a consumer and describes the occurrence of SINUSITIS (pressure from eyebrow between eyes, and cheekbone), HEADACHE (headache-left side) and LYMPHADENOPATHY (swollen lymph nodes in neck /behind ear left side) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced HEADACHE (headache-left side) and LYMPHADENOPATHY (swollen lymph nodes in neck /behind ear left side). On 10-Mar-2021, the patient experienced SINUSITIS (pressure from eyebrow between eyes, and cheekbone). At the time of the report, SINUSITIS (pressure from eyebrow between eyes, and cheekbone), HEADACHE (headache-left side) and LYMPHADENOPATHY (swollen lymph nodes in neck /behind ear left side) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
back ache; intense achy; rigors and chill; Could not sleep; second dose of BNT162B2 on 08Jan2021, first dose was given on 19Dec2020; This is a spontaneous report from a contactable physician (reported for herself). A 43-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: El3249), via an unspecified route of administration (left arm) on 08Jan2021 (10:00 AM) at single dose for Covid-19 immunization. The patient received the first dose of BNT162B2 on 19Dec2020 (10:00 AM). Medical history included Celiac disease and allergies to medications, food, or other products: Latex, salicylate, wheat (celiac). Concomitant medication included melatonin (MELATONIN). The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that at around 30 hours after second vaccine dose (09Jan2021, 05:00 PM), the patient experienced back ache. At 36 hours post vaccine she developed intense achy and rigors and chill that lasts about 6 hours. The patient could not sleep during that time (10pm-330am). The patient took Tylenol at 1:30am. The symptoms abruptly stopped and felt perfectly fine after. There was a treatment received for the adverse event. The outcome of events was recovered on an unspecified date. The patient has not been tested for COVID-19 since the vaccination. This case is non-serious.
Off balance numbness on left side blurred vision in the left eye. Dx: Bell's Palsy. Rx: Prednisone, VALTREX, Ocular lubricant.
This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache lasted for 3 weeks) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination. No medical history was reported. Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR) for an unknown indication. On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Feb-2021, the patient experienced HEADACHE (Headache lasted for 3 weeks). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency; PARACETAMOL (TYLENOL) at an unspecified dose and frequency and NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency. At the time of the report, HEADACHE (Headache lasted for 3 weeks) outcome was unknown. Action taken with mRNA-1273 in response to the event was not applicable. This case was linked to MOD-2021-053409.
I had the shots/Suspected Vaccination Failure; Still ended up with a case of shingles/broke out on my face.; This serious case was reported by a consumer via interactive digital media and described the occurrence of 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, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: I had the shots/Suspected Vaccination Failure) (serious criteria GSK medically significant) and shingles (Verbatim: Still ended up with a case of shingles/broke out on my face.). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 11-MAR-2023 The case was received from the patient via interactive digital media. The patient had the Shingles shots and still ended up with a case of shingles that broke out on his/her face. The reporter stated that patient (another person) who showed up at the physician office also had it on his face. The physician even made a comment that he had never seen anyone who had the shots and then had them on their face and might be something missing in the vaccine that was causing this to happen. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available. This case is linked with US2023AMR041952, reported by same reporter.; Sender's Comments:  US-GSK-US2023AMR041952:same reporter
Getting over shingles, have had vaccination/Suspected vaccination failure; Getting over shingles; Still have some itching; Still having pain; 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, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, pruritus and back pain. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was recovering/resolving and the outcome of the pruritus and back pain were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, pruritus and back pain to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient had shingles vaccination and just getting over shingles.  The patient still had some itching, still had some pain, mostly in back. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation were unknown at the time of reporting. No contact details were available.
Sore arm at injection site within 4 hours of booster.  fatigue, nausea, body aches/pains, chills, slight headache started about 7 hours after booster. Mostly improved next morning, however light headed and mild aches. Rested dec 2. Eve of Dec 2 aches returning, slight nausea. Still experiencing. Taking ibuprofen and resting
Maternal exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 21-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided. Treatment information was not provided.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
15 minutes after injection: itchy leg & scalp; blood pressure 150/90; clinic gave me Benadryl and monitored until blood pressure was 125/80; itchiness, headache and tiredness continued for one week
Soreness down entire arm, hard lump at injection site. Lasting > 4 wks.
Pt. felt too weak to get out of bed the day after the IPV.  She developed a pruritic rash on her legs which was unresponsive to Benadryl.  There were no other vaccines administered and this was a booster shot only.
4-1-2011 mother presents to clinic requesting child, immunization record. Mother reports that her baby died 3-31-2011 at approximately 10:50 am. She reports the following: On 3-30-11 at 12:30pm she brought patient to the CHD for a routine well baby visit and immunizations. The child was done with the visit and receiving his shots by about 1pm. The rest of the day the child was sleepy and ate about 2 oz of formula vs his normal 7 oz at a time. At 11:30 pm she performed his routine diaper change and feeding. At that time he was moist to touch, but not running a fever (she never took his temperature but he felt warm to touch). 3-31-11 2AM; the baby accompanied the family to the ER for another child's scraped knee. They returned at 4AM, in which the mother reports she fed the baby 2 oz and did a diaper change. 10:40 AM the mother woke up and checked the baby, the baby was sleeping on his stomach. She reports that she does not believe in putting the baby on his back, because she thinks the baby will choke, she admits that she was trained by the provider, he should be on his back for sleeping. She then went out to the garage to have a cigarette. She returned at 10:50 am to get the baby up. The babies arm was flopped out and looked yellow, she checked the baby for breathing, and he was not breathing, then called 911. I gave the mother a copy of the child's immunization record. Offered Healthy Start bereavement services, she declined, stating she has enough family support for that.
On the day of vaccine he was up several times saying he was not well with a cough and the next am until 10am he felt better. Friday night he was sleeping and in the middle of the night it was itchy and the next am he had hives, big areas in his chest. Back, legs and neck big red blotches, Called nurse line on sat am and they said to give Benadryl and it cleared on 30Nov2021.
Itchy hives on my arms and near my ankles.  Looks almost like a pimple (without a white-head) and is very itchy.
Pt. noted headache PM of receiving vacc. (7/27/16). On 7-28-16 noted (R) deltoid area red, warm, itched, chills. On 7-29-16 upper half (R) arm red, warm to touch, swollen, itching. No dizziness, weakness, difficulty in breathing or swallowing noted. Severe local reaction.
A few hours after injection noticed red and soreness at injection site.  Was worse the next day.  1/29/21 Pain and redness continue with swollen lymphs in L  axillary  Entire arm painful to move, breasts sore.  States she has taken Tylenol, Advil, and Aleve at times  for pain relief.  Saw Doctor today  and put on Keflex for possible Cellulitis.
Fever 103.7, violent body spasms, serious difficulty breathing. Body spasms lasted for several hours, breathing improved after treatment at hospital. Remained unavailable.
Injection site pain on day if vaccine. Next day headache. Day after that (today) fever (102) and body aches.
On 3/14/21 patient started with left flank pain that radiated to left shoulder and increased pain while taking a deep breath. Mother called on 3/16/21 and patient was seen in primary clinic for issue. She had labs and xray done. Xray showed possible mild opacity in left lower lobe and to do ct scan. Ct pe study done same day showing bilateral lower lung pulmonary emboli and lower lung patchy infiltrates. Patients pain progressively got worsened and was seen in the er to be transferred to outgoing facility for care.
01/11/2022: Event occurred after Janssen vaccine dose.  Patient presents to the emergency department for multiple complaints however her chief complaint is respiratory distress.  Present for couple days progressively worsening and has been absolute worse today.  Patient states she has a productive cough clear to white sputum.  Denies hemoptysis.  Denies chest pain.  Patient states her respiratory distress is worsened since being here in the hospital.  She admits to diarrhea has been ongoing since September.  patient was discharged from the hospital on the December 20 on p.o. antibiotics .Recently in hospital in December for altered mental status, acute encephalopathy and had E. coli bacteremia at that time. denies: vomiting, fever,  01/12/2022: BiPAP set increased to 20/8 FiO2 80%. Start remdesivir and Decadron
Pt had a high fever 4-5 hours post vaccination, as well as a rash all over his body and edema in hands and feet.
Burning rash down my arms, under my chest, down my rib cage. Measle look like bumps. Hundreds of raised bumps. Extremely itchy, very uncomfortable.
ER visit - tachy to 120's, fever, myalgias, short of breath, diaphoresis
Information has been received from a nurse referring to a patient of unknown age and gender. Concomitant therapies included sterile diluent. Information about concurrent condition, drug reactions/allergies and medical history was not provided. On 11-SEP-2018, the patient received one dose of improperly stored (-9 Celsius (C) degree to 8 C degree for 68 minutes; previous temperature excursion: -9 C degree to 8 C degree for 76 minutes) VARIVAX (lot # N029634, expiration date 23-OCT-2019; strength and route were not reported) for prophylaxis; reconstituted with properly stored sterile diluent (as reported lot# R002715, expiration date 20-FEB-2020). No adverse effects reported. The reporter called because of a data logger. Sender's Comments: US-009507513-1809USA005628: US-009507513-1809USA011283: US-009507513-1809USA011743: US-009507513-1809USA011744: US-009507513-1809USA011745: US-009507513-1809USA011746: US-009507513-1809USA011747: US-009507513-1809USA011748: US-009507513-1809USA011749: US-009507513-1809USA011750: US-009507513-1809USA011751: US-009507513-1809USA011752: US-009507513-1809USA011753: US-009507513-1809USA011754: US-009507513-1809USA011755: US-009507513-1809USA011756: US-009507513-1809USA011758: US-009507513-1809USA011759.
unconsolable crying for 1 1/2 hrs @ a time, high pitched screaming, throwing up, low grade fever;
Information has been received from a Nurse Practitioner concerning a 21 year old female patient with penicillin allergy who on 02-MAR-2007 was vaccinated IM with a first dose of Gardasil. The NP reported that the patient had genital warts after receiving the Gardasil. On 19-MAR-2007 she first had itching and irritation. On 21-MAR-2007 she was examined and had both bacterial vaginosis and yeast infection. On 19-MAR-2007 she was treated with Diflucan and on 21-MAR-2007 she was treated with Flagyl. On 16-APR-2007 the genital warts were visually confirmed during the examination. The patient had tested positive for serum human papillomavirus prior to the vaccination. The patient's genital wart was persisting. Additional information has been requested.
Slept for six hrs. straight night shot was given. Next 3 nights extreme back pain area of back kidneys. ER on 4th day. Was given NORVASC-result-A-Fib.
Patient reports pain in arm ranging from elbow to shoulder. Pain with very slight movement. Pain began shortly after vaccine was administered and has lasted without relief for 2 weeks. Patient tried OTC pain medication including TYLENOL and ADVIL with no success. Patient has also tried moving arm around with no relief of pain.
Feeling of dehydration, stiffness in lymph areas (armpits, groin), low back pain (feeling like kidney pain), and irregular bleeding/menstruation
tightness in my throat; rash on my left forearm and left side continuing across my stomach; This is a spontaneous report from a contactable consumer (patient). A 68-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot number: EN6201) via an unspecified route of administration in the left arm on 10Feb2021 at 09:30 as a single dose for COVID-19 immunization. Medical history was not reported. It was reported that the patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications ("other medications in two weeks") included lisinopril taken for an unspecified indication on an unspecified date and unspecified if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 11Feb2021 at 13:00 the patient experienced tightness in my throat and rash on my left forearm and left side continuing across my stomach. The patient reported that she experienced side effects that included tightness in her throat and a rash on her eft forearm and left side continuing across my stomach. She stated that rash was listed under "allergic reaction", so she was not sure whether she should receive the second dose. She asked if we could advise. The patient reported that she did not receive treatment for the adverse events. The clinical outcomes of the events experienced tightness in my throat and rash on my left forearm and left side continuing across my stomach were both not recovered/not resolved. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
This spontaneous report as received from a certified nursing assistant refers to multiple patients of unknown age and gender. the patient's concurrent conditions, medical history and concomitant medications were not reported. On unknown dates, the patients were inadvertently vaccinated with improperly stored RECOMBIVAX HB (strength, dose, route and site of administration, lot # and expiry date were not reported). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.