chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms; 42 Patients received bivalent booster with 38 having improvement of symptoms; This spontaneous case was reported by a physician and describes the occurrence of OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms), THERAPEUTIC RESPONSE UNEXPECTED (42 Patients received bivalent booster with 38 having improvement of symptoms) and NO ADVERSE EVENT (No adverse event) in a patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for Long COVID.     No Medical History information was reported.    In 2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In 2023, the patient experienced OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms) and THERAPEUTIC RESPONSE UNEXPECTED (42 Patients received bivalent booster with 38 having improvement of symptoms). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms), THERAPEUTIC RESPONSE UNEXPECTED (42 Patients received bivalent booster with 38 having improvement of symptoms) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms) and THERAPEUTIC RESPONSE UNEXPECTED (42 Patients received bivalent booster with 38 having improvement of symptoms).    No concomitant medications were reported.  Reporter had been administering the 65 plus bivalent dose to her patients who have symptoms of long-haul COVID and had seen 88-90% success rate in resolving the symptoms of long-haul COVID. Vaccine was given within current guidelines except seven were under 65.  It was reported that, vaccine was given to patients for long COVID between Mar-2023 and 01-Aug-2023. 42 patients received bivalent boosters with 38 having improvement of symptoms of 50% or more.  Patients were treated for skin lesions, brain related problem, systolic blood pressure was 220, tachycardia greater than 150, and body aches. No adverse reactions occurred.  No treatment medications were reported.  This case contains information about patient 27 out of 42 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-735199 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-735199:Master case patient 1
After about 10 minutes post vaccination, patient complained of heart racing and dizziness.  She states that she has anxiety and was very anxious about getting the shot.   Patient vitals were monitored for  30 minutes, they were stable and she was allowed to leave after monitoring for 30 minutes with no other adverse effects.
Menstrual cycle began the morning after my vaccine (a week early), which isn?t typical for me. Cycle was extremely heavy and I called my OB for medicine to help with the amount of blood loss.
Patient stated she had redness and swelling of upper arm, from the top of the arm to above the elbow,  beginning on the third day after vaccination. There was soreness at the injection site. These symptoms lasted about a week. Patient used cool compresses to help relieve the symptoms.
Left upper arm red, swollen and hot to touch.  Complaints of fever and body aches.  Diagnosed with cellulitis.
Patient describes lower extremity weakness the day after her COVID vaccine. Pt too weak to walk without assistance. Patient was seen at Urgent Care and told to go to the Emergency Department. Patient was admitted to hospital for evaluation by PT/OT.
Patient reported that first dose caused cardiac and febrile symptoms including chest pain/discomfort, insomnia; Patient reported that first dose caused cardiac and febrile symptoms including chest pain/discomfort, insomnia.; Patient reported that first dose caused cardiac and febrile symptoms including chest pain/discomfort, insomnia.; Patient reported that first dose caused cardiac and febrile symptoms including chest pain/discomfort, insomnia; Patient reported that first dose caused cardiac and febrile symptoms including chest pain/discomfort, insomnia; This is a spontaneous report from a non-contactable pharmacist.     A 39-years-old female patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection (Batch/Lot Number: EN6199), dose 1 intramuscular, administered in Arm Left on 10Feb2021 as dose 1, single for covid-19 immunisation. Medical history included covid-19. The patient's concomitant medications were not reported. The patient receive other vaccine previously. Prior to vaccination patient was not diagnosed with COVID. Post vaccination patient did not test for COVID. It was Reported that, Patient reported that first dose caused cardiac and febrile symptoms including chest pain/discomfort, insomnia. Patient consented to receiving second dose after education with RN on an unspecified date with outcome of unknown.  No follow-up attempts are possible. No further information is expected.
Immediately after receiving the vaccine I could feel a firmness, swelling, and soreness at the injection location. At the time I thought it was simply due to having received a shot. But now it is many months later (approx. 4 months) and I can STILL feel a firmness at the injection site. I notice it especially when it is cold outside (less that 45*F) I feel a dull aching that weakens my whole left arm. I have not sought treatment, as I don't believe any Dr. would take me seriously. But this is concerning to me. I have asked friends and family who also received their Covid-19 vaccine and none of them have stating being able to detect their injection location much less be caused discomfort by it.
shoulder inflamed; shoulder hot to touch; very painful/left shoulder still remains inflamed, hot to touch and very painful; discomfort; This case was reported by a consumer via interactive digital media and described the occurrence of shoulder arthritis in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 30th March 2022, the patient received the 1st dose of Shingles vaccine. In March 2022, less than a week after receiving Shingles vaccine, the patient experienced shoulder arthritis, feeling hot, shoulder pain and discomfort. On an unknown date, the outcome of the shoulder arthritis, feeling hot, shoulder pain and discomfort were not recovered/not resolved.   It was unknown if the reporter considered the shoulder arthritis, feeling hot, shoulder pain and discomfort to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 31-MAR-2022 Reporter's Comments: This case was reported by a consumer via interactive digital media. The patient received Shingle vaccine on 30th March in morning. The patient's left shoulder still remained inflamed, hot to touch and very painful. The patients asked for how long  this pain/discomfort last. Additional Supportive Information:  The follow-up would not possible as no contact details were available.
Patient felt dizzy, felt feeling of impending doom - however he did not develop any rash / swelling of lips or wheezing. He was placed on 4 L O2 for 1 1/2 hrs and vomiting. His VSS. He was then release without any complications.
Approximately 12 hours after vaccine I got an excruciating headache that lasted for 8 hours.  (I've had Meningitis in the past and this was worse).  Once the headache went away I developed Vertigo that lasted approximately 14 days along with a feeling of brain fog. Approximately 2 1/2 weeks after vaccine I developed another excruciating headache with pain that radiated down the back of my throat (not sore throat pain).  The pain of the headache was also in the back of my throat.  This lasted approximately 12 hours.
Pt came to ER c/o body aches, cough, sore throat, rhinorrhea, nasal congestion, chills, fever.  Onset 5 days prior to arrival.
J96.00 ACUTE RESPIRATORY FAILURE 2/7/2021 UNSPECIFIED ANXIETY R09.02 HYPOXIA 2/8/2021 UNSPECIFIED ANXIETY J96.00 ACUTE RESPIRATORY FAILURE 2/7/2021 ABNL ABDOMINAL CT SCAN R09.02 HYPOXIA 2/8/2021 ABNL ABDOMINAL CT SCAN
Flu-like symptoms; Lethargic; Sniffles; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu-like symptoms), LETHARGY (Lethargic) and RHINORRHOEA (Sniffles) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Lupus syndrome (Lupus) and Depression. Concomitant products included HYDROXYCHLOROQUINE for Lupus erythematosus.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu-like symptoms), LETHARGY (Lethargic) and RHINORRHOEA (Sniffles). At the time of the report, INFLUENZA LIKE ILLNESS (Flu-like symptoms), LETHARGY (Lethargic) and RHINORRHOEA (Sniffles) had resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No treatment information was provided.
Extremely sore left arm, inability to sleep, wheezing, and headache/dizziness.
Had the shot two times both time. I felt tingling or electrical pulses in my body and head. Would wake out of sleep not breathing. I do not have sleep apnea never have, but I was feeling shocks and woke up with no air in my lungs. Was so scary woke up and sat out of bed because I wasn't breathing and feeling a type of shocking electrical feeling.
Nine hours after her 2nd Moderna shot: my 21-year-old daughter was at home, walking across the room, when she suddenly collapsed and was unconscious for about one minute. Luckily I was right there so I instantly tried to wake her, while my husband called 911, and she was in and out of consciousness for about ten minutes. She also vomited three or four times. By the time the paramedics arrived she was awake and able to communicate. Please note she has no history or fainting; she has never lost consciousness ever in her life, so this was an extreme, unusual, and frightening occurrence.
Patient states the day after receiving the vaccine (4/21) at around 9-10pm she developed a fever (unsure of temp), chills, and started shivering. This kept her awake until about 3am when she fell asleep. She said the following day (4/22) the fever and chills were gone but she didn't have any energy. The next day (4/23) she said she was fully recovered and felt fine.
This spontaneous report as received from a physician refers to three unspecified patients of unknown demography. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patients were vaccinated with improperly stored VARIVAX (Merck) injection, lot # J012773, expiry date: 09-OCT-2015 (strength, dose and route unspecified). No concomitant medications were reported. No adverse effects were reported. There were no product quality complaints (PQC) involved. No further details were provided. Additional information is not expected as the reporter did not wish further contact.
could no longer get an erection (after he received his 1st COVID-19 Vaccine); eczema flared; This is a spontaneous report from a contactable consumer (patient's mother). A 27-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm right on 11May2021 16:00 (Lot Number: EW0176) as DOSE 1, SINGLE for Covid-19 Immunisation. Medical history included eczema for about 7-8 years and sensitive to pharmaceuticals. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 12May2021, the patient's mother reported that her son could no longer get an erection (after he received his 1st COVID-19 Vaccine) and his eczema flared like nothing he had ever experienced before. Her son was just covered with eczema the day after his COVID-19 Vaccine, and applied the manuka honey everywhere he had eczema since it had kept the eczema under control. She said her son was very sensitive to pharmaceuticals and would not take pharmaceuticals because of the past side effects he had from them. They also believed that the vaccine had caused him not having erection. After three weeks, it started to come back a little bit but not as normal erection that he had before. The patient's mother was asking how long will the patient experience not having erection. They spoke to their doctor and told them that there is no relation between the vaccine and erection issues. At the time of report, the outcome of the events was recovering. The patient did not proceed on the scheduled second dose appointment because of the side effect.
The first menstrual period my daughter had after her second dose of the Pfizer vaccine was more severe than any period she has experienced since age 10.  She has been bedridden with terrible cramping and nausea and has been bleeding more than she has with any previous periods. She has never previously suffered from cramps or heavy bleeding.
Pt was given immunization on 03/14/2002. On 03/23/2002,  developed a fever with rash. Was seen on 03/25/2002. No fever on examination ; throat lesions and exanthem noted. No fever
Moderna --------Rash appeared on cheeks within 2 hours of the shot.  The dermatologist said it was Rosacea.
From initial information received from a health care professional on 6/3/05 regarding an adverse event occurring in the USA, it was reported that a 48 year old female patient received a dose of TET TOX ADS USP vaccine on 5/28/05 following a cut on her finger. The lot number, route and site of administration were not reported. Six days later, on 6/3/05, the patient presented to a physician's office with decreased blood pressure, decreased heart rate, swollen lips, respiratory distress, a headache and muscle weakness. It was reported that the patient recovered from these events. (OMIC)
Chronic dermatographia developed approximate 10-14 days after injection.  Affected area is body-wide.
On June 4th in the afternoon, experienced a burning sensation in his chest/lungs. It resolved with one dose of ibuprofen administered a few hours later.; On June 4th in the afternoon, experienced a burning sensation in his chest/lungs. It resolved with one dose of ibuprofen administered a few hours later.; This is a spontaneous report from a contactable consumer, the patient. A 12-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0168), dose 2 via an unspecified route of administration, administered in Arm Left on 02Jun2021 15:15 (at the age of 12-years-old) as a single dose for covid-19 immunization. Patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0191), dose 1 via an unspecified route of administration, administered in Arm Left on 14May2021 15:30 (at the age of 12-years-old) as a single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient did not have any allergies. The patient had no other vaccine within four weeks and no other medications received within 2 weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 04Jun2021 13:00 in the afternoon, the patient experienced a burning sensation in his chest/lungs. it resolved with one dose of ibuprofen administered a few hours later. The adverse event resulted in doctor or other healthcare professional office/clinic visit. The patient receive treatment with ibuprofen. Outcome of the event was recovered. Follow-up attempts are completed. No further information is expected.
No adverse event; Patient received an expired primary series dose as a second dose; Patient previously received 1st dose 22-Dec-2022 and 2nd dose on 13-Feb-2023; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received an expired primary series dose as a second dose), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient previously received 1st dose 22-Dec-2022 and 2nd dose on 13-Feb-2023) and NO ADVERSE EVENT (No adverse event) in a 48-year-old male patient who received mRNA-1273 (Spikevax) (batch nos. 057A22A and 057A22A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 22-Dec-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 13-Feb-2023, received second dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. On 13-Feb-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received an expired primary series dose as a second dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient previously received 1st dose 22-Dec-2022 and 2nd dose on 13-Feb-2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received an expired primary series dose as a second dose), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient previously received 1st dose 22-Dec-2022 and 2nd dose on 13-Feb-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient received an expired primary series dose as a second dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient previously received 1st dose 22-Dec-2022 and 2nd dose on 13-Feb-2023).    No concomitant medication was reported.  It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Vial size was reported as 5.5 milliliter. On 13-Feb-2023, the vial was initially stored in the refrigerator and thawed on the same day of administration.  Vial did not undergo any temperature excursions.  No treatment information was provided.
31DEC90 temp 103 - seen in ER- dc - normal PE on 1JAN91 345A- temp 105.7 in ER ?pink ear - placed on polymox. No other sx-fever down by eve of 2JAN91.
Information has been received from a physician concerning a female who was vaccinated IM with the first dose of GARDASIL (lot# not reported).  Subsequently the patient experienced arthralgia.  Per the reporter, the patient was diagnosed with juvenile rheumatoid arthritis.  The patient's rheumatologist recommended that she not continue the series.  No additional information was given.  Additional information has been requested.
blood clots in his lungs; This is a spontaneous report from a contactable consumer (reporter's daughter's father in law). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 2, single for covid-19 immunisation. Medical history included blood clots. The patient's concomitant medications were not reported. The patient received first dose of bnt162b2 for covid-19 immunisation on an unspecified date. On an unspecified date, the patient experienced blood clots in his lungs after the second dose. The patient was hospitalized on an unspecified date due to the event. The reporter stated that she had people she knows personally who have had a blot clot after the vaccine. Her daughter's father in law who also has a history of blood clots, after his second vaccine ended up in the hospital with blood clots in his lungs. Reporter stated that she does not want to report on her daughter's father in law as he was in another state and she thought he reported for himself, she only would be willing to complete information for herself. Outcome of event was unknown.  The lot number for the vaccine, bnt162b2, was not provided and will be requested during follow up.
Shingles that I had (2020) previously were likely reactived by the booster shot.
patient reports itching on neck and inside mouth and reports feeling like throat is scratchy, slightly lightheaded.  Epi Pen and Benadryl given.
Irritability and temp of 102 degrees (R) noticed at 6:20 PM per mom. Seen in ER.
Within 5 mins after receiving MMR and Varicella vaccines on L thigh and Hep A on R thigh she developed large urticaria rash on face and around site of injection on L thigh.
BUD date 04/07/2022 administered on 4/15/2022. Pfizer could not provide stability data beyond 04/09/2022 and recommended revaccination.
4/1/19 0700 am sudden nausea and dizziness - almost fainted - excessive sweating.
This case was reported by a consumer via call center representative and described the occurrence of blister in a 67-year-old female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included shingles (yearly for the past 4 to 5 years) and lymphadenopathy cervical. On 2nd November 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In November 2018, less than a week after receiving SHINGRIX, the patient experienced blister. On an unknown date, the outcome of the blister was unknown. It was unknown if the reporter considered the blister to be related to SHINGRIX. Additional details were reported as follows: The caller reported that she had shingles yearly for the past 4 to 5 years. She had a bad case over the summer of 2018. She was advised by her infectious disease doctor to get SHINGRIX. Prior to getting the dose of SHINGRIX her shingles was mostly resolved, though she thinks it might had lurking at a low level. Within a week or 2 of getting SHINGRIX she started having little shingles blisters pop out, and it had popping out ever since. She had swollen lymph nodes in the left side of her neck since summer. The swelling was up and down since summer, and this had continued since getting SHINGRIX. The reporter consented to follow up.
post vaccination rxn: HA and vomiting; fever of 100.4-100.6 for 24 hours
After receiving the injection, my face and neck turned bright red. It took about an hour for the redness to go down. The next morning, I noticed a few small pimples on my cheeks and a slight red /dry patch on my forehead.
After receiving her second dose, patient experienced lightheadedness and reported she "felt like she was going to pass out." She also reported nausea. We provided her with a trash can and a bottle of water and asked her to wait in the waiting room for at least 30 minutes to be monitored. Her breathing was stable throughout, and she did not lose consciousness. Pt stayed for at least 30 minutes until she felt better and was okay to drive home. We called her later in the day to check on her and she reported feeling better but had a headache and was laying down.
Information has been received from a registered nurse concerning a 16-month-old male, with no pertinent medical history or allergies, who on 19-MAR-2008 was vaccinated subcutaneous with 0.5 ml dose ATTENUVAX (lot # 659617/0187X). There was no concomitant medications. On approximately 29-MAAR-2008, 7-10 days post vaccination, the patient "developed an all over body rash and fever. "The patient sought medical attention via an office visit. No diagnostic labs were performed. At the time of the report the patient's status was recovering. It was also reported the patient's twin sibling had an adverse experience WAES # 0804USA02908. The records of testing prior to release of lot 659617/0187X have been rechecked and found to be satisfactory. The lot met the requirements of the center and was released by the regulatory agency. This is one of several reports from the same source. Additional information has been requested.