chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pain; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN (Pain) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030a21a, 002A21A and 069f21a) for COVID-19 prophylaxis.     Patient had no known allergies to medications, food and other products. Patient had never been diagnosed with or tested positive for COVID-19. It was unknown if the patient had acute illnesses at the time of vaccination and up to one month before.  Concurrent medical conditions included Muscle spasm since 07-Jul-2020 and Pain since 20-Jul-2020. Concomitant products included CYCLOBENZAPRINE from 20-Jul-2020 to an unknown date, ERGOCALCIFEROL from 15-Apr-2021 to an unknown date, METHYLPREDNISOLONE from 25-Aug-2021 to an unknown date and NAPROXEN from 20-Jul-2020 to an unknown date for an unknown indication.   On 22-Mar-2021 at 8:03 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 19-Apr-2021 at 3:40 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 01-Dec-2021 at 1:00 PM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 25-Aug-2021, the patient experienced PAIN (Pain). At the time of the report, PAIN (Pain) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered PAIN (Pain) to be not related.    The event did not cause the patient to seek medical care. There were no other potential causes. The patient had not experienced similar event in the past.  No treatment information was provided by the reporter.   This case was linked to MOD-2022-503399 (Patient Link).
FATHER OF CHOLD STATING THAT KIMBERLEE DEVILOPED FLU SX THE DAY FOLLOWING HER INJECTION
I had shingles twice after 2times I got the shot/Suspected vaccination failure; I had shingles twice; This 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.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK Receipt Date: 03-FEB-2023 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient had shingles twice after 2 times receiving the shot. Additional supportive information: This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Information has been received from a registered nurse concerning female patients of various ages who were vaccinated with GARDASIL.  All her patients who received GARDASIL experienced injection site pain and burning immediately upon injection.  This has caused some of the patients to not return for their subsequent doses.  The patients recovered while they were in the office.  These symptoms occurred with any dose of the series.  The patients sought unspecified medical attention.  Follow up information was received from the nurse stating that, she was not aware of any specific patients but rather a general statement was made regarding patients experiencing injection site pain and burning.  With HIPAA, the nurse would not feel comfortable providing any patient information anyway.  As this was a general statement, there will be no patient information coming from this office.
Began experiencing stiff joints and chills around 9pm Friday 2/5 which quickly proceeded to numbness and tingling in my legs making it hard to get up and walk. About an hour later it was followed up with chills which became severe, teeth chattering with full body stiffness  which proceeded through the night. Saturday morning 2/6 felt fine after waking up then about 12 I once again began to have extremely stiff joints, tingling in legs and extreme chills. I then took 800mg Ibuprofen and slept for and additional 4 hours. Since waking body is aching but has improved and tolerable  as of this morning 2/7
Pregnant at time of vaccination.  12/02/21 - 8 week ultrasound confirmed a missed miscarriage of an anembryonic pregnancy/blighted ovum.  First pregnancy, first miscarriage. Due Date was estimated for 07/12/22.  Beta HCG levels confirmed a non-viable pregnancy. D&C is scheduled for 12/7/21.
Localized edema on left arm with blood pooling NOT at the site of injection, but in lower arm towards elbow.
Fatigue; Headache; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue) and HEADACHE (Headache) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced FATIGUE (Fatigue) and HEADACHE (Headache). At the time of the report, FATIGUE (Fatigue) and HEADACHE (Headache) 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.   The Concomitant medications were not provided. The Treatment information was not provided.; Sender's Comments: Based on the current available information and temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. Fatigue and headache are consistent with the product safety profile.
No adverse event; Maternal exposure during breast feeding; This spontaneous case was reported by an other health care professional and describes the occurrence of NO ADVERSE EVENT (No adverse event) and MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding) in a 33-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS5051C) for COVID-19 prophylaxis.     No Medical History information was reported.   On 12-Jan-2023, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 12-Jan-2023, the patient experienced MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). On 12-Jan-2023, MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding) had resolved. At the time of the report, 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 assessment was provided for MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding).    No concomitant and treatment medications were reported.   Reporter did not allow further contact
dementia; bed ridden all of sudden after Moderna vaccine; He is not able to work; not able to eat by hand; became weak; Body aches/ sore arm which was worst on next day; This spontaneous case was reported by a consumer and describes the occurrence of DEMENTIA (dementia) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026C21A and 021C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Stroke in 2017. Concurrent medical conditions included Dementia (dementia and stroke together in 2017) since 2017 and Diabetes. Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID], ATORVASTATIN, METFORMIN, AMANTADINE, LISINOPRIL and GLIPIZIDE for an unknown indication.   On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-May-2021, the patient experienced DEMENTIA (dementia) (seriousness criterion medically significant), BEDRIDDEN (bed ridden all of sudden after Moderna vaccine), GAIT INABILITY (He is not able to work), MOVEMENT DISORDER (not able to eat by hand), ASTHENIA (became weak) and MYALGIA (Body aches/ sore arm which was worst on next day). The patient was treated with IBUPROFEN SODIUM (IBUPROFEN [IBUPROFEN SODIUM]) on 29-May-2021 at an unspecified dose and frequency and PARACETAMOL (TYLENOL) on 28-May-2021 at an unspecified dose and frequency. At the time of the report, DEMENTIA (dementia), BEDRIDDEN (bed ridden all of sudden after Moderna vaccine), GAIT INABILITY (He is not able to work), MOVEMENT DISORDER (not able to eat by hand), ASTHENIA (became weak) and MYALGIA (Body aches/ sore arm which was worst on next day) outcome was unknown.            Treatment medication not reported.  Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable.  Wife called in on behalf of husband and report that, patient received Moderna vaccine 2nd dose on 28 May 2021 in right arm and same day afternoon he has sore arm and worst on next day. After that he had body ache and dementia. He had dementia and stroke together in 2017. He is bed ridden all of sudden after Moderna vaccine. He is not able to walk, not able to eat by hand and he became weak and he is able to do all by himself earlier before vaccine. On 28 May 2021 he took Tylenol and on 29 May 2021 he took Ibuprofen and on 30 May 2021 he took his regular medicine which are Aspirin, Metformin, Atorvastatin, Amantadine, Lisinopril and Glipizide.  Company Comment : Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
itching; shortness of breath; This is a spontaneous report from a contactable consumer or other non hcp. A 72-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in Arm on 28May2021 (Batch/Lot number was not reported) as 1st Dose, Single Dose for covid-19 immunization. The patient's medical history was reported as itch in her back (sometimes get this same itch back in the past). The patient's concomitant medications were not reported. On Wednesday, 02Jun2021,the patient experienced itching, no rash, shortness of breath. The case was assessed as non-serious by the reporter. The outcome for the events was Unknown.  Information on the lot/batch number has been requested
welt on lt arm w/fever spike to 103;3MAR95 DPH given & cool compresses;welt size of dime w/rash @ site of inj;1050AM mom reported fever down & pt much improved;
On 1/5/21 Patient noted that the deltoid in which she received the vaccine was swollen, with bluish looking marks initially that transitioned to redness and a patchy, itchy, raised, red rash that spread down her arm, across her chest and abdomen. On 1/6/21, the rash worsened, resulting in patient going to the ER. Benadryl was prescribed and she was told to follow up with her primary MD.
This case was reported by a pharmacist via call center representative and described the occurrence of muscle pain in a adult female patient who received SHINGRIX (batch number ZN22Z, expiry date unknown) for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced muscle pain and radiating pain. On an unknown date, the outcome of the muscle pain and radiating pain were unknown. It was unknown if the reporter considered the muscle pain and radiating pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported but the patient could be 62 or 63 years old. The healthcare professional (HCP) had a patient who complained of muscle pain from SHINGRIX injection, radiated down her arm pit and her back shoulder after her shot. The HCP asked, should the patient get the 2nd dose of SHINGRIX.
General malaise; symptoms others described; Smelling idk chemical or metal smell from skin; This is a spontaneous report from a contactable nurse, the patient. A 62-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW6207) via an unspecified route of administration in the left arm on 14Mar2021 at 11:00 (at the age of 62-years-old) and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the right arm on an unknown date in 2021 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. Medical history included Systemic Lupus, Sjogren's and stage 4 splenic lymphoma rare. The patient was allergic to milk and adhesive in bandages. Concomitant medications included unspecified medications (MANUFACTURER UNKNOWN) for stage 4 non-Hodgkin lymphoma. The patient previously took pethidine hydrochloride (DEMEROL) and morphine (MANUFACTURER UNKNOWN) and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 15Jun2021 at 12:00, the patient experienced general malaise and symptoms others described. The patient's was a bit worse because she was fighting stage 4 non-Hodgkin lymphoma, a rare spleen cancer with immunotherapy. Her last treatment was over 8 months back. The patient kept smelling chemical or metal smell from her skin. It was bizarre. She was sure that it was nothing and she was on too many medications to plug them in. If the list was asked she would take a screenshot and send it. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events general malaise, symptoms others described and kept smelling chemical or metal smell from her skin were not resolved at the time of this report.
Approximately 9 hours after injection, I had a fever of 101, neck pain, back pain, SIGNIFICANT increase in afib, tachycardia, fatigue, shortness of breath, dizziness, nausea, arm pain.  Some of these symptoms lasted about 1 week (neck and back pain, dizziness, nausea, arm pain); however, the increase in atrial fibrillation, fatigue and shortness of breath I still have 8 months later.  Also, I had the full dose of Moderna because it was not decided until later that the dose should be halved. My quality of life has been decreased because of that.
From correspondence received from manufacturer it was reported that a 2 month old infant received an IPOL vaccination (administration date and lot number not specified). Sometime after the vaccination the patient developed a fever. Further information is requested. From follow up information received at manufacturer on 12/9/02, it was reported that the 2 month old female infant received first doses of TRIPEDIA, lot number U05144, given IM in the left thigh, COMVAX, lot number 04802, given IM in the right thigh and PREVNAR, lot number 480567, given IM in the right thigh, as well as IPOL, lot number T0285, given SC in the right thigh on 8/21/01. The reporter stated that the manufacturer for DTap was SmithKline, however, the lot number provided was verified by MIS as an Aventis product. Patient developed fever the same day as the vaccination and was seen by a physician. Reportedly the patient recovered. Responsible physician, vaccine administrator and patient information were also provided. The case is closed.
Breakthrough case of Covid sx onset 05/10/2022. Sx began on 05/10/2022, mild sx of sore throat (48 hours), fever 103 which lasted about 34-36 hours, then a little cough for about a week and slight fatigue. Tested positive 05/11/2022.
Patient received vaccination and sat speaking to the pharmacist for a few minutes regarding the vaccination and history of fainting. Patient did not complain of any issues, but after the fainting recalled feeling a little lightheaded. As the patient stood up to leave, he immediately fainted and fell forward, landing face down and chipping 2 teeth. The pharmacist saw the patient fall and immediately came to the patient and turned him on his back. Patient was unconcious, with eyes slightly open and breathing normally. Pharmacist tapped patient on both shoulders and called his name until he came to. Pharmacist questioned patient, oriented x3 with no recollection of what had caused the fainting but knew he had just received a vaccination. Pharmacist aided patient in sitting up, then eventually getting off the floor and having a seat on a chair. Pharmacist offered to call 911 for the patient, who refused. Patient was upset about fainting but moreso about chipping his 2 teeth as a result. Pharmacist offered patient water and advised patient to contact someone to come pick him up. Pharmacist sat with patient until patient's fiance arrived to take him to the dentist, about 40 minutes. Patient walked out of pharmacy with no repeat occurrences. Patient went to dentist for examination and to potentially fix broken teeth.
6 pts who recvd 3 doses of Engerix-B did not respond; no tx given;
Urinary frequency and urgency. He experienced the same adverse symptoms after his first Covid vaccine as well. It took about 2 weeks  to fully resolve.
Information has been received from a healthcare worker referring to a patient of unknown age and gender. On an unknown date the patient might have been vaccinated with a fourth dose of GARDASIL (dose, lot #, expiry date and route were unknown). No adverse effects were reported. The reporter stated that she needed to find out if this fourth dose had been given to the patient. Additional information has been requested.
Patient  arrived to  Public Health Vaccination POD at the Fairgrounds for a Covid-19 vaccine on 4/10/2021. He received a dose of Janssen, Lot #1808982, in his left deltoid at 11:37am. In the car with him were 3 other adults/relatives who also received the vaccine and an infant in a car seat; Patient was the driver. After receiving the vaccine, patient pulled away from the table, reportedly became faint, briefly lost consciousness, and crashed his Jeep into the barricade at the side of the large garage door where he was attempting to exit. The Jeep sustained damage to the front passenger side. Medics were called to the scene. The first medic on the scene noted that Patient was diaphoretic and a noted an irregular pulse. Patients seat was reclined. Additional medics from ambulances in the parking lot arrived to the scene. Patient was put on a stretcher and taken to the ambulance. An IV was started and glucose level checked (result 98). Medics continued evaluation and patient was ultimately transported to Medical Center for further evaluation.
Developed erythema, edema, heat and pruritis over right triceps (injection site) after the 5th dose of Anthrax vaccine prior to deployment.
given punctured IPOL post excursion with no reported adverse event; Initial information received on 01-Nov-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves 4 unknown age and unknown gender patient who was given punctured IPV (VERO) [IPOL] post excursion with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was reported that that 4 patients were given punctured IPV (VERO) (lot V1A024M; Expiration Date :17-Feb-2024) post excursion with no reported adverse event (product storage error) (unknown latency).  Action taken : not applicable.  Outcome: Unknown.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Covid Breakthrough of fully vaccinated. PCR Test positive (2022-04-27). Sore throat, mild coughing Injected Antibody (2022-04-29)
Immediately after administering the Hepatitis B vaccine in the left arm, which was the second vaccine administered in the left arm, the patient and I noticed swelling in the arm. No redness was noted in the left arm, but the patient did complain of some discomfort and pain. I asked the patient to wait in the waiting room for 15 minutes so that I could monitor any further swelling or reactions. After 15 minutes the swelling was not as significant as first noted. Yet, slight swelling remained. The patient was given two 200mg tablets of Ibuprofen.
This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), PAIN IN EXTREMITY (Pain in feet), COUGH (Cough), SWOLLEN TONGUE (Felt like tongue was swollen) and RASH (Pin spot rash around neck area) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006M20A and #001B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On 11-Feb-2021, the patient experienced DIZZINESS (Dizziness), PAIN IN EXTREMITY (Pain in feet), COUGH (Cough), SWOLLEN TONGUE (Felt like tongue was swollen), RASH (Pin spot rash around neck area), NAUSEA (Nausea), FATIGUE (Tiredness/ extreme tiredness) and CHILLS (Chills). At the time of the report, DIZZINESS (Dizziness), COUGH (Cough), SWOLLEN TONGUE (Felt like tongue was swollen), RASH (Pin spot rash around neck area), NAUSEA (Nausea) and CHILLS (Chills) outcome was unknown and PAIN IN EXTREMITY (Pain in feet) and FATIGUE (Tiredness/ extreme tiredness) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown. Concomitant product use was not provided. Treatment information was not provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. This case was linked to MOD-2021-065572.