chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Numbness on fingers; What she describes as "nerve symptom; Tingle on fingers; She is feeling "complete pain" on the same arm of the injection; Swelling of her arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPOAESTHESIA (Numbness on fingers), NEURALGIA (What she describes as "nerve symptom), PARAESTHESIA (Tingle on fingers), VACCINATION SITE PAIN (She is feeling "complete pain" on the same arm of the injection) and VACCINATION SITE SWELLING (Swelling of her arm) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030o20a and 011g20a) for COVID-19 vaccination.     Concomitant products included ESCITALOPRAM for an unknown indication.   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Jan-2021, the patient experienced HYPOAESTHESIA (Numbness on fingers), NEURALGIA (What she describes as "nerve symptom), PARAESTHESIA (Tingle on fingers), VACCINATION SITE PAIN (She is feeling "complete pain" on the same arm of the injection) and VACCINATION SITE SWELLING (Swelling of her arm). At the time of the report, HYPOAESTHESIA (Numbness on fingers), NEURALGIA (What she describes as "nerve symptom), PARAESTHESIA (Tingle on fingers), VACCINATION SITE PAIN (She is feeling "complete pain" on the same arm of the injection) and VACCINATION SITE SWELLING (Swelling of her arm) had not resolved.            Treatment details included she had not taken any medication yet, but she is going to take Ibuprofen.
This case was reported by a consumer via call center representative and described the occurrence of shingles in a 61-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. The patient's past medical history included breast cancer. Concurrent medical conditions included lymphedema. In September 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, the patient received the 2nd dose of SHINGRIX. In January 2019, less than a year after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced cellulitis (serious criteria hospitalization and GSK medically significant) and blistery rash. On 1st March 2019, the patient experienced shingles (serious criteria hospitalization). On an unknown date, the patient experienced product supply issue. The patient was treated with nystatin. On an unknown date, the outcome of the shingles and blistery rash were not recovered/not resolved and the outcome of the cellulitis and product supply issue were unknown. It was unknown if the reporter considered the shingles, cellulitis and blistery rash to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on either 7th September 2018 or 14th September 2018. The patient thought that the rash might be fungal, so tried treating it with Nystatin cream, but the rash continued to spread. A couple weeks before the date of reporting,  she was admitted to the hospital for cellulitis. While at the hospital, she showed the doctors her rash and they also treated it Nystatin. The cellulitis and rash were on the same side, but not at the same location. She was in the hospital for a week. on 1st March 2019, after discharge from the hospital, she saw her regular physician. Her regular physician looked at her rash and diagnosed it as shingles. The rash has blistered, but was not as bad as it could have been. She is upset that she developed shingles before getting the 2nd dose, and that she could not get the second dose months ago due to the shortage.
This spontaneous report was received from a consumer via market research program regarding unspecified number of patients. Concurrent conditions and medical history was not reported. On an unknown date, unspecified number of patients were vaccinated with PNEUMOVAX23 (dose, route of administration, anatomical location and lot number was unspecified by reported). No concomitant medication was reported. On an unknown date, unspecified number of patients got pneumonia only after having taken the PNEUMOVAX23. The outcome of the events was unknown. The causal relationship between the events and PNEUMOVAX23 was unknown. This is one of 2 reports received from the same reporter. Additional information has been requested.
PATIENT RECEIVED FIRST VACCINATION ON 03/18/2021 AND THE NEXT DOSE ON 04/09/2021 WITH ONLY 22 LAG DAYS IN BETWEEN DOSES.
1st dose 2 years ago, 2nd not received; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 79-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received the fist dose 2 years ago).   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: 29-NOV-2022 Reporter's Comments:  This case was self-reported by the patient.  The patient stated that 2 years ago his wife, brother, nephew, niece and himself, received only one single dose of Shingrix. The patient stated they all received the shot in the arm. The patient was never informed that Shingrix was given in two doses series; hence, they never received a second Shingrix dose.  The patient declined consent for safety follow up with healthcare professional.  The patient declined to provide date of birth and age instead.  The patient declined to provide relatives information and age.  The patient could not provide Shingrix lot, expiration date information, dosage or route of administration. No additional information provided.  The reporter did not 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. This is 1 of the 5 cases reported by the same reporter.; Sender's Comments:  US-GSK-US2022AMR179084:Same reporter US-GSK-US2022AMR179085:Same reporter US-GSK-US2022AMR179086:Same reporter US-GSK-US2022AMR179087:Same reporter
veloped shingles rashes was on on left side of back and extending towards her stomach; chills; ever 99.1F; stomach ache; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (veloped shingles rashes was on on left side of back and extending towards her stomach), ABDOMINAL PAIN UPPER (stomach ache) and PYREXIA (ever 99.1F) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced ABDOMINAL PAIN UPPER (stomach ache). On 16-Feb-2021, the patient experienced HERPES ZOSTER (veloped shingles rashes was on on left side of back and extending towards her stomach) and PYREXIA (ever 99.1F). At the time of the report, HERPES ZOSTER (veloped shingles rashes was on on left side of back and extending towards her stomach), ABDOMINAL PAIN UPPER (stomach ache) and PYREXIA (ever 99.1F) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients; Frozen vials, removed and transported at refrigerated temp, re-frozen at ti me of arrival; They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients), PRODUCT STORAGE ERROR (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (Frozen vials, removed and transported at refrigerated temp, re-frozen at ti me of arrival) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 061E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (Frozen vials, removed and transported at refrigerated temp, re-frozen at ti me of arrival). At the time of the report, EXPIRED PRODUCT ADMINISTERED (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients), PRODUCT STORAGE ERROR (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (Frozen vials, removed and transported at refrigerated temp, re-frozen at ti me of arrival) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The vial was moved to fridge on 06-Oct-2021.  It was unknown that if the lot number undergone to temperature excursion on not.  The state of the vaccine was partially thawed/liquid at the time of excursion. The vails size were 5.5 mL or 7.5 mL. Total duration of excursion was reported as maximus as 4 hours.  No treatment medications were reported.
This case was reported by a consumer via call center representative and described the occurrence of shingles in a adult male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, 14 days after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was recovering/resolving. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The reporter's husband received the SHINGRIX vaccination on left arm approximately one month before the date of reporting. The patient developed shingles on his left shoulder and the back of his head, two weeks after receiving the vaccination. The reporter gave permission for husband's physician to be contacted.
Whole body itching for 7 days (arms, hands, legs, torso and pelvis).
precipitation of fever, skin lesions/rash head, toe, blisters, yellowish on color;did not scab over;may have been secondary to varicella or measles vaccine;fever preceded rash by 2 days;
COVID 19; COVID 19; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 56-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Oct2022 at 13:00 as dose 4 (booster), single (Lot number: 057F22A) at the age of 56 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Dysautonomia" (unspecified if ongoing), notes: Other medical history: Dysautonomia. The patient's concomitant medications were not reported. Past drug history included: Known allergies: aspirin, reaction(s): "Allergy"; Known allergies: epinephrine, reaction(s): "Allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Feb2023, outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective, covid-19 (received Paxlovid as COVID-19 treatment on 20Feb2023).; Sender's Comments: Based on available information, a lack of efficacy with the suspect vaccine BNT162B2, BNT162B2 OMI BA.4-5 in this patient cannot be completely excluded.
Post 24 hours with noted swelling and redness and itching to upper right arm. Warm to touch and pink colored rash on inner aspect of arm. Purple discolored 4x3 inch size area noted at injection site.
right eye hurting; backache; hip ache; very bad headache; lil sore on left arm; This spontaneous case was reported by a consumer and describes the occurrence of EYE PAIN (right eye hurting), BACK PAIN (backache), ARTHRALGIA (hip ache), HEADACHE (very bad headache) and PAIN IN EXTREMITY (lil sore on left arm) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced PAIN IN EXTREMITY (lil sore on left arm). On 11-Feb-2021, the patient experienced EYE PAIN (right eye hurting), BACK PAIN (backache), ARTHRALGIA (hip ache) and HEADACHE (very bad headache). The patient was treated with NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency; ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) at an unspecified dose and frequency and PSEUDOEPHEDRINE at an unspecified dose and frequency. At the time of the report, EYE PAIN (right eye hurting), BACK PAIN (backache), ARTHRALGIA (hip ache), HEADACHE (very bad headache) and PAIN IN EXTREMITY (lil sore on left arm) 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.   Concomitant information not provided. Treatment included Aleve, Aspirin, Pseudoephedrine
1-2 days after injection, I noticed a red patch of discoloration around the injection site. The entirety of the discolored area is sensitive to the touch as if mildly bruised. The size of the area is roughly 2 and 1/2 inches in circumference. It does not itch as of this writing. There have no other observed side effects from the vaccination.
4OCT96 arm/shoulder muscle pain lt spreading to rt side & descending to legs;c/o extreme muscle pain & gen edema;hosp;
A physician reported that a 5 month old male received Rota Shield, Tripedia, IPV and Hib vaccines on 6/15/99. On 6/18/99 he developed severe irritability crying and vomiting. By 6/25/99, the mother reported that the infant had lost 1/2 lb. The reporter declined to provide additional information.  From additional correspondence received on 01/24/00, it was reported; "My 'report' of this incident was in the form of a query about possible adverse actions to the vaccine, Rota-shield. I was investigating a complaint received by a peer review committee against a physician who had administered the vaccine. I had no direct knowledge to the case and informed the clerk who requested the information. The details of the complaint against the physician and the identifies of the individuals involved is confidential. I have no further information on this situation." From following correspondence received on 08/06/01, it was reported that the patient's recovery status is unknown. No further information available regarding this patient or this case. This case is closed.
Got a dose 11 days earlier from today; A spontaneous report was received from a healthcare professional, concerning a 70-years-old female patient, unknown race and ethnicity, who received Moderna's COVID-19 vaccine (mRNA-1273) and patient got a dose 11 days earlier from today (inappropriate schedule of product administration).  No medical history was reported. The concomitant medication included unspecified psychiatric medications.  On 19 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: not provided), intramuscularly for prophylaxis of COVID-19 infection. On 03 Mar 2021, the patient received their second of two planned doses of mRNA-1273 (Lot number: not provided), intramuscularly in left arm.  The healthcare professional reported that on 19 Feb 2021, the patient got her first Moderna dose. The patient did not disclose to them and on 03 Mar 2021, got another dose of Moderna vaccine which was second dose to left arm. The healthcare professional reported that the patient got a dose 11 days earlier from today. No treatment information was reported.  Action taken with second dose of mRNA-1273 in response to the event was not applicable.  The outcome for the event, patient got a dose 11 days earlier from today, was considered as resolved on 03 Mar 2021.; Sender's Comments: This report refers to a case of inappropriate schedule of vaccine administered for mRNA-1273 (Lot #: Not Provided) with no associated AEs reported
swelling in arm pit noticed on self examination; excess sweating on left arm pit after minor exercise; Lymph Nodes swelling; soreness in left arm and left arm pit; soreness in left arm and left arm pit; Slight fever; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0173) via an unspecified route of administration in the left arm on 03May2021 at 15:30 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. Medical history included pre-diabetes. The patient did not receive concomitant medications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0161) via an unspecified route of administration in the left arm on 16Apr2021 at 15:45 as a single dose for COVID-19 immunisation. The patient did not have any allergies to medications, food, or other products. 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 04May2021, the patient experienced lymph node swelling, soreness in left arm and left arm pit and slight fever. On 05May2021, the patient experienced swelling in armpit on self examiniation and excess sweating on left arm pit after minor exercise. On 06May2021, in the morning swelling increased and soreness. The patient took paracetamol (TYLENOL) 250 mg and the swelling decreased in the evening. 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 taken as a result of the events which included treatment with paracetamol (TYLENOL). The clinical outcomes of the events lymph nodes swelling, soreness in left arm and left arm pit, slight fever, swelling in armpit and excess sweating on left arm pit were resolving at the time of report.   No follow-up attempts are needed. No further information is expected.
Cellulitis reported by patient - doctor prescribed Clindamycin 300mg capsules q 6 h x 10.
First flu shot ever given at 2:35, observed for 10 minutes.  3:10 patient developed itchiness with one raised area (hive) right forearm, no SOB or systemic c/o.  3:15 patient given Benadryl 25 mg SL.  Area responded within 5 minutes.  4:10 rechecked asymptomatic.
Pt expired in Community Hospital ED on 3-10-21.  This was 5 days after receiving  his second Moderna covid vaccination.  Hospital nurse says ED report says multiple system problems.
only time I've experienced the flu was when I had a flu shot each time losing a week of work; Initial information regarding an unsolicited valid non-serious case received from a consumer (patient) via Agency through social media on 27-Nov-2020.  This case involves a patient of unknown demographic who only time experienced the flu was when he had the flu shot influenza vaccine each time losing a week of work (influenza) .  The patient's medical history, past medical treatment(s), concomitant therapy, past vaccination(s) and family history were not provided.  On an unknown date, the patient received suspect Influenza Vaccine produced by unknown manufacturer (lot number and expiry date not reported) at an unknown dose via unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date (latency: unknown) after starting the suspect vaccine therapy, the patient experienced only time flu  (influenza) when he received flu shot each time  losing a week of work so the patient gave would be afraid to take it again.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of the reporting, event outcome was unknown .  There will be no information available on batch number for this case.
Headache, Myalgia, Fever, injection site reaction Narrative:  employee missed two days of work 1/10 and 1/11 due to above symptoms following second dose
STOMACH ACHE; FLU-LIKE SYMPTOMS; SICKNESS; NOT FEELING WELL; HEADACHE; This spontaneous report received from a patient concerned multiple patients. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced stomach ache, flu-like symptoms, sickness, not feeling well, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the not feeling well, stomach ache, flu-like symptoms, sickness and headache was not reported. This report was non-serious.
/o sore arm & fatigue since receiving the vaccine on Friday. Deveolped low grade temp on Monday, taking tylenol & ibuprofen PRN, No other complaints at this time. Advised to continue with Tylenol/ibuprofen and contact PCP if symptoms worsen.
Around 7-7:30 PM, I started to feel weird tingly feelings run up and down all of my limbs at the same time but it was over in about 2 minutes. Then I couldn?t stop my eyes from continuously rolling back into my head. That happened for about 4 minutes or so sometimes it would happen like 3 or 4 times in a row and sometimes it would be every 20 seconds or so. I was extremely confused and forgetful for the next 40 minutes and then I slowly began to be able to recall stuff.