chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Day after vaccine 101.2 temp; Felt sick for about 12 hrs; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8735) via an unspecified route of administration in the left arm on 22Apr2021 at 12:45 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19 on 07Apr2021. The patient had no known allergies. Prior to the vaccination, the patient was diagnosed with COVID-19 positive on 07Apr2021. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included paracetamol (TYLENOL) and ibuprofen (MANUFACTURER UNKNOWN); both from an unknown date for an unknown indications and unknown if ongoing. On 23Apr2021 at 07:00, day after the vaccine, the patient experienced 101.2 temperature (temp) and felt sick for about 12 hours. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. On 23Apr2021 at 07:00, the patient underwent body temperature test and the result was 101.2 (unspecified units). Therapeutic measures were not taken as a result of the events. The clinical outcome of the events day after vaccine 101.2 temperature was resolved on an unknown date in Apr2021 and the event felt sick for about 12 hours was resolved on 23Apr2021 at 19:00.  No follow-up attempts are needed. No further information is expected.
vaccine given 16 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine given 16 days post expiry) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine given 16 days post expiry). On 22-Nov-2021, EXPIRED PRODUCT ADMINISTERED (vaccine given 16 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.  The patient had no adverse events.   This case was linked to MOD-2021-395985.
Information has been received from a physician concerning a female who "last week" was vaccinated with a single dose of Zostavax (Oka/Merck).  In August 2007, the patient came back in to the office and she had shingles on the patient's thoracic area.  The patient was not immunocompromised.  Medical attention was sought and the physician put the patient on an antiviral medication.  The patient was recovering.  No product quality complaint was involved.  Additional information has been requested. 12/21/07 This is in follow-up to report(s) previously submitted on 9/24/2007. Initial and follow up information has been received from a physician concerning a 77 year old female with a history of allergic reaction to E-MYCIN, KEFLEX, DORYX, MACRODANTIN, sulfonamide allergy and an ULTRAM allergy who on 02-AUG-2007 at 10:55 was vaccinated SC in the left arm with a first dose of ZOSTAVAX (Oka/Merck) (Lot#658086/0761U). The patient was not immunocompromised at the time of vaccination. There was no illness at the time of vaccination. On 08-AUG-2007 the patient developed red lesions on the left side of her abdomen and a little bit on the lateral side of her rib cage. This had been "very painful" for her. The patient was diagnosed with shingles on her thoracic area. Medical attention was sought on 10-AUG-2007 and the physician prescribed FAMVIR 500 mg twice a day for 7 days. Additional therapy as of 10-AUG-2007 included calcium (unspecified), chondroitin sulfate sodium (+) glucosamine sulfate, CENTRUM, aspirin, VAGIFEM, cefaclor, MONUROL, rizatriptan benzoate (MSD), hydrocodone bitartrate, alendronate sodium (MSD) and LOPRESSOR. It was noted that as far as the physician knew, the patient does not have any history of being immunocomprised so he is going to check some basic lab work such as cell counts and things like these just to make sure nothing funny is going on. Lab studies were performed with abnormal results of WBC 11.3, Granulocyte % 78, Absolute Granulocyte of 8.8 and Absolute Monocyte of 1.1. The patient was recovering. There was no further information provided. No product quality complaint was involved. Additional information has been requested.
I noticed, there is like a ball on my armpit, it's swollen and it's painful.; I noticed, there is like a ball on my armpit, it's swollen and it's painful.; I noticed, there is like a ball on my armpit, it's swollen and it's painful.; This is a spontaneous report from a contactable consumer or other non hcp. A 38-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: Unknown) via an unspecified route of administration on an unspecified date (At the age of  38-years-old)  as single dose for COVID-19 immunization.  The patient medical history was reported as none. The patient's concomitant medication was reported as No, just Vitamins, start and stop dates were unspecified.  When probed for the concern, patient stated he received second vaccine, (today is Thursday) on Tuesday patient noticed, there was a ball like on his armpit, it's swollen and it was painful. Patient inquired whether that was normal. Regarding the lot number, the reporter stated that, he took the card home, does not have it with him. Patient stated that there were No Lab test and no Treatment was received. Patient reported he noticed it this morning(as reported), he kind of felt something but this morning it's really swollen. The outcome of the events was reported as an unknown.   Information about lot and batch number was requested.  Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Progressive - Tinnitus, vertigo, hearing on&off in left ear, stuffed up feeling in left ear, very difficult hearing with background noise. Vertigo side to side most days. Fell forward on Feb 1, 2020. Currently it has progressed to being daily lack of hearing along with manageable vertigo and tinnitus.
Throat irritation; This spontaneous case was reported by a consumer and describes the occurrence of THROAT IRRITATION (Throat irritation) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 075A21A) 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) (unknown route) 1 dosage form. On 01-Mar-2021, the patient experienced THROAT IRRITATION (Throat irritation). On 01-Mar-2021, THROAT IRRITATION (Throat irritation) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medication were  reported No treatment medication were reported   Most recent FOLLOW-UP information incorporated above includes: On 09-Jul-2021: Report was received on 09 July 2021 and contains information on the event outcome getting updated from unknown to resolved and about receiving the second dose.
pleurisy; This case was reported by a consumer via interactive digital media and described the occurrence of pleurisy in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Shingles vaccine and Influenza vaccine Quadrivalent unspecified season. In March 2020, unknown after receiving Shingles vaccine and Influenza vaccine Quadrivalent unspecified season, the patient experienced pleurisy. On an unknown date, the outcome of the pleurisy was not recovered/not resolved.   The reporter considered the pleurisy to be related to Shingles vaccine and Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient experienced pleurisy from  the shingles, flu shot taken on the same day. Since last march, patient was still suffering from it. The patient was then told months later, never to take two vaccines at the same time. The patient stated that months too darn late.
I began to experience a neuropathy or cold and uncomfortable sensation in both arms in late June, 2021.  It is in the outside or lateral aspect of the upper arms and forearms.  It feels like coldness of the skin and is very uncomfortable. It has not decreased in intensity and I feel it constantly but the intensity varies throughout the day.
Patient with history of COVID-19 vaccination hospitalized with COVID-19 detected PCR. Provider discharge note "81 YO male presented to ED with 2 days of increasing abdominal distention.  Last bowel movement 3 days ago.  Denies abdominal pain or vomiting.  No fever/chills, though notes burning with urination for the last few days.  Last took Xarelto last night. (HPI per Dr)"
Appt on 11-18-14. Received MCV4 shot in right deltoid, IM. Patient started having swelling next day and seen at our office on 11-20-14-red, swollen, hot to touch. Treated w/KEFLEX 500 mg BID, elevation BENADRYL. R/C appt on 11-21-14.
No adverse event; Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 day beyond use date were administered; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 day beyond use date were administered) and NO ADVERSE EVENT (No adverse event) in a 61-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 052D22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 23-Nov-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 23-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 day beyond use date were administered). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 day beyond use date were administered) 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 day beyond use date were administered).    Concomitant medication was not provided. It was reported that they had more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 day beyond use date. The lot number for the monovalent vaccines with their corresponding BUD dates: 027C21A (BUD - 21May2021), 053C21A (BUD-01Jul2021), 939902 (BUD - 02Sep2021), 011F21A (BUD - 04Nov2021), 042J21A (BUD - 17Feb2022), 056M21A (BUD - 12May2022), 082B22A (BUD - 08Sep2022). The lot numbers for the bivalent vaccines with their corresponding BUD dates and the interval period of administration. 052D22A, (BUD - 17Nov2022), dates of administration: 18-28Nov2022, 023H22A, (BUD - 15Dec2022), dates of administration 16-20Dec2022. Treatment information was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-704416 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 24-Jan-2023: Live follow-up received and added patient details and vaccination details updated. On 24-Jan-2023: Live follow-up received and had no new information.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704416:Master Case
The patient indicated they felt fine but when they went to swallow they felt like there was a lump in their throat.  Vitals was good, blood pressure slightly high but when Pt. left they was feeling ok.  Pt. received medical attention for the incident, reported back to us that they had her take benedryl for the incident.
Employee reports 1/4  he had a sore arm, later that night HA, fever, chills.  1/5 1600 headaches progressed to migraine with extreme fatigue.  1/6 evening he went to ED due to symptoms and history of blood clots in the brain.  CT was done in the ED.  It showed signs of COVID in the CT chest.   COVID test negative. 1/7 AM SOB and cough started.  HA continues but manageable, dizziness and a crawling feeling under skin. 1/8 AM tightness in chest, crawling under skin increased, HA, dizziness and slight bodyaches.
body aches, stuffy head, chills with shakiness Temp 101.6 cold sweats, loss appetite x 48 hours
Narrative: Rash, developed will circumscribed baseball sized area of erythema/rash over the injection site. This started about 4 days after the vaccination and intermittently persisted for " a few weeks." It was not associated with pruritus, induration, or slough-but was intermittently warm to touch. She applied cold packs and aloe, but no other therapies.
administered expired vaccine to patient after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered expired vaccine to patient after the manufacture date of expiration) in a 78-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 070H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 08-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered expired vaccine to patient after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered expired vaccine to patient after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter.  Expiration Date for the lot 070H21A was reported as 04-Apr-2022 with total of 173 doses.  The date in which the vial was initially stored in the refrigerator was unknown  The vial did not undergo any temperature excursions.  No treatment medications were provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow-up received contains non significant information.
Pounding headache. Chills. Weakness. Ear pain. Lack of appetite.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Headache-Medium, Systemic: Hypotension-Mild
Patient did not disclose he received Pfizer on 3/25/21 and 4/16/21. No adverse reaction noted. Provider made aware.
This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Booster dose administered 24 hours post puncture), PRODUCT STORAGE ERROR (The vial was first punctured on 01-Aug-2022 at 9:30 AM, post puncture the vial was stored in fridge and administration of vaccine on 02-Aug-2022 at 9: 15 am and 9:30 AM) and NO ADVERSE EVENT (No adverse event) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013B22A) for COVID-19 prophylaxis. Concurrent medical conditions included House dust mite allergy, Pollen allergy and Allergy to animal dander (dog dander). On 02-Aug-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Booster dose administered 24 hours post puncture.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was first punctured on 01-Aug-2022 at 9:30 AM, post puncture the vial was stored in fridge and administration of vaccine on 02-Aug-2022 at 9: 15 am and 9:30 AM) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Booster dose administered 24 hours post puncture.), PRODUCT STORAGE ERROR (The vial was first punctured on 01-Aug-2022 at 9:30 AM, post puncture the vial was stored in fridge and administration of vaccine on 02-Aug-2022 at 9: 15 am and 9:30 AM) and NO ADVERSE EVENT (No adverse event) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Booster dose administered 24 hours post puncture) and PRODUCT STORAGE ERROR (The vial was first punctured on 01-Aug-2022 at 9:30 AM, post puncture the vial was stored in fridge and administration of vaccine on 02-Aug-2022 at 9: 15 am and 9:30 AM). No concomitant drug was reported. The vial was initially stored in the refrigerator on 14-Jul-2022. The vial did not undergo any temperature excursions. For 30 minutes the vial was exposed to room temperature range. The patient received second booster dose. No treatment drug was reported. This case was linked to US-MODERNATX, INC.-MOD-2022-618807 (E2B Linked Report). Sender's Comments: US-MODERNATX, INC.-MOD-2022-618807: same reporter first patient.
This spontaneous report was received from a registered nurse and refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patients were vaccinated with the improperly stored doses of VAQTA (dose, route, lot # and expiration date were not reported) for prophylaxis. The vaccines were reconstituted whit a properly stored sterile diluent (MRK) (lot # and expiration date were not reported). There were no adverse effects reported. Administered doses of vaccines experienced the temperature excursion of 9 degrees Celsius for 56 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA015115: US-009507513-1704USA010748: US-009507513-1704USA015112: US-009507513-1704USA015113.
Employee described history of rash to hands, arms and abdomen that initiated after 1st dose, but didn't attribute to vaccine or report at time of 2nd dose vaccine administration.  Was being treated as "eczema" due to hx of eczema.  Three hours after receiving second Moderna dose developed a bloody nose, neck pain, back pain, chills; and rash to hands, arms, stomach "worsened" per employee.  She reported to ER for evaluation and had COVID test which resulted negative; no additional treatment per employee. Has subsequently followed up with her primary and continues with eczema cream, no additional treatment.
Patient was seen at the MC ER for c/o elevated blood sugar and dehydration, poor oral intake and chronic diarrhea.  Patient was admitted for further evaluation and treatment.
Fever, fatigue, localized facial edema, urticaria, nausea, headache
Received MMR, VZV, DTAP, Prevnar, HIB on 2/27 in morning. Very lethargic during day started vomiting that night in AM 2/28 persistently lethargic, temp to 105, face began to swell. Cyariotic extremities. Went to ER 2/26 evening.
Pt had been vaccinated.  1st dose 5/28/21, second dose 6/18/2021. 1/17/2022 had covid like illness and tested positive. 1/29/22 pt had chills, body aches, HA, taking tylenol/ibuprofen around the clock for symptoms.  admitted 2/2/22 dx with MIS-C (mild case) KY2098.  elevated d-dimer, elevated CFP, Ferritin and IL-6,  vomiting, diarrhea, elevated bilirubin, neck pain, myalgia, conjunctival injection. discharged 2/4/2022 after steroids, asa, IVIGx2.    FOUND as part investigation.  Reporting to VAERS since pt previously vaccinated.
small red bumps that developed on her neck, chest; skin was itching for 2 days, starting on her hands and arms, and progressing to her abdomen, back and one leg; This is a spontaneous report from a non-contactable consumer or other non hcp. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration on 18Feb2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that on Thursday, 18Feb2021 the patient received the first Covid-19 vaccine and on 23Feb2021 her skin was itching for 2 days, starting on her hands and arms, and progressing to her abdomen, back and one leg, she took Benadryl for the itching 2 nights in a row. This morning she sent me a photo of small red bumps that developed on her neck, chest and back, she reported that she does not have any itching today. She has not yet seen a healthcare provider. Therapeutic measures were taken as a result of itching. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
This healthy 12 month old female received routine immunizations on 5/13/2013 - first hepatitis A lot # AHAVB690CA (SK) to right thigh and MMRV combo lot # (? H011233 Merck) to left thigh. That evening mom reported seeing 2 small red slightly raised hives "like a bug bite" to child's right forearm. These hives lasted about 20 minutes and resolved. However over the next 3-4 days 1-2 hives would return 2-4 times a day to one extremity (either left or right arms/legs) and would be gone within 20 minutes. No hives were seen on the torso. Mom denied child had any fever, crying, shortness of breath, wheezing, or any systemic symptoms. Child was very active, playful with bright eyes and eating, behaving normally. These hives did not appear to itch as child acted oblivious to them. Mom did not treat hives with any medication. 2 hives were present this morning to right arm prior to visit pediatrician; however they had resolved prior to MD arrival. Child is currently hive free.