chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Hot at injection site; injection site spot wasn't hot or raised or itchy; not as Itchy red spot not as defined a circle as the first one; red,hot,reased and not as itchy red "spot"; Red at injection site; raised 4.5 inch at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Hot at injection site), VACCINATION SITE SCAR (injection site spot wasn't hot or raised or itchy), VACCINATION SITE PRURITUS (not as Itchy red spot not as defined a circle as the first one), VACCINATION SITE RASH (red,hot,reased and not as itchy red "spot") and VACCINATION SITE ERYTHEMA (Red at injection site) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Skin rash (Had genetic skin rashes in past.). Concurrent medical conditions included Sulfonamide allergy and Seasonal allergy (Seasonal allergy (hay fever)). Concomitant products included MULTIVITAMIN [VITAMINS NOS], ACETYLSALICYLIC ACID (ASPIRIN 81) and CALCIUM, COLECALCIFEROL (CALCIUM VITAMIN D) for an unknown indication.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021 at 10:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (Hot at injection site), VACCINATION SITE SCAR (injection site spot wasn't hot or raised or itchy), VACCINATION SITE PRURITUS (not as Itchy red spot not as defined a circle as the first one), VACCINATION SITE RASH (red,hot,reased and not as itchy red "spot"), VACCINATION SITE ERYTHEMA (Red at injection site) and VACCINATION SITE SWELLING (raised 4.5 inch at injection site). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (Hot at injection site), VACCINATION SITE PRURITUS (not as Itchy red spot not as defined a circle as the first one), VACCINATION SITE RASH (red,hot,reased and not as itchy red "spot"), VACCINATION SITE ERYTHEMA (Red at injection site) and VACCINATION SITE SWELLING (raised 4.5 inch at injection site) had resolved and VACCINATION SITE SCAR (injection site spot wasn't hot or raised or itchy) had not resolved.            This case was linked to MOD-2021-012126 (Patient Link).
10-12hr p/vax onset crying, tender, swelling ant thigh w/erythema & induration 5x8cm-refusing to walk;sx bilat thighs @ site inj;
Patient developed a rash after the first dose of HPV (10/6/2016) on body and injection site was red and swollen. At this visit, shortly after receiving the flu and HPV vaccine, his face was flushed and he felt 'tired". Patient was given benadryl and fluid. He was observed for 20 minutes and felt better.
29JAN97 productive cough, afeb;RVC positive influenza A 30JAN97; 4FEB97 med given x 21 days;
Patient received Janssen vaccine @ 11:44 am, while in the recovery area @ 12:01 pm, c/o numbness in the left neck area, blurry vision> VS 136/80, 63,20, Sats 99% on RA.  12:05, patient stated numbness was no longer present, VS @ that time: 140/92, 55, 24 Sats remained unchanged. Continued to monitor, final VS check @ 12:10 pm, 152/96, 54, 22 Sat's remain unchanged, no further c/o of discomfort of any kind.  DC from recovery @ 12:25, all symptoms resolved, gait steady accompanied by Sister (who was present for vaccine as well).
Patient started having chills around 6:30pm, approx 4 hours after receiving vaccine. She had a fever, aches, headache, and was very cold. Patient recovered within one day.
HIB was not mixed with DTaP. Patient received vaccine w/o reaction. Patient must return to clinic for ACTHIB.
Sore arm; Headache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 25Apr2021 (Lot number: EUO170) at the age of 48 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Ragweed allergy" (unspecified if ongoing), notes: known allergies- ragweed; "Allergic to dogs" (unspecified if ongoing), notes: known allergies- dogs; "Allergic to cats" (unspecified if ongoing), notes: known allergies- cats; "Allergy to plants" (unspecified if ongoing), notes: Known allergies-trees; "Obesity" (unspecified if ongoing); "Hashimoto's disease" (unspecified if ongoing), notes: Hashimoto's. Concomitant medication(s) included: SYNTHROID; ADIPEX [PHENTERMINE]; METFORMIN; HYDRODIURIL. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 26Apr2021, outcome "recovered" (2021), described as "Sore arm"; HEADACHE (non-serious) with onset 26Apr2021, outcome "recovered" (2021), described as "Headache". Therapeutic measures were not taken as a result of pain in extremity, headache.  No follow-up attempts are possible. No further information is expected.  Additional information: The patient did not receive any other vaccines within four weeks prior to the 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. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the events.
No immediate adverse reaction. No fever. Day 2 post vaccination fatigue, blurred vision, confusion, weakness, lethargy, inability to concentrate, loss of balance, anxiety feeling weird.  Symptoms would come- had to lay down-last ~2 hours-feel okay.  Again, same symptoms would start; 4-5 times a day every day.  By day 7 post vaccination symptoms were severe; activities of daily living severely compromised. Blood pressure elevated 180's/100's (no history of hypertension).  Emergency room visit was unremarkable.  Next morning, 03/15/2021, EMS called to home.  Blood pressure 217/112 finger stick 178 (no history diabetes).  Transported to ER.  B/P remained elevated.  Cardiac negative.  Head CT negative. Medications given in ER: Labatelol 10mg IV.  Monitored and released to home.  Diagnosis:  Hypertensive Encephalapathy with TIA's. New onset hypertension. Meds: Lisinopril 10 mg daily.  Seen by primary care on 03/17/2021. Elevated blood pressure continued 150/100's.
Information has been received from a physician concerning his daughter who was vaccinated with a dose of GARDASIL vaccine (yeast) (lot#, dose, site and route not reported). The physician reported that his daughter complained that the injection was painful. The patient's outcome was unknown. Additional information is not expected.
Peripheral neuropathy on both of her legs; Soreness on the injection site; The site was more itchy; inappropriate schedule of vaccine administered; Numbness; This spontaneous case was reported by a consumer and describes the occurrence of NEUROPATHY PERIPHERAL (Peripheral neuropathy on both of her legs) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20A006M20A and 006M20A029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (no historical condition reported.).   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In February 2021, the patient experienced HYPOAESTHESIA (Numbness). On 23-Feb-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of vaccine administered). On 24-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (The site was more itchy). On an unknown date, the patient experienced NEUROPATHY PERIPHERAL (Peripheral neuropathy on both of her legs) (seriousness criterion medically significant) and VACCINATION SITE PAIN (Soreness on the injection site). In February 2021, HYPOAESTHESIA (Numbness) had resolved. On 23-Feb-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of vaccine administered) had resolved. At the time of the report, NEUROPATHY PERIPHERAL (Peripheral neuropathy on both of her legs) had resolved and VACCINATION SITE PRURITUS (The site was more itchy) and VACCINATION SITE PAIN (Soreness on the injection site) outcome was unknown.            Concomitant product use was not provided by the reporter. No treatment information was provided. 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.   Most recent FOLLOW-UP information incorporated above includes: On 31-Mar-2021: Event: Numbness start date and recovered date updated.; 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.
This spontaneous report as received from a pharmacist refers to a 73 years old female patient with drug allergies to codeine. The patient was subcutaneously vaccinated with a dose of 0.65 ZOSTAVAX (lot number reported as 0565AE, expiry date 23-MAR-2013) on 22-OCT-2012. NO other co-suspects were reported. No concomitant medications were reported. On an unknown date of October 2012, the patient experienced redness, itching, swelling and soreness around injection site after receiving ZOSTAVAX. The patient also developed little "pinkish" area within the redness around injection site and she went to see physician. The physician (name unspecified0 prescribed antibiotic (name unspecified) for the patient. The outcome of redness around injection site, little "pinkish" area within the redness around injection site, soreness around injection site, swelling around injection site and itching around injection site was unknown. Additional information is not expected.
Missed second scheduled Moderna Dose (>42 days); dizziness; This spontaneous case was reported by a pharmacist and describes the occurrence of DIZZINESS (dizziness) and PRODUCT DOSE OMISSION ISSUE (Missed second scheduled Moderna Dose (>42 days)) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, the patient experienced DIZZINESS (dizziness). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed second scheduled Moderna Dose (>42 days)). At the time of the report, DIZZINESS (dizziness) and PRODUCT DOSE OMISSION ISSUE (Missed second scheduled Moderna Dose (>42 days)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   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.
Information has been received from a registered pharmacist (R. Ph)concerning a 56 year old female patient with drug allergy to unspecified opioids and no known medical history who on 19-APR-2011, was vaccinated with a dose of ZOSTAVAX (Merck), 0.65 ml, subcutaneously, (lot number not reported). Concomitant therapy included methadone HCl. On 22-APR-2011, the patient called to R. Ph to report that she had broken out in blisters at the injection site, at unspecified time following vaccination. Also, R. Ph reported that the patient reported a single, dime-sized blister surrounded by multiple smaller blisters, which were not painful unless touched. BENADRYL (unspecified dose) was given to treat the blisters. The patient received sought medical attention by a telephone call to pharmacist. No lab test was performed. This is one of several reports received from the same source. At the time of the report, the patient had not recovered. Additional information has been requested.
Difficulty breathing, hoarseness, red eyes, fever of 101.3, achy joints.
Patient was inadvertently administered the Pfizer monovalent COVID-19 vaccine instead of the bivalent.
Sore arm  On 01/11/2021 I tested positive for Covid 19
Achy feeling in arm where administered; swelling and warm to touch. Very tender (burning sensation). Tightness in throat; congestion.
sharp pain in the right kidney; covid arm; This spontaneous case was reported by a consumer and describes the occurrence of RENAL PAIN (sharp pain in the right kidney) and VACCINATION SITE REACTION (covid arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RENAL PAIN (sharp pain in the right kidney) and VACCINATION SITE REACTION (covid arm). At the time of the report, RENAL PAIN (sharp pain in the right kidney) and VACCINATION SITE REACTION (covid arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medication were reported. Treatment medication was not provided.
The pt experienced erythema, induration, swelling, mottling of both the upper extremities, possible cellulitis.
Left arm swollen, red, warm to touch. Mother gave MOTRIN po to child. Given 5/22/12 pm - Went to school 5/23/12 but sent home by school nurse.
This infant took a small nap after his shots. He woke up around 1 PM, with inconsolable crying and screaming until around 5:30 PM when he napped again.
c/o light headedness, ems evaled pt. declined further treatment. or eval symptoms resolved.
Fever, chills, bodyache, 1wk co-incident with Altace starting increase WBC 24k. Serum sickness.
This spontaneous report as received from a healthcare worker refers to a female patient of unknown age. On 07-SEP-2007 the patient was vaccinated with the first dose of GARDASIL (Lot # not reported) (dose and route not reported). No other co suspects were reported. No concomitant therapy was reported. The healthcare worker stated that the patient received the first dose of GARDASIL when she was 22 years old. The patient was in the office to see if she's eligible to receive the second dose. No adverse effect reported. Additional information has been requested.
I have pain around the back of shoulder blade and injection site pain.; injection site pain; This is a spontaneous report from a contactable consumer or other non healthcare professional. A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown, Expiration date: unknown), via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient had pain around the back of shoulder blade and injection site pain. The patient wants to know can he get the second dose of the vaccine. The outcome of events were unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Received vaccine around 11:15am. Started coughing with mucus and congestion around 2:30 pm. Also felt eyes swelling, became hoarse. Took over the counter Benadryl and Robitussin. Layed down. Started to feel mouth and tongue get funny. Headed to ER. Upon arrival to ER having trouble breathing. Ended up admitted to hospital. Discharge with oral Prednisone. Unsure of actual meds given in ER. No other abnormal ingested foods or meds that day. Influenza vaccine was only difference-11/14/08-records received  for DOS 10/28/08-presented to ED with C/O harsh barky cough and lips swelling on evening after receiving flu vaccine. Eyes itchy and red. Tingling in lips. Admitted overnight for angioedema questionable reaction to flu vaccine.
less than two weeks after receiving her second covid vaccine, the patient developed acute onset, severe, right sided headaches concerning for a thunderclap headache. she was seen in the clinic. given the severity of her symptoms, she required a CT-angiongram of the head and neck to rule out intracranial bleed, fortunately which was negative.
The cases were received on 21 March 2014 at GPV. Initial misuse report received from a healthcare professional on 24 September 2013. A 03-year-old patient had received 0.25 ml of FLUZONE on 19 September 2013. A 03-year-old patient had received 0.25 ml of FLUZONE on 19 September 2013. It's an underdose. No adverse event was reported. List of documents held by sender: none.
100 degree fever day 1 Body aches day 1-2 Extreme fatigue day 1-3 Sore throat day 2 Headache day 2-3 Painful swollen eyelids (more left eye) day 3 and 4 (today is day 4 and unresolved)
This spontaneous report was received from a Registered nurse regarding a 15 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 01-AUG-2018, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot# N004798 with expiration date: 31-OCT-2019 (dosing details and route of administration was not reported) for prophylaxis (product storage error). No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1804USA005153.
drastic increase in migraine headaches, Angina, and appendectomy(hospitalization)
Vitamin D deficiency; Electrolytes deficiency; Swollen hands and feet; Head ache; Fatigue; Nauseated; This spontaneous case was reported by a consumer and describes the occurrence of VITAMIN D DEFICIENCY (Vitamin D deficiency), ELECTROLYTE IMBALANCE (Electrolytes deficiency), PERIPHERAL SWELLING (Swollen hands and feet), HEADACHE (Head ache) and FATIGUE (Fatigue) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 21-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VITAMIN D DEFICIENCY (Vitamin D deficiency), ELECTROLYTE IMBALANCE (Electrolytes deficiency), PERIPHERAL SWELLING (Swollen hands and feet), HEADACHE (Head ache), FATIGUE (Fatigue) and NAUSEA (Nauseated). The patient was treated with COLECALCIFEROL (VITAMIN D 3) for Vitamin D deficiency, at an unspecified dose and frequency and GLUCOSE, POTASSIUM CHLORIDE, SODIUM CHLORIDE, SODIUM CITRATE DIHYDRATE (ORS [GLUCOSE;POTASSIUM CHLORIDE;SODIUM CHLORIDE;SODIUM CITRATE DIHYDRATE]) for Electrolyte disturbance, at an unspecified dose and frequency. At the time of the report, VITAMIN D DEFICIENCY (Vitamin D deficiency), ELECTROLYTE IMBALANCE (Electrolytes deficiency), PERIPHERAL SWELLING (Swollen hands and feet), HEADACHE (Head ache), FATIGUE (Fatigue) and NAUSEA (Nauseated) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Laboratory data was blood works returned bad.
Flushing sound in my left ear, as if I'm hearing something inside me head, pulsating too. Also felt heart racing two days before this annoying sound began.
Rash on upper chest, neck & cheeks.  No SOD, edema.  Took Benadryl 25 mg at workplace.  Rash resolved by 4 pm.
Patient seen in the Urgent Care Center approximately 2 days after administration of vaccine with complaints of redness, warmth at injection site and mild induration.  Pt was treated with Ibuprofen and Benadryl and advised to follow up with primary care clinic for any further problems.
Narrative:  COVID infection following COVID vaccine series 08/24 pt cc: fatigue exposure: unknown 08/31 Janssen, dose #1 09/05 CTA PE impression: 1. Negative for central PE. 2. Severe multifocal consolidation compatible, greatest at the lower lobes compatible with history of COVID pneumonia. 09/05 CXR impression: 1. Multifocal patchy interstitial and airspace opacities in the mid to lower lung zones, which may represent COVID-19 pneumonia given the history. Superimposed bacterial pneumonia remains a possibility. 2. Possible small bilateral pleural effusions. 09/05 COVID swab, result: detected 09/05 pt admit to medcine cc: confused, agitated, dx: Severe COVID-19 Pneumonia, Acute Hypoxic Respiratory Failure LOS: 2 days 09/05 TROPONIN I: 0.391 09/05 ABG: ABG: i-pH 7.52, i-PCO2 27.9, i-P02 54, i-HCO3 23.0 09/05 DDIMER: 67.14 09/05 LACTIC ACID: 2.18 09/05 PT/INR 14.6/32.3 09/05 BNP: 128.0 09/05 PROCALCITONIN: 0.22 09/05 SARS-COV-2 Variant Sequencing result: pending 09/15 pt deceased
The patient was administered a COVID shot without consent. The patient had been scheduled a flu vaccination. Once arriving at the Pharmacy, the provider did not confirm any information, gave the patient the shot, and only afterwards realized a mistake had been made.
Swelling and pain/redness started 24 hr. after vaccine at site of injection 6/5/08.  6/6/08-AUGMENTIN/BENADRYL.
Pregnant Patient at 30 weeks visited Pharmacy for boostrix vaccine, while administering I noticed a spill from the side of the vaccine vial so I immediately stopped. I contacted the Patients doctors office and we discussed the incident and the nurse request re-administering vaccine in the opposite arm (right arm).  Also I contacted our clinical coordinator and we check CDC best practices which also recommended re-administering. I called after a while to check on patient and she is doing well
Initial report received on 25 November 2009 from a health care professional. A 58 year old female, with no known allergies and a history of hyperlipidemia, received a right deltoid intramuscular injection of H1N1 (lot number UP016AA) and a left deltoid intramuscular injection of FLUVIRIN (Novartis, lot number not reported) on 24 November 2009. The patient had no illness at the time of vaccination and it was unknown if she had any adverse events following prior vaccination. The following day, on 25 November 2009, the patient experienced significant swelling, warmth and redness at both injection sites. She had no systemic reaction. At the time of the report, the patient had not recovered.
This spontaneous case reported by a consumer, describes the occurrence of pyrexia (fever) and headache in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 025C21A) for COVID-19 immunization. No medical history reported. On May 2, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19  vaccine), intramuscular; 1 dosage form. On May 2, 2021, patient experienced pyrexia (fever). On May 4, 2021, patient experienced headache. The patient treated with Tylenol (paracetamol), at an unspecified dose and frequency. At the time of the report, pyrexia (fever) and headache: unresolved. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. No concomitant medications reported.