chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Hives on legs; This non-serious case was reported by a consumer via call center representative and described the occurrence of hives in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18-FEB-2023, the patient received the 1st dose of Shingrix (intramuscular, left deltoid). On an unknown date, an unknown time after receiving Shingrix, the patient experienced hives (Verbatim: Hives on legs). The outcome of the hives was resolved (duration 1 hr).   The reporter considered the hives to be related to Shingrix.     The company considered the hives to be related to Shingrix.   Additional Information: GSK Receipt Date: 12-APR-2023 The patient reported this case for himself. He received Shingrix shot number one in February 2023. He was not sure but thought it was on the 18th Feb 2023. Sometime after receiving Shingrix shot the patient broke out in hives on his legs. The patient stated that there was nothing else different he did, not change laundry detergent. He stated that the hives were not terrible and the hives resolved in about an hour. The patient contacted GSK to seek adviced whether should he receive or not dose 2. The reporter did not consent to follow-up.
bad cough, still lingering; This case was reported by a consumer via call center representative and described the occurrence of cough in a 61-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   In March 2022, the patient received the 1st dose of Shingrix. In March 2022, 1 day after receiving Shingrix, the patient experienced cough. On an unknown date, the outcome of the cough was not recovered/not resolved.   It was unknown if the reporter considered the cough to be related to Shingrix.     Additional Information: GSK receipt date: 12-MAY-2022 Reporter's comment: The patient received 1st dose of Shingrix in mid-March and day after he/she started with a bad cough and it was still lingering.  The patient was wondering whether anyone else had experienced such a reaction.
This spontaneous report as received from a physician via a company representative refers to an 82 year old male patient. The patient's pertinent medical history, drug reaction or allergies and concomitant therapies were not reported. On 04-DEC-2017, the patient was vaccinated with PNEUMOVAX 23 (lot # N022650; expiry date unknown) in the left arm for prophylaxis. Dosing details were not reported. On 05-DEC-2017, the patient was admitted to an unspecified hospital complaining of fever, generalized weakness, left shoulder pain and swelling. The patient was discharged from the hospital on 08-DEC-2018 and had fully recovered. Causality assessment was not provided by the reporter.
Scalp burning; suspected shingles in my scalp; redness in one area on the left side; Slight headache; Minor arm pain; Shooting pain in the left ear; This spontaneous case was reported by a nurse and describes the occurrence of EAR PAIN (Shooting pain in the left ear), PAIN IN EXTREMITY (Minor arm pain), SKIN BURNING SENSATION (Scalp burning), HERPES ZOSTER (suspected shingles in my scalp) and ERYTHEMA (redness in one area on the left side) in a 55-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 No adverse event (No reported medical history).    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jan-2020, the patient experienced EAR PAIN (Shooting pain in the left ear). On 31-Dec-2020, the patient experienced PAIN IN EXTREMITY (Minor arm pain) and HEADACHE (Slight headache). On 06-Jan-2021, the patient experienced SKIN BURNING SENSATION (Scalp burning), HERPES ZOSTER (suspected shingles in my scalp) and ERYTHEMA (redness in one area on the left side). The patient was treated with VALACICLOVIR HYDROCHLORIDE (VALTREX) at a dose of 1 gram three times a day. At the time of the report, EAR PAIN (Shooting pain in the left ear), PAIN IN EXTREMITY (Minor arm pain), SKIN BURNING SENSATION (Scalp burning), HERPES ZOSTER (suspected shingles in my scalp), ERYTHEMA (redness in one area on the left side) and HEADACHE (Slight headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   no concomitant medication provided   Reporter did not allow further contact; Reporter'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.
Sensation of something getting stuck in the chest; Headache; Labored Breathing; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Labored Breathing), CHEST DISCOMFORT (Sensation of something getting stuck in the chest) and HEADACHE (Headache) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concurrent medical conditions included No adverse event.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, the patient experienced DYSPNOEA (Labored Breathing) and HEADACHE (Headache). On 12-Mar-2021, the patient experienced CHEST DISCOMFORT (Sensation of something getting stuck in the chest). At the time of the report, DYSPNOEA (Labored Breathing), CHEST DISCOMFORT (Sensation of something getting stuck in the chest) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication list was not provided. Treatment information was not provided.
Patient contracts covid after 1st vaccination; This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (Patient contracts covid after 1st vaccination) in a  patient of an unknown age and gender 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 COVID-19 (Patient contracts covid after 1st vaccination). At the time of the report, COVID-19 (Patient contracts covid after 1st vaccination) 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 provided No treatment medications were provided
allergies; on the floor in pain; bedridden; hard coughing; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 2022NVX-US-000002855.  A 47-year-old female patient received BNT162b2 (BNT162B2), on 11Jun2021 as dose 1, single (Batch/Lot number: unknown) at the age of 45 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG HYPERSENSITIVITY (non-serious), outcome "unknown", described as "allergies"; PAIN (non-serious), outcome "unknown", described as "on the floor in pain"; BEDRIDDEN (non-serious), outcome "unknown"; COUGH (non-serious), outcome "unknown", described as "hard coughing".  Additional Information: On 03Aug2022, it was reported that a patient started treatment on 11Jun2021 with Pfizer dose 1 for COVID-19 immunization. It was reported the patient experienced: allergies, was bedridden, had hard coughing, and was on the floor in pain. No further follow-up is anticipated.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Information has been received from a female patient of unknown age referring to herself. Information about pertinent medical history, concurrent condition and concomitant therapy was not reported. On an unspecified date in June 2013(reported as "about 2 years ago") the patient was vaccinated with ZOSTAVAX (strength, lot#, dosage, frequency and route unspecified). On an unspecified date in 2015(reported as "currently") the patient had a mild case of shingles. The outcome of the event was unknown. Additional information has been requested.
My whole head was aching only my left side and it keeps traveling from one place to another; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (005570). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 18Jan2023 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose: 1, Manufacturer: Unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose: 2, Manufacturer: Unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose: 3, Manufacturer: Unknown), for COVID-19 Immunization. The following information was reported: HEADACHE (non-serious) with onset 19Jan2023, outcome "not recovered", described as "My whole head was aching only my left side and it keeps traveling from one place to another".  Additional information: Patient reported that on 18Jan2023 got a Covid shot in left arm fourth shot the next morning. I woke up on my left side. Patient's whole head was aching only left side and it keeps traveling from one place to another. It's now 29Jan2023 and patient still had the same symptoms after going to the doctor patient need help.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Red, swollen hard lump at injection site, sore throat, swollen glands in throat area
Fever; chills; migraines; brain fog; fatigue; This is a spontaneous report from a non-contactable female physician (doctor of acupuncture) reported for herself via Pfizer sales representative. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, lot Number unknown, expiration date unknown), as single dose, via an unspecified route of administration on an unspecified date as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date, after receiving first dose of vaccine the patient experienced fever, chills, fatigue, migraines, and brain fog. This patient was willing to be contacted and followed as she gets her second dose in a few weeks. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected
Swollen, bruised, erythematous, hard, tender-to-touch, radius of erythema size of baseball
Congestion, stuffy sinuses fill up drain and repeat.  Feels like lump in throat and cannot get deep breath in for 8 weeks. Anti histamines no help.  Anxiety after 4-5 weeks.  Lack of sleep due to drainage and asthma.
48 YOF went in for her first dose of Covid vaccine and was injected with an empty needle. RN did not specify if needle had been used previously and looked for a second needle which was also empty. After checking several needles she found one that had been prefilled. Pt received her first dose at 0930. Felt a cold sensation and brief pain at site.  She is concerned that first needle used on her had been previously used on someone else.    PCC: Headache is a common side effect after covid 19 vaccination. Can last 24-48 hrs. Advised to call back with lot number and Rn information who injected pt for fu.  There is no way for us to determine if needle had been previously used or never prefilled.  Fu with pcp  Side effect reported: Headache since this morning after first dose.
Chest pain, unclear etiology for four days.  Supportive treatment with acetaminophen, ibuprofen.  Plan for cardiac echo
This case was reported by a nurse via sales rep and described the occurrence of pain in arm in a male patient who received BEXSERO. On 1st July 2017, the patient received BEXSERO. On 1st July 2017, less than a day after receiving BEXSERO, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved. The reporter considered the pain in arm to be almost certainly related to BEXSERO. Additional details were provided as follows: The age at the time of vaccination was not reported. The patient received a dose of BEXSERO into an unknown arm.
Hot and cold flashes, nausea, soreness at injection site. Symtoms lasted approximately 1.5 days.
Local reaction on left arm, occurred approximately 6 hours after administration. Area red, swollen and firm. Also itchy and faded after 2 days of administration. Applied aloe and green tea soothing burn cream one time only. (per pt)
6-11-13 received Tdap at physical from 6/12/13 mom called office and stated child began N/V within 12 hrs of receiving vaccine, Temp 104+ 6/13/13 TC to mom she states child is fever free by late morning. Drinking OK now.
Covid breakthrough case. May 09 my wife tested positive, and I tested and was negative. May 13 I wasn't feeling great I went to the pharmacy and got a test and on the 14 I was positive. I had a cough an little fever and very lethargic. I texted my doctor and he called me back that Sat and he sent me a script for PAXLOVID. I took the medication for 5 days and Tylenol and it helped the fever. I still have somewhat of a cough.
Numbness, tingling, burning sensation of tongue.  Diaphoresis and angioedema
arm was sore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 10Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Mar2021, outcome "unknown", described as "arm was sore".  Additional Information: No medical questions referred or forwarded to Medical Information  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from the practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 24-JAN-2018 and 10-APR-2018, the patient was vaccinated with an improperly stored dose of ROTATEQ (strength were unknown) (lot# N003984 and expiration date 19-NOV-2018; lot# N024295 and expiration date 24-MAR-2019) orally for prophylaxis, respectively. The sterile diluent (MERCK) (lot# and expiration date were unknown) was properly stored. No adverse event was reported. The excursion temperature on 08-NOV-2017, 16-NOV-2017, 23-JAN-2018, 06-JUN-2018, 03-JUL-2018 and 14-AUG-2018 was 47 degree Celsius for maximize 15 hours. The excursion temperature on 07-DEC-2017 was 50 degree Celsius for maximize 8.75 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1809USA003709: US-009507513-1810USA001951: US-009507513-1810USA001952: US-009507513-1810USA001953: US-009507513-1810USA001954: US-009507513-1810USA001955: US-009507513-1810USA001956: US-009507513-1810USA001957: US-009507513-1810USA001958.
Severe cramping during regular menstrual periods on 8/23/21, 9/19/21, & 10/16/21.
Started experiencing sensitivity on the injection site the same day and it has lingered to this day 9/27/2023.
Cellulitis at injection site. Seen in Peds clinic and prescribed Clindamycin on 30 Sept 2016.
congestion; blotchiness kind of like hives but they stay instead of come and go like hives.; terrible aches; immediate rash after the 2nd dose, Rashes are now starting to pop up after the second dose; severe chills; chronic fatigue; fever; floaters in the left eye after 2nd dose; visual disturbances; blurry left eye; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 04-Mar-2021 and was forwarded to Moderna on 05-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VITREOUS FLOATERS (floaters in the left eye after 2nd dose), VISUAL IMPAIRMENT (visual disturbances), VISION BLURRED (blurry left eye), NASAL CONGESTION (congestion) and URTICARIA (blotchiness kind of like hives but they stay instead of come and go like hives.) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003A21A and 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced VITREOUS FLOATERS (floaters in the left eye after 2nd dose), VISUAL IMPAIRMENT (visual disturbances) and VISION BLURRED (blurry left eye). On an unknown date, the patient experienced NASAL CONGESTION (congestion), URTICARIA (blotchiness kind of like hives but they stay instead of come and go like hives.), PAIN (terrible aches), RASH (immediate rash after the 2nd dose, Rashes are now starting to pop up after the second dose), CHILLS (severe chills), FATIGUE (chronic fatigue) and PYREXIA (fever). At the time of the report, VITREOUS FLOATERS (floaters in the left eye after 2nd dose), VISUAL IMPAIRMENT (visual disturbances), VISION BLURRED (blurry left eye), NASAL CONGESTION (congestion), URTICARIA (blotchiness kind of like hives but they stay instead of come and go like hives.), PAIN (terrible aches), RASH (immediate rash after the 2nd dose, Rashes are now starting to pop up after the second dose), CHILLS (severe chills), FATIGUE (chronic fatigue) and PYREXIA (fever) outcome was unknown.            Reporter did not allow further contact
3MAY woke up irritable, 3May fever 101, 3May 13 sz, focal sz at hosp. Taken to another hosp.
NOTICED A SMALL PUSTULE WITH INFLAMMATION AND DISCOMFORT AT INJECTION SITE. 11/09/2009 INFLAMMATION RESOLVED BUT A LINE OF DEMARCATION NOTICED APPROX. 1 1/2 INCH AROUND INJ. SITE.
Swollen, hot, red, raised patch of skin at site of injection (in left arm)
Information has been received from a physician concerning a 16 year old female with no medical history or drug allergy who on 05-JAN-2009 was vaccinated with the third dose of GARDASIL (lot # 0544X), 0.5ml. IM.  There was no concomitant medication.  The patient developed a rash in the area of the injection site almost immediately after receiving her third dose of GARDASIL vaccine on 05-JAN-2009.  The rash, which was red and blotchy, extended from the deltoid area to the elbow but it was not known whether right or left arm involved.  The patient was given BENADRYL and the rash resolved by 06-JAN-2009.  The patient sought attention by office visit.  Additional information has been requested.
Client called to report an adverse event post-COVID vaccination. RN spoke to the client on 8/12/21. Client reported that she received a COVID Moderna vaccine on 8/3/21 at a TCHD mobile event (confirmed). In the several days following vaccination, client stated that she had a fever, headache, mild swelling at the injection site, and itching at the injection site. Due to the itching, client began taking Benadryl daily. On 8/10/21, client reported a drastic increase in swelling and redness at the injection site that extended through her shoulder. The client reported that the redness looked like ?paint dripping?. The client began to feel 'tingling' in her hand due to the large amount of swelling. On 8/11/21, client reportedly began to have trouble breathing and called her primary care physician (PCP). She was seen by her PCP on 8/11/21 and received steroid medication and an Epi Pen to carry in case of future anaphylaxis. Per the client, her PCP told her this was an allergic reaction and recommended that she not receive the second dose of COVID Moderna. Client reports that she has no chronic illnesses, but does have an anaphylactic allergy to PCN and a mild allergy to codeine.
Shot 3 d ago. Redness appeared next day. Tender. Just increasing in size then left thigh.
Weight has gone down 10 lbs.; This spontaneous case was reported by a consumer and describes the occurrence of WEIGHT DECREASED (Weight has gone down 10 lbs.) 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.   In 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced WEIGHT DECREASED (Weight has gone down 10 lbs.). At the time of the report, WEIGHT DECREASED (Weight has gone down 10 lbs.) outcome was unknown.            Patient received flu shot last week after receiving both the doses of Moderna COVID-19 vaccine and experienced cough, chills and felt tired the entire week after. Patient was still coughing a little and had this reaction which was not over yet. It was also reported that the patient never had a reaction to the flu shot before. It was reported that the patient was unsure about the timelines of weight loss but she thinks that that it happened over a course of 2 years. Concomitant medications was not provided by the reporter. Treatment information was not provided.
This spontaneous report as received from a healthcare worker refers to an 11 year old patient of unknown gender. The patient's pertinent medical history and drug reactions or allergies were not reported. On 28-AUG-2013, the patient was vaccinated with the first dose of VAQTA, pediatric (route and dose were not reported, strength reported as 25/0.5 (unit not provided), lot # J003719, expiry date: 27-SEP-2015). On 29-AUG-2014, the patient was vaccinated with the second doe of VAQTA, pediatric (route and dose were not reported, strength reported as 25/0.5 (unit not provided), lot # K007791, expiry date: 22-AUG-2016). On 02-SEP-2015, the patient was vaccinated with the third dose of VAQTA, pediatric (route and dose were not reported, strength reported as 25/0.5 (unit not provided), lot # K007791, expiry date: 22-AUG-2016). On 02-SEP-2015, the patient was vaccinated with the third dose of VAQTA, pediatric (route and dose were not reported, strength reported as 25/0.5 (unit not provided), lot # L009445, expiry date: 01-JUN-2017. Concomitant medications were not reported. No adverse effects were reported. Additional information has been requested.
SOB ;DIZZINESS ; BRADICARDIA;  ; HYPOTENSION;  SEMI COLLAPSE;  Diaphoretic; 911 called Patient recovered transport not needed .