chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial unsolicited report received from a nurse via social media on 10 Oct 2016. This case is linked with 2016SA188144, 2016SA188556, 2016SA188803, 2016SA188804, 2016SA188805, 2016SA188806, 2016SA188807, 2016SA188808, 2016SA188809, 2016SA188810, 2016SA188811, 2016SA188812, 2016SA188813, 2016SA188814, 2016SA188815, 2016SA188816, 2016SA188817, 2016SA188818, 2016SA188819, 2016SA188820, 2016SA188821, 2016SA188822, 2016SA188833, 2016SA188834, 2016SA188835, 2016SA188836, 2016SA188837, 2016SA188838, 2016SA188839, 2016SA188840, 2016SA188841, 2016SA188842, 2016SA188844, 2016SA188845, 2016SA188846, 2016SA188847, 2016SA188848, 2016SA188849, 2016SA188850, 2016SA188851, 2016SA191730, 2016SA191735, 2016SA191739, 2016SA191741, 2016SA191743, 2016SA191744. This case involves a patient (age and gender not reported) who was vaccinated with a dose of INFLUENZA VACCINE (batch number, expiry date, dose, route and site of administration was not reported) on an unspecified date in 1975. The patient medical history and concomitant medications were not reported. On an unknown date and time frame following the vaccination, the patient got sick. The patient lab tests and corrective treatment was not reported. The outcome of the event was unknown. List of documents held by sender: none.
itchy rash on left side of the face; Pregnant; This spontaneous prospective pregnancy case was reported by a nurse and describes the occurrence of RASH (itchy rash on left side of the face) and MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.    No Medical History information was reported.    On 27-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 27-Dec-2020, the patient experienced RASH (itchy rash on left side of the face) and MATERNAL EXPOSURE DURING PREGNANCY (Pregnant). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Rash face, at an unspecified dose and frequency. On 27-Dec-2020, RASH (itchy rash on left side of the face) was resolving and MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) had resolved.        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 product use was not reported. Treatment information was not provided.; Reporter's Comments: This case concerns a female, who experienced a non-serious expected event of Rash and non-serious unexpected event of Exposure during pregnancy. The event of Rash occurred same day as the first dose of the mRNA-1273 administration which started resolving with treatment with Diphenhydramine.   Based on the current available information and temporal association between the use of the product and the start date of the Rash, a causal relationship cannot be excluded.
Throbbing headache; Arm throbbing; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Throbbing headache) and PAIN IN EXTREMITY (Arm throbbing) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039B21A and 047A21A) for COVID-19 vaccination.     Concomitant products included OXYCODONE and AMOXICILLIN for an unknown indication.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Apr-2021, the patient experienced HEADACHE (Throbbing headache) and PAIN IN EXTREMITY (Arm throbbing). At the time of the report, HEADACHE (Throbbing headache) and PAIN IN EXTREMITY (Arm throbbing) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medications included aspirin. Action taken with mRNA-1273 in response to the events was not Applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-079087 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-079087:Son case
This spontaneous report was received from a registered nurse refers to an unspecified number of patients of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On an unspecified dates, the patients were vaccinated with an unspecified improperly stored doses of GARDASIL, lot # K008931 and expiration date 03-APR-2017, lot # K011562 and expiration date 08-APR-2017, (routes of administration and anatomical locations were not provided). No adverse symptoms were reported. There was no product quality issues involved. This is one of several cases from the same reporter. Additional information has ben requested.
Pt vaccinated with Influenza Vaccine developed hives over entire body, low grade fever.
A spot in her leg that is still sore to the touch; She felt on the right side of her leg between her knee and ankle like many bee stings; Her skin was tingling; Dry skin; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (She felt on the right side of her leg between her knee and ankle like many bee stings), PARAESTHESIA (Her skin was tingling), DRY SKIN (Dry skin) and SKIN REACTION (A spot in her leg that is still sore to the touch) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid disorder NOS and Blood pressure abnormal. Concomitant products included CETIRIZINE for an unknown indication.    On 16-Apr-2021 at 10:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FEELING ABNORMAL (She felt on the right side of her leg between her knee and ankle like many bee stings), PARAESTHESIA (Her skin was tingling) and DRY SKIN (Dry skin). On an unknown date, the patient experienced SKIN REACTION (A spot in her leg that is still sore to the touch). The patient was treated with AVENA SATIVA FLUID EXTRACT (AVEENO) at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (She felt on the right side of her leg between her knee and ankle like many bee stings), PARAESTHESIA (Her skin was tingling), DRY SKIN (Dry skin) and SKIN REACTION (A spot in her leg that is still sore to the touch) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications also included thyroid pill, inhaler, blood pressure pill
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider(s) recommended, and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 30-NOV-2014, a healthcare provider, at a pharmacy, administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 20-DEC-2016, the patient was treated by a healthcare provider at a medical and dental center for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death; aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
Pt presented with stomach pain and diarrhea 12 hours after vaccine administration and body rash, welts, and tachycardia about 26 hours after vaccine administration.  Pt treated & diagnosed by Dr. at ambulatory care center.  Dx was anaphylaxis from vaccine & Dr. advised hospitalization, family declined.
COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 27-year-old female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a registered nurse concerning a 71 inch, 190 pound, 67 year old, retired, male who on 11-OCT-2007 was vaccinated with a second dose of pneumococcal 23v polysaccharide vaccine (lot#635674/0380K), intramuscularly in the left deltoid at 10:07 am. Concomitant therapy included ADACEL (Lot #C2825AA) intramuscularly in the right deltoid on the same day at 10:07 am. On an unspecified date the patient developed pain, edema, and redness at the site for one week. The patient never had a reaction previously. The patient recovered within one week of onset. No further information is available.
Information has been received from a physician concerning a male who in September 2007, was vaccinated with a dose of Zostavax.  Concomitant therapy included vitamins (unspecified).  Subsequently the patient experienced malaise, sniffles and general weakness.  The patient recovered after 7 days.  No diagnostic laboratory tests were undertake.  A product quality complaint was not involved.  Additional information has been requested. This is in follow-up to report (s) previously submitted on 12/21/2007. Information has been received from a physician concerning a male with no pre-existing allergies, birth defects, medical conditions, who in September 2007, was vaccinated with a dose of ZOSTAVAX vaccine (Merck). Concomitant therapy included vitamins (unspecified). Subsequently the patient experience malaise, sniffles and general weakness. The patient recovered after 7 days. No diagnostic laboratory tests were undertaken. There was no illness at time of vaccination. There were no adverse events following prior vaccinations. There was no product quality complaint. Follow-up information indicated that "there was no problem". Additional information has been requested.
I received the first Shingrix vaccine dose on the date noted above. One day post-injection, a fever of 101 degrees developed, as did aching in both knees. These symptoms disappeared within a day or two, however, joint pain returned several weeks later. The pain was in knees, hips and shoulders with both left and right sides of the body being involved with each of those joints. Aleve was helpful in reducing the pain, but after several weeks of ongoing symptoms, I scheduled an appointment with my physician. I am awaiting the MD's advice on anti-inflammatory treatment for which blood pressure considerations must be taken into account.
Information has been received from a medical assistant concerning an 80 year old female with diastolic dysfunction, hypertension, systolic murmur, cholesterol high and hypothyroidism, and no drug allergies who on 10-FEB-2009 was vaccinated SQ with a 0.65 ml dose of ZOSTAVAX (Oka/Merck) (lot # 663199/1551X).  Concomitant therapy included (MICARDIS HCT), PROVERA, SYNTHROID, LIPITOR, ADVAIR, aspirin, K-TAB, OPTIVAR OPHTHALMIC SOLUTION, NASONEX, ALBUTEROL and CLONIDINE.  Subsequently the patient experienced shingles like rash on the right side of her body.  The patient sought medical attention at physician's office.  No lab tests were performed.  As of 16-FEB-2009, the patient has not recovered.  Additional information has been requested. This is in follow-up to report (s) previously submitted on 3/27/2009.  Follow-up information was received from a registered nurse (R.N.) which reported that an 80 year old female at 10:00 am 10-FEB-2009 was vaccinated IM into arm with a first dose of ZOSTAVAX.  There is no illness at the time of the vaccination.  It was reported that the patient came back to office on 16-FEB-2009 at 09:30.  The patient developed rash on head, vesicular lesion and a couple of nodules on back of scalp which "appeared like shingles but unsure".  No lab tests were performed.  Three weeks after the vaccination, the patient recovered.  No further information is available.
Patient received the Tdap vaccine on 1-29-14. He never developed a fever or any other sx. He slept fine. The next morning 1/30 he awoke with a sore arm 10 min later he felt dizzy, vomited, then fainted. He was fine the rest of the day.
On 2/5/2021 I noticed an itchy feeling in the right arm at the injection site.  The area felt a little hard. The next day, 2/6/2021, the area was quite red, hard, and swollen upon examination. There had been a little redness and pain for the first 2-3 days after injection which had gone away until the symptoms noted appeared on 2/6/2021,  I have applied 1% hydrocortisone to the area and taken some diphenhydramine. The feeling of itchiness and the redness have improved.
Skin rash appearing specially in the morning. Minor few spots of rashes were notices on the second day of the second dose. More sever skin rash appeared again on April 4th. Today, April 6th is the worst day where more skin rash appeared all over my body. Took Zyrtec to cope with it which is helping.
Nausea at 09:00pm then slight fever, vomiting 04:00am. No treatment. Symptoms subsided aprox. 02:00pm 8/14/2013.
This case was reported by a consumer and described the occurrence of sore arm (injection site) in a 63-year-old female subject who was vaccinated with influenza vaccine unspecified (manufacturer unspecified). A physician or other health care professional has not verified this report. Concurrent medical conditions included acid reflux, diabetes, high blood pressure and high cholesterol. Concurrent medications included metoprolol, triamterene + hydrochlorothiazide, aspirin, amlodipine, pravastatin, pantoprazole and insulin. On 8 October 2013 at 15:30 the subject received 1st dose of influenza vaccine unspecified (unknown details, right arm). On 9 October 2013, 1 day after vaccination with influenza vaccine unspecified, the subject experienced sore arm (injection site). The subject sought medication attention at her doctor's office. The subject planned to "continue follow up with her physician on an unknown date." At the time of reporting the event was unresolved.
fatigue; slowest down her brain again, hit her down/ it was not a dizziness, could hardly think; had to go to bed and could not get up that night; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of FEELING ABNORMAL (slowest down her brain again, hit her down/ it was not a dizziness, could hardly think), HYPERSOMNIA (had to go to bed and could not get up that night) and FATIGUE (fatigue) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026LC0A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (had a very bad time, had to be hospitalized for 10 days because the virus affected her brain; she felt she could not think, or operate.) in July 2020. Concomitant products included PARACETAMOL (TYLENOL) for Arthritis, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) and LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced FEELING ABNORMAL (slowest down her brain again, hit her down/ it was not a dizziness, could hardly think) and HYPERSOMNIA (had to go to bed and could not get up that night). On 23-Jan-2021, the patient experienced FATIGUE (fatigue). On 23-Jan-2021, FEELING ABNORMAL (slowest down her brain again, hit her down/ it was not a dizziness, could hardly think) outcome was unknown. At the time of the report, HYPERSOMNIA (had to go to bed and could not get up that night) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications also included blood pressure medications and medication for bedtime. No treatment information was provided.
Systemic: jaw tightness-Mild, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Additional Details: experienced numbness and tingling from left shoulder down to left hand
Vertigo starting at 7pm the night of the vaccine.  The next morning woke with continued vertigo and fatigue.  Still in bed on 1/5/2021 at 12:30pm.
My face went numb, that was the first symptom 10/15 min after immunization. I got tachycardia (I tend to have a rapid hart beat but this was pumping pretty good). I also had some GI distress (watery diarrhea) and that lasted for a while. Later I got really weak and shaky, fatigued, that night I woke up with night sweats, and chills, woke up completely drenched, I had to change the sheets and pajamas. 5 days after the vaccine I was really exhausted, the fatigue was awful. There was also an itching sensation but no hives.
Swollen lymph node under right armpit; Tender lymph node under right armpit/tenderness has extended into under right arm area; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the right arm on 14Apr2021 at 16:00 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant past medical history. The patient had no known allergies to medications, food or other products. The patient did not take any other medication within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 23Apr2021 at 09:30, 9 days after first dose. the patient experienced swollen and tender lymph node under right armpit (injection site was right arm) and noticed tenderness. On 25Apr2021, the tenderness had extended into under right arm area. The adverse event resulted in emergency room or department or urgent care. No therapeutic measures were taken as a result of the adverse events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event swollen lymph node under right armpit and tender lymph node under right armpit/tenderness has extended into under right arm area were not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Slight headache and moderate arm pain ;  both arm pain and headache gone by next morning; this is for reporting purposes only; no care needed; all side effects abated in a reasonable time period.
24hr p/vax pt arm was reddened & swollen (55 x 40mm);
Information has been received from a physician indicating that the office received 10 packs of hepatitis A virus vaccine inactivated (Lot #647587/0966N), and 2 bottles were broken. One vial neck was broken and the vial completely shattered, and a second vial neck/top was broken off. A nurse in the office cut her finger on the broken bottle, and it bled. Unspecified medical attention was sought. A product quality complaint was filed. Additional information has been requested.
I CONTACTED THE PATIENT TODAY AND SHE INFORMED ME OF HER ADVERSE REACTION.  SHE REPORTED THAT ON 01/12/21 10 MINUTES AFTER MODERNA ADMINISTRATION PATIENT WENT TO HER VEHICLE AND SPOKE WITH SPOUSE OUTSIDE OUR PARKING LOT.  SHE STATED SHE BEGAN TO FEEL THROAT TIGHTENING UP AND UNABLE TO SWALLOW SHE DROVE HERSELF TO PHARMACY AND TOOK BENADRYL. AND SYMPTOMS IMPROVED.
Information has been received from a physician referring to a 15 year old female patient. On 23-NOV-2015 the patient was inadvertently received a dose of GARDASIL 9 (dose, strength and route unknown, once, lot#: K026247, expiration date: January 2017) instead of GARDASIL. No adverse effects were reported. Additional information has been received.
2 days after 2nd shot, left side of neck swelled, lymph nodes in that area also swollen and hard.  Neck is still swollen as of today may 24, over a month later. I have a tingling sensation though out the day. It started going up my neck. The tingling now goes up my neck, into my left arm and down into my chest.
Slight soreness in left arm at injection site. No OTC treatment taken and soreness is minor and manageable.
developed cold sores and runny nose the next morning (9/30/23),  developed nasal congestion and puffy eyes  Sunday 10/1/23 evening/Monday 10/2/23 morning.
elevated BP for 24 hours; pain in the ear; low grade fever; chills; pain in the joints; sharp shooting pain in the crown of the head; This is a spontaneous report from a non-contactable consumer, the patient. A 58-year-old female patient received unknown dose of BNT162B2 (Pfizer -BioNTech Covid-19 mRNA Vaccine, lot number: EL3247), via an unspecified route of administration on 15Mar2021 (at the age of 58-years-old), as a single dose for COVID-19 immunisation . Medical history included hypothyroidism and autoimmune disease. Concomitant medications were not provided. Prior to 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 have allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 16Mar2021, the patient experienced low grade fever, chills, pain in the joints, ear, sharp shooting pain in the crown of the head and elevated BP for 24 hours. No therapeutic measures were taken for the events. The clinical outcome of the low grade fever, chills, pain in the joints, ear, sharp shooting pain in the crown of the head was recovering and for elevated BP for 24 hours it was recovered on 17Mar2021.   Information about lot/batch number cannot be obtained. No further information is expected.
This case was reported by a healthcare professional and described the occurrence of rash in a 47-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline). There were no concurrent medications. On 4 August 2008 at 13:30 the subject received 2nd dose of ENGERIX B in the left arm. On 4 August 2008, at an unspecified time after vaccination with ENGERIX B, the subject experienced rash and fever. A systemic reaction. The healthcare professional considered the events were clinically significant (or requiring intervention). The subject was treated with BENADRYL. At the time of reporting the events were unresolved.
Sore arm at injection site along with facial and swelling on the right side. Patient also reports headache and joint aches and pain.