chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from an investigator concerning a 21 month old male child who received his 1st dose of Prevnar on 12/8/00 and later that day, the child was taken to a local ER with urticaria and angioedema. The child has since recovered. Angioedema was considered a "Medically Important Event". Both the investigator and the medical monitor agree that these events were 'probably' related to vaccine administration. Follow up information received on 03/09/2001 clarified that the patient did not experience angioedema as previously reported. The patient experienced urticaria only. Therefore, this report has been downgraded to non-serious.
Jaw pain on left side behind ear.  Hard to chew and tender  to the touch.
This case was reported by a healthcare professional, who was also the vaccination subject, that described the occurrence of arm soreness in an adult female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). On 20 October 2007, the subject received an unspecified dose of FLULAVAL (unknown, left deltoid). On 20 October 2007, less than one day after vaccination with FLULAVAL, the subject experienced arm soreness and arm weakness. The reporting healthcare professional/subject reported that she has experienced left arm soreness and weakness since receiving the FLULAVAL vaccine. At the time of reporting the events were unresolved.
Patient developed chicken pox (diagnosed by MD) on 04/23/07.  She was given Varicella vaccine  on 6-22-01,, The MD prsecribed Acylovir and Cephalex to treat the chickenpox.
Patient contracted COVID after being fully vaccinated.  No boosters Shortness of breath, cough, congestion.
Certain stuff has been tasting nasty; smells funny/ smelling nasty; This spontaneous case was reported by a consumer and describes the occurrence of TASTE DISORDER (Certain stuff has been tasting nasty) and PAROSMIA (smells funny/ smelling nasty) in an 18-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0HF21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Oct-2021, the patient experienced TASTE DISORDER (Certain stuff has been tasting nasty) and PAROSMIA (smells funny/ smelling nasty). At the time of the report, TASTE DISORDER (Certain stuff has been tasting nasty) and PAROSMIA (smells funny/ smelling nasty) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided. Treatment information was not provided.  She went to chipotle and chick-fil-a which both were unappetizing to her.
Pfizer Covid 19 EUA Pt reported arm heavyness and sore throat. Pt self medicated benadryl then alert staff. Monitered times one hour and reported no worsening of symptoms.
This case was reported by a consumer and described the occurrence of facial muscle weakness in a 39-year-old female subject who was vaccinated with Havrix for prophylaxis. A physician or other health care professional has not verified this report. Concurrent medications included DTP vaccine given the same day as Havrix. On 19 October 2007 at 12:00 the subject received 1st dose of Havrix (unknown, left arm) because she was traveling abroad. On 26 October 2007, 7 days after vaccination with Havrix, the subject experienced muscle weakness, loose skin, eye irritation, eye redness, eyes oozing and weight loss. This case was assessed as medically serious. At the time of reporting the events were unresolved.
Site of injection is itching; Site of injection has red mark; pain on the site of injection; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE PAIN (pain on the site of injection), VACCINATION SITE PRURITUS (Site of injection is itching) and VACCINATION SITE ERYTHEMA (Site of injection has red mark) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced VACCINATION SITE PAIN (pain on the site of injection). On 25-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Site of injection is itching) and VACCINATION SITE ERYTHEMA (Site of injection has red mark). On 21-Feb-2021, VACCINATION SITE PAIN (pain on the site of injection) had resolved. At the time of the report, VACCINATION SITE PRURITUS (Site of injection is itching) and VACCINATION SITE ERYTHEMA (Site of injection has red mark) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication details was reported. No treatment medication details was reported.
Psoriasis,; TMJ; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 25-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25Oct2021 at 16:00 as dose 2, single (Batch/Lot number: unknown) at the age of 25 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Location of injection: Arm Right, Vaccine Administration Time: 03:00 PM), administration date: 04Oct2021, when the patient was 25-year-old, for Covid-19 immunization. The following information was reported: PSORIASIS (non-serious) with onset 03Dec2021 at 08:00, outcome "not recovered", described as "Psoriasis,"; TEMPOROMANDIBULAR JOINT SYNDROME (non-serious) with onset 03Dec2021 at 08:00, outcome "not recovered", described as "TMJ". The events "psoriasis," and "tmj" required physician office visit and emergency room visit. Therapeutic measures were taken as a result of psoriasis, temporomandibular joint syndrome. Additional information: The patient was administered the most recent COVID-19 vaccine at Pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID. Since the vaccination, the patient tested for COVID-19 was Unknown. The patient received Medication as a Ae treatment. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
No additional AE/PQC reported.; temperature excursion / the vaccines were administered after the excursion; This spontaneous report was received from an office manager and refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history, allergies, drug reactions were not provided. The patient's concomitant therapies included sterile diluent.  On 02-NOV-2021, the patient was vaccinated with an improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin) (PROQUAD) in dose 0.5 ml, (lot # U017140, verified as valid with expiration date 28-NOV-2022, albumin status: rHa) (dose number, route of administration and anatomical location were not reported) for prophylaxis (product storage error). The temperature to which the vaccine was exposed was 6 Fahrenheit degrees up to 14 Fahrenheit degrees and the time frame was reported as 4 hours and 14 Fahrenheit degrees up to 46 Fahrenheit degrees for 4 hours and 45 minutes. No previous temperature excursions were reported. No additional adverse event was reported (No adverse event). It was unknown if a digital data logger was involved.  This is one of several cases received from the same reporter.; Sender's Comments:  US-009507513-2203USA001850: US-009507513-2203USA007379: US-009507513-2203USA001841: US-009507513-2203USA001716: US-009507513-2203USA001578: US-009507513-2203USA001612: US-009507513-2203USA001617: US-009507513-2203USA001688: US-009507513-2203USA001890:
Patient received ZOSTAVAX and FLUVIRIN vaccines and developed severe blistering the next day on her arms. The pustules were extremely inflamed and eventually drained and healed within a week.
Pt developed chills, low grade temp next afternoon. Injection site warm to touch, large, red area over (R) tricep tender to touch superomed to rash, itchy large hive.
Eczematous rash, most likely atopic eczema. Developed about 3 months after 4th injection in primary anthrax vaccine absorbed vaccination series. Exacerbation after 5th injection in 1/03.
dizziness; lightheadedness; left arm is swollen; lymph nodes are swollen; severe pain in armpit; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), DIZZINESS (lightheadedness), SWELLING (left arm is swollen), LYMPHADENOPATHY (lymph nodes are swollen) and AXILLARY PAIN (severe pain in armpit) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, the patient experienced DIZZINESS (dizziness), DIZZINESS (lightheadedness), SWELLING (left arm is swollen), LYMPHADENOPATHY (lymph nodes are swollen) and AXILLARY PAIN (severe pain in armpit). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, DIZZINESS (dizziness), DIZZINESS (lightheadedness), SWELLING (left arm is swollen), LYMPHADENOPATHY (lymph nodes are swollen) and AXILLARY PAIN (severe pain in armpit) 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.   Concomitant medication include birth control  medication.    Most recent FOLLOW-UP information incorporated above includes: On 30-Mar-2021: TCR Updated
patient reported severe pain two days after injection.  patient cannot lift arm above shoulder level.  patient currently using OTC ibuprofen and ice on the area.  She reports that the pain is somewhat lessened since it began but is still very severe.
Pfizer on 4/3 and 5/1. Postive on 11/10
Developed Chicken Pox, mild case.  Taking Benadryl and using Calamine lotion.
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Physician). The reporter is the patient.  A 60-year-old male patient received BNT162b2 (BNT162B2), in Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 60 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Autoimmune disorder" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of covid-19, drug ineffective. Clinical significance: Covid rebound. Tested poistive, and took 5 days of paxlovid BID, tested negative following return of symptoms and tested positive on day 11.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events drug ineffective and covid-19 and BNT162B2.
This spontaneous report was received from a physician via company representatives referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 15-OCT-2014, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 0.5 mL (Vls 10 SDV) (Lot # K007822, expiration date 15-AUG-2015) single dose, route and anatomical location were not provided. There was no concomitant medication provided. No adverse effects were reported. On an unknown date, the PNEUMOVAX had a temperature excursion for 360 hours, the lowest recorded temperature was 20 degrees F (-6.667 Celsius). The vaccine status was reported as "in excursion", the storage criteria and the vaccine excursion were reported as "Refrigerator (R)". There was no product quality complaint involved. This is one of several cases received from the same reporter. Additional information has been requested.
This spontaneous report as received from a healthcare worker refers to a 66 year old female patient. The patient's medical history included hypothyroidism. There was no drug reaction or allergies. In 2000, the patient was vaccinated with PNEUMOVAX23 (lot#, dose and route not reported) with no adverse events. On 01-MAR-2013, the patient was vaccinated intramuscularly with a 0.5 ml dose of PNEUMOVAX23 (lot# H013399; exp. date: 07-MAR-2014). Concomitant therapy included levothyroxine sodium and tetanus toxoid immunization. On 01-MAR-2013, the patient experienced headache, heart palpitations and redness, warmth, and tenderness of her hip at the injection site. The patient sought medical attention; she sent an e-mail to the office. The patient was treated with ice to injection site. At the time of the report the patient was recovering from the events. The relatedness of the events with the PNEUMOVAX23 was not provided. Additional information has been requested.
Could not breath well; Body ache; Fever; Headache; bee sting bite like on both legs and back; Skin is very dry; This spontaneous case was reported by a patient and describes the occurrence of DYSPNOEA (Could not breath well), PAIN (bee sting bite like on both legs and back), DRY SKIN (Skin is very dry), MYALGIA (Body ache) and PYREXIA (Fever) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included CLONIDINE, LOSARTAN and HYDROCHLOROTHIAZIDE (HYDROCHLORTHIAZID) for an unknown indication.   On 28-Apr-2021 at 12:00 PM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, the patient experienced PAIN (bee sting bite like on both legs and back) and DRY SKIN (Skin is very dry). On 28-Apr-2021 at 11:30 AM, the patient experienced DYSPNOEA (Could not breath well), MYALGIA (Body ache), PYREXIA (Fever) and HEADACHE (Headache). At the time of the report, DYSPNOEA (Could not breath well), PAIN (bee sting bite like on both legs and back), DRY SKIN (Skin is very dry), PYREXIA (Fever) and HEADACHE (Headache) outcome was unknown.            Concomitant medication was not reported.  Action taken with mRNA-1273 in response to the event was Not Applicable   It was reported that the patient took 1st dose a month before
This spontaneous report as received from an unspecified other health professional refers to a patient of unknown age and gender. On 21-FEB-2013 the patient was vaccinated with ZOSTAVAX lot # 1601AA. The route of administration and anatomical location was not provided. The expiry date of the ZOSTAVAX was 13-JAN-2013, while it was administered on 21-FEB-2013. No adverse symptoms were reported. Additional information has been requested.
Rash observed in patient's arm after administering Flu vaccine. Patient complained of pruritus.
Nausea, dizziness, lightheadedness - worst in the morning, lasting over an hour.  Nothing helped it or changed it.
INJECTION SITE PAIN, FEVER, MYALGIA, MALAISE Narrative: MISSED ONE DAY OF WORK 1/27/21 BUT RETURNED TO WORK 1/28/21- "FEELING FINE" EXCEPT ARM STILL SORE
The shot site was swollen for two days after the injection.  I had nausea, dizziness, and tiredness.  Three days after the injection (today), I had shakiness, extreme fatigue  and felt like I was going to pass out.
Cough; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Cough) 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 COUGH (Cough). At the time of the report, COUGH (Cough) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medication were reported. No treatment medication were reported.
Pain and swelling at site size of grapefruit with small red induration , headache, body aches, nausea
Smelling intense cigarette smoke when no-one is smoking for  About week or so and continuing now as of June 13, 2021
1st dose July31, also had shingles this year; It's been seven months since my first shot; This case was reported by a consumer via call center representative and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had shingles in March of unspecified year).   On 31st July 2021, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 9 months after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced shingles and incomplete course of vaccination. On an unknown date, the outcome of the shingles and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The patient self-reported the case. The age at vaccination was not reported for the 1st dose and the age at vaccination was not applicable for 2nd dose of Shingrix. After receiving 1st dose of Shingrix, the patient had shingles in the year of reporting. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete vaccination schedule. The patient asked if he/she could take the 2nd shot now or needed to start over. No contact Information was given by the patient. Note- As follow up is not possible and the patient mentioned he/she had shingles this year (year of reporting), shingles was coded as event for 1st dose.
Patient with history of oral allergy syndrome presenting to COVID vaccine medical after throat tinging 15 min after 2nd Pfizer vaccine.  No objective signs of anaphylaxis.  Patient was given 25mg of PO Benadryl at 1040 and monitored for 1 hour, with normal vital signs throughout and improved symptoms.  Patient released and counseled on red flags symptoms that would warrant evaluation in the Emergency Room
This spontaneous report has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. No information was provided regarding the patients' medical history, concurrent conditions, drug, allergy history or concomitant medications. On an unknown date, the patients were vaccinated with improperly stored doses of VAQTA (dose, strength and route of administration were not provided) lot # M017982, expiration date 13-SEP-2017, for prophylaxis. No adverse effects were reported. The doses of VAQTA were exposed to a temperature excursion of 32°Fahrenheit (°F) to 35°C (32.4F) during a time frame of 16 hours, which was not detected by the data logger. There was a previous temperature excursion reported.
Administered additional bivalent booster to immunocompromised patient who is not over 65.
Site: Pain at Injection Site-Severe, Systemic: Numbness (specify: facial area, extremities)-Severe, Error: Shoulder Joint Injury (prolonged pain, tingling, etc.), Additional Details: Numbness at site of injection causing imobility
A report was received from a health care professional on 12/17/03 concerning a 7 year old male vaccinee who inadvertently received a sub-optimal dose of Fluvirin on 12/15/03. On 12/15/03 a vaccinee inadvertently received a dose of 0.25ml of Fluvirin. No adverse events had occurred as a result at the time of this report. There was insufficient information to determine the reporter's causality assessment. Update 3/15/04: Further information was received from a health care professional indicating that the vaccinee did not experience any adverse reaction. The vaccinee did not contract influenza and he later received the full dosage of Fluvirin in mid January. No follow up pending. All information received.
At area surrounding injection site (L) deltoid. Pt reports a "red, flat, blotchy rash". Four to five "lesions" in this area that are very tender. These are all approximately nickel-sized. Generalized malaise as well.
Shortly after receiving 2nd vaccine, developed 2nd superficial blood clot in right leg. Also developed blood clot after receiving 1st vaccine but not sure if the vaccine had anything to do with it or not. Just seems awfully coincidental. Hasn?t had any clots since 2008 until this year.
patient was given diluent only and not the active portion of the vaccine. medication was not mixed.
The patient received a Moderna booster dose of 0.25mL. She is only 14 years old and does not meet the age requirement for this booster dose. The patient's parents were notified. The patient does not display any adverse reactions or symptoms.
24 Hours after the shot I had a heavy feeling in the chest and felt like I really had to pull hard to breathe in, this continued to get worse and I had difficulty talking for extended times at work.  Thinking I was having allergy issues, I tried an albuterol nebulizer and that did not provide relief.  This continued for approximately 10-11 days, slowly getting better after 8 days.  On March 10 I went to my Pulmonologist (xray done, no fluid seen or heard) and on March 11, the Cardiologist. Both doctors believe I had an "immunogenic response"  to the vaccine.  I have since had a tight, clutching feeling around the heart when I start to exercise.  This continues daily and it is now April 21st.  I am fearful of the second shot so have decided to not get it.  I may wait for a booster, but I am very fearful of another vaccine.