chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a registered nurse refers to a 4 month old patient. On 28-AUG-2013 the patient was vaccinated with the first dose of ROTATEQ, suspension 2, (lot#, expiration date and route unspecified). On 28-OCT-2013 the patient was vaccinated with improperly stored of ROTATEQ, suspension 2, (lot# J007283, expiration date 27-SEP-2014 and dose unspecified). No adverse event reported. This is one of several reports received from same source. Additional information is not expected.
whole body was aching (after dose 1); injection site was very painful (after dose 1); This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (whole body was aching (after dose 1)) and VACCINATION SITE PAIN (injection site was very painful (after dose 1)) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027L20A, 031M20A and 034F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MYALGIA (whole body was aching (after dose 1)) and VACCINATION SITE PAIN (injection site was very painful (after dose 1)). At the time of the report, MYALGIA (whole body was aching (after dose 1)) and VACCINATION SITE PAIN (injection site was very painful (after dose 1)) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medication were reported. No treatment information was provided by the reporter.   This case was linked to MOD-2021-377214, MOD-2021-377195.
This spontaneous report as received from a pharmacy technician refers to a 4-year-old patient of unknown gender. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant medications were not reported. On 07-FEB-2018 the patient was vaccinated with improperly stored dose of VARIVAX (lot # N022979, expiry date: 23-AUG-2019) (dose, frequency and route were not reported) for prophylaxis. No adverse effect was reported. The VARIVAX temperature excursion occurred on 14-DEC-2017 and 30-DEC-2017. On 14-DEC-2017, the vaccine was exposed to the temperature of 16.9 degree Fahrenheit (F) for 30 minutes. On 30-DEC-2017, the vaccine was exposed to the temperature of 6 degree Fahrenheit (F) to 14 degree F for 30 minutes. It was reported that the event was because of data logger. No product quality complaint was involved. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1802USA001558:
2 days after menactra vaccine, pt noted to have weakness and numbness of upper arms, which progressed to involve lower extremities with weakness and numbness, also noted to have difficulty walking, and difficulty holding up his arms.  No respiratory difficulties.  On followup the next day, child feeling better, with no weakness and numbness
On 3-1, 2022, I noticed a great elevation in blood sugar. I could not control the blood sugar so I reached out to the doctors office and the doctor said I needed to reach out to the Pharmacy Specialist. I spoke with her on 3-1, 2022 and told her of my blood sugar spiking. She told me to increase my insulin dosages. We kept having to steadily increase my insulin doses. In early June, 2022 I started noticing my blood sugar levels were becoming more normal and adjusted as needed. I am now doing better.
Breakthrough case admission after 2 vaccines  Pfizer 1/15/21 lot# EL0140;  Pfizer 2/5/21 lot# EM9810
This is a spontaneous report from a contactable consumer, based on information received by the regulatory authority (manufacturer control no: 20210831000373) for an unknown patient. A patient, of unspecified age and gender, received the 3rd (booster) dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection, batch/lot# not reported), via an unspecified route of administration, on an unspecified date, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. Historical vaccine included the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection, batch/lot# unknown), via an unspecified route of administration, single dose; and second dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection, batch/lot# unknown), via an unspecified route of administration, single dose, for COVID-19 immunization for COVID-19 immunization. The patient had off-label use of dose 3 booster vaccine. The patient had a headache after the first day and swollen lymph nodes. The outcome of events unknown. No follow-up attempts needed. Information about lot/batch number cannot be obtained. No further information expected.
Child presented with 5 cm circle at site of injection. Best description is a hive. Treated with Benadryl and cool compresses.
Patient had received 2  Pfizer COVID19 primary series  vaccines and was given a Moderna COVID 19 vaccine as the booster dose.
Headache began immediately after vaccine administration, B/P 180/118, Denies chest pain, SOB, pruritus, rash, blurred vision, recommended transport by EMS but patient declined
Severe body aches, no taste, has made eczema flair up, lack of energy. Tylenol makes the  aches better. Started day after shot, still continuing to date.
This initial spontaneous case, was received from other health professional (nurse) on 27-Sep-2017, concerning a 56-year-old adult male patient. The patient's medical history and concomitant medications were not reported. On 19-Sep-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml, batch number: 00444611A, expiry date: Jun-2018, route of administration: intramuscular, anatomical location: deltoid). On the same day, after 12 hours of vaccination, the patient developed rash all over the body. No treatment was taken by the patient for the event. It was assumed that, there were no further issues with the patient. At the time of this report, the outcome of the event was not reported. The reporter assessed the event as non-serious and considered the causality of the event as related. Follow up received on 07-Nov-2017: The route of administration (intramuscular) and anatomical location (deltoid) of the vaccine were updated. It was assumed that, there were no further issues with the patient. The narrative was amended accordingly.
Hoarseness, paleness, weakness, dizziness, diarrhea. These symptoms are ongoing. Mom states will take child to physician.
SHORTNESS OF BREATH; ABDOMINAL PAIN; LEG PAIN; HIGH TEMPERATURE; HEADACHE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced shortness of breath, abdominal pain, leg pain, high temperature, and headache. Laboratory data (dates unspecified) included Body temperature (NR: not provided) high. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the high temperature, headache, abdominal pain, leg pain and shortness of breath was not reported. This report was non-serious.
Severe back ache and groin. Like a kidney infection. Hard to move without experiencing pain. This is not a small amount of pain either! Also had a headache first!
Soreness at injection site; Body aches; General fatigue; Most recent dose details product=COVID 19, other vaccine same date product=Influenza Quad Valent; Most recent dose details product=COVID 19, other vaccine same date product=Influenza Quad Valent; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 48 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 01Dec2021 11:30 (Lot number: FH8030) at the age of 48 years as dose 1, single for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), administered in arm right, administration date 01Dec2021 (Batch/Lot number: unknown) as dose 1, single for immunisation. Relevant medical history included: "Insomnia" (unspecified if ongoing). Concomitant medication(s) included: LUNESTA; IBUPROFEN; TRUVADA. The following information was reported: OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 01Dec2021, outcome "unknown" and all described as "Most recent dose details product=COVID 19, other vaccine same date product=Influenza Quad Valent"; VACCINATION SITE PAIN (non-serious) with onset 01Dec2021 19:00, outcome "not recovered", described as "Soreness at injection site"; PAIN (non-serious) with onset 01Dec2021 19:00, outcome "not recovered", described as "Body aches"; FATIGUE (non-serious) with onset 01Dec2021 19:00, outcome "not recovered", described as "General fatigue". The action taken for influenza vaccine was unknown. Therapeutic measures were taken as a result of vaccination site pain, pain, fatigue.  Additional Information: The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to COVID vaccine. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of vaccination site pain, pain and fatigue which included treatment with ADVIL. Since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
tight chest/dry or tight chest a week after receiving the 1st dose; low grade fever; body ache; chills; headaches; exhaustion and insomnia at the same time; exhaustion and insomnia at the same time; This is a spontaneous report from a contactable consumer.   This female consumer (patient) of unspecified age reported for herself that she received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: UNKNOWN) via an unspecified route of administration on 03Apr2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 10Apr2021, the patient experienced tight chest/dry or tight chest a week after receiving the 1st dose, low grade fever, body ache, chills, headaches, exhaustion and insomnia at the same time. It was great. She had no repercussions. On 10Apr2021, she had a low-grade fever, body ache, chills, headaches, exhaustion and insomnia at the same time and tight chest. It was a week later/after she got the vaccine. Her husband (age: 65) received the Pfizer vaccine, had it 2 weeks before. His side effects were within the first 3 days which was normal. When she got her shot and did not feel anything for a week. then wham, he was sleeping on his. He was tired. He had low grade fever and chills for 5 days. Mine was later. Her dad (age 94) also received the Pfizer vaccine. He did not have any side effects and he did not even feel the needle and 2nd shot (he got on the 10th) he felt the shot this time. So far so good. He was feeling great. She wants to know if it was normal to experience fever, headache, insomnia and dry or tight chest a week after receiving the 1st dose. She received the 1st dose last 03Apr2021 and 2nd dose will be on 24Apr2021. Provided contact number and hours of operation. Unaddressed medical questions referred or forwarded to Medical Information. Outcome was unknown for all the events.  Follow-up (12Apr2021): This is a follow-up spontaneous report from a contactable consumer reported verbatim and event description.  No follow up attempts are possible. Information about lot/batch number cannot be requested. No further information is expected.
C/o Dizziness. Patient noted to be leaning toward floor to pick up water from  floor. Patient V/S assessed. She is very alert, oriented x4/ V'S 117/67 P62 T98 R18 PO2 99% on room air.  Patient's parents were contacted as per request by patient. Once patient's parents arrived at site, nurse escorted patient out of facility. Ambulating with no difficulty. No  fatigue noted.
Pfizer/BioNTech COVID 19 vaccine EUA C/O "heart coming out of chest", itching, and hot feeling approximately 10-15 minutes after injection. She took 25mg Benadryl PO one hour before vaccine. Was given 25 mg oral Benadryl at 1410. HR and blood pressure returned to normal and pt was released within 20  minutes of reaction.
This spontaneous report as from an other via social media who obtained the information from a campaign against the HPV vaccine and released a video, who reported that a 20 year old female patient prior to receiving GARDASIL was healthy, vibrant and fun-loving. It was reported that the patient's physician gave her all the right reasons to receive GARDASOL. On an unknown date, was vaccinated with a dose of GARDASIL (dose and route not reported). Prior to receiving GARDASIL there was no mention of GARDASIL side effects. On an unspecified date, the patient began fainting and days later was found dead in bed. It was reported that it was no coincidence that the patient died after receiving GARDASIL. This is one of several reports received from the same source. No further information is available.
Information has been received from a registered nurse concerning an 18 year old female with no medical history and no known allergies who on 21-DEC-2007 was vaccinated intramuscularly with a 0.5 mL first dose of Gardasil (Lot #659441/1446U). There was no concomitant medication. On 23-DEC-2007 the patient's mother called the nurse practitioner and reported that her daughter woke up that morning with pain over her left eye and nausea. No laboratory diagnostic studies were performed. On 27-DEC-2007, the patient's mother called again and stated that the symptoms had resolved. No product quality complaint was involved. Additional information has been requested. 02/12/2010 Follow up information from the registred nurse indicated that the patient had received a second dose of GARDASIL on 10-MAR-2008 and experienced no adverse symptoms. No product quality compliant was involved.  Additonal information has been requested.
Received vaccine on 9/29/2021, next day experienced pain in arm, not able to lift arm. Contacted primary care physician on 10/2/21 patient stated at this point arm was burning so bad they could not handle it. Nurse recommended continued care at home to include deltoid raises and compresses. Pain continued, patient was seen by primary care on 10/23 and was diagnosed with SIRVA.
Confusion, shock as in not being able to move around much or lack of interest, hard to breath.
I got Shingles 10 Days after my 2nd Booster Shot. Now I'm diagnosed  with PHN.
Patient was recently hospitalized for acute respiratory failure, diagnosed with COVID, was noted ot have abdominal distention
Vaccine at 8:30am in the morning.  Around 4 pm started feel warm, weakness.  Took Tylenol 1000 mg.  Helped a little bit.  Today still having bodyache and chills.
Thyroiditis with throat and neck pain.  9/3/21 - First dose of Moderna COVID-19 vaccine 10/1/21 - Second dose of Moderna COVID-19 vaccine Beginning spring of 2022 I began feeling pain and discomfort on the lower right side of my neck.  During my annual well visit to my primary care physician in July of 2022, he noticed my thyroid seemed to be enlarged and set upon the diagnostic course of action described in detail below in Item 19.
constant dizziness and headache; pain and stiffness in arms, shoulders, and neck; occasional numbness in both arms; tightness in the chest, brain fog
Rash; This case was reported by a consumer via interactive digital media and described the occurrence of rash in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was not recovered/not resolved.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were provided as follows: The age at the vacination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received Shingix and had rash. The reporter asked how long did rash last.
This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient Received vaccine beyond Expiry date) and PRODUCT STORAGE ERROR (Exp. date Vaccines went into 2-8 C thaw state on or about 20-Dec-2021) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination. No Medical History information was reported. On 17-Feb-2022 at 7:30 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 17-Feb-2022 at 7:30 PM, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient Received vaccine beyond Expiry  date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Exp. date Vaccines went into 2-8 C thaw state on or about 20-Dec-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient Received vaccine beyond Expiry date) and PRODUCT STORAGE ERROR (Exp. date Vaccines went into 2-8 C thaw state on or about 20-Dec-2021) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No Concomitant product use was reported. The patient received vaccine past its 30 day expiry date. The vaccine went into 2-8 degree Celsius thaw state on or about 20-DEC-2021. The vaccine was administered up until it manufactured expiry date of 04-Apr-2022. The patient received booster dose. No treatment information was provided.
body ache; This is a spontaneous report from a contactable consumer or non-Health Care Professional. A patient of unspecified age and gender received bnt162b2 PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiry date: Unknown), dose 1 via an unspecified route of administration on 01May2021 as 1ST DOSE, SINGLE DOSE for covid-19 immunization. The patient medical history was not reported.The patient's concomitant medications were not reported. Patient took Second dose of bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot number was not reported on 22May2021 for covid-19 immunization. The reporter stated, the patient first shot was on 01May2021 and patient did not have any symptoms, mean just body ache but that was all. The first shot did not gave me any problem. The outcome of event body ache was unknown.  Information about lot/batch number has been requested.
Patient experienced a red lump at injection site and itching all over body.  Patient was advised to take benadryl.
This case was reported by a consumer via call center representative and described the occurrence of fever in a female patient who received SHINGRIX for prophylaxis. On 29th June 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 29th June 2018, less than a day after receiving SHINGRIX, the patient experienced fever, injection site erythema, injection site swelling, injection site warmth and injection site induration. The patient was treated with ibuprofen. On 30th June 2018, the outcome of the fever was recovered/resolved. On an unknown date, the outcome of the injection site erythema, injection site swelling, injection site warmth and injection site induration were recovering/resolving. The reporter considered the fever, injection site erythema, injection site swelling, injection site warmth and injection site induration to be related to SHINGRIX. Additional details were provided as follows: This case was previously reported to a doctor. The patient's date of birth was not obtained. The age at vaccination was not reported. The patient received SHINGRIX vaccine on an unknown arm. The reporter was the patient who experienced fever that resolved the next day and also had injection site reaction that included redness, swollen area approximately 3 inches across the arm that was hard and warm to the touch. The patient reported that her doctor advised to take Ibuprofen to help with that. The patient had denied permission to contact their physician.
Later on the night, my arm was sore. I was very fatigue to the point that my body had elephant trunk arms. I had bad headache. I felt like I was hit by a bus. I had a tingle on my left side. I was so cold to a point that I was shaking. These symptoms lasted for about 72 hours. I have a slight cough that is continuing. I had SOB breath and neck pain that developed 2 to 3 months later.
Status epilepticus requiring intubation and ICU admission, as well as antiepileptics to stop seizure activity.
came back to clinic & showed lt deltoid area swollen w/tenderness & warmth;states was sick during NOC & was unable to sleep w/fever & nauseous feeling, chills & h/a
Headache; Fever; Vomiting; This is a spontaneous report from a non-contactable consumer, the patient. A 21-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206), via an unspecified route of administration in the left arm on 13Mar2021 at 14:45 as a second dose, single for COVID-19 immunization. The patient's medical history was not reported. It was not known whether the patient was diagnosed with COVID-19 prior to vaccination. It was reported that the patient was not pregnant at the time of vaccination. The patient did not have any allergies to medications, food, or other products. The patient's past drug history included BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW6200), via an unspecified route of administration in the left arm on 19Feb2021 at 09:45 as a first dose, single for COVID-19 immunization. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. The patient has not tested for COVID-19 since having the vaccine. The patient's concomitant medications taken within two weeks of vaccination included Tylenol (MANUFACTURER UNKNOWN), Advil (MANUFACTURER UNKNOWN), Sambucus (MANUFACTURER UNKNOWN) all from and to an unknown date and for an unknown indication. On 14Mar2021 at 01:00 (as reported), the patient experienced fever, body temperature reported as of 105.7 (unspecified unit), vomiting and headache. Therapeutic measures were not taken for the events (fever, vomiting and headache). The clinical outcome of the events fever, vomiting and headache were not recovered. No follow-up attempts are needed. No further information is expected.
Horrible chills, pain all-over my body, terrible headache.  Arm so sore  I could barely raise it. I felt like I was going  to die.  I did not have anything  like this with the first two Phizer shots. Today (day after shot) I am better after 3  tylenol.
On way home from flu clinic, patient experienced pain in left leg. After arriving home pt had episode of shaking, felt cold, perhaps fever. The next day she slept most of day. Did not seek medical tx or take temp. The following day she was back to normal.