chrisvoncsefalvay/vaers-outcomes huggingface dataset:
shingles; Subsequent to the ZOSTAVAX inoculation, the pt was treated by a physician at a healthcare center for shingles.; This initial spontaneous report was received from a lawyer regarding a case in litigation involving a female patient (pt) of unknown age. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date in 2012, the pt was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) (dosage regimen, route of administration, lot number and expiration date were not reported) at a hospital as prescribed and/or administered by a healthcare provider, for the long-term prevention of shingles and herpes Zoster related conditions. On an unknown date, subsequent to the zoster vaccine live (ZOSTAVAX) inoculation, the pt experienced shingles (herpes zoster). The pt was treated by a physician at a healthcare center (vaccination failure). It was reported that the pt would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; 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 include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of the herpes zoster and vaccination failure was not reported.   The reporter considered the herpes zoster and vaccination failure to be related to Zoster Vaccine Live (ZOSTAVAX).
pt recvd vax & w/in 10mins hands, ears, mouth, nose, eyes began to swell & rash;sxs inc to entire body;trouble breathing, throat closing;given Epi, Cortisone, DPH & transferred to ER-given Phenegran, monitored in ER 2hrs;sxs subsided
Three days post vaccine, the pain from the injection site worsened and migrated to the shoulder and persists to this day.
swollen lymph node under left arm causing pain; swollen lymph node under left arm causing pain; This is a spontaneous report from a contactable consumer reported for herself that a 51-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 51-years via an unspecified route of administration in left arm on 24Feb2021 at single dose for COVID-19 immunization. Medical history included high blood pressure; fibromyalgia; kidney stones. Patient had no allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included paracetamol (TYLENOL ARTHRITIS); enalapril; amlodipine; hydrochl (as reported). The patient historically received first single dose of BNT162B2 at the age of 51-years via an unspecified route of administration in left arm on 03Feb2021 03:00 PM for COVID-19 immunization. On 26Feb2021 06:00 AM, the patient experienced swollen lymph node under left arm causing pain. It was unknown if treatment was received for the adverse events. The events result in doctor or other healthcare professional office/clinic visit. Outcome of the events was not recovered. Since the vaccination, the patient has not been tested for COVID-19.   Information on the lot/batch number has been requested.
12/01/21 Dr. note: " 57 y.o. male with history as noted below who presents with syncope, cough, fever, chills, nausea and vomiting. He reports for the past week he has had productive cough with yellow phlegm, no blood, and generalized malaise, myalgias, subjective fever, chills, multiple episodes of NBNB emesis >4x daily. He denies loss of taste, smell, abdominal pain or diarrhea. He has been taking Tylenol and cough syrup as needed. While walking to the bathroom today, he felt weak and fell losing consciousness shortly, and hit the left side of his head. He endorses mild dull headache, and denies vision changes, shortness of breath, palpitations, chest pain. He received the Moderna Covid vaccine 3/15/2021 and 4/12/2021. He did not receive the flu shot this year. He denies sick contacts or recent travel history. He denies any medical history and does not take any medications. He had a cholecystectomy over 20 years ago. He denies smoking, alcohol and illicit drug use. Endorses family history of lung cancer in his father. He lives with his wife, does not use any assistive devices, and is full code.   In the ED, 101.6, hypoxic 89% on room air and placed on 6 L nasal cannula. COVID positive. WBC 11.4, Hb 12.5, Plt 134, Cr 1.00, electrolytes wnl, AST 38, ALT 27, ALP 52, procalcitonin 1.48, d-dimer 661, fibrinogen 584, CRP 17.2, LDH 430, CK 268, INR 1.3, IL-6 pending. EKG: NSR, possible left atrial enlargement and septal infarct undetermined age, HR 77, QTc 40. CXR: Mild peripheral infiltrates and peripheral opacities seen with atypical or viral pneumonia. S/p remdesivir, decadron, tylenol, ibuprofen, NS bolus."
FEVER (101.3 F), HEADACHE, MUSCLE PAIN, TIREDNESS, CHILLS, NAUSEA
After vaccine was given on 2/24 it was red and that went away in two days.  Now on 3/4 I woke up with itching, bright red, and hot to the touch.
On the Friday on the 5th, I went to coffee and on the way home it felt like my lip is swelling. I looked and noticed it swollen. It is still swollen as of today. I just sent a message to my doctor.  I have taken some allergy medication that I had and some Benadryl.
1 cm raised patch ~ 1cm above MMR injection site in right arm, occurred almost immediately after injection. Child observed for ~20min. Rash enlarged to 1.5cm, no spread to other area and no breathing problems. Diphenhydramine 5ml given.
Pt called 48 hours after DTaP administration with "Red, swollen and hot to touch at site." (R) arm. Pt went to ER 10/7/15 Dx: (1) Local reaction to vaccine. (2) Cellulitis that cannot be totally ruled out. Antibiotics given and BENADRYL. Sx resolved.
No adverse event; She stated her last booster dose was on 19Oct2022/drug exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a pharmacist and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (She stated her last booster dose was on 19Oct2022/drug exposure during pregnancy) and NO ADVERSE EVENT (No adverse event) in an adult female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 19-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) Booster dose. Last menstrual period and estimated date of delivery were not provided. On 19-Oct-2022, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (She stated her last booster dose was on 19Oct2022/drug exposure during pregnancy). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (She stated her last booster dose was on 19Oct2022/drug exposure during pregnancy) had resolved and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for MATERNAL EXPOSURE DURING PREGNANCY (She stated her last booster dose was on 19Oct2022/drug exposure during pregnancy).    Concomitant and treatment medications were not reported.  The patient did not have any medical history/conditions, allergy, concomitant diseases and risk factor including any previous COVID-19 diagnosis.  Company comment This spontaneous case concerns an adult female patient with no medical history reported, who received a booster dose of mRNA-1273.222 (BA.4/BA.5) vaccine and no adverse event was reported. Last menstrual period and estimated date of delivery were not provided. The outcome of pregnancy was not reported. There is no further clinical information provided for medical review. No adverse event was captured as not related following the SMP because there were no associated adverse events. The benefit-risk relationship of mRNA-1273.222 (BA.4/BA.5) vaccine is not affected by this report.   Reporter did not allow further contact
SUSPECTED COVID-19 INFECTION; REVACCINATION WITH DIFFERENT COVID-19 VACCINE; This spontaneous report received from a patient of unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: erythromycin allergy. The patient received covid-19 vaccine ad26.cov2.s (dose number in series: 1) (suspension for injection, route of admin not reported, batch number: 1802072 expiry: UNKNOWN) dose was not reported, 1 total administered to left arm on 10-MAR-2021 for covid-19 prophylaxis. No concomitant medications were reported. It was unknown whether patient had any adverse events following covid-19 vaccine ad26.cov2.s (dose number in series: 1). The patient received, Non-company suspect vaccine tozinameran (Pfizer Biontech covid-19 vaccine) (dose number in series: 2) (form of admin, route of admin were not reported, batch number: FH8030 and expiry: UNKNOWN) dose was not reported, administered to left arm on 24-NOV-2021 for covid-19 prophylaxis which was revaccination with different covid-19 vaccine (dose number in series 2). On an unspecified date of 2022, the patient had covid-19 symptoms which was Suspected covid-19 infection (dose number in series 2). The patient was treated with Paxlovid (form of admin, route of admin were not reported, batch number: Unknown and expiry: UNKNOWN) dose was not reported administered from 18-AUG-2022 to 22-AUG-2022 for treatment of covid-19. It was reported that patient symptoms had resolved after 5 days of Paxlovid. The patient continued to isolate/work from home. On 26-AUG-2022; 06:00 symptoms returned (Suspected covid-19 infection) (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s and tozinameran (Pfizer Biontech covid-19 vaccine) was not applicable, and treatment with Paxlovid was discontinued. The outcome of the revaccination with different covid-19 vaccine and suspected covid-19 infection was not reported. This report was non-serious.
On 11/25/22 I started feeling bad, my throat was hurting, the pain was unlike anything I have ever felt. After eight days I went to the local clinic. I had taken a home COVID-19 test that was negative, they test me for influenza that came back negative. Although the test came back negative, I was given a round of antibiotics to help me to get rid of what I had. The pain is gone, I still do not have as much energy as I normally do, I am still coughing. I do not feel like I have recovered, I am taking naps and I am unable to take my daily walks.
Two days after vaccine I started with pain in my jaw joint down my neck into both arms that lasted 2 minutes, then it came back in a couple hours and now it's still coming and going. It's more in my right arm and I cannot lift my arm when it's happening and it leaves me weak, trembling and in a cold sweat and sometimes I'm real hot. In February I went to the hospital and 4 doctors looked at me, I stayed there one day overnight .  I kind of think that I was given the whole vial of the vaccine and want to know how long will it take for it to wear off, I watched them draw up the vaccine and they gave me everything in the vial. I think I got the whole vial.
Migraine; Illness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (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: MIGRAINE (non-serious), outcome "unknown", described as "Migraine"; ILLNESS (non-serious), outcome "unknown", described as "Illness".  Customer Verbatim: I did two shots of your vaccine and right now I am with migraine. It is not possible to live with this illness.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Joint aches and pains, headache, fatigue, coldness in my hands and feet.  Symptoms lasted about 20 hours, with a bit of residual fatigue and odd feelings for about 1 more day.
12/24/2021: Event occurred after 2nd vaccine.   72-year-old female who comes to the ED for evaluation of weakness.  Patient admits to low-grade fevers, decreased appetite, short of breath, and weak. Denies any chest pain.  In ED, initially SPO2 92% on 4 L. Creatinine 2.02, positive for Covid.  CXR with pneumonia.  patient had to be placed on 9 L mid flow with SPO2 in the low to mid 90s.
Client was given his second dose of the Pfizer vaccine and 10 to 15 minutes following the injection the client c/o a headache an the left and right side of his head. He stated that he did not have an reaction to the first dose. he said that he thought it would just past but it didn't. So I took vitals immediately and asked if he had any pre-existing conditions to which he answered no. His vitals were normal and remained normal throughout the incident (144/92, 71, 20, 98% o2, 97.1. He denied any allergies. His breathing and safety was maintained throughout the event. He did say he had not eaten anything so we gave him some cracker and water. After 10-15 minutes he stated that he felt much better and the headache was just about gone. He denied any dizziness or nausea. I kept him for another 15 minutes and he answered all question appropriately and I had him stand and ambulate without incident. So I discharged him and advised him to follow-up with his doctor.  Retook vitals (136/88, 68, 18, 98% o2). He ambulated himself out of the clinic without incident.
This non-valid, spontaneous report was received from a registered nurse, referring to an unspecified number of patients of unknown age and gender. No information was provided regarding the patients' medical history, previous drug reactions, allergies, concurrent medical conditions or concomitant medications. On unknown dates, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB lot number N034005 (expiration date 31-JAN-2020) and lot number reported as "N021920" (expiration date 07-FEB-2020) for prophylaxis (doses, routes and anatomical locations of administration were not reported). Additionally, the patients were vaccinated with ROTATEQ by oral route, lot number N005078 (expiration dates 22-NOV-2018 and 04-OCT-2018) for prophylaxis (doses were unknown), GARDASIL 9 lot number N020352 (expiration date 10-APR-2020) for prophylaxis (doses, routes and anatomical locations of administration were not provided) and M-M-R II for prophylaxis (dose numbers, routes and anatomical locations of administration were not provided; lot numbers N010496 [expiration date 31-MAR-2019], N014485 [expiration date 10-MAY-2019], and N023149 [expiration date 24-AUG-2019]). The vaccines were reconstituted with sterile diluent which was reported to be properly stored. The doses of all vaccines were exposed to a temperature excursion below 32 degrees Fahrenheit (F) (also reported as 31F) during a time frame of 15 days, which was detected by the Digital Data Logger. There was no prior temperature excursion and no adverse effects were reported. Follow-up information was received from the nurse on 17-DEC-2018. The reporter provided patients' demographics which made the case valid. This report refers to a 12-year-old patient of unknown gender. On 11-JUN-2018 the patient was vaccinated with an improperly stored dose of GARDASIL 9 lot number N020352 (expiration date 10-APR-2020). This is one of multiple reports received from the same reporter.; Sender's Comments: US-009507513-1807USA011661:
Red rash on left breast like a hatch of 2 square inches; Rash is raised; Rash has white little pustules coming out across it; A little fatigue; Slight headache; Shingles; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (Red rash on left breast like a hatch of 2 square inches), RASH PAPULAR (Rash is raised), RASH PUSTULAR (Rash has white little pustules coming out across it), HERPES ZOSTER (Shingles) and FATIGUE (A little fatigue) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Sore back. Concomitant products included IBUPROFEN for Sore back.    On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, the patient experienced FATIGUE (A little fatigue) and HEADACHE (Slight headache). In April 2021, the patient experienced HERPES ZOSTER (Shingles). On 19-Apr-2021, the patient experienced RASH ERYTHEMATOUS (Red rash on left breast like a hatch of 2 square inches), RASH PAPULAR (Rash is raised) and RASH PUSTULAR (Rash has white little pustules coming out across it). The patient was treated with HYDROCORTISONE for Adverse event, at an unspecified dose and frequency. In May 2021, HERPES ZOSTER (Shingles) had resolved. At the time of the report, RASH ERYTHEMATOUS (Red rash on left breast like a hatch of 2 square inches), RASH PAPULAR (Rash is raised), RASH PUSTULAR (Rash has white little pustules coming out across it), FATIGUE (A little fatigue) and HEADACHE (Slight headache) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       This case was linked to MOD-2021-176879 (second dose case) (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 30-Jun-2021: Follow up received contain significant information added new event shingles and updated outcome of all the reported events from unknown to recovered.
Patient is under the age of 18 but they requested to get Moderna booster and that is what was administered to them. At this time they have not had any reactions to the dose.
On 02/14/2023, started having a thumping and jabbing pain in my left ear. On 02/21/2023 I got the Prevnar Pneumonia vaccination. Then on 02/27/2023 started getting occasional stabbing pain by left temple and thought it was a migraine. Noticed entire left side of face was sensitive to touch. Left eye felt like it had something in it and was uncomfortable. The next day felt an intense stabbing pain in my left ear. Left side of scalp was very sore in certain spots, with the area's constantly changing. At one point the pain did become steady and throbbing. Next day 3/1/2023 started to have a sore throat as well. Started to use warm compresses to help. By the next day 03/02/2023 I couldn't open my jaw wide enough to eat an apple. My head hurt when I turned my head to the left, and my ear hurt when I swallowed. On 03/03/2023 I took 2 EXCEDRIN and it helped. Went to my doctor on 03/06/2023 and was sent to have an MRI. Results were normal. My doctor recommended that I see a Neurologist if pain persisted. I've started feeling better after a week.
Injection site (left arm) red, firm and warm to the touch.  Per mom it started a day after injections, also stated it's first time it happens.
TENDER LUMP ON COLLAR BONE; TENDERNESS UNDER EAR TO UNDERNEATH SIDE OF BREAST; SWELLING; SORENESS AND JOINT PAIN; 5 TINY PIN SIZED BLISTERS ON CHEST AND TRUNK; SUN BURNED FEELING AT INJECTION SITE; SORE ARM; ARM MUSCLE SORENESS FROM INJECTION SITE TO SHOULDER JOINT TO MID ARM (ELBOW TO SHOULDER); WARM PAIN; This spontaneous report received from a patient concerned a 57 year old of unspecified sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 180502, and batch number: 180502 expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 11:20 for prophylactic vaccination. No concomitant medications were reported. On 10-MAR-2021, the subject experienced warm pain. On 10-MAR-2021, the subject experienced sun burned feeling at injection site. On 10-MAR-2021, the subject experienced sore arm. On 10-MAR-2021, the subject experienced arm muscle soreness from injection site to shoulder joint to mid arm (elbow to shoulder). On 11-MAR-2021, the subject experienced 5 tiny pin sized blisters on chest and trunk. On 12-MAR-2021, the subject experienced tender lump on collar bone. On 12-MAR-2021, the subject experienced tenderness under ear to underneath side of breast. On 12-MAR-2021, the subject experienced swelling. On 12-MAR-2021, the subject experienced soreness and joint pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from 5 tiny pin sized blisters on chest and trunk, was recovering from sore arm, tender lump on collar bone, soreness and joint pain, and swelling, and had not recovered from warm pain, tenderness under ear to underneath side of breast, sun burned feeling at injection site, and arm muscle soreness from injection site to shoulder joint to mid arm (elbow to shoulder). This report was non-serious.
Low-grade fever and intermittent headache beginning the day after receiving vaccine, and continuing for around two weeks. Was tested for Covid-19 twice, both negative.
Information has been received from a registered nurse concerning a patient who was vaccinated with a dose of pneumococcal vaccine 23 polyvalent. It was reported that the patient was previously vaccinated with pneumococcall vaccine 23 polyvalent. The patient subsequently developed a local reaction, fever, and aches. Unspecified medical attention was sought. The nurse also reported that two other patients developed local reactions, one of which developed a high fever and went to the ER (WAES0212USA01473 and WAES0212USA01988). Additional information has been requested.
Patient fainted after receiving Gardasil injection.  Pt. given ammonia capsule and was aroused easily.  Pt. color improved and given crackers and Sprite.  Pt. alert and orinted. Pt. advised to remain in clinic for 20 minutes and then left with caretaker.
swelling on her left arm; headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (swelling on her left arm) and HEADACHE (headache) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid disorder and Hypertension (high blood pressure). Concomitant products included CANDESARTAN for Hypertension, LEVOTHYROXINE SODIUM (SYNTHROID) for Thyroid disorder, ACETYLSALICYLIC ACID (ASPIRIN LOW) for an unknown indication.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced VACCINATION SITE SWELLING (swelling on her left arm) and HEADACHE (headache). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) on 12-Mar-2021 at an unspecified dose and frequency. On 13-Mar-2021, VACCINATION SITE SWELLING (swelling on her left arm) and HEADACHE (headache) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-073171 (Patient Link).
local swelling w/erythema & warmth approx 5-10min p/inj;approx size 1" induration w/erythema;
Extreme itching and rashes until I took benedryl at bed time (Tuesday) and minor itching on Wednesday.
Patient was in office for visit on 12-3-12. Concerns of vaccine reaction. Symptoms include swelling, redness and itching left upper arm.