chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician concerning himself who on 30-APR-2009 was vaccinated with ZOSTAVAX (Merck) by the intramuscular route. On 30-APR-2009 the patient developed generalized ache and myalgia which he was treating with ADVIL. It was unknown if the patient sought medical attention. At the time of reporting, the patient was not recovered. Follow-up information has been received from a physician concerning himself, a 61 year old male who on 30-APR-2009, at 17:00, was vaccinated with a first dose of ZOSTAVAX (Merck) at left deltoid. There was no medical history. The patient developed generalized myalgias for 2 days. It was unclear if generalized myalgia was a "normal" reaction to medication given. The patient didn't seek medical attention. Additional information is not expected.
12-14-06- redness, warm to touch, achy Left arm (lower deltoid); 12-15-06 warm(not hot to touch), red, edema. (red area measures approx 4.5x 2.5in) (edema approx 1.5x1in lower deltoid); 12-15-06 To ER, physician recommended Triamcinolone cream and told reaction to immunizations; 12-18-06 redness gone, arm better, no complaints.
Within 2 hours post vax, the pt experienced chest pain, left arm pain, EKG changes, low grade fever. These are the symptoms the pt described over the phone.
Small 1-2 mm papules w/out vesicles on bilateral arms & chest.
itching from scalp to legs; tongue and lip swelled; tongue and lip swelled; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of PRURITUS (itching from scalp to legs), SWOLLEN TONGUE (tongue and lip swelled) and LIP SWELLING (tongue and lip swelled) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRURITUS (itching from scalp to legs), SWOLLEN TONGUE (tongue and lip swelled) and LIP SWELLING (tongue and lip swelled). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Itching all over, Tongue swelling non-specific and Lip swelling, at a dose of UNK dosage form. At the time of the report, PRURITUS (itching from scalp to legs), SWOLLEN TONGUE (tongue and lip swelled) and LIP SWELLING (tongue and lip swelled) 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.   Concomitant medication was not reported.  The physician reported that the itching from scalp to legs did not break out in a rash.
This spontaneous report as received from a health care worker via inventive health field representative, refers to a 60 year old female patient. Medical history and concurrent conditions were not reported. On an unspecified date sometime in September 2013, the patient was vaccinated with ZOSTAVAX "one single shot", route "injection". Dose and lot number were not reported. In approximately 2013, 2 days after receiving ZOSTAVAX the patient developed a cellulitis like rash. The outcome of cellulitis like a rash was reported as recovering. No lab diagnostic studies were performed. The patient sought medical attention, saw the doctor. Additional information is not expected.
This spontaneous report as received from an office manager refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 29-DEC-2017, the patient was vaccinated with improperly stored Oka/Merck VARIVAX (lot # M034586; expiry date: 27-JUL-2018), which was reconstituted with properly stored sterile diluent (lot #M026303, expiry date: 11-MAR-2019) (incorrect product storage). The vaccine was stored at a temperature of 15ºF to 46ºF for 132 Days. There was no previous temperature excursion. Digital data logger was involved. No adverse effects reported. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1802USA012317: US-009507513-1802USA012323: US-009507513-1802USA012326.
Injection site pain; headache for 2 days; neck and lower back joint pain; neck and lower back joint pain; fever of 101; nausea; chills; neck and lower back joint pain; lethargy; This is a spontaneous report from a contactable Nurse (the patient).  A 30-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EH9899, expiration date unknown), intramuscularly, on 31Dec2020 at 07:30 (at the age of 30-years-old) an unspecified dose in the left arm for COVID-19 vaccination.  Medical history included anxiety and depression from unknown dates. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. The patient was administered the vaccine in the hospital. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Jan2021 at 01:00 the patient experienced vaccination site pain, headache for two days, neck and lower back joint pain, fever of 101 degrees, nausea, chills and lethargy. The patient did not receive any treatment for the events. The clinical outcomes of vaccination site pain, headache for two days, neck and lower back joint pain, fever of 101degrees, nausea, chills and lethargy were reported as recovered. It was also reported that since the vaccination the patient had not been tested for COVID-19.
hepatitis B nonresponder; Literature Report:   This literature report has been received from authors of a published article, titled as above, regarding an adult patient. The medical history, current conditions and concomitant medications were not provided.  On an unknown date, the patient was vaccinated with initial series of hepatitis B vaccine (recombinant) (dose, frequency, route, lot# and expiration date were unknown) for prophylaxis at age of 57 (unit not provided). And the patient was vaccinated with the second series of hepatitis B vaccine (recombinant) (dose, frequency, route, lot# and expiration date were unknown) for prophylaxis at age of 58 (unit not provided) on an unknown date. Total number of standard hepatitis B vaccine (recombinant) doses were 7. The patient did not respond to two complete standard hepatitis B vaccine (recombinant) vaccine series and was termed as nonresponder (Vaccination failure). The outcome of vaccination failure was unknown.  The causality between vaccination failure and hepatitis B vaccine (recombinant) was related.  A copy of the published article is attached as further documentation of the patient's experience. ; Sender's Comments:  US-009507513-2207USA004701:
This spontaneous report was received from a nurse and refers to unspecified number of unspecified patients of unknown age and gender. No information about the patients' pertinent medical history, concomitant medications, drug reactions or allergies was provided. On unknown dates, the patients were vaccinated with improperly stored doses of VAQTA (dose, route of administration, lot # and expiration date were not reported). The vaccine underwent a temperature excursion of maximum 46.9 degrees Fahrenheit for 15 minutes and minimum 34.9 degrees Fahrenheit for 2 hours (6 cycles). It was reported Digital Data Logger was involved. There were no previous temperature excursions. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
No additional AE reported; an adult dose of VAQTA was administered to a pediatric patient; This spontaneous report was received from a nurse and refers to a pediatric patient of unknown exact age and gender. There was no information regarding the patient's medical history, concurrent conditions and concomitant medications provided.  On 19-MAR-2018, the patient was administered with an adult dose of Hepatitis A Vaccine, Inactivated (VAQTA) (dose, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis (product administered to patient of inappropriate age). No additional adverse event was reported.
I tested positive for Covid-19 on March 23, 2023 I experienced stuffy nose, headache, nasal drainage, I was taking a steroid for my symptoms.
sore arm for a long period; ache; inflammation to my cervical area which is damaged from fusions; 48-72hrs of fever; COVID-19; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (sore arm for a long period), PAIN (ache), INFLAMMATION (inflammation to my cervical area which is damaged from fusions), COVID-19 (COVID-19) and PYREXIA (48-72hrs of fever) in a  patient of an unknown age and gender who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.   In 2020, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. In December 2022, the patient experienced COVID-19 (COVID-19). On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm for a long period), PAIN (ache), INFLAMMATION (inflammation to my cervical area which is damaged from fusions) and PYREXIA (48-72hrs of fever). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (sore arm for a long period), PAIN (ache), INFLAMMATION (inflammation to my cervical area which is damaged from fusions) and COVID-19 (COVID-19) outcome was unknown and PYREXIA (48-72hrs of fever) had resolved.            Concomitant medications were not reported.  Reported that patient received the COVID vaccine on 04-Nov-2023 and did not experience any after effects. Patient received the initial (Moderna) shot in 2020, followed by the booster. Both time patient experienced sore arm for a long period and 48-72hrs of fever, aches, and inflammation to cervical area which was damaged from fusions.
generalized muscle and joint aches/pains, chills, fever, nausea, significant fatigue and weakness, headache, inappetence; aches and pains started at 3am on 9/12/2021 and intensified throughout the following hours until their peak around 11am; approximately 7pm on 9/12/2021 is when the symptoms,  other than headache and fatigue started to resolve.
Patient experience rash on left arm of small, raised, itchy whelps between wrist and shoulder. Whelp near elbow is somewhat blistered. Recommended hydrocortisone 1% cream OTC for treatment and that patient contact primary doctor.
temperature excursion due to a refrigerator malfunction, dose post temperature excursion outside acceptable guidelines for excursion standards with no reported adverse event; Initial information received on 19-Apr-2022 regarding an unsolicited valid  non-serious case received from a other health professional via call center.  This case involves a 38 years old female patient who experienced temperature excursion due to a refrigerator malfunction, dose post temperature excursion outside acceptable guidelines for excursion standards with no reported adverse event while receiving vaccine diphtheria-2/tetanus/5 ac pertussis vaccine [Adacel].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included measles vaccine, mumps vaccine, rubella vaccine (MMR) for immunization; and influenza vaccine (Flu)for Immunisation.  On 23-Mar-2022, the patient received a  0.5 ml dose of suspect diphtheria-2/tetanus/5 ac pertussis vaccine (batch lot :C5873AA,Expiry date :30-Jun-2023) (unknown dosage, route, formulation )via intramuscular route in the right deltoid for immunization.  On 23-MAR-2022 (latency :same day)the patient developed a non-serious event of temperature excursion due to a refrigerator malfunction, dose post temperature excursion outside acceptable guidelines for excursion standards with no reported adverse event (product storage error) following the administration of diphtheria-2/tetanus/5 ac pertussis vaccine.  Action taken : not applicable.  At time of reporting, the outcome was Unknown for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Seizure activity: stopped breathing and was given CPR by mother until EMS arrived. Transported to hospital for evaluation and admitted for observation. Diagnosis includes probable encephalopathy secondary to DTaP, Metabolic Acidosis, Dermatitis
pt recvd vax;11nov woke up w/ rash on trunk only;described as small red dots w/ whitish area around each dot,per mom;T 102.4;responded by apap;pt seen by MD & dx:sl case of measles;
Staff reported low blood pressure reading.  Patient admitted into ER with Dx Hypotension and given IV fluids.  Pt later discharged back to home.
day p/inj red wheal 1" diameter & felt tired x 2-3 days;had seen a dentist prev to vax;2OCT didn't feel well;felt lousy;3OCT95 had subjective fever & woke up 430AM 4OCT95 w/tingling, nervous agitated & felt weird;passed out couple sec
A bump and a 3 inch rash at the site of administration of the vaccine; A bump and a 3 inch rash at the site of administration of the vaccine; This spontaneous case from the was received on 24-Sep-2020 from other non-health professional via The Agency (reference number: SEQW20-02263) and concerned a patient of an unknown age and gender.  The patient's medical history and concomitant medications were not reported.   On 17-Sep-2020, the patient was vaccinated with Flucelvax QIV (influenza vaccine, subunit influenza virus vaccine polyvalent, dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid) for influenza prophylaxis. The batch number reported was 283849 and expiry date was 30-Jun-2021.   On the same day, after receiving Flucelvax QIV, the patient developed a bump and a 3-inch rash at the site of administration of the vaccine. The patient did not receive any corrective treatment for the events.  On an unspecified date in Sep-2020, the patient recovered from the events.  The reporter did not provide a causality assessment.  The case was assessed as non-serious.  This case is linked to cases 202004678, 202004696, 202004697, 202004699, 202004700, 202004701, 202004702, 202004703, 202004704, 202004705 and 202004706, due to the same reporter.  Additional non-significant information received on 06-Jan-2021 from other non-health professional via The Agency (reference number: SEQW21-00065) with additional information received on 12-Jan-2021 from other health professional (reference number: SEQW21-00149) (being processed together): Two reporters were added. Reference numbers added. No changes in narrative.  Company comment: A patient of an unknown age and gender was administered Flucelvax QIV vaccine. On the same day, after receiving Flucelvax QIV, the patient developed vaccination site rash and vaccination site mass. The patient's medical history and concomitant medications were not reported. Chronology is plausible. Causality is assessed as possibly related for both events.; Sender's Comments: A patient of an unknown age and gender was administered Flucelvax QIV vaccine. On the same day, after receiving Flucelvax QIV, the patient developed vaccination site rash and vaccination site mass. The patient's medical history and concomitant medications were not reported. Chronology is plausible. Causality is assessed as possibly related for both events.
Started feeling pain at/near the injection site.  Dull ache to more intense pain needing otc pain reliever. Pain comes and goes. Pain is worse in my left arm. Right arm has the same symptoms, but not as intense. Pain in both arms can last for several hours if not treated.
Within 20 minutes started to feel mild nausea 7 dizziness, then flu like symptoms throughout the rest of the day, severe sore muscles, fatigue, lots of rest, sore arm at injection site, next day noticed quarter size rash on arm at injection site that grew to small grapefruit within 2 days, extremely painly and itching, contant heachaches, cold, arm swollen at site, upset stomach. I have been sick now for 6 days. Is this normal?
Friday 7-28-17 evening patient got chills, achy joints, deep cough, fatigued, stuffy nose, fever. Shot vaccine location was warm and achy. Fever is gone today (7-31-17).
From initial information received on 6/3/05 from a health care facility regarding an adverse event occurring in the USA, it was reported that a five year old female patient received a dose of TRIPEDIA, lot number U1343AA, administered IM in the right deltoid on 5/28/05 at her well child visit. Three days later, on 5/31/05, the patient developed generalized hives as well as swelling of the eyes and lips. She was initially treated with Benadryl and later prescribed either Zyrtec and Claritin. It is unknown at this time whether she recovered from the events. 6/8/05: This case is being upgraded to serious as based on medical judgement. From additional information received on 6/8/05 through a telephone call to the reporting facility, it was reported that according to the patient's chart, the child had an allergic reaction to DTaP. The patient was prescribed Benadryl orally for two days, but was switched to Zyrtec 5mg orally for five days, as Benadryl made her sleepy. Per the physician, the child has no history of previous allergic reactions. In addition, she did not develop any reactions to the four doses of DTaP she received overseas. Following the events, the physician received a telephone call from the patient's mother, who stated that the child was much better. It was not reported whether the patient fully recovered from these events. (OMIC)
CHILLS; HEADACHE; MUSCLE ACHE; This spontaneous report received from a patient concerned an 18 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, and batch number: 1808980 expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 on left deltoid for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced chills. On 06-APR-2021, the subject experienced headache. On 06-APR-2021, the subject experienced muscle ache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, muscle ache, and chills. This report was non-serious.
Myalgias, chills, mild headache, mild nausea, dizziness,  fatigue
Hospitalized  acute hypoxemic respiratory failure triggered by COVID 19 with early pneumonitis and also acute COPD exacerbation.
The patient experienced pain since receiving her flu vaccine on 10/22/08.  On 11/21 she saw her physician and he did an x-ray.  Based on the x-ray the physician believes the vaccine was injected into her "biciptical tendon."
Injection Site Wheal - Information has been received from a health care professional concerning an 11 year old male patient who in approximately August 2000 was vaccinated with measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live ( second generation ) (635125/0400K).  Subsequently the patient developed a large wheal at the injection site that when treated with ice resolved within 30 minutes.  The reporter stated concern regarding the lot of the vaccine.  It was reported that 3 other patients (WAES # 00081640, 000829072 and 00082073)  had a similar experience following exposure to measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation).  No further information is expected.
Onset of upper respiratory symptoms the following week, low-grade fever, sore throat, loss of voice, chest congestion lasted 2 weeks. About 4 days in, I went to urgent care made me do a COVID test prior to entry of building and they also  did a strep test. They just recommended I stay hydrated and rest. Symptoms were not getting any better so I made a telehealth appt with my doctors office. My primary was unavailable so I saw a different provider. I had my appt with them on May 17th. She sent in 2 prescriptions, albuterol inhaler and codeine cough syrup. The inhaler helped with my symptoms.
Within minutes of receiving his MMR and Chicken Pox Vaccines, patient turned red, itchy, and started sneezing.  He then started to swell in his face and went into anaphylactic shock. His oxygen level started to drop and his blood pressue was off as well.  He was given 2 doses Benadryl and finally given the EPI PEN.  He was then given an oxygen mask with a breathing treatment. (This is the SECOND time patient received these vaccines but had no reaction the first time).  He was monitored at the pediatricians office for a couple of hours then we were instructed to take him to the hospital for overnight observation.
The pt developed a fever and irritability, a decrease in appetite, bacteremia and was placed on Ceftriaxone. The pt's fever resolved the following day.
02/10/2021 pt was vaccinated and the syringe was lose and liquid ran down pt's arm, pharmacist gave a 2nd dose but not a full dose right after, pt experiencing arm soreness, vomiting
nov 16/21 - vaccine -booster nov 17 - 18  red arm and glands under arm inchadas- fever nov 24-25-26 weak legs -  nov 28- headache -vomit- dizzie- lef side body shake few minutes- weak legs special left side nov 28-dec 2- hospitalized dec 2 - dec 6 at home - tires weakness
Fever, chills, severe headache, body/back ache for 28-32 hours
3-4 days after Td injection, pt noticed itching at injection site. By the next day, swelling of upper left arm began. At time of this report, pt states swelling has been increasing. In comparison to rt upper arm, swelling is seen at injection site in moderate amt. Swelling present in bicep area in greater amt approx 3 cm at bicep only. No redness or heat noted.
pt recvd vax & had fever 101; pain; swelling; warmth at inject site; stiff leg; pallor; high pitch scream lasting > 4 hrs;
Throat felt odd, pain at the site of injection that day. Unable to sleep until CPAP removed. Fever, very red face, hot, cold, swollen and painful wrists and other joints. In bed sleeping. Can't take anything for pain because of his heart meds (we're unsure what is safe until we see his heart doctor again).
Patient had a fever that peaked at 101.5 degrees about 13 hours after receiving the quadravalent flu shot. Patient also has redness around the injection site.