chrisvoncsefalvay/vaers-outcomes huggingface dataset:
no adverse effects reported; improperly stored VARIVAX administered to patient; This spontaneous report was received from a medical assistant regarding a patient of unknown age and gender. There was no information reported about the patient's concomitant medications, pertinent medical history and drug reactions or allergies.   On 16-OCT-2019, the patient received an improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) for prophylaxis (lot number R018933 has been verified to be a valid lot number, expiration date reported as 02-JUL-2019, but upon internal validation established as 02-JUL-2020; strength, dose, route of administration and anatomical site were not provided). The vaccine was exposed to a temperature excursion of 15 Fahrenheit degrees to 46 Fahrenheit degrees (34.2 Fahrenheit degrees) during a time frame of 4 hours. It was stated that there was no previous temperature excursion and that the call was not because of a data logger. No adverse effects were reported.
A report was received from a health professional on 10/17/2001 concerning a 74 year old male who experienced an overdose of Fluvirin on 10/17/2001. The patient received a Fluvirin vaccination on 10/12/2001, then again on 10/17/2001 in error. There were no adverse events reported at the time of reporting. There was insufficient information to determine the reporter's causality assessment.
High BP (systolic around 200mmHg); Loss of balance; Difficulty breathing/shortness of breath; Disorientation; This spontaneous case was received on 05-Oct-2020 from other non-health professional (consumer) via agency (reference number: SEQW20-02933) and concerned a 76-year-old female patient.  The patient's concurrent conditions included hypertension, hypercholesterolemia and type 2 diabetes (T2D). The patient's concomitant medications included losartan, hydrochlorothiazide, Ozempic (semaglutide), metformin and ezetimibe, all used for unreported indications.  On 02-Oct-2020, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, MF59; dose: 0.5 ml, route of administration: intramuscular and anatomical location: left upper arm) for flu prevention. The batch number was 279812 and expiry date was 30-Jun-2021. It was the first time that the patient got vaccinated with Fluad Quadrivalent.  On 03-Oct-2020, one day after receiving Fluad Quadrivalent, the patient started feeling difficulty breathing, shortness of breath and developed high blood pressure (BP) (systolic around 200mmHg). In addition, the patient experienced disorientation and loss of balance. After, she went to the urgent care and started feeling better when she arrived there. Electrocardiogram (ECG) revealed that the patient had no abnormalities. The patient did not receive any treatment associated with the events.  On an unspecified date in Oct-2020, the patient visited her healthcare provider.  At the time of initial reporting on 05-Oct-2020, the patient was recovering from the events. The patient reported being better.  The reporter did not provide a causality assessment to Fluad Quadrivalent. The patient reported an adverse side effect she experienced after having her Fluad vaccine.   The reporter assessed the events as non-serious.  Company comment: Blood pressure systolic increased, balance disorder, dyspnoea and disorientation were associated with the use of the suspect product - Fluad Quadrivalent. Causality is assessed as unrelated for blood pressure systolic increased since the patient suffers from hypertension and for other reported events causality is assessed as unlikely related due to suggestive chronology and presence of confounding factors, concomitant medications. (unlikely related defaults to related for reporting purposes); Sender's Comments: Blood pressure systolic increased, balance disorder, dyspnoea and disorientation were associated with the use of the suspect product - Fluad Quadrivalent. Causality is assessed as unrelated for blood pressure systolic increased since the patient suffers from hypertension and for other reported events causality is assessed as unlikely related due to suggestive chronology and presence of confounding factors  concomitant medications. (unlikely related defaults to related for reporting purposes)
Adverse event: redness (about the size of a baseball), swelling near injection site, warm to touch. Doesn't really bother the patient, just wanted to let us know. Suggested the patient apply ice and take ibuprofen or tylenol for pain. Follow up with us or her physician if symptoms worsen.
Watery eyes, runny nose, itchy skin, shortness of breath, cough, chest tightness.  2 hours post flu shot.
Verbalizes a small welt at site of injection with very mild itching. Came to clinic on 10/26/2015 to have site assessed. Horseshoe shaped red area fits safety device on needle. Mild redness around site.
Myalgia, Fever,  FATIGUE, CHILLS Narrative: STAYED HOME FROM WORK
Patient came in today stating she has arm pain from her flu shot given 3 months ago. It has not gotten better and is affecting movement and sleep.
Patient felt dizzy 3 min after vaccination. Patient was cool, pale, clammy also had blurry vision. Patient were told to lay flat and felt better after 5 min. Doctor assessed patient to be fine after 30  min.
fatigue; swelling at the injection site; headache; nausea; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE SWELLING (swelling at the injection site), HEADACHE (headache), NAUSEA (nausea) and FATIGUE (fatigue) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. MOD020B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, the patient experienced INJECTION SITE SWELLING (swelling at the injection site), HEADACHE (headache) and NAUSEA (nausea). On 18-Apr-2021, the patient experienced FATIGUE (fatigue). On 19-Apr-2021, INJECTION SITE SWELLING (swelling at the injection site), HEADACHE (headache) and NAUSEA (nausea) had resolved. On 22-Apr-2021, FATIGUE (fatigue) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No concomitant and treatment details were provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-114464 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-114464:crosslinked; wife case
Left Bell's Palsy.  Symptoms (difficulty drinking, eyelid was not working properly) came on over several hours 8/1/2009.
pain in my arm; This case was reported by a consumer via other manufacturer and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included denosumab (Prolia) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and Prolia at an unknown dose and frequency. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm and adverse drug reaction. On an unknown date, the outcome of the pain in arm and adverse drug reaction were unknown.   It was unknown if the reporter considered the pain in arm and adverse drug reaction to be related to Shingrix.  Additional details were provided as follows: The age at vaccination not reported. The patient received 1st dose of shingrix vaccine had minor side effects and experienced pain in arm. The patient wanted to know if GlaxoSmithKline have a list of the most common side effects reported after receiving the first dose of the vaccine The person who was beside the patient during the call, asked if Prolia had some interaction with Shingrix.
Blisters and rash in  my chest and on right arm! Took OatMeal baths
Information has been received from a registered nurse concerning a 10 year old male with no past medical history and no allergies who on 04/28/1998 was vaccinated with the first dose of varicella virus vaccine in the left arm SC. There was no concomitant medication or illness at the time of vaccination. On 01/11/2002, the pt developed a mild case of chickenpox. The pt was prescribed Benadryl for the itch. Follow-up info reported no other adverse events. No further info is available.
This literature marketed report as received from the authors of a published article, concerns a 10 month old female patient. Her past medical history was significant for an admission at 3 months of age for community-acquired pneumonia. She had no other medical problems and was fully vaccinated for her age. Her parents denied any sick contacts and there was no family history of immunodeficiency. On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) injection (exact dose, route of administration, anatomical location, lot # and expiration date were nor provided). Other suspect vaccine received on an unknown date, included Haemophilus influenzae type B vaccine (manufacturer unknown) (formulation, dose, intervals and route of administration were not provided). On an unknown date, she presented with 5 days of fever and cough to the reporters' emergency department. The patient was diagnosed with an upper respiratory infection and discharged from the hospital without antibiotics. Vancomycin and ceftriaxone were initiated for presumed community acquired pneumonia complicated by empyema. The Gram stain of the pleural fluid revealed moderate white blood cells, moderate Gram-negative rods, and rare Gram-positive cocci. However, the pleural fluid culture initially remained negative. After 3 days of antibiotics, the patient continued to have high fevers, her inflammatory markers remained elevated, and she continued to require mechanical ventilation. On an unknown date, vancomycin was discontinued, and the patient was transitioned from piperacillin (+) tazobactam to ampicillin (+) sulbactam. The patient's leukocyte count and C-reactive protein (CRP) trended down during her hospitalization. Before discharge, the patient underwent an immunodeficiency workup. She had normal T-cell subsets, natural killer cells, and B cells. immunoglobulins were normal or elevated. An human immunodeficiency virus (HIV) screening test was negative. Her initial Haemophilus influenzae type B (manufacturer unknown) and pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) antibody titers were just below the lower range of normal for a previously vaccinated child (vaccination failure). After 12 days of hospitalization, the patient was discharged from the hospital on oral amoxicillin (+) clavulanate to complete a 4-week course of antibiotics. The patient was scheduled to receive repeat vaccinations and have repeat titers drawn; however, she was lost to follow-up. The authors reviewed her laboratory findings with an immunologist who felt that the suspicion for an immunodeficiency was low. The outcome of the event was unknown. The reporter considered the event to be related to pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) and Haemophilus influenzae type B (manufacturer unknown). Additional information has been requested.
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 15-FEB-2019, the patient was vaccinated with one improperly stored dose of VARIVAX, lot # R023502, expiry date: 16-AUG-2020 (exact dose, route of administration and anatomical location were not provided) for prophylaxis. The administered dose of vaccine was reconstituted with improperly stored sterile diluent, lot # R034106, expiry date: 22-JUN-2021 (dose, route of administration, anatomical location and indication were not provided). The reporter did not know temperature and time frame of excursion. There was no previous temperature excursion. It was not reported if digital data logger was involved. No adverse effects were reported. This is one of 4 reports received from the same reporter. Sender's Comments: US-009507513-1903USA005458: US-009507513-1903USA005459: US-009507513-1902USA010800.
left shoulder decrease range of motion; left shoulder pain; left shoulder stiffness; This case was reported by a pharmacist via call center representative and described the occurrence of joint range of motion decreased in a 56-year-old female patient who received Herpes zoster (Shingrix) (batch number 4257F, expiry date 11th September 2021) for prophylaxis.   On 2nd April 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 10th April 2019, 8 days after receiving Shingrix, the patient experienced joint range of motion decreased, shoulder pain and stiffness shoulder. On an unknown date, the outcome of the joint range of motion decreased, shoulder pain and stiffness shoulder were not recovered/not resolved.   It was unknown if the reporter considered the joint range of motion decreased, shoulder pain and stiffness shoulder to be related to Shingrix.  Additional details were provided as follows: This case was reported by pharmacist for herself. The patient received Shingrix on left arm. Two weeks after the 2nd dose of Shingrix, the patient experienced shoulder stiffness, decrease in shoulder range of motion and shoulder pain, however as per onset date the patient experienced events 8 day after receiving Shingrix. The affected shoulder was the left shoulder. Core outcome of the joint range of motion decreased, shoulder pain and stiffness shoulder were not recovered/not resolved, however in source document the outcome of this events were reported as recovering/resolving. The reporter consented to follow up.
NAUSEA, VOMITING, FATIGUE, DID NOT SLEEP, CRAMPING AND SORENESS IN INJECTION ARM; FEET AND LEGS.
First day after, I had all symptoms. Headache, body aches, fever, nausea. 24 hours later I developed a red rash with pain, tenderness and warm feeling and to the touch.
81yr old female who presents to ED via private car with complaints of weakness.  Patient states she tested positive for covid today in the clinic and was discharged to home.  Patient states she received a call at home and was instructed to come to ED for fluids and admission due to kidney function.  Patient denies pain at this time.  States she just feels weak.  Patient states she received her covid vaccine in March. ED then hospitalized for 5 days. pneumonia, weakness, dehydration, elevated AST, elevated crp
Large blotchy rash at injection site within 10" of injection. Rx with Zyrtec.
SEVERE SIDE EFFECTS; This spontaneous report received from a patient concerned a patient of unspecified age and 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, and batch number were not reported) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On APR-2021, the subject experienced severe side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of severe side effects was not reported. This report was non-serious.
PT C/O STIFF, SORE SHOULDER, PAIN MOVING TO HER NECK.
Admitted to hospital with faitgue, shortness of breath for the past 7 days. Diagnosed with covid 4 days prior
I noticed the itchiness and heat about an hour after I received the vaccination.  By the time I went to bed at approximately 10 PM, the site was beginning to get very hard.  By the next day, the site of the vaccination was the size of a baseball and very hard in addition to very red and itchy and painful.  Benedryl eliminated the itchiness.  However, it is five days later and there is still a very hard and a little less than half the size of a baseball.  Most of the pain, heat and redness is gone, but the site is still very hard and itchy.
DTaP vaccination #5 reaction erythema - possible cellulitis 8 x 7 cm around injection site.
Patient had a positive COVID test on 2/18/2022 and passes away on 2/24/2022.
Site of PNEUMOVAX shot is red, warm, and irritated. Pt says it hurts but is not itchy. Warm to touch. Has been taking Tylenol. She will let us know if it gets worse and we will call to follow up regardless.
Left arm: skin blistering, skin bumps, crusting, pruritus, skin redness.
Patient had a red area that is warm-to-touch (from COVID-19 booster injection site to elbow). Treatment involved ice pack for comfort.
Rashes on wrists, ankles, knees, elbows and other spots. Appears as a lot of small red dots that make a trail on my skin
A week after the vaccine shot I had received a flu vaccine. I had a sore throat that was scratchy, I had to constantly clear, I also had white bumps. I was tested for COVID, flu and strep all came back negative. I was prescribed a round of antibiotics, yet the sore, scratchy throat persisted, the white bumps on the back of my throat spread to the back of my tongue. I called my regular PCP and told her it looked like thrush. She prescribed me medication for thrush and within two to fours days everything was gone.
felt achy; tired; chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN (non-serious), outcome "unknown", described as "felt achy"; FATIGUE (non-serious), outcome "unknown", described as "tired"; CHILLS (non-serious), outcome "unknown", described as "chills".  Additional information: 2-3 days after receiving 2nd Covid vaccine felt achy, tired and had chills. Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
redness and swelling on left arm, not near the injection site.  patient was told to seek medical attention if it spread. it did, went to see urgent care and was diagnosed with cellulitis and got antibiotics to resolve infection.
No adverse event; patient received second Bivalent dose before authorized; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PRODUCT USE ISSUE (patient received second Bivalent dose before authorized) and NO ADVERSE EVENT (No adverse event) in an elderly male 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.   In September 2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In February 2023, received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. In February 2023, the patient experienced PRODUCT USE ISSUE (patient received second Bivalent dose before authorized). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT USE ISSUE (patient received second Bivalent dose before authorized) 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 PRODUCT USE ISSUE (patient received second Bivalent dose before authorized).    Patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine was unknown. Concomitant medication details not reported by the reporter. It was reported that patient got one in Sep2022 when it came out and a second Feb2023. Treatment details was not reported by the reporter.   Reporter did not allow further contact
Information has been received from a nurse via a company representative referring to a currently 60 year old female patient. The patient's concurrent condition, concomitant therapy and medical history were not reported. On an unknown date the patient was vaccinated with ZOSTAVAX (vaccine dose, frequency, route, lot# and expiration date were unknown) for vaccine to prevent shingles.  On an unknown date the patient's arm was red and swollen after receiving ZOSTAVAX vaccine injection. No treatment was performed. The patient sought medical attention for the nurse. The outcome of the events was unknown. Causality was not provided.
PATIENT DID NOT COMPLAIN ABOUT ANY SIDE EFFECT. HOWEVER, DAUGHTER REPORTED THAT PATIENT WAS FOUND DEAD AT HER HOUSE LAST NIGHT 08/02/21
felt unwell-inc through day;T102;nausea, trouble keeping anything down, achy, chills;
towards the back of her arm she saw two little marks/ One was perfectly round and red; towards the back of her arm she saw two little marks/ One was light colored; She did have some swelling; warm to the touch; This spontaneous case was reported by a nurse and describes the occurrence of ERYTHEMA (towards the back of her arm she saw two little marks/ One was perfectly round and red), SKIN DISCOLOURATION (towards the back of her arm she saw two little marks/ One was light colored), SWELLING (She did have some swelling) and FEELING HOT (warm to the touch) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003F21A and 003F21A) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid disorder NOS (diagnosed at age 40). Concomitant products included LIOTHYRONINE for Thyroid disorder NOS, MULTIVITAMIN [VITAMINS NOS], UBIDECARENONE (COQ-10) and VITAMIN C [ASCORBIC ACID] for an unknown indication.   On 11-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (towards the back of her arm she saw two little marks/ One was perfectly round and red), SKIN DISCOLOURATION (towards the back of her arm she saw two little marks/ One was light colored), SWELLING (She did have some swelling) and FEELING HOT (warm to the touch). At the time of the report, ERYTHEMA (towards the back of her arm she saw two little marks/ One was perfectly round and red), SKIN DISCOLOURATION (towards the back of her arm she saw two little marks/ One was light colored), SWELLING (She did have some swelling) and FEELING HOT (warm to the touch) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient stated everything seems to be on track so far and she had routine bloodwork due in August. Patient called her doctor to know if it was okay to take something for her side effects.  No treatment medication were provided.   This case was linked to MOD-2022-492176 (Patient Link).