chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 76-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included VALTREX tablet for shingles. The patient's past medical history included shingles (in 2016 on her breasts associated with swelling and welts), swelling and welts. On 6th February 2019, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, the patient started VALTREX at an unknown dose and frequency. On 14th February 2019, the dose was changed to an unknown dose and frequency. On 6th February 2019, not applicable after receiving SHINGRIX and unknown after starting VALTREX, the patient experienced inappropriate schedule of drug administration. In February 2019, the patient experienced extensive swelling of vaccinated limb, erythema, pruritus, muscle pain, injection site pain and stress. On an unknown date, the patient experienced inappropriate dose of drug administered. VALTREX was continued with no change. On an unknown date, the outcome of the extensive swelling of vaccinated limb, erythema, pruritus, muscle pain, injection site pain, stress, inappropriate schedule of drug administration and inappropriate dose of drug administered were unknown. It was unknown if the reporter considered the extensive swelling of vaccinated limb, erythema, pruritus, muscle pain, injection site pain and stress to be related to SHINGRIX. It was unknown if the reporter considered the stress to be related to VALTREX. Additional details were received as follows: The patient was on VALTREX as maintenance dose prescribed to her by her eye doctor. The patient was supposed to take the VALTREX every day but she has only been taking it three times a week prior to receiving SHINGRIX vaccine, which led to inappropriate schedule of drug administration and inappropriate dose of drug administered. The stopped taking VALTREX before she received the SHINGRIX. The patient received SHINGRIX in the left arm. The patient experienced itching, redness and swelling below the injection site which went all the way down to her elbow. The patient also experienced muscle pain and pain at injection site. These side effects were progressively getting worse, except the redness which was not as bad as before. On 14th February 2019, the patient started taking VALTREX 1g three times a day that she had on hand from before. On 15th February 2019, the patient met with an accident as someone hit her from the back, and this has caused increase in stress. At the time of reporting, the patient had an appointment scheduled with her dermatologist. The reporter did not consent to follow up.
This spontaneous report as received from a nurse refers to unknown number of patients of unknown demographics. No information about medical history, concurrent conditions and concomitant medications ware reported. The reporter stated that unknown number of patients were vaccinated with VAQTA (dose strength, route not reported) that had been improperly stored. Approximately on an unknown date in July 2014 (reported as between 09-JUL-2014 and 16-JUL-2014). No adverse effects reported. The outcome of events reported is unknown. No product quality complaint was involved. This is one of the several reports received from the same source. Additional information has been requested.
Per ED Provider Report, the patient collapsed while outside on 3/25/21. Ambulance was called to the scene where patient was found unresponsive. Patient was transferred to Hospital.  Patient was in full cardiac arrest upon arrival. CPR was initiated. Patient deceased. Patient's mother stated the patient had been feeling badly for 2-days, but refused to seek medical treatment.
Approx 3pm on 11/21/09 noticed pain of left side. Approx 8:30am 11/22/09 --> urgent care Dx Shingles. Rx Acyclovir. Started as soon as she picked up Rx. Sx - lethargy, chilling, pain L side, mild headache, tingling of left arm.
This spontaneous report was received from a pharmacist and refers to a 63-year-old male patient with atrial fibrillation and with no drug reactions or allergies. The patient's pertinent medical history included a myocardial infarction in February 2016. As concomitant therapies, the patient took amitriptyline hydrochloride (manufacturer unknown); butalbital; acetaminophen (+) caffeine; carvedilol; cyclobenzaprine hydrochloride; diazepam (manufacturer unknown); EFFIENT; GENERLAC; oxycodone; pantoprazole; pravastatin; tamsulosin hydrochloride, and zolpidem. On 07-APR-2017, the patient was vaccinated with a dose of ZOSTAVAX subcutaneously, lot number: M032141, expiration date: 02-OCT-2017 (Strength, anatomical location, dose, and frequency were not provided) for prophylaxis. On the same date reported as "from the time of vaccination", the patient experienced a "severe" local injection reaction characterized by redness that measured 6 to 8 inches. No treatment was given to the patient, and he did not undergo any laboratory test or diagnostic procedure. At the time of this report, the patient did not recover from the adverse event. The causal relationship between the therapy with ZOSTAVAX and the adverse event was not reported. No product quality complaint was involved. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA004335.
Left lymph node swollen; Left lymph node sore; This is a spontaneous report from a contactable healthcare professional. A 38-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 03Apr2021 at 10:00 (at the age of 38-years-old), as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not receive any other medications within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 05Apr2021 at 06:00, the patient experienced left lymph node swollen and left lymph node sore. No therapeutic measures were taken as a result of the reported events. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The clinical outcome of the events left lymph node swollen and left lymph node sore were recovering at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Patient is fully vaccinated. Hospitalized from 11/23-11/26, 2021.  admission dx:  acute respiratory failure, hypoxia, CAP, sepsis, Pneumonia due to COVID.  Patient is a known case of diabetes COPD and hypertension presented to the hospital with acute shortness of breath related to pneumonia. SpO2 91% on RA.  Treated with IV Levaquin, steriods, oxygen.  Discharged to home with home oxygen.
A few days after first dose, started experiencing muscle pain in right hip  and thigh which has continued.  Also  have continued arm soreness since first dose on 3/5/21.  A couple of days after second dose on 4/2/21, started having severe muscle pain in left hip and thigh as well as continued soreness in left arm.  Also having occasional, brief chills after second dose.
Dizziness  BP: 116/68 Pulse 68     No Any Pain     P.T.O.  #18 Advised patient to drink more water 2. Patient wait in observation area for extra 15 mins.  3. Revocered from dizziness and stated he feels ok now and went home.
Child received Typhoid vaccine on 6-15-11 - 2 hrs later developed uncontrollable shivering. No fever - no local reaction noticed. (child had been seen & dx with strep on 6-14-11).
she had joint pain for 1 day; chills for 1 week; headache; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), dose 2 via an unspecified route of administration on 20Feb2021 (Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient received first dose of BNT162B2 (PFIZ-ER-BIONTECH COVID-19 VACCINE, Lot number: not reported) administered on unspecified date for covid-19 immunisation. Reporter called on behalf of her mother. While gathering information she transferred the phone to her mother and stated that she got the 2nd dose of vaccine last 20Feb2021. The Patient reported she can't even remember the 1st dose date. She reported an adverse event after she got the 2nd dose until now. The patient experienced joint pain for 1 day, chills for 1 week on unspecified date. On 20Feb2021 patient experienced headache from the date of the 2nd dose until now. The patient reported she is taking herbal tea to lessen the pain. The patient wanted to know the reason why she is experiencing those. The outcome of the events Joint pain and chills was unknown while outcome of the event headache was not resolved.  No follow-up attempts are possible; information about lot/batch number cannot be obtained
Patient began having lower extremity weakness on the day reported. The weakness increased each day until the day of admission on 31AUG2015. At that time the patient could not dress himself due to significant weakness and could only stand and ambulate with assistance. The weakness was greater in the lower extremities than the upper with a predominance in the hip flexors. The patient maintained 2+/4 reflexes in upper and lower extremities throughout his admission. The patient was suspected to have Guillain-Barre syndrome based on his increasing motor weakness and elevated protein without organisms on lumbar puncture. The patient was treated with IVIG x5 days and experienced some improvement in weakness. He was discharged on convalescent leave with continued outpatient physical therapy. Whether patient made a full recovery was not known at the time of report.
first dose in 2019 and has not received his second dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable to this report. The reporter was a (Health Care Professional) HCP calling on behalf of the patient.  Till the time of reporting the patient did not receive 2nd dose, which led to incomplete course of vaccination. The reporter reported with very limited information. No additional information was provided. The reporter did not consent to follow-up.
pt recvd rubella vax & subsequently testing was neg for rubella antibodies;no further details were provided;
Rash developed on face and neck. Severe arm pain at the injection site. Papule development.
Soreness of arm, low-grade fever, chills, body aches, sore throat started around 8 AM the day after the vaccine.  Felt progressively worse throughout the day.  Took ibuprofen, slept and after a several hours started feeling better.   Day #2 felt fine; asymptomatic Day #3 felt tired, slight headache Day #4 normal
On 02APR2023 I had a low grade, fever, cough, sore throat, muscle aches. I contacted my doctor who prescribed an antiviral medication. I recovered very quickly I tested negative for COVID-19 two weeks later.
02/08/22 presents to ED for "Fatigue, SOB, cough". PMHx of "severe CAD with VF arrest, A. fib flutter in sinus rhythm on apixaban, non-Hodgkin's lymphoma hypertension asthmatic bronchitis"
On August 9th and she received her first and second injections of Engerix - B, with no untoward effects. On Feb 24, 2000 she received the third dose of Engerix and approximately 2 weeks later experienced a rash. She consulted a dermatologist and had a skin biopsy. She was diag with granuloma annulare. She was not hospitalized. The patient is undergoing further evaluation to rule out collagen-vascular disease. Treatment included topical cortisone cream.
A college student was accidentally given two Fluzone Quadrivalent doses within one flu season/No AE; Initial information was received on 17-Jan-2020 regarding an unsolicited valid non-serious case from a nurse.  This case involves a 19 year old female patient who accidentally received two doses of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  Medical history, medical treatment, vaccination and family history were not provided.  The patient received first and second 0.5 mL dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot UT6657NA and UJ305AB, expiry date-30-Jun-2020) via an unknown route in the left deltoid on date 16-Oct-2019 and 15-Jan-2020 respectively.  It was a case of an actual medication error due to extra dose administered.  At the time of report, no adverse event was reported.  The patient thought that she was being asked about a calendar year rather than a flu season year. The clinic's system did not flag the patient as having already received the flu shot for this season, so another dose of Fluzone Quadrivalent was given.  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 Directive and Module VI of the Practices. 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.
Pt states:  two days post Flu Mist he has sharp chest pain and was short of breath.  Seen in ER and was diagnosed with myocarditis.  Pt treated in hospital and was told to follow up with his Dr.  4/23/09 Received hospital medical records of 4/14-4/18/2008 & 10/20-10/21/2008. FINAL DX: myopericarditis; hypothyroidism Records reveal patient experienced chest pain, SOB, fever, chills, generalized weakness, fatigue & body aches x 1 day.  Admit temp 101.1.  Slowly improved but still had episodes of tachycardia, dyspnea & pleuritic chest pain intermittently w/activity.  D/C to home on continued NSAID w/cardio f/u.    Patient readmitted 10/20-10/21/2008. FINAL DX: retroperitoneal hematoma; hypothyroidism; mild pericarditis. Records reveal patient developed right groin pain which progressively worsened & moved from right groin into abdominal RLQ.  Improved & d/c to home.  3/19/09 Received multiple ER visits:  10/14/2008 ER visit: FINAL DX: endocarditis vs myocarditis, viral syndrome & chest pain Records reveal patient experienced myalgias & fevers, chest pain, SOB x 3 days.  Transferred to higher level of care for cardiac cath.  10/19/2008 ER visit: FINAL DX: right retroperitoneal hematoma s/p cardiac cath; s/p myocarditis Records reveal patient experienced abdominal pain, nausea, right groin swelling where catheter inserted.  Transferred to higher level of care.  11/12/2008 Outpatient PFT testing which was WNL.  12/1/2008 ER visit: FINAL DX: pleurisy Records reveal patient experienced chest pain x 1 day.  Tx w/NSAIDS & rest. D/C to home.
2-3 minutes after patient received 2nd dose of Pfizer covid-19 vaccine, patient experienced these symptoms: warmth, feeling faint, dizziness, blurry/cloudy vision, chills. Patient lied down on the floor and called 911. Took patient's blood pressure: 137/90. Continued to monitor patient for ~40 minutes until husband came to pick her up. Patient felt better after lying down and was able to sit up right, ate chips and drank water. Patient did not have any water or meals prior to getting the shot, Firemen came to check-up on her. Took her blood pressure reading ~15 minutes before she left: 157/90. Counseled patient and husband on: serious adverse symptoms to lookout for and seek medical attention, to continue to closely monitor her symptoms and condition, and to contact her healthcare provider if she experiences flu-like symptoms. Provided Pfizer VIS.
Ringing in ears after receiving the vaccine. It started after the first dose of the vaccine, continued through the second and third (booster) dose on 10/24. Ringing in ears is near constant. No other lingering adverse effects of the vaccine.
The patient reported having cough, sore throat and wheezing within hours of getting vaccine. Neck stiffness, swollen neck and shoulders, headache and wheezing was present on morning of 8/23/12.
Severe muscle crAmps And spAsms in Left Arm and Leg. Nausea and fever. Approximately for 8 - 10 dAy from Vaccines. I waited for VAERS material which took about 10 days, so I didn't go back to Hospital
6 days following immunization started waking at night, crying, agitated. On 7th day, rash lower back. On day 9, rash at injection site, 2.5 cm of edema, erythema and excoriations.
states received the covid vaccine - developed inc hrt rate, rigors, flushing was monitored in the vaccine clinic, and then escorted to the ED -states the ED observed until sx dec - was told she had a catacholemine response, states is feeling fatigued
Expired vaccine used; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 004m21a) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Expired vaccine used).    No concomitant medications were reported. It was unknown whether patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Caller mentioned that "disease control had just approved extended expiration dates" and wanted to know if it was extended. When asked the caller stated that there were no remaining vials unused of that lot number and agent reminded the caller that no patients should receive doses from expired vials. Dose was administered after 30-day Use by Date or after manufacturer date of expiry. Vial did not undergo any temperature excursions.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-701125 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-701125:Master case
No additional AE reported; ROTATEQ that experienced a temperature excursion was administered to a patien; This spontaneous report was received from a physician referring to a patient of unknown age and gender. The patient's pertinent medical history, concomitant therapies and drug allergy or reactions were not reported.   On 18-OCT-2021, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 2 ml (lot # T040207, expiration date: 18-JUL-2022; strength was not reported) orally for prophylaxis that experienced a temperature excursion (product storage error).         The vaccine underwent temperature excursions of 33 Fahrenheit (F) for 15 minutes, 33 F for 10 minutes and 33 F for 5 seconds. The previous temperature excursions were not applicable. No additional adverse events were reported (no adverse event).
Information has been received from a female consumer who on approximately 10-SEP-2009, "a week ago" was vaccinated with a third dose of PNEUMOVAX.  The next day on approximately 11-SEP-2009 the patient started experiencing swelling of the arm, redness and warmth.  By the evening her whole top of the arm was swollen and painful.  After couple of days the patient recovered.  This was her third time she was vaccinated with a pneumonia vaccine.  The other two times were years ago and she did not remember if she had any adverse reactions to them.  No further information is available.
Pt stated he had redness in the area of injection, swelling at injection, fever of 103 degrees F, and clammy.
sick; Initial information received on 08-Dec-2020 regarding an unsolicited valid non-serious social media case received from a consumer.  This case involves a patient of an unknown demography who got sick (illness), while he/she received Influenza vaccine.  The patient's medical history, medical treatments, vaccinations, family history and concomitants were not provided.   On an unknown date last year, the patient received a dose of suspect Influenza Vaccine produced by unknown manufacturer (batch number and expiry date not reported) via an unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, patient got sick (illness), unknown latency following the administration of Influenza vaccine.  No laboratory data was provided.  It was not reported if the patient received a corrective treatment.  The outcome of event was unknown.  There will be no information about batch number for this case.
Patient received their 2nd dose of Pfizer pediatric COVID-19 vaccine, however, the vaccine that was administered had been diluted on 11/30/21.  When the vaccine was administered it was outside of the time frame the manufacturer has established for stability.
This case was reported by a consumer via interactive digital media and described the occurrence of adverse reaction in a male patient who received HPV 16-18 (HPV vaccine) for prophylaxis. On an unknown date, the patient received HPV vaccine at an unknown dose. On an unknown date, unknown after receiving HPV vaccine, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown. It was unknown if the reporter considered the adverse reaction to be related to HPV vaccine. Additional details were received as follows: The age at vaccination was not reported. The reporter was concerned about how terrible the vaccine was. It was on the top of the list with so many adverse reactions and side effects. The patient received vaccine and left bad enough reactions. This case was linked with case US2018GSK214693, reported by the same reporter (Daughter's case).
pt recvd flu vax is 1 of 15 pts who devel influenza & was hospitalized;
Pt contacted me through 3rd party on 12/16/21 that her arm had been hurting since the shot. She saw her doctor on Nov. 18th and they said "oh, it was given too high and it can last 6 months" She was concerned that the MD didn't offer to have it checked out. When I talked to her today she said its still hurting.
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were no provided. The reporter stated that 26-OCT-2018, the patient received an expired dose of VAQTA, lot # N020689, expiration date: 22-OCT-2018, intramuscular, for prophylaxis, (dosage, frequency and strength were no provided). There were no adverse events reported.