chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On 31-DEC-2012 the patient was vaccinated with ZOSTAVAX, 1DF, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of shingles. On or about 01-JUN-2013, the patient was treated at a clinic for the onset of a blistery rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. On or about 28-AUG-2013, the patient was treated again at the clinic for ongoing and worsening symptoms which was diagnosed as zoster neuralgic. The patient has been prescribed VALTREX and analgesics for management of his painful symptoms. As a direct and proximate result of these malfunctions, the patient has suffered and will continue to suffer significant medical expenses, lost wages, pain and suffering, and other damages. Additional information has been requested.
Patient reported shortness of breath, chills and cough with thick clear sputum that came on suddenly.
complains of headache, pain, swelling and redness at Tdap injection site which started 5 days post vaccination. No fever and no aches. 6 days post Tdap vaccination she reports having 2 episodes of tachycardia (120-140) while at work and questions if related to Tdap vaccination. When evaluated Pulse was 96 and BP 110/84. Left deltoid was tender to touch and red and slightly swollen; limited ROM due to discomfort; afebrile. Obivious localized reaction from Tdap. Consulted CDC help line for any reports of tachycardia with Tdap and none aware.
right hip was very painful, it killed him/ right hip started to kill him/ couldn't walk without his hip giving way from the pain; hardly could walk on it/ couldn't walk without his hip giving way from the pain/didn't have any problem with walking around until he took the vaccine; This is a spontaneous report from a contactable consumer (patient). An 82-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL9264), via an unspecified route of administration (left arm), on 02Feb2021 09:00, at single dose, for covid-19 immunization. Ongoing medical history included cholesterol, GERD, heart, and prostate. Concomitant medication included carvedilol (COREG) from 2011 and ongoing for heart; lovastatin (MEVACOR) from 2011 and ongoing for cholesterol; alfuzosin hydrochloride (UROXATRAL) from 2011 and ongoing for prostate; omeprazole (OMEPRAZOL) from 2016 and ongoing for GERD; torsemide from 2001 and ongoing for water pill for his heart; and sacubitril valsartan sodium hydrate (ENTRESTO) from 2011 and ongoing for heart. The patient took the first dose of the Pfizer vaccine yesterday, 02Feb2021, at 9:00 and at 15:00 his right hip was very painful, it killed him; hardly could walk on it. His right hip started to kill him. He couldn't walk without his hip giving way from the pain. He didn't have any problem with walking around until he took the vaccine. He wanted to know if it was going to go away. The patient had not recovered from the adverse events at the time of the report. The adverse events did not require a visit to a physician or ER. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. He was planning to receive the second dose on 23Feb2021 and mentioned that he was having a heart test later this week.
A non-serious spontaneous report of flu-like symptoms has been received form a physician concerning an eight-year-old male, subsequent to FLUMIST. Neither the patient's medical history nor the concomitant medications were reported. The patient received FLUMIST on 21-Nov-2011. On 05-Dec-2011, the patient experienced flu-like symptoms. The reporter stated that he did not believe that the patient was having a reaction to FLUMIST and he was going to conduct a rapid flu test. The outcome of the event flu-like symptoms was not recovered.
Approximately 2 hrs 30 min post administration I experienced mild parasthesia in my left ring finger and pinky finger and mild left arm muscle weakness and mild lady hand grasp weakness.  This episode lasted about 40-45 min, self resolved completely with no intervention.
Extensive arterial thrombus of the left lower extremity. Partial right lower extremity thrombus.  Interventions include heparin therapy and evaluation by cardiovascular surgery and interventional radiology
(OMIC) Information has been received from a physician concerning a 16 month old female with no medical history or allergies who on 2/21/2006 was vaccinated with a dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live + varicella virus vaccine live (upgrade process) (lot 652232/0772R). Concomitant therapy that day included a dose of diphtheria toxoid (+) Hib conj vaccine (tet toxoid) (+) pertussis acellular Biken vaccine (+) tetanus toxoid (TRIHIBIT). On 3/20/2006 the patient developed painful weeping lesions that crusted over along one dermatome. The lesions were on her right leg, upper thigh. The skin was denuded and showed evidence of a skin infection. There were less than 50 lesions. Unspecified medical attention was sought. No laboratory diagnostic test were performed. The patient was treated with amoxicillin + clavulanate potassium Augmentin. At the time of the report the patient was recovering, but had not yet been seen for a follow up visit. There was no product quality complaint involved. It was noted that therapy had been discontinued. Additional information has been requested.
arm ache; arm swelling; swelling that extended all over the elbow.; adverse event extended to elbow/ arm ache and arm swelling that extended all over the elbow.; This case was reported by a nurse via call center representative and described the occurrence of pain in arm in a 60-year-old female patient who received Herpes zoster (Shingrix) (batch number L7S74, expiry date 26th March 2022) for prophylaxis.   On 2nd June 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced pain in arm, swelling arm, swelling of elbows and pain in elbow. On an unknown date, the outcome of the pain in arm, swelling arm, swelling of elbows and pain in elbow were unknown.   It was unknown if the reporter considered the pain in arm, swelling arm, swelling of elbows and pain in elbow to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and experienced arm ache and arm swelling that extended all over the elbow. The reporter consented to follow up.  No further details were provided.
administered vaccine after temp excursion NOT supported; This spontaneous report was received from a nurse referring to a 4 months old patient of unknown gender. There was no information about the patient's concurrent conditions, drug reactions, allergies, medical history, and concomitant therapies provided.     On 16-JUN-2020, the patient was administered an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ)(lot # 1660704, expiration date 20-MAR-2021; exact dose and route of administration were not reported) for prophylaxis. No additional AE details are available.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2008USA013130: US-009507513-2008USA013131: US-009507513-2008USA011564: US-009507513-2009USA002369:
headache; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a patient and describes the occurrence of HEADACHE (headache) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEADACHE (headache). At the time of the report, HEADACHE (headache) outcome was unknown.            Reporter did not allow further contact
A spontaneous report was received from a consumer concerning a 77-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events headache the whole day, nauseated, muscle ache,  The patient's medical history was not provided. Concomitant medications reported were Depakote, Prozac, Crestor, Welbutrin, Synthroid, Tramadol, Vit C, Calcium, Vit. D3 all  for drug use for unknown indication.  On 13 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: Detail Batch Number) intramuscularly for prophylaxis of COVID-19 infection.  On 13 Feb 2021, the patient experienced the event(s) headache the whole day. nauseated, muscle ache.  Treatment details included :no treatment taken.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), headache the whole day, nauseated,muscle ache,  was unknown.
fatigue; hypersomnolence; alert and sweaty; This spontaneous case was reported by a health care professional and describes the occurrence of FATIGUE (fatigue), HYPERSOMNIA (hypersomnolence) and HYPERHIDROSIS (alert and sweaty) in a  patient of an unknown age and gender 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On an unknown date, the patient experienced FATIGUE (fatigue), HYPERSOMNIA (hypersomnolence) and HYPERHIDROSIS (alert and sweaty). At the time of the report, FATIGUE (fatigue), HYPERSOMNIA (hypersomnolence) and HYPERHIDROSIS (alert and sweaty) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       N0 concomitant medications are provided by the reporter. treatment to the events not reported.   This case was linked to MOD-2021-086001 (E2B Linked Report).; Sender's Comments:  MOD-2021-086001:Patient case
p/vax pt devel attenuated varicella rash 2 1/2wk later;no complications or sequelae from the rash;
PEDIARIX given in Left thigh. Vaccine leaked around needle where connected to syringe. Unsure of how much of the vaccine that infant received.
Patient began to appear flushed and sweaty. Was unable to speak clearly. Patient was placed in a wheel chair and taken to the Emergency Dept.
Presented w c/o of fever, shortness of breath and was diagnosed with COVID-19.  Patient was noted to be hypoxic and was started on O2, IV steroids, abx, Vit C, zin.  Patient was out of window for remdesivir.  Patient slowly improved and was able to be weaned off to room air.
This spontaneous report was received from a nurse refers to a patient of unknown age and gender. No pertinent medical history was reported. On 12-FEB-2015, the patient was vaccinated with expired dose of RECOMBIVAX HB INJ (lot # J001836 and expiration date 01-FEB-2015) (strength, dose and route were not reported). No adverse events reported. No product Quality Complaint (PQC) was involved. Additional information has been requested.
Localized area of redness and warmth > 11-12cm in size; (L) thigh.
Left thigh has large 4.5 x 7.5' erythematous swelling on anterior thigh, mild induration at center, no inguinal adenopathy; patient is ambulative, well.
My left knee became stiff and swollen, but it has gotten worse and now very swollen and stiff at knee, below and above knee.; My left knee became stiff and swollen, but it has gotten worse and now very swollen and stiff at knee, below and above knee.; This is a spontaneous report from a contactable consumer (Patient). A 61-years-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6206, Expiration date was not reported), via an unspecified route of administration, administered in Arm Left on 06Mar2021 07:45 (age at vaccination 61 years) as 1st dose, single dose for covid-19 immunisation. Patient had no medical history, No known Allergies. Patient had no covid prior or since vaccination. Concomitant medications in two weeks included losartan (LOSARTAN); hydrochlorothiazide (HYDROCHLOROTHIAZIDE); cetirizine hydrochloride (ZYRTEC); esomeprazole magnesium (NEXIUM); acetylsalicylic acid (BABY ASPIRIN). On 06Mar2021 08:00 the patient experienced his left knee became stiff and swollen, but it has gotten worse and now very swollen and stiff at knee, below and above knee. The outcome of events was not recovered.  No follow-up attempts are possible. No further information is expected.
rt upper arm swollen & ecchymotic, warm to touch, large area of redness surrounding inject site; ice to site;
Area of injection sight is very sore, red and covers about a 2 inch across span and is 5 inches down from shoulder. Patient was told to take ibuprofen daily and rub the area with rubbing alcohol.
Intense pain upon injection. Shortly after leading to face and neck tightness which resolved. But severe pain in arm continued to develop over the next day.  I am still having pain in my arm since that flu shot. The pain does not get better with nsaids. Worsens with certain movements such as putting on a shirt, lifting arm up or turning over in bed.
5/19 - Left side body pain.  Nerve pain.  localized to rib area.   5/20 - Left side body pain.  Nerve pain.  localized to rib area.  Took some curcumin at lunch and pain went away for 5-7 hours and returned in the evening. 5/21 - In addition to left side nerve pain, woke up with right leg nerve pain. Localized to side of my right leg.   Just a couple inches above the knee on the external side of my leg.  I took curcumin at lunch and then again in the evening.  Pain went away completely for my left side and my right leg. 5/21 - Elevated temperature.  I would periodically break out into a sweat and then it would go away.  I took my temperature and found it was slightly elevated.  I normally run 97.5 or so.  It was 98.9 when I took it.  It would pass quickly (but it would happen if I was just sitting and working). 6/2 - Ankle swelling.  Both left & right ankles swollen.   Slept with legs elevated.  It  has been warm, but I have never had a problem with swollen ankles. 6/3 - Swelling was reduced on both ankles when I woke up on 6/3.  As the day went on, left ankle is swollen.  Right ankle is fine.
Menstrual spotting for 4 days then started my period 11 before I was due. I'm on hormonal birth control and do not otherwise have spotting or early bleeding.
Patient stated she experienced soreness after vaccination, worsening each day after. Then had pain, redness, swelling at injection site, requiring antibiotic course. Then started to spread to neck and face on 5-19-18.
D68.9 COAGULOPATHY, UNSPECIFIED TYPE 3/23/2022 ADULT OBSTRUCTIVE SLEEP APNEA J96.20 ACUTE ON CHRONIC RESPIRATORY FAILURE 3/23/2022 ADULT OBSTRUCTIVE SLEEP APNEA D68.9 COAGULOPATHY, UNSPECIFIED TYPE 3/23/2022 PULMONARY HTN J96.20 ACUTE ON CHRONIC RESPIRATORY FAILURE 3/23/2022 PULMONARY HTN D68.9 COAGULOPATHY, UNSPECIFIED TYPE 3/23/2022 ATRIAL FIBRILLATION, PAROXYSMAL    CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED J96.20 ACUTE ON CHRONIC RESPIRATORY FAILURE 3/23/2022 ATRIAL FIBRILLATION, PAROXYSMAL    CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED D68.9 COAGULOPATHY, UNSPECIFIED TYPE 3/23/2022 ACUTE ON CHRONIC RESPIRATORY FAILURE J96.20 ACUTE ON CHRONIC RESPIRATORY FAILURE 3/23/2022 ACUTE ON CHRONIC RESPIRATORY FAILURE D68.9 COAGULOPATHY, UNSPECIFIED TYPE 3/23/2022 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED J96.20 ACUTE ON CHRONIC RESPIRATORY FAILURE 3/23/2022 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED D68.9 COAGULOPATHY, UNSPECIFIED TYPE 3/23/2022 ATRIAL FIBRILLATION, PAROXYSMAL    PROSTHETIC HEART VALVE LEAKAGE, SUBSEQ J96.20 ACUTE ON CHRONIC RESPIRATORY FAILURE 3/23/2022 ATRIAL FIBRILLATION, PAROXYSMAL    PROSTHETIC HEART VALVE LEAKAGE, SUBSEQ D68.9 COAGULOPATHY, UNSPECIFIED TYPE 3/23/2022 SEPTIC SHOCK J96.20 ACUTE ON CHRONIC RESPIRATORY FAILURE 3/23/2022 SEPTIC SHOCK D68.9 COAGULOPATHY, UNSPECIFIED TYPE 3/23/2022 ACUTE ON CHRONIC RESPIRATORY FAILURE J96.20 ACUTE ON CHRONIC RESPIRATORY FAILURE 3/23/2022 ACUTE ON CHRONIC RESPIRATORY FAILURE D68.9 COAGULOPATHY, UNSPECIFIED TYPE 3/23/2022 ACUTE ON CHRONIC RESPIRATORY FAILURE J96.20 ACUTE ON CHRONIC RESPIRATORY FAILURE 3/23/2022 ACUTE ON CHRONIC RESPIRATORY FAILURE
This spontaneous report was received from a healthcare worker refers to a patient of unknown age. On an unknown date, the patient was vaccinated with temperature recursion experienced PEDVAXHIB lot # J009714. The outcome of the event was not reported. On 22-APR-2014, a phone call was placed to healthcare worker. The phone call went directly to voicemail. A voicemail message was left requesting that the healthcare worker return the phone call. Additionally, a request was made for patient identifiers, lot number and expiration date and date of vaccination. On 22-APR-2014, a phone call was received from healthcare worker. The healthcare worker was able to list the vaccines that experienced a temperature excursion. The healthcare worker stated she would do further research and attempt to fax over the list of patients who received the vaccines that had experienced a temperature excursion, by Lot number and also include the date of vaccination. The event temperature recursion experienced vaccine was considered to be not related to PEDVAXHIB. This case is linked to the case # 1404USA010658, # 1404USA010659, # 1404USA012082, # 1404USA012083, # 1404USA012084, # 1404USA012085, # 1404USA012086, # 1404USA012087, # 1404USA012088 and # 1404USA012089 (same reporter link). Additional information has been requested.
Patient described symptoms consistent with expected effects of Moderna mRNA vaccine, at the anticipated time-frame, and was advised so. Patient requested the event be reported anyway.  Patient did not express that these effects were severe, or that they warranted medical intervention.
HTN; He had a sore arm at first however; Flu like symptoms; Redness on both arms, face, and various pars of his body/The redness was severe; Redness on both arms, face, and various pars of his body/The redness was severe; Fever; Tiredness; Weakness; Neck stiffness; This is a spontaneous report from a contactable consumer (patient). A 74-years-old male patient received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine, in a Pharmacy, via an unspecified route of administration on 04Feb2021 (Batch/Lot Number: EL9262) as single dose for COVID-19 immunization. Medical history included seizure from 2006 to an unknown date. The patient's concomitant medications were not reported. The patient stated that he had a sore arm at first (in Feb2021) however, 5 days later, in Feb2021, he reported flu like symptoms, redness on both arms, face, and various parts of his body, fever, tiredness and weakness, neck stiffness. He talked to a physician assistant and pharmacist and both thought it was an unusual event and said to report it to Pfizer. The redness was severe. He had to use some cream on his hands. Moreover the patient reported that he had currently hypertension. His second dose is scheduled for 25Feb2021. He isn't sure if he should get the second dose or not. He did not get a copy of the Fact Sheet for Recipients and Caregivers. The patient asked if he could get Moderna vaccine for his second dose. He also stated he would talk to his primary care physician about this, but will probably start over with the Moderna vaccine and get two doses of their vaccine. The events outcome was unknown at the time of the report.  Follow-up attempts are completed. No further information is expected.
patient accidentally received third dose of Shingrix; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (first two doses of Shingrix were administered back in 2018).   On 5th February 2023, the patient received the 3rd dose of Shingrix. On 5th February 2023, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   Linked case(s) involving the same patient:  US2023023345   Additional Information: GSK Receipt date: 13-Feb-2023. Reporter's Comment: The reporter was pharmacy manager. Caller reported patient accidentally received third dose of Shingrix. Caller did not have patient demos at time of call, as they were not in the pharmacy. Pharmacist called to inquire for any information on a third dose of Shingrix. Reporter was unable to provide any additional information. The reporter consented to follow-up. Additional Supportive Information: Patient accidentally received third dose of Shingrix, which led to extra dose administered. Case US2023023345 was identified as duplicate case of US2023023336.All the future correspondence will be added to case US2023023336 (case of record).
Information has been received from a nurse practitioner (N.P.), concerning a patient of unknown age and gender. In 2010, three years ago, the patient received the first and second doses of GARDASIL (doses, route and frequencies were not reported). It was reported that now, in 2013, the patient would like to receive the third dose of GARDASIL. No adverse symptoms were reported. Additional information has been requested.
It's chronic pain in my left shoulder and it goes down into my elbow. The pain into my elbow started this morning 9/16/2021. The pain has gotten a lot more intense. I can't do anything with it. I alter heat and ice on the area. I started physical therapy in August from the first shot. I didn't connect the symptoms between the two doses until I got the second vaccine. I notice the exact same symptoms.
1st dose 23rd january 2019, 2nd not yet; First dose administered 01/23/2019; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 45-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 23-JAN-2019, the patient received the 1st dose of Shingrix. On an unknown date, the patient did not receive the 2nd dose of Shingrix. On 23-JAN-2019, an unknown time after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced inappropriate age at vaccine administration (Verbatim: First dose administered 01/23/2019). On an unknown date, the patient experienced incomplete course of vaccination (Verbatim: 1st dose 23rd january 2019, 2nd not yet). The outcome of the inappropriate age at vaccine administration and incomplete course of vaccination were unknown.   Additional Information: GSK Receipt date: 27-APR-2023 The pharmacist reporting a second dose greater than 6 months and had not yet been administered. The health care practitioner consents to safety team follow up.  No additional adverse event details available at this time. The reporter consented to follow up. The first dose administered at age of 45 years, which led to Inappropriate age at vaccine administration. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
NO ADVERSE.  Reporting administration error only.  Patient was given expired vaccine.  FK5618 expired on 08/31/2022 according to Pfizer website.  But, vial with that LOT# was given to patient on 09/09/2022.  Pfizer had no guidance.  Per CDC administration errors algorithm, patient was rescheduled for re-vaccination.
Large allergic reaction at the site of injection. Big, white itchy spot about the size of a silver dollar, surrounded by many other smaller spots. Came on very suddenly a week after the Moderna vaccine, within a matter of moments from first feeling a bit itchy.