chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; On 05 Mar 2021, she received first dose of COVID-19 vaccine manufactured by Moderna. On 21 Apr 2021, she received second dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (On 05 Mar 2021, she received first dose of COVID-19 vaccine manufactured by Moderna. On 21 Apr 2021, she received second dose) and NO ADVERSE EVENT (No adverse event) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No Medical History information was reported.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. On 21-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (On 05 Mar 2021, she received first dose of COVID-19 vaccine manufactured by Moderna. On 21 Apr 2021, she received second dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (On 05 Mar 2021, she received first dose of COVID-19 vaccine manufactured by Moderna. On 21 Apr 2021, she received second dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            No concomitant medications was reported. No treatment medications was reported.  It was unknown if patient was enrolled in a COVID-19 vaccine trial.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2021-622911.
I received the shingles vaccine on 22 Aug 07. I was diagnosed with shingles on 2 Jul 09. I had hurt and had breakouts for several weeks prior to suspecting shingles. Doctor prescribed 2 prescriptions, Valtrex and Lyrica. I could not take Lyrica because it made me really dizzy.
High fever, prolonged crying and agitation, restlessness, irritability lasting 5 days, weightloss/loss of appetite.  Very unlike her everyday behavior.  Was examined at her 12 month well check    Then taken for follow up 5 days later (post vaccination), no explained illnesses could be found.  One week later, irritability and behavior returned to normal.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was inoculated with ZOSTAVAX (lot number, dosage, and route of administration not provided) on or about 22-DEC-2015, as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 01-JUN-2016, the patient was treated at an eye clinic for a painful rash that was diagnosed by the physician as a severe case of shingles keratitis, a condition where the shingles virus spreads to the eyes. Herpes viral keratitis can damage the eye and cause permanent blindness. Although shingles is an incurable condition, the patient was prescribed LYRICA, acyclovir, and trifluridine 1% eye drops to help manage her painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Upon internal review, shingles keratitis was determined to be medically significant. Additional information has been requested.
61 Year old female presented with shortness of breath and was found to have a platelet count of 11 k/ul ( She had a platelet count of 184 k/ul 12 days prior). She received 2nd dose of Pfizer vaccine 21 days prior to the event. She received steroids with improvement in platelet count.A diagnosis of immune thrombocytopenia ( non thrombotic) was made.
Headache, nausea, soreness, muscle soreness, dizziness, arm pain,
Headache (unresponsive to acetaminophen)  Neck & shoulder soreness / tightness
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age or gender. No information was provided regarding the patient's concomitant medications, pertinent medical history, drug reactions or allergies. On 19-DEC-2017, the patient was inadvertently vaccinated with an expired dose of ZOSTAVAX subcutaneously (exact dose was not reported; lot # M038864 with the expiration date of 12-DEC-2017) for prophylaxis. The administered dose of ZOSTAVAX was reconstituted with sterile diluent (lot# and expiration date were not reported). No adverse effects were reported.
Adverse effect of other vaccines and biological substances, initial encounter on 2023-07-01.
rt sided twitching of head, mouth & arm- 3-4 twitching lasting 10-20 sec total time;2 or 3 episodes in 24hr;
Patient is a 87 y.o. female patient of, DO with history of hypertension, hyperlipidemia, CKD stage III, colon cancer, generalized osteoarthritis, vitamin D deficiency, history of pulmonary embolism on Eliquis, recent admission from 9/14/2023 to 9/25/2023 for acute metabolic encephalopathy in the setting of hypertensive emergency and possible sepsis presented to Hospital with concern of altered mental status and increased fatigue.  On arrival patient found to have a fever of 101.9 °F with tachycardia and tachypnea.  Patient tested positive for COVID-19 infection.  Patient is being admitted for further management.   COVID-19 pneumonia Acute metabolic encephalopathy 2/2 above resolved Acute hypoxemic respiratory failure secondary to COVID, resolved Patient's CODE STATUS was confirmed with patient's son, patient is DNR CC CXR no acute cardiopulmonary pathology on admission Patient was desatting requiring 2 L of oxygen with admission   Continue respiratory support, keep SPO2 above 94% Continue IV Decadron 6 mg daily Consult ID.  They started Paxlovid.       AKI 2/2 dehydration, resolved Mild hyponatremia, resolved Creatinine elevated 1.51 on presentation with baseline around 1 Start patient on gentle IV fluid hydration   Hypertension Continue amlodipine and metoprolol Holding losartan due to AKI   Hyperlipidemia Continue statin   History of pulmonary embolism Continue Eliquis   Hypophosphatemia Replacement ordered
This spontaneous report as received from a registered pharmacist refers to a 79 years old female patient. The patient was vaccinated with a dose of ZOSTAVAX (Lot # H016762, expiration date 11-DEC-2013) SQ on 21-DEC-2012. No concomitant medications were reported. The pharmacist reported that on 26-DEC-2012, the patient developed an itchy red rash on both legs. The patient did not receive treatment for the adverse event. There were no Lab diagnosis or studies performed. At the time of the report, the patient was recovering. Additional information has been requested.
Patient states that arm has been sore for over 1 month. Now on a course of prednisone.
Severe sleepiness, for over 7 days, very bad headache, sweating and high fever, no appetite.
refrigerator containing Fluzone went down to 29.1F. After that excursion, injections administered to patient / no AE; Initial information received on 07-Feb-2020 regarding an unsolicited valid non-serious case received from other health professional.  This case was linked to cases 2020SA032577, 2020SA038302, 2020SA038343, 2020SA038344, 2020SA038345, 2020SA038346, 2020SA038347, 2020SA038348, 2020SA038349, 2020SA038350, 2020SA038351, 2020SA038352, 2020SA038468, 2020SA038469, 2020SA038470, 2020SA038471, 2020SA038472, 2020SA038467, 2020SA038474 and 2020SA038473 (same reporter)  This case involves a 6 years old patient of unknown gender who received 0.5 ml dose of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE] lot UJ254AC (Expiry date 30-Jun-2020) via unknown route in the left Deltoid for Prophylactic vaccination which was exposed to refrigerator down to 29.1F.  Medical history, medical treatment(s), concomitant therapy, vaccination(s) and family history were not provided.  It was an actual medication error case due to Product storage error temperature too low (Product storage error).  Patient did not receive any adverse event at the time of reporting.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance 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.
Syncope Narrative:  Complaint of lightheadedness 15 seconds after administration of vaccine. Patient lowered to floor safely by RN, followed by syncope and loss of consciousness. EMS called. Patient returned to baseline oriented with stable vital signs following event. Patient left clinic in stable condition after monitoring by RN for approximately 1 hour.
Nausea and loss of appetite after first hour following injection. Some dizziness and headache. Second day fever spiked to 101 within a 30 minute time frame. Body aches and joint pain worse than I?ve felt in years, couldn?t sleep due to the pain, took Tylenol and slept for 16 hours, still had fever the next day (day 3) couldn?t move my arm for 4-5 days.  Didn?t eat for 2.5 days following injection.
Information has been received from a physician concerning a 15 month old female with no medical history or concurrent condition who on 16-JUL-2009 was vaccinated subcutaneously with the first 0.5 mL dose of MMR II (lot # 663164/1583X).  Second suspect vaccine included a dose of VARIVAX (Merck) and a dose of VAQTA on the same date.  Concomitant therapy included a dose of PENTACEL and a dose of PREVNAR on the same date.  On 26-JUL-2009 the patient "developed a measles-like rash that covered about 80% of her body." The patient sought medical attention by visiting the physician's office.  The patient recovered on unspecified date.  Additional information has been requested.
A report had been received from a consumer concerning a female patient. Patient had allergies to ibuprofen where she got blood blisters on her legs and mouth, allergies to AUGMENTIN where she got a rash. Patient received nasal FLUMIST (intranasal), 0.2 millilitres, single administration for flu prevention on 30-Sep-2015. Patient reported that she got nosebleed, sore throat, and general stuffiness like a head cold for three days and then it stopped. Patient stated that the nosebleed never happened to her before and this was the first time. The patient recovered from sore throat, general stuffiness like a head cold and nosebleed on an unspecified date. The company physician assessed nosebleed, sore throat and general stuffiness like a head cold to be non-serious.
Left axillary lymphedema (swollen under arm pit).  Can?t sleep on that side or lay arm flat on that side. Right side is perfectly fine.   Slight left neck swelling also. Significant injection site pain with mild redness and swelling. Joint/muscle pain. These events also occurred after my  first  covid Pfizer but not until day 4-5 and very mild. I have not taken any medication as of yet.
headaches; fever; diarrhea; felt terrible; shivering; This case was reported by a physician via call center representative and described the occurrence of headache in a 78-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In May 2019, the patient received the 1st dose of Shingrix (intramuscular). In May 2019, less than a day after receiving Shingrix, the patient experienced headache, fever, shivering, diarrhea and feels awful. On an unknown date, the outcome of the headache, fever, shivering, diarrhea and feels awful were recovered/resolved.   It was unknown if the reporter considered the headache, fever, shivering, diarrhea and feels awful to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The physician reported that his wife received Shingrix. After vaccination in the evening she developed headaches, fever, shivering and diarrhea. The shivering was so bad that it was like she had rigors. The shivering resolved within about a day, but she still felt terrible for 3 days before the symptoms resolved. The patient looked so bad that he was close to taking her to the emergency room when it suddenly improved.
I tested positive for Covid (for the first time) on October 19th. My symptoms were mild, but I took Paxlovid when I felt a cough coming on. I tested negative on October 27 and 29. On October 30, I developed a cough that my doctor told me was a "post-Covid" infection, but continued to test negative for Covid. I was treated with Tussin pearls and codeine. I am still mildly affected by the cough today.
Approx. 2 hours after vaccination patient reports tingling around the mouth, which spread to both arms and legs with numbness and weakness in legs. States hand spasmed closed and tongue swelled. Patient was at home, mother called EMS and was transported to the ER. Per patient symptoms resolved within an hour of onset. Released from ER to home per patient report.
This spontaneous report was received from the patient's husband regarding a 20 year old female patient. Patient had no drug reactions/allergies. Information on pertinent medical history and concomitant medications were not reported. On 20-FEB-2018, the patient received GARDASIL 9 at an unspecified ob-gyn medical office to avoid hpv (prophylaxis) (dosing details were not reported). On 27-FEB-2018, the patient found out that she was pregnant through an unspecified pregnancy test. Last menstrual period was 15 through 20, January 2018. Patient did not seek any medical attention. The reporter stated that he was uncomfortable providing information. No product quality complaint (PQC) was present.
I have noticed a high pitched tone in my ears when it is quiet.  I have not lost any hearing.  I did have my hearing checked in 12/2021.  I do not recall noticing this with the first two shots, just after the booster in 11/2021.
J96.00 ACUTE RESPIRATORY FAILURE 12/1/2022 ESRD (END STAGE RENAL DISEASE) R57.9 SHOCK, UNSPECIFIED 12/1/2022 ESRD (END STAGE RENAL DISEASE) J96.00 ACUTE RESPIRATORY FAILURE 12/1/2022 SUPRAVENTRICULAR TACHYCARDIA R57.9 SHOCK, UNSPECIFIED 12/1/2022 SUPRAVENTRICULAR TACHYCARDIA J96.00 ACUTE RESPIRATORY FAILURE 12/1/2022 ENCEPHALOPATHY R57.9 SHOCK, UNSPECIFIED 12/1/2022 ENCEPHALOPATHY J96.00 ACUTE RESPIRATORY FAILURE 12/1/2022 ESRD (END STAGE RENAL DISEASE) R57.9 SHOCK, UNSPECIFIED 12/1/2022 ESRD (END STAGE RENAL DISEASE) J96.00 ACUTE RESPIRATORY FAILURE 12/1/2022 COMFORT CARE ONLY R57.9 SHOCK, UNSPECIFIED 12/1/2022 COMFORT CARE ONLY
whole body aches, difficulty taking a deep breath, fever, blood pressure dropped to 98/68. onset "middle of the night" after receiving vaccine at 5pm
It was reported in an internet news article that an 18 year old female was vaccinated with Gardasil. In the article an infectious disease expert stated that "this vaccine stings a lot". The 18 year old college freshman consumer reported "it sure does". "She said other shots tend to hurt only at the moment of the needle stick, and not after the vaccine plunges in". She further stated, "it burns". The consumer felt that the pain and burn was related to therapy with Gardasil. No further information is available.
Elevated heart rate about 20 bpm for 2 hours. I thought it was anxiety.; Mild sore arm; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old (non-pregnant) female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EN6207), via an unspecified route of administration in the left arm on 19Mar2021 at 19:15 (at the age of 46-year-old), at dose 1, single for COVID-19 immunisation. Medical history included brain tumor, Respiratory tract congestion (undiagnosed constant congestion) and cough from congestion. The patient had allergy to band-aid adhesive (Known allergies: Bandaid adhesive). The patient did not receive any other medications within two weeks of vaccination. 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 4 weeks prior to the vaccination. On an unspecified date in 2021, the patient experienced mild sore arm. On 19Mar2021 at 19:15, immediately after the first shot, the patient experienced elevated heart rate about 20 bpm for 2 hours. The patient thought it was anxiety. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. On 19Mar2021 at 19:15, the patient underwent lab test and procedure which included heart rate and the result was elevated heart rate about 20 bpm. The clinical outcome of elevated heart rate was recovered on 19Mar2021 at 21:15. The clinical outcome of mild sore arm was unknown at the time of reporting.    No follow-up attempts are needed. No further information is expected.
Sudden death; A spontaneous report was received from Pfizer concerning a 60-year old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced sudden death.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 05 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (lot/batch:  unknown) for prophylaxis of COVID-19 infection.  On 08 Jan 2021, the patient died. No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not applicable.   The patient died on 08 Jan 2021. The cause of death was unknown/not reported. Plans for an autopsy were unknown/not provided.; Reporter's Comments: Very limited information regarding the event has been provided at this time and is insufficient for causality assessment. Further information has been requested.; Reported Cause(s) of Death: unknown cause of death
fever (highest 102.3) lightheadedness   took Tylenol (x2)
Experiencing tiredness and fatigue; This case was reported by a pharmacist via call center representative and described the occurrence of tiredness in a 65-year-old female patient who received Herpes zoster (Shingrix) (batch number 7797J, expiry date 12th May 2023) for prophylaxis.   On 16th February 2022, the patient received the 1st dose of Shingrix. In February 2022, less than a week after receiving Shingrix, the patient experienced tiredness. On an unknown date, the outcome of the tiredness was not recovered/not resolved.   It was unknown if the reporter considered the tiredness to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix vaccine and was now experiencing tiredness and fatigue. The vaccine administration facility was the same as primary reporter. No further information reported. The reporter consented to follow-up.
covid arm; Moderna rash; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (covid arm) and RASH (Moderna rash) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A and 014M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-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 VACCINATION SITE REACTION (covid arm) and RASH (Moderna rash). At the time of the report, VACCINATION SITE REACTION (covid arm) and RASH (Moderna rash) outcome was unknown.            Concomitant medication information was not provided by the reporter.                            Treatment information was not provided by the reporter.   This case was linked to MOD-2021-437129 (Patient Link).
1445 Post immunizations, patient complained of a headache and was sitting in the waiting room. His mother called to the nurse and I that he is having a seizure. On assessment patient was arching his back in the chair, eyes rolling to the back of the head and was rigidly involuntarily moving arms and legs. His head was supported by his father. EMT called by father. This lasted no greater than 45 sec. Soon patient relaxed and was lethargic and drifting in and out of sleep. Able to speak and state name. Denies chest pain, SOB, headache. Pupils equal and reactive to light. VS done, BP 68/46 Patient lifted and carried to exam table to lay down. HR 77, Temp 97.4 tempanic, O2 sat 99%, BP rechecked 94/68, HR 87, O2sat 98%. Neuro exam done, patient mildly lethargic, Oriented x3, PERRLA, CN II-XII intact, equal hand grasps and equal strong toe bends. 1455 EMT by bedside BS done 125. Neuro exam done by EMT WNL. Patient denies pain, chest pain, or SOB. Parents asked if they would like to go by ambulance to the ER. Patients parents refused and states they will call his pediatrician to see if he would like to see him vs driving to the ER.  1510 Discussed care with Dr the patients pediatrician. He states that this appears to be a adverse reaction to the TDAP vaccine and to report the findings to CDC. When asked where the patient should get evaluated. He states, "watch him for 2 hours, give him water and crackers, and send him home. But I am not responsible and you should call your collaborative MD." 1520 Dr called no answer and left a message. 1530 Reassessed patient, alert and oriented x3, VS stable. Neuro exam normal. Patient denied headache, chest pain, shortness of breath, throat discomfort, weakness, or paralysis. He remembers feeling the headache then the next thing he remembers is being lifted to the exam room. 1542 Dr, the Medical Director called and suggested we send patient to the ER for evaluation and seizure workup. Agreed with plan and discussed with parents. Parents agree and will be evaluated at parents preference ER. Advised parents to let him lay down in the car for the trip to avoid hypotension, monitor him closely and if seizure reoccurs call 911. They are asked to followup here Monday for recheck.
My second shot resulted in some chills; Fever; This is a spontaneous case received from a consumer (patient). A patient of an unspecified age and gender received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient experienced some chills and fever after getting second shot. It was reported that patient guess that just proves that the first shot was working. The side effects only lasted a day. The outcome of the events was recovered.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.