chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. In 2015, a healthcare provider administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 17-NOV-2016, the patient was treated by a healthcare provider for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
Pulmonary embolism; This literature-non-study case was reported in a literature article and describes the occurrence of PULMONARY EMBOLISM (Pulmonary embolism) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.   LITERATURE REFERENCE:     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 50 microgram. On an unknown date, the patient experienced PULMONARY EMBOLISM (Pulmonary embolism) (seriousness criterion medically significant). At the time of the report, PULMONARY EMBOLISM (Pulmonary embolism) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant and treatment medications were not reported. The study included adults with age equal to or more than 50 years.  All subjects were divided in two groups, first received RZV vaccine two weeks after booster dose of Moderna vaccine and second group received concomitantly. Both groups received second dose of RZV after two months of first dose. Author concluded that co-administration of mRNA-1273 booster vaccine with RZV was immunologically noninferior to sequential administration and had a safety and reactogenicity profile consistent with both vaccines.  Company Comment: This is a literature non-study case concerning a patient of unknown age and gender with no medical history, who experienced the serious (due to medically significant) unexpected AESI pulmonary embolism.  The event occurred after receiving a booster dose of mRNA-1273 vaccine (dose number and event date not reported). No concomitant and treatment medications were reported. The outcome of the event was reported as unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Left hip pain, inflammation, loss of strength (weak), motor sound in ear, shaking (involuntarily movement), blood clot found in left leg.
About 10 hours after the vaccine I started shaking uncontrollably, severe chills, teeth chattering uncontrollably which lead to biting my tongue several times, with my jaw locking at times. It felt nearly impossible to get up out of bed but after about 20 minutes I was able to get up and put on many layers of clothes for warmth. I took my temperature but it was normal 98.7 and I took 600mgs ibuprofen.
Started coughing late in the evening and it lasted most of the night.  After that cough became less frequent and down to just a couple of times a day.
Patient administered incorrect vaccine. Pediatrician contacted family 8/18/18 and notified them in the words of the mother that patient "accidentally got shingles vaccine rather than chicken pox vaccine yesterday."  Presented to Urgent Care with fever, cough, runny nose and mother reports patient is "lethargic."
Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concurrent medical conditions included No adverse event.    On 12-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication list was not provided. Treatment information was not provided.
kind of bad; thought she was coming down with a cold; very confused; fatigue/tiredness; This spontaneous case was reported by an other health care professional and describes the occurrence of FEELING ABNORMAL (kind of bad), NASOPHARYNGITIS (thought she was coming down with a cold), CONFUSIONAL STATE (very confused) and FATIGUE (fatigue/tiredness) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022C21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19. Concurrent medical conditions included Multiple sclerosis.    On 29-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Sep-2021, the patient experienced FEELING ABNORMAL (kind of bad), NASOPHARYNGITIS (thought she was coming down with a cold), CONFUSIONAL STATE (very confused) and FATIGUE (fatigue/tiredness). The patient was treated with PARACETAMOL, PHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE (THERAFLU [PARACETAMOL;PHENIRAMINE MALEATE;PHENYLEPHRINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (kind of bad), NASOPHARYNGITIS (thought she was coming down with a cold), CONFUSIONAL STATE (very confused) and FATIGUE (fatigue/tiredness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Medical history and concurrent conditions were not provided. On 05-JAN-2015, the patient was vaccinated with an expired dose of M-M-R II subcutaneous, 0.5 ml, lot number H012142, expiry date 29-JUN-2014. No adverse effect reported. Additional information has been requested.
Left Deltoid - 9cm raised warm erythematous area. No exudate. Painful.
Pt recvd vax & exp acute urticaria; pt was seen by MD & treated w/Hydroxyzine, Antihistamines;
Approximately 5 - 6 minutes after receiving the Pfizer vaccine she began to complain of feeling very hot and sudden onset nausea.  Her skin was noted to be cool and her ears and face were flushed.  Her blood pressure was elevated 180/90. She denied any pain or tingling in her chest or extremities. She was escorted to the emergency room for further evaluation.
24 hours after my 2nd vaccine I had symptoms of severe fatigue and body aches. I had a low grade fever and headache. The following morning I had pain in my left axilla, low grade fever, headache and body aches. I left work early because of severe fatigue and was out the following day for symptoms due to covid vaccine.
Tested positive for covid.; Tested positive for covid.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 24Aug2021 as dose 1, single (Lot number: FC3182) and on 16Sep2021 as dose 2, single (Lot number: FC3180) at the age of 28 years for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 22Feb2023, outcome "recovered" and all described as "Tested positive for covid.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (22Feb2023) Positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of drug ineffective, covid-19.    No follow-up attempts are possible. No further information is expected.
7 hours after vaccine -> very sudden weakness in arm & legs. Violent shaking. Fever. 102 degrees. Lasting 14 hours. Vaccine given at 12:06 pm - 10/20/11.
Monday started having swelling behind my neck between my two shoulders and then a headache began. Went to Healthcare expressed by the doctor did not think it was blood clot, but probably related to the vaccine. Gave me a steroid and muscle relaxer sent me home to call provider next day. Had Televisit with primary?s Wednesday April 14, 2021, by then news had broke about the new type of blood clot CVST and the low platelet count, I explained still had headache and swelling, sour stomach over night(have had this before) and felt weak for a brief few minutes on right side but quickly went away, also was walking for a brief few minutes like I was drunk, again went away after a few minutes.  Discussed with primary my anxiety could be contributing to some of the extra feelings I was having, agreed to do bloodwork to check platelet levels. She did not think it was blood clots discussed with me about what I needed to look for and to go to ER immediately if I experienced any of them.  Blood work did today, Thursday April 15, 2021.  still headache and some swelling in back of neck between shoulders, dizzy off and on. All pain moderate to mild. Awaiting blood work for next step.
Patient's mother reports patient c/o of chest pain with inhalation, swollen/sore throat, weakness, and dizziness with change of position. Pt's mom was advised to take pt to ED or urgent care for evaluation.
Patient accidentaly received a dose of 0.3ml of concentrated vaccine instead of reconstituted vaccine. At the time the error was caught, we contacted Pfizer who said that it is not harmful but that they are more likely to experience pain in the injected arm and should be monitored for symptoms. A claim was filed with pharmacy and the patient was contacted. At that time she was reporting pain at the injection site. The patient's pediatricians office was contacted and when the pediatrician spoke to the family they reported arm pain as well.
No additional AE reported; administered improperly stored PNEUMOVAX 23 Syringe; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. Information about pertinent medical history, drug reaction/allergy and concomitant medication was not provided.       On 02-JAN-2021 (reported as night before last), the patient was vaccinated with improperly stored dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (lot # T022294, expiration date 26-MAR-2022; strength, dose, route of administration and anatomical location were not reported) for prophylaxis (product storage error). No adverse event (AE) or product quality complaint (PQC) was reported. No product quality complaint (PQC) was reported. Current temperature excursion was 60.57 Fahrenheit degrees for 6 hours and 39 minutes. There was no previous temperature excursion.
The day after receiving flu vaccine, she reported neck rigid & very painful. Has had similar reaction with previous flu shots (no fever).
C/o weakness, lightheadedness and redness above injection site, up neck and down back x 2 hours.
For over two weeks after vaccine 1 suffered from dizziness, disorientation, hot and cold sweats, joint pain and had a lump in my arm. These are not acceptable side effects.
Patient claims 3 hours after receiving the vaccine his foot began to swell. It is now 24 hours after receiving the vaccine and he claims the foot has continued to swell.
flu; Initial information received on 26-Dec-2022 regarding an unsolicited valid social media non-serious case received via consumer/non-hcp.  This case involves patient of unknown demographics who experienced flu while receiving vaccine Influenza Vaccine (Flu shot).  It was unknown if the patient had any medical history, concomitant disease or risk factor.   On an unknown date in Oct, the patient received suspect Flu shot produced by unknown manufacturer at (unknown: formulation, strength, dose, lot number, route in unknown administration site) for prophylactic vaccination. Information regarding batch number requested.  On an unknown date in first week of December, the patient developed flu (influenza) at unknown latency following the administration of Influenza vaccine.  Action taken: Not applicable.  Corrective treatment: not reported.  At time of reporting, the outcome was Unknown for the event influenza.
Approximately 5 minutes after receiving the Moderna COVID-19 vaccine in my left deltoid, my mouth felt prickly and tasted metallic, my lips and tongue turned red and slightly swollen, along with swelling in my throat. After about 30 minutes the oral sensations improved, but my throat tightness increased. With some difficulty I swallowed a 25 mg capsule of diphenhydramine. Fifteen minutes after ingesting the capsule, the esophageal swelling improved slightly. Over the next 18 hours I continued taking 50 mg diphenhydramine every 4-6 hours. On 12/31/20 I no longer experienced any oral/esophageal swelling or abnormal sensations. However on 12/31/20 I developed severe pain and swelling at the injection site, extending to the left shoulder, head and neck, along with profound fatigue and full body myalgias and arthralgias, lasting through 1/3/21. I felt well January 4-6. However, on the evening of 1/6/21 I again developed  severe pain and swelling at the injection site, extending to the left shoulder, head and neck, along with profound fatigue and full body myalgias and arthralgias, persisting until 1/9/21. On 1/8/21 I additionally experienced pruritis and erythema on my left deltoid, this resolved spontaneously on 1/10/21.
Pt recvd 3 doses of Hep B & subseequent to 3rd dose, pt devel serum sickness as well as hepatomegaly;
Pain traveled up shoulder to ear; Pain traveled up shoulder to ear; strong dizziness that dissipated to minor dizziness within 15 minute wait; Pain in shoulder to neck; This is a spontaneous report from a contactable consumer (patient). A 46-years-old non-pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283, expiration date unknown), via an unspecified route of administration (left arm) on 13Jan2021 at 10:45 at a single dose for COVID-19 immunization. Medical history included Polycystic Ovarian Syndrome (PCOS), allergies, excessing calcification of veins and arteries, high blood pressure (BP), and known allergies to trees, grass and weeds. Concomitant medications included metformin (METFORMIN), rosuvastatin (ROSUVASTATIN), levothyroxine (LEVOTHYROXINE), and liothyronine (LIOTHYRONINE). The patient had no other vaccine in four weeks. On 13Jan2021, the patient experienced pain traveled up shoulder to ear, strong dizziness that dissipated to minor dizziness within 15-minute wait and pain in shoulder to neck has lessened 48 hours later, but still present. The patient had no COVID prior vaccination and had no COVID test post-vaccination. No treatment administered for the events. The events were resolving at the time of the report.
This spontaneous report was received from a physician and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with a dose of improperly stored VARIVAX 1 dose (lot # L050561, expiration date: 14-DEC-2017; route was not provided). No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.
Pt was given a MMR vaccine on 07/18/08, he then reported having a rash and reddened eyes two weeks later, pt was instructed to seek medical attention, pt went to his PCP and was told it was because of his allergy to Neomycin, Pt signed a consent form stating he was not allergic to neomycin.
The last time I took a flu shot I almost died; Initial information received on 26-Nov-2022 regarding an unsolicited valid social media non-serious case received from a consumer/non-hcp (non-healthcare professional).  This case involves a patient of an unknown age and gender who reported the last time I took a flu shot I almost died after receiving influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect Influenza Vaccine produced by unknown manufacturer (with an unknown strength, formulation, administration site, lot number and expiry date ) for immunization.  On an unknown date, the patient reported last time he took a flu shot he almost died (Adverse event) (latency: unknown) following the administration of influenza vaccine.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.  Outcome: Unknown.
Patient presented to pharmacy on 5/18/2019 with rash at injection site on left deltoid extending towards left bicep about 3 inches in diameter.  Was not raised.  Patient states that it was painful, but had not spread since the initial presentation on the morning of 5/17/2019, the day after she received the injection.  She was instructed to take benadryl for the rash, tylenol for the pain, and to seek medical treatment if the rash began to quickly spread, became very painful, and/or she developed a fever (temp > 100.5).
second dose is past 36 day mark; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose is past 36 day mark) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose is past 36 day mark). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose is past 36 day mark) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose is past 36 day mark) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose is past 36 day mark). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose is past 36 day mark) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 11-May-2021 and was forwarded to Moderna on 11-May-2021.  On an unknown date, post vaccination, the patient reported that she is 36 days late on her 2nd dose of the COVID-19.   No treatment information was provided
pt recvd vax in lt arm-arm swollen & red welt appeared next day; also red streak from welt to elbow; seen by MD given ATB & DPH;
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Feb2021 at 16:00 as dose 1, single (Lot number: EL9269), in left arm, on 24Feb2021 at 16:00 as dose 2, single (Lot number: EL9269), in left arm, on 05Nov2021 at 15:00 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 23May2022 at 15:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 49 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "anemia" (unspecified if ongoing); "malabsorption syndrome" (unspecified if ongoing); "gastroparesis" (unspecified if ongoing); "IBS" (unspecified if ongoing), notes: Other medical history:IBS. The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant) all with onset Jun2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of covid-19, vaccination failure.  Clinical course: Report about covid treatment reported as Yes. If vaccine received reported as Yes. Other medication in 2 weeks reported as No. Anti-viral details: product: COVID 19 Treatment, brand: Paxlovid, treatment start date: 28Jun2022, treatment stop date: 02Jul2022, Indication: Treatment of COVID-19. adverse event reported as The most horrible taste in mouth, with heartburn and regurgitation. Stopped taking Paxlovid on 2Jul2022. Last dose taken was seven out of ten.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
no adverse event; Monovalent doses administered after the BUD to patients.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients) and NO ADVERSE EVENT (no adverse event) in a 67-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 065K21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 26-May-2022, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 26-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients.). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients).    Patient ID was reported as unknown. It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. No concomitant drug was reported. No treatment drug was reported.   This case was linked to MOD-2022-691014 (Patient Link).