chrisvoncsefalvay/vaers-outcomes huggingface dataset:
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 condition, or concomitant medication. On or about 30-OCT-2016, the patient was vaccinated with ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, as recommended for routine adult health maintenance and 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. The patient began to experience painful symptoms. On or about 07-APR-2015 (note this is prior to vaccination date), the patient was treated by a nurse practitioner for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. The patient has been prescribed ZOVIRAX and hydroxyzine for management of her painful condition. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, 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. Additional information has been requested.
rec eived her first dose of Moderna COVID-19 vaccine on 03/04/2021, and was not due for a second dose until April 1, 2021. She was inadvertently given her second dose of Moderna COVID-19 vaccine one week too early on 03/25/2021. I spoke with patient on 03/26/2021 and notified her of administration error and recommendations for time intervals. I explained that there are not currently studies to show the effect on vaccine given too early, but that per guidance there is no requirement or recommendation to repeat or give any further doses and that she will be considered fully immunized at this time. She reports that she has done well so far with only a sore arm since her second dose.
sore; red circle; warm to the touch; headache; fatigue; joint pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 59-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series completed., Unknown manufacturer.), for COVID-19 immunisation. The following information was reported: PAIN (non-serious), outcome "unknown", described as "sore"; RASH MACULAR (non-serious), outcome "unknown", described as "red circle"; FEELING HOT (non-serious), outcome "unknown", described as "warm to the touch"; HEADACHE (non-serious), outcome "unknown"; FATIGUE (non-serious), outcome "unknown"; ARTHRALGIA (non-serious), outcome "unknown", described as "joint pain".  Additional information: On an unknown date, the patient experienced red circle, warm to the touch, sore, headache, fatigue and joint pain which took place after use of product.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
pt recv vax 2MAY(6 & 20MAY96 pt devel a varicella-like rash consisting of 4 lesions;pt to MD w/o fever;
This spontaneous report as received from a the patient's mother refers to her 21 years old daughter. The patient did not had any pertinent medical history, drug reactions or allergies. On 04-MAR-2015, the patient was vaccinated with VARIVAX (Merck) 0.5 ml, subcutaneous. Concomitant therapies included influenza virus vaccine and unspecified bacterial meningitis shot [therapy unspecified]. In March 2015, a couple of days after receiving VARIVAX (Merck), the patient developed sore arm and redness in the injection site. Subsequently, the patient recovered from the adverse events. The patient's mother also reported that on an unspecified date, the patient developed "sore arm" after receiving an unspecified flu vaccine and "sore arm" and redness at the injection site after receiving an unspecified bacterial meningitis shot. The patient did not sought medical attention and did not received treatment for the adverse events. No lab diagnostics studies were performed. No product quality complain was reported. Additional information has been requested.
This case was reported by a nurse via sales rep and described the occurrence of headache in a 53-year-old female patient who received SHINGRIX. In March 2018, the patient received SHINGRIX. In March 2018, less than a week after receiving SHINGRIX, the patient experienced headache, pain in arm, injection site swelling and fever. On an unknown date, the outcome of the headache, pain in arm, injection site swelling and fever were recovered/resolved. It was unknown if the reporter considered the headache, pain in arm, injection site swelling and fever to be related to SHINGRIX. Additional details were reported as follows: The patient experienced a headache, fever of 101.7, sore arm that lasted 3 to 4 days and puffiness as the injection site. The patient was feeling better a week after receiving the vaccination. The reporter sent an email to the field representative to provide the information. The adverse event was reported in after hours by the field representative. The reporter was unable to provide any additional details other than that the reporter received the vaccination a week prior of reporting.
Patient called 10/19/17 stated the area around her vaccination was swollen, red, and warm. It was painful to the touch.
Tetanus injection site red, swollen, warm to touch, Donor went to her Doctor - Antibiotic prescribed
Narrative: NAUSEA AND FATIGUE WERE BRIEF LASTING ONLY A FEW HOURS. SORENESS AT INJECTION SITE CONTINUES Symptoms: NauseaVomitng & FATIGUE,SORENESS AT INJECTION SITE
Swelling non specific, erythema and tenderness at injection site, muscle aches. Nausea. Vomiting.
Fever (37° - 38°C) and chilling, nausea, muscular pain, joint pain, weakness, urine burn.
WOKE UP WITH  PAIN IN BOTH HIPS AND KNEES (INSPITE OF PAIN I STILL WENT TO THE GYM) COULD NOT DO THE EXCERCISE TO  NORMAL LEVEL BUT ACCOMPLISHED SOME WORK OUT
vison was not focusing; Headache; This spontaneous case was reported by a pharmacist and describes the occurrence of VISUAL IMPAIRMENT (vison was not focusing) and HEADACHE (Headache) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LOVASTATIN, GLIPIZIDE, METFORMIN HYDROCHLORIDE (METFORMIN ER), SACUBITRIL VALSARTAN SODIUM HYDRATE (ENTRESTO), FUROSEMIDE, METOPROLOL and CLOPIDOGREL for an unknown indication.   On 06-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-May-2021, the patient experienced HEADACHE (Headache). On an unknown date, the patient experienced VISUAL IMPAIRMENT (vison was not focusing). At the time of the report, VISUAL IMPAIRMENT (vison was not focusing) and HEADACHE (Headache) 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.   Treatment medication was not provided by the reporter.
sore, warm to touch (same as previous injections) new event - red rash a few inches across and down from the inoculation, also from elbow to wrist and including thumb, index finder and top of hand has numbness, tingling sensation.
15 year old given Moderna bivalent booster. Moderna authorized for 18+ only. Mother notified by vaccinator on site.
The short hurts like hell; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain (Verbatim: The short hurts like hell). The outcome of the pain was not resolved.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.     It was unknown if the company considered the pain to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 20-JUN-2023 This case was reported by patient via interactive digital media. The patient reported that he or she received Shingles vaccine and the shot hurts like hell.  Patient states that he/she had them in his/her hair and down the side of my face, after 4 years I'm still dealing with the side effects Follow up was not possible, as no contact details were available.
Platelet level of 9,000 after going to doctor for severe bruising and petichia.
This spontaneous report as received from a Licensed Practical Nurse refers to multiple unspecified patients of unknown age and gender. The patients' concurrent conditions and medical history were not provided. On unknown dates the patients were vaccinated with improperly stored PNEUMOVAX 23 (therapy type: digital data logger: lot # K020215, expiry date: 15-MAY-2016). Concomitant medication was not mentioned by the reporter. The vaccines were stored at 32.4F for a time frame of 3 hours and administered to the patients. The call was a result of "data logger". No adverse effects were reported. No additional information was provided. Product quality complaint was filed. Additional information has been requested.
This spontaneous report was received from a health professional referring to multiple patients of unknown age and gender. On an unknown dates, the patients were vaccinated with PEDVAXHIB (Lot# J011963, 20-JUN-2016; J013943, 14-AUG-2016; J015437, 09-OCT-2016; J016186, 24-OCT-2016; K002747, 09-DEC-2016) dose and route of administration were not provided. No adverse effect reported. This service request was first opened on 30-JUN-2015, when a pharmacist called to report a vaccine temperature excursion but any adverse event was reported at that time. However, this adverse event was reported on 11-AUG-2015, during a call back by this healthcare worker. This is one of several reports received from the same source. Additional information has been requested.
Passed Out in Bathroom; Bloody Nose; Nausea; A spontaneous report  was received from a consumer concerning for his wife, a 70-year-old, female patient who received Moderna (mRNA-1273) vaccine and experienced events Bloody Nose/Epistaxis, Nausea, and passed out in the bathroom/Loss of consciousness.  The patient's medical history was not provided. No relevant concomitant medications were provided by the reporter.  On an unknown date, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch number: unknown) via an unknown route for prophylaxis of COVID-19 infection. On 17 Mar 2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (Batch number: unknown) via an intramuscularly on Arm for prophylaxis of COVID-19 infection.   On 17 Mar 2021, Bloody Nose, Nausea, and the consumer Passed Out in the Bathroom before being taken to the Emergency Room. Seriousness criteria for all events was considered as Hospitalisation. No Treatment information was provided.   The patient received both scheduled doses of mRNA-1273 prior to the events therefore, action taken with the drug in response to the events was not applicable.  The outcome of the events, Bloody Nose, Nausea, and passed out in the Bathroom was unknown at the time of this report.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Onset of headache 02/07/19 1730, headache persisted with increased intensity throughout 02/08/19.  Sore throat onset 02/08/19 in am. Ibuprofen 200mg taken approximately 0900 02/08/19 with minimal relief. 02/08/19 approximately 1100 intensity of headache increased. 02/08/19 approximately 1300 self administered dose of Theraflu. Went to Clinic, Clinic HCP (does not remember provider name) stated that symptoms were a mild reaction to Hepatitis B vaccination and advised to treat with robitussin and zyrtec for symptom control. Afebrile during clinic visit. Zyrtec 1 tab taken yesterday. Robitussin dose x 2 yesterday. 02/09/19 0450 awaken with headache and sore throat with decreased intensity from previous day, new symptoms of nasal congestion. Robitussin 1 dose and saline nasal spray taken. Currently at 0818 02/09/19 reports mild sore throat, moderate intensity headache (decreased from yesterday) and nasal congestion.
swelling in injection site, and pain radiating through arm. patient went to walk in clinic and was prescribed prednisone for 2 weeks. patient is still being monitored
This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient. A 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Feb2021 at 14:00 as dose 1, single  (Lot number: EL9264), in left arm, on 08Mar2021 at 14:00 as dose 2, single (Lot number: EN6203), in left arm, on 14Nov2021 at 14:00 as dose 3 (booster), single (Lot number: FH8030), in left arm and on 12Apr2022 at 15:00 as dose 4 (booster), single (Lot number: F24991) at the age of 61 years, in left arm for Covid-19 immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing); "SVT" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". Therapeutic measures were taken as a result of vaccination failure, Covid-19. Clinical information: No Other medication in 2 weeks. Paxlovid was taken as treatment, Start date was 30May2022,stop date was 03Jun2022. Recurrence of Covid approximately 5 days after finishing dose on 08Jun2022. Patient had no known allergies. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Sender's Comments: Based on the information available a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of LOE.
Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Mild, Additional Details: Lasted a few minutes and then patient felt normal
Sore arm for one day after 1st vaccination; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 12Apr2021 (Lot number: EW0158) at the age of 52 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "no" (unspecified if ongoing). There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "recovered" (2021), described as "Sore arm for one day after 1st vaccination". Therapeutic measures were not taken as a result of pain in extremity.  Additional information: The patient received second vaccination on 04May2021. Sore arm for one day after 1st vaccination. No known allergies. No other medications in two weeks. No COVID prior vaccination. No COVID tested post vaccination.   No follow-up attempts are needed. No further information is expected.
Patient was not able to move her arm; Pain in the upper left arm; Patient felt tired/Patient felt exhausted; Pain in the left shoulder; could not drive due to pain in the left arm; This spontaneous case was reported by a consumer and describes the occurrence of HYPOKINESIA (Patient was not able to move her arm), IMPAIRED DRIVING ABILITY (could not drive due to pain in the left arm), PAIN IN EXTREMITY (Pain in the upper left arm), FATIGUE (Patient felt tired/Patient felt exhausted) and ARTHRALGIA (Pain in the left shoulder) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033H21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (4 months before the pandemic she got sick for over a month), COVID-19 (but experienced vomiting and high fever during 3 weeks and got dehydrated.) and COVID-19 (3rd time was about 1 month before the first shot.). Concurrent medical conditions included Diabetes. Concomitant products included VITAMINS NOS for an unknown indication.    On 04-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jan-2022, the patient experienced HYPOKINESIA (Patient was not able to move her arm), PAIN IN EXTREMITY (Pain in the upper left arm), FATIGUE (Patient felt tired/Patient felt exhausted) and ARTHRALGIA (Pain in the left shoulder). In January 2022, the patient experienced IMPAIRED DRIVING ABILITY (could not drive due to pain in the left arm). On 05-Jan-2022, FATIGUE (Patient felt tired/Patient felt exhausted) had resolved. On 14-Jan-2022, HYPOKINESIA (Patient was not able to move her arm), PAIN IN EXTREMITY (Pain in the upper left arm) and ARTHRALGIA (Pain in the left shoulder) had resolved. In January 2022, IMPAIRED DRIVING ABILITY (could not drive due to pain in the left arm) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       After the first shot, patient felt tired and exhausted for one day, and experienced pain in the upper left arm and shoulder, and she could not move it for a week and a half, she was not able to drive during that time lapse.  No other vaccines given within 1 month prior to Moderna COVID-19 vaccine. The events did not cause the patient to seek medical care. She had no experienced similar events in the past.  No treatment information was reported.   This case was linked to MOD-2022-479233 (Patient Link).
Immediately after injection, feeling of headache, saw stars, feeling hot and then passed out falling back on exam table, at same time showing seizure like symptoms by kicking legs and body vibrating for 2-3 minutes while mom yelling at her to wake up. Nurse not in room, she was going to look for paperwork concerning another vaccination for that day. Patient woke up from hearing her mom yell and didn't remember passing out. She only remembered headache, stars and feeling hot.
This spontaneous report was received from the patient's mother referring to her daughter a 19 year old female patient with a history of drug reaction to unspecified steroids and VICODIN, other concurrent conditions and medical history were not provided. On 23-NOV-2011, 30-MAR-2012 and 15-AUG-2012, the patient was vaccinated respectively with first, second and third dose of GARDASIL (dose, route, concentration, site of vaccination and lot number were not provided).  Concomitant therapies included unspecified birth control therapy, AMBIEN and omeprazole (manufacturer unknown). On an unspecified date in 2012, (reported as 3 years ago) and soon after the completion of the series of GARDASIL, the patient experienced fatigue, headache, disturbance in attention, insomnia, nausea, arthralgia (joint, hips and knees pain) and myalgia. On an unspecified date in 2015 in the past six months, the reporter stated that arthralgia, headache, and insomnia got worse and the patient experienced pain (full body pain), movement disorder (difficulty moving her hands), peripheral swelling, swelling face, joint stiffness, depression, anxiety, vertigo, dizziness, tremor, asthenia, retching, dyspepsia, decreased appetite, severe muscle spasms (cramps in hands and legs) and paraesthesia (hands falls asleep). In December 2015, the patient experienced diplegia (couldn't move her legs). On an unspecified date, the patient sought for medical attention. On an unknown date, the patient received treatment for the adverse events that included Amoxicillin (500 mg, bid), Doxycycline (Tablet, oral, 1 DF, bid), Cefuroxime (Tablet, 1 DF, bid) and Gabapentin (Tablet, 1 DF, tid). At the time of the report, the outcome of fatigue, movement disorder, peripheral swelling, swelling face, depression, anxiety, vertigo, dizziness, tremor, asthenia, retching, dyspepsia, decreased appetite, muscle spasms, paraesthesia, pain, headache, disturbance in attention, insomnia, nausea, arthralgia and myalgia was reported as not recovered, otherwise the outcome of diplegia was reported as recovered after 30 minutes and the outcome of joint stiffness was reported as recovering. Upon internal review diplegia was considered as medically significant. Additional information has been requested.
diffuse rash after Pfizer Covid-19 vaccine. Treated with H2 and H1 blockers
Almost fainted after having Gardasil vaccination.  In the 5-6 hours following vaccination had 100 + temperature as well as chilling and muscle cramps.
On 2/20/2021 the pt noticed he had a 4" red itchy rash below the injection site.  On 2/25/2021 the rash is still present but no longer itching.  Pt has not contacted his PCP regarding his symptoms or taken any meds at this time.
Fever of over 102 degrees F, body aches, chills, headache, lethargic.
Presented with respiratory failure r/t covid. CXR showed pneumonic infiltrated. treated with iv remdesivir. Pt discharged home on room air.
Fainted for about 30 seconds, took about 15 minutes before he felt ok enough to walk out, headache and tingling/numb arms after coming to. This lasted for about an hour.
vaccine may have been expired at the time of administration. Patient did not experience any adverse effects from the vaccine
1/10/04 developed chicken pox after being exposed to older sibling. Had approximately 3 dozen lesions. No fever or other symptoms.
This spontaneous report as received from a physician assistant and a medical assistant refers to a 5 years old male patient with +4 allergy to eggs. The patient was vaccinated with, 0.2 ml M-M-R II on 31-OCT-2012 (not a full dose) lotnumber reported as H011889, expiration date 25-JUN-2012. No other co-suspects were reported. No concomitant medications were reported, On 31-OCT-2012 a skin test with M-M-R-II was performed and the patient experienced wheal at injection site, swelling of the area of injection and exhibiting redness of the area of injection. No treatment information was reported. The outcome of wheal at injection site, swelling of the area of injection and exhibiting redness of the area of injection was reported as not recovered/not resolved. There was no relatedness for wheal at injection site, swelling of the area of injection and exhibiting redness of the area of injection reported for M-M-R II. Additional information has been requested.
Swelling in Left Arm - Ibuprofen 400mg three times a day for 10 days.
Myalgia Pain at site, chills, fever and fatigue Narrative:  Other Relevant History:
Bigeminy PVC?s within 1 hour of administration, followed by chest pain and shortness of breath within 90 min. Continues 3 days later
I experienced hives on my face that same day in the evening around 7:00pm-7:30pm. I applied aloe vera on face and took Benadryl, after 5-10min my face was cleared.
Fever and chills after the injection.  No noticeable signs until I got the blood clot a year later.
Headache, extreme fatigue, disconnect with reality.   Stopped communicating; developed paranoia, began to have self neglect, not caring for self ir doing normal Hygiene   Within days had visual and tactile hallucinations, flat affect, began cutting self.
Hives, angioedema H1N1 given 11/17. Symptoms began and recurred through 11/19-12/02 - given IV SOLU-MEDROL x 2 prednisone taper, antihistamines.