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. On or about 07-FEB-2015, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) at a supermarket, for routine adult health maintenance and the intended purpose of the long-term prevention of shingles and zoster-related injuries. Upon information and belief, on or about 07-FEB-2015, a physician recommended, prescribed, and/or administered the ZOSTAVAX for its intended purpose of long-term prevention of shingles and zoster-related injuries. The ZOSTAVAX did not prevent shingles or zoster-related injuries as intended. On or about 28-OCT-2016, the patient was treated by a physician for zoster-related rash. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles and zoster-related injuries, 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.
10 days after being administered the MMR vaccine my daughter ran a fever of around 100-101 and developed a a red rash starting on her torso and then extending onto her limbs  and her face.  The rash exhibited itself in the form of small red dots. I took my daughter into the doctor after seeing this and the doctor said he suspected it was the reaction from the MMR vaccine given 10 days prior to reaction.  No treatment given and resolved on its own 3 days after onset.
Information has been received regarding a case in litigation from a lawyer, an approximately 74 year old female patient, and her spouse. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On an unknown date in 2015, at approximately 72 years of age, the patient was administered the ZOSTAVAX (lot number, dosage and route of administration not provided) by a pharmacist at a pharmacy. On an unknown date in 2017, the patient was treated by a healthcare provider for the following injury resulting from her use of ZOSTAVAX: Shingles. The outcome of the shingles is unknown. The patient claims damages as a result of: injury to themselves, loss of consortium, loss of services, and economic losses. Additional information has been requested.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. No information on patients medical history or concurrent conditions was provided. On an unknown dates, the patient were vaccinated with an unspecified number of improperly stored doses of MMR II (strength, dose, route of administration, lot# and expiration date were not reported). No information on patients concomitant medications was provided. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports from the same reporter. Additional information has been requested.
Patient called on 4/9/21 asking about whether side effects from Janssen vaccine should still be present since he had the vaccine on 4/7/21.  Patient said he had fever within 24 hours of the vaccine and was feeling miserable (severe fatigue, chills, fever, nausea, headaches).  He said he was feeling slightly better than the first 24 hours but still feeling really bad. He has been taking Advil which has help slightly.  I advised him to monitor symptoms and to call dr if symptoms get worst and to keep us posted.    I called patient today to follow up with patient and he said that he was not feeling that much better.  He did have a virtual visit with his doctor and was prescribed azithromycin, prednisone, and an inhaler.  Patient has been on medication for a couple of days.  He will continue meds and call us if things do not improve
Breakthrough case of COVID-19: I have a headache, a runny nose, and a a scratchy throat, and fatigue.
pt recv vax & lab eval revealed neg surface antigen, neg surface antibody & core antibody pos;
Very sore arm with hard area at injection site, hematoma at injection site (day1), Headache, muscle pain, joint pain, fatigue (day 2), rash on left arm upper and lower (day 3 and 4 - current day).
This was given hours  after expiration date- Per Medical Director employee notified to get second vaccine since no data from Johnson and Johnson about coverage. Employee notified by telephone of event but states" Do I have to get another? I want to talk with my family about it".   No adverse effects
Lump size of a pea on collarbone; Pain if touched; This is a spontaneous report from a non-contactable consumer, the patient. A 29-year-old non-pregnant female patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 30Mar2021 at 05:30 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma and bronchitis. The patient had no allergies to medications, food, or other products. Concomitant medications included cyanocobalamin (VITAMIN B12), women's multivitamin (MANUFACTURER UNKNOWN) and birth control (MANUFACTURER UNKNOWN). Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 05Apr2021 at 17:00, 6 days after the shot, the patient experienced lump size of a pea on collarbone and caused pain if touched. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events lump size of a pea on collarbone and pain if touched was not resolved at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sore arm; Itching; Chills; Myalgia; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching), CHILLS (Chills), MYALGIA (Myalgia) and VACCINATION SITE PAIN (Sore arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 11-Jan-2021, the patient experienced PRURITUS (Itching), CHILLS (Chills) and MYALGIA (Myalgia). On 12-Jan-2021, the patient experienced VACCINATION SITE PAIN (Sore arm). At the time of the report, PRURITUS (Itching), CHILLS (Chills), MYALGIA (Myalgia) and VACCINATION SITE PAIN (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Treatment information was not provided/unknown.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
LIGHT RUNNY NOSE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced light runny nose. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from light runny nose. This report was non-serious.
After given flu shot, patient started to feel nausea but did not vomit and stomach pain.  During the night, patient experienced nasal drip, watery eyes and swollen glands.
Flu-like symtoms; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu-like symtoms) and FATIGUE (Tiredness) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 27-May-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu-like symtoms) and FATIGUE (Tiredness). At the time of the report, INFLUENZA LIKE ILLNESS (Flu-like symtoms) and FATIGUE (Tiredness) outcome was unknown.            No concomitant medications were reported No treatment drugs were reported
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 09-DEC-2014, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23, 0.5 ml, (lot # K009105, expiration date 21-JAN-2016) (route and dose were not reported). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative excursion time (hour), the lowest recorded temperature (Fahrenheit degree) and the type of excursion (R/F) for each time were 48, 34 and R; 144, 31 and R. The storage criteria was refrigerator (R). This is one of several reports received from the same source. Additional information has been requested.
Pt developed swelling of fingers, hives, & tight jaw 1 day after receiving Hep A #1 & Hep B #2.
Clinic Supervisor reported that 6 kids received Rotarix diluent alone with our mixing it.; Clinic Supervisor reported that 6 kids received Rotarix diluent alone with our mixing it.; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Rota (Rotarix lyophilized formulation) (batch number KB7FJ, expiry date 19-SEP-2024) for prophylaxis.   On 25-OCT-2023, the patient received Rotarix lyophilized formulation. On 25-OCT-2023, an unknown time after receiving Rotarix lyophilized formulation, the patient experienced inappropriate preparation of medication (Verbatim: Clinic Supervisor reported that 6 kids received Rotarix diluent alone with our mixing it.) and inappropriate dose of vaccine administered (Verbatim: Clinic Supervisor reported that 6 kids received Rotarix diluent alone with our mixing it.). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 02-NOV-2023 Clinic Supervisor reported that 6 kids received Rotarix diluent alone with our mixing it which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up via email. This case is 1 out of 6 cases reported by the same reporter.; Sender's Comments:  US-GSK-US2023152368:Different patient US-GSK-US2023152363:Different patient US-GSK-US2023152373:Different patient US-GSK-US2023152370:Different patient US-GSK-US2023152371:Different patient
Redness and heat from injection site distal towards elbow. Continuing to expand for next 72 hours. 4 inches in diameter.
Guest developed pain in left arm after being administered a FLUZONE HD injection. Her arm is fine when not moving but use is limited due to the pain. It at times bother her to where she has trouble sleeping.
Shortness of breath; This is a spontaneous report from a contactable consumer (Parent). An unspecified age of male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number not provided), via an unspecified route of administration on an unknown date Aug2021 as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date Aug2021, the patient experienced Shortness of breath. It was reported that My son just had the vaccination conducted on Saturday and he is now experiencing shortness of breath and I am sure you could find out if there is any advise you can give us what can we expect in terms of the shortness of breath, what can we expect and how long it's usually last, so forth and so on. Reporter was informed about the role of Pfizer drug safety and Pfizer Medical Information and provided with the number as # and requested to dial the option 3 and informed about timings as 8 AM to 8 PM from Monday to Friday as per EST. Product details and pharmacy details could not be probed as the reporter was unwilling to complete the report. Hence limited information available over the call.The outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  Follow-up activities closed. Batch/lot number not available for [vaccine/BNT162B2], F/UP closure to be managed as significant
06/03/02 myoclonic jerks during sleep. Started out occurring every few seconds for several hours. Over the course of about a week, the occurred less and less frequently and eventually stopped.
A report was received from a health care professional on 12/17/03 concerning a 5 year old female vaccinee who inadvertently received a sub-optimal dose of Fluvirin on 12/16/03. On 12/16/03, a vaccinee inadvertently received a dose of 0.25ml of Fluvirin. No adverse events had occurred as a result at the time of this report. There was insufficient information to determine the reporter's causality assessment. Update 3/15/04: Further information was received from a health care professional indicating that the vaccinee did not experience any adverse reaction. The vaccinee did not contract influenza and she later received the full dosage of Fluvirin in mid January. No follow up pending. All information received.
PATIENT WAS GIVEN 0.2ML OF THE 30MCG FORMULA INSTEAD OF 02.ML OF THE 10MCG FORMULA,
11/9/2021 recurrent itching  swelling and redness and edema. Hardened nodule approximately 6cmx12cm. No redness noted.
On 08/25/21 client reported that following her 1st dose Moderna COVID vaccine received 07/24/21 she developed a fever, body aches, vomiting and cough. She states that she was hospitalized for 7 days at Hospital. She had since recovered and was presenting for a 2nd dose Moderna vaccine.
Patient's family report that patient developed new onset migraines after first vaccine and then after 2nd vaccination developed seizure disorder with grand mal seizures,  acute diastolic heart failure, respiratory failure.
RECEIVED HALF DOSE FOR THEIR BOOSTER DOSE; OFF LABEL USE; This spontaneous report received from a health care professional concerned a 33 year old female of unspecified race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient previously received covid-19 vaccine ad26.cov2.s( manufacturer not specified) (suspension for injection, route of admin not reported, batch number: unknown expiry: unknown) dose was not reported, 1 total, administered on unspecified date for prophylactic vaccination. (dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number 211A21A expiry: Unknown) 0.25 ml, 1 total, administered on 27-NOV-2021 for prophylactic vaccination (dose number in series 2). No concomitant medications were reported.  On 27-NOV-2021, the patient experienced received half dose for their booster dose (vaccine under dose and off label use). HCP (from public health department) stated that there were 33 patients who received half doses (0.25ml) for their booster or 3rd dose. Most of them were patients from Texas. HCP stated that something was printed and disseminated that said to administer .25ml. HCP was not sure where that information came from. Stated it was over the holidays so people could have thought that info changed and staff was just not made aware. HCP stated that they figured it out after the event because they could not figure out how so many doses were given. They were looking for a discrepancy in the number of vials perhaps, but then realized that half doses were given (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the received half dose for their booster dose and off label use was not reported. This report was non-serious. This case, from the same reporter is linked to 20211202250, 20211201046, 20211202193, 20211201228, 20211201168, 20211200752, 20211201351, 20211200994, 20211201450, 20211202199, 20211202469, 20211204104, 20211202379, 20211201179, 20211201443, 20211220152, 20211220146, 20211220262, 20211220250, 20211220145, 20211219871, 20211219926, 20211220155, 20211200723 and 20211201082.
Generalized sweating, "hot flashes", anxiety.  Slight dizziness.  No respiratory distress, no wheezing, no labial swelling, no hives.  No hypotension. BP 150/80, then 130/80, pulse 80-90. Temp 98.0F. Slight flushing noted on anterior chest. Sxs lasted for 3 hours after receiving shot.  Pt took Diphenhydramine 50mg at 4pm and by 6pm reports feeling better, but drowsy.  By 10pm, sxs resolved.  By next morning, pt denies any sxs, no remaining sweating, dizziness or flushing.  Only complaint is tenderness at injection site.
About 10 minutes passed after the shot was given, patient returned to pharmacy counter in pain, self described as chest pain 6/10 initially then trending to 1-2/10 couple minutes after we sat her down with water given, also self claimed left unilateral pain 9/10 initially intermittently then went down to 0/10 after about 30-40 minutes since symptoms started. Upon observation, she stated that she started having sinus drainage and pressure after 30 minutes post shot. We have provided hydration and anti-histamine per guidelines to alleviate her symptoms. We have reached to her primary care provider for an appointment to check up and as of 12:35pm@3/25/19 we have yet to be able to set up an apt but will cont. to try.
The next day I noticed I couldn?t move my neck at all that its been since May and nothing relieves the pain. The pain migrates from neck to mid back in my spinal cord. Extreme arm pain where im unable to do my daily chores. The whole right side of my body went numb for hours including ny brain.  I I contacted ny doctor and xrays were taken .  My arms are getting numb very often and im in pain 24/7  I enjoyed a gym and the pain doesn?t get better I do iv infusion with vitamin that supposed to help with pain and fatigue and its not helping  Now im paying a chiropractic   I was not feeling this way before the vaccine, its very clear i had a reaction which im unable to work due to how unwell i feel every day.
Patient was due for her Pfizer monovalent Dose#2. She was instead given the Bivalent Booster.
sore arm; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration in arm left, on 19Feb2021 at 14:30 at 68 years (Lot Number: EM9809), as single dose, for COVID-19 immunisation. Medical history included drug hypersensitivity. Patient was not pregnant and was not pregnant at time of vaccination. Patient did not experience COVID-19 prior to vaccination. Concomitant medications included omeprazole (unknown manufacturer), amlodipine (unknown manufacturer); biotin, calcium pantothenate, choline bitartrate, cyanocobalamin, folic acid, inositol, nicotinamide, pyridoxine hydrochloride, riboflavin, thiamine mononitrate (B COMPLEX), vitamin d3 (unknown manufacturer). Patient did not receive any other vaccine in four weeks. The patient experienced sore arm (non-serious) on 19Feb2021 at 21:00 with outcome of recovered.  The patient underwent lab tests and procedures which included COVID-19 virus test (nasal swab): negative on 03Dec2020.    Follow-up attempts are completed. No further information is expected.
*patient has own epi-pen. 1:45 - administer shot 1 2:00 - racing pulse 2:15 - 2:25 dizzy, lightheaded, vertigo, nauseous 2:30 - lips tingling, numb 2:35 - took benedryl 25 mg 2:35 - knot in throat, slight trouble swallowing, nose running a lot which is abnormal, coughing to clear throat 2:45 - symptoms subsiding 3:00 - symptoms gone
Information was received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. On or about 30-DEC-2015, the patient was inoculated at a pharmacy with ZOSTAVAX (lot number, dosage, and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 13-MAR-2017, the patient was treated by a physician assistant  for the onset of a blistery rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles which had begun to break out in November of 2015, and had manifested persistently for nearly two years. On or about 21-MAR-2107, the patient was treated again for ongoing and worsening pain, at which time she was also diagnosed with post-herpetic neuralgia, a chronic condition of nerve damage and pain secondary to shingles infections. The patient has been prescribed valacyclovir hydrochloride (VALTREX) (in incrementally increasing doses), biofreeze, lidocaine, gabapentin, aspercreme, and valacyclovir for management of her 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.