chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient states that his arm and shoulder have continued to be sore ever since he received the second dose of the Shingrix vaccination in September.  He also states he started getting constant headaces soon after receiving the second dose of the Shingrix vaccination.  I recommended he go to see his physician and that I would report this to VAERS.  Patient has not reported back yet
'The needle leaked / not sure how much of the vaccine was administered; This case was reported by a pharmacist via call center representative and described the occurrence of accidental underdose in a 65-year-old female patient who received Herpes zoster (Shingrix) (batch number MB7RR, expiry date 8th October 2022) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of Shingrix on an unknown date).   On 3rd April 2021, the patient received the 2nd dose of Shingrix. On 3rd April 2021, unknown after receiving Shingrix, the patient experienced accidental underdose. On an unknown date, the outcome of the accidental underdose was unknown.   Additional details was reported as follows: The age at vaccination was not reported. Pharmacist reported that while administering a Shingrix vaccine to a patient the needle leaked about 4 drops, so the reporter was not sure how much of the vaccine was administered, which led to accidental underdose. The reporter consented to follow up.
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from contactable reporter(s) (Pharmacist) from product quality group. The reporter is the patient.  A 50-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Dec2020 at 06:45 as dose 1, single (Lot number: EJ1685), on 13Jan2021 at 06:45 as dose 2, single (Lot number: EK9231), in left arm, on 28Oct2021 at 09:30 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm and on 24Apr2022 at 13:15 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 50 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "h/o asthma" (unspecified if ongoing); "known allergies: Gluten" (unspecified if ongoing). Concomitant medication(s) included: GABAPENTIN, start date: 08Jul2019; ESTROGEN, start date: 08Jul2019; PROGESTERONE, start date: 08Jul2019. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Indication: Covid-19 treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Other medication in 2weeks were reported as, Yes. Anti-viral details contain; Product, COVID 19 Treatment, Paxlovid. Treatment start date was 08Jun2022 and Treatment stop date was, 12Jun2022 for the treatment of COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of serious events vaccination failure and COVID-19 cannot be totally excluded.
A few hours post vaccine, the patient developed a rash under her arms. The patient was treated with Azmacort MDI. The next morning the rash had spread to the patient's stomach and back. A baking soda bath was given and 24 hours later the rash was completely gone.
Rash returning on her other arm, abdomen and neck; Red rash that started on her left forearm and has spread; Rash that started on her left arm and spread; Hot rash that started on her left forearm and has spread; Itchy rash that started on her left forearm and has spread; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE WARMTH (Hot rash that started on her left forearm and has spread), VACCINATION SITE PRURITUS (Itchy rash that started on her left forearm and has spread), RASH (Rash returning on her other arm, abdomen and neck), VACCINATION SITE ERYTHEMA (Red rash that started on her left forearm and has spread) and VACCINATION SITE RASH (Rash that started on her left arm and spread) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concurrent medical conditions included No adverse event.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021 at 2:00 AM, the patient experienced VACCINATION SITE WARMTH (Hot rash that started on her left forearm and has spread), VACCINATION SITE PRURITUS (Itchy rash that started on her left forearm and has spread), VACCINATION SITE ERYTHEMA (Red rash that started on her left forearm and has spread) and VACCINATION SITE RASH (Rash that started on her left arm and spread). On 06-Apr-2021, the patient experienced RASH (Rash returning on her other arm, abdomen and neck). On 06-Apr-2021, VACCINATION SITE WARMTH (Hot rash that started on her left forearm and has spread), VACCINATION SITE PRURITUS (Itchy rash that started on her left forearm and has spread), VACCINATION SITE ERYTHEMA (Red rash that started on her left forearm and has spread) and VACCINATION SITE RASH (Rash that started on her left arm and spread) had resolved. At the time of the report, RASH (Rash returning on her other arm, abdomen and neck) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication list was not provided. Treatment provided include diphenhydramine.
This case was reported by a pharmacist and described the occurrence of red rash injection site in a subject of unspecified age and gender who was vaccinated with FLUARIX, (GlaxoSmithKline).  In October 2008, the subject received a dose of FLUARIX (.5 ml, unknown).  In October 2008, at an unspecified time after vaccination with FLUARIX, the subject experienced red rash injection site and pharmaceutical product complaint.  The pharmacist received a call from a nurse at a nursing home facility that reported that 80 out of 100 subjects developed a "grapefruit size bright red" rash at the injection site.  At the time of reporting the outcome of the events were unspecified.  For the other 79 linked subjects please see cases : A0756483A - A0756514A, A0756516A - A0756562A.  The CRC provided lot number AFLUA3208A to QA regarding this product complaint, while the report received in CMG Safety stated AFLUA3508A.  With a possibility of a coding mistake to batch AFLUA320AA and on the basis that there are 80 cases out of 100, it was decided to ask for a Quality investigation (including cold chain) of all three batches (correct numbers: AFLUA350BA, AFLUA320BA and AFLUA320AA).  On 16 January 2009, QA results were received for batches reviewed of (AFLUA320AA and AFLUA320BA) : AFLUCA320, AFLUA320A, and AFLUA320B.  The report indicated that no deviation that could be linked to the complaint and no cold chain deviation was recorded on the batches  AFLUA350BA, AFLUA320BA and AFLUA320AA).  On 16 January 2009, QA results were received for batches reviewed of (AFLUA320AA and AFLUA320BA) : AFLUCA320, AFLUA320A, and AFLUA320B.  The report indicated that no deviation that could be linked to the complaint and no cold chain deviation was recorded on the batch AFLUA350BA.
no adverse event; This spontaneous case was reported by a patient and describes the occurrence of NO ADVERSE EVENT (no adverse event) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, NO ADVERSE EVENT (no adverse event) outcome was unknown.            No concomitant medication provided. No treatment medication provided. The patient mentioned is it safe to take vitamins, ibuprofen, and unknown medication after the second vaccine for side effects.
Information and follow-up information has been received from two physicians concerning a patient (gender unknown) who at the age of 8 weeks was inadvertently vaccinated with a dose of Pneumovax 23. At the age of 16 weeks, the patient was inadvertently vaccinated with a second dose of Pneumovax 23. The physician stated that there was an error on the part of the office. Specifically, 70 doses of Pneumovax 23 was ordered instead of Prevnar because both products were next to each other on the order form and then 40 doses were administered by accident. It was reported that there was no confusion in regards to product packaging. The physician stated that the problem had been corrected at the office and he did not foresee any future problems. Follow-up reported that unspecified medical attention was sought and on an unspecified date, the patient was vaccinated with a dose of Prevnar. At the time of the report, there were no adverse experiences reported. Additional information has been requested.
Mother of patient states that the childs whole body is covered in chicken pox with only one spot that is blistered.
Received vaccination 10/16/14. Still have pain 11/19/14. Can't raise arm or do certain motions. Numbness and tingling. Feels like muscle twisting.
1. Seizures approximately 30 hrs. after immunizations not febrile 2. No PH seizures 3. Normal neuro No reaction to previous vaccines at age 2 mo. 10/13/06-DC Summary for DOS 8/29-8/31/06. DC DX: Movement disorder Presented to PCP office with "jerking episodes", received vaccine 1-2 days prior to presentation. Irritable following vaccines, low grade fevers. Noted to have episodes of "leg flexion and arm flexion with eyes being shut tightly.". Each episode lasted a few seconds at a time and would have 2-3 episode at home approximately 10 minutes apart.  Exam on admission" WNL. Hospital course: No further jerking episodes during stay. Thought that patient had a possible "movement disorder", no underlying etiology was ever identified.
At approximately 1:00 p.m. on same day of vaccine (Sunday), had bout of diarrhea;  another and final bout approximately  24 hours later  Sore arm - applied ice to area At approximately 1:00 a.m. (early Monday morning) fever set in - approximately 100 degrees - lasted thru Tuesday.  Did not take anything for fever as nausea and vomiting began At approximately 2:00 a.m. (same day) severe aches and pains.   Nausea and vomiting began.  Intermittent vomiting thru Wednesday a.m.   Unable to drink liquids as nausea sometimes severe.  Nausea continues through today - not as bad as last week. Contacted doctor's office on Wednesday, April  14.   He advised me to got to ER as he was concerned I was dehydrated since I could not drink liquids.    Received IV of fluids and Zofran to ease nausea.   Received prescription for oral Zofran.
Around 3 days after the first shot, I got a very bad headache. I went to bed and woke around 4 am, my left side was weak and droopy. I laid back down until 6 am, it had gotten worse. I felt almost paralysis on the left side. My wife called the EMT and they came and took me to the ER. At the ER, my bp was 212/108. They started me with IV meds to try and get it down. I was kept overnight, the next day it was dropping some, the doctors added Carvedilol (25mg), Hydrolazin (100mg) to help with my blood pressure. I came home, then the following day I developed a rapid HR, I went back to the ER, my bp was 170/90. They gave me some more IV drugs to bring my bp down, they kept me about 3 hours. I did not have a stroke but the symptoms were due to my high blood pressure. I have been taking the added meds since trying to get my bp more stable. BP will rise high in the evenings. Following up with kidney doctor.
Joint pain and headaches. Also full body raised bumps (non pruritic, non pustular).  Headaches resolved in about 1 week, joint pain and bumps have lasted a couple weeks now.
This spontaneous report was received from a pharmacist regarding a patient of an unknown age and gender. The patient's medical history or concurrent conditions were not provided. On 09-JUL-2015, the patient was vaccinated with an improperly stored dose of ZOSTAVAX (dose, route and lot number were not provided). Concomitant medication was not provided. No adverse effects were reported. Additional information has been requested.
Within 24 hours of the vaccination had debilitating stabbing pain (occipital, cervico, brachial)crescendo episode lasting 1 hour 40 minutes.  On a scale of 1 to 10, was a 10 and required ambulance service to hospital.  CRT scan showed nothing.  Three days later another episode causing another visit to hospital.
Mild swelling and soreness and the injection site. Extreme fatigue the following day. No fatigue the next day.
PT WAS GIVEN PFIZER MONOVALENT VACCINE, SHOULD HAVE BEEN GIVEN PFIZER BIVALENT, NO ADVERSE EVENT, OUTCOME - IS PER CDC GUIDANCE PT CAN RECIEVE A BIVALENT BOOSTER IN 4 MONTHS AS PT IS NOT IMMUNOCOMPRISED
Fever, chills, some short term memory loss, loss of appetite, lethargy the day following vaccination. Massive headache for 12+ hours beginning on 04/13/2021 with diminished headache, loss of appetite and difficulty with thought processing continuing currently at 9pm on 04/14/2021.
nerve root irritation; This case was reported by a consumer via interactive digital media and described the occurrence of nerve root irritation in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced nerve root irritation. On an unknown date, the outcome of the nerve root irritation was recovered/resolved. It was unknown if the reporter considered the nerve root irritation to be related to Shingles vaccine. Additional details were provided as follows: The case was reported by the patient himself/herself. The age at vaccination was not reported. The patient received the 1st dose of Shingles shot on left side and patient stated that it irritated the nerve in the shoulder and neck on the side where he/she got the shot. For tolerance of 2nd dose refer case US2021AMR163732.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR163732:same reporter.
Pt. states that after receiving the 3rd Booster 10/29/2021, started experiencing symptoms 10/30/2021 of numbness in the legs *both, in continence during a 15mins, extreme fatigue, and dizziness. No noted Primary visit/communications.
Seizure around 4:40 am on 2/27/2021.  Shaking, eyes drawn in, fists clenched, some foaming at mouth, unresponsive.  Ambulance called to the home.  Transported to hospital.
overnight nausea; fatigue; a little bit of a headache; temperature; This is spontaneous report from a contactable consumer(patient) via regulatory authority.   A male patient of an unspecified age received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 01May2021 (Batch/Lot number was not reported) as dose 1, single dose for COVID-19 immunization.The patient medical history and concomitant medications were not reported. The patient experienced overnight nausea, fatigue, a little bit of a headache, temperature on an unspecified date. The patient underwent lab tests and procedures which included pyrexia: between 99.4 to 100.9. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Patient developed a fever of 100.5. The following night it increased to 101.6.  At this point we called the doctor and got blood work done which is when we found that her platelets and hemoglobin were extremely low.
Information has been received from a consumer concerning a 3 year old child who was placed on therapy with MMR II (dose number and vaccination date not reported).  The consumer heard about the patient through her sister about 3 years ago.  Subsequently the patient developed an "allergic reaction" after receiving MMR II.  The patient experienced seizures and a "paralyzed mental state".  It was unknown whether medical attention was sought.  The patient's out come was not reported.  This is one of two reports from the same source.  Additional information has been requested.
Information has been received from a registered nurse concerning an outbreak of chickenpox in a child, between the ages of kindergarten to 4th grade, who had been vaccinated subcutaneously with a first dose of 0.5 mL of varicella virus vaccine live (Oka/Merck). Subsequently, the child developed chickenpox. The child may have 50 lesions or more. Additional information is not expected. This is one of several reports from the same source.
The evening I got headaches, chills, muscle, loss of smell and taste. The third day I woke up with swelling like hives and rash around my right eye. I took 10mg of Claritin. The hives spread around the back of my neck and the rest of my body over the course of the morning. Within a few hours it had spread to my chest and my throat felt like it was closing. I had taken Benadryl but it didn't seem to help. I was also fatigued but had no shortness of breath. I had not eaten anything before the hives started. It had been 48 hours after the shot that I was in the Emergency Room, the hives started around 36 hours. I was given Epinephrine 3mg, Prednisone and Famotidine and given steroids for a few days. I have not had any problems since the first three days after the ER visit.
pt stated that he developed a bump on the fore arm of the right arm and lower part of his back.  He stated is was like hives and it is very itchy .  Pt states the rash is no longer there but he is still itchy.  He took Benadryl, applied cream, and took prednisone for his symptoms.
This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies was provided. On 18-JAN-2017 at 14:22, the patient was vaccinated with an improperly stored VARIVAX (lot # M031969) for prophylaxis (expiration date, dose and route of administration were not reported). It was reported that the vaccine underwent previous temperature excursions, but the number of previous excursions, time frames and values of incorrect temperature were unknown. A digital data logger was used. No adverse effects were reported. Product quality complaint was not involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1701USA008441: US-009507513-1704USA000389: US-009507513-1704USA000390: US-009507513-1704USA000391: US-009507513-1704USA000392: US-009507513-1704USA000393: US-009507513-1704USA000394: US-009507513-1704USA000395: US-009507513-1704USA000396: US-009507513-1704USA000397: US-009507513-1704USA000398: US-009507513-1704USA000399: US-009507513-1704USA000400: US-009507513-1704USA000401: US-009507513-1704USA000402: US-009507513-1704USA000403: US-009507513-1704USA000404: US-009507513-1704USA000405: US-009507513-1704USA000406: US-009507513-1704USA000407: US-009507513-1704USA000408: US-009507513-1704USA000409: US-009507513-1704USA000410: US-009507513-1704USA000411: US-009507513-1704USA000412: US-009507513-1704USA000413: US-009507513-1704USA000414: US-009507513-1704USA000415: US-009507513-1704USA000416: US-009507513-1704USA000417: US-009507513-1704USA000418: US-009507513-1704USA000419: US-009507513-1704USA000420: US-009507513-1704USA000421: US-009507513-1704USA000422: US-009507513-1704USA000423: US-009507513-1704USA000424: US-009507513-1704USA000425: US-009507513-1704USA000426: US-009507513-1704USA000427: US-009507513-1704USA000428: US-009507513-1704USA000429: US-009507513-1704USA000430: US-009507513-1704USA000431: US-009507513-1704USA000432: US-009507513-1704USA000433: US-009507513-1704USA000434: US-009507513-1704USA000435: US-009507513-1704USA000436: US-009507513-1704USA000437: US-009507513-1704USA000438: US-009507513-1704USA000439: US-009507513-1704USA000440: US-009507513-1704USA000441: US-009507513-1704USA000442: US-009507513-1704USA000443: US-009507513-1704USA000444: US-009507513-1704USA000445: US-009507513-1704USA000446: US-009507513-1704USA000447: US-009507513-1704USA000448: US-009507513-1704USA000450: US-009507513-1704USA000451: US-009507513-1704USA000452: US-009507513-1704USA000453: US-009507513-1704USA000454: US-009507513-1704USA000455: US-009507513-1704USA000456: US-009507513-1704USA000457.
Fever, chills, runny nose, cough, body aches - day after administration of vaccine x 1 week - sx increase - patient was seen at hospital ER.
A little achy; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (A little achy) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039F21A) for COVID-19 vaccination.     Previously administered products included for COVID-19 immunisation: Johnson and johnson COVID-19 vaccine (The next day the patient woke up nd was still queasy.) on 07-Mar-2021. Past adverse reactions to the above products included Chills worsened with Johnson and johnson COVID-19 vaccine.    On 08-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On an unknown date, the patient experienced MYALGIA (A little achy). At the time of the report, MYALGIA (A little achy) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.  After the introduction of Johnson and Johnson vaccination, the patient had really bad chills on the middle of the night. On the next day, the patient was queasy and had low grade flu symptoms for the whole day.
Acute severe malaise, weakness, facial weakness, sl nausea, funny sensation on back of head.  direct exposure to influenza A. Pt. c/o N/V, cough, fever, chest burning. Tamiflu given,
1 of 4 pts who exp an inj site rxn following vax;lederject syringe w/ 5/8" needle was used;rxn included itching @ site, hardness, swelling, & redness;size of rxn not measured, but very noticeable
Within 10 minutes of injection patient fainted, was out for 10 seconds or less.  He fell straight back but didn't appear to hit his head on floor. Paramedics were called, his vital signs were stable and parents declined transport to hospital.  Spoke with mom later in evening and he appeared to be doing fine except for headache pain.
This spontaneous report as received from a medical assistant concerning an unknown number of patients of an unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date the patients were vaccinated with a dose of GARDASIL (dose, dose number, lot number, expiration date and route were not reported. The medical assistant reported that on an unknown date, that unspecified patients received improperly stored GARDASIL, exposed to -1C for 24 hours on 19-AUG-2014. No adverse effects were reported. This is one (1) of four (4) reports from the same source (MARRS 1409USA002639, 1409USA006394, 1409USA006395 and 1409USA006396). Additional information has been requested.