chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse effects; received a dose of M-M-R II which was reconstituted with expired STERILE DILUENT; This spontaneous report as received from a pharmacist refers to a 48-year-old female patient. No information regarding the patients' pertinent medical history, drug reactions or allergies and concomitant therapies was provided.     On 26-APR-2019, the patient received a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) , recombinant human albumin (rHA) (lot # R019391, expiration date 05-JUL-2020) (frequency, dose, strength, and route of administration were not reported) for prophylaxis, which was reconstituted with expired sterile diluent (lot # M026304, expiration date: 13-MAR-2019) (frequency, dose, strength, and route of administration were not reported). Both the measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and sterile diluent were properly stored and had no previous temperature excursions. No adverse effects were reported.
Patient was given incorrect vaccines. Did not show and verbalized having any adverse effects. Patient was given an appointment to follow up with provider if any concerns or reactions.
sore arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 62 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 12Feb2021 (Lot number: EN6201) at the age of 62 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Type 2 diabetes mellitus" (ongoing), notes: Diagnosed within the last 5 years; "High blood pressure" (unspecified if ongoing), notes: Investigation Assessment: Yes; "High cholesterol" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN taken for type 2 diabetes mellitus; TELMISARTAN; PRAVASTATIN taken for blood cholesterol increased; VITAMIN C ACID taken for supplementation therapy; VITAMIN D3 taken for supplementation therapy. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Time the Vaccination Was Given: between 14:00-15:00, Batch number: EL8982, manufacturer: Pfizer, Anatomical Location of Administration :Right arm), administration date: 20Jan2021, when the patient was 62 years old, for Covid-19 immunisation. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm". The event "sore arm" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: She said that recently they went to have their antibodies tested, her husband is coming up with no antibodies on the quick test. They are saying that he does not have any antibodies. Does he need a booster? It is important to let Pfizer know. He has been tested twice. Once with a rapid test and the other was with a blood test through the physician's office. The second dose had to be defrosted and they had to wait to get the second vaccine. She said that they had to prepare it to be able to administer it at the clinic. She got vaccinated with the same lot numbers and she had strong antibodies, but he has diabetes and high blood pressure and has no antibodies. Time the Vaccination Was Given: between 2-3 in the afternoon for both doses. Emergency Room: No. Physician Office: Yes. Prior Vaccinations (within 4 weeks) If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s): None  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101068833 same product and event, different patients
This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history and concurrent conditions was provided. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ lot # L027726, expiration date: 10-MAY-2017 and lot # L035276, expiration date: 09-JUN-2017, orally, (dose was not reported). There were no concomitant medications reported. It was stated that the vaccines underwent a temperature excursion of 49 degrees Fahrenheit for 6.5 hours. No previous temperature excursion was reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Per caller, she is not aware if either patient had any symptoms after administration. No additional AE's/PQC's reported.; Per caller, excursion occurred on 8/20/2021. Caller notes, the V ARlV AX has been administered to (2) patients.; This spontaneous report has been received from a nurse, concerning to a patient of unknown gender and age. No information was provided regarding the patients' pertinent medical history, concomitant medications, concurrent conditions, and previous drug reactions or allergies.  On 20-AUG-2021, the virus vaccine live (oka/merck) (VARIVAX) was improperly stored at -14.2 degrees Celsius (C) for a timeframe of 16 minutes (min); there were not previous temperature excursions reported (product storage error).   On 27-AUG-2021, the patient was vaccinated with one (1) improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (lot number T028306 has been verified to be a valid lot number, expiration date reported and established as 20-AUG-2022) as prophylaxis (exact dose, dose number, vaccination scheme frequency, route of administration, and anatomical location of vaccination were not reported). No other adverse events reported (no adverse events).  This is one of two reports received from the same reporter; Sender's Comments:  US-009507513-2109USA005038:
Information has been received from a certified medical assistant concerning a female who, within the last 2 months, was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot # 649694/0386P).  Subsequently, the patient developed a local site reaction of slightly raised area, painful, red, hot.  The patient sought unspecified medical attention.  It was also reported that 4 other female patients experienced adverse events following administration of pneumococcal 23v polysaccharide vaccine within the last 2 months.  No product quality complaint was involved.  Additional information has been requested.
sick; Initial information received on 29-Nov-2020 regarding an unsolicited valid serious case received from a consumer (patient) via social media.  This case involves a patient of unknown age and gender who became sick (illness), while he/she received vaccine INFLUENZA VACCINE.  The patient's past vaccination(s) included Influenza vaccine as prophylactic vaccination.  The patient's past medical history, concomitant therapy, medical treatment(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient became sick (illness) (Unknown latency) following the administration of INFLUENZA VACCINE. The patient was hospitalized for three to seven days once in extensive care for this event.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of report, the outcome of event was unknown.  Information on the batch number was requested; Sender's Comments: This case involves a patient (unknown age and gender) who experienced illness after vaccination with INFLUENZA VACCINE. The time to onset was unknown. Further information regarding medical history, concurrent condition during vaccination, previous vaccination and tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
Felt like absolute crap for 3 to 4 weeks after the first vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 30Jun2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FEELING ABNORMAL (non-serious), outcome "unknown", described as "Felt like absolute crap for 3 to 4 weeks after the first vaccine".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt had minor shortness of breath and redness after vaccination. Pt was monitored by both Pharmacist and Pharmacist in Charge. Informed pt that if necessary, epinephrine would be administered and EMS would be contacted. Pt refused treatment and did not want to contact EMS. Grandmother (legal guardian) did not disagree with her. Pt and grandmother were advised to go to Urgent Care. Pt went to a local urgent care where they administered fluids, O2 and epinephrine. Pt went home in good health per grandmother.
Patient here for first dose of Covid vaccine series.  Pfizer Bivalent dose was given, Pfizer monovalent should have been given. No side effects reported.
I received my second shot of the HPV on 8/5/21 and had my last period on July 30th but nothing after that. I took 3 pregnancy tests and they all came out negative.
Diagnosed as: Bells Palsy.  The patient is a 60 year old male who presents with facial weakness. Note for "Facial weakness": Here today for f/u visit from ED. Went to ED 2 days ago for 2-day history of right facial droop and numbness, and could not close his right eye. Did not have weakness of any extremity, dizziness, headache, seizure, nausea, tingling, visual changes, or loss of consciousness.  Treated with acyclovir and prednisone course.
Pt was given Pfizer as second dose, first dose given on 5/17/21  was Moderna. No reaction noted.
My breathing became more labored; cough; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 53-years-old female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: unknown; Expiration Date: unknown), via an unspecified route of administration, administered in left arm on 07May2021 14:15 as single dose for COVID-19 immunization. The patient's medical history included anxiety, seasonal allergy, rubber sensitivity, allergic to latex, take monthly allergy shots for pollen and pollutants from an unknown date. Concomitant medications included fluoxetine 40 mg, ethinylestradiol, ferrous fumarate, norethisterone acetate, cetirizine hydrochloride taken for an unspecified indication. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 07May2021 at 16:00, two hours after vaccination, the patient experienced cough. Not a bad cough just more of the feeling to clear throat. 30 min later the cough was more persistent and felt it in lungs, breathing became more labored. The patient used 3 pumps of Albuterol Inhaler and breathing became normal 30 min later, still had a mild cough until bedtime. The patient woke up this morning feeling fine. The patient did not take treatment for cough. Device Date : 08May2021. On an unspecified date in May2021, the patient was recovered from the events.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Left thigh 1.5 cm round violaceous nodules hypoechoic well-circumscribed lesion on ultrasound. Sent to gen surg for possible biopsy or removal.
Abscess at site of vaccines. Pustular drainage 6 days after vaccine administration. Treated with drainage and Septra.
felt like room was spinning; Felt off balance; Pricking Skin sensation; hotness at injection site; redness at injection site; injection site soreness; injection site swelling; This case was reported by a consumer via call center representative and described the occurrence of injection site warmth in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th June 2019, the patient received the 1st dose of Shingrix. On 20th June 2019, 1 days after receiving Shingrix, the patient experienced injection site warmth, injection site erythema, injection site pain, injection site swelling and tingling skin. On 21st June 2019, the patient experienced room going round and balance disorder. On an unknown date, the outcome of the injection site warmth, injection site erythema, injection site pain, injection site swelling, room going round, balance disorder and tingling skin were recovered/resolved.   It was unknown if the reporter considered the injection site warmth, injection site erythema, injection site pain, injection site swelling, room going round, balance disorder and tingling skin to be related to Shingrix.  Additional information was provided as follows: The patient received 1st dose of Shingrix at 2 PM. The pharmacist said that it would hurt and might got red swelling at the injection site. By Thursday, it was little bigger than a silver dollar. It was very red, hot and very sore to touch and felt like needles were pricking at the injection site. Friday morning, the patient woke up with same symptoms but felt off balance when she tried to get out of bed. She did not felt like the room was spinning while laying down but only when standing up. On Saturday and Sunday the soreness and redness subsided. The patient was afraid to receive 2nd dose of Shingrix.
Numbness on complete left side of body.  No strength problem and no weakness just jump.  Bottom of left foot has pins and needles.  Left side of have including left side of lips and tip of tongue numbness.  30 minutes after shot the numbness started on the tip of tongue and lips and then woke up next morning and whole left side of body was topically numb to touch. Now 3 days post shot and slight numbness moving to right side of face and arm.
pt rcvd vx; pt experienced lethargy, photosensitivity, fever; t 102 & irritability; treated w/ ab for possible bacterial infection & apap for fever;
Local reaction at vaccine site 10 days after shot, red, warm, hard, itchy.  Had hospitalist look at and they recommended Benadryl.  Symptoms resolved
Mother called two days after vaccine; pt. had weakness and fever the day after the injection. Was well at the time I spoke with mother.
I took the Vaccine early Saturday Morning, 5/1/21 @ 6:50 am, I started feeling bad around 6 pm that evening, awakening at 1:00 am 5/2/21 feeling like I have Covid19 with My entire body in pain including Underneath My left arm in My Lymph Nodes...  The Pain is unbearable to the point I can't keep it down, I have to keep it over My head or hold it out away from My body...
Within minutes of administration of vaccine the patient became hot, sweaty, dizzy  and nauseous.   First vitals taken at 3:24,  showed increased heart rate.  Patient was moved back to vaccination booth so they could lay down in privacy.   Five minutes later vitals showed heart rate increased further.   At this time 911 was called.  We continued to monitor patient and prepared an Epi-pen, which was not administered.  EMS arrived and took over.
Dizziness; nausea; hot flashes; bouts of chills; runny nose; headache started on left side of head behind ear then progressed to frontal portion of head; Injection site pain; sore arm; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ERS737) via an unspecified route of administration in the left arm on 31Mar2021 at 12:00 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. Medical history of the patient was not reported. The patient did not have any known allergies to medications, food, or other products. The patient did not receive any concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 31Mar2021 at 15:30, few hours after getting vaccine, injection site pain/sore arm became noticeable. The patient woke up the next morning and arm was still feeling heavy and sore. The patient also experienced dizziness and nausea within 20 minutes of getting out of bed and while in shower, to the point of that the patient had to stop shower to go lay down. Then the patient experienced what seemed like hot flashes while laying down, got up about 25 minutes later and dizziness had subsided but later in the day experienced bouts of chills and runny nose, then headache started on left side of head behind ear then progressed to frontal portion of head. Therapeutic measures were not taken as a result of the reported events. 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 clinical outcome of the events injection site pain, sore arm, dizziness, nausea, hot flashes, bouts of chills, runny nose and headache was unknown at the time of this report.  No follow-up attempts are needed. No further information is expected.
lethargy; mild headache; slight temperature; body aches; arm was sore at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 51-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In November 2020, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 4 months after receiving Shingrix, the patient experienced injection site pain, lethargy, headache, body temperature increased and general body pain. On an unknown date, the outcome of the injection site pain, lethargy, headache, body temperature increased and general body pain were recovered/resolved.   It was unknown if the reporter considered the injection site pain, lethargy, headache, body temperature increased and general body pain to be related to Shingrix.  Additional details were reported as follows: The patient reported for himself. The patient received Shingrix vaccine around early November, might be 11/2020 in his right deltoid. His arm was sore at the injection site, which lasted for 4 days and then resolved. He also had mild headache, lethargy, slight temperature and body aches, which only lasted for a few hours. Lot number not available for the vaccines. The patient consented to follow up. This case has been linked to US2021AMR056308, reported by the same reporter; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR056308:same reporter
Redness, swelling of the left upper arm (about 2/3 of the upper arm / heat - cellulitis.
About 2 or 3 days after the injection, she began to feel pain and itching. Days 4 and 5 after the injection were the worst. She has a red circle/ bruising to the area just above the left bicep even though the vaccine was given in the left deltoid.
A spontaneous report has been received from a Physician concerning a 13 year old, Male subject, who had been receiving FLUMIST quadrivalent (intranasal). FLUMIST quadrivalent started on 31-Dec-2014. The reporter stated that the patient experienced inadvertently administered expired FLUMIST quadrivalent to four patients which started on 31-Dec-2014. The outcome of the event of inadvertently administered expired FLUMIST quadrivalent to four patients is unknown. The report was considered to be non-serious.
About 6-8 hours after receiving injection was having chills, sweating and shivering. Hands and feet were very sore and stiff. All areas of past trauma painful and continue to be so.
Pneumococcal 23 was ordered & prevnar 23 was given. No adverse events noted.
after the booster dose she had severe nausea; vomiting again; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (159558). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), on 19Dec2021 as dose 3 (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: BNT162b2 (Dose: 1), administration date: 07Mar2021, for COVID-19 immunization; BNT162b2 (Dose: 2), administration date: 28Mar2021, for COVID-19 immunization, reaction(s): "She reports severe debilitating nausea starting 12 hours after the second dose.", "States she was vomiting so much she went to the ER". The following information was reported: NAUSEA (non-serious) with onset Dec2021, 12 hrs after the suspect product(s) administration, outcome "unknown", described as "after the booster dose she had severe nausea"; VOMITING (non-serious) with onset Dec2021, 12 hrs after the suspect product(s) administration, outcome "unknown", described as "vomiting again". The events "after the booster dose she had severe nausea" and "vomiting again" required emergency room visit.  Additional information: Female consumer states that she received her 1st dose 07Mar2021, 2nd dose 28Mar2021, and a booster dose 19Dec2021. She reports severe debilitating nausea starting 12 hours after the second dose. States she was vomiting so much she went to the ER. She took Zofran which did not help. They gave her something for the nausea at the ER that did help after a couple hours. States she had to get an IV. 12 hours after the booster dose she had severe nausea and vomiting again and went to the ER again. States it wouldn't stop. States she would like to stay up to date on her vaccines, but she is concerned and could not put her body through that every time.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300112540 Same patient/vaccine/event, different dose;
Mouth sores on roof of mouth and cheek (white/very sore) about 1 week after injection. Tongue sores (red/swollen/sore) on both sides and tip of tongue + a fizzing feeling on top of the tongue starting about 10 days after injection.  Fizzing feeling on roof of mouth (opposite side to previous sore) at same time as tongue sores. At this date, the roof of mouth and cheek sores are healed, but the tongue sores have spread and make eating and talking challenging.  Additional side effects - Increased asthma for 7 days after injection - treated with Albuterol and Dulera. Tiredness and chills within first 2 days of injection Sore upper arm for 2 days, followed by continued soreness in elbow.
Swelling of left arm with large knot and hot to touch. No pain. Diagnosed with cellulitis of left arm status post vaccine. Treatment with Duricet 250mg bid for 10 days. Treatment started 7/24/02.