chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No additional AE reported. No PQC reported.; Inadvertently administered post expiry date.; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided.  On 24-AUG-2021, the patient was inadvertently vaccinated with an expired dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (recombinant Human albumin) (M-M-R II) lot # S025158 was confirmed to be valid, expiration date 13-AUG-2021, for prophylaxis (dose, route and site of administration were not reported). No additional adverse event was reported.
Same day post vax, the child started having persistent, inconsolable crying lasting less than 3 hours. He also had localized swelling at the injection sites on the left lower extremity.
Sudden and continuous ringing in my ears for the past 24 hours.  I have never had this condition before.
Given Pfizer first dose and Moderna 2nd dose. No signs or symptoms or treatment required
Cough; headache; low grade fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Cough), CHILLS (chills), HEADACHE (headache) and PYREXIA (low grade fever) 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 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, the patient experienced CHILLS (chills) and PYREXIA (low grade fever). On 13-Apr-2021, the patient experienced COUGH (Cough) and HEADACHE (headache). At the time of the report, COUGH (Cough), CHILLS (chills), HEADACHE (headache) and PYREXIA (low grade fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   No treatment information was provided.
Diluent was not used prior to 0.2 dose being given.  No s/s noted while patient was in clinic.
When administering the vaccine, patient pulled away, needle came out of left arm and more than half the dose was not administered. After consulting guidelines, the full dose was administered in the right arm.  The patient's mother advised to watch for side effects, sore arm, fever and tiredness.
Patient had shingles outbreak one week after receiving immunization. This started on 3/6 and is still active. Patient has painful blisters. She is currently being treated with acyclovir.
Pt developed a temperature of 103F, swelling and redness of arm and painful to move. Treated with aspirin, Tylenol and ibuprofen. Was test for Staph and was negative at time of vaccine.
throwing up; Tiredness; Chills; Nausea; Feeling unwell; Dizzy; Rapid heartbeat; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry were not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization, and gabapentin (unknown manufacturer), via an unspecified route of administration on an unspecified date at an unspecified dose and frequency for neuropathy. The patient's medical history and concomitant medications were not reported. On Monday (unknown date), the patient had the Pfizer COVID-19 Vaccine, then the patient was fine on Tuesday. On Wednesday, the patient took for the first time Gabapentin pill because the patient have neuropathy. About 2 hours after the patient took the Gabapentin, the patient started throwing up, and was not feeling well. But that all passed over. Since Wednesday (unknown date), the patient had tiredness, chills, nausea, felling unwell, dizziness, and rapid heartbeat. And the patient looked up and saw that all these could be side effects of the vaccine. The outcome of the events was unknown.  Information on the batch/lot number has been requested.
Systemic rash, on arms, neck, stomach, chest, and back; itching, increased body temperature
My son was seen by a developmental specialist on 11/16/01 all scores were between 87-102 (85 normal) after the shot he was seen on 10/29/03 and 3/7/03 his development has decreased and he was labeled PDD. Follow up on 06/06/2004: "[pt] has been diagnosed PDD (Pervasive development disorder) I feel he was fine, before his MMR shot. I have him on video talking-he now doesn't speak." "Please continue researching these vaccinations. It is so unfair to parents to feel the way I feel. Thank you."
Initial unsolicited report received from a healthcare professional via other company (Pfizer) (Manufacturer Report Number: 2016578021) on 03-Jan-2017. This case involves a female patient (onset age not reported) who was vaccinated with a dose of INFLUENZA VACCINE (Influenza Virus Vaccines) (batch number, expiration date, dose, dose in series, route and site of administration were not reported) on an unspecified date. Patient's medical history and concomitant medications were not reported. On an unspecified date, following vaccination the patient experienced allergy to vaccine (allergies: influenza virus vaccines). Laboratory investigations and corrective treatment were not reported. The outcome of the event was not reported. List of documents held by sender: none.
Approx. 5 hrs. after receiving yellow fever vaccine c/o chills, progressively worse through evening.  Did not check his temp.  Today 1/4/08 c/o "no energy, joint soreness".
Employee arrived for routine Hep B inj #2. Denies previous reaction to inj #1. Inj give without incident, no signs or symptoms of reaction. Patient had fallen on knee prior to injection. Medical Records received from Alegent ER stated patient experienced cardiopulmonary arrest. Final autopsy report received on 1/24/06 revealed COD severe arteriosclerosis, hypertensive cardiovascular disease and coronary artery disease.
Subsequent to receiving varicella virus vaccine live, laboratory evaluation revealed failure to seroconvert following vaccination. No further information is available.
experienced swings in blood pressure, like extremely low and also high blood pressure; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 80 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1 (Manufacturer unknown)), for covid-19 immunisation; Covid-19 vaccine (Dose 2 (Manufacturer unknown)), for covid-19 immunisation. The following information was reported: BLOOD PRESSURE FLUCTUATION (non-serious), outcome "unknown", described as "experienced swings in blood pressure, like extremely low and also high blood pressure". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: The reporter and the father experienced side effect after getting the third booster shot for the vaccine. Patient experienced swings in blood pressure, like extremely low and also high blood pressure.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient received both the Fluzone HD and Pneumovax 23 shots in separate arms. In the arm with the Pneumovax 23 he is experiencing redness, swelling, and itching in his elbow area 24 hours post vaccination. I told him to use a cold compress and take a benadryl tablet to see if that helps his symptoms and to let us know if it gets worse.
Approx 5 hours after injection, pt c/o extreme muscle pain in legs arms, back and abdomen. -No local reaction noted @ injection site. Pt also c/o H/A and nausea no V/D no fever. Symptoms lasted until 1-16-09 @ noon. : per mom report.
pt developed severe pain to the left upper extremity from her shoulder to her elbow that was very sensitive to light touch;  This happened on day 1, I saw her on day 3.  On day 3 she had developed a red  area that surrounded the site of the injection and was warm to touch.  The sensitive area had narrowed down to this red area and the rest of the arm had improved;  patient said that she could not lift her arm beyond shoulder level for 2 days.  it was improving at the time I saw her
Shingles; This spontaneous report was received from a lawyer, regarding a case in litigation and refers to a currently approximately 65-year-old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On or about 18-DEC-2014, the patient was administered zoster vaccine live (ZOSTAVAX) vaccine (dose, route of administration, anatomical location, lot # and expiry date were not provided) for the long-term prevention of shingles and zoster-related conditions, by a healthcare provider at physician's office. Subsequently, on an unknown date, the patient was treated by a healthcare provider for the following injuries resulting from the patient's zoster vaccine live (ZOSTAVAX) use: shingles. The outcome of shingles was not provided. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Lesions started  10/06/09 -at injection site- stated sl. fever - Temperature unknown. Multiple fluid filled raised bumps Rt arm/back/chest and head 4-5 days - Lesions are itchy and slightly tender - Denies fever/nausea or vomiting/headache/previous skin problem or previous hx of chickenpox.
Several hours post vaccines patient felt slight pain in arm around site of injections. Returned 1 week later with similar complaints. 2nd complaints 2 weeks later.
Approx 10:18 am  after injection complained  of shortness of breath, tingling fingers and toes, dizziness.  History of asthma.  Lungs clear. B/P 163/7; 144/77 and 137/70;   Observed and given some sprite.  Discharged at 10:52 am.
trouble breathing; trouble breathing and extremely stuffy; lower back pain; stiff neck on left side all the way up behind ear; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (stiff neck on left side all the way up behind ear), BACK PAIN (lower back pain), DYSPNOEA (trouble breathing) and NASAL CONGESTION (trouble breathing and extremely stuffy) in a 70-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (stiff neck on left side all the way up behind ear). On 21-Feb-2021, the patient experienced BACK PAIN (lower back pain). On 23-Feb-2021, the patient experienced DYSPNOEA (trouble breathing) and NASAL CONGESTION (trouble breathing and extremely stuffy). The patient was treated with MONTELUKAST at a dose of 10 milligram; AZELASTINE at an unspecified dose and frequency and LORATADINE (CLARITIN [LORATADINE]) at an unspecified dose and frequency. On 22-Feb-2021, MUSCULOSKELETAL STIFFNESS (stiff neck on left side all the way up behind ear) and BACK PAIN (lower back pain) had resolved. At the time of the report, DYSPNOEA (trouble breathing) and NASAL CONGESTION (trouble breathing and extremely stuffy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.; 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.
Headaches front of head, behind and in front of right ear with tingling/numbness feeling. Pain in arm at injection site. Headaches with sensations occurred every day with tingling spreading in face area, for the two weeks  turning to numbness, slurred speech and inability to close right eye. Causing to seek treatment.
Flu like, tired, running nose, throat congestion, trouble concentrating .  Dizzy spells over last 2 weeks after apparent recovery
No adverse effect reported; temperature excursion / temperature: 11.1 C; This spontaneous report was received from a nurse and refers to a 13-year-old patient of unknown gender. There was no information regarding their medical history, concurrent conditions nor concomitant therapies provided.  On 30-JUL-2021, the patient was vaccinated with an improperly stored dose of hepatitis A vaccine, inactivated (VAQTA) 0.5 mL, lot # T023913, expiration date 31-MAR-2022 (route of administration and anatomical location were not provided) for prophylaxis. The administered vaccine was stored in a temperature of 11.1 degree Celsius (C) for 1 hour and 17 minutes. No previous temperature excursion was reported. Digital data logger was involved. No adverse effect was reported.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. devicelotnumber: T023913; expirationdate: 31-MAR-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability; Sender's Comments:  US-009507513-2108USA000581: US-009507513-2108USA000580:
Local redness, warmth & tenderness at injection site approximately 1 1/2 cm diam by 2 days after injection.
Deterioration to the point that he cannot hold a fork or tie his shoelaces; he also cannot go to the bathroom on his own; This spontaneous case was reported by a physician and describes the occurrence of MUSCULAR WEAKNESS (Deterioration to the point that he cannot hold a fork or tie his shoelaces) and HYPOKINESIA (he also cannot go to the bathroom on his own) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A15) for COVID-19 vaccination.     The patient's past medical history included Neuropathy (this decreased her mobility and weakened it (tenderness in the hands) but it had been improving well.) in November 2020.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, the patient experienced MUSCULAR WEAKNESS (Deterioration to the point that he cannot hold a fork or tie his shoelaces) and HYPOKINESIA (he also cannot go to the bathroom on his own). At the time of the report, MUSCULAR WEAKNESS (Deterioration to the point that he cannot hold a fork or tie his shoelaces) and HYPOKINESIA (he also cannot go to the bathroom on his own) 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.   concomitantly, in Nov-2020, Patient took only a pill at atb (Livoaquam). No treatment related information has been reported.
caller was drawing up the vaccine into the syringe and it filled really fast so she is not sure if she administered air or the full dose to the patient; The patient felt the poke and felt some pressure; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A 66 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 25Sep2021 (Lot number: 301458A, Expiration Date: Nov2021) as dose 3 (booster), 0.3 ml single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1st), when the patient was 66 years old, for Covid-19 immunization; Bnt162b2 (Dose: 2nd), when the patient was 66 years old, for Covid-19 immunization. The following information was reported: WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (non-serious) with onset 25Sep2021, outcome "unknown", described as "caller was drawing up the vaccine into the syringe and it filled really fast so she is not sure if she administered air or the full dose to the patient"; FEELING ABNORMAL (non-serious) with onset 2021, outcome "unknown", described as "The patient felt the poke and felt some pressure".  No follow-up attempts are possible. No further information is expected.  Additional Information: It was reported that,the caller is a pharmacist at (withheld) calling about the Pfizer covid 19 vaccine. The caller was drawing up the vaccine into the syringe and it filled really fast so she is not sure if she administered air or the full dose to the patient. The caller felt no pressure when giving the injection but the patient felt the jab or felt something. The caller was preparing two shots side by side and filled up the first one fine but with the second one the caller has a habit up puling it up to the 0.3 ml. The caller administered the one that was not filled with the injection. The patient felt the poke and felt some pressure. The caller is unsure of it was 0.3 ml and how it feels to inject air instead of the medication. When the caller gave the shot it was not normal. The first dose the caller drew up was fine but the second one was in question. The Patient had no medical history.  Follow-up #01 (27Sep2021): This is a follow-up spontaneous report from a contactable Pharmacist. A Pharmacist reported for 66-year-old male patient that, upon follow up, information included dose was booster, the booster dose administration date was 25Sep2021, Expiry Date was Nov2021 was added. Event verbatim (caller was drawing up the vaccine into the syringe and it filled really fast so she is not sure if she administered air or the full dose to the patient) onset date was 25Sep2021 added. Other medical information was added.  Follow-up #02 (27Sep2021): This is a follow-up spontaneous report from a contactable Pharmacist. A Pharmacist reported for 66-year-old male patient that, Upon follow up, no new event/SD was added.  Follow-up attempts are completed. No further information is expected.
sore arm; fatigues; chills; This is a spontaneous report from a contactable consumer (patient). A 31-year-old female patient received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN5318), via an unspecified route of administration on 16Feb2021 (at the age of 31 years old) as dose 1, single for COVID-19 immunisation. The patient has no medical history. The patient has never had COVID prior to vaccination. The patient is not pregnant at the time of vaccination. The patient's concomitant medications were not reported. No other vaccine was given in four weeks. The patient experienced sore arm, fatigues and chills on 17Feb2021. No treatment was given in response to the events. The patient underwent lab tests and procedures which included COVID test (post vaccination) via Nasal swab on 09Feb2021 which was negative. The outcome of the events was recovering.   Follow-up attempts are completed. No further information is expected.
Nausea, Vomiting, Unconsciousness (Reported by husband as fainting and potential seizure). Pt was disoriented and shaking. Pt was brought to the ED by her husband immediately. ED mentioned concussion and potential seizure activity.  Pt is not allowed to drive for 3 months and will follow up with a Neurologist.  Pt is not allowed to drive for 3 months and will follow up with a Neurologist.
On 11/15 experienced shortness of breath and high-blood pressure. Saw PCP 11/16. I was put on a beta-blocker and saw a cardiologists. By 11/20 my shortness and pain in my chest was so bad I had to go to urgent care. Went to the ER the same day. Had abnormalities in my chest. I received a dose of aspirin. I was discharged but diagnosed w/ POTS. I had an improvement over the next couple of weeks. On 12/08 during a flight I had to put on oxygen in midair and take to the ER immediately after my flight. I was put on aspirin again which made a massive improvement over the following 3 weeks. I'm still having occasional shortness of breath. I began Eliquis on 2/1. I will be returning to rheumatologist.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site itching in a 65-year-old female patient who received SHINGRIX (batch number HG4P3, expiry date 13th July 2020) for prophylaxis. Concomitant products included Sumatriptan, butalbital and LEXAPRO. On 14th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 16th May 2018, 2 days after receiving SHINGRIX, the patient experienced injection site itching. On 16th June 2018, the outcome of the injection site itching was recovered/resolved. It was unknown if the reporter considered the injection site itching to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the right deltoid. The patient reported to the pharmacist that she followed up with her physician.
Site: Redness at Injection Site-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: Person with her said she has concerns with injections but hasnt fainted with previous Pfizer Covid injection(s)  I attempted phone call to her residence 8:15pm to check on her but no answer. Event occured est 6:30pm, 911 emergency personel arrived 6:37pm, taken by stretcher 6:48pm
Was up all night; Throwing up; Chills; Nauseous; His whole body hurts; Diarrhea; He is afraid of is getting the second shot because he was sick for a couple of days; Both arms are hurting; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 50 year-old male patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 17Nov2021 19:30 (Lot number: FF2593) at the age of 50 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: INSOMNIA (non-serious) with onset 17Nov2021, outcome "recovering", described as "Was up all night"; VOMITING (non-serious) with onset 17Nov2021, outcome "recovering", described as "Throwing up"; CHILLS (non-serious) with onset 17Nov2021, outcome "recovering", described as "Chills"; NAUSEA (non-serious) with onset 17Nov2021, outcome "recovering", described as "Nauseous"; PAIN (non-serious) with onset 17Nov2021, outcome "recovering", described as "His whole body hurts"; DIARRHOEA (non-serious) with onset 17Nov2021, outcome "not recovered", described as "Diarrhea"; ILLNESS (non-serious) with onset 17Nov2021, outcome "recovered" (2021), described as "He is afraid of is getting the second shot because he was sick for a couple of days"; PAIN IN EXTREMITY (non-serious) with onset 17Nov2021, outcome "not recovered", described as "Both arms are hurting". Therapeutic measures were taken as a result of insomnia, vomiting, chills, nausea, pain, diarrhoea, illness, pain in extremity.  Additional information: The patient was afraid of getting the second shot because he was sick for a couple of days. He had the COVID-19 Shot and called because he was up all night, throwing up, he got the chills and nauseous, his whole body hurts and diarrhea and they told him to call back after, if things started to get better, it took him couple of days to come around and also he wanted to know if that was a normal reaction, the throwing up. The patient's diarrhea didn't improve. The second shot was due on 08Dec2021. The patient did not have any other medical condition. The patient had no prior vaccinations with in 4 weeks. The patient was slowly gets better, the diarrhea but his both arms were hurting. He was given Motrin, 600 mg. Time of vaccination was like 19:30 pm.  No follow-up attempts are possible. No further information is expected.