chrisvoncsefalvay/vaers-outcomes huggingface dataset:
large tender area below injection site on arm; received the larger than expected dose; flu-like symptoms for about 8 hrs.; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu-like symptoms for about 8 hrs.), VACCINATION SITE PAIN (large tender area below injection site on arm) and INCORRECT DOSE ADMINISTERED (received the larger than expected dose) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011F) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Oct-2021, the patient experienced INCORRECT DOSE ADMINISTERED (received the larger than expected dose). On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu-like symptoms for about 8 hrs.) and VACCINATION SITE PAIN (large tender area below injection site on arm). On 17-Oct-2021, INCORRECT DOSE ADMINISTERED (received the larger than expected dose) had resolved. At the time of the report, INFLUENZA LIKE ILLNESS (flu-like symptoms for about 8 hrs.) had resolved and VACCINATION SITE PAIN (large tender area below injection site on arm) outcome was unknown.            Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.  Patient was not immunocompromised.   This case was linked to MOD-2021-360706 (Patient Link).
Soreness in right arm/soreness in the right arm lasted for a few days; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Soreness in right arm/soreness in the right arm lasted for a few days) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 054C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included FLUOXETINE, LISINOPRIL, TRAZODONE and FENOFIBRATE for an unknown indication.   On 27-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-May-2021, the patient experienced MYALGIA (Soreness in right arm/soreness in the right arm lasted for a few days). At the time of the report, MYALGIA (Soreness in right arm/soreness in the right arm lasted for a few days) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment details were reported.   This case was linked to MOD-2021-260608 (Patient Link).
Pt received one Pfizer vaccination, and right afterwards got severe flu symptoms, chest pains, dizzy, nausea, sweating,  mentally very disoriented, and severe lethargy but difficult to sleep. He was unable to drive that night. These severe symptoms lasted for 7 days.  Pt continues to have episodic mental impairments and difficulty sleeping.
I had controlled blood pressure.  I started to have chest pains a few months ago.  I decided to go to the ER because my left arm numb and nodules showed up.  In the ER they did an EKG and they showed that I had blood clots in my lungs.  I was admitted to the hospital for 3 days.  They ran blood test and prescribed me blood thinners to take.  I have so many issues from the second vaccine.
Information has been received from a 76 year old female who on 06-MAR-2007 was vaccinated with Zostavax (Oka/Merck).  Concomitant therapy included PLAVIX, ZOLOFT, aspirin, NEXIUM, furosemide and lovastatin (manufacturer unknown).  Subsequently in 2007, the patient developed sores or blisters on her chin and lip.  The patient did not seek medical attention.  Additional information is not expected.
Breakthrough infection in vaccinated patient (completed series and had booster) and patient elected for palliative care and passed away while in hospital.
pt says she started feeling pain around the injection site.  She then felt dizzy, had blurred vision and was nauseated.  Her eyes were half shut and then she blacked out.  She then had a seizure  with shaking and convulsions.  She came to and felt weak and was clammy feeling and was pale.  Her hand arms and hands were tingling.  Paramedics took her to ER. They took vitals, did CT and lab work.  She was discharged to go home and FU w/ PCP.  On 6/10/21 she saw PCP where they did more lab work.  Her 2nd dose is scheduled on 6/29 at her doctors office where she will have medical supervision.  Pt says she is feeling better today but still has pain from where she fell when having the seizure.
Patient  had vaccine completed in right arm and was waiting for 15 minutes following the vaccine.  After 10 minutes the patient complained of numbness in her left hand and arm.  Fingers were cool to the touch but fingers on right hand were the same and pt states that is often her baseline.  She denied any pain, shortness of breath, or dizziness.  Vital signs were temp 99.4, pulse 97, O2 100% on room air, BP slightly elevated on 151/95.  Patient was escorted to Urgent care for evaluation and information was given to triage RN
The patient was given the vaccine at 4:01. She was asked to wait for 30 minutes after her vaccine due to her pcn allergy. The patient went to the restroom at 4:19 and her boyfriend came to the pharmacy and said she was light headed. The patient laid in the floor bc she didn't feel well, 4:20 I took her blood pressure 104/68 pulse 85. we elevated her head and gave the patient an ice  pack. Patient said she was queasy when she was filling out her paperwork. 4:24 patient was able to sit up and drink water. 4:28 BP TAKEN AGAIN 132/55 PULSE 97.  patient was feeling better at 4:33 I checked on the patient at 6pm and was feeling better
pt recv vax 23APR96 & 27APR96 pt devel rash & pustules indicative of chickenpox on rt upper abd near arm;@ time of report pt was fine
i accidentally administered the children's formulation instead of the adult dose. The patient was UNDER dosed.
Soreness and tenderness around injection side starting 2 hours after and continuously getting worse. Very low grade fever 10 hours after.
Vomiting.  Bile stained.  Abdominal pain. Anorexia. Air contrast enema + Abd. X ray + Abd ultra-sound.  8/24/09 Hospital records received DOS 8/6/09 to 8/7/09. Assessment Intussusception.  Patient presents with 2 days emesis. Barium air contrast enema (+) for IS and successful at reduction.
14 year old male reported not being able to see after receiving vaccine.  writer noted the boy's skin pale in color. The boy is able to follow command but has unclear speech. Paramedic on site. Per paramedic the boy has body weakness, mild headache, and blurred vision. Per paramedic vital signs are BP 107/63, R 16, PR 66. The boy recovered under the care of the paramedic.
Janssen 3/6/21, Moderna 5/10/22. Positive on 8/18/22.
This literature marketed report as received from a physician refers to 52 patients of unknown age with HIV diagnosis. Individuals with HIV infection often have early waning of protective antibody following hepatitis B virus (HBV) vaccination. HIV viraemia at the time of vaccination may limit the durability of serum anti-HBV surface antibody (HBsAb) levels. The author included patients who had no history of prior HBV infection. On an unknown date the patients were vaccinated with RECOMBIVAX HB. A total of 186 vaccine responders were identified and out of that HBsAb was waned in 52 patients. The cumulative proportion of patients with sustained HBsAb is greater than or equal 10 IU/L was 83% at 2 years and then dropped to 56% at 5 years. The median time to loss of protective HBsAb in all patients were occurred at 8.3 years. The author was not able to evaluate the association between antibody waning and vaccine dose. The clinical significance of vaccinated HIV infected patients with HBsAb waning below 10 IU/L was unclear. The outcome of event was unknown. Additional information has been requested.
problem in her mouth, tooth problem; This is a spontaneous report from a contactable consumer(patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number and expiry date was not reported), dose 1 via an unspecified route of administration on 18Jan2021 as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On 30Jan2021, the patient experienced problem in her mouth that was tooth problem. Further patient explained she would receive 2nd dose of the vaccine on Monday, 08Feb2021 but on Saturday 30Jan2021, Patient had a problem with her mouth, a tooth problem, went to dentist yesterday, they told her there was nothing wrong with tooth or gums, that it was likely a virus and there was nothing they could do for it that it would have to go away on its own. The patient stated that she does not think this was due to the vaccine. The patient stated that she does not want Pfizer thinking she had a side effect that this is not caused by the vaccine. The patient wanted to know if it was okay to go ahead and get the second dose with the possible virus.  The outcome of the event was recovering.   Information on the lot/batch number has been requested.
Skin broke out in hives/eczema. I noticed it 2 weeks after vaccine given as it was getting progressively worse. Went to doctors a month after vaccine was given and doctor said it looked like eczema. was referred to allergist. Allergy doctor said it was contact dermatitis/eczema.  Treatment: take Zyrtec daily, hydrocortisone, vanicream, vanicream soap, hibiclens soap, daily baths. Severe symptoms lasted at least 3 months until treatment started to kick in.
Patient had loss of consciousness and fell after vaccine administration. Patient lost consciousness for less than one minute. EMS was called immediately. Patient's mother reported no seizure history.
Approximately 8 hours after vaccination, developed sudden malaise, nausea (no vomiting), then shaking chills which lasted about 8 hours, then ended with profuse sweating
Information has been received from a lawyer regarding a case in litigation concerning a 69 year old female patient. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX vaccine by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. In May 2014, the patient was administered the ZOSTAVAX by a pharmacist at a pharmacy (lot number, dosage and route of administration not provided). In June 2014, the patient was treated by a physician for the following injury resulting from her ZOSTAVAX use: Shingles. The patient claims damages including: injury to herself and economic losses. The outcome of the shingles is unknown. Additional information has been requested.
Headache; congestion (sinus); severe vertigo; Vomiting; Nausea; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EJ1685), via an unspecified route of administration on 29Dec2020 at a single dose on the right arm for COVID-19 immunization. The patient's medical history was reported as none. There were no concomitant medications. On 06Jan2021, the patient experienced severe vertigo. Patient also experienced headache, congestion (sinus) on an unspecified date. On 05Jan2021, patient experienced vomiting and nausea. Patient stated that she went to her primary care and was given patch for nausea and was given a different sinus brand to clear up the congestion. Patient stated that with all these, she is pretty sure that she does not want the second dose. Patient stated that she has symptoms of the vaccine than rather COVID and wanted to know what were the recommendations. The outcome of the event congestion (sinus) was not recovered, vomiting was recovered 05Jan2021, while the other events was recovering.
Pt has developed what she calls a "cold sore". She has reportedly never had this issue before and is convinced that it is related to the flu shot.
experienced a significant increase in the intensity and frequency of migraines; Severe migraine in five days following.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 53 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 16Apr2021 15:00 (Lot number: ER8731) at the age of 53 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Chronic migraine", start date: 01Mar2002 (ongoing), notes: Other medical history: Chronic migraine. Concomitant medication(s) included: SUMATRIPTAN taken for migraine (ongoing). Vaccination history included: Bnt162b2 (Dose:1, vaccine location=Right arm, Administration time=03:00 PM,, Lot Number: EP6955, No events reported), administration date: 25Mar2021, when the patient was 53 years old, for Covid-19 immunization. The following information was reported: MIGRAINE (non-serious) with onset 19Apr2021, outcome "recovered" (Apr2021), described as "Severe migraine in five days following."; MIGRAINE (non-serious), outcome "not recovered", described as "experienced a significant increase in the intensity and frequency of migraines". Therapeutic measures were taken as a result of migraine. Additional information: At Pharmacy or Drug Store facility where the most recent COVID-19 vaccine was administered. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not tested for COVID-19 since the vaccination. No Known allergies. The vaccination was followed by a very severe migraine that did not respond to treatment. In the following three weeks the patient experienced a significant increase in the intensity and frequency of migraines, resulting in 5 days off work. No follow-up attempts are possible. No further information is expected.
A report was received from a consumer on 10/14/2003 concerning an unspecified number of vaccinees less than 4 years of age who received Fluvirin subcutaneously on an unspecified date. On an unspecified date an unspecified number of vaccinees less than 4 years of age received Fluvirin subcutaneously.  The reporter indicated that the exact number was unknown but was believed to involve less than 20 vaccinees.  Vaccinees aged between 6 and 35 months were given 0.25ml and 0.5ml was given to vaccinees greater than 35 months.  No adverse symptoms had been noted. Follow up pending. Update 1, 7 November 2003: A follow up report was received from a consumer indicating that a male vaccinee less than 4 years of age received Fluvirin intramuscularly on 10/13/2003.  No adverse reaction had occurred at the time of the report.
A few days after the injection, my left wrist started to hurt as if I had sprained it. It hurt to rotate it. It felt like arthritis or something to do with my joints, but only in my left wrist. Then the pain began in my left elbow. More joint pain. Rubbing it helped alleviate the discomfort.  After about 2 weeks, the wrist pain subsided and disappeared. The elbow pain remains at the time of this submission.
Arm was itchy; Swollen arm; Rash; Experiencing pain, spreading through arm; Feeling poorly; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of FEELING ABNORMAL (Feeling poorly), INJECTION SITE PRURITUS (Arm was itchy), INJECTION SITE SWELLING (Swollen arm), INJECTION SITE RASH (Rash) and INJECTION SITE PAIN (Experiencing pain, spreading through arm) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0371920A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history.).    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Dec-2020, the patient experienced FEELING ABNORMAL (Feeling poorly). On 05-Jan-2021, the patient experienced INJECTION SITE PRURITUS (Arm was itchy), INJECTION SITE SWELLING (Swollen arm), INJECTION SITE RASH (Rash) and INJECTION SITE PAIN (Experiencing pain, spreading through arm). On 01-Jan-2021, FEELING ABNORMAL (Feeling poorly) had resolved. At the time of the report, INJECTION SITE PRURITUS (Arm was itchy), INJECTION SITE SWELLING (Swollen arm), INJECTION SITE RASH (Rash) and INJECTION SITE PAIN (Experiencing pain, spreading through arm) 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.   No relevant concomitant medications were reported. No treatment information was provided.   Based on the current available information and temporal association between the use of the product and the start date of the event, 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 event, a causal relationship cannot be excluded.
pt recv vax & 21SEP95 pt exp loss of taste progressing to numbness & pain over rt tongue, rt face, rt scalp;paralysis of eye & face;pt hosp & worked up for Bell's Palsy;t101;had temporal h/a since 26SEP95;pain was tight & tingling;
Pain at injection site, redden area, by evening 6:30PM tired, headache, continued through day 2, more pain and larger redden area.
Patient received the Pfizer Bivalent covid for the 5-11 year age range.  Was supposed to have received the 12 and up pfizer version. Provider notified and stated that patient did not need to receive additional dose.  Parent notified that no further doses needed at this time, and verbalized understanding.
Patient was found unresponsive by boyfriend around 1AM the next day. Boyfriend took patient to hospital where patient was diagnosed with adverse reaction to vaccination. Patient had extreme syncopal episode.
PT IS A 21 YOA MALE, WHO CAME AS WALK-IN FOR HIS FIRST DOSE OF THE PFIZER COVID VACCINE TODAY. PT WAS IMMUNIZED AROUNG 12:32PM. PT WAS ABLE TO WALK TO THE PHARMACY LOBBY AND SAT DOWN. ABOUT 12:34:57PM PT FAINTED WHILE SITTING DOWN. HIS MOM, WHO WAS SITTING ACROSS FROM HIM, NOTICED RIGHT AWAY AND CALLED FOR HELP. PHARMACIST CAME OUT STRAIGHT AWAY (ABOUT 12:35:15PM) TO TAKE CARE OF THE PT. ELEVATED HIS FEET RIGHT AWAY.. PT WAS CONSCIOUS AND RESPONSIVE.  PER MOM, PT WAS UNCONCIOUS FOR A COUPLS OF SECONDS & DID NOT HIT HIS HEAD. PER MOM, SO FAR PT ONLY HAD A SLICE OF BANANA BREAD AND CHOCOLATE MILK FOR THE DAY. PT SAID HE FELT DIZZY BEFORE FAINTING. PHARMACIST CHECK HIS BP & HR (122/86 & 56BPM), WHICH SEEMS TO BE WITHIN RANGE. PT WAS GIVEN SOME APPLE JUICE & SOME COLD PACKS TO PLACE ON HIS HEAD. PT WAS MONITORED FOR TOTAL OF 1 HOUR AFTER GIVEN VACCINE. PT IMPROVED AND ABLE TO GO HOME.  PHARMACIST STRONGLY RECOMMEND FOR PT TO BE SEEN BY PCP FOR A F/U. PHARMACIST ALSO F/U VIA PHONE CALL AFTER A COUPLE OF HOURS AND PER MOM PT IS DOING FINE.
Patient developed a mild erythematous macular rash that has become generalized and now with some pruritus on the arms today.  No intraoral edema or erythema, normal breath sounds.  Has slight cough.  Given Benadryl 25mg for sxs.  Had COVID in October 2020.
Patient asks that this be reported. He attributes the following to vaccination. He reported worsening dyspnea and heart pounding, was referred to emergency department in local hospital for evaluation and was found to have bilateral PE and DVT.  Diagnosis acute bilateral pulmonary emboli and bilateral deep venous thrombosis unprovoked. He was also found to have PVC and he he has chronic right bundle branch block He was prescribed Eliquis and discharged home
Shot administered in right arm.  Swelling/fluid build up under and right area of breast around armpit.  Soreness and tenderness in and around area.  This occurred after the second injection of the Pfizer vaccine.  Currently length of time for swelling is now  3 months exceeding recommended time for swelling to go away.  Swelling still exists and there seems to be no remedy.
No symptoms reported/ No complication or adverse reaction noted/reported.; patient received GARDASIL 9 outside of prescribing informaton/ second dose on 2/18/2019; patient received GARDASIL 9 outside of prescribing informaton/ first dose on 12/17/2019; Information has been received from a physician referring to a 45 years old patient of unknown gender. Information about concomitant medication, pertinent medical history and drug reactions/allergies was not provided.  On 17-DEC-2018 (conflicting information: reported as 17-DEC-2019), the patient received the first dose hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) outside of prescribing (lot number N009173, expiration date 20-NOV-2019; frequency and anatomical location were unknown) intramuscularly for prophylaxis (product prescribing issue). On 18-FEB-2019, the patient received the second dose hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot number R005341, expiration date 06-DEC-2020; frequency and anatomical location were unknown) intramuscularly for prophylaxis (product prescribing issue). No symptoms, complication or adverse reaction noted/reported.
pt recv vax 8APR97 & 18APR(7 inside of arm from shoulder to elbow bright red & hot;went to MD keflex given;called 21APR97 arm yellow now instead of red;no other problems;
rubbery legs; fall; problems walking; problem with legs from the knees down; dizziness when walking down hallway; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (rubbery legs), FALL (fall), GAIT DISTURBANCE (problems walking), LIMB DISCOMFORT (problem with legs from the knees down) and DIZZINESS (dizziness when walking down hallway) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Allergy (severe allergies), Hypertension and Osteoporosis. Concomitant products included LISINOPRIL for Hypertension, ALENDRONATE SODIUM (ALENDRONATE) for Osteoporosis.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced MUSCULAR WEAKNESS (rubbery legs), FALL (fall), GAIT DISTURBANCE (problems walking), LIMB DISCOMFORT (problem with legs from the knees down) and DIZZINESS (dizziness when walking down hallway). At the time of the report, MUSCULAR WEAKNESS (rubbery legs), FALL (fall), GAIT DISTURBANCE (problems walking), LIMB DISCOMFORT (problem with legs from the knees down) and DIZZINESS (dizziness when walking down hallway) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
TRANSIENT CEREBRAL ISCHEMIA 4/9/2023 ATRIAL FIBRILLATION, UNSPECIFIED ACUTE HYPOXEMIC RESPIRATORY FAILURE 4/12/2023 ATRIAL FIBRILLATION, UNSPECIFIED TRANSIENT CEREBRAL ISCHEMIA 4/9/2023 ANEMIA OF CHRONIC DISEASE ACUTE HYPOXEMIC RESPIRATORY FAILURE 4/12/2023 ANEMIA OF CHRONIC DISEASE