chrisvoncsefalvay/vaers-outcomes huggingface dataset:
very stiff in his legs and then it traveled up to hips briefly and then in his shoulders for a longer period of time; very stiff in his legs and then it traveled up to hips briefly and then in his shoulders for a longer period of time; very stiff in his legs and then it traveled up to hips briefly and then in his shoulders for a longer period of time; 1st dose on 16Mar2021 and 2nd dose on 30Mar2021= below 19-day interval; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 30Mar2021 (Batch/Lot number: unknown) at the age of 70 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FLU. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Time: 15:00, Lot: EN6207), administration date: 16Mar2021, when the patient was 70 years old, for covid-19 immunization. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 30Mar2021, outcome "unknown", described as "1st dose on 16Mar2021 and 2nd dose on 30Mar2021= below 19-day interval"; MUSCULOSKELETAL STIFFNESS (non-serious) with onset Apr2021, outcome "recovering", JOINT STIFFNESS (non-serious), MUSCULOSKELETAL STIFFNESS (non-serious), outcome "recovering" and all described as "very stiff in his legs and then it traveled up to hips briefly and then in his shoulders for a longer period of time". The event "very stiff in his legs and then it traveled up to hips briefly and then in his shoulders for a longer period of time", "very stiff in his legs and then it traveled up to hips briefly and then in his shoulders for a longer period of time" and "very stiff in his legs and then it traveled up to hips briefly and then in his shoulders for a longer period of time" was evaluated at the physician office visit. Therapeutic measures were taken as a result of musculoskeletal stiffness, joint stiffness, musculoskeletal stiffness.  Additional information: Patient has gone to a rheumatologist and has been under her care since April. Patient was on prednisone and then he was on calcium. No additional Vaccines Administered on Same Date of the Pfizer Suspect. Patient Had flu shot after the second dose of the COVID vaccine and had no reaction to it.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Redness, Swelling to (L) arm Spoke with MOC swelling has gone down, redness is going away.
Feeling a bit under the weather; This is a spontaneous report received from specialty pharmacy from a contactable consumer(patient). A 24-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via unknown route on Mar2021 (Batch/Lot number was not reported) at single for covid-19 immunisation; treprostinil sodium (REMODULIN, concentration of 5 mg/ml), iv drip from 30Jun2005 (Lot Number: 2101734; Expiration Date: 30Nov2021) to an unspecified date, at 0.150 ug/kg, continuing, for pulmonary arterial hypertension.  Medical history included ongoing pulmonary arterial hypertension. Concomitant medication(s) included warfarin sodium, ambrisentan and tadalafil, all taken for an unspecified indication, start and stop date were not reported.  It was reported that the patient felt a bit under the weather as he had his COVID shot recently. Action taken with IV Remodulin was not reported for the event of malaise. At the time of reporting, the outcome of malaise was unknown. The reporter did not provide causality for the event of malaise.  No follow up attempts are needed. No further information expected.
Patient state he received the vaccine on 7/31/18 from the pharmacy. Pt. states that evening he began to feel weak, low grade fever, HA, cough, and lethargic, and trouble walking w/o assistance.
received 2nd dose while positive with covid-19; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (received 2nd dose while positive with covid-19) 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 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, the patient experienced SARS-COV-2 TEST POSITIVE (received 2nd dose while positive with covid-19). At the time of the report, SARS-COV-2 TEST POSITIVE (received 2nd dose while positive with covid-19) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Apr-2021, SARS-CoV-2 test: positive positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant and treatment information were not provided. On 22-Jul-2021 reporter stated that COVID-19 Test result was a false positive and had three other tests performed and all resulted negative.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Lab data updated
COVID-19; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced covid-19. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid-19 was not reported. This report was non-serious. This report was associated with a product quality complaint: 90000201911.
shingles after getting the shot; This case was reported by a consumer via interactive digital media and described the occurrence of shingles 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 shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional details were provided as follows: The case was self reported by the patient. The age at vaccination was not reported. The reporter stated that, he/she got full blown shingles after getting the shot. The follow-up would not possible as no contact details were available.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Jul2023 as dose number unknown, single (Batch/Lot number: unknown) at the age of 74 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes type 2" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing); "gastro reflux" (unspecified if ongoing); "known allergies: peanuts" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective and covid-19, which included Paxlovid from 07Oct2023 to 12Oct2023.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300328757 same patient, different drug/AE;
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from non-contactable reporter(s) (Physician). The reporter is the patient.  A 60-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Sep2022 at 17:30 as dose 4 (booster), single (Lot number: GJ2524) at the age of 59 years, in left arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 19Mar2021 at 14:00 as dose 1, single (Lot number: EN6204), in left arm, on 09Apr2021 at 14:00 as dose 2, single (Lot number: ET8729), in left arm and on 29Oct2021 at 16:00 as dose 3 (booster), single (Lot number: FE3592), in right arm for covid-19 immunisation. The patient's relevant medical history included: "HTN" (unspecified if ongoing); "CAD" (unspecified if ongoing); "hypercholesterolemia" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid received from 31Aug2023 to 05Sep2023.; Sender's Comments: Based on the information currently available, a lack of efficacy with bnt162b2, bnt162b2 omi ba.4-5  in this patient cannot be completely excluded.
Information has been received from a female who was vaccinated with a dose of ZOSTAVAX.  Subsequently the patient developed a rash and redness at injection site.  A product quality complaint was not involved.  Additional information has been requested.
2 days after my covid booster shot I had a second menstrual cycle this month. The last day of my last menstrual cycle was December 19th. My menstrual cycles are always regular although I have noticed that they had gotten a lot heavier following my  second Covid vaccinations in May of 2021.
The patient received the booster of COVID 19 vaccine undiluted (it was diluted with the normal saline solution).  For this reason, this patient received an overdose of the vaccine product. The patient showed left arm pain,  weakness,  sleepiness, headache  and diarrheas.
Dizziness diaphoretic, tinglin left index finger hx: hypoglycemia Narrative:  possible vagal response, c/o dizziness, drowsy/yawning, diaphoretic, and pulsating left index finger vs 1014: 134/76 64 98% RA 1034 VS 126/74 70 98% RA pt w/ hx: hypoglycemia. 1043: left clinic stable, denies dizziness w/ standing/walking. ice pack and juice give during observation
immun given 2PM @ 4PM pt began crying uncontrollably; mom called ER & was told probably a rxn to pertussis & should not receive it anymore; pt stopped crying @ 6PM;
Vertigo, onset on 6/16/01. Treated with Meclizine.
After my first dose on 4/13, my left ring finger, middle finger and pinky became wrinkly looking at all times, like I had been sitting in the bath. After my second dose on 5/4, the fingers became red at all times and slowly became numb. I experienced some pain and swelling in the fingers and on the inside of my elbow before it went numb. Three weeks after my second dose, my right thumb and index finger also became swollen, wrinkly, then numb.
Received shots 2/16/07. Developed chicken pox 2/25/07 all over body, fever, also cough and green nasal drainage, not sleeping well, walking clumsy.
Pt. noticed swollen, hive like, raised area at site of injection, approximately 20 hrs after injection.
approx 4 days p/vax pt devel redness, swelling, & warmth;area of 10cm x 8cm irregular margins, warmth, tenderness noted on 31OCT96;no swelling of elbow or shoulder;placed on Duricef;
Red, hot, swollen, knot, painful. Iced 15 on 15 off for 1 hour.  Anti inflammatory meds 5ml. 4 inches by 3.5 inches round red spot. Hard painful knot.
Visual distortion and pain in left temporal area minor at first then became worse distortion at distances over time. Can not drive due to double vision distortion in left eye. Told possible palsy of eye, 6 cranial nerve. Vision corrected when treated with Prism lens by eye doctor.
Swelling, pain and reddening of vaccine site. Fever of 100.5 F. chills, muscle aches, exhaustion, sleeping, headache, then sweats. As of 10/22/2012 at 10:12 PM on this report, pain, swelling and redness are still there, fever is down, chills and sweats are gone, some muscle aches remain.
Information has been received from a healthcare worker referring to unspecified patients of unknown age and gender. No information about medical history, concurrent conditions were reported for the patients. On unknown dates, the patients were administered with unknown number of doses of improperly stored ROTATEQ (dose strength, lot # unspecified, orally). No adverse effects reported. This is one of the several reports received from the same souce. Additional information has been requested.
After patient received this vaccine dose, it was discovered that the vial had been stored outside of the recommended temperature range calling into question its efficacy  After conferring with immunization experts it was determined that this dose needs to be repeated.  Patient was contacted by the person completing this form and made aware of this information.  The patient has agreed to repeat this vaccine dose and has scheduled to return on 20 April 2021.
Intense throbbing pain on the back of my neck below the cerebellum; Fingers numbness on both hands; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EM6206) via an unspecified route of administration in the left arm on 07Mar2021 at 09:45 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received sulfamethoxazole/trimethoprim (MANUFACTURER UNKNOWN) and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had not received any other medication with in two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 08Mar2021 at 10:00, the patient experienced intense throbbing pain on the back of her neck below the cerebellum and fingers numbness on both hands. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not  been tested for COVID-19. The clinical outcome of the events intense throbbing pain on the back of her neck below the cerebellum and fingers numbness on both hands was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Large red area, swelling, hot to touch. Starting evening when shot was administered, cough, headache, very tired-referred to primary physician told her to apply ice pack.
delayed cutaneous hypersensitivity reaction  Narrative: onset of rash X 10 days post vaccination;  Duration 3 days.
This case was reported by a physician via call center representative and described the occurrence of fatigue in a 60-year-old female patient who received SHINGRIX for prophylaxis. On 20th June 2018, the patient received the 1st dose of SHINGRIX. On 21st June 2018, 1 days after receiving SHINGRIX, the patient experienced fatigue. On 22nd June 2018, the outcome of the fatigue was recovered/resolved. It was unknown if the reporter considered the fatigue to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX vaccine on left deltoid. The patient experienced extreme fatigue the day after receiving the SHINGRIX. The event lasted about 24 hours. The reporter consented to follow up.
has a history of gout / his gout was in remission for the past 12 years / gout came back 1 week after receiving first dose; This case was reported by a consumer via call center representative and described the occurrence of gout flare in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included gout. Concurrent medical conditions included kidney transplant and dialysis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, 1 week after receiving Shingrix, the patient experienced gout flare. On an unknown date, the outcome of the gout flare was not recovered/not resolved.   It was unknown if the reporter considered the gout flare to be related to Shingrix.  Additional details were provided as follows: This case was reported by patient himself. The age at vaccination was not reported. The patient had history of gout and stated that gout was in remission for the past 12 years. The patient had received first dose of Shingrix and his gout came back 1 week after vaccination. The reporter enquired if there was way to reverse Shingrix. The reporter filed adverse event with limited information and refused to provide any further information. The reporter did not consented to follow up.
swelling and redness at injection site day after shot - used over the counter Benadryl. Swelling/redness went down completely by Sunday (1/10) Saturday 1/9 - 2 days after vaccine experienced extreme fatigue, slight head ache and body aches. Used Advil for these symptoms. Sunday 1/10 - still felt slight fatigue and headache. Used Advil and also drank emergen-C packet. By mid day felt much better with nearly no symptoms.
Aqd shot @ 1:30pm - Symptoms developed by 5:00pm - hard knot on upper left arm -> redness, swelling & pain (severe) around entire upper left arm. General redness ???? entire arm -> improving by 11/25/04, recovered by 11/29/04.
Developed fever, sore throat, earache, headache, decreased intake. Seen in ER. Temp 106, decreased with antipyretico. Onset 10 11,2002. Fever, sore throat, ear ache, headache, decreased intake. T max at home 103-104. Seen at ER Oct 13, 2003. temp at ER 106. Decrease with anti's to 98.6 degrees.
expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vaccine used) in a 94-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Nov-2021 at 10:59 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 04-Nov-2021 at 10:59 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vaccine used). On 04-Nov-2021 at 10:59 AM, EXPIRED PRODUCT ADMINISTERED (expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment information was provided.
Initial unsolicited report received from a consumer via other company (Pfizer) (manufacturer report number - 2016333726) on 15 July 2016. This case involves a female patient (age was not reported) who was vaccinated with a dose of Tetanus Vaccine (Batch number, expiration date, dose, route and site of administration was not reported) on an unspecified date. Patient's ongoing illness, medical history and concomitant medications were not reported. On an unspecified date, post vaccination, patient was allergic to tetanus vaccine. Laboratory investigations and corrective treatment were not reported. The outcome of the event was not reported. List of documents held by sender: none.
Stroke on right side from foot to top of head.  Iv medication to embolyze the clot(s) given with 2 days in hospital.  generalized weakness for about a week after.  2 weeks later experienced a mild heart attack and was hsopitalized for night and day
Pt. was administered Afluria and left the pharmacy, pt fainted leaving the pharmacy. Pt got back up on her own will
Mild flu, vomiting, temperature 101, chills, joint pain, tired.  MD said to stay on reg. meds, use ventilator if needed if worse go to ER via ambulance.
flushed; hives; tongue felt "thick"; the lump in my throat feels bigger; This is a spontaneous report received from a contactable pharmacist. A 23-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EL0142), via an unspecified route of administration in the left arm on 22Dec2020 (at the age of 23-years-old) as a single dose for COVID-19 immunization. The patient's medical history included: allergies to medications, food, or other products (unspecified). It was unknown if the patient was pregnant at the time of vaccination. The patient's concomitant medications were not reported. It was unknown if the patient received any other vaccine within 4 weeks prior to the vaccine. On 22Dec2020, approximately 8 minutes after vaccine administration, the patient began feeling flushed. She reported to the observation area, and the registered nurse noted hives on her left neck (22Dec2020). The patient was brought back for closer monitoring. The doctor evaluated the patient. Vital signs were monitored every 5 minutes (22Dec2020). The patient was given 50 mg diphenhydramine (BENADRYL) orally. Some improvement was noted in hives; however, the patient began to state her tongue felt "thick" and "the lump in my throat feels bigger" (both on 22Dec2020). Per doctor, 0.3 mg epinephrine (MANUFACTURER UNKNOWN) given intramuscularly with rapid improvement in hives. The patient reported feeling some improvement as well. The patient was taken to the emergency department for ongoing observation. The patient was released from emergency department after observation. The clinical outcome of flushed, hives, tongue felt "thick", and "the lump in my throat feels bigger" was recovered on an unspecified date.; Sender's Comments: Based on the compatible time association, the events flushing, urticaria, tong disorder, sensation of foreign body are possibly related to suspect BNT162B2 administration. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
This spontaneous case, was initially received from other health professional (nurse) on 06-Oct-2017, concerning a 43-year-old adult female patient. The patient did not receive any concomitant medications. On 02-Oct-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, batch number: 195128 (reported as 195198), expiry date: 30-Apr-2018, route of administration: intramuscular, anatomical location: deltoid). The patient received the vaccine after the multiple temperature excursion over a week. It was reported that, the storage temperature of the vaccine fluctuated between 36-degree F and 48.18-degree F, which reached to maximum 49-degree F over a week instead of storing between 36-degree F to 46-degree F and no adverse event was reported. The reporter assessed the report as non-serious. Non-significant case correction received 06-Oct-2017: Batch number (195128) was captured in the case form and narrative was amended accordingly.
Immediate mild dissociation (derealization) upon getting injection along with a drop in serotonin levels. By hour six after injection, total dissociation (depersonalization-derealization) and significant drop in serotonin levels. Loss of balance, formation of coherent speech. The total dissociation lasted for about four hours.