chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a physician and refers to the two adult, twins patients (exact age unknown) of an unknown gender. No information on the patients' concurrent conditions, pertinent medical history, drug reactions or allergies was reported. On an unknown date, when the patients were children, they were vaccinated with doses of RECOMBIVAX HB (dose, route of administration, lot number and expiration date were not reported). On an unknown date in 2016 (reported as "now"), the patients had blood work done to see titers against Hepatitis B virus and the tests were negative. The outcome of the event was unknown. The relatedness between the event and the RECOMBIVAX HB was not reported. Additional information has been requested.
Flare of hidradenitis suppurativa in the left axilla, groin, labia and abdomen at once.  Two of the abscesses became infected with warmth around the site and causing extreme pain. General malaise was felt as well.
pt recv vax 29JUN93 & 4JUL94 exp a small sz;this may have been coincidental (since pt did have occasional small sz). The annual follow-up information obtained on 4/16/02 states that the pt is a vaccine injured child. At the age of four months pt experienced a status epilepticus grand mal seizure 8 1/2 hours after his DTP vaccine. This resulted in permanent brain damage. The complete extent of this damage was not realized until pt aged and experienced developmental delays. Pt's vaccine damage from teh DTP vaccine resulted in a seizure disorder. His seizures remained uncontrolled by medications. He also has autism, moderate mental retardation, ADHD, ETC as a result of this DTP vaccine. Pt has a small seizure 5 days after these injections since he did have an existing seizure disorder. This may have been coincidental. Pt's hyperactivity became so out of control after this time that he had to go on medications in Sept 1993 to help controlhis hyperactivity Aggression, impulsiveness, etc. We do not know if the vaccines may have had an effect on his hyperactivity increase. As of April 2002, pt remains  on medications for his hyperactivity and also remains on medications for his seizure.
Fever, aches in my whole body, headache, fatigue that sent me to bed.
severe throwing up; This case was reported by a consumer via interactive digital media and described the occurrence of vomiting in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced vomiting. On an unknown date, the outcome of the vomiting was not recovered/not resolved.   It was unknown if the reporter considered the vomiting to be related to Shingrix.  Additional details were as follows: The age at vaccination was not reported. After receiving dose of Shingrix, the patient experienced throwing up. The reporter repoerted that, was there anything I can do for her, or give her. The reporter did not consent to follow up.
PNEUMOVAX.  Extreme pain, some swelling, warm to touch. 3-4 inches above injection site to 10 inches below injection site and back of elbow at joint. Had weakness in arm.(couldn't hold coffee cup).
Arm pain at injection site first night and ongoing Fever, body aches day after Fever day 2 Fever day 3, arm is hot and still painful
Upper arm swelling seen in ER in "cellulitis" 2 days after vaccine ----> Keflex, Benadryl were erythema "adverse reaction" doubt. Allergy DC Keflex, referred to allergist.
COVID; COVID; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 46-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17Feb2021 as dose 1, single (Lot number: EL9266), in left arm, on 10Mar2021 as dose 2, single (Lot number: EN6205), in left arm and on 25Aug2021 as dose 3 (booster), single (Lot number: FC3181) at the age of 46 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hashimoto disease" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing); "Obesity" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID. Past drug history included: Ceclor, reaction(s): "Known allergies: ceclor". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) positive; (unspecified date) negative; (18May2022) Positive. Therapeutic measures were taken as a result of covid-19.  No follow-up attempts are possible. No further information is expected.
This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired booster 1 day beyond the MFG Exp. Date) and PRODUCT TEMPERATURE EXCURSION ISSUE (vial exposed to several temperature excursion) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059H21A) for COVID-19 vaccination. No Medical History information was reported. On 28-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired booster 1 day beyond the MFG Exp. Date) and PRODUCT TEMPERATURE EXCURSION ISSUE (vial exposed to several temperature excursion). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered expired booster 1 day beyond the MFG Exp. Date) and PRODUCT TEMPERATURE EXCURSION ISSUE (vial exposed to several temperature excursion) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. No treatment medications were reported. It was reported that the unpunctured vial was moved from Freezer to the refrigerator on 10-Mar-2022 and kept in the refrigerator under recommended temperature. Storage condition at the time of the excursion was Refrigerated storage. Maximum or minimum temperature reached was 36° to 46°F. Excursion duration was 15.5 hours past expiration, approximately dose was administered at 3:24 PM on 28-Mar-2022. Vial was moved from freezer to refrigerator on 10-Mar-2022, They had discarded the vial post that date. Vaccine was normal and in liquid phase during visual inspection. 1 vial of 10 dose each was impacted. There was no previous excursion happened and vial was unpunctured.
Rt deltoid hard, red and swollen at injection site. Patient reports arm itches. Site is cool to the touch. Patient reports being afebrile and had a hot flash.
THE PATIENT PRESENTED TO THE PHARMACY 2 WEEKS AFTER HER VACCINE WITH HAVING AT INJECTION SITE; ITCHING, A SMALL BUMP THAT WAS TENDER TO THE TOUCH.  SHE EXPLAIN THAT IT WAS MUCH BETTER SINCE IT HAD BECOME REALLY SWOLLEN AFTER THE INJECTION. THE PATIENT WAS REFERRED TO HER PRIMARY PHYSICIAN TO BE EVALUATED.
Pt experienced usual difficulties in Oct, 2014 - continues to have significant (R) sided visual loss.
Felt very sick for almost 48 hours; Whole left side of the body was numb for about a day; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0186), via an unspecified route of administration in the left arm on 21May2021 at 15:00 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. Other medical history was reported as none. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 21May2021 at 16:00, the patient felt very sick for almost 48 hours and the whole left side of the patient's body was numb for about a day. The events did not result in doctor or other healthcare professional office/clinic visit, 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 felt very sick for almost 48 hours and the whole left side of the patient's body was numb for about a day was recovered on an unknown date in May2021.   No follow-up attempts are needed. No further information is expected.
No adverse event; inadvertently gave the monovalent vaccine instead of the bivalent booster dose for their 3rd booster dose at 0.5ml to a patient; This spontaneous case was reported by a medical assistant and describes the occurrence of INCORRECT DOSE ADMINISTERED (inadvertently gave the monovalent vaccine instead of the bivalent booster dose for their 3rd booster dose at 0.5ml to a patient) and NO ADVERSE EVENT (No adverse event) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 083B22A, 004M21A and 013F21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Oct-2022, received fifth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 05-Oct-2022, the patient experienced INCORRECT DOSE ADMINISTERED (inadvertently gave the monovalent vaccine instead of the bivalent booster dose for their 3rd booster dose at 0.5ml to a patient). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INCORRECT DOSE ADMINISTERED (inadvertently gave the monovalent vaccine instead of the bivalent booster dose for their 3rd booster dose at 0.5ml to a patient) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INCORRECT DOSE ADMINISTERED (inadvertently gave the monovalent vaccine instead of the bivalent booster dose for their 3rd booster dose at 0.5ml to a patient).    No concomitant medications were reported.  It was reported that the patient was inadvertently gave the monovalent vaccine instead of the bivalent booster dose for their 3rd booster dose at 0.5ml and They want to know if they can still give the bivalent booster dose to the patient. If so, when and what is the dose.   Patient has not reported any adverse reactions.
This case was reported by a healthcare professional and described the occurrence of inappropriate schedule of drug administration in a 2-day-old female subject who was vaccinated with Engerix B for prophylaxis. Concurrent vaccinations included Engerix B 1st dose, given on 06 December 2007. Concurrent medications included Vitamin K, Ampicillin Ceftazidime, Erythromycin and Eye medication. On 7 December 2007 the subject inadvertently received a 2nd dose of Engerix B at 10 mcg. This was considered to be a medication error and an inappropriate schedule of drug administration. The subject received a dose of Engerix B one day following the first administration. It was reported that the subject was hospitalised. No adverse events were reported.
Moderna COVID-19 Vaccine EUA: Delay of menstrual cycle by one month
Starting the day after receiving the vaccine, I woke up with a sore arm. Then, it started turning pink, swelling up and feeling hot. It reached a certain degree, then it started gradually going down. It was getting better by the next day. I have had this happen with a shot before. I did not treat it with anything.
p/vax pt exp a significant inj site rxn described as swelling, redness & warmth extending from the inj site to the elbow of the rt arm measuring approx 19cm x 9cm;pt tx w/ice pack & DPH;
This spontaneous report as received from a pharmacist refers to an unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with an incorrect measuring of ZOSTAVAX less than 0.65 ml, one shot route not reported, (lot# and expiration date were not reported). The reporter stated that the full 0.65 ml volume could not be prepared due to a product underfill (pqc filled). No adverse effects reported. Additional information has been requested.
This spontaneous report as received from a physician via field representative refers to a 34 years old female patient. The patient's pertinent medical history and drug reaction/allergies were unspecified. On an unknown date, the patient was vaccinated with GARDASIL (dose/frequency, route and lot number not reported). The physician reported to the field representative that the patient was on therapy with unspecified steroids and was in end stage renal failure because of her therapy with GARDASIL. The patient was also diagnosed with tuberculosis on unspecified date after receiving GARDASIL. The patient's present status and outcome of the events were unknown. The reporting physician considered the event of end stage renal failure related to therapy with GARDASIL and causality of tuberculosis was unknown. Upon internal review the event of End stage renal failure was determined to be medically significant. Additional information has been requested.
Guillain-Barre; Paralyzed in the beginning; Initial information was received on 27-Oct-2020 regarding an unsolicited valid serious case from a consumer/non-healthcare professional via social media.  This case involves a male patient (age unspecified) who had Guillain barre (Guillain-Barre syndrome) and was paralyzed in the beginning (paralysis) after he received INFLUENZA VACCINE.  Medical history, medical treatment(s), past vaccination(s), concomitant medications 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 (12 years ago), the patient developed a serious Guillain barre (Guillain-Barre syndrome) and was paralyzed in the beginning (paralysis) (unknown latency) following the administration of INFLUENZA VACCINE. He had to be taught again just like a baby and there was no fix for him.  These events were assessed as medically significant.  No laboratory data was provided.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome of events were unknown.  The information on lot number was requested for this case.; Sender's Comments: This case concerns a male patient (age unspecified) who had Guillain-Barre syndrome after vaccination with INFLUENZA VACCINE, produced by unknown manufacturer. The time to onset is unknown. Additional information regarding medical history, condition at the time of vaccination and lab data excluding other etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.
This spontaneous report as received from a registered nurse refers to two patients of unknown age and unknown gender. The patients were vaccinated intramuscularly with live ZOSTAVAX (lot number not reported) on 27-AUG-2012. No other co-suspects or concomitant medications were reported. No known adverse effects. It was unspecified if the patients had sought medical attention. Follow up information received with an aware date of 12-SEP-2012, telephone attempts to obtain follow up was unsuccessful. Follow up information was received from the registered nurse who reported that the 12 year old patients were vaccinated via a wrong route (intramuscularly) with the first dose of live ZOSTAVAX (lot number: 0468AE, dose not reported) on 22-AUG-2012 (previously reported as 27-AUG-2012) at 13:30. Additional information is not expected.
This non serious case was received on 24 February 2009 from a health care professional. A seven month old patient received second dose of FLUZONE (lot number UT283EA) on 13 February 2009. The patient received the first dose of FLUZONE (lot number unknown) on 23 January 2009. February 2009 the patient experienced a fever and was cranky. The patient went to the doctor's office on 24 February 2009 and did not have any symptoms at that time. The patient subsequently recovered. No further information was provided. List of documents held by sender: none
Incident reported to provider on date of appt of 2nd immun 27APR92; 26FEB92 pt became cyanotic & gasping for breath in crib 2 days after 1st DTP/OPV/HBOC; paramedic transport to hosp ER p/CPR per babysitter;
Itchy, achy, warm to touch, pt noticed on 5/6/16 in the afternoon. Area approx. 3" x 9".
I gave birth to a healthy baby boy who was 4 weeks early on 5/10/21.  I had developed severe preeclampsia the week prior and had to be induced.  The baby weight 6lbs 140z. I developed a pulmonary embolism on 5/14, just four days after delivering. I do not take birth control pills nor have I ever smoked. I do not have a personal or family history of blood clots. I was in the hospital from 5/14-5/16 for management of the PE.   I am now on blood thinners for at least 3 months.  The doctors are not positive as to where the clot came from, but think possibly the ovarian vein which is very rare.  CT scan did not show any active thrombus, just signs of inflammation to that are. Bilateral lower extremity Doppler ultrasounds were negative.  I will be worked up by hematology to make sure I do not have a clotting disorder as a clot from the ovarian vein is so rare.
Fever (101-101.5 sustained for 18 hours from symptom onset), chills, general pain through body (but especially in joints), severe migraine, blurred vision, metallic taste in mouth, brain fog, confusion, and I had a panic attack during the middle of the night that lasted around 30 minutes (I do not normally have panic attacks)
Platelet count Result: 147 (Norm Low: 150, Norm High: 400); This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 24May2023 at 14:00 as dose 5 (booster), single (Lot number: GL2042) at the age of 68 years intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Anatomical site of injection: Arm Left, Route of administration: Intramuscular, Batch/Lot number: EN6205), administration date: 09Mar2021, for Covid-19 immunisation; BNT162b2 (DOSE 2, SINGLE, Time: 15:00, Anatomical site of injection: Arm Left, Route of administration: Intramuscular, Batch/Lot number: EW0158), administration date: 12Apr2021, for Covid-19 immunisation; BNT162b2 (DOSE 3 (BOOSTER), SINGLE, Time: 10:00, Anatomical site of injection: Arm Left, Route of administration: Intramuscular, Batch/Lot number: EW0187), administration date: 05Nov2021, for COVID-19 immunisation; BNT162b2 (DOSE 4 (BOOSTER), SINGLE, Time: 13:00, Anatomical site of injection: Arm Left, Route of administration: Intramuscular, Batch/Lot number: FK9893), administration date: 12Apr2022, for COVID-19 immunisation, reaction(s): "Total knee replacement". The following information was reported: PLATELET COUNT DECREASED (non-serious) with onset 12Jun2023, outcome "unknown", described as "Platelet count Result: 147 (Norm Low: 150, Norm High: 400)". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Anatomical site of injection was Shoulder.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300111188 same patient/ product, different dose/event (LOE);
Patient came into Vaccine Clinic today for Pfizer 5Y-11Y Covid Vaccine. Patient previously received 2 doses of 6mo-4Y Pfizer which is a three dose series and is switching to the 5Y-11Y for the third dose. Time frame between second and third dose should be 2 months or more. Patient received their 2nd dose on 7/20/2022 and shouldn't be due for third dose until Sept 18th. Vaccine was administered to the patient today, 9 days too early. Information was sent to patient's primary care provider to advise parents if necessary.
fever 103.7 ax reading occurred 28JAN92 1PM fussy, not sleeping well, wanting to be held alot 27JAN low grade fever started 27JAN92 evening;
This case was reported by a physician via a sale representative and described the occurrence of injection site pain in a 28-year-old female subject who was vaccinated with BOOSTRIX. On 4 November 2011 the subject received a dose of BOOSTRIX (unknown route). On 4 November 2011, less than one day after vaccination with BOOSTRIX, the subject experienced injection site pain, injection site redness and swelling injection site. At the time of reporting the outcome of the events was unspecified.
Severe headache, severe body aches, chills, nausea 3 hours post vaccine. Took ibuprofen. Symptoms resumed 6 hours later. Took more ibuprofen. Symptoms persist 5 hours later. Persistent pain in arm at rest at injection site. Persistent severe body aches and headache. Extremely uncomfortable. OTC ibufrofen ineffective.
first dose: pain in the arm; first dose: headache; This is a spontaneous report from a contactable consumer or other non hcp. A 32-years-old male patient received bnt162b2 (BNT162B2, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 16May2021 (Batch/Lot Number: EW0167; Expiration Date: 31Aug2021) as DOSE 1, SINGLE for COVID-19 immunization. Medical history was reported none. The patient's concomitant medications were not reported. The patient experienced first dose: pain in the arm on 16May2021, first dose: headache on 16May2021The outcome of the events was unknown.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 84-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 05May2023 as dose 6 (booster), single (Lot number: gj3268) at the age of 84 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 4 (booster), single (Batch/Lot number: unknown) and as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Past drug history included: Tricor, reaction(s): "Allergy to Tricor"; Celebrex, reaction(s): "Allergy to Celebrex"; Protonix, reaction(s): "Allergy to Protonix". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (05Jun2023) negative; (07Jun2023) negative. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received COVID 19 Treatment as Paxlovid with start date 02Jun2023 and stop date 06Jun2023.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300226561 Same patient, different drug and event;