chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Expired dose administered to 14 patients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose administered to 14 patients) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 068H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 06-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose administered to 14 patients). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired dose administered to 14 patients) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported.  Date the vial was initially stored in the refrigerator: 14-Mar-2022 the vial did not undergo any temperature excursions.  No treatment medications was reported.
bone pain; red spots on her hands; had taken away a fear; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BONE PAIN (non-serious), outcome "recovered", described as "bone pain"; RASH (non-serious), outcome "unknown", described as "red spots on her hands"; FEAR (non-serious), outcome "unknown", described as "had taken away a fear".  Additional information: It was reported that, patient had bone pain (all her bones hurt) in the day and night that lasted almost 3 weeks, she also developed two red spots on her hands. She did not receive the second dose of the vaccine because the bone pain lasted longer than she planned to receive the second dose, she mentions "being afraid" of receiving the second and third doses due to the reaction she experienced. She wants to know if these reactions disappear over time or if this could affect her bones.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Woke up day after booster (10/29/2021) with a  CRUSHING headache. None of my current medicines are new so the headache wasn?t  from my usual meds. The CRUSHING headache lasted all day and even woke up the next day  (10/30/2021) with a much milder headache but still the headache. Feel like I?m nursing yesterday?s headache.  If the headache is still ongoing come Monday I?ll call my primary doctor
Approx. 30-45mins after leaving office (following appt with Dr.) pt experienced strange taste in mouth followed by onset of profuse sweating rash of upper body including neck, sl wheeze, throbbing (headache that lasted 5-10mins then resolved). Drove back to office, eval by Dr. given 0.2mg epinephrine sq. BP 150/86 AP 100, 10mins later BP160/80 AP 84. States feeling better 10mins after epi, with con't sense of feeling much better after 20mins. Rash resolving, no further wheezing, OK to leave per Dr. after 40mins of observation. Advised to take Benadryl 50 mg at home call back any concerns. Pt states allergic to shellfish (anaphylaxis) bees (carries epi pen) IPV dye, codeine.
I had the shot at 12:30pm.  I went bed about 10pm, and woke up to my right arm having a series of tiny shooting pain tingling (at specific spots, as if it were a pin prick traveling up and down my arm; pinging randomly across the arm). This  was accompanied by an extreme desire to scratch/itch my arm where the pin pricks were being felt. I found myself scratching my arm in my sleep. There didn't seem to be a discernable rash of any color, but by the next day, i was seeing slight welts at various points along my upper and lower outer arm. I would feel a sharp pin-prick/tingle and instantly would feel the urge to scratch it. The scratching continued -- but not consistently. Sometimes for an hour or two at a time, seemingly coming out of no where. The arm was fine and then I'd wake up or be jolted by the sharp pin prick accompanied by the insane desire to scratch my arm.   These 'spells' of tingling and itching have continued until today (one week and one day after getting the #2 Moderna shot.  I have managed this with Benedryl (it worked by addressing the itching somewhat and provided relief from the tingling - it made me sleepy); anti-itch creams (soothed the skin topically), ice (to take the sting/itch sensation away) and calamine lotion (didn't really work). Tonight (1/8/2021 I cannot sleep. Although the itching and sensations seem to be intermittent, I have woken up the last couple of nights with intense itching and tingling to the point I couldn't sleep  Usually Benedryl calms everything down, but tonight it isn't helping at all and I am crawling out of my skin.  I have not gone to my Primary Care Physician, but will call and go in tomorrow.
Pt ate well but slept from 330PM for 24 hrs only waking long enough to eat; MD said no more Pertussis vax;
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 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Nov2021 as dose 3 (booster), single (Lot number: FH8028), in left arm and on 12Apr2022 as dose 4 (booster), single (Lot number: FK9893) at the age of 60 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), first regimen (Batch/Lot number: unknown) at single (dose 2, single) and second regimen (Batch/Lot number: unknown) at single (dose 1, single) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The patient did not receive other medication in 2weeks.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive; positive, notes: continued to have symptoms and test positive for 12+ days. Therapeutic measures were taken as a result of drug ineffective, covid-19. Anti viral details: product: COVID 19 treatment, Brand: Pfizer, treatment start date: 15May2022, treatment stop date: 19May2022, indication: Treatment of COVID-19.  No follow-up attempts are possible. No further information is expected.
PATIENT REPORTED VIA TELEPHONE THAT HER ARM STARTED SWELLING BELOW THE INJECTION SITE, BUT ABOVE THE ELBOW, ON 6/18/21. IT IS ALSO VERY WARM TO THE TOUCH. PATIENT WAS ADVISED TO SELF-MONITOR AND TO SEEK MEDICAL TREATMENT IF THE SWELLING PROGRESSED. PATIENT WAS ADVISED TO USE OTC AND SELF-CARE REMEDIES IN THE MEAN TIME. PATIENT WAS NOT ASSESSED IN-PERSON BY PHARMACIST.
Body aches, fever, headache, red painful swelling of left arm below injection site that increased and spread over 4 days
Client age 12 accidentally received Johnson and Johnson Vaccine instead of Pfizer. Parent aware of situation. Medical director was notified immediately concerning incident. MD spoke with parent. Md to follow up with parent/child, instructed to monitor child closely for any reactions. Child and parent instructed to wait for 30 minutes. After 30 minutes no reported symptoms of adverse reaction noted. Md indicated would continue to follow up with parent for any changes noted.
300pm-sclera became red, eyelids became very itchy & burning. 330pm-Sxs disappearing. 7pm-took a nap & woke up @ 7pm, sxs gone did not take any meds.
COVID Breakthrough- Presented to the ED on 1/4/22 with SOB going on for 2 days. Patient says she tested positive for COVID on 12/27/21.
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a adult female patient who received SHINGRIX for prophylaxis. On 1st June 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced arm pain for a week after receiving SHINGRIX.
COVID ARM--STARTED WITH ITCH ON MARCH 1ST AND THE REDNESS GOT BIGGER AND BIGGGER WITH ITCHING, CALLED DR. AND HE RECOMMENDED I TAKE ZYRTEC AND APPLY CORTISONE CREAM,   SAW DR. ON MARCH 5TH.  CONTINUE WITH ZYRTEC AND CREAM UNTIL THE 11TH WHEN THE REDNESS AND ITCHING WAS GONE.  MY DAUGHTER TOOK PHOTO OF ARM.
Five minutes after administration, patient's father approached pharmacist and stated pt wasn't feeling well. Upon approaching pt, patient threw up. Nurse was called and patient had low blood pressure. Patient was told to sit longer and then patient drank water and felt fine after 25-30 minutes.
Extreme lower leg pain 14 hours after the injection. Headache, extreme fatigue, nausea.
Patient developed significant difficulty breathing and tightness about 15 minutes after receiving the vaccination. Patient received, IV fluids, IM epinephrine, IV solumedrol, IV Pepcid, IV Benadryl. Also received a nebulized albuterol treatment. Patient improved and was observed for 2 hours and discharged home.
A report has been received from a Health Professional concerning a, patient of unknown gender, who had been receiving FLUMIST, once/single administration. FLUMIST started on an unknown date. The HCP stated it was approximately 6 days post-expiration and had been administered to the patient. The outcome of the event of administered expired FLUMIST to patient was unknown. The report was considered to be non-serious.
Headache, Myalgia, Fever, SkinRash & UrticariaPruritis
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' pertinent medical history, concomitant medications and drug reactions or allergies reported. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB injection, lot # L040458, expiration date 04-FEB-2018 (dose, anatomical location and route of administration were not specified). No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Pt says 3 days after taking the vax she developed an itchy rash on her lower right arm to the top of the arm.  The rash started on her left arm and the lower part of her neck towards her chest and stomach area.  The rash was also on the shoulder areas around her neck.  She was using Calamine and Natralia for the rash.  She had video appt w/ her Lupus Dr. on 3/25/21.  He ordered blood work.  Her white blood cell count was 4 (which is rare for her) and is normally 2.8.  She has been to 2 dermatologist.  She went to Dr. on 4/2/21.  He evaluated her skin she was given a prescription but never filled it.  She saw Dr. on 4/7/21.   She was given a steroid cortisone cream which seems to help.   Her rash is about 90% gone at this time.
This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (14 patients administered bivalent Moderna covid-19 vaccines after 30 day beyond use date), PRODUCT STORAGE ERROR (14 patients administered bivalent Moderna covid-19 vaccines after 30 day beyond use date) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 021H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (14 patients administered bivalent Moderna covid-19 vaccines after 30 day beyond use date), PRODUCT STORAGE ERROR (14 patients administered bivalent Moderna covid-19 vaccines after 30 day beyond use date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (14 patients administered bivalent Moderna covid-19 vaccines after 30 day beyond use date), PRODUCT STORAGE ERROR (14 patients administered bivalent Moderna covid-19 vaccines after 30 day beyond use date) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (14 patients administered bivalent Moderna covid-19 vaccines after 30 day beyond use date) and PRODUCT STORAGE ERROR (14 patients administered bivalent Moderna covid-19 vaccines after 30 day beyond use date).    No patients had been administered monovalent vaccine after the beyond use date.  Doses were administered from 8DEC2022 to 10JAN2023. Concomitant medications were not reported.  No treatment information was provided
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE  ACUTE NON ST ELEVATION MI HYPOTENSION
Flu-like symptoms X 2-3 days No headache. Pt has had 6 severe episodes of chest pain from 7/99 - 5/02. Both problems continue to the present.
CANNOT MOVE IT AND SEEMS PARALYZED; PAIN IN LEFT ARM ON INJECTION SITE; This spontaneous report received from a patient concerned a 53 year old male. 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, and batch number were not reported) dose was not reported, administered on 23-NOV-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced cannot move it and seems paralyzed, and pain in left arm on injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the pain in left arm on injection site and cannot move it and seems paralyzed was not reported. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard operating procedure as the case assessed as non-serious.
Information has been received from a Licensed practical nurse referring to unspecified patients of unknown age and gender. On unknown date the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot # M021407 with expiration date of 30-APR-2018; strength, dosage, frequency and route unspecified). Temperature was 49 F and time frame was total cumulative 84 minutes. No adverse event was reported. This is one of several reports received from the same reporter. Additional information has been requested.
pain, swelling at site and in axillary area on 03/12/2022, shoulder pain and limited ROM starting on 03/14/2022
abnormal lab results, on anti coagulants for heart valve replacement and has thrombocytopenia
FEVER, MYALGIAS, HEADACHE  Narrative: FEVER 100.6; EMPLOYEE MISSED 1 DAY OF WORK
On 10/07/2022, I accidentally used 1.3 mL of normal saline diluent for the Pfizer-BioNTech COVID vaccine for ages 6 months-<5 years of age. Instructions for this vaccine are very clear that one is supposed to use 2.2 mL of normal saline to dilute the 6 month-<5 years vaccine, but I mistakenly used the The 1.3 mL of diluent used for the ages 5-11 vaccine vials. This under-diluted form of the vaccine was administered to this patient. This means that this patient received a 4.7 mcg/0.2 mL dose of the vaccine instead of the advised 3 mcg/0.2 mL. I have already notified both my office manager and the MD in the office at the time I realized my mistake, and I have reported this incident to both Pfizer and the CDC.  NO ADVERSE REACTION(S) THAT WRITER IS AWARE OF AT THIS TIME (10/10/2022).
I developed swelling and hives over 75% of my body and was given a shot of Epi shot because my throat closed.  I developed a weakened immune system from the vaccine.  I am 8 week pregnant and developed a Blighted Ovum and I am currently going through a miscarriage to date.  Rather not release any info regarding the pregnancy
pt recvd vax & later became fussy, an hr later generalized tonic/clonic sz, lasted about 2 1/2 mins; t104, 4 days later temp resolved, devel rash, fussy, ? roseola;
Insomnia night of receiving vaccine, next day horrible headache, and have had night sweats since receiving the vaccine. It has been a little over a week ago now that I had my 1st vaccine.
about 1 1/2 to 2 hr post vax started crying uncontrollably & since w/few breaths;T100;seen in ER;hosp;APAP given;pertussis rxn;
Information has been received from a medical assistant referring to multiple unknown patients. The patients' concurrent condition, medical history and concomitant medication were not reported. On an unknown date, the patients were vaccinated with improperly stored (6.6 degrees Fahrenheit for 30 minutes) doses of VARIVAX (dose and route were unknown, lot # and expiration date were M009764, 23-FEB-2018; M14309, 21-MAR-2018; M015731, 30-MAR-2018). No previous temperature excursion was reported. Data logger was involved. No adverse event was reported. This is one of two reports received from the same reporter. Additional information has been requested.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Severe, Systemic: Tachycardia-Mild, Additional Details: Patient experienced disorientation about 8 minutes after vaccination, clammy, sweaty, tachycardia, eyes unfocused.  Was aware of his surroundings after 5 to 10 seconds of symptom onset, but continued to profusely sweat.  Placed patient on prone position and elevated legs.  He felt immediately better.  Kept him lying down for an additional 30 minutes of observation, took blood pressure readings every 10 minutes.  Heart rate and blood pressure resumed normal range 125/79 and 50bpm.
Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Tachycardia-Medium
subtle weakness both hands onset early NOV92; markedly inc weakness 12NOV92 requiring use of lt hand to close rt, difficulty grasping pencil & pincer grasp; c/o paresthesias;
1 Missed menstrual cycle. I normally have regular cycles, every 28 days.
immunocompromised patient got half dose for third primary dose; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (immunocompromised patient got half dose for third primary dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.   In March 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced ACCIDENTAL UNDERDOSE (immunocompromised patient got half dose for third primary dose). At the time of the report, ACCIDENTAL UNDERDOSE (immunocompromised patient got half dose for third primary dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant products included medications that suppresses immune system.  The patient that received the 2-dose series of Moderna in March 2021 and came back in November-2021 to receive a third dose, but it was a half booster dose. No treatment information was provided by the reporter.
patient has MS, woke up in the middle of the night after she received shot unable to ambulate.  imaging was done and no evidence of demyelination lesions were found on thoracic/lumbar spine
pt recv vax & immed cried;while being consoled the pt devel bradycardia (HR 81) & apnea w/resultant dusky color;p/stimulation pt color improved to pale pink but cont to exhibit bradycardia (HR 901-00);approx 20min p/vax had starring episode
This case was considered medically important (OMIC). Information regarding Prevnar (pneumococcal 7 valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a consumer regarding a male child who experienced developmental delays. The pt received a dose on an unspecified date. Relevant medical history was not provided. Indication for Prevnar was immunization. Product was administered on an unspecified date. Dose regimen was 1 dose. Concomitant medications were not reported. The pt experienced developmental delays on an unspecified date. Outcome was unk. No additional information was available at the time of this report. The reporter declined to grant permission for follow up investigation.
The mother, took pt to ER on Sunday 9/17/06. PT right thigh became swollen. He was treated with ice pack plus Benadryl. Today the swelling has improved and pt is back to baseline.
FELT WARM; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 11-AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 11-AUG-2021, the patient experienced felt warm. Treatment medications included: paracetamol. The action taken with covid-19 vaccine was not applicable. The outcome of felt warm was not reported. This report was non-serious.
pt c/o numbness in lt arm & leg approx 1hr p/vax;school nurse reported that follow up check, student was doing better and reported no further sx;
rash on chest and neck progressing to numbness & tingling of face & tongue.  Went to ED, treated with Benadryl, solumedrol, famotidine.  some improvement after med administration & observation.  Pt sent home with steroid rx & Benadryl.