chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Reconstituted with incorrect diluent; Reconstituted with incorrect diluent, partial dose given; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA758A, expiry date 31st October 2024) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 28-Feb-2023 Reporter's Comments:  A medical assistant reported that a patient received a partial dose of menveo, as one Men A (lyophilized component) vial was reconstituted with an incorrect diluent The reporter consented to follow up. Additional Supportive Information: the patient received Menveo as one men A vial, which was reconstituted with incorrect diluent, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Low fever and malaise (flu-like) began late 11/13 and continued next day, worsening to disorientation and loss of mental clarity. Hospitalized 11/15/2019 -11/25/2019 for urgent treatment of viral encephalitis.
Approx 4 hours post vaccine, patient became dizzy and lightheaded. Resolved the next day. Some muscle soreness as well.
My mother started calling me (and other neighbors and relatives) in the middle of the night on March 25 with bizarre hallucinations, thinking people were sitting on her back deck or trying to get into the house to kill her.  I was worried and flew out to visit for 2 weeks in early April.  I urged her not to get her second shot, but she did on April 15.  She had hallucinations on April 16 and 17 that led her to open her door in the middle of the night, then seemed a little better the next few days. I returned home on April 23.  The hallucinations progressed and she ended up in the hospital on May 17, 2021, having walked out of her house in the early morning after being up all night thinking people were trying to break in to kill her.  We checked her out of the hospital on May 20 and either I or my brother has stayed with her ever since.  (I have had to take Family Leave from work to care for her.)   Yesterday a roommate/caregiver moved in.  My mother continues to be plagued almost constantly with hallucination/voices in her head, often saying negative things, although they are somewhat more benign than back in May/June.  Still, she can no longer live independently.  Her physical health is still good, but I am very worried what will happen if/when she gets her booster shot this fall.  There is a long wait to see a neurologist in this area, but she has an appointment and is hoping to find a medication to stop her hallucinations.  It has been devastating for her to lose control of her brain in this way.
out of rhythm; heart rate increased; shortness of breath; impaired vision; some dizziness; Reported sleeping more heavily than usual; woke with her hair wet as if had experienced a fever overnight; anxious; This is a spontaneous report from a contactable consumer (patient).  A 48-year-old female patient started received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot# not provided), via an unspecified route of administration on 03Feb2021 at SINGLE DOSE for COVID-19 immunization.  The patient has known allergies to sulfur and penicillin. Concomitant medications were not reported.  The patient received first dose of vaccine on 03Feb2021. Immediately following injection, felt as if her heart rate increased; felt as if it remained out of rhythm through Thursday evening eventually returning to a more regular rhythm. She also experienced shortness of breath, impaired vision and some dizziness noted in Feb2021. She also been sleeping more heavily than usual woke with her hair wet as if had experienced a fever overnight. She stated she felt better, but still not at what she would consider her normal self and was anxious about receiving the second dose and wanted to speak with someone to further discuss her concerns. Outcome of anxious was unknown while recovering for the remaining events  Information on the Lot/batch number has been requested.
Burning, itching, painful rash over back, stomach and groin.  Rash and swelling in hands and ankles
Patient left pharmacy after vaccination and reports she had to pull her vehicle over because she "was feeling weird" and stated she then had a syncopal episode. When she regained consciousness, she was not completely alert to surrounding for about a minute and was "drenched in sweat" and felt "clammy." Reported no other symptoms.
Client presents for 2nd COVID Pfizer vaccine.  Client reports she experienced numbness and tingling in lips after receiving first Pfizer COVID vaccine on 10/14/2021.  Onset was 20 min after vaccination.  Client reports it resolved on its own without intervention.   Did not follow up with primary doctor for 2nd dose guidance.  Client denies any chronic medical problems, not taking medications, denies allergies.  Denies any shortness of breath, trouble breathing or throat tightening with 1st dose.
some chills; fever; nausea; her right knee went out; she developed an ingrown toenail that was painful and she would not walk.; cough; ear hurting; stuffy nose; sore throat; just feeling sick; This is a spontaneous report from a contactable consumer (patient) received via Medical Information Team. A 76-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On unspecified dates, after the first injection of the vaccine, the patient experienced some chills, fever, and nausea that went away. Later, she reports her right knee went out and she developed an ingrown toenail that was painful and she would not walk. She was able to get the ingrown toenail removed by a doctor and was prescribed cefalexin (CEPHALEXIN), taken 4 times a day. At the time of the report, the consumer was experiencing cough, ear hurting, stuffy nose, fever, chills, sore throat, and just feeling sick. The patient was uncertain if this was due to the vaccine, the cefalexin, or some other reason. The patient was scheduled to get the second dose. The patient recovered from nausea and ingrown toenail on unspecified dates while the outcome of the other events were unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
[ second Shot on 2/27/2021]  on 2/28/2021 woke up early morning with severe headache. By evening I started feeling seve muscle pains and fatigue and chills.. ALso had sevre nausea and vomiting although I didnt eat anything due to nauses and tiredness. On 3/1/2022 right ear started chirping and clicking with post nasal drip- took Allegra_D 12 hr for couple of days. EAr ringing was maddening non stop like an alrm with 2 pitches - slightly low followed by high pitch  throught out night and day for almost 10 days. Was devastating depressing . Went to ENT who did not see anything wrong, Audiologist just confirmed [what I already knew and had for 2 years}-hearing loss. and tinnitus.
Patient received undiluted 2nd dose of COVID-19 pediatric series. Parents advised of error and to watch for potential side effect. Patient experienced mild fever and fatigue. Parents managed with OTC pain/fever reducer. Symptoms resolved after 2 days without complications.
pt recv vax 19MAR96 & cried unconsolably for approx 5hr;pt was fully recovered as of the date of this report
Pt was admitte dto the hospital with small bowel obstruction, sepsis, died 3 days later. Not a Covid related death
arm pain; Could not sleep; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21st June 2019, the patient received Shingrix. In June 2019, less than a week after receiving Shingrix, the patient experienced pain in arm and insomnia. On an unknown date, the outcome of the pain in arm and insomnia were unknown.   It was unknown if the reporter considered the pain in arm and insomnia to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient's friend. The age at vaccination was not reported. The age group was not reported, but was selected adult as per vaccine indication. After vaccination, the patient could not sleep because his arm hurt so much.
Patient requested a work note due to having a low grade fever, right arm soreness and a headache this am.  Patient informed that she could have a work note and that she could take Tylenol for the pain as needed and as directed.
5/28 - swelling of right eyelid, 5/30 - swelling of left eyelid, burning eye pain, itchy, felt dizzy, trouble focusing, fatigue
I received the second dose of the Pfizer COVID-19 vaccine on 3/11/2021. In August 2021, my husband tested positive for COVID-19. I avoided contact with him as much as possible. I was also tested for COVID-19, and the result was negative. I thought I was COVID-19-free until I was working in the garden one day and noticed I couldn't smell the basil or tomatoes. My doctor advised me that even if I had tested negative for COVID-19, if I had any symptoms of it, I had most likely caught it. I never developed any symptoms of COVID-19 besides the loss of the sense of smell, though I did have mild cold-like symptoms. I don't remember how long I was unable to smell, but I did eventually regain my sense of smell.
had a friend who dropped dead after getting the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (had a friend who dropped dead after getting the vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.            Concomitant product use was not provided by the reporter.  Action taken with mRNA-1273 in response to the event was not applicable.  This is a patient of unknown age and gender who received mRNA-1273 vaccine (batch no. unk) who died on  an unknown date after receiving the first dose of vaccine  No medical hx or concomitant products  Very limited information has been reported at this time. Further information is being followed up; Sender's Comments: This is a patient of unknown age and gender who received mRNA-1273 vaccine (batch no. unk) who died on  an unknown date after receiving the first dose of vaccine  No medical hx or concomitant products  Very limited information has been reported at this time. Further information is being followed up; Reported Cause(s) of Death: Unknown cause of death
The patient medical history and concomitant medications were not reported. The patient experienced tested positive for the covid19 virus on an unspecified date.  The patient underwent lab tests and procedures which included sars-cov-2 test: positive on unspecified date tested positive for the COVID-19 virus. A female and husband, male had their first dose of the PFIZER-BIONTECH COVID-19 VACCINE on 16Apr2021 and had developed some side effects with the vaccine. Her husband got sick this Sunday and had been hospitalized and had been diagnosed with Pneumonia. Also, both of them tested positive for the COVID19 virus. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
ACUTE DVT OF LEFT FEMORAL VEIN 2/9/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
This spontaneous report as received from a pharmacist refers to an unknown number of patients of unknown age and gender. It was reported that doses of VARIVAX (Merck) (lot #, dose and route not reported) that were improperly stored since an unspecified date in July 2014, had been administered to patients. No adverse events were reported. This is one of several reports from the same source. Additional information is not expected (reporter refused additional contact).
no additional AE reported; Vaqta involved in temperature excursion on 01/01/2021. Vaccine had been administered to 33 patients; This spontaneous report was received from a medical assistant and refers to a 2-year-old patient of unknown gender. Their concurrent conditions, medical history and concomitant therapies were not provided.   On 26-JAN-2021 , the patient was vaccinated with an improperly stored hepatitis A vaccine, inactivated (VAQTA) lot number: T013204, expiration date: 03-DEC-2021 (strength, dose, frequency and route of administration were not reported) as prophylaxis. Administered dose of vaccine experienced a temperature excursion of 47.01 degrees Fahrenheit for 1 minute and 30 seconds. Digital data logger was involved. There was no previous excursion noted. There was no additional adverse event reported.  This is one of 33 reports from the same reporter (original case # 2102USA004059). combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. devicelotnumber: T013204; expirationdate: 03-DEC-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2102USA003923: US-009507513-2102USA004059:
headache, fever,chills,muscle ache,naseau, vomiting, no appetite,diarhhea
This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and stress. The patient was treated with acyclovir. On an unknown date, the outcome of the vaccination failure, shingles and stress were unknown. It was unknown if the reporter considered the vaccination failure, shingles and stress to be related to Shingles vaccine and Shingles vaccine. Additional Information: GSK Receipt Date: 14-MAY-2022. Reporters comment: The patient self-reported the case via interactive digital media and described the occurrence of suspected vaccination failure. After receiving Shingles vaccine, the patient got shingles, two weeks ago from the date of reporting. The patient also had stress. The patient was going to take garlic every day and all day. This fresh he'll was unbelievable. The patient stated that, Acyclovir had not done it yet. Additional supportive information: This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory test confirming shingles were unknown at the time of reporting. Follow up would not be possible as no contact details were available.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 61-year-old female patient who received SHINGRIX (batch number 5MG5E, expiry date 5th May 2021) for prophylaxis. On 4th December 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 5th December 2018, 1 days after receiving SHINGRIX, the patient experienced injection site pain, injection site erythema and general body pain. On an unknown date, the outcome of the injection site pain and injection site erythema were not recovered/not resolved and the outcome of the general body pain was recovered/resolved. It was unknown if the reporter considered the injection site pain, injection site erythema and general body pain to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX on the left arm. The patient experienced mild body aches which went away. The patient also experienced injection site soreness and redness which was still persisted 10 days later. The reporter consented to follow up.
evening of 22FEB93 t104.0 R x 1 then steadily dec w/Tempra; pt fussy, crying; no sz, high pitched crying or screaming; temp on 23FEB93 1300 hrs; t102.4; went for walk in AM;
Patient received 0.4 ml of J+J COVID vaccination instead of recommended dose of 0.5 ml
HCP calling to report a TE/ VAXELIS administered to patients since the temperature excursion happened. No additional AE's; This spontaneous safety report, with reference number 02299086 (Interaction # 02299043) was received by the partner on 19-DEC-2022 and forwarded on 21-DEC-2022, from a health professional   Due to the nature of the event, the causality between the event "HCP calling to report a TE/ VAXELIS administered to patients since the temperature excursion happened. No additional AE's" and Vaxelis was not applicable.   Further information is expected.  For reference purposes, this case is linked to MCM-004407, MCM-004408, MCM-004409 and MCM-004410 (same reporter).  SIGNIFICANT FOLLOW UP INFORMATION was received on 03-JAN-2023 from the health care professional.  The reporter confirmed that there were no Adverse Events following Vaxelis administration to the patient.  Due to the nature of the event, the causality between the event "HCP calling to report a TE/ VAXELIS administered to patients since the temperature excursion happened. No additional AE's" and Vaxelis remains not applicable.  No further information is expected.
Woke up on day 2 with rash on upper torso, said it's getting better, he will call doctor in the morning.
Information has been received from a health professional concerning a female who was vaccinated with GARDASIL vaccine (yeast) and had a syncopal event. There was no concomitant medication. Subsequently the patient required the administration of amnonia salt to recover from the syncopal event. No other specifics were available regarding the patient, symptoms, the injection, or treatment. No other information available. No further information is available.
Stiffness in jaw; aching jaw; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the left arm on 03Apr2021 at 14:00(at the age of 36-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included gliclazide (CLARITIN) and multivitamin (MANUFACTURER UNKNOWN) from an unknown date for unknown indication. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 05Apr2021 at 12:00 the patient experienced stiffness in jaw and aching jaw. No therapeutic measures were taken as a result of the event. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events stiffness in jaw and aching jaw were not resolved at the time of this report   No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: To amend 1. Vaccine Facility Information added.
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender (reported as man). No information regarding medical history, concomitant therapies, current conditions and allergies was provided. On 19-SEP-2017, the patient was vaccinated with PNEUMOVAX 23 injection, intramuscularly in the left arm, lot # M035104 with expiration date 06-MAY-2018 (dose was not provided) for prophylaxis. Pharmacist reported, the patient was a thin man and after the injection of PNEUMOVAX 23, the reporter was not sure if she gave full dose. No adverse effects were reported.
IDIOPATHIC THROMBOCYTOPENIC PURPURA; This spontaneous report received from a consumer/other non-health professional concerned a female patient of unspecified age. On 22-APR-2021 and on 23-APR-2021, the patient was called, unable to reach the reporter. The voicemail was left for reporter. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose, frequency once total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, laboratory data included: Idiopathic thrombocytopenic purpura (NR: not provided) recently diagnosed with rare blood disease ITP. Reporter stated that after administration of covid-19 vaccine, she experienced rare blood disease that was idiopathic thrombocytopenic purpura.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of idiopathic thrombocytopenic purpura was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: A female patient of unspecified age experienced idiopathic thrombocytopenic purpura an unknown time after vaccine. No additional information was reported including medical history, concomitant medications, family history, or event history. There is insufficient information to make a meaningful medical assessment. Additional information has been requested including attempted contact with patient.
have the shingles got all my shots / suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional case details were reported as follows: The reporter was patient itself. The age at vaccination was not reported. The patient got all the shots a few months ago and had the shingles. The reporter requested everyone needs to get the shots. This case was considered as suspected vaccination failure, as details regarding laboratory test confirmation and time to onset for shingles were unknown at the time of reporting. The follow up was not required.
pt recvd vax;devel fever,ha,general aches & pain, rash, eve of vax;rash across back & very itchy;recommended that mom contacted fam MD;no more inject w/out MD's order because of rash;no resp difficulties;