chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a pharmacist refers to a 60-year-old (also reported as 61-year-old) female patient, who was hospitalized due to bowel obstruction on 25-AUG-2017 and was allergic to dextroamphetamine and penicillin. The patient's medical history included kidney stones. The patient's historical drugs included dextroamphetamine and penicillin. On 26-AUG-2017 (also reported as 28-AUG-2017), the patient was vaccinated with PNEUMOVAX 23 injection, 0.5 ml intramuscularly, lot # N014188 with expiration date of 22-JAN-2019 for prevention of pneumococcal disease. Concomitant therapies included TYLENOL, azithromycin, ceftriaxone, PEPCID, heparin, ZOFRAN and PERCOCET. On 28-AUG-2017, the patient experienced redness and swelling of skin and pain at injection site, which extended to her neck and face. The patient received treatment but no laboratory diagnostics were performed. The outcome of the adverse events was reported as recovering/resolving. The relatedness between the adverse event and PNEUMOVAX 23 was not reported. Additional information has been requested.
Tinnitus increased greatly after 2nd shot, within the same day.  Tinnitus is still very bad 2 months after shot.   Slight headaches started within a week of 2nd shot, would happen a couple time a week. After two months they have mostly gone away. Moderate Short term memory loss started after 2nd shot.  This has greatly improved after 2 months.
Red Bumps on Right thigh vaccine associated rash, noticed 2 days ago, fussy, decreased appetite, loose light green stools-1x.
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of PEDVAXHIB (lot # L042259, expiry date 18-AUG-2018; dose and route of administration were not reported). The doses were stored under the temperature of 50F for 35 minutes and the data logger was involved. There was no previous temperature excursion. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
This case was reported by a pharmacist via call center representative and described the occurrence of hives in a 65-year-old female patient who received SHINGRIX. On 3rd February 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In February 2018, 14 days after receiving SHINGRIX, the patient experienced hives, pruritus and scratch. On an unknown date, the outcome of the hives, pruritus and scratch were not recovered/not resolved. The reporter considered the hives to be possibly related to SHINGRIX. It was unknown if the reporter considered the pruritus and scratch to be related to SHINGRIX. Additional details were reported as follows: This case was previously reported to physician. The patient received SHINGRIX on an unknown arm, at an outside pharmacy. Two weeks after receiving the SHINGRIX vaccine, the patient developed hives and urticaria. The hives would resolve in one area of her body and develop at another part of the body. Less than a month after receiving SHINGRIX, the patient had scratch marks from where she had been itching them. On the day of reporting, the patient was admitted in the hospital. In response to the questions asked about the patient's admission, the reason was not disclosed. Additional details could not be obtained.
Information has been received regarding a case in litigation from a consumer concerning her 1 day old son who in approximately January 2004, was vaccinated with a dose of Recombivax HB (lot number: 646434/1023N). The reporter indicated that in approximately January 2004, after receiving the vaccination the patient's head blew up by at least 36 percent and "although his head was slightly molded, it can not be a mistake unless his molding resulted in a head more than twice as long as wide. His head was approximately normal before his vaccine". It was noted that the head circumference measurements come from licensed medical staff. The reporter indicated that her son was permanently injured. She is his primary care provider. Every day she has to look at him and see the damage that had been done. There is nothing in this world that would change that. She stated that she would never have her healthy, thriving, angelic little boy because of problematic vaccine lots that were given to him. She indicated that she needs to know this information so that something can be done that may possibly help him and improve his condition. The vaccine damage that had been done has left him functioning on a 1 to 9 month developmental level and he is nearly 4 years of age. Something could still be done to improve his prognosis. The event was considered to be disabling by the reporter. Additional information has been requested.
pt recv vax 18NOV97 & 19NOV97 6PM had 2 episodes of sudden onset of nausea, emesis, felt shaky noted HR inc to 116, tunnel vision lasting just a few seconds;had another 2 episodes happen on 23NOV97 & 24NOV97;no more hep B recommended;
A week post-injection, developed systemic hives. Hives (large and itchy) covered arms, legs, and part of face. Three days thus far.
PATIENT WAS ADMINISTERED THE SHRINGIX DILUTENT NOT MIXED WITH THE POWDER IM
I contracted Covid19 on 05/13/2022 with symptoms of sore throat, runny nose, congestion, headache, myalgia, loss of appetite, fatigue. I was prescribed Paxlovid on 05/13/2022, and my symptoms began to improve the next day. I am still fatigued, lack appetite, but my other symptoms are beginning to resolve.
nausea; tired; achy; This spontaneous case was reported by a pharmacist and describes the occurrence of NAUSEA (nausea), FATIGUE (tired) and MYALGIA (achy) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21A and 006B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-May-2021, the patient experienced NAUSEA (nausea), FATIGUE (tired) and MYALGIA (achy). At the time of the report, NAUSEA (nausea), FATIGUE (tired) and MYALGIA (achy) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was given. No laboratory details was given. No treatment information was given. Action taken with mRNA-1273 in response to the event was not applicable.
Information has been received from a Licensed Practical Nurse concerning a 22 month old male patient with a history of tick bite, reactive airways disease, and drug reactions or allergies reported as none who on 22-SEP-2008 was vaccinated with a dose of VARIVAX (Merck). There was no concomitant medication. On 30-JUL-2009 the patient experienced chickenpox. Symptoms presented as a "rash all over". The patient was advised to use oatmeal bath, calamine (+) zinc oxide lotion and BENADRYL. The patient sought an unspecified medical attention. The patient was completely recovered on 10-AUG-2009. Follow up information received from a licensed practical nurse indicated that he was a male patient who on 22-SEP-2009 was vaccinated subcutaneously with his first dose of VARIVAX (Merck) in his right arm, suspect therapy included his first dose of MMR II (Lot # 656614/0869U) which was administered subcutaneously in his left arm. There were no illnesses reported at the time of vaccination. Concomitant therapy included HAVRIX received intramuscularly in his right thigh and a fourth dose PREVNAR administered intramuscularly in his left thigh. According to the reporter, the adverse event began on 27-JUL-2009 (previously reported as 30-JUL-2009) as the patient presented to the office/clinic with numerous red bumps. A diagnosis of chickenpox was done at the clinic. The patient recovered on Aug-2009 (previously reported as 10-AUG-2009). There were no laboratories diagnostics studies performed. This is one of four reports from the same source. No further information is available.
patient reported headache soon after receiving vaccine. about 2-3 minutes later she said she felt nausea. she was coherent and knew her name and where she was but would drop her head and dry heave. we called 911 and continually monitored the patient until paramedics arrived
Initial information received on 12-Oct-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves 5 month old patient who received 0.25 ml FLUZONE QUADRIVALENT (batch number UT6259NA, expiry date 30 june 2019, route and site of administration were not reported) on 09 Oct 2018. It was a case of actual medication error as Inappropriate age at vaccine administration. It was unknown if any adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
A sizeable red/warm/itchy blotch appeared on my right arm where I had the Moderna COVID vaccine on Monday 01/18. The blotch appeared on 01/25, 7 days after the injection. I did not experience any immediate symptoms following the vaccine, just a sore arm. I spoke with a Dr. about the rash. She said no concerns at this time unless it grows or other symptoms appear.
pt recv vax 25AUG97-PM 26AUG97 340Pm noted a pimple on arm, later that PM noted 5 pox across chest;during noc devel fever 100;fever inc 103.7 & 102;APAP given & oatmeal bath & hydrocortisone for itchy pores;
Two days after the vaccine (7Sep2021), I awoke with severe pain all over my body. It never went away. I have since been diagnosed with Polymyalgia Rheumatica; Two days after the vaccine (7Sep2021), I awoke with severe pain all over my body. It never went away. I have since been diagnosed with Polymyalgia Rheumatica; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Sep2021 as dose 2, single (Batch/Lot number: unknown) at the age of 58 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "if covid prior vaccination Yes" (unspecified if ongoing), notes: if covid prior vaccination Yes. The patient's concomitant medications were not reported. Past drug history included: Codeine, reaction(s): "Allergic to codeine", notes: known allergies Yes, allergic to codeine. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: Unknown. Unable to locate or read the details, Location of injection: Left Arm), administration date: 22Aug2021, when the patient was 58-year-old, for Covid-19 Immunization.  The following information was reported: POLYMYALGIA RHEUMATICA (disability, medically significant), PAIN (disability) all with onset 07Sep2021, outcome "not recovered" and all described as "Two days after the vaccine (7Sep2021), I awoke with severe pain all over my body. It never went away. I have since been diagnosed with Polymyalgia Rheumatica". The event "two days after the vaccine (7sep2021), i awoke with severe pain all over my body. it never went away. i have since been diagnosed with polymyalgia rheumatica" required physician office visit. Therapeutic measures were taken as a result of polymyalgia rheumatica, pain.  Clinical course: Facility type vaccine Pharmacy or Drug Store. No other vaccine in four weeks. Two days after the vaccine (7Sep2021), she awoke with severe pain all over her body. It never went away. She has since been diagnosed with Polymyalgia Rheumatica (PMR). She was in a support group for PMR and have found that thousands of people across the globe also experienced the same thing following their 2nd dose. Adverse event resulted in [Doctor or other healthcare professional office/clinic visit, Disability or permanent damage]. Adverse event treatment: High dose steroids, long-term. The patient had covid prior vaccination. She had covid tested post vaccination.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Pt recvd series of 3 vax from spring 1990 thru AUG90.titer revealed pt was non-responder.
Patient received vaccines on 7/18/17 had reaction on 7/30/17. Admitted to ER for abscess on Lt. thigh. Had MRI-Showed Intramuscular Abscess.
had a localized allergic type reaction with 3cm induraiton and 8cm erythema. Started 24 hours after vaccine was administered. Expect to improve without any complication.
Pt presented with c/o right sided back pain & vesicular rash to right buttock & right leg.  Referred to FNP.  Dx: Herpes ZOSTER.  Rx:  VALTREX 500 mg TID X 7 days.  ZOVIRAX cream to affected area QID X 5 days TYLENOL #3 PRN - pain.
fever; headache; redness at injection site; swelling at injection site; warmth at injection site; This case was reported by a consumer via call center representative and described the occurrence of fever in a 62-year-old female patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On 16th August 2019, the patient received Boostrix .5 ml. In August 2019, less than a week after receiving Boostrix, the patient experienced fever, headache, injection site erythema, injection site swelling and injection site warmth. On an unknown date, the outcome of the fever and headache were recovered/resolved and the outcome of the injection site erythema, injection site swelling and injection site warmth were recovering/resolving.   It was unknown if the reporter considered the fever, headache, injection site erythema, injection site swelling and injection site warmth to be related to Boostrix.  Additional details were provided as follows: The case was reported by patient's husband.  The patient experienced fever of 101.5 degrees F, headache, swelling at the injection site, redness at the injection site, and warmth at the injection site. The reporter consented to follow up. The reporter did not provide any additional details and did not have the address of the health care professional(HCP).
employee received the COVID vaccine, after 15 minutes she felt her pulse racing, she sat down for a few more minutes before quickly standing and passed out
Pt came in today for 2nd MPX vaccine. Per pt, received 1st dose on 8.31.22 & was diagnosed with shingles 1 week post vaccination. Pt given 10 days valgancyclovir and resolved. Pt immuncompromised, + HIV. Pt with cleared up lesions today and no pain. Ok per physician to give vaccine today.
patient died from Haemophilus influenzae disease; Initial information regarding an unsolicited valid serious case was received from the physician via other health professional (MSL-medical science liaison) via medical information (Reference number- 00690240) and transmitted to Sanofi on 20-Jul-2021.  This case involves a nine-month-old patient (gender unspecified) who died from Haemophilus influenza disease (Haemophilus infection), after patient received HIB (PRP/T) VACCINE [ACT-HIB].  Medical history, medical treatment, vaccination, family history and concomitant medications were not reported.  On an unknown date, the patient received a third dose of suspect HIB (PRP/T) VACCINE [strength: 0.5 mL, lot number, expiry date and other dosing details were not reported] for prophylactic vaccination.  On an unknown date, the patient developed a serious Haemophilus influenza disease (Haemophilus infection), (unknown latency) following the administration of HIB (PRP/T) VACCINE. This event was assessed as medically significant and was leading to death.  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment before death for the event (Haemophilus influenza disease).  It was reported that, no autopsy was done.   On 15-Jul-2021 (the last Thursday), the patient died due to Haemophilus infection (cause of death was reported as Haemophilus influenza infection).  Information on the batch number was requested.; Sender's Comments: This case involves a nine-month-old patient (gender unspecified) who died from Haemophilus infection (unspecified disease type and serotype), after third dose vaccination with ACT-HIB. The time to onset is unknown. There is no information regarding pre-exiting or undergoing medical conditions during vaccination, previous vaccination and tolerance, laboratory investigations ruling out alternate etiologies. No laboratory confirmation. Also, no autopsy was performed. Based upon reported information, role of suspect vaccine cannot be assessed.; Reported Cause(s) of Death: Haemophilus influenzae disease
This spontaneous report was received from a register nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions and allergies were not provided. Concomitant therapies included sterile diluent. On 14-JAN-2019, the patient was vaccinated with VARIVAX lot # R006753, expiration date 06-MAR-2020 (frequency, dosage, strength were not reported) for prophylaxis. Call was due to a data logger. Temperature/time (47 Fahrenheit to 77 Fahrenheit ) 11 hours 28 minutes and (15 Fahrenheit to 46 Fahrenheit) 13 hours and 1 minute. On the same date, the nurse stated patients received unspecified doses of VARIVAX that were improperly stored (product storage error).
This spontaneous report as received from a physician refers to a 40 year old male patient. The patient's concurrent conditions and medical history were not reported. On 05-MAY-2015, the patient was vaccinated with a first dose of VARIVAX (Merck) (dose, route, lot# and expiration date were not reported). On an unspecified date in May 2015, the patient developed a nodular disseminated rash. The patient sought medical attention - he visited the physician on an unspecified date. The physician stated, that the rash was not vesicular in appearance and prescribed an unspecified antiviral medication (manufacturer unknown) to treat the rash. The outcome of rash was reported as not recovered/not resolved. The relatedness between the event and VARIAVAX (Merck) was not provided. Additional information has been requested.
10/30/14 8:02AM FLUZONE in (L) deltoid, 8:12 AM left deltoid and clavicle redness, blotchy, raised bumps. 8:15 BENADRYL liquid 25mg oral, 8:34 EPIPEN (L) lateral thigh as student had increasing redness on chest, neck. 8:40 transported to ER by EMT's. Transported to Hospital.
small, raised white bumps from inj to elbow lt arm noted 10JUN98 9PM;red lines noted 13JUN98 both arms & chest x 2d;gen red bumps 15JUN98 w/itching;eval @ clinic 18JUN98;contact dermatitis;hip discomfort;pain in shoulder & legs;T101.4;
Narrative: A 73yo male , received Pfizer Covid- 19 vaccine per policy and protocol First shot February 18. 2021 and the second shot on March 18th, 2021 No ADE was reported.
Hives on body; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives on body) in a 7-month-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027AS1A and 015M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Mar-2021, the patient experienced URTICARIA (Hives on body). At the time of the report, URTICARIA (Hives on body) outcome was unknown.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2021 at 10:38 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 11-Jan-2021 at 10:38 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 43.62   Concomitant products were not provided.  On 11-Jan-2021, Excursion time was 09 AM and 02 PM temperature was 34 and 35, total doses given for the day was 98, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 08-Jan-2021, vial was moved to clinic on 11-Jan-2021. 9  vials were sent to clinic. Vaccine BUD date was 07-Feb-2021  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported   This case was linked to MOD-2022-566976 (Patient Link).
Rashes on the face, back, body and extremities started 24 hrs from vaccination relieve Kw/ BENADRYL slowly. Still have rashes on the palms as of today.