chrisvoncsefalvay/vaers-outcomes huggingface dataset:
developed a papular rash over her trunk and upper thighs; rash was itchy; This spontaneous case was reported by a physician and describes the occurrence of RASH PAPULAR (developed a papular rash over her trunk and upper thighs) and RASH PRURITIC (rash was itchy) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hyperlipidemia.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH PAPULAR (developed a papular rash over her trunk and upper thighs) and RASH PRURITIC (rash was itchy). At the time of the report, RASH PAPULAR (developed a papular rash over her trunk and upper thighs) and RASH PRURITIC (rash was itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product information was not provided.  As treatment the patient received some 'cor'.
PATIENT CAME IN LAST EVENING AND SHOWED ME A LARGE RED ROUND AREA, HOT TO THE TOUCH.  SHE SAID IT HAS BEEN GROWING IN SIZE.
This spontaneous report as received from a Licensed Practical Nurse referring to a 20 patients of unknown age and gender. The patients' pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On 23-AUG-2017, 20 unknown patients were administered a dose of improperly stored VARIVAX Lot # M048203 expiration date 07-DEC-2018 for prophylaxis (strength and route were not reported) reconstituted with a properly stored sterile diluent (manufacturer unknown). The vaccines were stored at a temperature between -14°C to -10°C (-10.4°C) during a time frame of 13.15 hours (795 minutes). There were no previous temperature excursions and the call was no because of a data logger. No adverse effects were reported.
3 got shingles after vaccine/ Suspected vaccination failure; Got 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.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving 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.  Additional details were provided as follows: The age at vaccination was not reported. The patient got shingles after getting the Shingles vaccine. The reporter stated to stop with the big pharma propaganda. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting. This case is linked with the case US2021AMR197923 and US2021AMR197942, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR197923:Same reporter. Pt 1/3 US-GLAXOSMITHKLINE-US2021AMR197942:Same reporter. Pt 3/3
Mild soreness left arm for one day post vaccination; This is a spontaneous report from a contactable physician (patient). A 55-year-old male patient received bnt162b2 (BNT162B2 also reported as Covid-19 vaccine; lot number: EJ1685; expiration date: unknown), via an unspecified route of administration left arm on 19Dec2020 05:00 PM at a single dose for covid-19 vaccination. The patient has no medical history. The patient has no known allergies. The patient was not patient diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and did not have any other medications the patient received within 2 weeks of vaccination. It was reported that the patient received the COVID-19 vaccine in a hospital on 19Dec2020 05:00 PM. On 20Dec2020, the patient had mild soreness left arm for one day post vaccination. The patient has not been tested for COVID-19 since the vaccination. The patient considered the events as non-serious. No treatment received for the adverse event. The outcome of the event was recovered on an unspecified date.
DTaP and polio vaccine given in left thigh on 10/15/03. Seen in clinic on 10/17/03 for redness, diffuse swelling and induration on left thigh, warm to touch, 12cm x 13cm.
Received the injection, she stood up while her other family member got their vaccine. Went to sit down and when the immunizer came around, she was slumped over in her chair and presented with jerking motions. After about a minute, she came to and said that she was really dizzy.  We asked if she was okay and asked her to stay for an additional 30 minutes for further observation. She drank some water and ate a snack afterwards. She said she was okay to leave after that and her mother was driving her home.
Local reaction ,Body aches followed by chest pain , was evaluated at  Hospital ER , EKG and CXR were normal , was seen by me today ,His vitals ,exam and O2 sat were normal and he is asymptomatic
MenQuadfi pulled and administered in error.  MenB should have been pulled and administered.  No adverse events noted.  Called and notified father.
Patient's husband came into store on 10/29 to report an adverse event that occurred. Husband states that 6 days after receiving both Fluzone HD and Shingrix, she was admitted to the ER with the inability to walk/loss of muscle coordination. She was later transferred to Medical Center and was diagnosed with Guillan-Barre syndrome. The staff at Medical Center informed the patient that it occurred likely due to the vaccinations she received at our store. I have not confirmed the diagnosis or the treatment with the staff at Medical Center. The patient is currently still under care at hospital in the rehab facility as of 10/29/20. No extraordinary circumstances occurred during vaccination.
Product Storage Error and Administration; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong technique in drug usage process in a patient who received HBV (Engerix B) for prophylaxis.   On 27-JUN-2023, the patient received Engerix B. On 27-JUN-2023, an unknown time after receiving Engerix B, the patient experienced wrong technique in drug usage process (Verbatim: Product Storage Error and Administration). The outcome of the wrong technique in drug usage process was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 27-JUN-2023 The reporter stated that she believed the Engerix-B was activated yesterday (day before reporting) but was not discarded and was administered to a patient today (on the reporting day), which led to wrong technique in drug usage process. However, she was not certain. The reporter asked how long an Engerix-B PFS (pre-filled syringe) stable for once a needle had been placed. Provided CDC (Centers for Disease Control and Prevention) recommendations that state that the PFS should be used or discarded at the end of the workday.  The vaccine administration facility was the same as primary reporter. The reporter did not have any additional details surrounding the event (no patient identifiers, lot number, expiry date). She also declined follow up.
4/14/16 called clinic c/o soreness (R) arm. 4/26/16 clinic apt for (R) arm soreness. 6/18/16 physical therapy. 07/13/2016 Right shoulder xray. 07/13/16- Labs. 07/15/16 Labs. 08/04/16 Allergy clinic appt.
< 24 hours post vax, pt c/o severe pain, can't lift arm, localized edema, denied redness.
Upon awakening (17 hours after injection), had a headache; As the day progressed, my whole body started to ache as well; intermittant shooting pains in my ears; Arm started to be sore at bed time (about 8-10 hours after injection); Woke up in middle of night (atypical for me) with general feeling of being unwell; do not have a fever but have been feeling colder than normal; This is a spontaneous report from a contactable consumer (patient). A 37-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EL3247), via an unspecified route of administration, administered in left arm on 16Mar2021 at 14:00 (at the age of 39-years-old) as single dose for COVID-19 immunisation. Medical history included kiwi allergy psoriasis, exercise induced asthma and HLAB27 associated anterior uveitis, all from an unknown date and unknown if ongoing. The patient previously took first dose of BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EL3247) via an unspecified route of administration, administered in left arm on 23Feb2021 at 14:15 for COVID-19 immunisation and had sore arm. Prior to vaccination, patient was not diagnosed with COVID-19. Patient did not receive any other vaccine within four weeks of vaccination. Concomitant medication(s) included norethindrone, Vitamin D3, fish oil and multi-vitamin. On 16Mar2021 at 22:00 (8-10 hours after vaccination), patient arm started to be sore at bedtime and woke up in middle of night (which was atypical for patient) with general feeling of being unwell. On 17Mar2021 (17-hours after vaccination), upon awakening patient had a headache and as the day progressed, whole body started to ache as well and experienced intermittent shooting pains in her ears. On an unspecified date, patient not had fever but had been feeling colder than normal. Patient received no treatment for the events. Since the vaccination, patient had not been tested for COVID-19. The outcome of all the events was recovering.  No follow-up attempts are needed. No further information is expected.
Directly after giving the vaccine the patient fainted. Patient "came to" and paramedics were called.  When they got here, he fainted again and they took him to the hospital.
pt recv vax;3 days later,devel severe bacteremic pneumococcal lt lower lobe pneumonia w/ hypoxemia;lost at least 10-12lb;MD feels it's hard to suspect relationship b/w immun & acute illness it is intended to prevent;
Information has been received on 05-JAN-2018 regarding a case in litigation from a lawyer and a male patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. The patient was inoculated with ZOSTAVAX (lot number and expiration unknown) subcutaneous on or about 29-NOV-2010, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster or shingles. On or about 25-NOV-2015, the patient was treated for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster or shingles. The patient has been prescribed valacyclovir hydrochloride (VALTREX) for management of his painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
This spontaneous report as received from a physician refers to an unspecified number of unspecified patients. The Physician called to report that an unspecified number of unspecified patients may have been administered VARIVAX (Merck) (Lot#, dose/frequency, route unspecified) that were improperly stored on unspecified dates from May 2012 to December 2012 at an unspecified healthcare facility. No adverse effects reported. This was one of several reports that received from the same source. Additional information is not expected.
Fatigue; moderate headache; This is a spontaneous report from a contactable Nurse reporting for herself.  A 34-years-old female patient  received bnt162b2 (BNT162B2; Lot # EL0140 )vaccine  , intramuscular  in the left arm on 18Dec2020 15:15 at single dose for covid-19 immunisation .  Medical history included hypersensitivity to medications including  amoxicillin sodium + clavulanate potassium] (AUGMENTIN)  from an unknown date.   The patient's concomitant medications were not reported.  On 18Dec2020 22:00  the patient experienced fatigue and headache (6/10) refractory to caffeine or hydration. The nurse did not try tylenol or NSAIDs as  wanted to prevent interference with immune response. The outcome of both the event was not recovered.
Information has been received from an investigator concerning a 6 month old female with gastrooesophageal reflux (November 2011) who entered a study. On 28-DEC-2011, consent was obtained and was randomized to be vaccinated with DTaP+IPV+HepB+Hib at 2 months, 4 months and 6 months of age. On 28-DEC-2011, 28-FEB-2012 and 24-APR-2012, the subject was vaccinated IM with the first, second and third 0.5 ml doses, respectively, of DTaP+IPV+HepB+Hib (injection site not reported). Other study vaccines included on 28-DEC-2011, 28-FEB-2012 and 24-APR-2012 the first, second and third doses of the following ROTATEQ 2ml po and PREVNAR 13 0.5ml IM (injection site not reported) to complete childhood vaccination series. Previous therapy history included HepB 0.5 ml IM on 26-OCT-2011. On 29-APR-2012, the subject experienced intussusception (intensity severe) and was hospitalized on 30-APR-2012. On 27-APR-2012 (Friday), day 3 post vaccination (as reported), the subject's parents called with symptoms of light blood in stool. Parents were informed to watch if more blood shows up then to go to the clinic. On 29-APR-2012 (Sunday), day 6 (as reported), more was noticed. The subject was brought to the clinic. The subject was sent to the ER for blood work (no further information provided) and was then sent home. On 30-APR-2012, day 7, subject presented to the clinic for vomiting blood. Subject was sent to the hospital. An ultrasound was done and showed intussusception. An air enema was done to correct the intussusception and was successful. The subject was "held" overnight for observation until 01-MAY-2012. On 01-MAY-2012, the subject was doing well and was released. At the time of reporting the subject was recovering from the intussusception. There was no action taken with study vaccine therapy. The investigator considered the third dose (24-APR-2012) of ROTATEQ was related to intussusception. The investigator reported that "given past known association of intussusception with an earlier generation rotavirus vaccine, the possibility that the ROTATEQ is the cause must be considered even though large scale studies showed a decreased risk over general population of developing such a bowel obstruction." The investigator considered DTaP+IPV+HepB+Hib and PREVNAR 13 as not related to intussusception. Intussusception was considered to be an other important medical event by the investigator. Additional information has been requested.
Blood pressure was unusually high/BP is elevated/ but it has been as high as 178/95; This is a spontaneous report from a contactable female consumer, the patient via Pfizer-sponsored program. A 67-year-old female patient (not pregnant) received the first dose of (Pfizer COVID-19 Vaccine, solution for injection, lot number: unknown) via an unspecified route of administration on 12Mar2021 (Friday) on left arm as a single dose for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Medical history included hypertension. Patient had no allergies. Patient received Prescribed: Lisinopril 40 mg; Clonidine .0225 mg; Hctz 25 mg; Pravastatin 5 mg in two weeks. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. Patient noted that the evening of and the next two days after the vaccine (12Feb2021 at 05:15 PM) my BP is elevated. It's usually within normal range (125/82), but it has been as high as 178/95. Inquiring if that is a side effect. Relayed PMI number and transferred to unit queue due to high call volume. Will fax to company. No treatment was received for the events. Outcome of the event was Recovered.  Information on Lot /Batch Number has been requested.
arachnoid cyst on brain; blood pressure shot up to 163/100.; dizziness; Tingling in forehead, back of head; numbness on right side of face; This is a spontaneous report from a contactable consumer (patient).   A 65-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 18Mar2021 09:00 AM (Batch/Lot Number: EN6208), at the age of 65-years at vaccination, as (SINGLE DOSE) for COVID -19 immunisation.  Medical history included Hashimoto's disease, high blood pressure, Hailey-Hailey, Known allergies: sulfa and dyes. The patient is not pregnant at the time of the report. The patient does not have COVID prior vaccination. Concomitant medications included lisinopril taken for an unspecified indication, start and stop date were not reported; levothyroxine taken for an unspecified indication, start and stop date were not reported; calcium, ergocalciferol (CALCIUM +D) taken for an unspecified indication, start and stop date were not reported. On 18Mar2021 09:15 AM, the patient had dizziness, tingling in forehead, back of head, numbness on right side of face. The patient notified the staff. They suggested she wait an additional 5 minutes and take Benadryl when I got home. The patient took the Benadryl and slept all day and night. The next morning, 19Mar2021, the patient thought she was improving but by 12(noon), the numbness, tingling of face and head was back. Her blood pressure shot up to 163/100. She went to urgent care and they gave her Clonidine to bring blood pressure down. CT scan done and showed that the patient have arachnoid cyst on brain. The patient will be scheduled for MRI, MRA, and carotid artery ultrasound. She was given scripts; Clonidine and hydrochlorothiazide. The events arachnoid cyst on brain  and blood pressure shot up was assessed as serious, event caused hospitalization. The events involve emergency room visit. The outcome of the events was not recovered. Treatment was given for the events. The patient was not tested for COVID post vaccination.
Patient woke up with cold sores of mouth; This spontaneous case was reported by a consumer and describes the occurrence of ORAL HERPES (Patient woke up with cold sores of mouth) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included MAGNESIUM and VITAMIN D [VITAMIN D NOS] for an unknown indication.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, the patient experienced ORAL HERPES (Patient woke up with cold sores of mouth). The patient was treated with VALACICLOVIR HYDROCHLORIDE (VALTREX) on 28-Apr-2021 at a dose of 2000 milligram. At the time of the report, ORAL HERPES (Patient woke up with cold sores of mouth) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       2nd dose is scheduled today 28Apr2021 which patient states she plans to receive. Asking if there is a drug interaction between Valtrex and the Moderna COVID19 vaccine? Reports no other side effects since receiving first dose of Moderna COVID19 vaccine on 30Mar2021.
congestion; cough; itchy throat; chills; Fever; felt that she can't breath; felt tired; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (felt that she can't breath), NASAL CONGESTION (congestion), COUGH (cough), THROAT IRRITATION (itchy throat) and CHILLS (chills) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 23-Apr-2021 at 12:30 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021 at 2:30 PM, the patient experienced FATIGUE (felt tired). On 23-Apr-2021 at 9:00 PM, the patient experienced DYSPNOEA (felt that she can't breath). On 24-Apr-2021, the patient experienced NASAL CONGESTION (congestion), COUGH (cough), THROAT IRRITATION (itchy throat), CHILLS (chills) and PYREXIA (Fever). At the time of the report, DYSPNOEA (felt that she can't breath), NASAL CONGESTION (congestion), COUGH (cough), THROAT IRRITATION (itchy throat), CHILLS (chills), PYREXIA (Fever) and FATIGUE (felt tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was included Benadryl.
Woke up with hypersensitive abdomen to the touch, tiredness, painful right wrist (wrist frequently 'cracks' through out the day), very similar symptoms when I had covid a few months ago but w/o the sinus and pulmonary symptoms related to infection.
vomiting,  B/P- 151/98, P-62, blood sugar- 149
Information has been received from a certified medical assistant concerning a 74 year old female with no pertinent medical history, drug reactions or allergies who on 30-NOV-2007 was vaccinated into the left tricep with 0.5ml of Zostavax (Oka/Merck).  Concomitant therapy included alendronate sodium (MSD), atenolol, losartan potassium-HCTZ (MSD) and NORVASC.  On 30-NOV-2007 the patient developed an erythematous, zoster like rash at the injection site.  Medical attention was sought.  At the time of reporting the patient was recovering.  There were no diagnostic studies performed.  There was no product quality complaint.  Additional information has been requested.
This patient's mother stated her child started breaking out with chicken pox on 04/28/01. He had six in total pox, itchy. PPD is all that was listed.
Initially a small area of redness and warmth developed over the injection site. Within a few areas, the area grew in size to 10 x 9.5 cm with induration, warmth, and redness.  Minimal pain at site but pruruitic.  Applied ice, ibuprofen with increased redness at 36 hours past vaccine.
Cellulitis of left upper extremity started within 24 hours of receiving vaccine. Patient was seen by Dr  and prescribed cephalexin 500 mg by mouth three times daily for 10 days.
For several days following shot I had extreme Anxiety.  Never experienced anything like it before.    After a few days it passed.   However since that time I have experienced 2 more events -- the first several months after and the 2nd one just this week.    Its near debilitating when it occurs and I find it difficult to function as become myopic and highly stressed about trivial stuff that never bother me.
The patient given MODERNA as booster dose to J&J, felt dizzy 7 minutes later. Patient was given water.