chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information has been received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 20-DEC-2011, the patient was inoculated with ZOSTAVAX vaccine (lot number, dosage and route of administration not provided), at a pharmacy as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On or about 13-JUN-2016, the patient was treated by a physician at a medical center/clinic for a blistering vesicular outbreak, that was diagnosed as severe shingles. The patient was prescribed acyclovir for management of her painful symptoms. On or about 24-JUN-2016, the patient sought subsequent treatment from the medical center/clinic by the physician for the diagnosis of neuropathy a condition that stems from herpes zoster or shingles rash causing incessant pain. The patient was prescribed pregabalin (LYRICA) to relieve her painful symptoms and chronic pain. As a direct and proximate result of ZOSTAVAX vaccine, and or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. 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. The reporter considered the events to be related to ZOSTAVAX. The outcome of the events is unknown. Upon internal review, the event of neuropathy was determined to be a medically significant event.  Additional information has been requested.
Cellulitis at injection site. Treated with Rocephin 500 mg IM and Keflex 500mg a 4 times a day for 10 days.
This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 30-NOV-2015, the patient was vaccinated with improperly stored RECOMBIVAX HB (exposed to the following temperatures and cumulative time frames colder than 36F: In September of 2015, the coldest temperature was 34F for 346.7 hours (over 14 days); In October of 2015, the coldest temperature was 34F for 492.6 hours for a total of 839.3 hours (35 days); In November of 2015, the coldest temperature was 34F for 192 hours, for a total of 1,031.3 hours (43 days)) with lot number: L010595, expiry date: 12-NOV-2016 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Patient feeling light headed. Vital taken on patient while they rested on gurney. Declined further treatment.
Colleague is now COVID positive and ill with cold symptoms, fever, aches, cough, headache; Colleague is now COVID positive and ill with cold symptoms, fever, aches, cough, headache; This is a spontaneous report from a contactable Other Health Professional. A 30-year-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection), dose 1 intramuscular on 04Feb2021 (at the age of 29-year-old) (Batch/Lot Number: EL3247) as DOSE 1, SINGLE, dose 2 intramuscular on 25Feb2021 (Batch/Lot Number: EL3247) as DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. It was unknown if the patient was pregnant. It was unknown if the patient was pregnant at time of vaccination. The patient underwent lab tests and procedures which included COVID 19 test: positive on 12Sep2021. The patient was covid positive and ill with cold symptoms, fever, aches, cough, headache (vaccination failure and covid-19) (medically significant) on 15Sep2021. It was unknown if patient received treatment for events. Outcome of events were not recovered.   The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product bnt162b2 to the reported vaccination failure / COVID-19 cannot be ruled out.
A few minutes after the injection pt complained of her throat feeling tight. Pt was observed by the provider for 30 minutes with another set of vitals completed on her. No hives, no swelling. Pt felt fine and after being monitored for 30 minutes with no other reaction other than her throat tightness, which resolved before pt left the clinic, was release. Administration of vaccine was at 3:45 and pt was cleared and released at about 4:05pm.
Appendicitis symptoms; Acute stomach pain; This is a spontaneous report from a contactable consumer (patient). A 30-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 14Apr2021 13:15 (at the age of 30years) as single dose for Covid-19 immunization. There were no medical history and concomitant medications. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 16Apr2021 12:00PM, the patient experienced appendicitis symptoms and acute stomach pain. There was no treatment received for the adverse events. The patient has not been tested for COVID-19 since the vaccination. The outcome of events was not recovered.    Information about lot/batch number has been requested.
Family is noticing that patient is having seizure like jerking movements since being vaccinated and is in worse condition since the vaccine was given
Pt was given 0.25ml of Covid-19 Bivalent Booster instead of 0.50 ml
She got her vaccine, at home as  Public Health came and gave it to her, she was fine for 15 minutes, and she came upstairs and she started having a hard time swallowing and breathing.  She had experienced that before and stayed calm, and probably about an hour it passed.  She then she started feeling really weird and in a day she started having uncontrolled shaking, and put on a sweatshirt, coat and she continued to shake, and got under the covers and could not stop shaking with the chills.  She was then sick to her stomach and could hardly stand up, she has two broken feet and was not able to stand that lasted for about a week.  Every part of her was hurting and she was afraid to get up for fear of falling.  After a week the reaction started to subside and in the meantime she developed hives on the back of her legs and on her stomach.  The one on her stomach was so bad that it was the size of a grapefruit, and looked like she had been severely burnt, which is now basically just going away and has lasted for over a month.  It was next to the wound that has not closed from her previous surgery.   The blister was full of liquid which she left alone for it to heal on it's own.  She had a telehealth conference with her endocrinologist  who told her that she was not to get any vaccines of any kind.    Public Health did call her the day before the 2nd shot and she explained to the supervisor what had happened and she also informed her that they would not give it to her and not to get the 2nd vaccine or any other vaccines.   This supervisor was part of the team that was trying to get her to heal with the wound vac from her previous surgery.   She does not carry an Epi-Pen for any other allergic reactions.
Hospitalized 01/06/2022; COVID-19 positive 01/06/2022; fully vaccinated  BRIEF OVERVIEW: Discharge Provider:  Primary Care Provider: MD Admission Date: 1/6/2022 Discharge Date: Jan 15, 2022 DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: COVID-19 [U07.1]   HOSPITAL COURSE: Patient was admitted with intractable back pain due to compression fracture of her L3 vertebra. She was managed with opioids for pain control. PT/OT. Was evaluated by orthopedics team Dr., and due to her recent COVD19 infection, surgery is deferred to early February. No neurological deficits were noted at discharge, patient was stable to be discharged to home. Initially plan was to send to acute rehab, and insurance denied this.    COVID-19 infection. Asymptomatic from respiratory standpoint. Reinfection. No therapy provided.   S/P right lung transplant. No BOS. Previous ACR, DSA. Stable. Continue current home medications.
The patient experienced fever of 101 degrees; Chills; Body aches; Loss of appetite; Pain at the injection site; This is a spontaneous report from a contactable nurse (patient's mother) via a Pfizer sales representative. A 16-year-old male patient received meningococcal group b rlp2086 (TRUMENBA) and meningococcal vaccine a/c/y/w (manufacturer unknown), via an unspecified route of administration in arm on an unspecified date at a single dose for immunization. Medical history included ongoing asthma and patient has been taking medication for symptom control. The patient's concomitant medications were not reported. The patient was administered both meningococcal group b rlp2086 and meningococcal vaccine a/c/y/w at the same time in separate arms. The patient experienced fever of 101 degrees, chills, body aches, loss of appetite and pain at the injection site on an unknown date. Patient was otherwise normal and healthy. The events resolved on an unknown date after approximately 48 hours.  Information on the batch number has been requested.
Not sure if related but started having vertigo issues after 5/7 shot.  Started 5/29/22 and am still having them as of today (7/3/22).  The 1st 10 days were the most severe.  The dizziness is less acute but still present on a daily basis.
From initial information received on 7/13/04 from the patient's mother regarding an adverse event occurring in the USA, it was reported that a 29 year old male patient was bit by a wild cat and received a post-exposure IMOVAX RABIES vaccination, lot number W1419, and an IMOGAM USP HT, lot number W1367 (routes and sites of administration were not reported) on 2/26/04. Soon after the vaccinations (exact onset unknown), the patient began to not feel well and experienced nausea, vomiting, extreme fatigue, and a large weight gain. The patient gained approximately 60 pounds since February 2004. He was scheduled to see a doctor on 7/13/04. The patient's recovery status was not reported. From follow up phone call from a hospital pharmacist on 7/15/04, she stated that the reported adverse event was not due to the rabies vaccine or the rabies IMOGAM USP HT. She has agreed to fax the dates of all the rabies vaccine given. Patient did complete the series of five doses. From additional information received on 10/19/04 from a telephone contact with  the patient's mother, it was reported that the patient has not yet fully recovered from these events. No other information was provided at this time.
I?ve had four squamous cell carcinomas, one right lower arm, one right lower front leg, one lower left leg and one left upper arm. I?m reporting these as I?ve read squamous cells may be a side affect from moderna Covid vaccine. I?ve received two initial vaccines and two boosters with the following dates; 1/5/21, 2/2/21, 11/9/21 and 4/13/22.   I am reporting this as I?ve read squamous cell carcinoma may have a link to moderna Covid vaccine and boosters.
Next 2 days too weak to get out of bed.  Severe pain in all joints - arms legs, feet. Shortness of breath. Increase in colitis symptoms. Extreme increase in arthritis symptoms. 3 severe dizzy spells. Cardiologist doubled my cardiac medicine due to shortness of breath.
Pt received H1N1 vaccination on 12/02/09.  Pt states the following day she developed fine bumps on her foot.  On 12/04/09 the bumps traveled to her back and arms.  By 12/05/09 the bumps were also on her hands.  Pt was advised to make an appointment with her medical provider.  Her appointment is scheduled for 12/07/09.
90 minutes after receiving vaccine, mouth started tingling at 9pm took 2 Advil PM. At 10pm face started tingling and itching, then took 2 expired Benadryl. By 10:30 entire body was itching severely. No difficulty swallowing , breathing or tongue swelling. Applied 1% Hydrocortisone cream to back, arms, legs and face, then fell asleep. Upon waking at approx 8 am, felt only mild itching and skin tenderness. Felt fatigued all day.  No further medication was taken. Symptoms resolved by midday.
Numbness of Left hand with 2-3 minutes of injection. Completely resolved with 8-9 minutes of onset.
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 84-year-old female patient who received SHINGRIX for prophylaxis. On 3rd December 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 3rd December 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm and mobility decreased. On an unknown date, the outcome of the pain in arm was not recovered/not resolved and the outcome of the mobility decreased was unknown. It was unknown if the reporter considered the pain in arm and mobility decreased to be related to SHINGRIX. Additional information received as follows: This case was reported by the patient's daughter. The patient received SHINGRIX on the left arm. The patient experienced arm pain so much so that it was difficult to lift her arm. The reporter did not give consent to follow-up.
Pins and needles started seconds after the shot.  Started right where the shot went in, down my arm, around my neck to the other arm.  Within a few hours they were felt throughout my whole body. Itchiness all over. Trouble sleeping started that night.  As I was about to start a dream, my stomach muscles would spasm, then my heart would start pounding out of my chest, then a zap would shoot up to my head and my head, eyelids and eyes would vibrate.  Body vibrations were felt as well all over.  I would lay my head on my pillow and i could feel the vibrations throughout my head, shoulders, and body.  I also felt like my eyes couldn't focus together, like when you take your glasses off and it takes a few seconds for them to focus.  I did go to the Harrisburg Hospital the first night at about 3am in the morning, per my GP nurse line instructions.  The hospital did a gullian barre test on me and it was negative.  They told me that they thought I had a vitamin deficiency and sent me home, no other tests.  I went to my GP and tested for vitamin deficiency.  They said I was only slightly low in vitamin D.  I changed my vitamins and upped my dosage of D. These symptoms continued for a couple weeks but did start subsiding.  The being awakened as I started a dream continued sometimes but it was less dramatic.  The pins and needles started to subside.  Then I had an ear infection and was diagnosed with fluid behind my ear on September 27 I was diagnosed fluid in the ear.  I was given a strong steriod, Methylprednisone, and as soon as I took it, the pins and needles came back, as well as many other side effects because that is strong drug.  I have been off that drug for 5 days now and I was told that it stays in your system for a while so I don't know if some of the side affects I am feeling are from the steroid or the shot.  But  as of now, the vibrations are still in my body from time to time.  I do need a sleep aid at night.
She lost her hearing in just one ear within a month of getting her #2.  Within one month of getting #3 she started with shortness of breath and was diagnosed with cardiomyopathy, bilateral pulmonary embolism, pulmonary hypertension.
Presented to ED 7/2/2022 with increasing weakness, poor appetite, congestion.  Antibiotic therapy with IV zosyn, zithromax. Defer IV steroids as patient with no hypoxia. Admitted to Memorial hospital. Previously admitted to the hospital 6/22/2022. Febrile illness was noted without an infectious process identified. He was sent to rehab but has not been participating in rehab. He is increasingly weak and fatigued. Transferred to Hospice on 7/3/2022 and died there on 7/8/2022. Cause of death is listed as Pneumonia due to Covid-19. Submitter does not have access to full medical record. If further information is needed, please contact hospital and hospice records.
Muscle soreness at injection site, followed by body aches, headache, joint pain, chills and fever for about 16 hours
Inappropriate schedule of vaccine administered; Extreme armpit pain; extreme low back pain; headache; nausea; fever; chills; slight cough; extreme fatigue; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ep7533) via an unspecified route of administration in the right arm on 30Mar2021 at 15:00 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. Medical history included diabetes, obesity. The patient had known allergies to penicillin and cephalosporins. Concomitant medications included magnesium lactate (MANUFACTURER UNKNOWN), ibuprofen (MANUFACTURER UNKNOWN) and acetylsalicylic acid (ASPRIN) for unknown indication from an unspecified date. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Em9809) via an unspecified route of administration in the right arm on 12Mar2021 at 08:15 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 30Mar2021 at 20:00, the patient experienced extreme armpit pain, extreme low back pain, headache, nausea, fever, chills, slight cough and extreme fatigue. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the event. The clinical outcome of the event extreme armpit pain, extreme low back pain, headache, nausea, fever, chills, slight cough and extreme fatigue was resolving at the time of report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Two weeks after I received the vaccination my hair stylist noticed I had hair loss. She had not noticed this hair loss six weeks prior at my previous appointment. I went to see a dermatologist who prescribed a topical solution that I have been using on the patches where my hair is thinning.
Spoke with PUI caregiver who confirmed that PUI was discharged last night and brought back home by an Ambulance. Caregiver stated that PUI symptom onset was on 9/11 with chills and body aches. On 9/13 PUI complained of shortness of breath and was transported to the hospital. Patient is fully vaccinated.
Patient experienced a headache Tue evening of vaccine administration.  Headache was "tolerable" and went away by morning.
Vaqta was injected into the left arm.  Patient felt "immediate severe" pain with numbness in tingling in left, and then right arm and chest.  She went back to work.  About 1.5 hours after the vaccine was given, she was "white as a sheet" and felt like her "throat was closing."  She described difficulty swallowing and shortness of breath.  She was taken to the ED and treated with epinephrine 0.3mg IM, Benadryl IV, Solumedrol IV, and Pepcid IV.  She was prescribed an epineprhine autoinjector for home use and a Medrol dose pack.  She reports that she had "cold symptoms" with a sore throat, stuff nose, and "neck pain" for about two weeks after the vaccine was given.
Information has been received from a medical assistant referring to a 25 year old female patient with none drug reactions/allergies. The patient's medical history included 8 previous pregnancies with 4 elective abortions and 2 miscarriages. The patient became pregnant again with last menstrual period (LMP) of 17-DEC-2015 and expected delivery of date (EDD) of 22-SEP-2016. On 14-JAN-2016 the pregnant patient was vaccinated with GARDASIL (lot # K010215, expiration date: 05-MAY-2017, 0.5 ml, intramuscular). On the same day, HIV testing and obstetric panel were performed (result not provided). On 17-JAN-2016, the patient went to an unspecified emergency room, complaining of vaginal bleeding where she received a diagnosis of "impression: spontaneous abortion." The outcome of abortion spontaneous was reported as recovering/resolving. The causality was not reported. Upon internal review, spontaneous abortion was considered to be medically significant. Additional information has been requested.
Swelling; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Swelling) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SWELLING (Swelling). At the time of the report, SWELLING (Swelling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment information was provided.
On 4-9-98 pt recv vax; on 4-10-98 pt exp redness and swelling at the injection site and inguinal node tenderness.  Pt dx=abscess at the injection site.  Pt tx=Augmentin.
This spontaneous report as received from a Doctor of pharmacy refers to a 62 years old male patient with no pertinent medical history and no drug reactions or allergies. The patient was vaccinated with lot # (671452/1124AA expiration date 12-OCT-2012), with a 0.65 ml dose of ZOSTAVAX on 15-NOV-2011. No other co-suspects were reported. Concomitant medications included bupropion hydrochloride, magnesium oxide, potassium (unspecified), naproxen, trazodone hydrochloride, multivitamins, simvastatin (manufacturer unknown), gabapentin, vitamin D (unspecified), docusate sodium, CETRIZIN and ropinirole. The pharmacist reported that on approximately 28-JUN-2012, "about 2 - 4 weeks ago", the patient developed varicella - like rash. The patient had about 20-30 lesions, raised rash on his back and legs, which would blister, then form scabs and fell off over the time. No treatment information was given. There were no Lab diagnosis or studies performed. The patient sought unspecified medical attention. The outcome of varicella - like rash was reported as not recovered/not resolved. Additional information has been requested.