chrisvoncsefalvay/vaers-outcomes huggingface dataset:
It was reported the patient had COVID; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (It was reported the patient had COVID) in an 8-decade-old patient of an unknown gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (It was reported the patient had COVID). At the time of the report, COVID-19 (It was reported the patient had COVID) outcome was unknown. Not Provided          No concomitant medication information was provided. It was reported that a patient received 2 shots of an mRNA, either the MODERNA or PFIZER. Treatment information was not provided.  Company Comment: This spontaneous case concerns an  8 decade old  patient  of an unknown gender with no medical history reported , who experienced non-serious , unexpected , AESI of Covid 19 which occurred on an unknown date with vaccination with reported two doses of mRNA-1273 vaccine ( dose numbers and date of vaccination not reported ) . The details surrounding the events like treatment information , medical consultation or  if any laboratories /diagnostic procedures done were not reported. Outcome of the event is unknown. The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.; Sender's Comments: This spontaneous case concerns an  8 decade old  patient  of an unknown gender with no medical history reported , who experienced non-serious , unexpected , AESI of Covid 19 which occurred on an unknown date with vaccination with reported two doses of mRNA-1273 vaccine ( dose numbers and date of vaccination not reported ) . The details surrounding the events like treatment information , medical consultation or  if any laboratories /diagnostic procedures done were not reported. Outcome of the event is unknown. The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.
Patient is 29-year-old male who presents with a headache. Two days ago he had typhoid and anthrax vaccines. Later on that evening he developed headache, arthralgias, nausea, myalgias, photophobia, and intermittent difficulty breathing. He was seen in this emergency department and had a negative chest x-ray, negative CT, negative BMP, and normal CBC. He was given IV fluids and TORADOL with some improvement in his symptoms, today he was seen by the doctor and a chest x-ray was repeated which was negative. He also had negative labs note is unclear as to what those labs were. He was given XANAX and VICODIN. His symptoms did not improve he presents tonight. He was unable to take the VICODIN due to vomiting.
Increased heart rate, back of throat swelling (minor), dizziness, itching, felt flush, felt as if my body was buzzing-rushing, could not concentrate, felt as if I was going to faint, later my legs felt 3xs their size.   Took Benadryl.
Irregular period; Heavy bleeding; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0167) via an unspecified route of administration in the right arm on 29Apr2021 at 15:00 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to tree nuts, shellfish, soy and bees. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included bupropion hydrochloride (WELLBUTRIN) for an unknown indication, since an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8437) via an unspecified route of administration in the right arm on 01Apr2021 at 15:00 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 19May2021, the patient experienced irregular period. The patient always had a regular cycle prior to the vaccine and also reported heavy bleeding, sometimes occurring twice a month. The events did not result in doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken for the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events irregular period and heavy bleeding, sometimes twice a month was not resolved at the time of this report.
EXTRACTION OF MODERNA VACCINE FROM THE VIAL WAS NOT CONSISTENT WITH A MODERNA TECHNIQUE I.E. MORE THAN 20 DOSES WERE DRAWN FROM THE VIAL.
Tenderness, swelling, itching, heat rash in irregular shape over area of vaccination started 2/4/21 at 6 PM, slightly improved on 2/5/21.
This spontaneous report as received from a nurse regarding an unspecified number of patients of unknown age. There was no information about concurrent condition and historical medication. On 20-AUG-2015, the patients were vaccinated with improperly stored MMR II lot # J013316, expiration date 22-OCT-2015 and lot # K005175, expiration date 10-APR-2016. No concomitant medication was reported. No adverse event was reported. No PQC (product quality complaint) was involved. The outcome of the event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Approximately 3 days after shot I started having shortness of breath. This progressed into coughing fits while laying down and feeling a tightness in chest. And irregular heat beat.
After returning home from receiving influenza shot. Asthma attack - visit to hospital ER. Flu shot received 8/19/11.
5-4-10 DTAP #4 (L) arm -> fever and lethargy within 2hrs -> hives 24 hours later. No illness. 5-7-10 - Exam -> Urticaria trunk, limbs, palms, and soles. Remainder of exam benign. Treatment: BENADRYL, Topical HYDROCORTISONE cream.
Had trouble breathing right after vaccine and they kept me for 45 mins until I started feeling better. When I got home I started having pain in injection site that spread to my upper arm, shoulder and neck that hasn't gone away. I had fever, sore throat, sick to stomach that lasted 3 weeks.
The patient had a significant exposure after 2nd Pfizer vaccine, she developed mild symptoms and tested positive for COVID 19 on 2/23/21.
1/12/21 er HPI: HPI 78 y.o. female who presents with pain swelling and redness left wrist and hand associated with  fever according to EMS, but temperature in the ER is 98.4° F. patient was said to have fallen on 1/7/2021.  *incidental finding bacterial pne*   1/12/21 admission History: The patient is a 78 y.o. female with a past medical history notable for  Dementia, atrial fibrillation, CHF, diabetes, reflux. The patient presents for evaluation of  Worsening issues of decline and trouble with breathing. Patient was evaluated the ER and found to have a urinary tract infection in addition to pneumonia. Due to patient's dementia history is difficult to take outside of history of which was taken for patient's nursing staff at skilled care facility. Patient's past medical history, past surgical history, social history, family history, medications allergies were reviewed
Incorrect product storage; No additional AE; Nurse reporting patient administered PROQUAD and VARIVAX instead of MMRII.; overdose; This spontaneous report was received from a nurse, concerning to a patient of unknown age and gender.   The patient's medical history, concomitant therapies and concurrent conditions were not provided.  On 22-APR-2022, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD)  lot #W004694 has been verified to be a valid lot, expiration date 08-AUG-2023, administered for prophylaxis (strength, dose, route of administration  and anatomical location were not provided), and  varicella virus vaccine live (oka/merck) (VARIVAX) for prophylaxis (strength, dose, route of administration, anatomical location, lot# and expiration date were not provided)  instead of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (wrong product administered, overdose). No additional adverse event were reported. The temperature was from 14 to 46  Fahrenheit  (also reported as -10 centigrade up to 8 centigrade), in addition the temperature was measured as 40 F for 120 hours. (product storage error).   .
Pt called to report that shortly after his vaccination, he started to have pain in his hip which had been operated on in May 2018. He had not previously felt pain in his hip consistently since the time immediately following the surgery. Patient is contacting his physician regarding further actions.
Urticarial rash started 4 days after administration of pneumovax. Rash started on forearms then spread to trunk ant/post, back of legs, face, palms and soles, wheezing. Patient also had flu shot 11/5/2001. (8 days before rash.)
Information has been received from a licensed practical nurse concerning a child who on an unspecified date was vaccinated with Varivax. It was reported that approximately 20 days following the vaccination the child developed a generalized rash. Unspecified medical attention was sought. At the time of this report, the outcome of the rash was unknown. Additional information has been requested.
Presented with ams and seizures.  Incidental Covid positive. Developed Covid PNA later.  Treated with abx.  D/C back to Facility..
This case was reported by a nurse and described an adult male patient who did not respond to the hepatitis B vaccine recombinant (Engerix-B) immunization series.  The nurse stated there were two patients; however, no patient identifiers were provided.  The patient's medical history, concurrent conditions and concurrent medications were not reported.  On unspecified dates the patient received 3 doses of Engerix B (lot ENG5540A2).   The patient inadvertently received the pediatric dosage for all 3 injections.  On an unspecified date approximately six weeks later, a hepatitis B surface antibody titer was negative.  The nurse stated that the immunization series was to be repeated.
This was my COVID booster shot. Vertigo started on the morning after the shot. My PC prescribed  Meclizine and sent me to Physical Therapy. The Vertigo started after my initial shot 2/1/2021 and I ended up in the ER. The Vertigo was on again off again through early November 2021 I had no Vertigo for 3 week and after getting the booster on 12/2 3021 it came back. This is my 2nd report regarding Vertigo from the COVID shot.
Medical facility was contacted by another agency for vaccinating a patient under 12 years old.  Contacting agency has this same patient with a different date of birth. This patient only came to this medical facility for Pfizer Covid vaccination on 9/1/2021. Our registration records show a different birthdate was written in as the birthdate and consent for vaccination was signed by patients parent. Contacting agency is sure that patient has a different birthdate based on their own records.
Patient was administered a Moderna Covid-19 Vaccine second dose from a vial that was unpunctured for more than 24 hours.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient was administered a Moderna Covid-19 Vaccine second dose from a vial that was unpunctured for more than 24 hours.) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 053C21A and 005C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient was administered a Moderna Covid-19 Vaccine second dose from a vial that was unpunctured for more than 24 hours.). On 15-Jun-2021, EXPIRED PRODUCT ADMINISTERED (patient was administered a Moderna Covid-19 Vaccine second dose from a vial that was unpunctured for more than 24 hours.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided. No relevant concomitant medications was reported.
One full week after vaccination (4/22), an allergic reaction occurred at the vaccination site on the left upper arm, including swelling, heat, hives, and itching occurred; a large red mark encompassed the shot site and the hive welt. One welt, approximately four inches in diameter covered the site; on top of that welt were smaller individual hives. Benadryl was taken immediately. Swelling, heat, and skin irritation remained through the next two days (4/23-24) and another Benadryl dose.  Swelling has subsided (4/25), but the red mark expanded, following the contour of the tricep. Skin irritation and itchiness remain.
Seen in Hospital Emergency Room on 7/25/10 for an itchy rash on posterior arms and back and no constitutional symptoms. Skin exam described as consistent with chicken pox pruritic crops of vesiculopustular lesions on erythematous base in various stages of healing with classic varicella eruption per doctors note.
On 4/7/2021 the patient came into pharmacy to receive her second dose and checked "Yes" to the question of: Have you ever had an allergic reaction to a previous COVID-19 vaccine or any component of the COVID-19 vaccine, including polyethylene glycol (PEG) or polysorbate?  I asked the patient what her reaction to the vaccine was and she told me she experienced throat swelling and facial swelling and took a Benadryl that day.  4/7/2021 was the first the pharmacy was alerted by this patient that she experienced this allergy or any side effects from her dose 1 of the vaccine.
Left ear felt partly plugged and mild vertigo started 5 days after the shot.  I saw an ENT on day 10, who prescribed prednisone (40 mg tapered).  It didn't help, and may have caused an episode of BPPV which started day 11, one day after I started the prednisone.  I was able to reverse the BPPV at home using the Epley maneuver.  I still feel un-balanced and as if my brain and skull move at different times.   This symptom occurred with my first two shots, but I didn't report it.  The vertigo lasted 3 weeks in each of the prior instances.
This spontaneous report has been received from a nurse practitioner regarding a patient of unknown age or gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. The patient was vaccinated with improperly stored VARIVAX dose number 1 on 10-DEC-2013 and dose number 2 on 16-JAN-2014, both from lot # H018451 with expiry date of 09-OCT-2014 (dose unknown). No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review of records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. This is one of the several reports received from the same reporter. Additional information has been requested.
Developed shingles (herpes zoster); painful rash to nose, lateral to right eye.
17-year old pregnant female received Moderna covid - 19 vaccine. No adverse reaction reported so far.
Have had joint pain and fatigue since the vaccine 2nd dose. More so in the right elbow than other joints. Wrists, elbows, hip, ankle joints pain. Getting tired very quickly when trying to workout though I worked out 4-5 days a week up until the 2nd vaccine dose.
Roughly 12 hours following my first dose my left arm became very sore and difficult/uncomfortable to lift or move.  At about 15 hours following the dose (2:30am on 9/12/2021) I woke up with: rigors (shivering, feeling cold, copious sweating), fever of 101.8F,  nausea, vomiting, retching that lasted 16 hours, subsiding around 6:00-7:00pm on 9/12/2021. During that time I also had intense muscle spasms/contractures in bilateral lower extremities that lasted for about six hours beginning around 02:30am on 9/12/2021. I also experienced significant changes in my smell and taste that lasted roughly 3 days. Within a week of getting the vaccine my hair began to fall out from the root at about a couple handfuls per day. My hair fell out at this rate for 3-4 weeks and began slightly improving up until the time i received my second dose of vaccine at which time the hair loss returned to falling out at handfuls a day and at this time has not resolved or improved.
Information has been received from the registered nurse on 02-JAN-2014. It was reported that GARDASIL vaccines were stored in improper temperatures and were administered to overall number of 132 patients. This report refers to one of the patients involved: a patient of unspecified age and gender, who was administered dose of GARDASIL (dose and route unknown) on 17-JUL-2013, lot # H021608 expiration date: 13-AUG-2015). No adverse event was reported. This is one of the report from the same source. Additional information is not expected.
Massive swelling and redness at the injection site, very painful and hot to the touch starting a few hours post injection and lasting through 05/03/2021.  Additionally, I had severe nausea, body aches and headaches on the 4/29.  I have continued to have severe headaches and body aches since the injection (today is the 9th day) as well as a dry, hacky cough.
Patient is an 89 year old male with PMH of HTN, MI, hypothyroid, HLD, GERD, CAD s/p stents x4 and PPM who presents to the ED from the nursing home with respiratory distress. Patient opens eyes to verbal stimuli but is not answering questions. History is obtained from the ED record. As per ED record, patient was 88% on RA, was placed on 10L/min at the facility and arrived in the ED on NRB with O2 sat of 96%.  In the ED, BUN 80, Cr 4.8, GFR 12, Na 148, K 5.8, Cl 116, AST 78, ALT 70, BNP 385. Rectal temp 93.7. Rapid covid test is positive. Flu is negative. CXR shows bilateral patchy infiltrates c/w Covid, can not exclude effusion. Patient is found to have body jerking, and is thought to be being shocked by ACD with possible torsades. Nursing home was contacted and it was noted that patient has a PPM but no ACD. EKG shows baseline artifact w/ atrial pacing with delayed ventricular contraction. Dr was consulted and patient was started on Amiodarone drip.
Woke up an 08/19 with erythema, warm, swelling of inject site left thigh. Already taken Keflex for impetigo of face, Recommended Benadryl and cold compresses.
This case is linked with case; 2013-05765 and case number: 2013-06246 (reported by the same reporter) Initial misuse report received from a healthcare professional on 24 April 2013. An adult patient was given DAPTACEL instead of ADACEL. (No more information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
I'm 32 years old. Before I put this vaccine I was active.  I walked 6 miles a day at my job.  Ever since I put this vaccine I cant stand for periods at a time because of the constant pain in my legs my doctor has told me  its Peripheral neuropathy. The get so cold and the pain kicks in after.  I'm now talking Gabapentin 300 mg twice a day . This medication make me sleep for 12 hours straight.  I feel like I'm now 60 years old with all this pain and it's not going  away.  Please fix this horrible vaccine.  I have had all my vaccines before this one and have never had a reaction like I'm having with this vaccine.  Its horrible.  Fix it.
This is in follow-up to report (s) previously submitted on 9/24/2008. Information has been received from a 66 year old male with no allergies who on 18-AUG-2008, 2 days ago, was vaccinated with ZOSTAVAX (Oka/Merck) 0.65 ml (lot # not reported). Concomitant therapy included atenolol. On 19-AUG-2008 the patient experienced rash from elbow to wrist and behind his knees after vaccination. The patient's rash from elbow to wrist and behind his knees persisted. The patient sought medical attention. Additional information has been requested. Information has been received from a 66 year old male with hypertension, Chronic obstructive pulmonary disease, a history of chickenpox and drug allergies to CELEBREX and CLONAPIN who on 18-AUG-2008, 2 days ago, was vaccinated with ZOSTAVAX vaccine (Oka/Merck) 0.65 ml (lot # 658867/1413U) SC in left arm. Concomitant therapy included atenolol. On 19-AUG-2008 the patient experienced rash from elbow to wrist and behind his knees within 24 hours of vaccination. There was no recent exposure to chickenpox. The patient's rash from elbow to wrist and behing his knees persisted. The patient sought medical attention. Additional information has been requested.
Modern a COVID-19 Vaccine EUA I was given the injection last Monday and noted erythema itchiness and swelling to the site and I figured I?d keep an eye on it. Also I had been enrolled in the v-safe with the CDC so I felt if there was ever a red flag, that they would be aware. After about 2 days it seemed better but then on 1/4/2021 I noticed it was itchy  again and I saw that I had a couple of blisters but they did go away after a hour. I now have the erythema, itchiness and a very hard (bigger than a half dollar) area surrounding the injection site.  Today is day two of having this and no swelling noted in my axilla or lymph nodes. No fever.
pt recv vax 21JAN99 11AM & felt dizzy, sweat, BP 110/60;comfort measures given;