chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a physician refers to a 2 years old patient of unknown gender with allergy to lidocaine, prilocaine (EMLA) cream allergy and contact dermatitis. The patient was vaccinated with dose 1 MMR II (lot #, dose and route not reported) on 09-JUN-2009. No other co-suspects were reported. Concomitant medications included prednisone (manufacturer unknown), sulfamethoxazole, BACTRIM, methotrexate, mercaptopurine, amoxicillin, AUGMENTIN and PREVACID. The physician reported that the patient had a collapsed lung on an unspecified date and was then diagnosed with Lymphoclastic Leukemia on 26-APR-2011 and was currently on chemotherapy. The patient under his care who received a single dose of MMR II at one year of age was now presenting to his practice with "classic symptoms of Mumps." He reports that the patient had enlarged parotid glands and elevated Amylase levels. The patient received MMR II at another physician's practice, so he did not have the lot number. At the time of the report, the patient was currently in the physician's practice and was not recovered. The outcome of collapsed lung was unknown. The relatedness for the reported events was not provided for MMR II. Upon internal review, the event of lymphoblastic leukaemia was considered medically significant. Additional information has been requested.
Mom calling today to report that on 3/25/09 bright red lump appeared on left leg where she received vaccines at 1yr wcc 3/6/09. No warmth, dime sized with tiny whole in center. No discomfort. Mom reports needle came out of skin and nurse reinserted needle.
Headache booster; Joint pain booster; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache booster) and ARTHRALGIA (Joint pain booster) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 vaccination.     Concurrent medical conditions included Lyme disease and Central nervous system inflammation (Central nervous system inflammation syndrome).   On 03-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Sep-2021, the patient experienced HEADACHE (Headache booster) and ARTHRALGIA (Joint pain booster). On 04-Sep-2021, HEADACHE (Headache booster) and ARTHRALGIA (Joint pain booster) had resolved.            Patient stated that the symptoms subsided in the night of the 4-Sep-2021.   Patient did not took Tylenol that was prescribed by a pharmacist.   This case was linked to MOD-2021-308000 (Patient Link).
sleepiness; exhaustion; fever (102F); vomiting; Bad Headache; Very sick; Nauseous; muscle problems; This is a spontaneous report from a contactable consumer and Medical Information Team . This consumer reported for a 69-year-old male patient (husband) . This 69-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: GM9810 and expiry date unknown, Solution for injection), via an unknown route on 03Feb2021 (at the age of 69-years-old) at single dose arm for COVID-19 immunization. The patient received both doses of the vaccine. The patient experienced no symptoms up until last night of 08Feb2021. The patient also had sleepiness, exhaustion, muscle problems, vomiting, and fever (102F). So, that 6days ago and he was tired nothing major. On 09Feb2021,the patient started getting very tired and he slept up until about 03:00 in the morning while he got up the patient was nauseous, very sick ,very high fever 102 F fever and bad headache. Treatment with paracetamol (Tylenol) was initiated. Outcome of the events sleepiness, exhaustion, muscle problems, vomiting, Nauseous, Bad Headache and Very sick was unknown. The action taken in response to the event(s) for BNT162B2 was not applicable.
headache; back pain; This is a spontaneous report received from a contactable reporter(s) (Physician) for a Pfizer sponsored program.  A 62 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "headache"; BACK PAIN (non-serious), outcome "unknown", described as "back pain".  Additional information: Enrolment form states, " Diagnosis: Adenocarcinoma of the lung T3 with involvement of the pericardium, N3 with involvement of the mediastinum, M1b with distant spread and a malignant pericardial effusion, stage IV. EGFR mutation negative. ALK positive 80% rearranged.; This patient's CEA continues to go up. She's having symptoms. She's having headaches. She has some back pain. However, this could also be related to the fact that she got the COVID vaccine because it all started when she got the COVID vaccine. "Suspect product(s) (provide Name / Indication/Dosage/Start and Stop date where possible): Lorbrena / C34.32 / 100 mg.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Extreme muscle soreness at site of injection on upper left shoulder. The pain has lasted over one week and has not yet totally subsided. My left arm is almost immobile, but it is gradually improving.
she caught COVID and is fully vaccinated; she caught COVID and is fully vaccinated; This is a spontaneous report received from non-contactable reporter(s) (Other HCP).  A child female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "she caught COVID and is fully vaccinated". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the available reported information, the causal association between the events drug ineffective and covid-19 and the suspect drug BNT162B2 cannot be excluded.
Information has been received from a medical assistant and a physician concerning a 25 year old female patient who in approximately September 2008, was vaccinated with her second dose of GARDASIL (Lot not provided).  Following the vaccination the patient experienced tingling from her elbow to her pinky intermittently (off and on for several months).  As of 19-DEC-2008 the patient's symptoms persisted.  Additional information has been requested. Follow up information received from the physician concerning the female patient (weight 173 pounds, height 68 inches) who in July 2008, was vaccinated with the second dose of GARDASIL (lot # 660387/1967U). In July 2008, the patient experienced numbness in injection arm, joint pain in elbow and joint pain in knuckles and tingling from her elbow to her pinky. As of December 2008 the patient recovered. Additional information is ot expected,
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. Information regarding the patient's past medical history, concurrent conditions, or concomitant medication was not provided. The patient was inoculated with ZOSTAVAX (lot number, dosage, and route of administration not provided) on or about 11-JUN-2014, at a medical group as recommended for routine adult health maintenance for the prevention of shingles. It was reported that the ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent and chronic strain of herpes zoster. On or about 08-JUL-2016, the patient was treated by a physician for a blistering ocular outbreak which was diagnosed as severe herpes zoster, or shingles. The patient has been prescribed VALTREX to attempt to manage and relieve her 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. Upon internal review, ophthalmic herpes zoster was considered medically significant. Additional information has been requested.
This case was reported by a nurse and described the occurrence of swelling in a child male patient who received ENGERIX B (batch number 7CL99, expiry date 2nd April 2016). In September 2014, the patient received the 2nd dose of ENGERIX B. On an unknown date, unknown after receiving ENGERIX B, the patient experienced swelling. On an unknown date, the outcome of the swelling was unknown. It was unknown if the reporter considered the swelling to be related to ENGERIX B. Additional information received: The nurse reported that the mother stated that the child developed swelling after receiving the ENGERIX-B vaccines.
No Adverse event - Pt is doing completely fine and talk to mother at 9.30am 3/20/21
Information has been received from a registered nurse (RN) concerning a 12-month-old male with a penicillin allergy, a history of reactive airway disorder and sinusitis, who on 16-NOV-1999 was vaccinated intramuscularly, instead of subcutaneously, with a 0.5 milliliter dose of varicella virus vaccine live (Oka/Merck). There was no concomitant medication. On the morning of 19-JUN-2007, at the age of 8, the patient experienced 50-75 chicken pox lesions. He was treated with diphenhydramine hydrochloride (BENADRYL) as needed. There were no laboratory or diagnostic tests performed. The outcome for the chicken pox is reported as not recovered. No product complaint was involved. Follow-up information received indicated that the vaccination did not occur at the current physician's office. The patient developed 50-75 lesions on the abdomen, chest and back. The patient weighed 73 pounds. Treatment also included sarna lotion. On 30-Jun-2007 the patient recovered. Additional information is not expected.
Patient received the Pfizer COVID-19 vaccine on 1/20/21 and 2/10/21 so was fully vaccinated when they tested positive for COVID-19 on 9/1/21.
Left acute brachial plexus neuritis. Severe left-sided neck, shoulder and arm pain for about 6 days, progressing to left hand, arm, and shoulder muscle weakness.
A female patient developed swelling and itchiness of the tongue, body ache, blurred vision, dizziness, nausea, chest pain and myalgia while receiving RabAvert.  The second dose of RabAvert, 1ml, was administered on 07/29/2004.  Past medical history and concomitant medication were not specified. After the first RabAvert dose, the patient stated her tongue felt itchy and swollen.  Benadryl was taken with relief of symptoms.  Later that evening, she complained of feeling achy.  She developed blurred vision, which improved but was present at the time of this report.  After the second RabAvert dose on 07/29/2004, she experienced a strange feeling of her head, dizziness, nausea, chest pain and muscle pain.  The muscle pains were persisting at the time of this report.
Swelling and redness at site, gradually increased in size to over 3", lasting 3 days.  Arm was unable to be touched and itched for most of the 3 days.   Eyes- unable to move eyes without pain, pain was worse in left eye and lasted 3 days. Right eye improved after 2 days.  Pain was a stabbing pain.
My left arm where the shot was administered, my underarm developed a huge swollen lymph node that lasted for about 4 days before the swelling went down.
Patient presented to clinic requesting an additional booster with a card indicating 2 primary doses on 8/26/21  and 10/20/21. After shot given was noted she actually had primary doses on 2/16/21 and 3/17/21, and then boosters on 8/26/21 and 10/20/21 so vaccine given on 4/14/22 is not valid. She is not moderately or severely immune compromised. Advised her that she was not eligible for the booster today as currently there is only approval for her for 2 primary and 2 boosters. She thought she was based on her age and the recent approval for an additional booster for those over age of 50.
This spontaneous report as received from a registered nurse refers to a 3-year-old female patient. The patient's medical history included being very behind on immunizations. On 23-FEB-2015 and 19-FEB-2016, the patient received an unspecified hepatitis B vaccination. Additionally, on 19-FEB-2016, she received unspecified medication reported as "PENTACIL" and unspecified rotavirus and pneumococcal vaccines as well. On 19-MAR-2019, the patient was vaccinated with third dose of (Thimerosal Free) RECOMBIVAX HB injection, lot # R021370 with expiration date of 07-NOV-2020, 0.5 milliliter (dose also reported as 0.5 mgl) (route of administration and vaccination site were not provided), to immunize against hepatitis B and with a dose of PEDIARIX (dose, route of administration, vaccination site, lot # and expiration date were not provided) as prophylaxis. The patient accidentally received both suspect vaccines together. No adverse event was reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1903USA010012: US-009507513-1903USA010026.
on 10AUG92 visited ER @ 2105 hrs; pt had been crying inconsolably for past hr or so; pt had a cough for the past 2 wks, no fever, no chills, no nausea or vomiting; tenderness around inject site; t101.3;
Intense pain at injection site!! Malaise, fever to 102 debility > 24 hrs.
Chills Fever Max Recorded 101.4 Heart Rate Max 122 average 111-115 bpm at rest Nausea Extreme Fatigue Slept 16 hours the first day Lack of appetite 2 days NO TREATMENT OTHER THAN DR OFFICE RECOMMENDED TYLENOL
sore left injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore left injection site arm) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-May-2021, the patient experienced VACCINATION SITE PAIN (sore left injection site arm). At the time of the report, VACCINATION SITE PAIN (sore left injection site arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment information was not provided by the reporter.   This case was linked to MOD-2021-354394.
Received first dose of Pfizer COVID vaccine on 3/24. Positive with COVID on 3/31. Hospitalized for COVID on later date.
AFTER PATIENT GIVEN THE SHOT SHE REPORTED ITCHING  AFTER HER FIRST VACCINE IN NOVEMBER, BUT DID NOT REGISTER  THAT IT WAS VACCINE RELATED UNTIL SHE GOT HOME WHEN HER THROAT STARTED TO FEEL FUNNY. SHE REPORTS THAT SHE TOOK BENADRYL AND IT HELPED HER. THIS WAS REPORTED TO LPN AFTER SECOND VACCINE WAS GIVEN. LPN HAD PATIENT WAIT FOR 30 MINUTES IN OFFICE WITH HER. AT APPROXIMATELY 0940- PATIENT REPORTS ITCHING ALL OVER HER UPPER EXTREMITIES, DENIES TROUBLE BREATHING OR HER THROAT FEELING FUNNY AT THIS TIME. BENADRYL 2ML ADMINISTERED TO PATIENT IN RIGHT ARM BY RN AT 0947.  PATIENT DENIES TROUBLE BREATHING, THROAT SWELLING, NO HIVES OR RASH NOTED. PATIENT JUST REPORTS ITCHING ONLY TO UPPER EXTREMITIES. AT 1005 PATIENT STATES ITCHING IS GETTING BETTER AND SHE FEELS BETTER SINCE THE BENADRYL INJECTION AND PATIENT LEAVES THE CLINIC.
vision loss; Severe Migraine over her right eye; blurriness, can't see out of right eye, very blurry was reported as worsened; Body Aches; Nausea; Chills; This is a spontaneous report from a contactable consumer (patient herself). A 69-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), batch lot number unknown, on 22Mar2021 at 09:15 (at the age of 69-year old) at single dose for COVID-19 Immunization. Relevant medical history was not reported. The patient received first dose of the same vaccine on 01Mar2021, on the left arm. Caller states that she has usually gotten sick with the flu shot. Concomitant medications were not reported. On 22Mar2021 the patient experienced chills. On 23Mar2021 the patient experienced nausea, body aches and severe migraine over her right eye and vision loss. She stated that when she covered her good eye she could not see the couch due to blurriness in the right eye. The patient was treated with ibuprofen and acetaminophen (TYLENOL), used hot packs, cold packs and a hot water bottle.The patient recovered from chills on 23Mar2021, she was recovering from nausea and body aches but was not recovered from severe migraine over right eye and can't see out of right eye, very blurry (reported as worsened).     Information about lot/batch number has been requested.
Starting feeling extremely nauseated 20 minutes after receiving vaccine. My right arm(lower) became itchy and red about 9:45am. I went to see Nurse to ask if symptoms were normal at 10am. I began vomiting and getting dizzy while talking the nurse. 10:05 am I was driven by friend to ER at 10:30am. Was seen by emergency room physician at 11am. My temperature was 99.15, dizzy, nauseated, rash on lower right arm and extreme need to urinate while at Hospital. I was given a shot in my left hip to counter act the Flu vaccine. I was observed for about 2-3 hours. I became clear minded and some what normal after 3 hours. I was given a prescription and order for bed rest for 24hours. After 24hours I felt back to my normal self, except continued bowel irritation and a cyst found(small) on my left shoulder where shot was given, and frequent need to go to the restroom to urinate.
Systemic: Patient feels numb and tingley on the face and lip and travel to arms then leg-Mild, Systemic: Numbness (specify: facial area, extremities)-Mild, Additional Details: pt said she feels numbness and tingly on face then migrated to lip. once that goes away it moved to her leg
Numbness in limbs, constant pressure headache, brain fog, unable to concentrate, achy arms and legs, muscle weakness, pins and needles sensation in hands and feet, extreme fatigue. Still ongoing more than a month after first shot, the symptoms had a slow onset. Prior to the first shot, was living an active lifestyle and maintaining fitness. Now, the symptoms have become debilitating and extremely frustrating.
Patient had reported facial rash approximately 1 hour after her first vaccine, resolving after <24 hours.  No other symptoms to suggest serious allergic reaction and no reported h/o other serious allergic reaction in past.  She was pretreated with 25 mg oral diphenhydramine before her 2nd vaccine dose and placed in the 30 minute observation area.  She developed sensation of tongue swelling just over 20 minutes after vaccine dose and was brought to medical tent. Vitals were within normal limits.  She was not in distress.  She continued to complain of tongue swelling.  No difficulty breathing or swallowing, no rash or nausea. Epi-pen was administered as well as additional diphenhydramine 25 mg. Medics called.  Repeat vitals stable. She improved after epi-pen but subsequently developed complaint of throat tightness and was noted to have mild facial flushing approximately 15 minutes later, therefore a second epi-pen was administered. Medics arrived shortly thereafter and she was transferred to hospital. During her observation period she disclosed that she had had a serious reaction to Sulfa in childhood but was not sure what it was.  She had not previously disclosed this.
Patient received dose #2 of Pfizer vaccine on 6/10/2021 @ clinic and was notified by email that vial was left in freezer past recommended time frame. Medication expired beyond its freezer allowable date. Email recommended patient get re-vaccinated with dose again. Affiliated Physicians re-administered dose on 6/12/2021 as recommended. No adverse reactions identified on site.
father of patient scheduled the faxing for patient with the wrong  date of birth 10/31/2008 instead 10/31/2010. Per father, he mixed up birthdates for his two sons and as a result patient was administered adult Pfizer dose of 0.3ml instead of pediatric Pfizer dose of 0.2ml. Wrong vaccine. Patient was doing good after 15 minutes of monitoring and a follow up call on 11/07/2021 with his Father.
07/09/2022 I had a headache off and on a few days before that. When I got up I had a headache and throughout the day I had an almost sore throat and body aches. I had no will to do anything but sit around. I took a home COVID test and it was positive. On 7/13/2022, I went to the my doctor's office and tested positive for COVID. I had been taking MUCINEX and TYLENOL for my symptoms, so my doctor did not have me do anything else. I have not recovered, but I am a little better.
Passed out, complete loss of consciousness for over a minute, loss of control of bodily functions, occurred while driving home.
Assessment and Plan   Patient is a 83 y.o. male patient of DO with history of alternating esotropia, anemia, A. fib, BPH, cardiomyopathy, COPD, GERD, hypertension, hyperlipidemia, hypothyroidism, OA, valvular disease presented to Hospital with shortness of breath.   Acute hypoxia with respiratory failure Acute COPD exacerbation Secondary to COVID-19 infection Cough for 4 days, shortness of breath started today Evaluate for home O2 Discharge on decadron and azithromycin   Covid-19 Virus Infection Date of onset of symptoms: 11/20/22 Symptoms present on admission: Cough and shortness of breath Date of covid positive test: 11/24/22 Vaccination status: vaccinated Imaging: CXR-nonacute Oxygen requirements on admission: 2 L Current oxygen requirements: 2L Medical therapy: remdesivir, steroids, and zithromax Consultants following: None Anticipated special isolation end date: 11/30/22 Inflammatory labs WNL Discharge home with oxygen   Multiple myeloma Diagnosed July 2022 Follows with Dr. Continue home Revmilid, acyclovir, Bactrim   Thrombocytopenia Likely related to multiple myeloma and COVID infection No gross bleeding Monitor CBC Count now 84 Follow up outpatient with oncology   Chronic anemia Hgb 12.9 Baseline around 13 No gross bleeding Monitor CBC Atrial fibrillation Continue home Cardizem, metoprolol and Coumadin, ASA INR 2.5 Goal INR 2-3     Hypothyroidism Continue home Synthroid   Hyperlipidemia Continue home statin   BPH Continue home dutasteride   Hypertension Mild hypertension on admission Continue home metoprolol, Lasix   Tobacco abuse Advised on smoking cessation
pt recv vax 6FEB97 & 1hr later pt devel severe flu-like sx, dizziness, fatigue, fever, malaise & chills;most sx persisted for 2 to 3 days but the flu like sx persisted for about 1.5wk;
A Pfizer (adult) covid vaccine was administered from the vial 2 hours beyond the 6 hour time frame.  Per Pfizer, their studies have been conducted up to 18 hours beyond this window so we were within the time frame where the conditions were maintained. Pfizer did not recommend any further action.
Patient received vaccine at 7pm Tuesday 11/10/09 and spiked fever of 103 with head and neck ache. Symptoms subsided after 24 hours.
Patient called reporting she received her vaccination at 2pm and by 9pm she had chills, a headache, fatigue and difficulty walking.
Fever to 102, rigors, myalgia, headache, malaise x 36 hours post vaccination. Same symptoms for 1st and 2nd immunizations.