chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Iron deficiency on 12Apr2021; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A 54 year-old female patient received bnt162b2 (BNT162B2), administration date 01Apr2021 (Lot number: EP7534) at the age of 54 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Blood pressure" (unspecified if ongoing), notes: Additional Information for Other Conditions: I take Blood pressure pills. Concomitant medication(s) included: VITAMIN D [VITAMIN D NOS]; VITAMIN B12 [VITAMIN B12 NOS]. The following information was reported: IRON DEFICIENCY (non-serious) with onset 12Apr2021, outcome "unknown", described as "Iron deficiency on 12Apr2021". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: Patient missed her 2nd dose scheduled last April 22 and she is calling to make a schedule again but in a different facility or location. Patient 1st dose was given April 1. When probed for concern, patient stated, she was supposed to go and get second dose on the 22nd and she miss that appointment, so patient want to know if she can go to another location or what do I need to do. Patient stated she thought that's she was calling pfizer for to see where she can get her second shot patient already talked to one person.  No follow-up attempts are possible. No further information is expected.  Follow up (24Apr2021): The initial case was missing the following minimum criteria: No adverse event. Upon receipt of follow-up information on (24Apr2021), this case now contains all required information to be considered valid.
Patient fainted approximately less than 5 minutes after dose, Patient regained consciousness within 60 seconds and was taken by ambulance for observations. Patient stated nervousness with needles after event
Approximately 20-30 min. after receiving vaccines felt nauseated. Then she cx of headache, weakness and vomiting. She called her father who took her to the hospital ER. States her face began to swell and throat too. Was given BENADRYL and ZOFRAN.
Local reaction, red, swollen, hurts, no temp.  Shots on Tuesday reaction gone on Friday.  Did not see a doctor.  Used cold compress at injection site.
My first shot was administered at the clinic. The CDC reached out and said that anyone that received a shot there needed to restart their doses.  I then received my second Moderna shot and had very hard symptoms for four days. Fever was around 103.  I just received my third modern on 5/16. I have had a fever between 100-103 for three days. I have been nauseous and throwing up. I have rigors so bad that my body has a hard time. My lymph nodes under both armpits are swollen. And of course, my arm is painful to move. The pain I experienced in the first night was as close to the pain i had when going into labor with my child.   I thought you might want this information as there isn't any research out there on people who have received three vaccinations.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 76 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 27Sep2021 (Lot number: FF2588) at the age of 76 years as dose 3, booster, administered in arm right, administration date 11Feb2021 (Lot number: EM9810) as dose 2, single and administered in arm right, administration date 19Jan2021 (Lot number: EL3247) as dose 1, single for Covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: ATORVASTATIN CALCIUM, start date: Jan2018; NITROFURANTOIN MONO/MAC, start date: Mar2022, stop date: Mar2022; VITAMIN D3, start date: Oct2021; CRANBERRY, start date: Mar2022. The following information was reported: VACCINATION FAILURE (medically significant), outcome "unknown", described as "indication=Treatment of COVID-19"; COVID-19 (medically significant), outcome "unknown", described as "swelling of face, lips indication=Treatment of COVID-19". Anti-viral details: Product: Covid-19 treatment, Brand: Pfizer, Treatment start date: 22Mar2022, Treatment stop date: 23Mar2022, Lot Number: FX2741, Indication: Treatment of Covid-19, Adverse event: Allergic reaction (swelling of face, lips and hives on thighs and buttocks). Reaction happened immediately after evening dose on 1st day of treatment. No reaction to morning dose on 1st day. Adverse event country: Unknown, Adverse event start date: 22Mar2022, adverse event start time: 11:45PM, AE resulted in: Hospitalization, number days hospitalization: 1, If treatment AE: Yes, AE treatment: IV Benadryl in ambulance, Known allergies: No, medical history: None, Privacy policy consent: Yes. No follow-up attempts are possible. No further information is expected.
A few days after my first dosage, I started getting incredible itching all over my back, as well as some on my arms and chest. I tried to ignor it but I found myself scratching and scratching. I tried all sorts of creams and washes. I hadn?t changed any soap or clothes. I put in for a dermatologist consult with my PCP. I couldn?t imagine this was from the vaccination so I hadn?t even brought it up. I finally got a derm appt for 01/25/2021.  My first Moderna vaccine was 01/27/2021 and my second Moderna vaccine was 01/24/2021. When I went to my first appt, I was told it appeared to be allergic. I did not even tell her that I had the second Moderna vaccine the day before because I didn?t think there could be a connection. I had a derm f/u on 03/25/2021. The allergic rash was no longer diffuse but in patches, mostly on back and some on chest. She thought is could be eczema, something I never had on my body. A biopsy was taken.
second dose on day 24; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose on day 24) 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-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Jan-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose on day 24). On 27-Jan-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose on day 24) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment information was provided.
Arm hurt so bad it went all the way up an around back of my neck; Migraines; Fever; Chills; Real fatigued; Throwing up; lost weight; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm hurt so bad it went all the way up an around back of my neck), WEIGHT DECREASED (lost weight), MIGRAINE (Migraines), PYREXIA (Fever) and VOMITING (Throwing up) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm hurt so bad it went all the way up an around back of my neck), WEIGHT DECREASED (lost weight), MIGRAINE (Migraines), PYREXIA (Fever), VOMITING (Throwing up), CHILLS (Chills) and FATIGUE (Real fatigued). At the time of the report, PAIN IN EXTREMITY (Arm hurt so bad it went all the way up an around back of my neck), WEIGHT DECREASED (lost weight), MIGRAINE (Migraines), PYREXIA (Fever), VOMITING (Throwing up), CHILLS (Chills) and FATIGUE (Real fatigued) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication provided by reporter.  Patient mentioned that all events went on for a week.  No treatment medication provided by reporter.   This case was linked to MOD-2021-220819, MOD-2021-220819 (Patient Link).
Nausea, Vomiting, Dizzy, Chills around 4:30pm on Wednesday, April 7th until the morning of April 9th.
first dose  06-JAN-2021 , Second dose 14-FEB-2021; COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose  06-JAN-2021 , Second dose 14-FEB-2021) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Psoriatic arthritis.    No Medical History information was reported.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free. In 2021, the patient experienced COVID-19 (COVID-19). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose  06-JAN-2021 , Second dose 14-FEB-2021). At the time of the report, COVID-19 (COVID-19) had not resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose  06-JAN-2021 , Second dose 14-FEB-2021) outcome was unknown.            No concomitant medications were reported No treatment medications were reported It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
After receiving flu vaccine for 1 min, patient felt sweating, dizziness and nausea. Advised pt. to sit down, relax and take a deep breath. After 5 min., patient started to feel better. No Epi-pen was needed. After sitting and relaxing for 30 min, pt. felt fine and ok to go home.
Extremely sleepy; Arm hurts; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of SOMNOLENCE (Extremely sleepy) and PAIN IN EXTREMITY (Arm hurts) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011M20A and 032M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SOMNOLENCE (Extremely sleepy) and PAIN IN EXTREMITY (Arm hurts). At the time of the report, SOMNOLENCE (Extremely sleepy) and PAIN IN EXTREMITY (Arm hurts) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No treatment information was provided Caller provides consent for Safety to follow up with them or their HCP.
flue-like systems, headache, achiness, developed a small red bumpy rash approximately 2 weeks later that lasted for several months.
Redness, itchiness, swelling, warmth, pain, and hardness around injection site.
pt recvd DTP on 26MAY92 5-6 hrs later had high pitched cry-very irritable-screamed called pvt MD who advised APAP; rxn began 2 hrs later;
after the second injection, feel I may have some longer lasting effects in my bicep muscle and shoulder joint; after the second injection, feel I may have some longer lasting effects in my bicep muscle and shoulder joint; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program . The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 09Feb2021 (Lot number: EN6201) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st inj. 15Jan2021, Lot EL1283), administration date: 15Jan2021, for COVID-19 immunisation. The following information was reported: MUSCLE DISCOMFORT (non-serious), MUSCULOSKELETAL DISCOMFORT (non-serious), outcome "unknown" and all described as "after the second injection, feel I may have some longer lasting effects in my bicep muscle and shoulder joint".  No follow-up attempts are possible. No further information is expected.
Information has been received on 13-APR-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 27-AUG-2013, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route, at a family medicine facility as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster. On or about 25-MAY-2016, the patient was treated at a family medicine facility for a blistering vesicular outbreak which was diagnosed as herpes zoster, or shingles. The patient has been prescribed valacyclovir and triamcinolone acetonide cream for management of her painful symptoms. As a direct and proximate result of the ZOSTAVAX, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, 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.
Reporter indicated multiple individuals in various stages of their vax schedule who recvd Engerix-B or Recombivax exp arm hurting during inject & transient numbness in area of inject;
No adverse reaction. KINRIX given at 15 mos - licensed for 4-6 year old.
This spontaneous report has been received from a healthcare professional via a company representative referring to a patient of unknown age and gender. The patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not reported. On an unknown date, the patient was vaccinated with M-M-R II (strength, dose, route, anatomical location, lot number and expiration date were not provided) for prophylaxis. On an unknown date, the patient missed a dose of M-M-R II (drug dose omission) for an unknown reason.
Child apparently limping on left leg. Around noon, leg became very swollen to the whole thigh, down to the knee. Upon evaluation on 5/26/10 at 2:15 pm leg measured at upper thigh is approx 11/2 inches larger on the left than the right, with the edema just at the knee. Leg has some light redness and warm to touch. Appointment made with Dr. to be seen.
HOT, ITCHY, 2 INCHES IN DIAMETER, SWOLLEN. NO TREATMENT.
no adverse effects; patient inadvertently received an expired dose of VAQTA on 6/24/2019.; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies, previous drug, reactions, allergies, historical drugs or medical history.  On 24-JUN-2019, the patient inadvertently received an expired dose of hepatitis a vaccine, inactivated (VAQTA) (formulation, strength, dose, frequency, route of administration, anatomical location, indication, were not reported). Lot No. R013858 has been verified to be a valid lot number, expiration date not reported, but upon internal validation established as 12-JUN-2019. No adverse event was reported.
Case number PHHY2014US057494 is an initial literature report received on 10 May 2014. The authors discuss about an algorithm which was developed using the Brighton collaboration case definitions was more efficient for determining diagnostic certainty. This report refers to 12 months old male patient. He had history of atopic dermatitis, egg allergy (prick +) and reports of hives after eating carrots. On an unknown date, he visited the allergist's office to receive his 1st influenza vaccine. Due to the patient's history of egg allergy, he received seasonal influenza vaccine (manufacturer and batch number unknown) was administered per 2-part protocol to right quadriceps. First dose of vaccine was given at a dose of 0.05 cc intramuscularly. He was noted to have full strength, which was monitored for 30 minutes. No other adverse reaction was noted. Second dose of vaccine was given at a dose of 0.02 cc intramuscularly. Within 30 minutes of the second dose, he experienced urticaria of neck, anterior torso and both arms. He also became fussy and started crying. He had increased work of breathing, coughing, stridor, retractions, mild erythema and angioedema of uvula. The following lab values were noted after second vaccination: respiratory rate was 42 bpm, O2 saturation was 93%, pulse rate was 137 bpm and systolic blood pressure was 176. The patient was treated with epinephrine intramuscularly along with cetirizine, prednisolone and albuterol. He went home and the night after the clinic visit, he experienced diarrhea, mild wheezing and a blotchy rash. He was treated in the clinic with albuterol and BENADRYL. The family reports that the child had not eaten any eggs, nuts or carrots and there were no changes in the home. The authors concluded based on the algorithm developed from the Brighton collaboration case definition for anaphylaxis this case met the Brighton level 1 criteria.
Within hours of getting the shot, patients left eye started turning red. He visited a medical facility and they diagnosed him pink eye and gave him antibiotic drops. The drops did not seem to be working and by that Monday he went to see the eye doctor. Eye doctor said it was viral pink eye and thought it was strange that this came about right after the vaccine and in the eye on the same side he was vaccinated. Over the next days and weeks, the viral infection moved to the other eye. Both eyes stayed swollen, red and tearing constantly. He has lost some of his vision and says that things far away are very fuzzy looking. The doctor said it was the worst case of viral pink eye he has ever seen and that he would have it for the long haul of 4 to 6 weeks. He had to do a medical withdrawal from college due to missing too much of the nursing program he is enrolled in. The pinkeye is still ongoing and we don't know when it will be over.
Pfizer tromethamine vial was punctured and open the day before on February 17th and stayed in the refrigerator. The administrator "thought" it was a new vial for the day of February 18th and gave one dose to a patient. The vial was opened for 22 & 1/2 hours before one dose was drawn up.
This is a spontaneous report from a non-contactable consumer (patient). A 58-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 16Apr2021 16:45 (Batch/Lot Number: EN0161) as 1ST DOSE, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient previously took lisinopril and experienced allergy. After getting shot about 1/2 hr later tongue on right side started going numb and right side of face started to swell on 16Apr2021 17:30. Therapeutic measures were taken included steriods and antihistamine. Patient visited doctor or other healthcare professional office/clinic visit for events. Outcome of events was recovered.   No follow-up attempts are possible. No further information is expected.
eyes roll up then come back down; inc body rigidity; eyes blood shot; lethargic, cries out in discomfort; v/s t97.9 R; BP 98/62; P67; R20
On 6/18:  Headache, diaherrea,  fever, chills,  fatigue On 6/19:  Fatigue, dry eyes when waking, slight diaherrea, rash under injection site, painful  injection site  On 6/20:   Fatigue, slight dry eyes when waking, slight rash under injection site, painful injection site
A report has been received from a health professional concerning a female subject, who had been receiving nasal FLUMIST Quadrivalent. FLUMIST Quadrivalent started on 30-DEC-2014. Reporter stated that we inadvertently administered expired FLUMIST to two patients on 30-DEC-2014. The outcome of the event inadvertently expired FLUMIST Quadrivalent to two patients was unknown. The report was considered to be non-serious.
5 days after first does ear pain in both ears; Muffled sounds; This spontaneous case was reported by a patient and describes the occurrence of EAR PAIN (5 days after first does ear pain in both ears) and HYPOACUSIS (Muffled sounds) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced EAR PAIN (5 days after first does ear pain in both ears) and HYPOACUSIS (Muffled sounds). At the time of the report, EAR PAIN (5 days after first does ear pain in both ears) and HYPOACUSIS (Muffled sounds) had not resolved.            No concomitant and treatment medications were reported.   This case was linked to MOD-2021-259158 (Patient Link).   Reporter did not allow further contact
A non-serious spontaneous report of Henoch-Schoenlein purpura and upper respiratory infection was received from a physician concerning a 6 year-old male, subsequent to receiving FLUMIST.  At the time of FLUMIST administration the patient had a mild skin rash that the physician diagnosed as a fungal infection.  No concomitant medications were reported.  The patient received FLUMIST on 26-Nov-2008.  Around 01-Dec-2008 the patient experienced a mild upper respiratory infection that was resolving on 04-Dec-2008 at the time the patient was seen due to Henoch-Schoenlein purpura (HSP).  No treatment was given for the HSP, the patient was monitored.  The HSP resolved later in Dec-2008.
Patient received vaccine on 8/6/17. Next day patient reported excessive swelling, irritation, but no other concerning symptoms at the time. On 8/19/17, patient presented to administering pharmacist, and showed her arm, where a scab had formed and fallen off. The skin was lighter underneath that area, possible scarring. Patient does have a tattoo on that arm, but I verified that shot was administered in a non ink containing area of that arm. Patient is still experiencing some irritation/scabbing. Recommended monitoring, self care such as keeping moisturized, and follow up with physician if irritation continues or signs of infection.
A non-serious spontaneous report of administration to pregnant female was received from a consumer/husband concerning his wife, an adult female. At the time of report, 28-Sep-2009, the patient found out that she was two weeks pregnant. Two weeks prior to 28-Sep-2009 she received FLUMIST. There was no adverse event associated with this pregnancy. Treatment and reporter/sponsor causality assessment are not applicable.