chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a registered nurse concerning a 7 year old male who in 2001 (12 months of age) was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). In June 2007 (2 months ago), the patient experienced shingles. Unspecified medical attention was sought. Subsequently, the patient recovered from shingles. A product quality complaint was not involved. Additional information has been requested.
Information has been received from a registered nurse concerning a male over 60 years old who on 21, Dec 2006 was vaccinated subcutaneously with a 0.5 ml dose of Proquad instead of varicella-zoster virus vaccine live (Oka/Merck) (MSD). It was reported that there was no product confusion, but rather that both vaccinations were stored next to each other in the same freezer and a nurse "grabbed the wrong one" The patient did not experience any known symptoms. Unspecified medical attention was sought. No additional information to report. There was not a product quality complaint involved. Follow-up information was received form a nurse who reiterated that there was no product confusion but human error. The bottles were stored near each other and the administering nurse accidentally pulled out the wrong one.
This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (Felt sick after second moderna COVID vaccine), SKIN DISCOMFORT (Bumps in both the index fingers), ANXIETY (Anxiety), DEPRESSION (Depression) and INFLAMMATION (Inflammation increased just prior to next Humira dose) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis and Panuveitis.    No Medical History information was reported.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-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) at an unspecified dose. In 2021, the patient experienced IMMUNISATION REACTION (Felt sick after second moderna COVID vaccine). On 17-Aug-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products). On an unknown date, the patient experienced SKIN DISCOMFORT (Bumps in both the index fingers), ANXIETY (Anxiety), DEPRESSION (Depression), INFLAMMATION (Inflammation increased just prior to next Humira dose), NASOPHARYNGITIS (Trouble getting over cold), HYPOAESTHESIA (Hands got numb) and PAIN IN EXTREMITY (Pain in both index fingers / Pain in Hands). At the time of the report, IMMUNISATION REACTION (Felt sick after second moderna COVID vaccine), ANXIETY (Anxiety), DEPRESSION (Depression), INFLAMMATION (Inflammation increased just prior to next Humira dose), NASOPHARYNGITIS (Trouble getting over cold), HYPOAESTHESIA (Hands got numb), PAIN IN EXTREMITY (Pain in both index fingers / Pain in Hands) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) outcome was unknown and SKIN DISCOMFORT (Bumps in both the index fingers) had not resolved.            No concomitant medication were reported.  It was unknown if patient was enrolled in a COVID-19 trial.  Causality for the co-suspect Humira was provided as Not reported.   The patient experienced wearing off effect. On 17-Aug-2021 Patient received 1st booster dose of Pfizer Biontech COVID-19 Vaccine through intramuscular route. indication was provided as COVID-19 Vaccination.   No treatment medication information provided.
Patient fully vaccinated for COVID with Janssen vaccine on 3/7/2021.  Patient admitted for respiratory failure on 11/1/21, and remains hospitalized on 11/3/21, and not ready for discharge.
On 4-15-21, patient started having breathing problems and shortness of breath.   He had a cough that he had productive phlegm.  He continued to get worse.  On 4-18-21, he fell getting out of the shower and slumped onto the floor, stating that he couldn't breathe.  His wife and neighbor took him to the local ER.  His condition improved with oxygen.  He was admitted on 4-18-21 and then was transported by Air Evac to ICU.  He was placed on the ventilator prior to leaving on 4-21-21 and transferred to hospital.  His condition continued to deteriorate and he passed away on 4-25-21.
Fatigue post injection; This case was reported by a consumer via interactive digital media and described the occurrence of fatigue in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fatigue. On an unknown date, the outcome of the fatigue was unknown.   It was unknown if the reporter considered the fatigue to be related to Shingrix.  Additional details were provided as follows: The age group was not reported but was selected as per the vaccine indication. The patient asked duration of fatigue post Shingrix injection.
Injection site pain in right arm. Tingling, burning, and numbing sensation in right arm. Swelling in left and right hands. Denies rashes/hives or shortness of breath.
6-7-07 Dr phoned clinic regarding vaccine reaction. Assessed pt in clinic stated LD swollen, red, hot to touch size approx 8x7 cm. Pt presented to unit after report from MD. All above info repeated MD ordered Benadryl for pt.
Fever - 104F; Spotting; Chills; Aches; migraine; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (Fever - 104F), INTERMENSTRUAL BLEEDING (Spotting), CHILLS (Chills), MYALGIA (Aches) and MIGRAINE (migraine) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049C21A) for COVID-19 vaccination.     No medical history was provided by reporter.  No concomitant medication reported.     On 28-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 29-Apr-2021, the patient experienced MIGRAINE (migraine). On 29-May-2021, the patient experienced PYREXIA (Fever - 104F), INTERMENSTRUAL BLEEDING (Spotting), CHILLS (Chills) and MYALGIA (Aches). The patient was treated with ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) at an unspecified dose and frequency and IBUPROFEN (MOTRIN [IBUPROFEN]) at an unspecified dose and frequency. On 30-Apr-2021, MIGRAINE (migraine) had resolved. On 30-May-2021, CHILLS (Chills) and MYALGIA (Aches) had resolved. On 31-May-2021, PYREXIA (Fever - 104F) and INTERMENSTRUAL BLEEDING (Spotting) had resolved.
Covid 19 after Covid Vaccines; Covid 19 after Covid Vaccines; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "just has always had a weak stomach" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Covid 19 after Covid Vaccines". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Caller States that she started taking the medication on Thursday when she found out she had Covid 19. Caller mentions that she has had the shots, she got them, she thinks, in April or May. States that she has received 2 doses of the vaccine The patient received Paxlovid (Batch/lot number: 1918538A; Expiry Date: Mar2023) ongoing since 22Sep2022, twice a day for 5 days; three tablets in morning, three tablets at night for COVID-19. Caller denies any other medications, medical conditions, labs, testing, or treatments relevant to these events.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
hot flashes for a month and a half; This is a spontaneous report from a contactable consumer (patient reported for self). A 79-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 11Mar2021 as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient had earlier received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. The patient has been experiencing hot flashes for a month and a half from an unspecified date. The patient went through her change of life in her 30's and she was way past that. The patent was turning 80-years-old at the end of the month. The patient saw her health care professional and he did not know what to do but told her that this could happen to a woman later in life. He basically gave her no advice or recommendations of what to do. After the patient received shots, she did not experience any reaction to it. The patient was querying whether hot flashes have been reported after receiving the Pfizer COVID-19 vaccine and how long the hot flashes last. The clinical outcome for the event was unknown.  Follow-up attempts are completed. Information about lot/batch number cannot be obtained. No further information is expected.
1.5 wks post vax pt devel-weakness, fatigue, numbness/tingling; progressed to a "feeling of paralysis"; admitted for SOB & chest pain; p/hospitalization pt unable to ambulate on own; also devel facial weakness; GBS;
He developed thigh swelling that same day that lasted a few days. About one week after his shots, he developed discrete bumpy rash at site of vaccines. Rash faded away eventually the following week.
Throat closing, tongue swelling, eyes felt hot, knot with heat, went to ER and got BENADRYL shot.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions and medical history were not provided. On unspecified dates, the patients were vaccinated with improperly stored doses of PEDVAXHIB of lot# L051122, expiry date: 12-OCT-2018. Concomitant medication was not mentioned by the reporter. No adverse effects were reported. No additional information was provided. Product quality complaint was not filed. Additional information has been requested.
Seriousness Criteria other medically significant (OMIC). Initial report received on 6/28/06 from a health care professional. An 18 year old male pt with no significant medical history and who had recently cut his left finger, had received his second IM injection of Decavac, lot number U1724BA, in the left deltoid on 5/18/06. Three days post immunization, the pt developed right anterior thigh numbness with associated weakness and pain. The pt was treated with anti inflammatory medication and was referred to a neurologist. The pts appointment with the neurologist is scheduled for 7/20/06. The recovery status of the pt was reported as not recovered. Follow up information received on 9/11/06. Per the reporter, the pt did not have any recent sports on non related sports injuries at the time of the adverse event on 5/21/06. He was prescribed Naprosyn in the physicians office for the adverse event. Reportedly no diagnostic test lab date were performed. The pt was subsequently evaluated by a neurologist and an EMG/NCS test was reported as being negative. The contact information was provided for the neurology consult. The pt did require subsequent plastic surgery for complications of the laceration to the left index finger. At the time of this report, the pt had not recovered from these adverse events. Follow up information received on 9/22/06. A copy of the neurology consult on 7/20/06 was received. Per the reporter, the pt had actually received the Decavac vaccination on 5/18/06, in the buttock not the deltoid as previously reported. This is not a recommended site of administration by the manufacturer for Decavac. The pt presented on 7/20/06, with numbness on the right anterior thigh. He stated he had no pain just numbness. He said that walking increased the numbness, but that he did not have any back pain, and that his left leg was fine. On examination by the neurologist, the pt had normal reflexes in his arms, but the right knee jerk was somewhat decreased compared to the left. Motor strength testing showed obvious abnormalities. Sensory exam revealed scratch sensation subjectively decreased over the entire circumference of the right thigh anterior posterior, lateral, and medial to the mid buttock and to above the inguinal ligament. Nerve conduction study revealed screening motor and sensory studies to be normal. The neurologist impression was right thigh circumferential numbness with no electrical evidence of any peripheral nerve injury to account for the numbness. The circumferential numbness is not an anatomic distribution as multiple nerve and root territories are involved. It is possible that there has been some spinal cord injury. A suggestion for imaging of the thoracic, lumbar spine, and brain were made ad multiple sclerosis can produce unusual areas of numbness. These test were not scheduled at this visit. The recovery status of the pt was reported as not recovered. Due to medical evaluation of this new information, this case is being upgraded to serious.
Fever 12 days out from the vaccination/fever averages 100F during the day; This is a spontaneous report received from a contactable pharmacist (patient himself). A 60-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: Unknown and Expiry date: Unknown), via an unspecified route of administration on 07Apr2021 (at the age of 60-year-old) as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient previously took first dose of BNT162B2 on an unspecified date for COVID-19 immunisation. On an unspecified date in Apr2021, the patient reported to have a fever 12 days out from the vaccination, his fever averaged 100 Fahrenheit during the day. There was no other symptoms. The patient's laboratory test and procedure on an unknown date included body temperature: 100F during the day. The clinical outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected.
pain in his arm, neck, shoulder, and back; pain in his arm, neck, shoulder, and back; pain in his arm, neck, shoulder, and back; pain in his arm, neck, shoulder, and back; headache; This is a spontaneous report from a contactable consumer or other non healthcare professional. A 60 year old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 06Apr2021 09:45 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included hypertension from an unknown date and unknown if ongoing. Concomitant medication(s) included acetylsalicylic acid, butalbital, caffeine (FIORINAL [ACETYLSALICYLIC ACID;BUTALBITAL;CAFFEINE]) taken for an unspecified indication, start and stop date were not reported. The patient experienced pain in his arm, neck, shoulder, and back causing pain in extremity on an unspecified date with outcome of unknown , arthralgia on an unspecified date with outcome of unknown, headache on an unspecified date with outcome of unknown.    Therapeutic measures were taken as a result of this with Fiorinal and Tylenol.  Follow-up (07pr2021): This is a follow up spontaneous report received from a contactable consumer (patient) reported that: Caller received first vaccine last week Tuesday. Caller took pain killers before for a headache and then after for his arm which was sore. Wants to know if that will decrease the efficacy of the vaccine.  Follow-up (17May2021): Follow-up attempts completed. No further information expected.
Vesicular lesion 1cm in size of site of injection. Noticed morning of day after injection when band aid removed.
MOTHER EXPLAINED PATIENT EXPERIENCED BURNING SENSATION DOWN ARM FOR AT LEAST 3-4 HOURS.  USED COLD COMPRESSES AND TYLENOL.  BECAUSE OF PRE-EXISTING CONDITION, MOTHER DID NOT RELEASE PATIENT'S NAME OR DATE OF BIRTH 01/01/2005 WAS ENTERED BECAUSE THE SYSTEM WILL NOT ACCEPT INFORMATION WITHOUT A BIRTH DATE.
PT EXP HIVES 3 DAYS AFTER RECEIVING HIS SECOND INJECT OF ENGERIX B ON 1-18-90. EVALUATED (2-12-90) BY IMMUNOLOGIST BECAUSE OF RECURRING EPISODES OF PERIORBITAL EDEMA. NO HEPATITIS B SURFACE ANTIBODY WAS NOTED.
NOTICED REDNESS AND HEAT WITH SWELLING IN HER ARM THE NEXT NIGHT AFTER RECEIVING THE VACCINE.
Large red blister the size of nickel on leg. Small red dots on arms. All appeared approximately 10-14 days after injection.
Patient received ZOSTAVAX in left arm on 3/17/16. On 3/18/16 (in the evening). Patient woke up with swelling, itchiness and a lump at injection site. The itchiness/swelling resolved over the next two days and patient is feeling fine, as of 3/21/16.
Awakened unable to breath, 1-2 min. Occured several times per night for 3-4 wks. Occurrence reduced to once/mo or so. Saw 2 throat drs, but was never diagnosed with illness.60 day follow-up received on 09/27/00 states the pt has breathing difficulty. The inability to breathe for 1 minute or so. The pt is able to breathe out, but can't breathe in.
At 1400, nausea and yea he started.   By 1800, started to become tachycardic. Took Bystolic as ordered. The morning of 2/2/2021 awoke at 0600 with shortness of breath, tachycardia, hypoxia, headache, body ache, chills, nausea, and dizziness.  VO2 max took a noticeable drop per garmin vivoactive 3. PCP was notified and instructed to monitor.   Cardiologist and neurology were consulted and prednisone taper given on 03/05/2021.   Shortness of breath and tachycardia slowly changed to only on exertion improved until finally ending 3/21/2021. Continued to have palpitations, headache, and body aches until about 04/07/2021.
Patient's left arm became red and swollen 1  day after receiving the flu shot. Instructed parent to apply cool compresses to area affected.
Abrupt onset of temp to 103F, myalgias, headache, rash over head and trunk 3weeks after immunization. Maculopapular rash c/w varicella. Treated by his primary physician with Prednisone taper Omnicef. Greatly improved at 1 week rash resolved at 2 weeks. No known sick contacts except ill child (unk illness) 3 days prior to onset of his symptoms.
Erythema, warmth, induration from shoulder to upper portion of lower arm c/w cellulitis developed on day 3 after administration (given 10/31/06, seen my myself on 11/2/06).  Treated with Keflex 500mg 4/day for 7 days.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Sep2022 as dose 4 (booster), single (Lot number: GH9702) at the age of 47 years, in left arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 12Apr2021 as dose 1, single (Lot number: EW0153), in left arm, on 03May2021 as dose 2, single (Lot number: EWO173), in left arm and on 22Nov2021 as dose 3 (booster), single (Lot number: FPFD0809), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "former smoker" (unspecified if ongoing); "obesity" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 18Sep2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (18Sep2023) Positive; (22Sep2023) Negative; (23Sep2023) Negative; (01Oct2023) positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid from 18Sep2023 to 23Sep2023. Clinical course: Adverse event: covid rebound: Tested positive 18Sep2023, started Paxlovid the same day. Symptoms were gone and I tested negative within 4 days on 22Sep2023. Tested negative again on the fifth day 23Sep2023. I got symptoms and tested positive again on 01Oct2023..; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300315079 Same patient, different product, different dose/event;
Stress; COVID-19 recurrent; Fatigue; body aches; Headache; Flu like symptoms; This spontaneous case was reported by a patient and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), STRESS (Stress), COVID-19 (COVID-19 recurrent), FATIGUE (Fatigue) and MYALGIA (body aches) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis (Moderate to severe).   On 11-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free (1 in 1 wk). In August 2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), FATIGUE (Fatigue), MYALGIA (body aches) and HEADACHE (Headache). On an unknown date, the patient experienced STRESS (Stress) and COVID-19 (COVID-19 recurrent). In 2021, INFLUENZA LIKE ILLNESS (Flu like symptoms), FATIGUE (Fatigue), MYALGIA (body aches) and HEADACHE (Headache) had resolved. At the time of the report, STRESS (Stress) and COVID-19 (COVID-19 recurrent) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  On unknown dates, the patient experienced stress and covid twice. in august 2021, the patient experienced fatigue after covid vaccine, body aches after covid vaccine, headaches after covid vaccine and felt like had flu after covid vaccine.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter causality for Humira (adalimumab) for the events of fatigue after covid vaccine, stress, covid twice, body aches after covid vaccine, headaches after covid vaccine and felt like had flu after covid vaccine was not provided.  No treatment medications were reported.  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.
Fever of 101 degrees, arm red and swollen at injection site, 14cm x 7cm. Steroids sent to pharmacy. TYLENOL and MOTRIN, cold compresses.
Received DTAP/HBV/IPV #3, HIB #3, Hep. A #1 P13, Varicella #1, MMR #1 on 5/19/10. Mother states had fever on 5/30/10 103 degrees F. Gave MOTRIN. On 5/31/10 had rash on face and body took to ER. 6/1/10 Child afebrile rash receding.