chrisvoncsefalvay/vaers-outcomes huggingface dataset:
got the third dose of GARDASIL 9/The primary care Doctor tells the patient to go and get a fourth dose one week later.; The primary care Doctor tells the patient to go and get a fourth dose one week later.; The Pharmacist did not give the patient the fourth dose due to reading the prescribing information.; no additional adverse events; This spontaneous report was received from a pharmacist and refers to a currently 24-year-old male patient. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided.  On an unknown dates (between the patient's 15 and 18 years of old), the patient was vaccinated with the first and the second doses of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (dose, lot #, expiration date, route and site of administration were not reported) for prophylaxis. On an unspecified date, he received a titer for HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) at his doctors office and got the third dose of the vaccine (dose, lot #, expiration date, route and site of administration were not reported) for prophylaxis. The doctor told the patient to go and get the fourth dose one week later, however the pharmacist did not give him the fourth dose due to reading the prescription information. No additional adverse event was reported.
My arm was swollen with fever. The redness continued to get bigger and farther around my arm. It was very sore.
Itching all over the body; shingles infection.; This spontaneous case was reported by a pharmacist and describes the occurrence of PRURITUS (Itching all over the body) and HERPES ZOSTER (shingles infection.) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRURITUS (Itching all over the body) and HERPES ZOSTER (shingles infection.). At the time of the report, PRURITUS (Itching all over the body) and HERPES ZOSTER (shingles infection.) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   A patient is due for their second dose. Patient mentioned that soon after the first dose she had itching all over her body but didn't report it. She went to her primary Health Provider yesterday and they told her that they though the itching was due to a shingles infection.
No additional AE.; HCP reported PROQUAD was administered to patients over the age of 13 years old.; Indicate at which point in the process the medication error occured: dispensing; This spontaneous report was received from a physician regarding an unknown number of patients of an unknown age and gender. Their medical history, concurrent conditions, and concomitant therapies were not reported.  On unknown dates, the patients over the age of 13-year-old were vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (strength, dosage regimen, lot #, expiry date, anatomical location, and route of administration were not provided) administered as prophylaxis (Product administered to patient of inappropriate age). No adverse events were reported.  Follow-up information has been received from the vaccine provider on 08-MAR-2023.   The patient was a 29-year-old female patient. On 24-JAN-2023, she was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot# W030217, expiration date 23-MAY-2025, administered subcutaneously. The reporter considered that the medication error occurred in the dispensing process (Product dispensing issue).   Lot Number W030217 is not valid for PROQUAD, as confirmed by the lot validation team.   This is one of two reports received from the same reporter.   This case was previously considered non-valid, but upon receipt of follow-up it was determined that the case is now valid, as patient identifiers were reported.; Sender's Comments:  US-009507513-2303USA003423:
Patients mother called the oncall of physician noted to inquire about symptoms that arose immediatly after vaccination (while under observation. The parent did not report this to the vaccinating facility.) Patient told mother that his throat was sore, and he felt hot. Patient then went home and vomited all within an hour of vaccination.
severe vertigo; arm hurts so badly; fever of 102.8 - 103.6 for 10 days; Fatigue; nausea; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (severe vertigo), MYALGIA (arm hurts so badly), PYREXIA (fever of 102.8 - 103.6 for 10 days), FATIGUE (Fatigue) and NAUSEA (nausea) 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VERTIGO (severe vertigo), MYALGIA (arm hurts so badly), PYREXIA (fever of 102.8 - 103.6 for 10 days), FATIGUE (Fatigue) and NAUSEA (nausea). The patient was treated with MECLIZINE [MECLOZINE] for Vertigo, at a dose of 25 milligram three times a day. At the time of the report, VERTIGO (severe vertigo), MYALGIA (arm hurts so badly), PYREXIA (fever of 102.8 - 103.6 for 10 days), FATIGUE (Fatigue) and NAUSEA (nausea) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102.8-103.6 (High) 102.8-103.6.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient declined to take second dose. No concomitant medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: Follow up received and added lab data, treatment medication and new events. Updated event outcome of myalgia to Recovered/Resolved.
This is a spontaneous report from a contactable office manager. This reporter reported similar events in the same patient after the second dose of PREVNAR 13. This is the first of two reports. A 2-month-old male patient received the first dose of PREVNAR 13 during his 2 month check up in the hospital on 11Jul2011. Relevant medical history included premature, born at 27 weeks. Concomitant medications were not reported. On an unspecified date after receiving the vaccine, the patient experienced severe respiratory problems, sleep apnea and then he turned blue. The outcome of the event was unknown. Based on the information provided in the case, this individual report would not seem to modify the benefit/risk profile of PREVNAR 13.
Loss of energy; Loss 15% of body weight; Loss of appetite; Brain fog; This spontaneous case was received on 31-Aug-2021 from other non-health professional (consumer) via Med Communications (reference number: SEQW21-01847) and concerned a male patient of unknown age.  The patient's medical history and concomitant medications were not reported.  On an unknown date in 2019, the patient was vaccinated with Afluria (TIV) (influenza vaccine; dose: 0.5 ml, route of administration: intramuscular and anatomical location: deltoid) for influenza prophylaxis. The batch number was not reported.  On an unknown date in 2019, an unknown amount of time after receiving Afluria (TIV), the patient experienced 15% of body weight loss and loss of energy, brain fog and loss of appetite. It was unknown if the patient received any corrective treatment.  At the time of initial reporting on 31-Aug-2021, the patient had not recovered from the events as the symptoms were still ongoing.  The reporter did not provide a causality assessment.  Company comment: A patient of unknown age was vaccinated with Afluria (TIV). On an unknown date in 2019, an unknown amount of time after receiving Afluria (TIV), the patient experienced 15% of body weight loss, loss of energy, brain fog and loss of appetite. The patient's medical history and concomitant medications were not reported. Causality is unassessable for all events, due to lack of information regarding diagnostic findings.; Sender's Comments: A patient of unknown age was vaccinated with Afluria (TIV). On an unknown date in 2019, an unknown amount of time after receiving Afluria (TIV), the patient experienced 15% of body weight loss, loss of energy, brain fog and loss of appetite. The patient's medical history and concomitant medications were not reported. Causality is unassessable for all events, due to lack of information regarding diagnostic findings.
This is a spontaneous report from a contactable nurse. A 6-month-old female patient received two doses of PREVNAR 13, first dose (lot number: S43262, expiration date: 30Sep2018) given on 09Jan2018 at the age of 2 months via intramuscular in the right thigh at 0.5 ml, single and second dose (lot number: T62563, expiration date: 29Feb2020) given on11May2018 at the age of 6 months via an unspecified route of administration in the right thigh at a single dose for routine immunization. Medical history included cough on 28Feb2018 and bronchiolitis and right otitis media; both on unknown dates. Concomitant medications included second dose of PEDIARIX (lot number: 33PA4, expiration date: 24Apr2020), via intramuscular in the left thigh on 09Jan2018 at unknown dose, third dose of ROTATEQ (lot number: N024294, expiration date: 26Feb2019), via oral on unspecified date at unknown dose and first dose of PENTACEL (lot number: C5428AA, expiration date: 09Oct2018), via unspecified route of administration on 11May2018 at unknown dose; all for immunization. The patient previously received first dose of PEDIARIX and first and second doses of ROTATEQ; all for immunization. On 11May2018, the patient experienced inappropriate schedule of vaccine administered as the second dose given at 6 months and 5 days. On 04Jun2018, the patient was congested. It was also reported that the patient was also congested on 14Jun2018. Outcome of the event congested was unknown.
patient became itchiy in her hands and limps became numb, her pulse was elevated to 105, b/p was 160/100 patient did not begin to feel any better ambulance was called and patient was transported to hospital
High pitched ringing in both ears. Is continuous and appropriate frequency 10,000 hrtz.
Swelling and Neuropathy in left extremities; Highest fever 103.5/febrile; Severe Nausea Vomiting; Severe Nausea Vomiting; Swelling and Neuropathy in left extremities; Vertigo; Severe migraine headache; This is a spontaneous report from a contactable Nurse (patient). A 43-years-old female patient received second dose of bnt162b2 (BNT162B2, lot_number=EL1284), intramuscular on 11Jan2021 15:00 at single dose on Left arm for covid-19 immunisation. Medical history included Hyperlipidemia, Mild Obesity (Treating with Medication), and Known- allergies: Strawberries - CT contrast, shellfish, iodine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included liraglutide (SAXENDA) and Medication for Mild Obesity. The patient historically received first dose of bnt162b2 for covid-19 immunisation. Details: (product=Covid 19, brand=Pfizer, lot_number=EH9899, administration_date=22Dec2020, administration_time=12:00 PM, administrator_route=Intramuscular, vaccine_location=Left arm, dose_number=1). After received second dose, the patient reported adverse-event included: Highest fever 103.5 - Severe Nausea Vomiting, Swelling and Neuropathy in left extremities, vertigo and severe migraine headache - continued to be febrile an additional 36hrs from injection time. Adverse-event-start-date: 11Jan2021. Adverse-event-start-time: 11:30 PM. Required medical management of nausea/vomiting with ondansetron 4mg; oxycodone 10mg for migraine. AE-resulted-in: [Doctor or other healthcare professional office/clinic visit]. The patient underwent lab tests and procedures which included body temperature: Highest fever 103.5. The event outcome was recovering. This reported was reported as non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.; Sender's Comments: Based on the compatible temporal association, the vaccination with BNT162B2 might play a contributory role in triggering the onset of the reported events. The impacts of this report on the benefit/risk profile of the product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Developed left leg pain beginning the Tuesday following the first Pfizer/BioNTech vaccination.  The following Monday, the left leg began swelling which prompted a trip to the urgent care and followed with an ultrasound. Ultrasound showed a deep vein thrombosis in the deep calf vein extending to the popliteal bifurcation but not past.  Treatment with Eliquis began in the emergency department on 01/25/2021.
Patient became very nauseous the evening he received the immunization (last night), and today he is extremely tired and weak - not wanting to get out of bed.
Large local reaction 2 cm  inferior to injection site. While this is not a severe reaction, patient request that I submit VAERA report on her behalf.    LUE Area of erythema measuring 4.5 inch x 2.5 inches, warmth to palpation, trace edema, mild ttp.  Patient has a h/o cellulitis with injections in the past. No systemic sx, doubt cellulitis, howevere, I Rxed Keflex 500 mg (one tablet orally x 5 days) with shared decision making and patient concern for cellulitis due to previous injection site reactions in the past to TDap and Toradol. Previous reactions improved with oral antibiotics.    Advised to begin oral antihistamine and cool compresses as dir.  Patient will follow-up in 5 days, sooner if red flag sx. Photo uploaded to chart.
Swollen left arm and tenderness around the immunization area. Also has a slight redness about 4 cm below the immunization area. Left arm pain. Treatmen: Naproxen DR 500mg B10x1 wk, Toradol injection adn Keflex (per ER visit).
Breakthrough case admission after 3 vaccines Pfizer 4/8/21 Lot# EW0158;  Pfizer 4/29/21 Lot# EW0176;  Pfizer 1/28/22 Lot# FJ5683
Vaccines given 8/22/07. On 8/23, parent noted red area distal upper (L) arm. Seen here 8/24/07. 5x5 cm, red, warm indurated area - distal upper left arm. Rx Bactrim x tsp. BID x 7d.
Severe chills the first night.  Severe headache all of the second day despite taking Tylenol.  Sore arm.
When I caught COVID-19 I had a scratchy throat and a cough that lasted for 5 days. I had no fever and nothing else. I took some Delsym cough syrup. Since then I have had stomach cramping and an increase in vertigo.  I also have been having back pain now. I went to the ER for my stomach cramps and back pain. I was prescribed dicyclomine. That medication didn't help anything. I saw my doctor today and he doesn't know what is causing this.
Pt experienced severe migrainous headache ("worst headache of life") & dizziness on the night of 11Oct90 (this was post 1st dose-11Oct90)  treated /w Fiorinal & "still has headache."
Chills; Fever; joint pain; muscle body ache; tiredness and fatigue; nausea; vomitting; dizziness; pain and discomfort in the injection arm; temperature of 99.7-99.9F all day; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), PYREXIA (Fever), ARTHRALGIA (joint pain), MYALGIA (muscle body ache) and FATIGUE (tiredness and fatigue) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Lot#031M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CHILLS (Chills), PYREXIA (Fever), ARTHRALGIA (joint pain), MYALGIA (muscle body ache), FATIGUE (tiredness and fatigue), NAUSEA (nausea), VOMITING (vomitting), DIZZINESS (dizziness), VACCINATION SITE PAIN (pain and discomfort in the injection arm) and PYREXIA (temperature of 99.7-99.9F all day). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, CHILLS (Chills), PYREXIA (Fever), ARTHRALGIA (joint pain), MYALGIA (muscle body ache), FATIGUE (tiredness and fatigue), NAUSEA (nausea), VOMITING (vomitting), DIZZINESS (dizziness), VACCINATION SITE PAIN (pain and discomfort in the injection arm) and PYREXIA (temperature of 99.7-99.9F all day) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99.7f (Low) 99.7F and 99.9f (Low) 99.9F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.
Hepatitis B surface antigen positive; This case was reported by a physician and described a 57-year-old female patient who received hepatitis B vaccine recombinant (Engerix-B) and subsequently tested positive for hepatitis B surface antigen. Medical history included renal failure (cause not specified) requiring hemodialysis. On 07 January 2004, prior to immunization with Engerix-B, the patient tested negative for hepatitis B surface antibody. On 23 August 2004, the patient received the first dose of Engerix-B (lot AHBVA077AB). Approximately four days later, on 27 August 2004, the patient tested positive for hepatitis B surface antigen. The physician considered the event to be related to vaccination with Engerix-B.
Hoarseness @ night after receiving the vaccine rotavirus vacc- (ROTATEQ).
Vial of Moderna went  past 30 day at 2-8 degree Celsius; Covid-19 vaccine that were given beyond the 30 day use by date.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Covid-19 vaccine that were given beyond the 30 day use by date.) and PRODUCT STORAGE ERROR (Vial of Moderna went  past 30 day at 2-8 degree Celsius) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 065K21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Covid-19 vaccine that were given beyond the 30 day use by date.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial of Moderna went  past 30 day at 2-8 degree Celsius). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Covid-19 vaccine that were given beyond the 30 day use by date.) and PRODUCT STORAGE ERROR (Vial of Moderna went  past 30 day at 2-8 degree Celsius) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication reported. it was reported that the dose was 0.25 7 patients received 2nd booster dose of moderna which was approximately 6-10 days past the 30-day expiration window.  At the time of this report, no patient has contacted about any reactions. No treatment medication reported.
Pt is 38 yo G4 P3 at 32 wks. Was given Tdap today as routine care. After 10-15 min, pt still at laboratory, she started to experience rash on arms and itchy on entire body. No difficulty breath or SOB or throat.
On the clinic day, the vaccine was transported out from the pharmacy to the facility without a digital data logger. The packing used for transport was refrigerated packaging tote to maintain a temperature of 36 F - 46 F.  However, that is not approved. The total time (from when vaccine left the pharmacy to the clinic completion) was less than 6 hours. There were no adverse events.
Headache, Myalgia & NauseaVomiting Narrative: Headache, myalgis, gi symptoms: resolved.
Pt has had flu shots in the past, no egg allergy. Left pharmacy felt fine but within 5 min of vaccine felt like a burning pain shooting down arm, left shoulder blade, left leg. Went to tingling. Pt had a fever, felt fatigue, rash, felt confused. SX went away after 24  hours.
The pt states 1 week post vax, the pt broke out in blisters and then scabs that covered blisters.
6 months past due for my second dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (6 months past due for my second dose) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (6 months past due for my second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (6 months past due for my second dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.
Initially, very hot entire right arm with 2-3+ pitting edema & dark red approximately 4inch circumference surrounding injection site.  This persisted for 2-3 data & I then spiked a temp (100.1) on day 4.  The local symptoms improved after day 4 and spear to have resolved completely.  Systemic - feeling like Mono/bad flu
Pt presented to nurse wit c/o itching all over. Nurse notified EMs and NP, directed by NP to notify 911. Ems on site administered benadryl and started IV to (R) hand 22 guage sodium  chloride given. Patient transported via ambulance by ambulance @ 11.54am
Patient states that their arm was swollen, warm to the touch, painful, and have pinkish spot around the arms injection site
administered, after gone out of range; This case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a female patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Boostrix and Boostrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 27-APR-2022 Reporter's Comment: The patient received Boostrix after it had gone out of range. All information provided was reported.  Registered nurse did not have a specific amount of patients when spoke to her so could not confirm. It was reported that, for additional information, please reach out to the healthcare professional. Additional Supportive Information: The patient received Boostrix after it had gone out of range, which led to incorrect storage of drug. This was 1 of 7 linked cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022070827:Same reporter. US-GLAXOSMITHKLINE-US2022AMR071808:Same reporter. US-GLAXOSMITHKLINE-US2022AMR071809:Same reporter. US-GLAXOSMITHKLINE-US2022AMR071810:Same reporter. US-GLAXOSMITHKLINE-US2022AMR071811:Same reporter. US-GLAXOSMITHKLINE-US2022AMR071812:Same reporter.