chrisvoncsefalvay/vaers-outcomes huggingface dataset:
side effects and an allergic reaction to this pneumonia vaccine; allergic reaction to this pneumonia vaccine; not being able to bend her arm; disoriented; whole arm swelled up; fever; sharp pain at the injection site; administered two shots together on the same day; This spontaneous report was received from a 68 years old female patient, who was referring to herself. The patient's current conditions included thyroid issues, asthma and 22 unspecified allergies. The patient had a history of epistaxis while on therapy with montelukast sodium (SINGULAIR) (case # 2101USA013273). Concomitant therapies included sucralfate and levothyroxine sodium.  On 13-NOV-2020, the patient was vaccinated with 2 shots of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (reported as "pneumonia vaccine" but lot # confirmed it was Company product) injection, prefilled syringe, intramuscularly, lot # T016159, expiration date was not reported but upon internal validation process, it was established as 28-FEB-2022 (dose and anatomical location were not reported) for prophylaxis (overdose).  On the same date, the patient started experiencing side effects and an allergic reaction to pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23). Her whole arm swelled up and it affected her arm muscles "intermittently". She was having a fever and was feeling disoriented and she was not able to bend her arm. At the reporting time, she was still feeling sharp pain at the injection site. She sought medical attention, but she did not receive any treatment for the event. No laboratory diagnostics or studies were performed. The outcome of the events was reported as not recovered.  The reporter considered side effects and an allergic reaction related to pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23). The causality assessment between the rest of the events and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not provided. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck. devicelotnumber: T016159; expirationdate: 28-FEB-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2101USA013273:
Information has been received from a nurse practitioner via Pfizer concerning a currently 66 year old female patient. The patient's medical history and concomitant therapy were unknown. On an unknown date, the patient was vaccinated with PNEUMOVAX23 (lot#, expiration date, dose and route unknown) for prophylaxis. On an unknown date, the patient experienced allergy to PNEUMOVAX23. The outcome of allergy to vaccine was unknown. The reporter considered the event to be related to PNEUMOVAX23. Additional information has been requested.
Feel awful; Weak; extremely fatigue; chills; fever of 101; Nauseous; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Feel awful), ASTHENIA (Weak), FATIGUE (extremely fatigue), CHILLS (chills) and PYREXIA (fever of 101) in a 91-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.     The patient's past medical history included No adverse event.    On 09-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, the patient experienced FEELING ABNORMAL (Feel awful), ASTHENIA (Weak), FATIGUE (extremely fatigue), CHILLS (chills), PYREXIA (fever of 101) and NAUSEA (Nauseous). At the time of the report, FEELING ABNORMAL (Feel awful), ASTHENIA (Weak), FATIGUE (extremely fatigue), CHILLS (chills), PYREXIA (fever of 101) and NAUSEA (Nauseous) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Feb-2021, Body temperature increased: 101 High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant medications was not provided by the reporter. Treatment information was not provided.   This case was linked to MOD-2021-013041 (Patient Link).
Patient came in and was due to get shingles vaccine #2. Vaccine was given at around 4:20pm. Once vaccine was given by medical assistant and upon her documenting the expiration date was 5/7/2022 given on 6/6/2022. Medical Assistant notified provider and notified Clinic Supervisor regarding expired Shingrix #2  given. Provider informed MA to disclose with patient that vaccine was expired however might not be as potent as an unexpired shingles vaccine and to keep a look out on any adverse side effect or allergic reactions that could possibly be given due to vaccine . MA disclosed the information with patient he understood. Provider wants for patient to wait until next visit 8/4/22 to reevaluate if shingles #2 will be given to patient. Patient waited for about 30 minuets after vaccine given to ensure of any possible reaction. Patient before leaving did not present with any adverse reactions and was informed by Supervisors to please call us or go to ER if any symptoms arise and patient verbally understood.
Patient was underage at time of vaccination. Patient received her first dose of Moderna at Pharmacy on 5/28/21. She returned for her second dose, but they were out of stock. She came here to complete her series. I called pharmacy to verify, and the pharmacist stated that he had received an email that approved Moderna for 16+ years old but now could not find it. Patient experienced no side effects after her first dose. I completed her series with her second dose.
The patient developed diarrhea 3-4 days after receiving the second dose of ROTATEQ; The patient then developed diaper rash; This spontaneous report was received from a nurse referring to a 4-month-old female patient.  The patient was born premature at 36 weeks gestation. Patient did not have concomitant medications and no known drug allergies (NKDA) were reported. On an unknown date in 2023, Coombs test was positive.   On an unspecified date in 2023, the patient received the first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral (strength, dose, vaccination scheme frequency, lot number and expiration date were not provided) as prophylaxis. The patient tolerated this first dose with no difficulty and did not have any side effects. Then, on 15-AUG-2023, she was vaccinated with the second dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), 2 mL, lot number X004919, expiration date: 04-JUN-2024, administered orally as routine vaccination (strength was not provided).  On an unknown date in August 2023 (reported as 3-4 days after receiving the second dose of the suspect vaccine), the patient developed diarrhea. The patient had diarrhea about 10 times a day for eleven days. Consequently, she then developed diaper rash due the diarrhea on an unspecified date in August 2023. No treatment was given for the event. On an unknown date in August 2023, the patient recovered from diarrhoea. The outcome of dermatitis diaper was not reported.   The causal relationship between rotavirus vaccine, live, oral, pentavalent (ROTATEQ) and diarrhea was not provided, while with diaper rash was not related.  Upon internal review, diarrhea was determined to be a medically significant event.
Fever, chills, body aches, vomiting within 4 hrs of vaccination.
PCV-13 administered on 4-27-2011. Parent called & was seen on 4-30-11 for (L) arm redness & warmth at site of vaccine injection.
sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (sore arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced PAIN (sore arm). At the time of the report, PAIN (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Moderna COVID vaccination received on 1/31/21.  Red, rash-like itchy spots on chest and back appeared on the evening of 1/16/21.
8 days after administration patient developed itchiness followed by erythema, calor, and induration at the injection site.  This initially was about 3x3 cm and has gradually grown over the past 24 hours to 5x5 cm in size with some mild pain to palpation.
Patient reported an asthma exacerbation and flu symptoms on 7/10/2021.  They resolved within 24 hours.
Received dose 1 as Moderna on 2/4/21.  Received Pfizer as dose 2. Noted no one asked him if he was there for dose 1 or 2 and that he was given a new card with the pfizer dose - wonders if they thought he was there for dose 1. Confirmed with clinic lead that this was not just a documentation error but received Pfizer as dose 2 after receiving Moderna as dose 1.
Information regarding Prevnar was received from a healthcare professional regarding a 9-month-old male patient who developed bacteremia and experienced titers less than 1 mcg/ml for serotypes 6B and 23F. The patient received the third dose on an unspecified date. The patient was hospitalized on 07-Feb-2007 with bacteremia. Antibody tests performed revealed less than 1 mcg/ml for serotype 6B and 23F. The child was discharged in stable condition.
Date: 5/28/09. Vaccines were administered and the patient remained in the exam room in a supine position for 15 minutes, with an additional 10 minutes spent in the clinic. One hour later, she presented to the school nurse with complaints of dizziness and nausea. Per the school nurse, her BP at that time was 88/62, pulse 96. (Her BP on previous exam ranged from 97/66 to 110/73). She had no dyspnea, pruritis, hives, diaphoresis, or mental status changes. Her nausea improved, but she complained of a headache after 15 minutes, at which point her BP was 88/64, pulse 76. At discharge home in the care of her parent, the school nurse also reported the patient's entire right arm was warm to the touch, with tremors. The patient experienced brief dizziness when she first sat up, but recovered quickly. OTC BENADRYL was administered by patient's mother. The patient returned to school the following day and reported no further episodes.
shingles; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: Unknown), via an unspecified route of administration on an unspecified date as 2ND DOSE, SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The 2 weeks after receiving second dose of vaccine patient developed shingles on an unspecified date. The patient stated that patient knew 6 other people in patients age group (50s - 60s) that also developed shingles as well, 14 days after your vaccine. Patient had to be hospitalized for an afternoon and the doctors said that the vaccine could have definitely woke up the sleeping virus in body. This has been an extremely painful experience, but patient still would have gotten the C19 vaccine. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
This spontaneous report as received from a pharmacist refers to a patient of unknown age with unspecified cancer "on the left side of patient's body". On 21-OCT-2014 the patient was vaccinated with PNEUMOVAX23 (dose, route and lot # was not reported) and influenza virus vaccine (manufacturer unknown) in the right arm. Concomitant therapies included Anastrozole. On 31-OCT-2014, the patient experienced a high fever and injection site reaction (redness, swelling) and went to unspecified Emergency Room. The outcome of injection site reaction (redness, swelling) and a high fever was unknown. Additional information has been requested.
This spontaneous report as received from a consumer refers to her 83 years old mother. The patient was vaccinated with a dose of ZOSTAVAX (Lot # not reported) on an unknown date in August 2012. The patient's relevant history, concomitant medications and past drug history were unknown. The consumer reported that on an unknown date in August 2012, the patient got the shingles. It was unknown if there was any relevant laboratory data. As of 15-SEP-2012, she had no had another ZOSTAVAX and her outcome of having the shingles in August 2012 was unknown. Additional information is not expected.
Left upper arm slightly swollen and red, started yesterday. Denies fever or pain. Gave Tylenol 7-23-08.
With in 2-5 min after getting immunization pt slumped down on the door where she was standing,her arms became somewhat rigid. No seizure activity noted. Pt responded within 15-20 seconds and said I must have been sleeping. Her color did not change, skin not clammy, respiration appeared nml, HR felt but not counted.
patients were administered with FLUZONE HIGH DOSE QUADRIVALENT that was NOT viable due to temperature excursion, no AE; Initial information received on 20-Nov-2020 regarding an unsolicited valid non-serious case from another health professional.    This case involves 20 patients of unknown demography who were administered with INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (lot number not reported via unknown route in unknown administration site that was not viable due to temperature excursion, on an unknown date.   Medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   It was a case of actual medication error due to incorrect product storage.   At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information on the batch number for this case.
pt recv vax & 16JAN97 devel t103 gave APAP, temp cont 17JAN97 made appointment w/MD;210PM had sz lasting 2min had approx 6 more sz lasting 45sec in MD office;temp inc 104-105;on d/c 18JAN97 t102;
Muscle sore; Redness 4-5 inches size; Itching; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Redness 4-5 inches size), VACCINATION SITE PRURITUS (Itching) and MYALGIA (Muscle sore) 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 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jan-2021, the patient experienced MYALGIA (Muscle sore). In January 2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness 4-5 inches size) and VACCINATION SITE PRURITUS (Itching). In January 2021, MYALGIA (Muscle sore) had resolved. At the time of the report, VACCINATION SITE ERYTHEMA (Redness 4-5 inches size) and VACCINATION SITE PRURITUS (Itching) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Pt. felt chills and delirious, confused for 3-4 minutes. Injected EPI  pen, Pt. sat for 5 minutes and we called 911 paramedic took to hospital, was stable BP. 114/85, pulse 72 was released after few hours.
Patient in for doctor's visit and was ordered Gardasil vaccination. Patient received vaccination and was instructed to remain in waiting are for 20 minutes after immunization. Patient was apprehensive from begining and stated that she did not like needles. Patient left immunizations room and went to front desk to make appointment and had a syncope episode at front desk. When called to front desk a provider and staff were tending to patient by placing legs above heart and patient was awake and coherent.
Immediate funny taste in back of nose, back of throat. Tingly tongue. In about 15 minutes, cheeks numb and swollen feeling.
13JAN97 as part of routine employee-pre-exposure prophylaxis;pt devel fatigue & resp dx on 23JAN97;the following day devel diffuse exanthem clinically consistent w/varicella;
This spontaneous report as received from a 73 year old female patient reporting on herself with high blood pressure, sulfa allergy, penicillin allergy, "lisitipril" allergy and allergy to eye drops. The patient's medical history included breast cancer. In October 2012 the patient was vaccinated with ZOSTAVAX subcutaneously (1 time vaccine, route, lot number and expiration date not reported). Concomitant therapies included CRESTOR, COREG, SYNTHROID, "Novax" and AVAPRO. On 20-JUN-2013 the patient stated that she had what she believed was an outbreak of shingles on her left injection side, on her left upper arm, and under her left breast. No treatment was given for the event. No lab diagnostics studies were performed. The patient did not seek for medical attention. The outcome of the event was unknown. Additional information has been requested.
No adverse event occurred, the child was given the correct dose amount out of the incorrect vial for age.
10 min after getting Tdap & Flu vaccines pt. looked pale then had a syncopal episode & per mom was not breathing well. She then had 10-15 sec of tonic clonic activity in arms & legs plus loss of bladder after episode pt very mildly postictal but was awake & alert with nl VS. No prior hx of szs. No URI or other sxs before vaccines. Obs. in clinic >1 hour & back to baseline.
This spontaneous report as received from a pharmacist refers to a female patient of who was about 65 to 70 years of age. No medical history was reported. On 18-NOV-2014, the patient was vaccinated with ZOSTAVAX (dose and frequency not provided). The concomitant therapy included anticoagulant (unspecified). The patient who received ZOSTAVAX contacted a pharmacy on 20-NOV-2014, complaining of "a golf-sized area of raised, red skin". The pharmacist had not directly observed this injection-site reaction, but he states that the patient reproted that surrounding the "golf-ball-sized area" was an area of dark pink skin "about the size of a tennis ball." The pharmacist contacted the service call center inquiring about what was considered "a typical injection-site reaction" for ZOSTAVAX. He reproted that he was not in the pharmacy with which the patient made contact. He state that he would be seeing the patient on 21-NOV-2014, and that he would be able to provide more details at that time because he would be having access to the patient's information. The pharmacist reported that He did not know whether or not the patient was developing a rash. The outcome of the events was unknown. The Causality assessment was not provided.
Difficult to breathing; Chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Difficult to breathing), CHILLS (Chills) and HEADACHE (Headache) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Sep-2021, the patient experienced DYSPNOEA (Difficult to breathing), CHILLS (Chills) and HEADACHE (Headache). At the time of the report, DYSPNOEA (Difficult to breathing), CHILLS (Chills) and HEADACHE (Headache) outcome was unknown.            No concomitant medication reported. No treatment information was provided
area got the first shot in a week ago is warm; area got the first shot in a week ago is itchy; area got the first shot in a week ago is hard; area got the first shot in a week ago is red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (area got the first shot in a week ago is warm), VACCINATION SITE PRURITUS (area got the first shot in a week ago is itchy), VACCINATION SITE INDURATION (area got the first shot in a week ago is hard) and VACCINATION SITE ERYTHEMA (area got the first shot in a week ago is red) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (area got the first shot in a week ago is warm), VACCINATION SITE PRURITUS (area got the first shot in a week ago is itchy), VACCINATION SITE INDURATION (area got the first shot in a week ago is hard) and VACCINATION SITE ERYTHEMA (area got the first shot in a week ago is red). At the time of the report, VACCINATION SITE WARMTH (area got the first shot in a week ago is warm), VACCINATION SITE PRURITUS (area got the first shot in a week ago is itchy), VACCINATION SITE INDURATION (area got the first shot in a week ago is hard) and VACCINATION SITE ERYTHEMA (area got the first shot in a week ago is red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were provided. No treatment information was provided.
Hives on injection site - left deltoid  and took ZYRTEC and hives resolved.
Patient received 2nd dose too early. 15th day instead of 21st day. Patient had verbally confirmed that it had been 3 weeks prior to giving the shot. Pharmacist realized after date was shown on patient's card (they had incorrectly filled the form). No adverse effects of patient. Patient is leaving in 2 days overseas to Africa and wanted to get her 2nd dose early.
(+) rash neck, arms, chest, back and legs, body aches, headache, fever.
L arm pain, weakness both arms, burning sensation, shakiness; now 2 months out still having this pain - persisting, occasional shakiness when going to write, numbness in hands
No swelling, fever, or redness. No abnormal signs or symptoms. Hepatitis A vaccine given mistakenly for HIB. Patient will come back for HIB.
Immediately after receiving flumist, pt felt nausea and vomited once. She subsequently felt progressively better.
dizziness; kind of a headache; has not been able to drive; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), HEADACHE (kind of a headache) and IMPAIRED DRIVING ABILITY (has not been able to drive) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     Concurrent medical conditions included Sleep disorder. Concomitant products included Norityptiline for Sleep disorder.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (dizziness), HEADACHE (kind of a headache) and IMPAIRED DRIVING ABILITY (has not been able to drive). At the time of the report, DIZZINESS (dizziness), HEADACHE (kind of a headache) and IMPAIRED DRIVING ABILITY (has not been able to drive) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.