chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain and sickness. On an unknown date, the outcome of the injection site pain and sickness were unknown. It was unknown if the reporter considered the injection site pain and sickness to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The caller initially called inquiring about the ingredients in the vaccine. She then mentioned that she was speaking to her pharmacist regarding the vaccine whom informed her that she had received the vaccine and got very sick. She probed further and she stated that the pharmacist mentioned that her arm was very painful at the injection site. She states that she mentioned some other things but she could not remember what those things were. She could not provide any additional information. No other demographics provided besides gender.
Client was vaccinated with Pfizer vaccines on March 6 and March 21, 2021 at a public health clinic in the state.  Developed Covid symptoms on 8/30 - temp 103.9, myalgia, headache.  Treated on 9/1 with antibody infusion at  Hospital.  Fever have subsided and treated with Tylenol.
This initial non-serious spontaneous case, was received on 01-Nov-2017, from a physician, concerning an adult male patient of unspecified age. This refers 18 of 84 patients. On an unspecified date in Oct-2017 (between 25-Oct-17 to 27-Oct-17), the patient was administered with AFLURIA (TIV) Thiomersal (batch number: 14649211A, dose, route of administration, anatomical location and expiry date: not reported). It was reported that, the vaccine was stored in cooler with ice packs for 6 days and had reached unknown temperature during transport instead of storing at 36-degree F and 46-degree F. And the same was administered to the patient. The reporter stated that the temperature was not monitored on 24-Oct-2017 and there were no reports of adverse effect after vaccination. The vaccine had been discarded. Follow up received on 09-Nov-2017 from a physician: Added event and reporter's comment. Amended narrative accordingly.
used it past the 12 hours, administered to 3 patients today- 30Nov2021; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (used it past the 12 hours, administered to 3 patients today- 30Nov2021) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031H21A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 30-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (used it past the 12 hours, administered to 3 patients today- 30Nov2021). On 30-Nov-2021, EXPIRED PRODUCT ADMINISTERED (used it past the 12 hours, administered to 3 patients today- 30Nov2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant drugs were not reported. Treatment medications were not provided.  It was reported that the vial was opened on 29-Nov-2021 and also reported that last shot was received from different pharmacy on 08-Apr-2021.   This case was linked to MOD-2021-403053 (Patient Link).
Began having rashes/hives on my upper left chest.  This has continued and now also happens on my left side, back, left chest, left leg, and scalp.  We have treated with topical and oral steroids and have not found any other cause for this and it is all left sided body which would eliminate it being soap/detergent related.
pt fainted immediately after administration for approx 5 seconds, called 911, pat came to and was ok. she was checked out by EMS and pronounced OK
Extreme nausea; Dizziness; Extreme fatigue; Different waves of chills to the point of she could not even move; Different waves of chills to the point of she could not even move; sweating; severe headache; just crap now; Now she smells metal; she has no sense of smell other than stinky metallic smell; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), via an unspecified route of administration in the right deltoid on 30Dec2020 08:15 at a single dose for vaccination. The patient's medical history included tested positive for COVID-19 from Jul2020. There were no concomitant medications. Around 30Dec2020 9:00 AM, she began experiencing extreme nausea and dizziness, extreme fatigue, different waves of chills to the point of she could not even move, sweating, severe headache, and just crap now. The patient's physician told that this is something she should report. It could possibly have been an immune response because she had possibly been exposed to COVID-19 that she probably had some sort of antibodies from then until now on Dec2020, even though she tested negative for COVID-19 and continued to test negative for COVID-19 on 2020. She smells metal on Dec2020. She has no sense of smell other than stinky metallic smell. Her taste is fine. Outcome of the headache was not recovered, of the metallic smell was unknown, of the remaining events was recovered on 30Dec2020 13:00.
Crook of opposite arm developed a rash; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP-6955) via an unspecified route of administration in the left arm on 15Mar2021 at 15:00 (at the age of 58-year-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP-7533) via an unspecified route of administration in the left arm on 06Apr2021 at 15:00 (at the age of 58-year-old) as a single dose for COVID-19 immunisation. Medical history was reported as not really. The patient previously took Erythromycin (MANUFACTURER UNKNOWN) and Levaquin (MANUFACTURER UNKNOWN) and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included multivitamin (MANUFACTURER UNKNOWN) and esomeprazole magnesium (NEXIUM) both for unknown indications from unknown start dates and unknown if ongoing. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 17Mar2021 the patient developed a rash on the crook of opposite arm. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. The clinical outcome of the event developed a rash on the crook of opposite arm was not resolved, at the time of this report.   No follow-up attempts are needed. No further information is expected.
A non-serious spontaneous report of inadvertent administration of expired H1N1 was received from registered nurse/health professional concerning an eight-year-old female. Neither relevant medical history nor concomitant medications have been reported for this patient. The original expiration date was 08-Apr-2010, which was reassigned to 29-Mar-2010. On 31-Mar-2010, that patient received the second dose of H1N1, Intranasal for an unknown indication. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments were not applicable and the event was considered to be resolved.
Client age 11y 9m presented for primary series of COVID vaccination. Client was inappropriately vaccinated with Pfizer.  No adverse events noted at that time. On 9/12/21, client presented for 2nd dose in primary series. Client was identified as too young for vaccination at that time. Client was 11y 10m old at the time. Client was not given 2nd dose at this visit. Client and family member were informed of age requirement for  vaccination and error with initial administration. Client and family encouraged to return for completion of primary series after 11/9/2021.
Rec'd vaccine at 1600 hrs & began itching lower back in evening.  Itching inc'd next day all over body & arm.  Lt arm itching & burning intensely the 2nd day with intense red color.  Nausea for 2-3 days.  Report & event to Dr.
Shingrix administrated subcutaneous; This case was reported by a pharmacist via call center representative and described the occurrence of intramuscular formulation administered by other route in a adult female patient who received Herpes zoster (Shingrix) (batch number 2g2x7, expiry date 29th July 2023) for prophylaxis.   On an unknown date, the patient received Shingrix (subcutaneous). On an unknown date, unknown after receiving Shingrix, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the intramuscular formulation administered by other route was unknown.   Additional Information: GSK Receipt Date: 06-APR-2022 Reporter's Comment: No adverse event was reported . The Vaccine Administration Facility was the same as primary reporter. The reporter consented to follow up.  Additional Supportive Information: The reporter reported that a patient was administrated in another site(subcutaneous) Shingrix, which led to intramuscular formulation administered by other route.
This case was reported by a healthcare professional and described the occurrence of sensitivity to latex in an adult (age 25 to 30 years) female subject who was vaccinated with FLUARIX (GlaxoSmithKline) and ADACEL (Merck).  In November 2006 the subject received a dose of FLUARIX at 0.5 ml and ADACEL.  At an unknown time following vaccination with FLUARIX and ADACEL, the subject likely developed a latex sensitivity.  The event was unresolved and considered to be probably related to treatment with FLUARIX.  In November 2007, the subject again received a dose of FLUARIX at 0.5ml.  Fifteen minutes after vaccination with FLUARIX, the subject developed hives and itching.  The subject was treated in the emergency room with BENADRYL and symptoms resolved after an unknown time period.  The healthcare professional considered the events were clinically significant (or requiring intervention).  The healthcare professional considered the events were probably related to vaccination with FLUARIX.
This spontaneous report as received from a nurse refers to roughly 20 unspecified patients of unknown age. On an unknown date, roughly 20 unspecified patients were vaccinated with VARIVAX (Merck) (injection, strength, dose, frequency, route of administration and indication were not provided) that reached 18.5 F for 10 hours and 44 minutes. This range was outside of storage conditions in product insert; however, the reporter stated that their in house stability data can support those conditions mentioned above that the VARIVAX (Merck) was exposed to. No concomitant medication was reported. No adverse effects reported. No product quality complaint (PQC) was reported. The outcome of events was unknown. No further adverse event information was available. Follow up information (after previous telephone attempt to obtain follow up information which has been unsuccessful) has been received from nurse concerning VARIVAX (Merck) temperature excursion and one patient of unspecified age and gender who was vaccinated with VARIVAX (Merck) (injection, strength, dose, frequency, route of administration and indication were not provided) (lot # J012384, exp date: 31-OCT-2015) that reached 18.5 F for 10 hours and 44 minutes. This is one of several reports from the same source. Additional information has been requested.
I can't move my left leg.; It's painful from my knee down; My left arm is painful; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (I can't move my left leg.), ARTHRALGIA (It's painful from my knee down) and PAIN IN EXTREMITY (My left arm is painful) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 04A21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes.   On 18-Mar-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, the patient experienced LIMB DISCOMFORT (I can't move my left leg.), ARTHRALGIA (It's painful from my knee down) and PAIN IN EXTREMITY (My left arm is painful). The patient was treated with OXYCODONE HYDROCHLORIDE, PARACETAMOL (PERCOCET [OXYCODONE HYDROCHLORIDE;PARACETAMOL]) for Pain, at an unspecified dose and frequency. At the time of the report, LIMB DISCOMFORT (I can't move my left leg.), ARTHRALGIA (It's painful from my knee down) and PAIN IN EXTREMITY (My left arm is painful) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product was Diabetes medications. Action taken with mRNA-1273 in response to the events was Not Applicable.   This case was linked to MOD-2021-051815 (Patient Link).
1st bivalent booster on 5Sep2022 and accidentally he received a 2nd bivalent booster on 3Dec2022; No adverse event; 1st dose of Moderna COVID-19 Vaccine on 12Feb2021, 2nd dose on 29Aug2021; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose of Moderna COVID-19 Vaccine on 12Feb2021, 2nd dose on 29Aug2021), EXTRA DOSE ADMINISTERED (1st bivalent booster on 5Sep2022 and accidentally he received a 2nd bivalent booster on 3Dec2022) and NO ADVERSE EVENT (No adverse event) in a 76-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 059F22A) for COVID-19 prophylaxis.     Patient did not have any diseases, allergies or medical conditions.  Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 Vaccine on 12-Feb-2021, Moderna COVID-19 Vaccine on 29-Aug-2021, MODERNA COVID-19 VACCINE and BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5) on 05-Sep-2022; for Product used for unknown indication: influenza vaccine. Past adverse reactions to the above products included No adverse event with MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5), Moderna COVID-19 Vaccine, Moderna COVID-19 Vaccine and influenza vaccine.    On 03-Dec-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) Additional Booster. On 03-Dec-2022,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose of Moderna COVID-19 Vaccine on 12Feb2021, 2nd dose on 29Aug2021). On an unknown date, the patient experienced EXTRA DOSE ADMINISTERED (1st bivalent booster on 5Sep2022 and accidentally he received a 2nd bivalent booster on 3Dec2022) and NO ADVERSE EVENT (No adverse event). On 03-Dec-2022, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose of Moderna COVID-19 Vaccine on 12Feb2021, 2nd dose on 29Aug2021) had resolved. At the time of the report, EXTRA DOSE ADMINISTERED (1st bivalent booster on 5Sep2022 and accidentally he received a 2nd bivalent booster on 3Dec2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown Route), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose of Moderna COVID-19 Vaccine on 12Feb2021, 2nd dose on 29Aug2021) and EXTRA DOSE ADMINISTERED (1st bivalent booster on 5Sep2022 and accidentally he received a 2nd bivalent booster on 3Dec2022).    Patient did not experienced any adverse events after any of the vaccines. Concomitant medication not reported. Treatment medication not reported.
serum sick rash;bitten by confirmed rabid cat;will give last dose 20OCT95 & manage w/steroids;
75yr old female presents with swollen right elbow. According to EMS patient fractured her elbow about 2 months when she fell outside. Tonight staff noticed  increase swelling to right elbow. Staff unable to assist patient to standing from sitting on toilet and bruise on left upper arm.  Noted right elbow swollen-ice applied on arrival. Closed displaced fracture of medial epicondyle of right humerus, unspecified fracture morphology, initial encounter ASSESSMENT/PLAN/DECISION MAKING: Elevated WBC noted, patient isn't septic and UA clear. Noted mild elevated in MCV and platelet count in the past ( possibly bone marrow). Path smear is pending. Patient was given a normal saline bolus base line for dementia. I discussed with her POA (sister) she may do well with a Nursing home placement. She will also be getting tylenol 500 mg three times daily scheduled for pain.
I encountered extreme fatigue about January 1st 2022, followed by a lot of aches and pains and that evening. I had nasal congestion that was very strong. The very next day January 2nd, I went to next level urgent care and took a PCR and tested positive. Initially took vitamins and ten days later, I went back and did another PCR test and they put me on antibiotic plus steroid and seemed to improve January 17th and then I started feeling worse and tested positive again. Doctor said I had a nasal sinus infection on top of COVID which is impending my healing. Prescribed amoxicillin 875mg twice daily for 10 days and I tested positive for COVID 21 days and then approximately around January 22 or 23. I started feeling much better. The fatigue dissipated and the aches and congestion dissipated.
This spontaneous report as received from a registered nurse and refers to two children patients of unknown age and gender. No information was provided regarding the patients' medical history, concurrent conditions or concomitant medications. On 23-FEB-2018, also reported as "26-FEB-2018", the patients were vaccinated with an improperly stored dose of VAQTA injection 25/0.5 (units not provided), lot number N023953 with expiration date on 05-NOV-2018  (dose and anatomical location were not reported) for prophylaxis. The administered dose of the vaccine experienced a temperature excursion as listed, as recorded by a data logger. On 21-FEB-2018,  in the range between 32°F at 29 °F, worst case 1 hour. On 22-FEB-2018, in the range between 32°F at 30 °F , worst case 1 hour . On 26-FEB-2018, in the range between 32°F up to 35°F (32.44F), worst case 3 hours. The vaccines had not had any previous temperature excursions. There was no adverse effect reported. No product quality complaint was involved. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1803USA006071:
Information has been received from a registered nurse concerning a 17-year-old male who was "probably" vaccinated with a dose of varicella virus vaccine live. The nurse reported that the patient had either impetigo or break through chickenpox. On 04-Sep-2003 the patient presented to the doctor's office with several scabbed vesicles. On 04-Sep-2003 a viral culture was performed with negative results. The nurse noted that she was unsure if the patient was vaccinated with varicella virus vaccine live previously. Follow-up information was received from the registered nurse which indicated that "this patient did not have chickenpox after all." The reporter also noted that this was verified by a negative result on the culture swab. No further information is expected. The nurse also reported a similar reaction in a female patient after vaccination with a dose of varicella virus vaccine live (WAES #0309USA01236).
Dr, I received 2 vaccines last Monday. I have had many tetanus shots so I'm pretty sure that was ok but I had a severe reaction to the second shot, pneumonia vaccine that you should be aware of and report. My injection arm was swollen shoulder to elbow, hot, bright red, hard and itchy and even today there is some hardness to my arm. I had a 101 degree fever, chills, bone pain and achiness for 3 days that made me take to my bed. I would like you to tell me what was in that vaccine so I know what I am allergic to and make sure it is in my chart that I can't tolerate this vaccine. Until I know what I am allergic to I can't think about getting the shingles shot you recommend I get, in case some of the same is in this vaccine also.
Fever, aches, joint pain, nausea, vomiting, diarrhea
Information has been received from a Pharm. D. health care student concerning a 42 year old female who on 14-APR-2006 was vaccinated with hepatitis A virus vaccine inactivated IM. The patient also received ENGERIX - B administered on 14-APR-2006. The pharmacy student reported that the patient received her third dose of hepatitis A virus vaccine inactivated in the series and on 14-APR-2006 the patient experienced abdominal pain, nausea, and chills. As of 20-APR-2006, the patient was still having those symptoms in addition to stabbing pain from the pelvic bone to the epigastrium, cramps and cold sores. the patient had no known exposure to anyone who had been ill. No further information was available at the time of reporting. The patient sought unspecified medical attention. Additional information has been requested.
Tenderness on the vaccination site; This is a spontaneous report from a contactable consumer (patient) via Pfizer-sponsored program COVAX US Support.  A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, batch/lot number was not reported) via an unspecified route of administration on 23Feb2021 as Dose 1, Single for Covid-19 immunization. The patient medical history and concomitant medications were not reported. On 23Feb2021, the patient experienced tenderness on the vaccination site. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Evening of 12/31, one day after vaccination patient with extreme leg pain, non weight bearing, extreme swelling of limb from hip to knee, fever of 105. Patient responsive but somewhat lethargic per mom. Fever responded minimally to medication and resolved after 9 hours of continuous motrin/tylenol.
Broke out into rash and welts all over stomach, back, chest, and spreading to underarms and pelvis area.