chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; Patient received their second dose of Moderna Monovalent from an expired vial; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received their second dose of Moderna Monovalent from an expired vial) and NO ADVERSE EVENT (No adverse event) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 057A22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 07-Nov-2022, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received their second dose of Moderna Monovalent from an expired vial). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received their second dose of Moderna Monovalent from an expired vial) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient received their second dose of Moderna Monovalent from an expired vial).    No concomitant medications were reported.  Vial size was reported as 5.5 mL The vial was initially stored in the refrigerator on 04-Nov-2022. The vial did not undergo any temperature excursions.  No treatment medications were reported.
Fatigue, nausea, starting 6 hours after vaccination.  Slept 18 hours, temperature 97, blood pressure 118/70, pulse 72, rate 16. site- normal.
Pt was given Rotavirus out of range preferred pt is 15 months, pt broke out with rash on stomach.
Information has been received from a physician concerning a female who was vaccinated with her first dose of GARDASIL vaccine (yeast). Concomitant suspect vaccination included second of third dose of hepatitis B virus vaccine (unspecified). The physician reported that within 24 hours of vaccination, the patient had hives and then had angioedema of her lips. The patient sought unspecified medical attention. Additional information has been requested.
- severe neck and mid-back pain started 1 day after vaccine (biggest adverse reaction) -dull pain when swallowing  -muscle weakness in right upper arm -slight fever day 1 -night sweat on day 2 -1+ week (ongoing)
This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a female patient who received SHINGRIX. In March 2018, the patient received SHINGRIX. In March 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain and injection site tingling. On an unknown date, the outcome of the injection site pain and injection site tingling were recovering/resolving. The reporter considered the injection site pain and injection site tingling to be probably related to SHINGRIX. Additional information was reported as follows: The age at vaccination was not reported, but the patient was over 60 years of age. The patient received SHINGRIX two weeks before the reporting date and had been experiencing injection site area pain and tingling since administration. The healthcare professional did not have full patient demographics or vaccine information at the time of the reporting.
This case was reported by a other health professional via sales rep and described the occurrence of lip swelling in a male patient who received BEXSERO. Concomitant products included BEXSERO. On an unknown date, the patient received the 2nd dose of BEXSERO. On an unknown date, unknown after receiving BEXSERO, the patient experienced lip swelling and welts. On an unknown date, the outcome of the lip swelling and welts were unknown. It was unknown if the reporter considered the lip swelling and welts to be related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced pain, redness and swelling at the injection site with the first dose of BEXSERO. This case was reported via vaccine inside sales representative at time of report of reaction to second dose. No lot number or expiration date or further details were reported. The physician was expected to call with a more detailed report. This case has been linked with case US2017109005 (same patient, reported for 1st dose of BEXSERO).
High fever (103-104), runny nose, cough, for 6 days. Suspected bronchiolitis but this was ruled out.
Flu vaccine was administered on 9/23. Pt developed severe cramping in thighs on 9/24 upon exertion. Pain and cramping caused the patient to fall. She was then taken to the physician. The patient needed help walking. MD gave TORADOL injection and prescribed FLEXERIL 10 mg 1 TID. This reduced cramping so patient was able to walk without assistance. Cramping has reoccurred with exertion. Blood work performed 9/30.
Vaccination error (Medication error) A non-serious, spontaneous report of 17-month-old female was given FLUMIST was received from a pharmacist in the United States. There was no adverse event associated with this medication error; therefore treatment and reporter/sponsor causality assessments are not applicable and the event is considered resolved. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Additional information received 12-Nov-2008. There were no events reported for the patient since vaccination.
heart pounding due to fever but quickly resolved.; felt feverish; Pharmacist also hit a nerve during the injection process and felt a pain throughout his entire arm.; This spontaneous case was reported by a patient and describes the occurrence of HEART RATE INCREASED (heart pounding due to fever but quickly resolved.), PYREXIA (felt feverish) and VACCINATION SITE PAIN (Pharmacist also hit a nerve during the injection process and felt a pain throughout his entire arm.) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 049121A, 060H21A, 040B21A and 027C24A) for COVID-19 vaccination.     The patient's past medical history included Shingles. Concomitant products included ATORVASTATIN, EZETIMIBE (ZETIA), ALIROCUMAB (PRALUENT) and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.   On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (Pharmacist also hit a nerve during the injection process and felt a pain throughout his entire arm.). On 24-May-2022, the patient experienced HEART RATE INCREASED (heart pounding due to fever but quickly resolved.) and PYREXIA (felt feverish). At the time of the report, HEART RATE INCREASED (heart pounding due to fever but quickly resolved.) had resolved and PYREXIA (felt feverish) and VACCINATION SITE PAIN (Pharmacist also hit a nerve during the injection process and felt a pain throughout his entire arm.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medications were reported.   This case was linked to MOD-2021-083015, MOD-2021-162188 (Patient Link).
Hospitalization for Pneumonia due to COVID-19 on dates  7/1/2023- 7/5/2023. Treated with dexamethasone, Remdesivir, vitamin C 1,000 mg PO daily, vitamin D 25 mcg PO daily, zinc 50 mg PO daily.
Soreness, pt stated that he was unable to bend and it just ached for over 2 weeks now
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 50-year-old female patient who received SHINGRIX (batch number 27J4P, expiry date 20th April 2019) for prophylaxis. On 18th October 2018, the patient received the 1st dose of SHINGRIX. In October 2018, less than a month after receiving SHINGRIX, the patient experienced nausea, headache, scab and pain in thumb. On 18th October 2018, the patient experienced injection site pain, bone pain, neck pain, feeling abnormal and pain. On 21st October 2018, the patient experienced rash, blister and burning sensation. On an unknown date, the outcome of the injection site pain, neck pain, scab, feeling abnormal and pain were not recovered/not resolved and the outcome of the bone pain, rash, blister, burning sensation, nausea, headache and pain in thumb were recovered/resolved. It was unknown if the reporter considered the injection site pain, bone pain, neck pain, rash, blister, burning sensation, nausea, headache, scab, pain in thumb, feeling abnormal and pain to be related to SHINGRIX. Additional details were provided as follows: The patient had no history of getting shingles. The patient was told by her physician to call GSK because the company needed her details. The patient did not know if her physicians reported the side effects to GSK. The patient had her dose of SHINGRIX in her left deltoid and on the same day of the SHINGRIX injection she experienced pain in her left deltoid. The pain radiated to her bones and to that left side of her neck. She said the whole area and around where she received the injection was in pain. It was like a dull achy feeling. Three days later the vaccination, the patient on her left forearm she had an angry looking spot, that started spreading on her arm where she got the injection. She started getting blisters, pain, hot burning feeling that she described as hot lava going down her arm and neck area on that side where she got the vaccine. The patient also experienced nausea and headache. Her blisters were gone at the time of reporting but the area still looked scabby. She could still see the marks where she had the blisters and the pain was still on her left arm and left side of her neck. She mentioned that even her left thumb was in pain. Even two days ago, she had pain on her thumb and had nausea from the pain. The patient had visited her physicians three times about these symptoms. The reporter consented to be followed up. The patient had provided the details of her physicians.
Information has been received from a health professional concerning a 20-month-old white male with no pre-existing allergies, birth defects or medical conditions, who on 21-JUL-2006 was vaccinated subcutaneously in the left thigh with a first dose of Varivax (lot# 65351/0346F). There was no illness at the time of vaccination. On 25-SEP-2006 the patient developed 7 vesicles on his abdomen and a rash on his face. No fever was noted. The patient was seen by a physician on 26-SEP-2006 and was diagnosed, no laboratory or diagnostic tests were performed. Subsequently, the patient recovered as of 02-OCT-2006. It was also noted that the child goes to daycare. Additional information has been requested.
pt recvd 2nd dose of vax on 5MAR92 & pt exp a vasovagal episode & recovered w/in 24 hrs; No further details were provided;
I received the pfizer vaccine for covid in 2021 and since that time I have been having joint pain in both hands and in elbow area; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: The reporter is the patient. A patient (no qualifiers provided) received BNT162b2 (BNT162B2), in 2021 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ARTHRALGIA (non-serious) with onset 2021, outcome "unknown", described as "I received the pfizer vaccine for covid in 2021 and since that time I have been having joint pain in both hands and in elbow area". Additional information: Patient would like to discuss this with someone. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
3Jan96 pt vax SC 1 dose varicella virus vax live. Pt exp mild case of chickenpox (8 lesions) & fever. Pt recovered 15Jan98.Pt exposed to sibling who devel chickenpox after vax w/varicella virus vax live.(WAES98011528) -See comments
Administered Menactra and TDAP to Left Deltoid, after TDAP inj. Student had syncopal episode for approx. 5-10 seconds. Student came to, states was feeling a bit dazed. Assisted to infirmary to lie down and to monitor. Monitored for 1 hour, had no other signs of syncope, VSS.
After the injection my lips started to tingle and not long after my lips and tongue felt numb; After the injection my lips started to tingle and not long after my lips and tongue felt numb.; This is a spontaneous report from a contactable consumer (patient). A 41-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN6202, Expiry date: not reported), via an unspecified route of administration, administered in Arm Left on 27Feb2021 at 16:15 (at the age of 41-year-old) as Dose 1, Single for COVID-19 immunization at hospital. Medical history included asthma from an unknown date and unknown if ongoing. There were no concomitant medications. No allergies known. If other vaccine in four weeks and other medications in two weeks was mentioned as no. If COVID prior vaccination and if COVID tested post vaccination was mentioned as no. The reporter stated on 27Feb2021 at 16:30 approximately 20 minutes after the injection my lips started to tingle and not long after my lips and tongue felt numb. My provider advised over the phone that I take an anti-histamine, which helped.  Adverse event resulted in none of the above. The outcome of events was recovering.  Lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Moderna COVID-19 Vaccine EUA   - Itchy, red, warm at injection site 8 days after injection.    - Followed 1.5 hours later by headache, fatigue, body aches.  Treated with ice pack and rest.  Contacted nurse @ PCP office.  Advised COVID test and isolation pending results.  Forwarded concerns to allergist for consult.  - Next day, injection site itchiness and warmth did not subside, redness around site expanded.  COVID test taken at 8:45am.  Allergist awaiting results of test, instructed to watch for cellulitis.  Continuing with isolation, ice/compression, and rest pending test results.
4 days after receiving the initial vaccination she began to have nausea and vomiting.  She had no signs of an infectious process. Weight prior to this was 123 lb.  Current weight is 108 lb.  She has persistent nausea, difficulty swallowing, constipation and urinary retention.  Recent hospitalization with extensive work up could not identify and infectious, metabolic or anatomic cause.
This spontaneous report as received from a physician refers to a male patient of unknown age. The patient's concurrent conditions and medical history were not reported. On 16-JUN-2015 the patient was vaccinated with GARDASIL 9 (unknown strength and dose) intramuscularly. Concomitant medications were not reported. On 27-JUN-2015, the patient had an adverse event after receiving the GARDASIL 9 and was diagnosed with erythema nodosum 11 days after receiving the initial GARDASIL 9 injection. The patient sought medical attention and visited physician's office and received MOTRIN as treatment in response to the event. The outcome of erythema nodosum was unknown. Causality assessment was not provided. There was no product quality complaint involved. Additional information has been requested.
Information was received on 06-JUL-2017 from an attorney in the form of an initial spontaneous report regarding a male patient (age not provided). On or about 06-NOV-2014 the patient was vaccinated with ZOSTAVAX as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent and chronic strain of herpes zoster and herpes zoster eye keratitis. On or about 03-APR-2015, the patient was treated by a physician assistant for a blistering vesicular outbreak which was diagnosed as severe herpes zoster, or shingles. On or about each of the date of 15-APR-2015 and 11-MAY-2015, the patient was treated again by the physician for continued and worsening symptoms of shingles outbreaks that had spread onto his face. On or about each of the dates of 21-JUL-2015, and 25-AUG-2015, the patient sought further treatment for the physician for new and worsening symptoms of shingles that had now spread to the eyes and scalp. He was then referred to an Ophthalmologic specialist for blurred and double vision. On or about 28-JUL-2015, the patient was treated by a physician for vision interruptions and painful blistering in the eye, which was diagnosed as herpes zoster eye keratitis. On or about 21-OCT-2015, 24-NOV-2015, and 22-DEC-2015 the patient had a medical encounter, during which he was treated by the physician to address symptoms of pain and interruptions in vision resulting from herpes zoster eye keratitis. On or about each of the dates of 26-JAN-2016, 29-FEB-2016, 25-MAR-2016, 19-APR-2016, 06-JUL-2016 and 15-NOV-2016 the patient received ongoing  treatment for worsening and uncontrolled herpes zoster eye keratitis which triggered an array of visual impediments and vision loss. On or about 21-MAR-2016 and 22-SEP-2016 the patient was evaluated by his primary care physician for new shingles outbreaks on his body in addition to the vesicles in his eyes and face. He was prescribed acyclovir, NEXIUM, LOTEMAX GEL, Refresh eye drops, PERCOCET, valacyclovir, ZOVIRAX CREAM and ZIRGRAN eye drops to attempt to manage and relieve his painful symptoms and damage to his eyes. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. Upon internal review, the events of persistent and chronic herpes zoster eye keratitis and vision loss were determined to be medically significant. Additional information has been requested.
As soon as I got the shot my arm hurt.  After about three hours my arm hurt to move, and I felt tired and my body ached.  I took 1 advil,  The advil did not help.   It felt like someone was stabbing my arm with a knife.  I could not even lay on my arm.  About 5 pm.  I was freezing so I took 2 advil . I put on a sweat shirt and sweat pants, got in bed and put two more covers on me.  I went to sleep and woke up around 11pm soaked.  Changed my clothes, took 2 more advil and bundled back up and went to bed.  Got up at 9 am on Saturday and still felt terrible all day.  Arm was still painful, still had body aches, fever and chills all day.  Did nothing but lay on the sofa.  I continued to take 2 advil every 6 hours all day long.  I had no energy, Went to bed around7pm and slept until Sunday around 9am.  On Sunday I did not take any advil.  I felt tired at first but then felt much better as the day went on.
This case was reported by a healthcare professional (nurse and subject) and described the occurrence of headache in a 58-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). Concurrent medical conditions included morning stiffness. Historic vaccination included seasonal influenza vaccine (non-gsk); Novartis; intramuscular; left deltoid given on 19 October 2011. Concurrent medications included RESTASIS, Vitamin D, Vitamin C and BIOTIN. On 18 January 2013 at 08:30 the subject received a dose of FLULAVAL (.5 ml, intramuscular, right arm). On 18 January 2013, immediately after vaccination with FLULAVAL, the subject experienced headache, stiff neck, muscle pain, eye lightening (described as "light going in and out of eyes"), neck burning, neck contraction, limited movement of neck, dizziness, and yellow vision. Within months after vaccination with FLULAVAL, the subject experienced chronic pain, hand pain, fatigue, arthralgia, weakness in thigh and decreased exercise endurance. The subject stated that since receiving the vaccination, she had "chronic pain that does not subside and her whole life is now different." Since receiving FLULAVAL, the subject stated that her morning stiffness did not "go away after exercising" and she had "trouble getting out of bed because the stiffness in her neck, back, and limbs are now chronic, occur every day and do not dissipate after exercising." She reported "pain in her left had that is ridiculous." She reported feeling "fatigued all the time and has myalgia and arthralgia that is listed in the FLULAVAL prescribing information." The subject described that she felt "like her muscles and tendons were too short so they pull. Her hands and feet hurt all the time and her thighs feel too weak." The subject stated that the contractions in her neck prevented her from moving freely. The reported ongoing muscle aches and pain. She reported that her "exercise endurance has been reduced (she has trouble doing lunges at work)." The healthcare professional considered the events were disabling. At the time of reporting the events were unresolved. The healthcare professional considered the events were probably related to vaccination with FLULAVAL. The subject stated that she was "certain that FLULAVAL caused all of these" events.
Patient received influenza vaccine instead of tetanus vaccine. Patient was informed of the mistake and both supervisor and provider were notified. Provider also spoke to patient afterwards.
Shingles; Information has been received from a lawyer regarding a case in litigation concerning an elderly female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the zoster vaccine live (ZOSTAVAX) by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 28-APR-2017, at age 65, the patient was administered the zoster vaccine live (ZOSTAVAX) vaccine by a pharmacist at a pharmacy (lot number, dosage and route of administration not provided). On an unknown date, the patient was treated by a physician for the following injury resulting from her zoster vaccine live (ZOSTAVAX) use: Shingles. The patient claimed damages as a result of: injury to herself, loss of consortium, loss of services, and economic losses. The outcome of the shingles is unknown.  Additional information has been requested.
G62.9 NEUROPATHY 7/9/2021 ESRD (END STAGE RENAL DISEASE)
red rash on chest & abd 2JUN97;not raised;enlarged lymph nodes lt inguinal area-rt inguinal area;tender pt kept grabbing self & say owie;fever 101 per mom;6JUN97 sleepy more than usual, fussy to see MD;
The staff member c/o fever, swollen lymph node  in the L axilla as well as local swelling and redness at vaccination site.