chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Shortness of breath not urgent.  recommended patient call physician or get examined by medical facility today.
Heartbeat unable to obtain of 14 week fetus Due date February 20, 2022
A report was received from a health care professional on 12 November 2003, concerning an unspecified number of vaccinees under 4 years who have inadvertently received Fluvirin on an unspecified date. On an unspecified date vaccinees under 4 years inadvertently received Fluvirin intramuscularly. The vaccinees did not experience any adverse symptoms at the time of reporting. There was insufficient information to determine the reporter's causality assessment. Update 1, 07 January 2004. A follow up report was received from a health care professional concerning a 2 year old female vaccinee who inadvertently received Fluvirin on 12 November 2003. On 12 November 2003, the vaccinee inadvertently received Fluvirin. The vaccinee did not experience any adverse symptoms at the time of reporting. No follow up pending, all information received. Multiple report master file. Cross reference with: PJP200400063, PJP200400064, PJP200400065, PJP200400066, PJP200400067, PJP200400068, PJP200400069, PJP200400070, PJP200400071, PJP200400072, PJP200400073, PJP200400074, PJP200400075, PJP200400076, PJP200400077, PJP200400078, PJP200400079.
rashes all across the chest; Armpit painful; armpits got really red; Swollen armpits,first started in right armpit and then to left armpit; smelly; received 2nd dose 41 days later; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received 2nd dose 41 days later), ERYTHEMA (armpits got really red), SWELLING (Swollen armpits,first started in right armpit and then to left armpit), SKIN ODOUR ABNORMAL (smelly) and RASH (rashes all across the chest) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0426204) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received 2nd dose 41 days later). On 08-Mar-2021, the patient experienced ERYTHEMA (armpits got really red), SWELLING (Swollen armpits,first started in right armpit and then to left armpit), SKIN ODOUR ABNORMAL (smelly) and AXILLARY PAIN (Armpit painful). On an unknown date, the patient experienced RASH (rashes all across the chest). On 05-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received 2nd dose 41 days later) had resolved. On 17-Mar-2021, ERYTHEMA (armpits got really red), SWELLING (Swollen armpits,first started in right armpit and then to left armpit), SKIN ODOUR ABNORMAL (smelly) and AXILLARY PAIN (Armpit painful) had resolved. At the time of the report, RASH (rashes all across the chest) outcome was unknown. Not Provided          Action taken with mRNA-1273 in response to the event was not applicable. Concomitant drug was not reported. Treatment for the event was not reported.
Information was received on 24-JUL-2017 from an attorney regarding a case in litigation concerning a female patient of unknown age. No information was received concerning the patient's medical history, concurrent conditions and concomitant medications. In or about 25-SEP-2012, the patient was vaccinated at a local pharmacy with ZOSTAVAX (lot number, dosage, and route of administration not provided), 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 strain of herpes zoster. On or about 13-OCT-2013, the patient was treated by a physician, for the onset of a painful vesicular outbreak accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, or shingles. The patient has been prescribed acyclovir for management of her persistent symptoms. 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 has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
p/vax pt began devel ulcers to nasal, oral & vaginal mucosa w/severe pain;pt seen  by MD;p/extensive work p pt negative for herpes or any STD;sx began subsiding on their own;
Localized reaction at injection site noted on Monday night (2/8), muscle is firm and inflamed. Red rash (non irritating) noted 2/9 AM at injection site.
got the vaccine, it gave shingles/suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by patient's siblings for his brother. The age at vaccination was not reported. The patient got the Shingle vaccine and it gave them shingles. This case was considered as suspected vaccination failure since the details regarding completion of primary immunization schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. This case is linked with US2021AMR252703, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR252703:same reporter, other patient
Dizziness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse effect (No medical history provided).    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jan-2021, the patient experienced DIZZINESS (Dizziness). At the time of the report, DIZZINESS (Dizziness) outcome was unknown.        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.   No concomitant medications were provided No treatment information provided
This spontaneous report was received from a registered nurse refers to 11 years old patient of unknown gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not provided. On 16-SEP-2016, the patient was vaccinated with improperly stored GARDASIL 9 (lot/batch number: M020103, dose, frequency, expiry date were not reported) for prophylaxis. The patient was vaccinated under Vaccines for Children Program (VCF). The vaccines underwent a temperature excursion of -0.3 C for 22 hours. The temporary temperature excursion was occurred in the fridge on 01-SEP-2016 however, it was not discovered till 26-SEP-2016. Digital data logger was involved. There was no previous temperature excursion. No adverse effects were reported. Product quality complaint (PQC) was not involved. Additional information has been requested. Sender's Comments: US-009507513-1612USA003706.
severe headache, chills, severe  body aches,  extreme fatigue , fever,  lasting app 30 hours, the next 24 hours had mild headache, aching and fatigue. Tylenol 500 mg 2 tabs, 3 doses taken with mild relief.   I felt like I had an extreme case of the flu
Note: Any requests for follow-up information on this case should be sent directly to the sponsor of this study, Sanofi Pasteur. This study case was received from the investigator on 12 November 2012. A 29-year-old male subject received the following vaccinations: On 23 July 2012 an injection of ACAM2000 (lot number not reported), on 18 July 2012 an injection of TYPHIM VI, sanofi pasteur SA (lot number not reported) and ANTHRAX (manufacturer and lot number not reported), and on 13 July 2012 an intramuscular injection of JAPANESE ENCEPHALITIS VACCINE (manufacturer and lot number not reported). The subject had no significant medical history. On 13 August 2012, the subject had a normal electrocardiogram (ECG). Troponin I results were not available. On 12 August 2012, the subject was diagnosed with acute pericarditis, unspecified. The outcome was not reported. Additional information will be requested from the investigator. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: None.
Pt has high functioning autism. Pt knew that she was going to get a shot and tried to sit still but when the needle touched her she moved. I tried to go as fast as I could go and when I looked at the volume after she moved her body there was a little more than half the dose still in the syringe. I am not sure how much actually got into the muscle though. Pt's mom decided that she would talk to her pediatrician and wait and see if anything changes with the new variant coming out as she does not want to make her daughter get this series and another if the guidance changes to a vaccine that is different. Pt's mom said she will see if she can talk her daughter into trying again if needed. Pt had barely turned 12 and was still pretty small so if half the dose or a little less did get in then it would be close to the kids dose.
She got her vaccine, her left foot up to her knee went totally numb/asleep.  She tried walking around and shaking it, rubbing it, trying to get some circulation back into it.  Then it lasted for about 10 minutes, then it subsided.  The next couple of days it had a sensation in it of numbness and pain/electrical type feeling going up into the leg, and further going up until she could feel it hit the lower part of her spine.  She had bent over and picked up some clothing and she could feel it hit the spine, severe pain.  She had to go and lay down and get off of her feet.  The sensation went up her lower limb and into her spine.  She felt it go into the tip of her other side of her body on the right side.  She went to the hospital on 6/1/21 and wanted to know what was going on.  They did an x-ray of her left foot and gave her 3 medications, Gabapentin, steroids and inflammation medicine and sent her home.  She FU with her pain management doctor who ordered some tests of her spine and got an injection of steroids to see if that would help, which did not help at all.  It grew and went into her upper body, her arms are totally weakness, has weakness in all of her limbs, burning and vibrating feeling inside with pain, electrical/numbness pain feeling.  She has been going to specialists/orthopedic surgeon, neurologist who ordered an MRI of the brain and cervical spine, and is awaiting those results.  They are supposed to do some electrical testing of her upper and lower body.  She does not have a diagnosis.  She had PT come out for 4 weeks, which was completed.   Her condition is getting worse and her doctors are trying to figure out what is going on and nobody is giving her an answer.   She is laying in a ball day and night in pain and goes where they tell her to find out what is wrong.  She feels as though she is going to be paralyzed soon.  She is able to walk a little, has a cane and a walker and if she does go out shortly will sit in the walker and can only push halfway down the isle and her legs give out and she has to have assistance to pull the walker to get her through the store.    She did not have any issues with her arms or legs before the vaccine.  She did have some lower back issues before, but nothing like this.
Ill; Temperature; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Ill) and PYREXIA (Temperature) 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 28-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced ILLNESS (Ill) and PYREXIA (Temperature). At the time of the report, ILLNESS (Ill) and PYREXIA (Temperature) outcome was unknown.            No concomitant medications were reported. No information regarding corrective treatment was reported by the patient.   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: NNI
HEAD GOT ALL CLOUDY AND FELT LIKE WALKING AROUND IN A FOG; DETERIORATING EYE SIGHT; REDDISH BROWN SPOT ON FOREHEAD; WHEN USING RIGHT HAND THE LEFT HAND RAISES; DECREASED STRENGTH IN THE LEFT HAND AND LEFT UPPER BODY; This spontaneous report received from a patient concerned a 66-year-old elderly male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number: Unknown, expiry: Unknown) dose was not reported, 1 total, administered on an unspecified date in MAR-2021 for prophylactic vaccination (Dose number in series 1). The batch number was not reported and has been requested.  On 30-JUN-2021, the patient experienced head got all cloudy and felt like walking around in the fog, eye sight start started to deteriorate, left hand had significantly decreased strength, left upper body also had significantly decreased strength, a reddish, brown spot on forehead, and when using the right hand, the left hand raises (Dose number in series 1). The reporter stated that there was no change of lifestyle prior to receiving the vaccine. The patient received booster covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number: Unknown, expiry: Unknown) dose was not reported, 1 total, administered at right arm on 03-Dec-2021 for prophylactic vaccination (Dose number in series 2). It was unknown if the patient experienced adverse events with covid-19 vaccine ad26.cov2.s. No concomitant medications were reported.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from head got all cloudy and felt like walking around in a fog, deteriorating eye sight, decreased strength in the left hand and left upper body, reddish brown spot on forehead, and when using right hand the left hand raises. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as the case assessed as non-serious
The vaccine expired on 15 May 2023, it was initially stored in the refrigerator on 20 May 2023 and administered on 20 May 2023.; No adverse event; they gave a Moderna booster on 20May2023, but the vaccine expired on 15May2023.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (they gave a Moderna booster on 20May2023, but the vaccine expired on 15May2023.), PRODUCT STORAGE ERROR (The vaccine expired on 15 May 2023, it was initially stored in the refrigerator on 20 May 2023 and administered on 20 May 2023.) and NO ADVERSE EVENT (No adverse event) in a 48-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 060F22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 20-May-2023, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 2.5 milliliter. On 20-May-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (they gave a Moderna booster on 20May2023, but the vaccine expired on 15May2023.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vaccine expired on 15 May 2023, it was initially stored in the refrigerator on 20 May 2023 and administered on 20 May 2023.) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (they gave a Moderna booster on 20May2023, but the vaccine expired on 15May2023.), PRODUCT STORAGE ERROR (The vaccine expired on 15 May 2023, it was initially stored in the refrigerator on 20 May 2023 and administered on 20 May 2023.) 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), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (they gave a Moderna booster on 20May2023, but the vaccine expired on 15May2023.) and PRODUCT STORAGE ERROR (The vaccine expired on 15 May 2023, it was initially stored in the refrigerator on 20 May 2023 and administered on 20 May 2023.).    No other vaccines in the 4 weeks prior to COVID-19 vaccine. The vial was initially stored in the refrigerator on 20 May 2023. The vial did not undergo any temperature excursions. Concomitant medication not reported.  Treatment medication not reported.
patient described that she felt  lethargic, dizziness, muscle weakness in legs and arms. she stated tongue felt heavy and numb.
Woke up with chills and 102 F fever 9 hours after second shot. Severe pain under left armpit (shot was in left arm).  Severe neck, shoulder and back pain. Chills  on and off and fever continued through 4am 4/18. Night sweats right before fever broke.  Gold ball size red inflamed mark where shot was given with slight itchiness began 4/18.
Pt recv vax on 12/1/97; approx 12/10/97 pt exp brachial neuritis, pain at vax site-LA; weak left hand
Information has been received from a nurse referring to an unspecified number of patients of unknown age and gender. Patients' concurrent conditions, concomitant medication and medical history were not provided. On unknown dates the patients were vaccinated with doses of improperly stored VARIVAX (Merck) (0.5 ml, subcutaneous, dose number, lot# and expiry date were not provided). No adverse event was reported. Additional information has been requested.
This spontaneous report as received from a healthcare worker concerning a patient of unknown age. No medical history and current conditions were reported. On an unknown date the patient was vaccinated with GARDASIL (lot # K005881, Expiry: 14-JAN-2017, 0.5 ml, intramuscular), which was improperly stored. No adverse events were reported. No product quality complaint was involved. No further information was provided. Additional information has been requested.
Reports she has pain mainly in her left side. Her legs. She could not bend over as it hurt too bad in the lower back to bend. Could not walk, left side. As of yesterday started on the right side. Now in the ER and cannot raise her right foot up. Slowly worsening.
I had a swollen upper left side , arm, and chest , severe pain, a uneasy feeling, and sharp or weird throbbing type pain ever so often. After a week of the symptoms getting worse and not stopping I went to the emergency room.
pt stated had gotten faint after flu shot couple years ago but was fine last year. Gave flu shot & insisted her to stay in store for 10-15 minutes. Manager spotted her on cameras from office going down at front register. went up, gave her chair to sit in, small sip of water. she has peaked but said her vision was better. suddenly she said she felt sick & started vomiting, vomited 2-3 times but said she felt better. suddenly got ash white & was not responding to my gestures.
Pt evaluated in clinic on 12/7/15 for rash. Petechiae had been present and increasing for 3 days. He was found to have platelets of 20,000 and was referred to Hemo/Onc for further evaluation and management. He has been followed by hematology and diagnosed with ITP. His platelet counts are slowly improving but not fully recovered.
Swelling, red spot, hard spot, painful, pins and needles in both feet and hands.
(L) arm upper swelling and redness 12 x 10 cm light red, mild induration was initially very red according to parent.
Influenza vaccination left upper arm 22May 2007. Pt had immediate pain (5/10) at the injection site which lasted 30 sec. About 6 hours later the pt noted redness and swelling from his shoulder to his elbow. He also had an achy pain (3/10) and itching around the injection site. He also felt tired and weak. He denied decrease ROM, strength, numbness/tingling in his left shoulder, arm or hand. He denied fever, N, V, diarrhea, rash, SOB, chest pain. Instructed to take Motrin and Benadryl which he did about 2 hours later. Pt slept all nite. Redness, swelling and pain were 50% better in the am. Itching had resolved. Pt took one more dose of Motrin and Benadryl that am. All sx resolved in 3-4 days.
MD office reported lacey maculopapular rash head to toe with fever of 102.
Left upper leg red, swollen, warm to touch.  Patient had no complaints of tenderness or pain.  Tylenol used to treat patient.
lower gums started swelling; ears swelled closed; skull hurt to lay that side on the pillow; This spontaneous case was reported by a consumer and describes the occurrence of GINGIVAL SWELLING (lower gums started swelling), EAR SWELLING (ears swelled closed) and HEADACHE (skull hurt to lay that side on the pillow) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B41A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced GINGIVAL SWELLING (lower gums started swelling), EAR SWELLING (ears swelled closed) and HEADACHE (skull hurt to lay that side on the pillow). At the time of the report, GINGIVAL SWELLING (lower gums started swelling), EAR SWELLING (ears swelled closed) and HEADACHE (skull hurt to lay that side on the pillow) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient checked with dentist on "Monday."  The dentist office provided antibiotics;    Treatment medication included antibiotics
Received vaccine on 29Oct2021 with an expiration date of 11Oct2021; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received vaccine on 29Oct2021 with an expiration date of 11Oct2021) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 29-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 29-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received vaccine on 29Oct2021 with an expiration date of 11Oct2021). On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Received vaccine on 29Oct2021 with an expiration date of 11Oct2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   no concomitant and treatment to the events not reported.