chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt states that 2 hours after getting her 2nd GARDASIL injection she experienced 20 minutes of sweating, dizziness, and stomachache. She also had a headache, which continued into the next day, but Tylenol helped.
This case was reported by a healthcare professional (pharmacy student, 4th year) and described the occurrence of tardive dyskinesia in a 64-year-old female subject who was vaccinated with FLULAVAL TETRA (GlaxoSmithKline). On an unspecified date in 2013 the subject received unspecified dose of FLULAVAL TETRA (unknown). The pharmacy student was unsure which flu vaccine was administered, but based on lot number review the provided lot number of "35GY3" corresponded to FLULAVAL TETRA. In 2013, within months of vaccination with FLULAVAL TETRA, the subject experienced tardive dyskinesia. The pharmacy student did not have much information at the time of the report. At the time of reporting the outcome of the event was unspecified.
red, rectangular area just under the site of injection for 3-5 days, really tired on 11/21 (the day after immuinization), then progressively better over next 2 days.
pt recv vax & devel a fever of 103 & an inj site rxn characterized by warmth, redness & swelling which extended from shoulder to fingertips;tx w/DPH & aleve & then w/Duricef w/o relief sx;pt began to improve on 26FEB & recovered;
MMR vaccine administered 11/08/2005, mom noted rubeoliform rash on trunk, slightly noted on extremities and face.
Chills, fever, headache, nausea, vomiting and fatigue beginning at 1:50 am and ending about 8:30pm after taking Tylenol at 6pm
Within several minutes after patient received vaccine she began to feel nauseous, upset stomach, diaphoretic. After approximately 15 minutes with no improvement in symptoms EMS was contacted.  EMS came and assessed patient. Her blood pressure, pulse, and blood sugar were within normal limits.  After several minutes after EMS arrived patient began to feel normally. Patient refused further treatment and left facility on her own with a friend.
Eczema /hive like rash on shins (both left and right) lasting about two weeks before clearing.  I have had similar reactions due to allergic reactions in the past but for the past several years.  It looked remarkable similar to internet photos of "Covid Arm" Rash - but was on my shins.  Treated with Benadryl capsules at night,  hydrocortisone OTC cream and moisturizer until cleared - approximately 2 weeks
Initial report received on 22 October 2007 from a health care professional. A 62-year-old female patient, with a history of cirrhosis of the liver, had received a left deltoid, intramuscular infection of Fluzone SV 2007-2008, lot number U2500AA, on 11 October 2007. One to two days post-vaccination, the patient experienced joint pain and entire body pain. She was examined in an emergency room on 15 October 2007 and was treated with prednisone and morphine and discharged with a prescription for OxyContin. The patient returned to the emergency room on 22 October 2007 and was complaining of generalized pain throughout her body to the point of having difficulty moving. she was again treated with morphine. Diagnostic testing included a full blood profile, chest x-ray and sedimentation rate. Results of the testing were not provided. At the time of this report, the patient had not recovered. Follow-up information was received on 10 December 2007 from a health care professional. Based upon the new information provided in this follow-up, this case has been upgraded to serious. It was reported that the patient experienced joint pain and "wheezing" the same day she received Fluzone SV 2007-2008. She was treated in the emergency room. A chest x-ray was negative. The patient had no fever at the time of examination, but did complain of diffuse joint pain. Laboratory work done in the emergency room was negative. The patient was started on a Medrol dose pack (methylprednisolone) was given oxycodone. She was seen for a follow-up visit on 19 October 2007 and was "feeling back to normal" at that time. On 26 October 2007, the patient was seen in the physician's office with complaints of a stiff neck, shoulder, and wrist (right). She was in mild discomfort, but no distress. There was no lymphadenopathy. Range of motion was limited secondary to pain from the base of the skull radiating down the trapezius and bilateral shoulder. There was no bruising or apparent swelling. The patient was diagnosed with polyarthralgia, myalgia and cervical spasm with no meningeal sign. She was prescribed Flexeril and Vicoprofen for pain. The patient was seen by the physician again on 29 October 2007 for follow-up. At that time it was reported that the patient had been diagnosed with polymyalgia rheumatica and per the reporter, the polymyalgic rheumatica was "perhaps related to Flu shot but it would seem unlikely based on the temporal relation of onset (i.e. less than 24 hours)". The patient's medications at the time of examination included Nexium, Albuterol inhaler, prednisone, and Caltrate. Upon examination, it was noted that the patient had mild swelling and pain with range of motion of large and medium joints. The treatment plan included continuing with current management and follow-up with a rheumatologist. It was reported by the physician that the patient recovered from her symptoms on an unspecified date.
42 Patients received bivalent booster with 38 having improvement of symptoms; No adverse event; Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms; This spontaneous case was reported by a physician and describes the occurrence of OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms), THERAPEUTIC RESPONSE UNEXPECTED (42 Patients received bivalent booster with 38 having improvement of symptoms) and NO ADVERSE EVENT (No adverse event) in a patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for Long COVID-19.     No Medical History information was reported.    In 2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In 2023, the patient experienced OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms). On an unknown date, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (42 Patients received bivalent booster with 38 having improvement of symptoms) and NO ADVERSE EVENT (No adverse event). At the time of the report, OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms), THERAPEUTIC RESPONSE UNEXPECTED (42 Patients received bivalent booster with 38 having improvement of symptoms) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      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 OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms) and THERAPEUTIC RESPONSE UNEXPECTED (42 Patients received bivalent booster with 38 having improvement of symptoms).    Concomitant product use was not provided by the reporter.  Reporter called in to report success of non-indicated use of vaccine to treat long-haul COVID symptoms and asking to connect with research team. Reporter had been administering the 65 plus bivalent dose to her patients who have symptoms of "long-haul COVID" and had seen 88-90% success rate in resolving the symptoms of long-haul COVID.   Vaccine was given to the patients for long COVID between March 2023 and 01-Aug-2023. 42 patients received bivalent boosters with 38 having improvement of symptoms and 50 % or more.  Vaccine was given within current guidelines except seven were under 65.   Patients treated for skin lesions, brain related problem, systolic blood pressure was 220, tachycardia greater than 150, and body aches which was improved.   No adverse reactions occurred.  Treatment information was not provided.   This case contains information about patient 35 out of 42 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-735199 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-735199:Master case
Pt received DTaP immunization 23Feb15 seen at urgent care 3/1/15 for dx cellulitis (R) upper arm trx with KEFLEX.
Developed right-lower lobe pulmonary embolism, was on Heparin drip, discharged home on apixaban. Also has junctional bradycardia.
The evening and day following the immunization I did have a fever, my arm was warm and sore, which I expected. On Sunday the 10th, I was having itching on my chest at the tops of my breasts and around the anal/vaginal area.  It has gotten worse in the last few days, and has spread from the tops of my ears to my thighs.  I went to see the doctor at the clinic yesterday the 13th- I have no rash, no hives, no visible signs or symptoms.  I am not allergic to eggs, nor have I started any new medications, until now- now I am on prednisone and vistaril.  I have not changed my eating habits and I have not changed any soaps, detergents, etc.  As far as I know I have not been exposed to any other compounds or poisons, have not been in any weeds or anywhere. I do not think they have been spraying for anything.  The only thing I could think of was exposure to a scabies patient about a month or so ago, but I do not have a rash, and the scraping that the doctor took from my skin was negative.  My husband does not have any itching and he did not get a flu shot.  Other than us, we have some house pets, but they are not having any problems either, and they don't hang outside for long.  When they are, they are confined to our back yard and we have not been spraying for anything either.  I have been racking my brain since this all came about and this is the only thing that I can think of that was different about my life and surroundings.
Heart palpitations; This is a spontaneous report from a contactable consumer. This 44-year-male consumer reported that received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation was Solution for injection, Lot Number: EN9581), via unspecified route in Left Arm on 24Feb2021 04:00, as single dose for COVID-19 immunization ((age at time of vaccination 44 years). The patient medical history included Sinus arrhythmia. The patient concomitant medications included Omeprazole. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed COVID-19 Prior to vaccination, Since the vaccination, has the patient been tested for COVID-19 as no. On 25Feb2021 the patient started having heart palpitations. Just one or two in the evening on day 1. Much more on day 2. Then randomly for a few days. More regular on day 8. Today is a mixed bag. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
I got up and had a really bad headache and fatigue.  I did not go to work due to the headache.  I took a Tramadol, got an ice pack, placed it on my head and put some lavender on my pillow, called into work and went back to bed. I still have the headache and fatigue, but I am able to work so far.
improperly stored vaccine; This spontaneous report was received from a nurse and refers to a patient of an unknown age and gender. There was no information about the patient's concurrent condition, concomitant medication and medical history provided.  On 19-JAN-2021, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) lot number: T022294 (lot number: T02294 was verified as non valid), expiration date: 26-MAR-2022 (exact dose and route of administration were not provided) for prophylaxis.  The vaccine experienced temperature excursion of 46.7 degrees Fahrenheit for 5 minutes. Previous temperature excursion was not detected. The data logger was involved. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T022294; expirationdate: 26-MAR-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Shortly received TWINRIX and TYPHIM injections pt complained of dizziness and weakness. Pt fell to the floor. He almost fainted bit was coherent the whole time. Called 911 for pt. BP was checked BP 133/89 P: 81. Pt was taken into hospital to follow up.
PATIENT REPORTED REDNESS AND SWELLING FROM THE SITE OF INJECTION DOWN TO THE ELBOW.
That evening he started feeling "lousy" and proceeded into a really bad cold. As of today, 10;22.22 , it has only gotten a little better. He states he was not around anyone else that could have just given him a cold, without getting the flu shot.
About 10 minutes after the vaccine was given, patient came to the counter and told us she thought she was going to pass out.  We had her sit down, but she insisted on lying down.  We walked around to our office to do so.  Before we got sat down, she passed out.  She was lowered to the ground slowly and did not hit her head.  Staff from the doctor's office came to help. Her BP was low, HR was around 50bbm, breathing was shallow and quick.  She settled down very quickly after getting her legs elevated. She refused to remove her masks.  Dr's took her to adult medicine in the clinic to do an EKG.  On 9/29/22, we heard back from her and she is still feeling dizzy a week later.  She reported her EKG was normal.
At the site of shot I have had redness but on Friday last it became larger and itchy(off and on) the next day spot bigger and same on Sunday and Monday. On Tuesday(yesterday) two more red spots lower down the arm and itchy. This morning those two red spots are now one.
Experienced symptoms of fatigue, headache, chest congestion, fever on 3/19. Tested positive on 3/21.  Doctor prescribed Paxlovid and took first dose PM on 03/22. Tested negative 3/28 and 3/30.  Woke up feeling sick again on 4/1 and texted positive. Same symptoms, not as severe. Tested negative 4/5. Tested positive 4/7. Did PCR test through Pharmacy on 04/8 (results received 4/12 and were positive).  Took home test on 4/12 and was negative.  Have had ongoing fatigue.
back itches; stated that both eyes are extremely dry; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Lot number: EW0182) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: PRURITUS (non-serious), outcome "unknown", described as "back itches"; DRY EYE (non-serious), outcome "unknown", described as "stated that both eyes are extremely dry".  Additional Information: Caller stated that she got the Pfizer vaccine a few months ago and back itches uncontrollably all day long and both eyes are extremely dry. Further question that Is for the Pfizer Covid 19 vaccine and Is for the second dose. Also wanted to know if there are any suggestions to do for her back to stop itching.  Follow-up attempts are completed. No further information is expected.
Sensation of throat spasm, headache, mild pruritus of neck and trouble focusing following Tdap, IPV and MCV4 immunizations and PPD.   Suspect this is related to a vasovagal reaction and not likely IgE-mediated.  We would not expect these symptoms to recur or, but if she develops other symptoms following an immunization she should return to Allergy/Immunology Clinic for further evaluation.
4 inch band around arm approximately 2 inches below injection site, red hot, swollen.  Neck swollen under chin area, tender to touch, no fever.  During time for reporting in office, arm decreased in color and temperature.  Patient states she received a pneumonia shot in 1994.
Headache, Myalgia, Arthralgia, SkinRash, Rash & UrticariaPruritus Narrative:
TRANSIENT CEREBRAL ISCHEMIA ACUTE STROKE DUE TO ISCHEMIA, UNSPECIFIED TYPE AND ARTERY HYPOXEMIC RESPIRATORY FAILURE, UNSPECIFIED ACUITY HYPOXIA
Patient had a seizure within one minute of Johnson & Johnson Covid-19 vaccine administration.  His eyes rolled back in his head, he was convulsing, incoherent, and arms were uncontrollably moving.  His blood pressure plummeted; he became pale, was profusely sweating, and passed out a couple different times.  He was given an epipen shot in the thigh shortly after these symptoms and was taken to the hospital via ambulance.   Patient is a very healthy 18 year old with no prior seizures, diseases, autoimmune disorders, allergies or other health ailments.
Vaccines given 5/20/09. Vomited starting 5/28. Temp to 104.6 starting 5/29. Mild rash, cough also. Developed severe red rash 5/29 - eventually spreading to entire body and red macules/patches with confluent areas on face, arms. Fever lasted 5-6 days and then subsided and rash improved. She also was treated at the same time for an ear infection with amoxicillin.   7/16/09 Hospital records received DOS 5/31/09 to 6/1/09. Assessment: Rash, Fever. Presented with maculopapular erythematous rash all over trunk, face and extremities. Itchy. Fever, discomfort. Fussy. Cervical lymphadenopathy. 9/1/09-ICD-9 codes 782.1 and 780.60.
The night of the injection I started developing left shoulder pain and reduced ROM in left shoulder. I have continued to have pain and restricted ROM and weakness in the left shoulder.
Pain in the injection arm after 3 weeks on the 2nd doose; This is a spontaneous report received from a contactable consumer, the patient. A 82-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6203) via an unspecified route of administration in the right arm on 01Mar2021 (at the age of 82-year-old) as a single dose for COVID-19 immunization. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) via an unspecified route of administration on 05Feb2021 as a single dose for COVID-19 immunization. Prior to the vaccination the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had no allergies to medications, food, or other products. Medical history was not reported. Concomitant medications were not reported. On 01Mar2021, the patient experienced pain in the injection site arm after 3 weeks, on the 2nd dose. The patient did not receive any treatment for the event. The clinical outcome of vaccination site pain was not resolved.  No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: in reporter tab, was ticked for slide 1 reporter, Race and Ethnic Group added, lot unknown=False, First dose received on 05Feb2021 at 82 years, on right arm. Relevant history updated, Vaccine Facility Information added, Event treatment updated.
Severely Nauseous; right now the nausea is the worse; Tiredness; Headache; General feeling of unwellness; insomnia; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 26Apr2021 (Lot number: EP6955) at the age of 71 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Fibromyalgia" (unspecified if ongoing), notes: Verbatim: Fibromyalgia; "Migraine" (unspecified if ongoing), notes: Verbatim: Migraine headache; "Thyoid" (unspecified if ongoing), notes: Verbatim: Thyroid; "Insomnia" (unspecified if ongoing), notes: Verbatim: Insomnia; "Arthritis" (unspecified if ongoing), notes: Verbatim: Arthritis; "Intervertebral disc degeneration" (unspecified if ongoing), notes: Verbatim: Degenerative disc disease. Concomitant medication(s) included: TRAMADOL taken for pain; TOPAMAX taken for migraine; SYNTHROID; MOBIC taken for arthritis; PRILOSEC [OMEPRAZOLE MAGNESIUM]; FLEXERIL [CEFIXIME]; ZANAFLEX. Vaccination history included: Bnt162b2 (1st DOSE, LOT# for first shot of COVID Vaccine: Consumer stated, "EN6205"), administration date: 01Apr2021, for COVID-19 Immunization. The following information was reported: NAUSEA (non-serious), outcome "not recovered", described as "Severely Nauseous; right now the nausea is the worse"; FATIGUE (non-serious), outcome "unknown", described as "Tiredness"; HEADACHE (non-serious), outcome "unknown", described as "Headache"; MALAISE (non-serious), outcome "unknown", described as "General feeling of unwellness"; INSOMNIA (non-serious), outcome "unknown", described as "insomnia". Therapeutic measures were taken as a result of nausea. Therapeutic measures were not taken as a result of fatigue, headache, malaise, insomnia.  Additional information: Concern: Consumer stated, "Ever since I got the COVID Vaccine I am experiencing the number of the side effects that are listed on the paperwork that I got, but  starting about Mid day yesterday, I have starting being nauseous severely nauseous and it's you know not going away, I have taken Dramamine (Treatment) and like little coke and soda crackers, what I wanna found out how long can I expect the nausea to go on and some of the other side effects?" when probed for if it Pfizer COVID Vaccine : Consumer stated, "Yes, I got my second dose, I had my second shot on April 26th".Consumer stated, "And I was having some other symptoms like being tired, having headache, the general feeling of  unwellness but right now the nausea is the worse".  No follow-up attempts are possible. No further information is expected.
This spontaneous prospective pregnancy report as received from a 41 year old female consumer refers to herself. On 03-JUN-2014 the patient was vaccinated with a dose of M-M-R II (lot # no reported), strength and dosage unknown, subcutaneous. The patient was also two months pregnant on reporting day (08-JUL-2014). The Estimated Due Date (EDD) was not reported and the last menstrual period was in approximately May 2014. She was not having any adverse reactions currently on that time. The pregnancy outcome was unknown. The outcome of the events was unknown. Additional information has been requested.
Vial was punctured on 8/16/21 and dose was administered 8/25/21
No additional adverse event; the patient was inadvertently administered a dose of VAQTA that was expired; This spontaneous report was received from a medical assistant referring to a 20 years old female patient. Information about medical history, concurrent conditions and concomitant therapies was not provided.        On 15-JUL-2020, the patient was inadvertently vaccinated with a dose of hepatitis a vaccine, inactivated (VAQTA) (lot # S018419, expiration date 12-JUL-2020; strength, dose and route were not reported) which was expired for prophylaxis (expired product administered). No additional adverse event was reported.
Patient did not receive Moderna booster due to malfunction/defective syringe.  During admiration, all the vaccine spilled out du to needle not properly attached to syringe.  When called Moderna for guidance in this matter, I was advised since patient did not get any liquid injected , it's advisable to give full dose immediately. I admitter 0.5mg dose of bivalent Moderna vaccine