chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Case reference number B0986716A was reported in a literature article and refers to a 46-year-old male subject who started developing symptoms of Raynaud's syndrome one week after receiving the first dose of an unspecified recombinant hepatitis B vaccine on an unspecified date (manufacturer, batch number, dose and injection site unknown). The subject is reported to have been healthy prior to the event. No other information on the subject's medical, family history or concurrent medication is available. A 46-year-old male subject presented to his primary care physician complaining of bilateral throbbing finger pain that was worse in the cold, at rest and at night, purplish discoloration, finger numbness and lightheadedness one week after receiving the first dose of an unspecified recombinant hepatitis B vaccine on an unspecified date (manufacturer, batch number, dose and injection site unknown). No information has been provided regarding any clinical examination or investigations performed on the subject during this visit. The subject presented to an emergency department one week later with concerns of digital ischemia. Once again, no information has been provided regarding any clinical examination or investigations performed on him; but the authors report that he was advised to take ibuprofen that was discontinued after three days due to lack of relief. The subject was admitted one week later (three weeks after vaccination) to hospital with the same symptoms and a 3-day history of black tarry stools. On clinical examination he was noted to have bilateral tender and edematous fingertips, splinter hemorrhages under all the fingernails and some duskiness to the fingertips of the thumb and index finger on the right hand. Laboratory findings were relevant for mild anemia, ESR 39, CRP 2.0, Normal C3 156, elevated C4 46 and CH 50 higher than 63. ANA was 1:100 nucleolar patterns. Rh factor, scleroderma and hepatitis and ANCA panel were negative. Anti histone Ab, Anti-IgG and Anti C3d were negative. Urinalysis revealed a trace of albuminuria and few RBCs. Occult blood was positive. Bilateral upper extremity CT angiogram revealed narrowing of the radial arteries and distal phalangeal arteries consistent with small vessel vasculitis. Chest X-ray and echography were normal. Abdomen scan revealed signs of small intestinal vasculitis. Diagnosis was Raynaud's syndrome with vaccine-induced vasculitis most likely immune-mediated. Treatment consisted of aspirin and calcium channel blockers. Outcome was improvement. Author's conclusion: In spite of its widespread use, hepatitis B vaccination is uncommonly associated with adverse events. However, physicians should be aware of rare instances of small and medium vessel vasculitis. Patients should be informed of this rare potential side effect of Hepatitis B vaccination prior to administration. Physicians should be aware of Vaccination induced Raynaud's vasculitis in the differential diagnosis of a patient presenting with vasculitic symptoms.
Woke up thinking the fan was causing me to be stuffy but it progressed to coughing and hacking and eventually I took a Covid test and it was positive.
I experienced mild fatigue and headache about 24 hours after shot.  It actually got a bit worse the 2nd day after the vaccine.  It is now the 3rd day after the vaccine and I am feeling better.  I also had significant pain at the sight of the injection, enough pain that it woke me up the night right after I received the shot when I rolled over in bed and pressed on the painful area.
Arthralgia, ankle and elbow occurred 2 days after vaccines, no arthritis.
Patient had 2 days of fever and nausea starting on 8/14/21. Tingling and numbness in the right arm and is continuous and current since 8/14/21. No menses for 1 month since 1st vaccine. No signs of pregnancy - pt has had her menses regularly prior to vaccine.
3 horizontal weltson right shoulder near injection. Two 4" long; the other 7" long running under armpit. Scratch-like. 1/2" wide. Hot Burning to touch. Red. Inflamed. Could not lift arm. Painful shoulder. 36 hours.
9:30 pm chills, escalating to shivering, then a fever and severe headache and arm pain throughout the night. Woke with a temp of 101.3 at 8am the next day, body aches, and headache. Fatigue and sweats until fever broke about 11am after more sleep. The afternoon decreased symptoms until only a mild headache and fatigue that night.
Within 72 hours of vaccination, she developed rhabdomyolysis, confusion, and respiratory distress
Patient pale with apparent vasovagel event.  (Patient unresponsive, stiff, hands positioned up toward chest, fixed eyes, held breath approximately 30-40 secs.).  Patient then was conscious, communicative and pallor improved within 1-2 minutes.  Patient symptom free and rechecked 15-20 minutes later, released home with mom.
genital herpes outbreak  Narrative:  He notes having developed outbreak of genital herpes w/an additional patch of 8x herpetic lesions on the posterior of his right thigh, just under his buttock. He notes having having an outbreak for 12x years and saw his  dermatologist, who did not rx any treatment/antiviral rx. The outbreak occured about 2-3x days after the vaccination and resolved after a week (verbally confirms that he no longer has any active lesions). Reviewed that while the vaccination likely did not cause an outbreak, related stress from the vaccination may have resulted in an outbreak. Advised to relax and rest after this 2nd dose with low threshold to contact dermatologist again if another outbreak occurs.
Flu like symptoms, severe pain at injection site 3 days after vaccination, rash across chest
Woke up the next morning with nausea, headache, chills and muscle aches. It has been ongoing now with only relief coming from Ibuprofen for symptoms. Concerned I should have taken longer time between having COVID and getting the vaccine. It was a approximately 3 days from time of being clear of isolation and any symptoms. There was no concern on the consent form of recently having COVID just a concern if you were presently positive.
Pleurisy and pleuritic chest pain..sharp stabbing pain in left chest with every breath.
Information has been received from a lawyer regarding a case in litigation concerning a patient of unknown age and gender. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date in 2015, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) by a physician, as recommended for routine adult health maintenance and for the long-term prevention of shingles. The ZOSTAVAX did not prevent shingles, and the patient subsequently contracted a persistent strain of herpes zoster. On an unknown date in 2016, the patient was treated for the onset of a severe vesicular rash, which was diagnosed as herpes zoster, or shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, 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.
Patient took vaccine and died two weeks later; Spontaneous report s were received from consumers via social media posts concerning an 86 year old male patient who received Moderna's COVID-19 vaccine and died.  There was no medical history provided. There were no concomitant medications provided.  On approximately 06 Jan 2021, the patient received the first of two planned doses of mRNA-1273 (Batch # unknown), intramuscularly for prophylaxis of COVID-19 infection.   All of the social media posts reported the patients death and, according to one post, the patient took two doses of Moderna's vaccine and died two weeks later.  The patient died on or before 23 Jan 2021. No additional information was provided.  Very limited information regarding this event has been provided at this time.  The benefit-risk relationship of Moderna's COVID-19 vaccine is not affected by this report.; Reporter's Comments: This case concerns a 86-year old male patient. The medical history and concomitant medication is not provided. The patient experienced Death. The event occurred approximately two weeks after receiving their second of two planned doses of mRNA-1273 (Lot unknown). Very limited information regarding this event has been provided at this time. Based on temporal association between the use of the product and the onset of the event, a causal relationship cannot be excluded and the event is considered possibly related to the vaccine. The benefit-risk relationship of Moderna's COVID-19 vaccine is not affected by this report.; Reported Cause(s) of Death: unknown cause of death
Patient states that the injection site began to get red and hot. He then noticed swelling to deltoid where vaccinated. Swelling increased and hives began to appear. No pain just discomfort and itching.
I was very fatigued, my whole body hurt and my joints hurt. It felt like I got ran over by a truck. The pain woke me up out of my sleep.  I got up and walked around the house. I took Tylenol and did not seek medical treatment. I just laid in bed for 4 days. I also felt nauseated, I could not eat I only drank water.
Fell and hit head from fainting. Sat for 20 minutes afterward. Alert, oriented. Drank some water. Follow up next day-unable to reach.
This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (vaccinated a patient who was 16 years old) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 01-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (vaccinated a patient who was 16 years old). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (vaccinated a patient who was 16 years old) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No relevant concomitant medications were reported. Treatment information was unknown.
Area around shot (about the size of a silver dollar) became red and warm to the touch.  It remained that way for approximately three weeks.  Had never had any kind of reaction to shots before.
pt recv vax & 2hr p/vax pt exp a h/a, dizziness & pain in the arm;
Dose administered to patient after vaccine expired; vaccine was left out in the fridge post puncture; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT STORAGE ERROR (vaccine was left out in the fridge post puncture) and EXPIRED PRODUCT ADMINISTERED (Dose administered to patient after vaccine expired) in a 25-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Aug-2021, the patient experienced PRODUCT STORAGE ERROR (vaccine was left out in the fridge post puncture). On 29-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered to patient after vaccine expired). On 22-Aug-2021, PRODUCT STORAGE ERROR (vaccine was left out in the fridge post puncture) had resolved. On 29-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Dose administered to patient after vaccine expired) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug details were reported. No treatment details were reported.  The vial did not go through an excursion previously. Only 1 patient was administered the dose. The vial was initially stored in the refrigerator on 22-Aug-2021, 30 days prior to 21-Sep-2021. The vial did not undergo any temperature excursion.
Patient presented to clinic on 4/10/21 requesting their second COVID-19 vaccine.  States he did not have his card, but his first dose was Moderna.  Patient returned to clinic on 4/12/21 with his card which showed his first  COVID-19 vaccine was actually Pfizer.  Patient states he had flu like symptoms for about 12 hrs after received the Moderna vaccine on  4/10/21.  The injection site on the left arm was red with warmth which he states he just noticed on 4/12/21.  Denies any other symptoms.
The patient's arm become red and swollen around the injection site. It was hot the the touch and the patient complained of itching along her entire arm.
Presented on 21DEC sharp burning pain in rt arm & shoulder; some numbness in rt hand; used APAP & hot compress; pt to return 7-10 days; returned on 28DEC knot still present; numbness subsided; some pain;
Within a  few minutes of administration, the patient began to feel ill and looked as if she was going to pass out.  We laid her on her back on a bench.  She was still conscious.  We called 911 and after they evaluated her, they stated that all her vital signs were good. She sat up for a few minutes, then decided she felt well enough to drive herself home.
Vaccine was given with a retracable syringe, but the needle would not retract back out due to RN error. The syringe was removed but needle in the patients arm and removed by RN. Appears patient recieved full amount of vaccine, none was left in the syringe. No negative side effects reported by patient.
08/26/22 presents to ED due to "hypoglycemia".  "no significant PMH"
20DEC93 1st lethargic, vent; 26DEC-sz, apnea, cyanosis, t107, 2.5wks mech vent; susp. liver dam; dec neuro func; 94-cont;d sz, porr feeding; devel seborrhea, head sym; nystagmus, cortical blindness/deafness, poss inborn error of meta
Cold-like symptoms; Congestion; Headache; Sore throat; This is a spontaneous report from contactable other HCP (patient's mother) and physician from a Pfizer sponsored program via medical information team. A 19-year-old male patient received first dose of bnt162b2 (COMIRNATY, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in arm left on 30Jul2021 at 14:00 (at the age of 19-year-old) as dose 1, single for COVID-19 immunization. The patient medical history was reported as none. The patient's concomitant medications were not reported. The patient had no other products. The patient received his first dose 28 days ago. On 24Aug2021, the patient experienced cold-like symptoms, congestion, headache and sore throat. Reporter called on behalf of her son (19-year-old) who received the first dose of the Pfizer COVID-19 vaccine last 30Jul2021 and is due to get his second dose of the vaccine but has cold-like symptoms with congestion, headache, and sore throat. Reporter wanted to know if it is contraindicated to get the vaccine while having these symptoms. The transferring agent stated that she has a patient's mom on the line that was calling about the Covid-19 Vaccine and reported that her son's second dose is scheduled for today, he is experiencing cold symptoms. Can her son take the second dose today. The caller verified the information provided by the transferring agent and clarified that she is a registered nurse. The clinical outcome of all the events was not recovered.  The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a elderly male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (1st dose unknown date). On 15th February 2019, the patient received the 2nd dose of SHINGRIX (intramuscular). On an unknown date, 1 hr after receiving SHINGRIX, the patient experienced injection site pain and shoulder blade pain. SHINGRIX was continued with no change. On an unknown date, the outcome of the injection site pain was resolved with sequelae and the outcome of the shoulder blade pain was recovering/resolving. It was unknown if the reporter considered the injection site pain and shoulder blade pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient in his 70's experienced injection site soreness for about 3 days and then resolved. The patient also reported that he had pain in both shoulder blades, particularly when sitting at a computer. The event was not resolved at the time of reporting. The reporter did not consent to follow-up. There is a discrepancy with respect time to onset. As per reported dates it is 4 days; however, as per source document (time between suspect drug administration and start of reaction/event) it is 1 hour. The clarification has been requested for the same.
Information has been received on 30-JUN-2017 from a pharmacist regarding a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 20-JUN-2017, the patient was vaccinated with a dose of ZOSTAVAX lot # M035696, expiration 07-NOV-2017 subcutaneous for prophylaxis which was improperly stored.  Concomitant therapies included sterile diluent (STERILE DILUENT) lot number M026304 expiration 13-MAR-2019. The pharmacist confirmed that no adverse events were present for the patient. The vaccine was stored at temperatures of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 24 hours 30 minutes and at temperatures of 15 degrees Fahrenheit to 46 degrees Fahrenheit for 8 hours 39 minutes. The pharmacist reported a previous temperature excursion but did not have the details. The call was made due to a data logger. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1707USA004031:
According to Patient: her arm hurt for several days after getting the shot and she had a hard time lifting her arm. She then mentioned that spouse was feeling so bad that he ended up going to the hospital for his arm".
body aches and sores, chills, sweats, covid related symptoms, redness of arm at injection site, for 24 to 36 hours
Red patches around the injection site; bumps around the injection site; itching around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Red patches around the injection site), SWELLING (bumps around the injection site) and PRURITUS (itching around the injection site) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced ERYTHEMA (Red patches around the injection site), SWELLING (bumps around the injection site) and PRURITUS (itching around the injection site). At the time of the report, ERYTHEMA (Red patches around the injection site), SWELLING (bumps around the injection site) and PRURITUS (itching around the injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.    Reporter did not allow further contact
Moderna booster injection 12pm on Nov 30; tiredness 10am the following day Dec 1 followed by low grade (100) fever and headache 12pm; took Tylenol 3pm; felt better in an hour; woke up feeling normal Dec 2
Pfizer-BioNTech COVID-19 Vaccine. 3/4/2021 pain in left are moving up arm from injection site, across back shoulders, and down right are above elbow from 3/4/2021 at 6:00 pm through  current time (3/7/2021 at 10:30 am.). 3/5/2021 at 10:00 am to current time (3/7/2021 at 10:30 am.) Burning under skin above both elbows throughout back shoulders and down back torso but not along spinal bones. Overall weakness and tiredness throughout body.  Slight headache begins and feeling unwell at 3/5/2021 at 10:00 am. 3/6/2021 at 8:00 a.m. through 3/7/2021 at 8:00 a.m. Dizziness and weakness, tiredness, severe/excursiating headache/ muscle pain/chilles/fever/feeling unwell/severe ringing in ears/unable to get out of bed. No relief from advil pain reliever. 3/6/2021 at 5:00 pm nausea added to all symptoms above last 2 hours. 3/7/2021 at 8:00 am to current time (3/7/2021) Able to get out of bed. Headache managable, dizziness presists, weakness/shakey/, minimal energy/burning underskin is still occurring but reduced in level somewhat. Muscle pain in arms/shoulders/back torso and chills is occurring but at a reduced level.
The day of the injection there was no reaction. Three days later I started getting a headache that would?ve been April 11 or 12th 2021. I do not usually get headaches I?ve had this headache since then it never goes away I?ve also experienced ear ringing  , jaw joint pain In what feels like inflammation I?ve been to my ear canals. No present sinus infection or allergy type symptoms related to sinus pressure and pain.. Almost constantly. Over the course of week two and week three had extreme fatigue , tiredness, insomnia, And also very narrowly localized pain?s of which I?ve never had before. The fatigue tiredness insomnia and pains seem to be Diminishing but the headache and ear ringing now goes away. Headache has increased and then decreased but it?s always present. Ear ringing Constantly. Jaw  joint pain Changes between mild to moderate.
Developed fever, aches, chills and headache within 8 hrs of dose. Developed auditory hallucinations which have persisted intermittently since that time. Persistent, tension type headaches also persisting.
This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a 67-year-old female patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced muscle pain, fatigue, dizziness, headache and inability to work. On an unknown date, the outcome of the muscle pain, fatigue, dizziness, headache and inability to work were unknown. It was unknown if the reporter considered the muscle pain, fatigue, dizziness, headache and inability to work to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. This was 1 of 2 cases, reported by same reporter for same patient.
Severe swelling and redness at site of injection. Spread out several inches around and down the point of injection. Very warm/hot to the touch.
Patient awoke with painful rash on right upper arm just inferior to vaccine injection site. This afternoon, also noted chills and joint aches. Took 800mg ibuprofen about 5PM, feels better now.
Vaccine given on 06/16/2005, that night developed fever of 103.4.  Febrile through the night, on 06/17/2005 patient described he could not feel his legs.  Saw the doctor that evening of 06/17/2005.  Took Tylenol as directed.  Fever was not present by noon on 06/18/2005.  Pt also reported shortness of breath.  By Sunday 06/19/2005 he had no symptoms.
IBS, headaches, achiness all over, bronchitis, stuffy nose > 1 week.