chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Psoriasis/spots and scarring/psoriasis sploches on waist/torso/arms; Scarring/spots; Hot flashes; Chills; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of PSORIASIS (Psoriasis/spots and scarring/psoriasis sploches on waist/torso/arms), SCAR (Scarring/spots), HOT FLUSH (Hot flashes), CHILLS (Chills) and NAUSEA (Nausea) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Plaque psoriasis.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced PSORIASIS (Psoriasis/spots and scarring/psoriasis sploches on waist/torso/arms), SCAR (Scarring/spots), HOT FLUSH (Hot flashes), CHILLS (Chills) and NAUSEA (Nausea). At the time of the report, PSORIASIS (Psoriasis/spots and scarring/psoriasis sploches on waist/torso/arms) and SCAR (Scarring/spots) was resolving and HOT FLUSH (Hot flashes), CHILLS (Chills) and NAUSEA (Nausea) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product information was not provided. The reporter's causality for the event(s) of chills, nausea and hot flashes with Humira(adalimumab) was no reasonable possibility. the reporter's causality for the event(s) of spots and scarring/psoriasis sploches onwaist/torso/arms unknown onset and spots and scarring/psoriasis sploches on waist/torso/arms unknown onset was  not provided. Treatment information was not provided. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in
Had pain at the injection site; tiredness; headache; muscle pain; chills; joint pain; fever; injection site swelling; injection site redness; nausea; feeling unwell; difficulty breathing; she has a bad cough; This is a spontaneous report from a non-contactable consumer. A 52-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) lot number and expiration date not provided, via an unspecified route of administration from 05Jan2021 to 05Jan2021 at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. In Jan2021, the patient reported all of the symptoms on the sheet including injection site pain, tiredness, headache, muscle pain, chills, joint pain, fever, injection site swelling, injection site redness, nausea, feeling unwell. The reporter also stated that the patient had difficulty breathing, she stated that every few words she has to catch her breath and she has a bad cough. The outcome of the event was unknown.  No follow-up attempts are possible. Information about Lot/Batch cannot be obtained.
Lightheaded; Fatigued/ very tired; Nosebleed; Sweaty feet; intense dreams; This is a spontaneous report received from a contactable consumer, the patient. A 57-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP6955) via an unspecified route of administration in the left arm on 22Mar2021 at 08:00 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history. The patient was allergic to unspecified medications, food, or other products. The patient did not receive any other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was tested for COVID-19. On 22Mar2021 at 08:00, after the injection the patient felt lightheaded and fatigued. The patient waited and monitored for 45 minutes before leaving. The patient had breakfast afterwards but very tired, went home and slept solid for 3 hours with intense dreams. The patient slept well the night before. The patient felt better as the day progressed. On 22Mar2021, at night, the patient went to bed early and woke up with a nosebleed, blood pooled in mouth from the nose bleed and sweaty feet. The patient underwent lab test which included blood test on an unknown date in Feb2021 and the result showed negative. The adverse event did not result in doctor or other healthcare professional office or clinic visit or emergency room visit. Therapeutic measures taken for the adverse events included water and blood pressure check (result not provided). The clinical outcome of events lightheaded, fatigue, nosebleed, intense dreams and sweaty feet was recovering.   No follow-up attempts are needed. No further information is expected.
Patient reports she is still experiencing injection site pain and muscle stiffness. She is unsure if it was related to the vaccine, but the pain is around the location she had her injection.
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. There was no information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies provided. On an unknown date, the patient was vaccinated with a dose of M-M-R II (lot #, expiration date and site were not reported), subcutaneously. It was provided that the dose of vaccine had been reconstituted with more than the recommended 0.5 ml. No adverse effects were reported. Additional information has been requested.
Pt's hands are swollen and red,  and felt numbness to face. Pt also c/o feeling a scratchy throat, like she swallowed something.   Pt went to the UC -received benadryl 50mg IM  occurred 15 minutes after  the second administration of the covid 19 vaccine. Given methylprednisolone 125mg  IV, benadryl 50mg IV. Prescribed zyrtec  x 3 days and medrol dose pack and discharged home.
Redness and itchiness at injections size, about 3 inches i diameter.  Not swollen or raised.
Stiff neck; Sore arm; Tired; Headache; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Stiff neck), PAIN IN EXTREMITY (Sore arm), FATIGUE (Tired) and HEADACHE (Headache) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure abnormal. Concomitant products included METOPROLOL for Blood pressure management, VITAMINS NOS for an unknown indication.    On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (Stiff neck), PAIN IN EXTREMITY (Sore arm), FATIGUE (Tired) and HEADACHE (Headache). At the time of the report, MUSCULOSKELETAL STIFFNESS (Stiff neck), PAIN IN EXTREMITY (Sore arm), FATIGUE (Tired) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications were reported.   This case was linked to MOD-2021-141949 (Patient Link).
pt c/o edema (localized) lt 6/m radiating to lt inguinal area; return ofc visit on 15MAY95; no medical tx;
Patient reported dizziness and generalized weakness seconds after Pfizer covid 2nd booster. Denied SOB, chest pain, nausea, or blurred vision. Vitals were taken every 5 minutes until dizziness resolved. Patient is diabetic, did not eat breakfast, and was very nervous about vaccination. Symptoms started resolving 10 minutes aftter vaccination and fully resolved after 15 minutes. Patient left site unassisted 30 minutes after vaccination. Patient was given water to drink and graham crackers to eat.
I DON'T KNOW if this was a reaction to vaccine: I felt "weird" for a few seconds, so I decided to take my blood pressure and heart rate.   HR 185, BP 90/57.  I continued to monitor and over next 90 minutes my HR went to 165 then 175, back to  165, and my BP got as low as 57/37 and everything in between that low and 90/57.  After about 90 minutes both HR and BP stabelized to 112/90.  I have never had any heart issues.  I have felt fine since then.
After the patient (my daugther's mother-in-law) coming back home, she could stick three stainless steel fork on to the site of the vaccination as if with magnetism. I attach a picture for your consideration to my email to VAERS on August 6, 2021.
Shoulder pain within 10 min. after shot.  Rash started the next day. Waited till Saturday, the 29th to see a doctor., and she diagnosed that I had Shingles. She gave me two medicines to get from my druggist. One was valacyclovir and the other was HYDORcodone. These helped to relieve the pain. I was limited to  5 of the HYDROcodone,  so when I was finished with those tablets, my nighttime pain in my shoulder was very uncomfortable.
After pt received first dose, about 5 min later approached pharmacy staff and stated they cannot see, and vision is black. Pharmacy manager walked him to take a seat and rest, was given a cup of water to drink. Vison came back and pt confirmed issues with vison wasn't immediate and started a few minutes after receiving first dose. Pt sat down and was observed for about 15-20 min and then confirmed vison was returned and left the pharmacy.
13:45: Patient reports feeling hot, chills and shivers and noted to have red patchy rash on neck and face, ears appear bright red.  Benadryl  25 mg administered.  14:05: Pt reports increased chest pain and shortness of breath, pt up to bathroom and came back dizzy and lightheaded and almost fell over. Oxygen sat 68% on 4 liters, O2 turned up to 6 liters 14:12: epinephrine 0.27mg (0.01mg/kg) IM administered. 1413: epinephrine 0.27 mg IM given in left upper mid thigh.  Oxygen sats in 60s on 8 liters face mask and pt struggling to catch breath and heart rate 80.  1420: 911 called and ambulance requested.  1440: ambulance arrived to home, pt on 8L of oxygen and O2 sats 75% pt placed on cardiac monitoring, waveforms very irregular and EMS concerned and requesting to transport pt to hospital. Pt paced and transported to hospital via ambulance.
Choking; Weakness; Sore throat; I kept waking up from it; This is a spontaneous report from a contactable consumer (patient herself). A 50-year-old female patient (non-pregnant) received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EN6199), via an unspecified route of administration on 05Mar2021 15:15 in right arm as single dose for covid-19 immunisation. The patient medical history was not reported. Known allergies was no. The patient had no other vaccine in four weeks. Concomitant medications included fluticasone propionate (FLONASE); vitamin d; cyanocobalamin (VITAMIN B12). On 05Mar2021 16:00, the patient experienced weakness after vaccination, sore throat last night and today, choking when sleeping, she kept waking up from it.  No treatment was received for the events. The patient had no COVID prior vaccination and was not tested COVID post vaccination. Outcome of events were not recovered.
Fever, headache, body aches, chills. For 24 hr. Treatment: Tylenol 500mg.
Case number PHHY2016US118696 is an initial literature report received on 27 Aug 2016. The author presented the case of a patient who had leukocytoclastic vasculitis (LCV) during the fall season of 2 consecutive years. This report refers to an 89 year old female patient with well controlled diabetes mellitus and hypertension. She also had paraproteinemia. Her vaccination history included administration of influenza vaccine (manufacturer and batch number: not reported) one year before following which she experienced LCV (see related case number: PHHY2016US118590). She was vaccinated with influenza vaccine (manufacturer and batch number: not reported) on an unknown date.  The patient presented with a recurrence of scattered erythematous non-blanching macules and palpable purpura on the bilateral lower extremities. Similar to the previous episode, review of systems was otherwise negative. She denied taking new medications or having recent infection. Complete blood count showed mild pancytopenia. Urinalysis result was within normal limits. During the interim, the patient had undergone radiologic imaging and had no evidence of a clinically significant lymphoma. Chart review revealed that the patient had received influenza vaccine 11 days before the onset of the current eruption. Upon further investigation it was discovered that the patient also received the influenza vaccine 11 days before the onset of initial eruption 1 year before. The final diagnosis was suspected to be LCV secondary to the influenza vaccine, given the identical onset of the episodes 11 days after vaccination and complete resolution between the 2 exposures. The patient had complete resolution of events within three weeks. The seriousness of the events was not reported, but the event leukocytoclastic vasculitis was upgraded as medically significant based on the NVS-IME list. There was no disease activity between episodes and the patient showed no sign of systemic involvement. The history of paraproteinemia was without evidence of clinically significant lymphoma on recent imaging. The patient was counseled to avoid the influenza vaccine next year. The author stated that there were no common risk factors for LCV identified in the previous cases aside from the administration of a vaccine and hence further research should be conducted to determine a causative link between LCV and vaccinations. The temporal nature of these cases of vasculitis following vaccination suggested an immunopathogenic link that has yet to be explained. The author also stated that it was interesting to consider the role of paraproteinemia in this case. Although the timing of the patient's episodes of LCV provided strong support for the vaccine's role, the possibility that an underlying paraproteinemia might have made the patient more susceptible to the eruption must be considered. Previous cases attributed to a vaccine had no other identified precipitating factors. The author proposed to perform a thorough search for additional etiologic agents such as paraproteinemia, particularly in a patient with recurrent LCV. No further information was provided.
34M no PMH present with sudden onset chest pain since midnight found to have myopericarditis post vaccine  34M no PMH present with sudden onset chest pain since midnight.  The pain started on the middle of the chest, substantially worse when lying down and better when sitting up or leaning forward, 9/10 intensity woke him up at night. +Pleurisy. +nausea and chills without fever. He has no exertional pain. No palpitations. No leg swelling, no sob. He lives weight and exerts himself daily yesterday morning he was able to lift weights without any pain.  No family history of early cardiac disease.  He has no shortness of breath, no fever chills, no nausea vomiting diarrhea, no recent sick contacts.  His second dose of Covid shot was 4d ago and he is just recovering from generalized body pains. At time of interview his pain is much better after toradol/colchicine
Arm soreness/aches started about 6hrs in (though injection sight was tender/sensitive to the touch pain became mostly localized around the armpit and shoulder area. Where the pectoral connects under the arm), then around 8hrs a headache and chills started. Chills and headache progressed and got significantly worse throughout the night.  By around18hrs headache had progressed to a migraine and nausea started (likely due to the migraine). Simply sitting up in bed was enough to push nausea to vomiting at which the migraine subsided for about 30min-1hr. Chills and aching arm persisted.  By 24hrs headache/migraine was nearly completely gone and chills had subsided. Arm pain persisted and got worse. Noticed around this time that there seemed to be mild swelling in the armpit. Around 48hrs in armpit area is still feels slightly swollen and causes a good bit a pain depending on how arm moves/rests. Injection sight still lightly tender. (currently the only symptom persisting)
Patient has experienced itchy red plaques (suspected pityriasis rosea per Dr.) that started a few days after the vaccine and has not gone away.
This case was reported by a consumer and described the occurrence of diarrhea in a 59-year-old male subject who was vaccinated with Twinrix for prophylaxis. A physician or other health care professional has not verified this report. The subject's medical history included allergy to erythromycin, bee sting allergy and penicillin allergy. Concurrent medications included Cipro. On 10 August 2007 at 09:00, the subject received 1st dose of Twinrix (unknown, left arm). Approximately 12 hours after vaccination with Twinrix, the subject experienced diarrhea. As of 15 August 2007, the event was resolved. On an unspecified date, the subject was scheduled to receive the 2nd dose of Twinrix, but the nurse declined to vaccinate him due to the diarrhea he experienced following the 1st dose of the vaccine.
Information has been received from a registered pharmacist concerning a 17 year old female patient who on an unspecified date had been vaccinated with MENACTRA, prior to the first dose of GARDASIL (lot # not reported), IM route, that was administered on 17-JUN-2008. On an unspecified date, the patient returned to the office for her second dose of GARDASIL but was inadvertently given MENACTRA instead. The pharmacist mentioned that the lot number that was documented in her records correlated with MENACTRA. It began with an "M". The pharmacist was aware that the GARDASIL lot numbers are 4 numbers followed by an alpha and this was not how the dose was documented. On 30-DEC-2008, the patient returned to the office and received a third vaccination that was GARDASIL (lot # not reported), IM route. The pharmacist mentioned that the lot number patterns for the first and the third doses match the GARDASIL standard. No adverse effects were reported. Additional information has been requested.
Tired, lethargic, tenderness to (L) deltoid where immunization was administered. Throbbing feeling along with difficulty lifting extremity.
Mid morning my arm itched, I rubbed the area and felt a hard bump.  When I looked at it there was nothing but a raised bump almost looked like a bug bite.  Through the day as I itched it, the bump dissipated but the area became red.  It now does not have a hard area just a round red dime size area and mild tenderness.
Pt developed a sore arm with 15 cm area of erythema, tenderness, induration, fever and flu like symptoms.
Minor is 12 y/o catch up series would not be required until 6 months have pasted, minor received 1st vaccine one month before
Had normal pain in injection site for 2-3 days.  Then starting on about day 6 site starting itching and noticed it was red, swollen, and very warm to touch.  Also at the same time got severe cold symptoms which included cough, stuffy nose, runny nose. Cold symptoms and arm redness still continue at this time.
Pfizer vaccines and 2 weeks after caller's 2nd Pfizer shot caller got Bell's palsy; she got calves pulsing after she got the second shot; The initial safety information received was reporting only non-serious adverse drug reactions. Upon receipt of follow-up information on 04Nov2022, this case now contains serious adverse reactions. Information processed together.  This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunisation. The following information was reported: BELL'S PALSY (medically significant), 2 weeks after the suspect product(s) administration, described as "Pfizer vaccines and 2 weeks after caller's 2nd Pfizer shot caller got Bell's palsy"; LIMB DISCOMFORT (non-serious), 2 weeks after the suspect product(s) administration, described as "she got calves pulsing after she got the second shot". It was reported that the patient received 2 shots of the Pfizer COVID-19 vaccine. Two weeks after the second shot, the patient experienced her calves pulsing. Her doctor then switched her to Moderna after that. Now, the patient takes Paxlovid (has taken 6 pills) and she was wondering if there are similar ingredients in the Paxlovid and the vaccine that could cause the same reaction because she wanted to check the lists ingredient by ingredient. On 04Nov2022, it was reported that 2 weeks after the second shot of Pfizer COVID-19 vaccine, the patient got Bell's palsy. The doctor didn't have a way to prove if the Bell's palsy was from the vaccine or not. So, the patient was told to get the Moderna. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
suspected vaccination failure; shingles; This case was reported by a consumer via social media interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, several weeks 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: The case was reported by the patient for herself/himself. The age at vaccination was not reported. The patient reported that, he/she got the Shingles vaccine and weeks later had the shingles. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure, since the details regarding the completion of primary vaccination schedule and laboratory confirmation for shingles were not provided. Note: As the number of weeks after which the patient experienced shingles was not confirmed hence considering the worst case approach, this case was considered as suspected vaccination failure case.