chrisvoncsefalvay/vaers-outcomes huggingface dataset:
MISSED THE SECOND DOSE; A spontaneous case report was received from a caregiver on 14-Jun-2019 for four consumers.  Based on the information obtained from the caregiver, four individual case safety reports PVX201906-000497 (PVX2019-1546; mother) and PVX201906-000498 (PVX2019-1547, eldest daughter) PVX201906-000499 (PVX2019-1548; son) and PVX201906-000500 (PVX2019-1549; youngest daughter) were created and cross-linked in the database.  This case describes a 47-year-old adult female consumer who "missed the second dose", while being on Vivotif for an unknown indication.  Case report: The consumer took the first dose of Vivotif on 11-Jun-2019 and missed her second dose which was due on 13-Jun-2019.  Action taken with Vivotif was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "missed the second dose" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "missed the second dose" was considered as not applicable. US-PaxVax Berna GmbH-PVX201906-000498: US-PaxVax Berna GmbH-PVX201906-000499: US-PaxVax Berna GmbH-PVX201906-000500:
Patient experienced weakness in the right hand, with pain, tension from the shoulder all the way down the arm, in a line through the elbow to the hand. Patient also had a localized lump at the injection site. He had some difficulty flexing his right upper extremity and has some shakiness in it when he did so.
After the 2nd vaccine, I had increased diarrhea. I was on the toilet about 20 times a day till early morning to 4 or 5 in the evening. I could only go on a short trip because I had to go to the bathroom about 3 or 4 times. I couldn't get off the toilet to eat or drink. I lost 20 pounds. It has continued for 3 months after 2nd vaccine. It ceased 4 or 5 weeks ago. I'm still having diarrhea but not as frequent. I have been recently diagnosed with crohn's disease. The symptoms just appeared after taking the vaccine. Maybe a year ago on lockdown I did have some of these symptoms but they were a little light. Some of my symptoms have ceased  4 or 5 weeks ago which are decreased frequent diarrhea, irritability, nausea, trouble concentrating, insomnia, intense migraines, or lingering headaches that lasted for two weeks, and sharp stabbing pains on all sides of my head. I had a rash that would appear on my hands, wrist, and forearm that would reappear every couple months off and on since about a year ago after receiving the vaccine. I had a rash on my lower abdomen once but it went away after about a day. I also had some swelling of my fingers. All of those symptoms went on full blown after 2nd vaccine.  I also experienced a flush of warmness over my face. When I looked in the mirror my face would be flushed red. This happened off and on but more frequently after the vaccine. It happens about 2 or 3 times out of the week. When I was sitting on my toilet at my apartment my head was at the same level as the electrical panel to the left of me. I experienced sharps pains in the head. They would just come out of no where. I had a reading for the electrical panel and it was close to 850 volts per meter which is 8x higher than the recommended volts per meter. I have been sitting by the electrical panel for 3 months days and evenings because I had to stay on toilet due to the diarrhea. I could feel that the radiation from the electrical panel was making me ill. Once I moved out of that apartment I did start to feel a lot better. I would like to know who is responsible for me being exposed to the high radiation for long periods of time.  I have been disabled because of this, and I haven't been able to work since.
Information has been received from a news source concerning a 20 year old female who on an unspecified date was vaccinated with GARDASIL. The reporter indicated that the patient believed that she had an adverse effect after receiving GARDASIL. The patient complained of nausea and dizzy spells after vaccination. No further information is available.
Pt stated psoriasis after her 2nd Moderna COVID vaccine in March of 2021. She woke up COVERED in psoriasis. In May/June of 2021, she came down w/psoriatic arthritis so bad, she was bedridden and when she did get up, she was still on a walker and could barely ambulate. Her only complaint now is GOUT. She takes allopurinol 100 mg b.i.d. and colchicine 0.6 mg every other day. She cannot increase the doses b/c of her renal function. Used to have a gout flare about once/year but now she can't get her uric acid level down chronically and can't understand why.
This spontaneous report as received from a pharmacist refers to a female patient of unknown age. A couple of days ago, the patient was vaccinated with a dose of ZOSTAVAX (dose and route unknown). The patient called the pharmacist and asked him if she could get her tooth extracted for scheduled dental appointment. Pharmacist did not know if patient had existing tooth problem or if tooth problem started after receiving ZOSTAVAX. The outcome of the patient was unknown. The causality was not assessed. Additional information has been requested.
fall, dehydration, AKI, hyponatremia, possible uremic encephalopathy, uremia
She did initially have sweats the first night, and a sore arm for 6 days, but is being seen today because last night, 7 days after the vaccine administration into her left arm, she developed a pink rash at the injection site.   Due to her history of DRESS syndrome, any rash side effect is concerning and warrants close monitoring. She is not having systemic symptoms at this time. She understands to watch for any throat swelling or breathing difficulty and would present to the ED or call 911 accordingly.   We discussed moving her 2nd vaccine dose to be given in the hospital setting rather than at the drive though although this is not mandatory given the drive through proximity to the hospital. She does not have history of anaphylaxis or any prior need for epi.      Use diphenhydramine cream every 6 hrs as needed for itching or rash.   If itching even between doses, then use the betamethasone cream up to twice/day. And or cold packs.
evening of day of vax pt devel redness & swelling of arm that extended to back;mom unsure of which arm affected;also had fever over 103 & hives on back;given DPH;
My torso started to get psoriasis spots in various places.  There is no history of psoriasis in my family, nor have I ever had skin problems before.  I took a blood test at medical center, and it showed that I was positive for this (something about a gene got switched on I think - I'm not a medical person).  We do not know if this was from the vaccine(s) or just something happening because I'm old and have lupus.  It was odd that it happened after the 3rd dose of Moderna dose, however.  I can live with this, but I wanted to let you know as it happened after the 3rd dose of Moderna.
(Fever) highest was about 100.8; Chills; Ache; every muscle is aching in his body; This is a Spontaneous report from a Contactable Consumer (patient's mother)  A 38-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH m-RNA COVID-19 VACCINE, formulation: Solution for injection, Lot number and expiry date: Not reported), via an unspecified route of administration on 12Apr2021 (at the age of 38-year-old) as Dose 2, single for COVID-19 immunization. Medical history and family history was not reported. The patient's concomitant medications were not reported. The patients mother stated that patient was asked to get 3 doses first shot of Pfizer biotech vaccine. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: Solution for injection), via an unspecified route of administration on 22Mar2021 (at the age of 38-year-old) for Covid-19 immunization. The patient first dose was effective and had typical side effects such as a very sore arm and he was very tired on the next day (23Mar2021). The patient experienced the side effects for 25 to 30 hours and then has been fine since then. As the clinic was shut down by state for not keeping the logs of temperature control, the patient was suggested to consider the first shot as invalid and to pretend that he dint get that first and second dose of either Pfizer or the Moderna. The patient was advised to take 3 vaccine shots. The patient received second dose from another facility and experienced much more intense side effects such as fever for about 12 to 15 hours that went up and down and the highest was about 100.8 degrees, chills and every muscle is aching in his body. This lasted for 1.5 days after the dose then went away. The patient was treated with Ibuprofen 200 mg for muscle and ache in body. All the events were recovered on an unspecified date.   No Follow up attempts are possible: Information about lot/batch number cannot be obtained. No further information is expected.
Death J96.01 - Acute respiratory failure with hypoxia J18.9 - Pneumonia, unspecified organism N17.9 - Acute kidney failure, unspecified G50.0 - Trigeminal neuralgia
Father reports his daughter has had fever, up to 102.4, this morning. Ibuprofen takes fever down to 101.2.
Signs and symptoms started at 22:30pm which was 13 hours after injection .   22:30pm  1/13/21  - muscle aches  - chills  - severe headache  - extreme fatigue  - runny nose   0600 am  1/14/21 - Nausea  - Vomiting  - Sweats occurred  - Fever 102 with Tylenol  - Extreme fatigue   12:00pm on 1/14/21  - Muscle aches - Fatigue  - headache  - Runny nose  - sweats  - fever 100.1 Witt ibuprofen   18:00pm 1/14/21  - muscle aches  - chills  - fever 99.8 with Tylenol  - extreme Fatigue  - Nausea kicked back in   22:00 pm 1/14/21 - chills  - Nausea  - body aches  - fever 99.6 with Tylenol   05:15am 1/15/21  - woke up in chills  - fever 100.2 took some more Tylenol with ibuprofen  - muscle aches  - headache  - fatigue  - runny nose    08:00am 1/15/21 - Sweats  - fever 99.1  - body aches  - Fatigue  - Runny nose
The patient had her first moderna vaccine on 2/3/2021 and developed a rash on her left arm on 2/11 where she got the vaccine,  and a few days later developed a tachycardic episode with HR raising to 115. It returned to normal after a short while. Patient had second moderna vaccine on 3/3/2021.  She developed a pruritic rash on her upper body including her torso on 3/14 . She was asked to take benadryl and pepcid on 3/15. She took 175 mg benadryl over the course of 48 hours. Early on the morning of 3/18 she woke up with palpitations which lasted for over an hour and her HR rose to as high as 160.
Patient has been declining in function at home since June 2021 and was brought to hospital for evaluation.  Patient continue to complain of weakness and fatigue.
This spontaneous report has been received from a consumer refers to a patient of unknown age. On an unknown date the patient was vaccinated with M-M-R II (lot#, dose and route unknown). The reporter mentioned on an unspecified date an anonymous patient developed Autism after received M-M-R II. The outcome was unknown. Action taken was not provided. Additional information has been requested.
The day of the vaccination, I felt  tired and took a nap (Thursday) On Friday, I continued to feel tired.  (Friday) On Saturday morning, I woke at 6 AM with a slight temperature  of 99.2 degrees. By 8:30AM my temperature was 98.4 degrees and I felt more normal. Hope that is the last of any effects.
PATIENT'S DAUGHTER REPORTED THAT HE WAS NOT ABLE TO MOVE HIS BODY AND HAD FEVER. SHE SAID HE WAS HOSPITALIZED .
Highly atypical Influenza vaccine.  Vaccine felt like fire going in, and I could feel pain as the serum seeped through the muscle.  Vaccination lasted longer than usual flu vaccine.  Injection site turned red from the moment of injection and began to harden and get warm.  Site closed and never abscessed, but around injection site and satellite areas were painful, hot and red.  I went to the ER.  The next morning still in level 3 pain.  I started Cephalexin, and they gave me a prescription for Bactrim.  I also covered the area with Bactroban ointment and a bandage.  ER staff told me to draw a circle around redness which was about the diameter of a quarter.  I was instructed to start the Bactrim immediately if it escaped the border.  Within hours it had grown beyond the border.  I started the Bactrim along with the Cephalexin.  I felt an extreme level of tiredness, as if my body was having to fight with all it had.  The next day the antibiotics had arrested the growth of the bacteria, and the area started turning a dark purple healing color and redness, tenderness, hardness, and heat went away from main lesion and satellite ones.  I believe that this was an invasive soft tissue infection with no drain that could have become quite serious if the antibiotics had not been started one day after the infection.  I have had many shots, administered allergy shots to myself.  I have never had a shot be so sore for so long, and react the way that did.  If it had only been bacteria from the skin, it probably would have abscessed and not had sub-dermal satellite areas that also never abscessed.  I believe that that shot was contaminated with MRSA.  I don't know if Merck manufacture it, but there is contamination being reported in another of their vaccines.  I feel lucky to be alive.
Axilary  and supra clavicular nodules pain Excessive fatigue Headache Joints pain
Tachycardia was very bad; Low grade headache; Lips was tingling/Tongue tingling; Sore arm; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 02-Apr-2021 and was forwarded to Moderna on 03-Apr-2021.    This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of TACHYCARDIA (Tachycardia was very bad), HEADACHE (Low grade headache), PARAESTHESIA ORAL (Lips was tingling/Tongue tingling) and PAIN IN EXTREMITY (Sore arm) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination.     Concurrent medical conditions included Tachycardia.    On 01-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 01-Apr-2021, the patient experienced HEADACHE (Low grade headache), PARAESTHESIA ORAL (Lips was tingling/Tongue tingling) and PAIN IN EXTREMITY (Sore arm). On an unknown date, the patient experienced TACHYCARDIA (Tachycardia was very bad). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of UNK dosage form. At the time of the report, TACHYCARDIA (Tachycardia was very bad), HEADACHE (Low grade headache), PARAESTHESIA ORAL (Lips was tingling/Tongue tingling) and PAIN IN EXTREMITY (Sore arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Apr-2021, Oxygen consumption: 94 Decreased. On an unknown date, Oxygen consumption: normal (normal) Normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Relevant concomitant medications were not reported.  Treatment information was included acetaminophen.   Most recent FOLLOW-UP information incorporated above includes: On 02-Aug-2021: Follow-up received on 02 Aug 2021, The follow-up document contains no new information; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Shingles; This initial spontaneous report was received from a lawyer and a female patient of unknown age regarding a case in litigation on 07-APR-2021. The patient's concurrent conditions, medical history, concomitant medications, drug reactions or allergies were not reported. In or around 14-AUG-2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, lot #, expiration date, route of administration, anatomical location not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unspecified date, shortly after receiving zoster vaccine live (ZOSTAVAX), patient had suffered rash under the lower left axila and pain radiating under the right breast and she was diagnosed with shingles. As a result, her symptoms resulted in physical limitations and severe, progressive permanent and incurable personal injuries not present prior to vaccination, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. At the reporting time, the outcome of shingles was considered as not recovered. The reporters considered the event to be related to Zoster Vaccine Live (ZOSTAVAX).     The reporters considered shingles to be a disabling event.
Pt. states that after receiving the 1st dose of Shingrix 09/09/2021, started experiencing symptoms 09/10/2021 of dizziness early morning than fainting twice. Paramedics called and treated in the field, EKG preformed (Normal), treated and sent home. Symptoms have subsided besides being fatigued.
Within one minute of injecting baby, Noticed redness, swelling to right brow. Redness to both thighs at injection sites, irregular, baby free of distress. Examined by MD and observed x 30 minutes. 04/05/2005 10:11 AM called mom: reports baby was ok after discharge.
right sided neck stiffness, hypertension 169/100, 91, 18, 98%
Milder sx initially with sore arm, myalgia's, subj. LGT.  Lasted a couple of days and fine for 3 days. About 48+ hours ago developed HA, fever LG, myalgia's, and last night noticed oblong area of erythema and induration of right upper arm (14 cm x 9.5 cm).  Warm, red , slightly tender to touch.  No fluctuance.     Seemed a bit better at time of visit and no fever in past 24 hours.  Feeling better today.  Size as above, confluent induration, mild warmth, erythema but not as red as pictures the night before.
pt indicated that she had some slight facial swelling on right side of face (same side shot was given).
18JUL, eight days p/vax pt seizured & quit breathing; was hospitalized & observed until fever subsided; was dc'd 19JUL on Ceclor & to have follow up w/MD;
Case number PHEH2013US021722, is an initial spontaneous report received from a nurse on 16 OCT 2013 with a follow-up received on 03 DEC 2013. This report refers to a 12-year-old female patient. She did not have any relevant medical history. Her vaccination status was up to date as per  her records. She was vaccinated with MENVEO (batch number: A11082) at a dose of 0.5 ml into left deltoid arm on 17 MAY 2013 (09:30). The reporter stated that MENVEO was compromised due to refrigeration malfunction. She was revaccinated with MENVEO on 25 NOV 2013. No adverse reaction was reported following this administration error. Follow-up received from the nurse on 30 DEC 2013. Updated information on medical  history, vaccination history and revaccination with MENVEO.
Information has been received from a physician concerning a 17 year old female with low blood pressure, who on 12-FEB-2008 was vaccinated IM with a 0.5mL first dose of GARDASIL. On 12-FEB-2008 post vaccination the patient "went catatonic" and was "non-responsive." The patient had a glassy stare and was emulating a seizure because her arm was flexing. The patient "came to" after 5 to 10 minutes and stayed at the office for an hour and 45 minutes. The patient was then released. It was reported that the series of vaccination would not be completed. The patient recovered on 12-FEB-2008. No product quality complaint was involved. Upon internal review "emulating a seizure" was considered to be an other important medical event. Additional information has been requested.
Initially right after the shot, vomiting, flu like symptoms almost like food poisoning.  Then a week after until present time he gets waves of swelling of the roof of the mouth, tingling and numbness of the feet, disorientation, that will last and hour and a half.  He becomes exhausted takes a nap and gets the wave of symptoms all over again.  Can't really lay down has to sit up sleeping.  Needs to take sleeping pill to be able to sleep.  Almost like having an internal seizure which doesn't manifest as a seizure, when he gets the wave of symptoms he gets exhausted.
I started having swelling in my legs and knee joints within a few days but I don't know if it is from the vaccine. I was diagnosed with chondrocalcinosis on Nov 4. I have had some calcium in my knee joints for several years but in the last 6 years I had only 3 incidents of knee pain & swelling all which lasted less than 3 days. Now I have had continuous swelling, joint stiffness and frequent knee pain when my knees swell up a lot plus intermittant pain on the sides of my feet, the right side of my right hand and deep muscle pain in my legs. I have had these symptoms for 86 days with only 5 or 6 with no pain. I think that the vaccine may have exacerbated what had previously been a very rare & brief flair up.
Painful lump near collarbone/ swollen lymph node; Painful lump near collarbone/ whole area surrounding the lump was sore/pain near my collarbone; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE LYMPHADENOPATHY (Painful lump near collarbone/ swollen lymph node) and PAIN (Painful lump near collarbone/ whole area surrounding the lump was sore/pain near my collarbone) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In August 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In August 2021, the patient experienced VACCINATION SITE LYMPHADENOPATHY (Painful lump near collarbone/ swollen lymph node) and PAIN (Painful lump near collarbone/ whole area surrounding the lump was sore/pain near my collarbone). The patient was treated with IBUPROFEN from August 2021 to August 2021 for Swollen lymph nodes, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE LYMPHADENOPATHY (Painful lump near collarbone/ swollen lymph node) and PAIN (Painful lump near collarbone/ whole area surrounding the lump was sore/pain near my collarbone) had not resolved.            No concomitant medications were reported by the provider.
reddness/rash began almost immediately after vaccine - no resp. diff or hives. Pt was seen later in day - MD dx ?allergy to gelatin in MMR - F/up w/allergist
twinge; This case was reported by a pharmacist via call center representative and described the occurrence of pain localised in a 77-year-old male patient who received Herpes zoster (Shingrix) (batch number 7X743, expiry date 22nd May 2021) for prophylaxis.   On 11th December 2018, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, less than a year after receiving Shingrix, the patient experienced pain localised. On an unknown date, the outcome of the pain localised was recovered/resolved.   It was unknown if the reporter considered the pain localised to be related to Shingrix.  Additional details were provided as follows:  The patient reported after the 1st dose of Shingrix in the left deltoid, he had a twinge in the nerve area, but did not think about it. For tolerance to the 2nd dose of Shingrix, refer case US2019073417.