chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Slightly Elevated Liver Enzymes Before Vaccine, More Elevated after Heplisav-B; Initial Report Received on 28-APR-2023  A physician reported that a patient (race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and the patient developed more elevated liver enzymes after vaccine.  Medical history was reported as unknown.    No relevant concomitant medications at the time of vaccination were reported.  In JAN-2023, the patient had a comprehensive metabolic panel (CMP) and the results were "slightly elevated."    On 19-APR-2023, the patient received a dose of HEPLISAV-B (Lot # and expiration date not reported and NDC # 43528-002-01) from a physician.   On 20-APR-2023, 1 day after having been vaccinated with HEPLISAV-B, the patient had a CMP test, and the results were "more elevated."  The physician reported that "Patient had slightly elevated liver enzymes before vaccine, were more elevated after Heplisav-B".  No side effects were reported.  No additional information was reported.   Company Comment:  The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Red area of upper right deltoid of arm. Some areas raised some area very red/purple color.
All symptoms gradually came on at 12:00am 12/30/20. After vaccine was received at 1:30pm on 12/29/20. Chills, fever, tiredness , nausea, arm soreness, headache, pins and needle feeling in right hand
Shingles; Information has been received from a lawyer regarding a case in litigation, concerning a patient (pt) of unknown age and gender. The pt's medical history, concurrent conditions and concomitant medications were not reported.   In 2018, the pt was inoculated with zoster vaccine live (ZOSTAVAX) by a pharmacist, for the long-term prevention of shingles and zoster-related conditions (dose, route of administration, anatomical location, lot number and expiration date were not reported).   Subsequently, on an unspecified date, the pt was treated by a health care provider at an office and urgent care, for shingles. As a direct and proximate result of the pt's use of the zoster vaccine live (ZOSTAVAX), the pt had and would continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future.  The event was considered to be not recovered.  The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Pt recv vax 20JAN98 same day pt exp swelling from the injection site to her fingers and the area was sore and red hot to touch.
BENADRYL given to pt for now. Will f/u with new or worsening symptoms. -Red, itchiness, tender, warm on (L) thigh where vaccines were placed.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE  CHRONIC HYPOXEMIC RESPIRATORY FAILURE ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE HYPOXIA
Arm became itchy on night 7 after receiving injection. Large, tight swelling at injection site.
Sore arm; This is a spontaneous report received from a contactable consumer (patient). This 67-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EN6203) via an unspecified route of administration on 04Mar2021 as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient reported she heard that the second dose of BNT162B2 gives flu like symptoms and inquired if this was true; further reporting she experienced only a sore arm after the first dose in Mar2021. The clinical outcome of sore arm was unknown.  Follow-up attempts are completed. No further information is expected.
Information has been received from a registered nurse concerning a 53 year old female who in February 2005 and March 2003 was vaccinated with a first and second dose of hepatitis A virus vaccine inactivated, respectively (manufacturer unknown). Concomitant therapy included a dose of hepatitis B virus vaccine rHBsAg (yeast) (manufacturer unknown). It was noted that the patient has been donating platelets for many years. She has given many times thus her blood is tested each time she donates. On 13-MAY-2005, her alanine aminotransferase (ALT) was very high. It was noted that the patient had no other symptoms. The patient was contacted and reported that she had received the vaccines. It was noted that she had donated many times since receiving the vaccines but this was the first indication of any abnormal results. It was also noted that the patient had no paper work identifying the manufacturer or any other pertinent information. Therefore, the reporter was not sure of the vaccine manufacturer, it is possible but not definite. No medical attention was sought. The patient's outcome was unknown. No product quality complaint was involved. No further information is available.
Tachycardia and Bright red Rash within 5-10 min of dose. Closing of throat, headache and blurred vision.  EMS called. Epi pen and IM Benadryl.  Severe arm pain with rash and blisters near injection site within 2 hours of injection.
Skin Rash after Peds Pfizer and DX with Gianotti crosti Rash. Went to ER on 12-24-21
Approx. 60 hrs. after vaccine woke up from sound sleep paralyzed from waist down, difficulty urinating went to ER no tests or treatment except for vomiting/nausea. Later was admitted to hospital by Dr. for tests and treatment of transverse myelitis.
Received 1st vaccine 1/5/21. Arm was tender. Around midnight 1/6/21 my arm was very painful to the touch, move, awful. 24 hours later just sore. On 1/7/2021 I started to feel short of breath and run down. Sinus infection symptoms. I was sent home from work to get a COVID swab. That evening I lost my taste and began to feel achey. Negative test on 1/10/21. Saw urgent care on 1/9/21 for Covid swab and visit. He diagnosed viral and was sure I was positive. On 1/11/21 my energy returned and I wasn?t achey. Congestion and cough. By 1/13/21 felt fine other than lingering wet cough. This morning, 1/14/21 I noticed my arm itched and looked at it and I?ve got a small red rash around the injection sight and tenderness on palpation.
This case was reported by a consumer via call center representative and described the occurrence of rash in a 70-year-old female patient who received Shingrix for prophylaxis. Co-suspect products included Boostrix for prophylaxis. Previously administered products included Zostavax. On 1st August 2018, the patient received the 1st dose of Shingrix (intramuscular) .5 ml and Boostrix (intramuscular) 1 ml. In August 2018, 7 days after receiving Shingrix and Boostrix, the patient experienced rash, pruritus, eosinophilic dermatitis and subacute spongiotic dermatitis. On an unknown date, the patient experienced stinging skin. On an unknown date, the outcome of the rash, pruritus and stinging skin were not recovered/not resolved and the outcome of the eosinophilic dermatitis and subacute spongiotic dermatitis were unknown. It was unknown if the reporter considered the rash, pruritus, stinging skin, eosinophilic dermatitis and subacute spongiotic dermatitis to be related to Shingrix and Boostrix. Additional details were provided as follows: About a week later after receiving Shingrix and Boostrix, the patient experienced a rash on her back, along with itching in the scalp area. The itching and rash continued across lower stomach, top of the breast, legs and consistently on the back. On 14th August 2018, She visited her primary care physician, who recommended her to a dermatologist. On 21th August 2018, She visited the dermatologist. She started putting on the steroid cream on her skin. Initially she was experiencing a lot of itching, then the itching decreased and she started to experience stinging on the skin. On 30th October 2018, She had a biopsy of her skin done and results showed spongiotic dermatitis with eosinophils, findings that could be seen in drug eruption or eczema and neurological condition. The rash and stinging was still present, along with some itching which was better than before. One of her primary care physician friend also suggested that the reaction she was experienced could also be from the Shingrix. The reporter did not want to consent for follow up. Emgergency room visit required. No further details were provided. Lab Comments: On 30th October 2018 biopsy was performed which showed result of spongiotic dermatitis with eosinophils, findings that could be seen in drug eruption or eczema and neurological condition.
Case number PHEH2012US016136 is an initial spontaneous report received from a nurse on 13 Aug 2012: This case refers to 19-year-old male patient. He was given only MenCYW-135 liquid conjugate component of MENVEO (batch number: X10130) intramuscularly on 13 Aug 2012. He did not receive the MenA lyophilized conjugate component of MENVEO. No adverse event was reported following this administration error.
Headache, Myalgia, Fever, chills, fatigue, sore and red injection site Narrative:
Patient presented to clinic for vaccination.  Patient filled out consent.  Had no complaints.  Did not mention to staff that he received both Moderna immunizations in February.  Staff found out from wife.  Patient still stated he did not remember receiving.  Patient seen by provider on 12th.  Wife brought in vaccine papers given a ta other facility
The vaccine was administered after a temperature excursion; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On an unknown date, the patient was vaccinated with an improperly stored of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) for prophylaxis (lot # U032086 has been verified to be a valid lot number pneumococcal vaccine, polyvalent (23-valent), expiration date reported and establish as 29-AUG-2023) (strength, dose, route of administration and anatomical location were not provided).  The temperature of storage and time frame of the excursion were 29.92° Fahrenheit (F) for 200 hours respectively.  If a digital data logger was involved was not reported.  The vaccine did not experience a previous temperature excursion.
pt recv vax & exp a sl fever & moderate blistering;pt seen by MD;the reporting MD felt pt exp was r/t vax;
had digestive problems and before she got the shot she could eat 10 foods without feeling pain and now can only eat one food that is rice; has inflammation in her body but does not elaborate further; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on 01Apr2021 as single dose for COVID-19 immunization. The patient medical history was none and concomitant medication was not reported. It was reported that the patient stated that she had the 1st dose of the BNT162b2 shot on 01Apr2021 and states on an unknown date in 2021, she had digestive problems and before she got the shot, she could eat 10 foods without feeling pain and now can only eat one food that was rice and was wondering how long this was going to go on for because it has been a week. The patient also had inflammation in her body on an unknown date in 2021 and would like to know if there was an interaction between inflammation in a person's body in general and the immunization that happens with the Pfizer BioNTech COVID-19 vaccine. Caller would like to know how long side effect was expected to last. The outcome of the events was unknown.  No follow-up attempts were needed. Information on Lot/batch number cannot be obtained.
I was called on Fri 6-1-07 about report of Temp 101.3 c/o aching joints, not feeling well since receiving shots on 5/30. Had been taking Tylenol denies any problems at either injection sites. BP per wife 119/84. I suggested he contact DR - was reported by wife later he was dehydrated - ? had bacterial infection. On 6/5/07 Dr states back to office on 6-4-07. Dr office called today - not sure what was problem - wanted me to report to VAERS.
Pt developed left sided facial tingling shortly after receiving her vaccination. She noted some very mild difficulty swallowing.. Her symptoms resolved after several minutes. She denied any other associated symptoms. No objective mouth/throat swelling appreciated. HR 46 which pt states is normal for her, BP 110/80, SP02 99%. EMS services were offered but pt declined and drove home.
FEVER CHILLS REDNESS PAIN, SWELLING AND VERY WARM TO TOUCH L ARM
Patient's mom gave wrong date of birth and therefore patient received vaccine at age 11, which was too young. Local DHS discovered birth date discrepancy and let us know. They believe mom did it so patient could get vaccine even though she wasn't old enough. Called mom to verify date of birth was 2009 and not 2008 and she said correct birth date. She had no concerns that patient received early and denied any adverse effects.
The vaccine was expired past the 30-day recommendations. At this time there have been no s/s of any adverse events
Approximately 4 hours after receiving the  Moderna COVID-19 vaccine (left-arm), my mother began to have moderate pain in her left arm, particularly in the left shoulder area. The pain continued to increase throughout the afternoon, until it became so severe (10 on a 10-point pain scale) by 8:30 pm on 3/10/21 , that she could no longer lift her arm. She took 500 mg of Tylenol to attempt to relive the pain and went to bed early.   At 2:45 am on 3/11/21, she needed to go to the restroom, and I (daughter) had to assist her to get out of bed, as she had no use of her left arm due to severe pain in that arm. While seated on the toilet, she indicated that her arm was extremely painful and she felt that she was going to pass out and felt nauseated. Within a minute, she lost consciousness and  I called emergency services. EMT arrived within 5 minutes and stated that her blood pressure was extremely low and she needed to be placed on the floor.  They placed her on a gurney and took her to the ambulance, where they started an IV and took her to her local hospital.  I followed shortly thereafter, where she was taken to the ER. She was admitted to the hospital for observation and given Ativan (she refused any opioids) She was ultimately diagnosed with vasovagal syncope due to the pain in her left arm. Two days later, the pain has subsided.
Pfizer vaccine was administered outside of Facility- reported by patient- ? NO LOT NUMBER WERE SUPPLIED --------------------------------------------------------------------------------------------------------------- G47.33 OBSTRUCTIVE SLEEP APNEA 3/22/2023 DM 1 W ULCER OF LEFT FOOT G62.9 PERIPHERAL NEUROPATHY 4/21/2023 DM 1 W ULCER OF LEFT FOOT J96.11 CHRONIC HYPOXEMIC RESPIRATORY FAILURE 5/2/2023 DM 1 W ULCER OF LEFT FOOT R09.02 HYPOXEMIA 4/20/2023 DM 1 W ULCER OF LEFT FOOT
Turned blue, convulsions, lasted 3-5 minutes, foaming at mouth and nose. taken to hospital via ambulance. Night prior (looking back, after the fact) patient had what may have been an absence seizure.
Patient presented to GVH ED after being found down at home, unresponsive and incontinent of urine. Patient's UDS was positive for benzos and oxycodone. Patient was found to be COVID positive incidentally. Previously was vaccinated with Pfizer on 3/1/21 and 3/27/21. Admitted to GVH 1/10/22 and discharged 1/13/22.
On December 27th patient found that the herpes rash that normally appears several times a year was present and had moved to the inner thigh and was a larger area than usual. She did several pulse treatments with acyclovir 400 mg for a 5 day course. However the rash appeared again as soon as course over. She is concerned that the rash is appearing more frequently and is larger and more severe. She blames the SHINGRIX vaccine.
Low grade fever (99.9), body aches, joint aches, and chills for 3 days.  I am breastfeeding my 3 month old. My baby  had low grade fever (99.8) on day 3 after I received the vaccine.
Vomited 3 hours after receiving vaccine.  She woke up at 1am the night of vaccine with chills, fever, sweats.  She felt nauseous, distressed.  She resolved without treatment.  Note that husband who also received a vaccine was sick, see additional VAERS form completed today.
Moderna vaccine given to a patient under the age of 18.  No other issues with the patient.
Redness; Pain in arm; rash; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Redness), PAIN IN EXTREMITY (Pain in arm) and RASH (rash) in a 48-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Apr-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (Redness), PAIN IN EXTREMITY (Pain in arm) and RASH (rash). At the time of the report, ERYTHEMA (Redness), PAIN IN EXTREMITY (Pain in arm) and RASH (rash) outcome was unknown.
pt recv vax 18FEB98 pt called clinic 20FEB98 & c/o h/a, cold chills, chest pains, diff raising lt arm;seen by 20FEB98 given med;
Information has been received from a physician concerning a 72 year old female with history of chickenpox in her childhood, who on 01-AUG-2008 was vaccinated with a dose of ZOSTAVAX (LOT # 658859/0411X) 06.5mL subcutaneously into her left deltoid. Concomitant therapy included alendronate sodium (MSD), atenolol and lovastatin (manufacturer unknown). On 04-AUG-2008, the patient developed shingles. The patient had 6-7 patches with vesicles on her left C-5 dermatome. On 05-AUG-2008, the patient began to experience pain in her left thumb. On 07-AUG-2008, the patient developed rash on the fingers of her left hand and spread to her arm. On 11-AUG-2008, the patient's vesicles on her left arm were diagnosed as shingles. Pain was quantified as 8, being 10 the most painful. The patient was being treated with VALTREX and ibuprofen. At th etime of reporting, the patient was recovering. There were no laboratory diagnostic studies performed. At time of reporting, the patient was recovering. Additional information is not expected.  Follow up: The patient was enrolled in the Varicella zoster virus Identification program to identify if VZV is present and if it is associated with the wild type VZV strain or with the Merck vaccine VZV strain.  The sample of the lesion was collected on 13-AUG-2008. The sample was taken from a not fluid filled vesicle lesion in her left arm. VZV DNA was not amplified. The PCR rersults for the specimen from the not fluid filled vesicle lesion, identified an inadequate specimen, negative for B-Globin, no strain I.D.  Additional information is not expected.
Fever, chills, aches, pains, confusion lasted 10 days.  But adverse things like spontaneous chills, fevers, the confusion have lasted 2 months.  I used to be able to multi-task.  Now I have to really concentrate to get through one task.  I am so far down from what I used to be even going through cancer treatments did not destroy me like this booster shot has.
10:00 AM - fatigue, headache, joint pain 2:00 PM - fever and chills 10:10 PM - passed out, approx 5-10 seconds. No memory for 2-3 seconds prior to or 2-3 seconds after passing out. Was caught by partner and no injury from fall occurred.
Weakness, Lethargy, difficulty speaking, difficulty with speech, muscle weakness in lower extremeties.
2nd dose reaction included extreme joint pain to where standing is painful in my feet, 103.4F temp with while alternating Tylenol/Advil q4h, large swollen lump in armpit and below clavicle which are extremely painful (on side of body where vaccine was administered). Stiff neck and jaw, severe headache, mild dizziness (was much worse after the 1st dose), nausea, fatigue.
First dose of the COVID-19 vaccine was given to patient on 11/30/2021. Second dose was given on 12/15/2021, which was 6 days prior to the recommended dosing schedule. Patient's mother was notified of the error and agreed to have vaccine repeated on or after 01/05/2022. No adverse events, outcomes, or treatment needed.  Patient tolerated and is doing well upon reevaluation by phone today.
red, swollen, induration (right arm). supportive: ice compress/ ibuprofen.
At just after 5 o'clock, pt received his 1st dose of the COVID-19 vaccine and about 10 minutes later he began to feel flushed in his face.  This was associated with some chest tightness as well.  He was referred to the emergency department.  He had no difficulty breathing and did not feel like his throat is closing.  He had no rash anywhere else on his body but does feel like his face is redder than usual.  His symptoms have not been associated with shortness of breath and has no abdominal pain.   Upon presentation to emergency department, the patient was hypertensive to the 220s but his vital signs were otherwise within normal limits.  Physical exam was fairly unremarkable with exception of some mild redness of the bilateral cheeks.  He had no rash there is no evidence of airway compromise or wheezing.  Low concern for acute anaphylactoid reaction.  Patient was given diphenhydramine.    Symptoms resolved and patient was discharged home.
Patient was given an additional DTaP in error on 4-28-2010.  I notified his mother immediately at clinic of the error and followed up with her on 4-29-2010.  At that time she reported that other than a low grade fever he was fine.  I called on 5-4-2010 to follow up and left a message.  On 5-13-2010 mother called to report that 1-2 days after he received his vaccinations his mood changed.  She states that he would drop to the floor and scream, cry for no reason and just become very upset which is not his usual nature.  She could not recall the exact date and time when  this started.  I called on 5-17-2010 to continue to follow up but no one was at home.  I will call again later.  Mother has notified their family doctor as well. I encouraged her to continue to monitor the patient's behavior and notify facility and patient's doctor of any changes or updates.
Fever, crying about 3 1/2 hours 4:30AM-8AM.  6 mos imm given previous morning about 10:30AM.
pt recv vax 25OCT96 in lt thigh & lt leg started swelling;pt very irritable;seen Saturday noc in ER for cellulitis;