chrisvoncsefalvay/vaers-outcomes huggingface dataset:
high blood pressure; Arm was sore the day after each covid-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (high blood pressure) and VACCINATION SITE PAIN (Arm was sore the day after each covid-19 vaccine) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Ankylosing spondylitis and Crohn's disease.    Concurrent medical conditions included Ankylosing spondylitis and Crohn's disease.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. On an unknown date, the patient experienced HYPERTENSION (high blood pressure) and VACCINATION SITE PAIN (Arm was sore the day after each covid-19 vaccine). At the time of the report, HYPERTENSION (high blood pressure) had not resolved and VACCINATION SITE PAIN (Arm was sore the day after each covid-19 vaccine) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: high.         No concomitant medications were reported.   It was unknown if patient was enrolled in a COVID-19 vaccine trial. On unknown dates, the patient experienced high blood pressure, never been high in life and arm was sore the day after each covid-19 vaccine.  The reporter's causality for the event(s) of high blood pressure, never been high in life and arm was sore the day after each covid-19 vaccine with Humira (adalimumab) was no reasonable possibility. The reporter assessed events high blood pressure and arm was sore the day after each covid-19 as reasonable possibly related to Moderna Covid-19 vaccine.  No treatment details were reported.  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.
Pt reported that after Tdap injection on 8/1/2011 she had mild chills/fever and body ache that same evening and a few days later broke out in welts & hives with itching. Sx have lasted over 2 weeks. Reported today 8/23/2011.
Upset stomache, headache, achy all over, metallic taste in mouth. All for a couple days.
per pt. after covid vac.  shot was given ,she fell palpitations and lightheadedness after few mins. receiving the vac.
After both vaccines I experienced numbness on the left side of my face. On 9/15/21 and 9/25/21 my face started twitching uncontrollably for maybe 15 minutes
Fully vaccinated and boosted once. Delivered 39 w baby vaginally. Baby patient DOB 9.9.22. Pediatrics, Central, no specific doctor noted.
Janssen COVID-19 Vaccine EUA Patient received Janssen Vaccine on 3/10/2021. Presented to ED on 7/10/2021 with hip pain of two weeks in duration. CT Angiogram showed a right inguinal hematoma and active extravasation and was medically managed. Patient subsequently developed shortness of breath and pneumonia and treated with 7 days of cefepime. Patient tested positive for COVID-19 using the Cepheid GeneXpert platform on 7/30/2021, which was the anticipated day of transfer to skilled nursing facility. On 8/4 she developed abd pain prompting KUB whihc showed SBO but patient deferred NG tube.Later she had CT chest neck and abd which showed worsening PNA with aspiration of bowel content and SBO and poss oropharyngeal  perforation. Patient did agree after detailed discussion with family about CT findings and IR able to place NG tube but shortly after she  began throwing up bile and needing high flow oxygen. She was not able to maintain oxygen saturation and family changed her status to AND, and she expired on 8/6 at 0415 AM.
Patient developed bruising bilaterally on both feet, and is also complaining of small blisters which just developed on hands.
I started to get itchy everywhere; cough; This is a spontaneous report from a contactable consumer (Patient). A 64-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date were not reported) via unspecified route of administration on unknown date in Feb2021 at single dose for covid-19 immunization. Patient also received Benadryl (manufacturer unknown, formulation unknown, lot number not reported (It doesn't say lot, it just says SJF001) and expiration Mar2022) on an unspecified date via unknown route for unknown indication. The patient's medical history included migraine. The patient's concomitant medications include adalimumab, Methotrexate, omeprazole, Olmesartan, Folic acid, Promethazine and bupropion hydrochloride. On an unknown date 2021, the night of that day, patient got a reaction, that evening, she started to get itchy everywhere, that would not stop. So, she took Benadryl but that did not help and saw her doctor in the morning, and he gave her an injection of steroid (treatment). So, she was wondering if she should go ahead and get second one or not. The other thing was she did develop a cough that lasted for about a week. Date for next shot was 10Feb2021. She took Wellbutrin, 300 mg because it was the extended release. The outcome of the events was unknown.  Information on Lot/Batch number has been requested.
Light head/dizzy/spins/nausea/vomiting/body and head ache and pains/chills/101.4 fever lasted for over 30 hours followed by headaches/fatigue that lasted an additional few days.  Currently on day 4 with occasional head pain and general fatigue.
Patient administered bivalent Moderna covid-19 vaccines after 30 day beyond use date; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered bivalent Moderna covid-19 vaccines after 30 day beyond use date) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 021H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered bivalent Moderna covid-19 vaccines after 30 day beyond use date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient administered bivalent Moderna covid-19 vaccines after 30 day beyond use date) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient administered bivalent Moderna covid-19 vaccines after 30 day beyond use date).    This case pertained information of patient 2th out of 14 patients.  No concomitant product reported by reporter.  14 patients administered bivalent Moderna COVID-19 vaccines after 30 day beyond use date. Doses were administered from 8-DEC-2022 to 10-JAN-2023.  No treatment medication reported by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-703586 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-703586:Master case
Herpes Zoster on 12/21/99. (Varivax given 11/9/99)
Pt had bloating and stomach discomfort in March 2022. Diagnosed with large ovarian  mass
Approx 1 hour post immunization became warm and developed a migraine headache took 2 Tylenol approx. 5 hour post onset. Laid prone in darken room which started to relive symptoms.
Shot hurt going in and it lingered. Immediate soreness but appeared normal. Later soreness increased. Body aches throughout the day and night; headache. Lasted day of shot and next day. Today (November 10, 2021), I feel much better. I just have headache and heaviness in my neck.
Cellulitis of left arm shoulder to elbow, consulted physician, Cephalexin 500mg  QID prescribed (7 days)
Patient c/o of symptoms starting that evening: chills, body aches, HA, fatigue that lasted for 2 days. Patient had COVID-19 in August 2020. Patient states "it feels like I had COVID all over again."
Deltoid ache which has since resolved. Ache in Shoulder/axillary joint, has continued through today (3 weeks since the Vaccine dose). Hurts when I left my arm above shoulder height
HAD A HEADACE, BUMPS ON FACE , COLD SORES LIKE ON UPPER AND LOWER LIPS. COULD HARDLY STAND, LASTED A FEW DAYS. AREA AROUND INJECTION WAS RED.
Almost immediately the patients face turned extremely red and swollen on the complete right side of her face. She immediately went to her physicians office and was directed to the emergency room at hospital. She was admitted and received an unknown I.V. and an unknown injection. After 2 hours she was released and was given 2 prescriptions to receive at her local pharmacy. The swelling lasted for 3 days. Five days later she had an identical reaction but it was on her left side of her face. A month later her blood was tested and she has had an  abnormally low blood platelet count.
I have been having twinges in my right arm and then the pain is causing my lower arm to hurt that it's hard for me to hold a pen and write and it hurts to straighten out my arm and I'm still getting the chills
an unspecified patient was 8 months and 10 days old when they received "their third dose" of ROTATEQ.; No adverse event reported; This spontaneous report as received from a registered nurse refers to a 8 months 10 days (34 weeks approx.) old patient of an unspecified gender. Patient's medical history and concurrent conditions and concomitant therapies were not provided.     On unknown dates, the patient was vaccinated with the first and the second doses of rotavirus vaccine, live, oral, pentavalent(ROTATEQ) orally (dose, lot # and expiration date were not provided) for prophylaxis. It was stated that third dose was given when the patient was 8 months 10 days years old (Inappropriate age at vaccine administration). No adverse event was reported.
I experienced a breakthrough case of COVID-19 with a fever of 100 degrees, pain in my toes, sore throat, disoriented, unable to stand, hair loss, body aches, loss of taste and smell, weight loss, sleepiness, shortness of breath, gastrointestinal issues, hemorrhoids, and I don't want to eat anything crunchy, I also don't have taste so I am not interested in eating any foods.
72 year old, male with past medical history significant for Parkinsons and internal hemorrhoids w/band ligation and recently vaccinated for COVID who then developed tibial rash and gingival bleeding. Platelets notably 2. Fibrinogen normal 357/unlikely DIC, Coags normal,  LDH normal unlikely TTP or MAHA and bilirubin normal, Retic also normal (not aplastic anemia), unlikely leukemia, smear unremarkable.  HIV negative, Hep panels. Some anemia, pending iron studies.Pending ANA /other labs. Do not suspect leukemia.  Suspect ITP
Brown reddish abnormal bruising of the left hand, top and bottom of forearm. No treatment. No improvement
Patient had two erythematous nodules on top left thigh some induration. No pustule. No warmth. No surrounding erythema scattered erythematous macules and papules (blanching) along suprapubic area. Sandpapery feel to area.
02/24/2021 11:30 PM Extreme fatigue Nausea Pain at injection site Swelling at injection site Muscle pain Chills  02/25/2021 1:00 PM Continuance of symptoms listed above 100.3 degree fever   Symptoms managed with Advil Dual Action (Acetaminophen and Ibuprofen)
brain aneurysm resulting in death.  1 day after receiving vaccine she was fatigued and went to bed at night like normal. 2 days after(friday morning) she was choking on saliva in bed, not responsive and was taken to ER where we found out she had a large brain bleed that ultimately ended in death 8 days after receiving vaccine.
Redness with tenderness and swelling to Injection site that increased in size over 24 hour period. Next day complained also of itching to Injection site.
C/O throat and tongue, itching at 11:50. Benadryl 25 mg administered per protocol. Patient tolerated medication well with oral hydration. Education provided
Patient states 1 day after receiving vaccination her arm was red, hard, swollen. She noted the reaction was a few inches below the actual injection site. After a few more days she presented with red itchy areas on both arms and chest area mainly, however there were also a few spots on her legs.
About 10 minutes after the injection, I experienced sudden onset of dizziness and shortness of breath, followed quickly by rapid heart rate. The shortness of breath and dizziness resolved in less than a minute. The rapid heart rate a few minutes later.
Approximately 3 months post vax, the pt developed a lack of speech and acting almost deaf. The pt has autistic enterocolitis, ileal lymphoid nodular hyperplasia and lymphocitic colitis. Ileum biopsy assessment indicated measles presence. He developed gross fat malabsorption, loose yellow stool / diarrhea, motility abnormalities, additional maldigestion (probably pancreatic insufficiency) high levels of yeast and fungus and bloating. He is a "non-responder" to three of his vaccinations, hep B, mumps and chicken pox. It is suspected that sub clinical seizure activity keeps "erasing" language as the pt acquires it. It is also suspected that the inflammation process described above involves the brain (encephalopathy) because he simultaneously has developmental regression, increased disorientation and self-stimulation, etc. Recently he has begun to roll his eyes up as high as possible while looking directly at a bright light and repeatedly flicking the switch on and off rapidly. We suspect an escalation of the epileptiform activity. He meets at least 44 mercury poisoning criteria.
3 patients experiencing optic nerve damage approximately 3 months after second dose of vaccine. 2 patients were Moderna and 1 was Pfizer.; This is a spontaneous report from a non-contactable other hcp. A 7-decade-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, (Batch/Lot number was not reported)), dose 2 via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Historical vaccine information included bnt162b2 (COMIRNATY) 1st dose on an unknown date for Covid-19 Immunization and experienced no events reported. On an unspecified date, 3 patients experiencing optic nerve damage approximately 3 months after second dose of vaccine. 2 patients were moderna and 1 was Pfizer on an unspecified date. The outcome for event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on the information available  a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of  optic nerve damage. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Received Tdap and flu vaccine in left arm per patient request. Patient states arm was sore and a little swollen on day of injection(11/04/08). The next morning when she woke up (11/05/08) she noticed a bruise at the injection site and her arm was swollen and painful to touch.  This morning she said it turned red and hot.  Patient instructed to apply ice packs to area. Take tylenol prn fever and/or swelling.  Take Benadryl prn itching.  Pt also instructed to follow up with PMD if s/s get worse.  Pt instructed to call prn if questions/concerns.  If patient experiences difficulty breathing call 911.  Pt informed that agency will follow up with her.
Outcome "fine" /p 1st 2 doses Engerix B, titer found nonresponse /p 3rd dose, will give additional doses, 2 additional doses of vax @ a 1 month interval given, outcome not yet known.
Left upper arm where pneumovax given area red, painful, and warm to palaption.  Diagnosis of cellulitis.  Treated with clindamycin for 7 days.
At injection site; a 1 inch welt; red, raised, swollen, hot, itchy a week after Dose 1 of Covid Moderna injection
Went into anaphylactic shock.  Started feeling dizzy and light headed 15 mins after the vaccine was given. At 20 mins my throat felt tighter and it was making me cough trying to get air so they gave me 50 ml of benedryl into my right arm. I started to pass out and my breathing was labored so I was given my epipen and taken to the ER. While I was there I was monitored for 4 hours and given 2 more medications. One was a steroid, I?m unsure on the second.
1st reaction was sore arm for 2 days.  Sire to touch and achy. Week later. Arm red and hot for a few days.  Next week arm sore and burning.  Tingling, pins and needles,  burning in random parts of body Arm, leg, face , back. Head.  Every part was hit.   The last two have continues through today almost 5 weeks after my shot. Went for second shot and they suggested I wait a little longer. Right now I am afraid to have second shot.
None- vaccine given 10 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (None- vaccine given 10 days post expiry) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 011J20A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (None- vaccine given 10 days post expiry). On 16-Nov-2021, EXPIRED PRODUCT ADMINISTERED (None- vaccine given 10 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication provided. No treatment information provided.   This case was linked to MOD-2021-395985 (Patient Link).
pt started itching on upper body whives-inj site was very hot to the touch & swollen; pt was put on Claritin & Atarax; pt devel numbness of the lips & matallic taste on 5OCT95;pt able to return to work 6OCT95
Patient presents with a 1.25" x 1.5" bruise at injection site surrounded by a 3" x 4" area of redness. Location is hard to the touch and produces heat. Injection site is painful.
Covid 19; Covid 19; This is a spontaneous report from a contactable consumer, the patient. A male patient of unspecified age received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: solution for injection), dose 1 via an unspecified route of administration, on 21Jan2021 (lot Number: UNKNOWN) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. On 07Feb2021, patient tested positive for Covid 19. He was supposed to get the second dose of the vaccine on 11Feb2021, but he did not get it due to the infection. The patient wanted to know when he can get his second dose. The outcome for the events were unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
After receiving 3 Lyme vaccines, I started having Lyme symptoms including joint pain, vertigo and fainting.
Sudden onset of intense itching and swelling with whelps at injection site on day 7 after injection.
7 years old received a dose of Kinrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 7-year-old female patient who received DTPa-IPV (Kinrix) (batch number 3KS4F, expiry date 22-MAR-2024) for prophylaxis.   On 16-MAR-2023, the patient received Kinrix. On 16-MAR-2023, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: 7 years old received a dose of Kinrix ). The outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 08-MAY-2023 The Kinrix dose was the patient's 5th DTaP and 4th IPV.  The vaccine administration facility was the same as primary reporter. The reporter consented to follow up and stated that did not send any patient information to email address. The seven-year-old patient was given Kinrix, which led to inappropriate age at vaccine administration.
Patient had what it seems like seizure after getting her vaccine which lasted about 30 seconds, EMS was called. Patient was transferred to  Hospital
Initial unsolicited report was received on 09 March 2015 from a consumer from a media report on the internet. The reporter also reported another event which is captured in case number 2015SA031445. A male patient, age and date of birth not reported was vaccinated on an unreported date with Influenza Vaccine, manufacturer, batch, site and route not reported. On an unreported date he suffered from a shoulder injury, had painful nerve damage into his left arm, can't raise his left arm and takes powerful medications. The patient "thought he actually stuck it into my bone." The patient's medical history, concomitant medications and laboratory tests were not reported. The patient outcome is not recovered. No further details were available at the time of this report. Documents held by sender.
Starting approximately one week after my Moderna booster, I started to experience daily rash / hive flare ups at various areas of my body. The flare ups and hive patch outbreaks continue to this day and are ongoing.
Information has been received from a consumer concerning her 36 month old son with gastrointestinal issues who on 24-JUL-1998 was vaccinated with first dose of MMR II (Lot # not reported) and HIB (unspecified carrier). Then on 24-APR-2001 when he three years old he received the booster MMR II (Lot # not reported) as well DTaP and IPV. When the patient was 3 years the patient had two brain seizures and was sent to the emergency room where he had a magnetic resonance imaging (MRI), 23 hour electroencephalography (EEG) and they checked his blood levels for minerals (results not reported), but he was not admitted to the hospital. Then when he was 3 and a half years old he was having speech problems. The patient was going to speech therapy but he eventually lost all of his speech and was mute. The patient then was diagnosed with autism around 4 years old and at that time he started to experience gastrointestinal problems, where he had to get an endoscopy done and had a number of biopsy which the physician's found a strain of the measles. The patient still went to speech therapy and spoke in sentences when it only pertains to him, his gastrointestinal problems only flared up occasionally, he had cognitive impairment and sensory integration dysfunction and he could not have dairy products, bakery products and sugar. Upon internal review, brain seizures and autism were determined to be other important medical events. Additional information has been requested.