chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine exposure via breast milk; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 01-Apr-2021 and was forwarded to Moderna on 01-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of EXPOSURE VIA BREAST MILK (Vaccine exposure via breast milk) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 vaccination.     The patient's past medical history included Pregnancy on 27-Dec-2013, Pregnancy on 16-Sep-2019 and Anemia in January 2018. Previously administered products included for Product used for unknown indication: Nicotine from January 2000 to January 2011.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPOSURE VIA BREAST MILK (Vaccine exposure via breast milk). At the time of the report, EXPOSURE VIA BREAST MILK (Vaccine exposure via breast milk) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
So, I woke up in the middle of the night and went to the bathroom because my bladder was hurting, and I passed out and I felt like I was to die, and I couldn't get up and walk. The people in my house said it looked like I was having a seizure and I felt like I was going to throw up and I ended up Vertigo. I had to to get help from a relative in the house to go to the restroom and go to my room. I think I would've been alone I was going to need an ambulance.
Injection site decreasingly red, swollen and achy disappearing after 4 days. On the 7th day (4/14) site began itching and has a small lump. On the 8th day (4/15) site was swollen, red and irritated and remains lightly itchy. Also, have had Diarrhea everyday since injection (decreasing in intensity).
The pt developed a fever and a seizure about 12 hours, post vax. He needed valium to "break". Dx: Atypical febrile seizure
Patient became dizzy/started losing his vision fairly quickly after receiving the vaccine. He kept repeating he couldn't see. He stumbled forward then fell down. Patient did hit his head. Store associate got him up and into a chair and started asking him questions. Mom stated he had just received vaccine. They were not told by the pharmacist on duty to stay to be monitored for 15 minutes after.  He did say that he had a headache. Gave the patient some water, had him move his arm around, and monitored patient until pharmacy closed.
Post excursion vaccine was administered with no adverse event; Initial information was received on 03-Oct-2022 regarding an unsolicited valid non-serious case received from a healthcare professional.  This case is linked to case 2022SA409280.  This case involves a 7 years old female patient received IPV (VERO) [IPOL] Post excursion vaccine was administered with no adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 5-COMPONENT, TETANUS VACCINE TOXOID (ADACEL); MEASLES VACCINE LIVE (ENDERS-EDMONSTON), MUMPS VACCINE LIVE (JERYL LYNN), RUBELLA VACCINE LIVE (WISTAR RA 27/3), VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (PROQUAD); and INFLUENZA VACCINE (FLU VACCINE) for prophylactic vaccination.  On 03-Oct-2022, the patient started taking IPV (VERO) solution for injection via subcutaneous route in right thigh (Batch number - V1A022M, Expiration date: 17-FEB-2024) for prophylactic vaccination.  On 03-Oct-2022, Post excursion vaccine was administered with no adverse event (poor quality product administered) (latency: same day).   Action taken: Not applicable.  Outcome: Unknown.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Information has been received from a woman in a physician's office concerning a 7 year old female with no allergies or medical conditions who on 04-APR-2000 was vaccinated SC in the left vastus lateralis with a first dose of Varivax (lot # 632042/1360J). Concomitant vaccination on the same day included a SC first dose in the right vastus lateralis of MMR II (lot # 634036/1711J). There was no illness at the time of vaccination. On 16-MAY-2006, the patient broke out with chickenpox lesions and was seen by the physician. No diagnostic laboratory tests were performed. The patient recovered on an unspecified date in May 2006. It was noted that the patient had no adverse events following prior vaccination. Additional information is not expected.
2 weeks after vaccination, a considerable worsening of my condition (ME/CFS). This consists of post-exertional malaise (PEM), fatigue & profound weakness.   After not getting better after 10+ weeks after this worsening of symptoms, my ME/CFS doctor advised to complete this form.
fever; headache; shivering; muscle pain; dizziness; weakness; itchiness; This case was reported by a consumer via call center representative and described the occurrence of fever in a 78-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th September 2019, the patient received the 2nd dose of Shingrix. In September 2019, less than a week after receiving Shingrix, the patient experienced fever, headache, shivering, muscle pain, dizziness, weakness and pruritus. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the fever, headache, shivering, muscle pain, dizziness, weakness and pruritus were unknown.   It was unknown if the reporter considered the fever, headache, shivering, muscle pain, dizziness, weakness and pruritus to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported but would be between 77 and 78 years. The patient experienced fever, headache, shivering, muscle pain, dizziness, weakness and itchiness. The patient was not been seen by her doctor and that she had been taking Tylenol to help with the side effects. The patient consented to follow up.
chills, uncontrollable shaking (boby would tense up/hurt every time shake.  felt like I was having convulses.  my teeth would not stop chattering), body felt cold/hot, unable to sleep, and full body achy/sore, and tired feeling.  The chills and uncontrollable body shaking happened twice (around 7:00-8:00 pm and sometime in middle night). I took alieve and probably 15 to 30 min later the body shake would stop.
Pt with onset of urticarial lesions on the evening of the injection. Initially responded slightly to antihistamines and oral steroids. Symptoms returned after cessation of steroids. Later developed respiratory symptoms and continued skin symptoms. Skin biopsy showed likely leukocytoclastic vasculitis. Chest CT with ground glass appearance. Acute elevation of peripheral eosinophil counts. Responded well to oral steroids. Skin lesions resolved. Follow up chest CT with near complete resolution of previous radiographic findings. Clinically returned to baseline health.
My daughter was given the nasal mist.  I have always gotten vaccinated and vaccinated my children.  I have ALWAYS believed it was a myth that you could get the flu from the vaccination.  That has all changed!!  She started out with a very bad stomachache in the evening and following day.  On Thursday, October 16th, she started to run a fever, which was up to 103 degrees at times.  The fever continued on October 17th and 18th.  She has body aches, chills, shaking with the chills.  In my opinion it is as bad as the flu itself.  It truly seems like she has gotten the actual flu from the nasal mist.  I have NEVER believed you could get the flu from a vaccine.  I will NEVER give my children the nasal mist ever again.  This is horrid!!!! The vaccination sheet lists her symptoms as a mild reaction.  This is not a mild reaction!!!  She is reacting just like she has the flu.  She is absolutely as sick as she would be if she had the flu itself.  She has missed some very important events due to this.  I am not happy!!!
This literature case, initially received on 26-Mar-2018, was reported by other health professional and concerns female patient of unspecified age. The aim of the article was to enhance understanding of the pathology of hematologic derangements in Hermansky-Pudlak syndrome for which literature and case reports of Hermansky-Pudlak syndrome were reviewed. The patient had a history of anaphylactic allergy during platelet transfusion for the treatment hematoma. The current conditions of the patient included, Hermansky-Pudlak syndrome, idiopathic dystonia and hematoma. On an unspecified date, the patient was administered with INN Flu Vaccine Seasonal (dose, route of administration, anatomical location, batch number, expiry date, trade name, manufacturer: not reported). On an unspecified date, after vaccination, the patient developed expanding hematoma over the course of 5 days. The platelet count was found to be normal with a count of 337. The patient also experienced dystonic episode characterised by sudden sensation of tightness/spasm in various parts of body (episode present upon admission began in her neck) which radiated into lower back, sacrum and bilateral upper extremities. The patient described spasms as a pulling sensation after which the body collapsed and was folded (as reported). The pain was expressed as 10/10 in severity. The patient was given pre-treatment with unspecified glucocorticoids and BENADRYL. The patient was transfused with 2 units of platelets without any complications. At the time of this report, the patient had recovered from dystonia and the outcome of the event expanding hematoma was not reported.
SIDE EFFECTS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of side effects was not reported. This report was non-serious.
one week afetr injection, I have a large, red, swollen and hot area around the injection site. It is also itchy.
6 days p/vax devel typical measles rash & diarrhea w/mild fever;rash spread from trunk & back to limbs upper & lower
Father reports child's inability to pronounce "A", "E", "O" sounds without hesitation. Father states he did not have any speech issues prior to the immunization.
Vaccinated 12/17/13. Morning of 12/18/13 noticed swelling at site of vaccination, about 1 1/2 inches round. Morning of 12/19/13 spot was more swollen, about 2" x 3", red color, itchy, sore to touch.
190 patients (9 different lot numbers) received a vaccine past the beyond used by date; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by 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)) 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) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by 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 (190 patients (9 different lot numbers) received a vaccine past the beyond used by date).    No concomitant and treatment medications were reported.  It was unknown whether patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine   This case was linked to US-MODERNATX, INC.-MOD-2023-704335 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704335:Master case
Two days post vaccination I did start to have flu and cold like symptoms. runny nose, fever, sore throat, and congestion. It has been three weeks and the sore throat and pressure behind my eyes has ceased and improved greatly, however, runny nose, congestion, and fever are still sticking around and causing my issues.
Information has been received from a physician concerning a 64 year old male, weight 154lb, height 66 inches, with no pre-existing allergies or medical conditions, who on 04-JUN-2008 at 09:52 was vaccinated with ZOSTAVAX (Oka/Merck) (lot#: 659406/0298X) SQ into the left arm. On 06-JUN-2008 at 08:28 the patient developed shingles.  The outcome of the shingles was not reported.  The patient sought medical attention with a physician office visit.  The reporter considered shingles to be disabling.  Additional information has been requested.
I felt really fatigued / really tired; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (I felt really fatigued / really tired) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    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 FATIGUE (I felt really fatigued / really tired). At the time of the report, FATIGUE (I felt really fatigued / really tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication details were provided.  No treatment information was mentioned.   This case was linked to MOD-2021-293546 (Patient Link).
I got my 3rd dose on 4/19/22 at 6:45pm. The following day (4/20/22) I was in bed (took off work the full day) with fever, chills, headache, and muscle / joint pain. I also noticed a sharp pain that sporadically occurred in both eyelids throughout the late afternoon. On  4/21/22 I woke up at 10am and my right undereye was slightly swollen and mildly purple on the lower lid. Over the course of the day, the swelling increased and extended into my mid-cheek. It is currently 9:14pm on 4/21/22 and the swelling persists. I am considering going to urgent care or seeing if I can visit a GP tomorrow.
no symptoms reported; HCP reported inadvertent administration of expired MMR-II that was stored properly; This spontaneous report was received from a pharmacist, referring to a patient. Information regarding the patient's pertinent medical history, concurrent condition and concomitant medication was not provided.  On 28-JUL-2023, the patient was inadvertently vaccinated with expired dose of measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live, rHA (M-M-R II) injection (1 dosage form, lot #U022175, expiration date 14-JUL-2023, exact dose, route of administration and anatomical location were not provided) for prophylaxis (Expired vaccine used). No symptoms reported. No additional adverse event (AE)/ product quality complaint (PQC) (No adverse event).
Client with generalized itching, no rash or hives approximately 15 min post getting vaccine. Client with no respiratory distress, VS WNL.  Client given 37.5 mg Benedryl on site and was monitored by EMS.  Spoke with client 3 hours post getting vaccine, itching is better, no rash, no hives, resting comfortably.
vaccine was stored in fridge beyond 30 days when administered to pt; follow up with pt; pt reported chills, headache; advised repeating dosage
A red painful rash outside of my field of vision was observed in a mirror after bathing and drying with a towel. My husband inspected the back of my left hip and upper thigh and saw a rash with blisters. Even though treatment with antiviral medication was begun the next day, the painful rash spread down my left leg covering the hamstring and calf muscles over the next week. Also, painful lesions formed, broke open and oozed on the lft side of my genitalia. It has been 43 days since the shingles outbreak was observed, and scabs still cover the largest blistered area on the back of my left thigh. These repeatedly slough off and re-develop; that is, my skin has not cleared up. In places where the scabs have disappeared, the skin is awash with hideous purplish-blue blotches. My dermatologist, diagnosed my skin eruption as a severe case of shingles on March 15, 2012. Immediately, these three prescriptions were written and filled: (1) Valacyclovir 1 gram for 7 days; (2) Tramadol HCL 50 mg, and (3) Prednisone 20 mg.  Since Tramadol did not provide sufficient pain relief taken 3 times per day, it was discontinued after 6 days and replaced with Prednisone.  While taking Prednisone one tablet daily for 1 week, I began to apply these topical prescriptions:  (1) 30 Bactroban 2% cream once per day and (2) 30 C-Shingles Gel #1 by Merrill three times per day.  At my second appointment, Dr. confirmed the seriousness of my condition by stating:  It is possible your nerve pain might persist for a long time after your skin has healed.  At present, I am afflicted with these distressing symptoms in the areas covered with the rash: (a) an acute burning itch that interrupts my daily activities, (b) creepy sensitivity as if something like a worm is crawling under my skin, and (c) the unusual feeling that a liquid like blood is running off my left hip and down to the thigh on my left leg.  These symptoms intensify toward the evening and before I retire and try to sleep, if sleep is even possible.  I am a BLIND victim of shingles who thought she was protected and assumed she did not need to carefully inspect her skin daily to observe changes such as flushing and blotches on the buttock and thigh area.  I was very foolish not to have acted in a suspicious and cautious manner.
On 6/7/21, my tongue felt numb on the right half, I thought I had just burned my tastebuds on my lunch. On 6/8/21 I was dizzy, my right eye and right side of my lip started twitching a lot, I thought I was just stressed. On 6/9/21 I woke up with mild muscle weakness in my mouth, and had no feeling or taste on half of my tongue. Went to a local urgent care and was given anxiety meds and a referral for a therapist. I also mentioned my right ear was feeling a bit painful like the start of an ear infection possibly, Dr never addressed the issue with my face muscles and my BP was 164/88. On 6/10/21 I woke up with both eyes swollen and more of my right facial muscles not functioning properly. Went to the ER where they asked about my face and other questions regarding the facial swelling, turns out I had an allergic reaction to the anxiety meds. They did some strength tests and diagnosed me with Bells Palsy, blood pressure was 152/110. Was given Valtrex by the ER DR to help with the Bells Palsy. Had a follow up appointment with my PCP on 6/14/21, she prescribed Predizone. By 6/21/21 most of my facial function had returned. I had a 6 week follow up with my PCP on 7/27/21, my facial function is still not 100% but is better than it was on 6/14/21. I am now seeing a therapist due to this event and my newfound fear of death or any other medical issues directly related from this vaccine.
Patient vaccinated on 9/26/19. Had some soreness on that date at night. on 9/27/19 in the am had a little redness applied ice at school. Came to office for visit. Local redness swelling and blotchy. Dx Cellulitis at apt with provider. Antibiotic prescribed along with Benadryl.
Loss of taste combined with a lasting metallic taste and near constant thirst. Specifically, the sensations of sweet and sour are almost completely lost.
Patient reported to center 1 day following Covid Vaccination. Vaccine was administered by local Health Department. Patient is having sever Left Arm Pain and is unable to move arm due to pain. Exam reveals, No lymphadenopathy, No erythema. No swelling, No warmth. Sensation intact on entire arm.  Radial pulses are equal bilaterally and strong.  Capillary refill is less than 3 seconds.  Temperature is 100.3.  All other vital signs stable.  Recommended Ibuprofen 600 mg three times daily with food and Benadryl 25 mg.  Patient send back to villa to rest.  Follow up call made at 1500, patient reports pain is decreasing, but still unable to move arm.  She reports no redness, no swelling, good sensation, good pulses.  She will call me tonight if any concerns.  She will follow up with Center tomorrow. Local ER Physician was consulted.
tendon inflamed; 2 days later developed extreme pain my my left ankle and calve.; 2 days later developed extreme pain my my left ankle and calve.; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 58-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number was not reported), via an unspecified route of administration on 04Mar2021 (58-years-old at the time of vaccination), as single dose for COVID-19 immunisation. The patient medical history was not reported. Concomitant medication included ticagrelor (BRILINTA), naproxen, chondroitin sulfate, glucosamine hydrochloride (OSTEO BI-FLEX [CHONDROITIN SULFATE; GLUCOSAMINE HYDROCHLORIDE]), vitamin b complex, vitamin c, vitamin d3, acetylsalicylic acid (ASPIRIN LOW), atorvastatin calcium (LIPITOR) taken for an unspecified indication, start and stop date were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 24Mar2021, the patient experienced Extreme pain in my right knee and thigh. Got the 2nd shot 04mar2021 and 2 days later developed extreme pain my left ankle and calve. Pain had not left yet (at the time of report). Therapeutic measures were taken as a result of tendon inflamed, 2 days later developed extreme pain my left ankle and calve as Prednisone and tramadol. Device Date was 29Jul2021. The clinical outcome of the event tendon inflamed was recovered in 2021 with Sequel, remaining all other events were not recovered at the time of the report.  The lot number for the vaccine, (PFIZER-BIONTECH COVID-19 VACCINE) was not provided and will be requested during follow up.
Injection site- swelling, redness, pain, tenderness,  itching - chills, fever, body aches