chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Adverse event started w/ c/o headache and extreme progressive weakness. Treated at Hospital Center briefly. Diagnosis Low platelets 28k, cerebral hemorrhage, and pneumonia. Transferred Hospital . Received multiple platelet transfusions (5 I believe), and treated w/ IV ABT. Pneumonia "resolved" only to return within a week. During hospital stay patient experienced fluid overload, kidney failure, and heart valve failure of replaced heart valve. Lengthy hospital stay ultimately ended with transfer to hospice and death.
8:30 am 9/11/12 - MMR 1 dose .5ml in upper outer (L) arm subcutaneous done pt complained of cold sweats, chills, shaking & diarrhea I didn't see pt at this time phone call from Homeaids called with this information. Pt very nervous & anxious and worked herself up while receiving MMR vaccine - pt very emotional changed & upset.
After the 1st dose, I had chills and had trouble walking. My legs moved incredibly slow. The arm pain lasted for 2-3 weeks and was INCREIDBLY bad. Soon after I got the additional vaccine (second dose) 5/4/21. I?ve been having bowel issues since then, and some numbing in limbs on and off.. but stomach issues every day... yesterday morning I thought I woke up with a HUGE migraine and nausea. Soon after I felt like my breathing was difficult. I felt like something was on my chest. I got up and took a shower/ didn?t work and I felt too weak. So I headed downstairs because my husband had just left. I grabbed my phone and felt like I should call an ambulance. My arm was going numb and my legs too. I woke up on the bathroom floor and dialed 911. My body was shutting down on me and I could feel it. Tingles all over my body. By the time the paramedics got there I couldn?t control my arms or legs AT ALL. My arms curled up into my chest mangled looking and so much pain. I couldn?t get words out and had ZERO ability to move my arms or legs, paramedics told me my PaC02 was 10. I am currently being evaluated and treated for a stroke with ZERO prior heart conditions. Additionally, I have a pain in my left arm where the injection was. Anything magnetic hurts it. Anything metal sticks to it. Forks, knives, Bobby pins, coins, magnets. They all stick to the site.
really itchy; rash around injection site like round red mark; swelling; really sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (really sore arm), PRURITUS (really itchy), VACCINATION SITE RASH (rash around injection site like round red mark) and VACCINATION SITE SWELLING (swelling) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced PAIN IN EXTREMITY (really sore arm). On 04-Apr-2021, the patient experienced PRURITUS (really itchy), VACCINATION SITE RASH (rash around injection site like round red mark) and VACCINATION SITE SWELLING (swelling). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 05-Apr-2021, PAIN IN EXTREMITY (really sore arm) had resolved. At the time of the report, PRURITUS (really itchy), VACCINATION SITE RASH (rash around injection site like round red mark) and VACCINATION SITE SWELLING (swelling) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant product use was reported Treatment information also included cold compresses
Approximately 6 hours after being vaccinated I began having chills, nausea, vomiting and pain in the arm of injection. I then developed a fever of 101.5, headache, body aches and a swollen lymph node in the armpit on the arm the shot was injected in. The following morning, nausea and vomiting had subsided. Approximately 24 hours later, fever and chills had subsided. Headache and fatigue lasted an additional 24 hours.
lt arm redness around deltoid/size of palm/warm to touch,pain w/movement,diff lifting arm over head/pain radiating to ax & lt neck;t99.2,nauseated,flu-like sx w/vomiting x 1wk;sx started 1 day p/vax
Left leg swelling and pain (no erythema or warmth). Episode of Emesis and diarrhea.
Large red circle where he received his shot, 3 to 4 inches. It was swollen and red. Sore throat.
Redness and warmth at injection site,  spreading approximately 3 inches below injection site. Area soft to touch with with slight itching.  No open areas.  No pain or loss of function of arm.  Temperature  98.6
Initial report was received from a healthcare professional on 05 September 2013. A female patient had received an injection of FLUZONE (lot number UH898AA) on an unspecified date (route, site and side of administration not reported). Approximately 5 hours after the patient received the vaccination, the husband called and asked the triage nurse to call the patient at home. The patient reported itchy throat, tightness in chest, rapid heartbeat, "cold chills," dry cough, and sore throat. The patient was told to go directly to the emergency department. The symptoms became worse so the patient called 911. The patient was admitted overnight to the hospital. The diagnosis was that it was unclear of the cause of symptoms but a possible reaction to the influenza vaccine. The patient previously received an influenza vaccine on January 2013 with no reactions. Outcome was not reported. This case is linked to cases 2013-09448, 2013-09508, 2013-09507, and 2013-09509. Documents held by sender: None.
Fussiness. Explosive diarrhea.  Baby very fatigued. Gas pains, irritability aggressive crying not easily consoled.
Suspected vasovagal episode, blurry vision, sweaty, hypotension, eval by EMS, transported to ER via ambulance.
pt recvd vax 21JUN93 & w/in a day or two pt had staring & irritability episode; had EEG & was admitted to hosp; dx w/infantile spasms w/poss relationship to DTP;
Presents with c/o vaccine reaction after last visit 1/13/17 mom report on 2/23/17 that patient initially had fever. The next day, she states that his ears and tongue got swollen, and he had difficulty swallowing (they were in route to another state at this time). She says he couldn't walk for 2 weeks afterward and this thighs were swollen also. She says she never took him to a hospital or other health care provider but instead had a person she knows who does natural remedies take care of him and his symptoms resolved. She never took a picture of his reactions.
threw up three times; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (threw up three times) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VOMITING (threw up three times). At the time of the report, VOMITING (threw up three times) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication provided Treatment medication was not provided
My child suffered severe reactions the night he received his 9 month shots.  He spiked a 103-104 fever that lasted 3 days with explosive diahrea that lasted 4-5 days.  Within 1 week, he lost all eye contact and did not answer to his name. 9/8/09-records received for dates of service: 6/15/06-well visit-6/29/06-bug bite 3 days prior to visit-8/1/06-ear pulling-exam normal. 10/2/06-concerns of autism spectrum disorder. Continues with ear pulling.
Vaccine (DTAP) administered 05/14/2003.  Returned to office on 05/16/2003 with left leg thigh-swollen, red and tender; low grade fever.  Treatment: ice packs and Motrin and Tylenol for fever.
This spontaneous report as received from a medical assistant refers to unknown number of patients of unknown demographics. On unknown dates in 2013, unknown number of patients were vaccinated with VARIVAX (Merck). Medical assistant reported that VARIVAX (Merck) were stored as high as 8 degree Fahrenheit everyday through September, October and November 2013. The vaccine that was improperly stored in September, October and the beginning of November have been used to vaccinate patients. No adverse effect was reported. Lot number and expiry dates were not reported. Additional information has been requested.
This spontaneous prospective pregnancy report as received from a nurse refers to a 17 year old female patient. There was no pertinent medical history and no drug reactions/allergies. On 28-JAN-2013, the patient was vaccinated with GARDASIL, via wet SD (lot # H016960, expired date: 02-DEC-2013) and also on 24-JUN-2014 (lot # H020901, expired date: 05-JUL-2015), intramuscular (dose not provided). There was no concomitant therapy. The patient became pregnant with last menstrual period (LMP) of 21-JUN-2014 and expected delivery date (EDD) of 28-MAR-2015. On 23-JUL-2014, a urine pregnancy test was performed that was positive for pregnancy. No known adverse effects. The outcome of pregnancy was not reported. Additional information has been requested.
15 minutes after initial injection, dizziness and dry mouth began.  Lasted approximately one hour.  3 hours after injection, broke out with rash and began itching, throat became tight.  I called my PCP who suggested a solumedrol injection along with Benadryl.  I choose to take 20 mg Zyrtec and call 911 if respiratory effect declined.  Had extreme lethargy all day.  Presently, short of breath, aches and such similar to side effects mentioned.
I am reporting this only since I think there is a slight labelling problem:  Last August, my medical assistant administered Merck's Varicella Vaccine to an adult who was intended to get the Zostavax.  There were no ill effects, but I sustept if the adult vaccine (14-fold more concentrated) had been given to a child...there might have been significant Side effects.  I reported this to Mercks online site >60 days ago but they never acknowledged the problem.  The problem I believe could be corrected by having the box and bottle clearly labelled "FOR ADULTS ONLY" or "FOR PEDIATRICS ONLY".
Patient reports that he has felt muscle pain in the injection site area since getting the vaccine. There is not inflammation or swelling, but patient reports the pain is better with ice.
3-hours later, I felt chilly, achy and runny nose. I took a home COVID-19 test and was positive the next day.
Patient received 1st dose of Pfizer at  job.  Patient came to pharmacy and requested a vaccine and patien was given Moderna. Patient did not divulge he had previously received a Pfize vaccine.  Patient's daughter asked pharmacist if father perhaps became ill with mild flu like symptoms because he received Modena after receiving Pfizer. Pharmacist  did not immunize patient with second dose of Moderna following CDC guidelines
Cold chills Sweating Low grade fever Nauseated  Body aches and pains Lethargic  Drowsy Swelling-injection site
Early Wednesday morning (2/24) around 5:00AM, I woke up to extreme pain in my left arm, primarily along the upper forearm, inside of my elbow, and lower bicep. There was no trauma or unusual behavior prior to onset of pain. It came on suddenly and worsened with extension of the arm. Symptoms worsened over the next few days, with pain intensifying and extending down into my hand and up into my armpit and shoulder. I tried ice, Ibuprofen, Acetaminophen, and Vicodin for pain relief, but nothing really helped other than the ice. On Saturday morning (2/27), I visited Urgent Care and was diagnosed as brachial plexis neuritis, aka Parsonage-Turner Syndrome by Dr and prescribed Prednisone and rest. On Sunday evening (2/28), I went to the ER seeking pain relief and second opinion. On Monday (3/1) morning, I was seen by ED doctors, and then three different neurologists. After doing an ultrasound which ruled out vein/artery thrombosis, the neuro team diagnosed Parsonage-Turner Syndrome. They've prescribed Gabapentin, Acetaminophen, and Ibuprofen for pain relief,  a follow-up neuro consult, an MRI for next Friday, and an EMG in a few weeks. Last night while sitting and reading, the same pain began in my right arm, similarly to how it presented in my left arm last week. The right arm pain is less than the left arm pain, but at this point seven days later, I am experiencing neuropathic pain in both arms.
Breakthrough case admission after 3 vaccines Moderna 4/13/21 Lot# 025B21A;  Moderna 5/27/21 Lot# 033C21A;  Modena 3/21/222 Lot#  042J21A
slight fever; overall flu-like symptoms; aches; feeling tired; swelling at injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE SWELLING (swelling at injection site), PYREXIA (slight fever), INFLUENZA LIKE ILLNESS (overall flu-like symptoms), PAIN (aches) and FATIGUE (feeling tired) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031B21A and 032M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 06-Apr-2021, the patient experienced INJECTION SITE SWELLING (swelling at injection site). On 07-Apr-2021, the patient experienced PYREXIA (slight fever), INFLUENZA LIKE ILLNESS (overall flu-like symptoms), PAIN (aches) and FATIGUE (feeling tired). At the time of the report, INJECTION SITE SWELLING (swelling at injection site), PYREXIA (slight fever), INFLUENZA LIKE ILLNESS (overall flu-like symptoms), PAIN (aches) and FATIGUE (feeling tired) outcome was unknown. Not Provided          Action taken was not applicable.  No treatment and concomitant medications were reported.
Patient was nervous prior to the vaccination. Once he received the vaccine he asked to use the bathroom and while he was in there he felt nauseous and came out of the bathroom. He then felt extremely light headed and nauseous that he almost collapsed to the floor. The pharmacist and myself (an immunizing pharmacy intern) rushed to check on him. He reported a little difficulty breathing but was still conscious. We proceeded to call 911 and gave one dose of 0.3 mg Epi-pen. After about 5 minutes he felt much better and was able to sit up. He reported that he never lost complete consciousness but was extremely nauseous and lightheaded. Patient handed over to EMS.
I experienced Vertigo and a migraine for three weeks. I also experience body aches and fatigue. I didn't have the ability to do anything or think. I took Tylenol consistently for the pain. These symptoms gradually lifted and went away. It took a total of three months for me to feel like I was back to myself.
SHE BEGAN TO ITCH ALL OVER HER BODY THE NEXT DAY BUT REPORTED THAT SHE DID NOT HAVE A RASH.
Patient was accidentally given a third dose; This case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28th July 2021, the patient received the 3rd dose of Shingrix (intramuscular). On 28th July 2021, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details were provided as follows: The nurse reported that, the patient was accidently administered third dose of Shingrix, which led to extra dose administered. The nurse wanted to know if the patient might have any complications.
Tingling and pain in rt. arm and hand, overall weakness, localized pain at injection site, faintness, numbness in rt. hand, Shortness of breath. Improved after 15 min.
56 adults patients received doses after its expiration date Jul 13, 2022; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (56 adults patients received doses after its expiration date Jul 13, 2022) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 004m21a) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (56 adults patients received doses after its expiration date Jul 13, 2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (56 adults patients received doses after its expiration date Jul 13, 2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (56 adults patients received doses after its expiration date Jul 13, 2022).    It was unknown whether patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Caller mentioned that "the CDC had just approved extended expiration dates" and wanted to know if it was extended. When asked the caller stated that there were no remaining vials unused of that lot number and agent reminded the caller that no patients should receive doses from expired vials. Dose was administered after 30-day Use by Date or after manufacturer date of expiry. Vial did not undergo any temperature excursions.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-701125 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-701125:Master case
Lightheadness, fainted events occurred 4 hrs /p vax received, 1st dose. Events resolved /w out treatment
I experienced Aphasia for about one hour. I was unable to understand written words and unable to think of words I wanted to say. (Example: I wanted to tell someone I was on vacation "for the next few days" but I wrote "for the next few years," then corrected this to "the next few weeks," but could not think of the word "days." I saw the word "folk" and kept reading it as "work." I knew I wasn't getting it right but needed someone else to tell me the correct word. I also experienced a blurry dot directly in the center of my vision. This lasted about 15 minutes. I understand the University  has had 4 women come in with Aphasis about 2 weeks after their 2nd vaccine.
PAIN IN ARM VACCINATION SITE - TO DATE. RUNNY NOSE - TO DATE HEADACHE  - TWO DAYS  SHORTNESS OF BREATH - TO DATE RASH AND HIVES ON HANDS, RIGHT ARM, AND FACE. TO DATE
Information has been received from a vaccine coordinator concerning an unspecified number of unspecified patients of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX (lot # M035687, expiration date 10-AUG-2018) (strength, dose, frequency and route were not reported) for prophylaxis. It was reported that the vaccines were exposed to a temperature between 5 fahrenheit degree and 14 fahrenheit degree during a time frame of 927 hours and another temperature between 14 fahrenheit degree and 46 fahrenheit degree during a time frame of 34 hours. After two excursions, the patients had administered the vaccine. Data logger was involved. No adverse effects were reported. Additional information has been requested.
Rheumatoid arthritis aggravated; Pain aggravated; Edema; This is a solicited report based on the information received by Pfizer from AbbVie Inc. (MFR Control No. # 21K-163-3883468-00). A contactable female consumer (patient) reported for herself. Solicited report from the USA by a consumer of a 55 year old female with events of non-serious "more pain if patient did not take rinvoq before 12pm each day, Edema, covid shot made rheumatoid arthritis more prevelant and not sure if rinvoq working as well as the humira was doing with rinvoq (upadacitinib)". There was no reported medical history. On unknown dates, the patient experienced more pain. If patient did not take Rinvoq before 12pm each day, covid shot made rheumatoid arthritis more prevalent and not sure if rinvoq working as well as the humira was doing. In 2021, the patient experienced edema. Covid-19 vaccine was also considered suspect. The patient had more pain if she did not took the Rinvoq before 12 pm each day. She was Not sure if Rinvoq was working as well as the Humira was doing. In 2021 she was diagnosed with Edema. Physician could not prescribe any other medications since she was on Lasix and water pills. She had Rheumatoid arthritis pain with Covid shot, covid shot made her Rheumatoid arthritis more prevalent. Symptom Rheumatoid arthritis pain had outcome of recovered. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On unknown date, patient received COVID-19 Vaccine manufactured by Pfizer.   Causality for RINVOQ(UPADACITINIB) The reporter's causality for the event(s) of more pain if patient did not take rinvoq before 12pm each day,  Edema, covid shot made rheumatoid arthritis more prevelant and not sure if rinvoq working as well as the humira was doing was not provided.  The reporter's assessment of the causal relationship of the events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.; Sender's Comments: Based on the information provided, A possible contributory role of the suspect product to the development of aggravated Rheumatoid Arthritis cannot be excluded. 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.
Menstrual/uterine cramps that I would describe as fairly intense. I don?t usually get cramps associated with menstruation, and I was not menstruating at the time, nor did I begin to, I just experienced the cramps over the course of 48 hours beginning the day after the first dose. The cramping was certainly not incapacitating but was for sure the most intense I?ve ever felt. Went away about 72 hours after receiving the shot. Also: very sensitive skin. The skin around my eyes tingling and then got red and puffy and itchy after applying a vitamin c serum I?ve used regularly for six months with no issues. Got worse over the course of a week and then resolved.
This spontaneous report was received from a nurse and refers to a 13 year old patient of an unknown gender. The patient's pertinent medical history, concurrent conditions and concomitant medication were not reported. Information regarding the patient's drug reactions or allergies were not provided. On an unknown, the patient was vaccinated with the first dose of hepatitis a vaccine, inactivated (manufacturer unknown) (lot # L031196, expiry date 05-FEB-2017) 1 ml, once intramuscularly intended for adults instead of hepatitis a vaccine, inactivated (manufacturer unknown) intended for adolescents. No adverse event was specified. No product quality complaint was involved. Additional information has been requested.