chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A few days after the first shot, I developed a tachycardia for the first time in my life, I was alarmed and hoped it was a unique thing and would go away. I had 4 or 5 more incidents of this before I got my 2nd Moderna shot. August 18, I had the 2nd dose. Within just a few days of that, I developed edema for the first time in my life. The swelling in my legs continued off and on for the next month, and I scheduled a doctors appointment for October 5.  On 9/30, the swelling in my leg was so bad that my husband and I decided we could not wait, and I reported to the ER at Medical Center. I was diagnosed with a blood clot in my lower left leg
Immunocompromised patient took 0.25 ml for his third dose; This spontaneous case was reported by a patient and describes the occurrence of ACCIDENTAL UNDERDOSE (Immunocompromised patient took 0.25 ml for his third dose) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939905, 016M20A and 026720A) for COVID-19 vaccination.     The patient's past medical history included Immunomodulatory therapy (Patient has cancer and is on immunotherapy) since an unknown date. Concurrent medical conditions included Immunocompromised (Patient is immunocompromised) and Bladder cancer (Bladder cancer started two months ago and is in remission).   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 04-Nov-2021, the patient experienced ACCIDENTAL UNDERDOSE (Immunocompromised patient took 0.25 ml for his third dose). At the time of the report, ACCIDENTAL UNDERDOSE (Immunocompromised patient took 0.25 ml for his third dose) outcome was unknown.            Patient's height was reported as 70 inches. Patient did not ever tested or diagnosed with COVID. Patient did not receive any other vaccines within 1 month prior to Moderna COVID-19 vaccine. Patient had the two primary doses and the third dose was a half dose. He states he didn't know at the time that he was supposed to get a full dose. No concomitant medications were reported.
Nausea, headache, sore arm, aches, chills, low-grade fever, sore throat
WICKED VERTIGO FOR COUPLE OF DAYS; BLAH GROUCHINESS; CHILLS; HEADACHE; This spontaneous report received from a patient via a company representative 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: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case.  No concomitant medications were reported. On an unspecified date, the subject experienced vertigo for couple of days, blah grouchiness, chills, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vertigo for couple of days, chills, headache and blah grouchiness was not reported. This report was non-serious.
still has pain in left arm; lymph nodes in both arms are swollen; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (still has pain in left arm) and LYMPHADENOPATHY (lymph nodes in both arms are swollen) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20K) for COVID-19 vaccination.     The patient's past medical history included Blood pressure high (high blood pressure).    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, the patient experienced PAIN IN EXTREMITY (still has pain in left arm) and LYMPHADENOPATHY (lymph nodes in both arms are swollen). At the time of the report, PAIN IN EXTREMITY (still has pain in left arm) and LYMPHADENOPATHY (lymph nodes in both arms are swollen) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information includes medication (unknown), and a cream for the pain.  No concomitant medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-072636 (E2B Linked Report). This case was linked to MOD-2021-072636 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: Additional information received on 07-May-2021 added event details, treatment information and dose 2 details.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-072636:
Pt had pain in left arm when receiving shot.  Pain continued to get worse over subsequent days and she has limited lifting and moving in arm.
I received my second vaccination Tuesday around 5:30pm. I had a lower back muscle spasm on Monday morning, but the muscles were feeling significantly better by the time of my vaccination. I again took two ibuprofen before bed Tuesday night to help with my lower back muscles relax. (After I took the medicine, I then read that you aren?t supposed to take ibuprofen after the vaccine - the pharmacy unfortunately had only told me not to take Motrin - regardless the only other medicine I took was one Tylenol Wednesday morning). Wednesday morning I woke up with extreme back pain. This was in fact the worst lower back pain I?ve ever experienced. That lasted for about four hours. After that, my back pain subsided and I felt fine from around lunchtime until about 3. At that point I started to feel muscle aches throughout my body but especially in my legs. Around 6pm I started to get severe chills for the next three hours, although I never registered a fever I was shivering  at times. By 9pm I started to feel quite warm. I went to bed at 10pm still feeling a bit warm but was able to fall asleep. At 1am (Thursday) I woke up suddenly and was wide awake for the next two hours.  I still felt a bit warm and my muscle aches were quite strong. At 3am I fell back asleep. I woke up at 9:30am in a pool of sweat. However, my muscle aches had subsided and temperature felt normal when I woke up, but I felt tired and had a headache. My tiredness went away by early afternoon on Thursday and my headache went away around 6pm on Thursday, after which I felt back to normal.
after I got the vaccine an hour after I started to get hives and a rash on my chest and face. The rash on my chest is gone but I still have the rash on my face. Warm to touch with hives. 1/13 Rib cage hurts, dizzines nausea and headache.
Information regarding Flumist (2003-2004 formula)(influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) was received from a parent regarding her 16 year old son who experienced leg buckling, felt like passing out, vomiting and blood sugar increased.  At 16 years of age, he received a dose on 12/11/03.  The pt's concurrent illness include diabetes melllitus since 4 years of age.  The reporter indicated that her son's blood sugar goes up and down routinely.  The reporter indicated that her 8 year old daughter developed a "stomach bug" on 12/10/03.  Indication for Flumist (2003-2004 formula) was immunization.  Product was administered on 12/11/03.  Dose regimen was 0.5mL 1 time per day IN.  Concomitant therapy included Lantus and Novolog.  The pt woke up on the morning of 12/12/03, and experienced leg buckling, vomiting, and he felt like passing out.  A blood sugar reading of 392 was "higher than normal" (blood glucose increased)(condition aggravated).  He was given 8 units of Novolog.  Later that same day, another fasting blood sugar reading was 145.  The reporter indicated that her son was resting in bed and "felt better". Follow-up information received from the reporter on 05-Jan-2004 provided the lot number and information on previous doses of vaccines. The reported stated that the patient recovered.
Fever 101, chills, sore throat and extremely severe body aches, headache, weakness and dizziness.  Treatment: Tylenol 325 mg Ibuprofen 600mg No improvement in symptoms
3 weeks after vaccination developed bilateral achy hip pain.  She did not present to healthcare provider at that time.  She had trouble walking due to pain.  Slowly resolved over the course of 2 months
1 1/2 hours after vaccine administration the patient complained of a headache and lossed consciousness for 3 minutes.  She regained consciousness, attempted to stand, and loss consciousness again for 3 minutes.  Paramedics transported her to the emergency room where it was determined that patient had a migraine headache.  She was released into the care of her mother.
headache; fever; A spontaneous report was received from a consumer concerning herself, who is a 37-years-old female patient received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events headache, fever.  The patient's medical history was not provided. Concomitant medications reported were sometimes sleeping pills.  On 2 Mar 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 012A21A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 2 Mar 2021, the patient experienced the events headache, fever.  Treatment for the events includes aspirin/paracetamol/caffeine and estazolam.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events headache, fever was unknown.
Patient received his Moderna # two vaccination on 2/22 then developed four days later (2/26)  left facial numbness along with a facial droop c/w Bells palsy.    The patient was seen on 3/1 and clinically his Bell's palsy had resolved.
Initial information received on 04-Feb-2019 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 12 months old male patient who received a dose of vaccine FLUZONE QUADRIVALENT. The patient's past vaccination(s) included first dose of FLUARIX on 18-DEC-2018 and the baby was unwell. The patient's past medical history, medical treatment(s) and family history were not provided. On 28-Dec-2018, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UJ088AB via intramuscular route in the left thigh. It was a case of actual medication error due to inappropriate schedule of vaccine administered as the patient received a first dose of FLUARIX 0.5ml on 18-Dec-2018 and FLUZONE QUAD on 28-Dec-2018 (within 4 weeks apart). It was not reported if the patient experienced any event after the administration of FLUZONE QUADRIVALENT. 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 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. Documents held by sender: none.
PT C/O SWELLING & ITCHING  SLIGHTLY DISTAL TO INJECTION SITE - SOME REDNESS DEVELOPED. O2 SAT 98 NO C/O SOB. PULSE 96. PT STATES THAT THIS OCURRED WITH THE SECOND VACCINE IN SERIES BUT NOT UNTIL 1 - 2 HOURS POST VACCINATION. ICE PACK OFFERED AND ACCEPTED. 25 MG BENADRYL OFFERED AND ACCEPTED BOTH WITH EFFECT PRIOR TO PATIENT LEAVING CLINIC. PT ADVISED NOT TO GET ANOTHER VACCINE UNTIL HAVING DISCUSSED SITUATION WITH PROVIDER.
Headache, Fever, Migraine headache, chills, night sweats, fatigue Narrative:
uncontrolled crying; I was fatigued; had the chills. (both doses); I have a persistent headache on the right side.; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER 8734) via an unspecified route of administration in the right arm on an unknown date in Apr2021 at 09:00 (at the age of 61-year-old) as a single dose for COVID-19 immunisation and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0172) via an unspecified route of administration in the right arm on an unknown date in Apr2021 at 09:00 (at the age of 61-year-old) as a single dose for COVID-19 immunisation. Medical history included diabetes. Concomitant medications included metformin (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date and pravastatin sodium (PRAVACHOL) for an unknown indication from an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 02Apr2021 the patient experienced Emotional reaction - uncontrolled crying (both doses) she was fatigued and had the chills (both doses) she had a persistent headache on the right side. No therapeutic measures were taken as a result of the events. The events didn't result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events uncontrolled crying, fatigued, chills and persistent headache were not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
SWOLLEN, WARM TO TOUCH, SORE TO TOUCH, SORE WITH MOVEMENT
No adverse event; Patient has received an additional 5 shots of the Moderna COVID-19 vaccine, including a Moderna COVID-19 bivalent vaccine approximately 7.5 months ago; This spontaneous case was reported by a patient and describes the occurrence of EXTRA DOSE ADMINISTERED (Patient has received an additional 5 shots of the Moderna COVID-19 vaccine, including a Moderna COVID-19 bivalent vaccine approximately 7.5 months ago) and NO ADVERSE EVENT (No adverse event) in a 6-decade-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 Vaccine (Additional 4 shots of the Moderna) and Moderna COVID-19 Vaccine (Primary series). Past adverse reactions to the above products included No adverse event with Moderna COVID-19 Vaccine and Moderna COVID-19 Vaccine.    In January 2023, the patient received seventh dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In January 2023, the patient experienced EXTRA DOSE ADMINISTERED (Patient has received an additional 5 shots of the Moderna COVID-19 vaccine, including a Moderna COVID-19 bivalent vaccine approximately 7.5 months ago). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXTRA DOSE ADMINISTERED (Patient has received an additional 5 shots of the Moderna COVID-19 vaccine, including a Moderna COVID-19 bivalent vaccine approximately 7.5 months ago) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        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 EXTRA DOSE ADMINISTERED (Patient has received an additional 5 shots of the Moderna COVID-19 vaccine, including a Moderna COVID-19 bivalent vaccine approximately 7.5 months ago).    No concomitant medication was reported.  Patient said that were getting all those shots like clockwork, every few months. He said that he was in his 50s and was a healthy individual. He wanted to know if having 7 shots so far was enough and did he need to get the next one that he has been asked to get. No treatment information was reported.   Reporter did not allow further contact
This spontaneous report was received from a Healthcare worker reported that M-M-R II were exposed to unspecified temperature conditions during a power failure for an unspecified period of time, were then administered to unspecified patients on unspecified dates. The indication, dose, route and lot # of the vaccine was not reported. No concomitant medications were reported. No adverse effect reported. At the report time the outcome of event was unknown. It was unknown if the patient sought medical attention. All telephone attempts to obtain follow-up information have been unsuccessful. This is one of several reports received from the same source. Additional information has been requested. AE term was amended. PT was changed to Incorrect storage of drug.
Fainted about 10 minutes after injection but 7 days later, patient was extremely lethargic with fatigue and somnolence for about 3 days.
Headache unable to improve with medication, body aches, fever up to 101, 3.5" nodule of erythema, warmth, pain at injection site.
Fever began 11/10/09 around noon and lasted until next morning.  TYLENOL given with no results.  Ibuprophen given & broke fever.  Fever 103 at highest point.  Rash to right leg - bumpy not vescular not red, just raised.  Still has some but only to right leg.
Patient reported having hives/rash that started on neck and face 4 days following vaccination on 2/23/2019. Went to urgent care on February 26 2019 and was prescribed Prednisone which he took for 5 days. He missed 2 days of work on February 26 & 27. Patient also received an allergy shot 2 days after receiving the 2 vaccines. He had 5 prior allergy shots of the same dose without any sign of a systemic reaction. He received the first series of both vaccines in 2001. He does not recall having any adverse reaction after receiving the first series.
This case was reported in a literature article and described the occurrence of optic neuritis in a 59-year-old female subject who was vaccinated with Influenza vaccine unspecified (manufacturer unspecified). On an unspecified date, the subject received an unspecified dose of Influenza vaccine unspecified (administration site and route unknown, batch number not provided). 2 weeks after vaccination with Influenza vaccine unspecified, the subject experienced optic neuritis. It happened on 2 occasions, each time after influenza vaccination. This case was assessed as medically serious by GSK. There were no evidence of neuroretinitis, syphilis or systemic lupus erythematous. At the time of reporting, the outcome of the event was unspecified. The authors considered the event was almost certainly related to vaccination with Influenza vaccine unspecified.
On 15th September, the patient had received her Menactra, TDaP, and IPV vaccinations.  She noted the onset of dyspnea and dysphagia about 10 minutes after receiving the vaccines.  She also noted slight nausea.  She also may have felt lightheaded.  Evaluation by an allergist demonstrated no allergy to immunizations.
Patient reported on 1/9/19 received flu vaccine at Public Health clinic 11/09/2018. She has had difficulty since the flu shot with right arm range of motion, interfering with her daily routine/exercise. She is no longer able to do push-ups and was able to do this prior to the injection. She has difficulty with lifting her arm above her head such as in taking her shirt off. Her shoulder is slowly improving and range of motion is better. She feels like it is lingering. Her primary care physician referred her to physical therapy.
As per pt self report, "after I took the COVID19 Pfizer vaccine, about 48 hours afterwards I developed blisters all over my body. On my face about 100, in my mouth, arms, legs, feet, just all over. I did a televisit with a doctor. I do not have a PCP, so the person I spoke with my insurance plan referred me to Doctor (pt does not have the phone number for MD) and he said it was an allergic reaction. The doctor prescribed Hydrocortisone and told me to take Benadryl and Claritin. It got worse the next day and over time. It took about a week to resolve"
Hives to face 10-15 minutes after administration. Refused BENADRYL. Will follow up with allergist.
I waited 10-15 minutes after receiving the shot and I started to get an overwhelming migraine headache. I was at the center, so I went to the ER. They put me in a dark room I received a Toradol shot and another shot to get rid of my headache. I was in the hospital for 3 days so they could monitor my migraine. While I was in the hospital, they changed my medicine. I was on 40 mg of Lexapro and they moved me down to 20mg. The first night I was in the hospital was horrible, but I feel that was from the vaccine. I kept pacing back and forth and didn't want to sit down. I do have anxiety and depression. Nothing has really helped with the headaches. I was given medications to take, but I don't remember to take them.
24-48 hours after injection, patient describes extreme radiating pain in left arm(vaccinated arm), not relieved by analgesics;  pain subsided but did not go away for one week.  Today(10/26/2009) pain has returned and is increased, localized at injection site;  denies redness or swelling but is tender to touch.
Patient says redness at injection site and face swelled, she also received the PNEUMOVAX at a different location that day so not sure which vaccine caused the reaction.
33 years old patient received pediatric dose of Engerix B vaccine; 33 years old patient received pediatric dose of Engerix B vaccine; This non-serious case was reported by a nurse via call center representative and described the occurrence of underdose in a 33-year-old male patient who received HBV (Engerix B pediatric) (batch number 333M4, expiry date 07-APR-2024) for prophylaxis.   On 05-JUL-2023, the patient received the 2nd dose of Engerix B pediatric. On 05-JUL-2023, an unknown time after receiving Engerix B pediatric, the patient experienced underdose (Verbatim: 33 years old patient received pediatric dose of Engerix B vaccine) and adult use of a child product (Verbatim: 33 years old patient received pediatric dose of Engerix B vaccine). The outcome of the underdose and adult use of a child product were unknown.   Additional Information: GSK Receipt Date: 05-JUL-2023 The reporter reported that the patient administered Engerix B vaccine and then realized that she had administered a pediatric dose after patient left the clinic. The reporter stated that at the time of reporting the dose had not been repeated. The vaccine administration facility was the same as primary reporter. The reporter did consent to follow up. The adult patient was administered a pediatric dose of Engerix B, which led to underdose and adult use of a child product
Sore arm; fever; chills; muscle pain; Fatigue; This case was reported by a consumer via other manufacturer and described the occurrence of pain in arm in an unspecified number of an adult patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm, fever, chills, muscle pain and fatigue. On an unknown date, the outcome of the pain in arm, fever, chills, muscle pain and fatigue were unknown.   It was unknown if the reporter considered the pain in arm, fever, chills, muscle pain and fatigue to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not applicable for this report. It was reported that two dose Shingrix vaccine, for instance which protects older adults against the virus that causes painful shingles, results in sore arms in 78 percent of patients and muscle pain and fatigue in more than 40 percent of patients. The vaccine also caused fever and chills. This case has been linked with the case US2020AMR248304, reported by reporter.
Pt c/o Lt upper arm sore, painful to lift arm. pain radiates into neck while lifting arm. Also c/o back aching "cramping feeling." Upper Lt arm appears tight. No fever noted. Pt started Tylenol today after TD A given. Sxs started the day imm given.