chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient is 27 weeks pregnant. Estimated date of delivery is 7/14/2023. Patient was given Heplisav B. Patient complaining of headache starting the evening of 4/14/2023 until today 4/18/2023. Patient states she is taking  tylenol which helps. Informed patient that headaches after vaccination can be a normal side effect, but if worsens or does not get better to seek medical attention, from her primary, OB, or to go to the nearest emergency room.
HYPOXEMIA 2/12/2023 &  3/12/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Reported 'facial swelling'; 'impending doom'. Noted eye swelling.  Pt given Epi 0.3 mg IM at start of reaction. IV placed and diphenhydramine 50 mg IV given 10 minutes after Epi 0.3 mg IM dose given. Approximately 18 minutes after reaction onset patient reported return of lip swelling and facial swelling with 'heavy face/head'. Pt given Epi 0.3mg IM to left deltoid. Pt transferred to ER via EMS. EMS response time approximately 60 minutes. Pt felt better after 2nd dose of Epi 0.3 mg IM.
About 4 days after flu shot, she developed rash on outer thighs & hives on inner thighs. She has taken ZYRTEC & rash is clearing up.
I received the Moderna Covid-19 Vaccine April, 27, 2021 and May 30, 2021. Lots 007C21A and 054C12A respectively at pharmacy. I woke up in the night Fri./Sat. and had pain in both arms and chest muscles. It would not go away so went to Chiropractor on June 19, 2021 thinking it was a pinched nerve. Symptoms became worse and was had weakness in both arms. When to Urgent Care who referred me to the ER with suspected heart issues. Went to the ER and found there were no heart issues, but found my liver enzymes were very elevated. Had ultrasound of liver, but didn't find any anomaly. Was discharged from hospital with same symptoms and followed up with Dr. on the elevated liver enzymes. Ultimately saw a specialist (GI) who ran multiple blood tests. Nothing was found and the liver enzymes were returning to normal. The GI Dr. told me I most likely had a virus that my body was fighting off. Symptoms continued and I saw my primary care physician and they recommended going to physical therapy to help regain strength in my arms. I have been going since September. My symptoms are now getting worse and had muscle fatigue and pain in legs, buttocks and other muscles. I saw Dr. yesterday October 26, 2021 and she we discussed this being a side effect of the Covid-19 Vaccine. She indicated she has seen some odd things due to the vaccine and stated that Moderna had the most severe side effects. She diagnosed me as having Myositis and instructed me to take 600mg of Ibuprofen three times a day for 12-15 days. This is what I am doing now. I have additional Dr. appointments with a Neurologist and Rheumatologist to see if there are other issues/damage/treatment.
As of 4/12/2021 started dry cough in the evening.  Started getting feverish and achy 4/13. Ongoing cough, fever, fatigue and aches led to covid test on 4/14 which was positive.
SHOT INJECTED AND PATIENT'S EYES ROLLED BACK AND COULDN'T HEAR US. PATIENT WAS DIAPHORETIC AND HAD PULSE.  PATIENT SLUMPED BACK IN CHAIR AND WAS GIVEN WATER.   IN 2 MINUTES, PATIENT WAS ABLE TO GET UP AND HAD DRIVER TO GO HOME.  CALLED TO CHECK ON PATIENT AT 8:45 PM AND LEFT VOICEMAIL.
has shingles and has had 2 shots/ Suspected vaccination failure; shingles; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The case was reported by the cousin of the patient. The age at vaccination was not reported. The age group was not reported, however it was captured as an adult as per vaccine indication. The reporter stated that the patient at the time of reporting had shingles and has had 2 shots, the original shingle shot and the newest one. This case was considered to be a suspected vaccination failure case, as the details regarding being full vaccination schedule, laboratory confirmation for shingles and exact time to onset were unknown.
Continual chest pain, easily fatigued and rapid heart rate throughout the day making it very difficult to sleep for any decent length of time (for at least 2 months).
Initial report received from a patient's mother on 24 November 2013. A 11 year old male patient, had received a dose of FLUZONE QIV (Lot number U4771AA, on left deltoid, route unknown) on 17 October 2013. On 18 October 2013, after receiving vaccine the patient experienced shaking his head back and forth all the time. Medical history includes flu shots. At the time of this report the outcome of adverse event was not recovered. Documents held by sender: none.
DTAP in left thigh 11/30/99.  Developed swelling of left leg and generalized urticaria with itching 1-2 days later.
318 patients received dose from vials beyond 30-day use by date; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date). On 22-Jul-2021, EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Date of Refrigeration 7-MAY-2021.  No concomitant medications and treatment details were reported.
This case was linked to case 2021SA412569 (CLUSTER). This case involves a 4-year-old male patient who received INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] exposed to the negative 7.8 degree Celsius over a period of 40 minutes and given to two patients after the excursion (product storage error). The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided. On 06-Dec-2021, the patient received a 0.5 mL dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (Frequency: once, lot UT7378KA, expiry date: 30-Jun-2022) via intramuscular route in the left deltoid for prophylactic vaccination. It was an actual medication error due to product storage error (latency: same day). At time of reporting, no adverse event reported. 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.
This spontaneous report was received from a immunization official referring to an unspecified patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not provided. On 21-APR-2017, the patient was vaccinated with an expired dose of M-M-R II and the albumin status was rHA; (strength, dose, route, frequency were not provided), the lot # was L012482 and expiration date of 10-APR-2017, for prophylaxis . The vaccine was reconstituted with sterile water diluent (unknown lot number and expiration date. However, the sterile water diluent was not reported to be expired when it was administered. No adverse effects were reported and no additional information was provided. There was no product quality complaint (PQC) involved. Additional information has been requested.
my entire body has been severely inflamed; suffer from occasional loss of arm movement; severe dizzy spells; body is alway in pain; mid lower back is in pain; severe fatigue; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 34-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 31Mar2021 at 19:45 as dose 1, single (Lot number: Er8730) at the age of 34 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Past drug history included: Morphine, reaction(s): "Allergy". The following information was reported: PAIN (disability) with onset 12Apr2021 at 12:00, outcome "not recovered", described as "body is alway in pain"; BACK PAIN (disability) with onset 12Apr2021 at 12:00, outcome "not recovered", described as "mid lower back is in pain"; INFLAMMATION (disability) with onset 12Apr2021 at 12:00, outcome "not recovered", described as "my entire body has been severely inflamed"; DIZZINESS (disability) with onset 12Apr2021 at 12:00, outcome "not recovered", described as "severe dizzy spells"; FATIGUE (disability) with onset 12Apr2021 at 12:00, outcome "not recovered", described as "severe fatigue"; MUSCLE DISORDER (disability) with onset 12Apr2021 at 12:00, outcome "not recovered", described as "suffer from occasional loss of arm movement". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (20Apr2022) Negative. Therapeutic measures were taken as a result of inflammation, muscle disorder, dizziness, pain, back pain, fatigue.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information provided and temporal association, a causal relationship between BNT162B2  and the reported events  inflammation, muscle disorder, dizziness, pain, back pain, fatigue 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 RAs, Ethics Committees, and Investigators, as appropriate.
extreme fatigue; coldness; He also mentioned that he always don't feel right.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 49 year-old male patient received bnt162b2 (BNT162B2), administration date Feb2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious), outcome "not recovered", described as "extreme fatigue"; FEELING COLD (non-serious), outcome "unknown", described as "coldness"; MALAISE (non-serious), outcome "unknown", described as "He also mentioned that he always don't feel right.".  Additional Information: The patient had experienced side effects following the vaccine. 5 days after getting the vaccine, patient experienced extreme fatigue and coldness. Patient mentioned that he had almost missed 2-weeks worth of work because of this. Caller said they got their dose on February and had still been experiencing some of the fatigue till today.  Patient wanted to know if we have any reports of lingering fatigue. Patient also mentioned that he always don't feel right.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
redness and pain at the shot site. it?s about a 2 inch circle. feels a little itchy. That?s all?no other symptoms. it?s still itchy and red today 16 hrs later but i feel otherwise normal.
LT IM where DTaP was given was red, warm to the touch no signs for cellultis was dx with allergic reaction, given warm compresses and TYLENOL/MOTRIN
No adverse event; Gave 2 doses of Moderna Covid-19 booster beyond 12 hrs; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Gave 2 doses of Moderna Covid-19 booster beyond 12 hrs) and NO ADVERSE EVENT (No adverse event) in a 58-year-old 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. 042H22A) for COVID-19 prophylaxis.     Question:Describe relevant medical history/conditions, allergy, concomitant diseases and risk factor.Answer:2nd recipient.     On 07-Feb-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 07-Feb-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Gave 2 doses of Moderna Covid-19 booster beyond 12 hrs). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Gave 2 doses of Moderna Covid-19 booster beyond 12 hrs) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) was unknown.   For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Gave 2 doses of Moderna Covid-19 booster beyond 12 hrs).    No concomitant and treatment medication were reported. Gave 2 doses of Moderna Covid-19 booster beyond 12 hrs. It was drawn up in a syringe 06Feb2023 & administered on 07Feb2023.   This case was linked to US-MODERNATX, INC.-MOD-2023-709077 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-709077:JC DOB- 3-MAR-1964
Tacycardia and shortness of breath, followed by chills.  Duration of 10 minutes until resolved. Subsequent abdominal pain with mild diarrhea and then extreme fatigue for 5 hours. Similar to a food allergy reaction
Subsequent to receiving one dose of varicella virus vaccine live the pt developed chickenpox consisting of 25-30 skin lesions. The pt also experienced sore throat and headache. The pt was seen on 11/22/99 by a physician. Additionally the pts 1 year old sibling who was never vaccinated with varicella virus vaccine live developed a sever case of chickenpox two weeks after exposure to his sisters varicella. The sibling experienced fever, cough, vomiting and an ER visit. Additional information has been requested. Follow up information from a physician reported the patient subsequently recovered.
I got COVID-19 April 12. I had a cough and razor blade sore throat, itchy and watery eyes, fever, chill for 4.5 days and I still have a very runny poop.
I received my first dose of the Moderna vaccine for COVID-19 on 1/13/2021 at around 11 AM. Later the same day, at 6 PM, I began to have severe chills, though I had no fever. I began to have very sore muscles and very sore joints. My joints were so sore that I could not raise my arms above my head. My hands hurt, even when I wasn't using them. I couldn't walk more than half a block without sitting down, because I was very short of breath. I was previously someone who was very active and walked 2 miles a day. On the day I got my first shot, all I wanted to do was sleep. All of the symptoms continued for about 4 days. At the time of this writing, the symptoms still continue, though they are not as severe. The symptoms are constant, though. Since receiving my first dose of the Moderna vaccine, I have received another dose and two boosters of the same brand. Every time I got a shot, the aforementioned symptoms increased in intensity for about 48 hours. I have seen a number of specialists since 1/13/2021. I've seen a pulmonologist, cardiologist, GP, rheumatologist, neurologist, and infectious disease specialist. Although I have never tested positive for COVID-19, I am currently being studied by a team a major medical team that is devoted to researching the symptoms of long COVID-19. The doctors don't really know why I am experiencing these symptoms, and that is why I am the subject of their study.
1st dose-pain in legs from hips down, with muscle weakness.  Difficult using steps and walking on anything other than paved areas or flooring even the lightest terrain chasing in a flat grassy yard proved unsteady). Progressively worsened over6 or 7 days before then leveled out and got slightly better. 2nd dose-severe leg pain, extreme leg weakness, difficulty doing daily task (bending to sit down/stand up-would need to support myself with arms).  Progressively got worse over three weeks before leveling out and started to see small improvements.
Redness swelling itching for 2 weeks since the day of vaccination Redness and lump gradually got larger
Immediately after receiving the shot, my son complained about a headache and "not feeling right." He went back to school, but as he came home the same afternoon he said he still did not feel well. We decided to go to hockey practice that evening and "sweat it out." Looking off and sluggish the entire practice, his head slumped forward in the car on the way home. This was his first seizure. It is now around 7,20 p.m. the same day he received Gardasil 9. He is still suffering from these seizures to this day.
Swelling of mouth and side of face 3 days after administration. Rash comes and goes. Significant swelling and redness at injection site. Pt went to clinic for symptoms.
This spontaneous report as received from a nurse refers to a patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions or concomitant medications were reported. On an unspecified date in 2016, the unspecified patients were vaccinated with 0.5 ml doses of (wistar ra 27-3) M-M-R II subcutaneously (lot # L027431, expiration date 22-JUL-2016) after the temperature excursion on 01-JUN-2016. The vaccines were stored in 8.8 Celsius degrees for 40 minutes. There was no previous temperature excursion. Digital data logger was not involved. No adverse effects were reported. Product quality complaint was not involved. Additional information has been requested.
dose administered to patient after more than 1 temperature excursion; dose administered to patient after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021 at 3:28 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 15-Apr-2021 at 3:28 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 46.94  No concomitant medications were reported.   Batch number 044B21A underwent temperature excursion on 15-Apr-2021 with temperature 34 degrees Fahrenheit from 9 AM. This vial was moved to fridge on 06-Apr-2021 and beyond use date for the vial was reported as 09-May-2021. Product moved to clinic on 15-Apr-2021.  Vial was stored in cooler 1, on 15-Apr-2021, temperature excursion at 9 AM: 34, 10 AM: 36, 11 AM: 38, 12 PM: 39, 1PM: 43, 2 PM: 44 and 3 PM: 44.    Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.    No treatment medications were reported.   This case was linked to MOD-2022-566976 (Patient Link).
Headache every night; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache every night) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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 HEADACHE (Headache every night). At the time of the report, HEADACHE (Headache every night) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No medical history, lab data, concomitant medications and treatment medications are provided.
patient who got one of the three doses of Gardasil 9; This spontaneous report was received from a pharmacist concerning a female patient of unknown age. The patient's pertinent medical history, drugs reactions or allergies and concomitant medications were not reported.  On an unknown date, the patient was vaccinated with one dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) via intramuscular for prophylaxis (strength, and anatomical location were not reported; lot number and expiration date were unknown by the reporter). However, that was the only dose received by the patient (reported as got one of the three doses). Therefore, on 17-AUG-2020, the patient experienced inappropriate schedule of product administration. The outcome of inappropriate schedule of product administration was unknown.