chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sore arm one day post vaccination, no other symptoms until event on May 28 which involved racing heart, shortness of breath.  Hospitalized in ER overnight. Release 8 hours after arrival. Upon return home, shortness of breath, wheezing, retention of fluids (leg and foot edema), low-grade fever
Hallucination - per pt daughter - she received MRI/lab tests @ ER - no result - hallucination started 1 - 2 hours after vaccination no treatment additionally @ ER
Developed fever about 4 hrs after shot, temp to 104.3 by 23:00. Also developed runny nose, cough and very fussy. Poor appetite today, drinking less, 3 wet diapers today.
Inflammation throughout body.  Tennis elbow, shoulder pain, wrist pain.  All of which I have had in past but did not have at time of vaccine.  All came on again at once 2 weeks after 2nd dose
I developed vertigo, dizziness and a headache. I went to urgent care on 9/26/09 and received Antivert. I went back to urgent care on 9/28 bacause of persistent symptoms. The symptoms finally resolved on 10/7/09
Muscle pain; Headache; Shivering fever; This non-serious case was reported by a consumer via call center representative and described the occurrence of muscle pain in a 65-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10-MAY-2023, the patient received Shingrix. In MAY-2023, less than a day after receiving Shingrix, the patient experienced muscle pain (Verbatim: Muscle pain), headache (Verbatim: Headache) and fever chills (Verbatim: Shivering fever). The outcome of the muscle pain, headache and fever chills were not resolved.   It was unknown if the reporter considered the muscle pain, headache and fever chills to be related to Shingrix.     It was unknown if the company considered the muscle pain, headache and fever chills to be related to Shingrix.   Additional Information: GSK Receipt Date: 11-MAY-2023 The patient self-reported this case. The patient reported that he/she received Shingrix shot about 24-hours ago from reporting and experienced muscle pain, headache and shivering fever. The reporter asked how long did the side effects last.
felt like had flu the next day; sore arm; extreme cold chills like shivering; extreme cold chills like shivering; Headache on the left side; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (felt like had flu the next day), VACCINATION SITE PAIN (sore arm), the first episode of CHILLS (extreme cold chills like shivering), the second episode of CHILLS (extreme cold chills like shivering) and HEADACHE (Headache on the left side) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047A21A and 023M20A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included AMLODIPINE for an unknown indication.   On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced HEADACHE (Headache on the left side). On 22-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (felt like had flu the next day), VACCINATION SITE PAIN (sore arm) and the second episode of CHILLS (extreme cold chills like shivering). 22-Mar-2021, the patient experienced the first episode of CHILLS (extreme cold chills like shivering). The patient was treated with BACTERIA NOS, YEAST (KOMBUCHA) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, INFLUENZA LIKE ILLNESS (felt like had flu the next day), VACCINATION SITE PAIN (sore arm), the last episode of CHILLS (extreme cold chills like shivering) and HEADACHE (Headache on the left side) outcome was unknown.            The action taken with  mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) was not applicable.   This case was linked to MOD-2021-059524 (Patient Link).
Generalized itching all over body. Patient received a steroid injection at dr office and a steroid dose pack to take for 6 days.
Tachycardic, HR to 108, BP 152/72, improved over 5 minutes sitting
Got the vaccine at 5:03 waited in the clinic for 15 min and left at about 5:27 started feeling throat swelling and numbness in my right side of the face. Got home at 5:35 called a Doctor and He told me to take Benadryl 50mg. Took it and 5-6 min I felt the swelling went down.
after recv vax pt exp fever of 101, given tylenol. noticed rash on trunk & arms, 2 weeks prior to vax,
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 73-year-old male patient received BNT162b2 (BNT162B2), on 01Oct2021 at 10:00 as dose 3 (booster), single (Lot number: EL3249) at the age of 72 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "Acid Reflux" (unspecified if ongoing); "Osteoporosis" (unspecified if ongoing); "Hyper-Cholesterol" (unspecified if ongoing); "Penicillin allergy" (unspecified if ongoing); "Steroid allergy" (unspecified if ongoing). Concomitant medication(s) included: FORTEO, start date: 31Mar2022. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "SUSPECTED COVID-19". Therapeutic measures were taken as a result of covid-19, drug ineffective.  Product investigation Summary Conclusion included the complaint for lack of effect of the Pfizer Biontech Covid-19 Vaccine lot EL3249 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods lot EL3249, fill lot EL3232, and the formulated drug product lot EL3225. A complaint sample was not returned, and photographs were not received. No related quality issues were identified during the investigation. There is no impact to product quality. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.  Clinical course: The patient received Paxlovid as a treatment medication for adverse event Covid-19.
Patient received vaccine around 2:30pm. Before vaccine, pt was nervous but was unaffected by the administration. Pt was told to wait in waiting area to be observed for 15 minutes but had left 5 min later because she was feeling hot and wanted to get some air. While walking, her knees fell weak, she felt dizzy and she tumbled down to her knees. We ran over and patient was conscious and we waited and observed her further. Then we sat her down, gave her some water and restarted 15 min waiting period.
In evening on the day following vax, pt's left thigh became pink and swollen. Progressed to involve left anterior and lateral upper thigh. No fever, limp or pain. Use warm compresses and Keflex for possible co-existing infection, but doubt infection.
Covid booster dose was provided to an individual under the age of 18, which appears to be ineligible for a booster. The patient did not denote any eligibility for a third dose due to immunocompromised status, however, the patient did attest to being eligible to receive the vaccine and the pharmacy personnel misread/misinterpreted the date of birth.
Moderna COVID-19 Vaccine EUA Injection site swelling and redness. Extreme fatigue (slept 15 hours), frequent chills, bad headache,  and nausea on1st day after shot. Lasted all day and into night. 2nd day after shot: Better- not as tired but still having some chills. Injection spot still swelled, red, and itching.
headache; Body aches; induration at the vaccine area; This is a spontaneous report from a non-contactable consumer (patient). A 34-year-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration on the left arm on 16Dec2020 11:00 at a single dose for immunisation. Medical history included sever dermatitis. The patient's concomitant medications were not reported. The patient previously took influenza vaccine and experienced drug hypersensitivity. The patient experienced body aches, headache, induration at the vaccine area on 16Dec2020 11:00. Ibuprofen was given as treatment for the adverse event. Outcome of the events was recovering. The events were considered non-serious. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested since the vaccination.  No follow-up attempts are possible. Information about Lot/Batch could not be obtained. No further information is expected.
pt recvd vax; swollen bilateral parotid; rash under chin & cheeks; to hlth ctr; referred to md;
Slight temp with chills, nausea and vomiting for two days, dry heaving for two days, I was only able to sip water or coke infrequently, no energy.  This is the third time I have been down.  The previous boosters gave me the same symptoms.
HCP called to state that the patient was given PROQUAD after a TE event.; no additional AE; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.      On an unknown date, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (dose, route of administration, lot number and expiration date not reported) for prophylaxis (product storage error). No adverse event was reported.; Sender's Comments:  US-009507513-2303USA006990: US-009507513-2303USA007002: US-009507513-2303USA006967:
I received my first Pfizer COVID19 vaccination 12/18/20 at my hospital (I work as a physician). Sometime between 12/24/20-1/7/21 I developed some L eye pain with reading. It felt like a deep ache in my eye. This went away after a few minutes after I took a break from reading and this is the first time I've ever had this sort of sensation. I received my second Pfizer COVID 19 vaccine on 1/8/21 as scheduled. The eye pain continued to occur intermittently (maybe once every 1-2 weeks over the course of Jan/Feb 2021) and I thought perhaps I needed new glasses. In March 2021 the pain became more frequent (occurring at least once a week or more) and I began to think my L eye vision was becoming a little blurry. In March, I also noted occasional generalized headaches much more frequently than usual (I am prone to stress related headaches maybe once a month at most). I also noticed my L eye was becoming red. Due to my history of an ocular autoimmune disease affecting the conjunctiva (ocular cicatricial pemphigoid) which had been in remission for years, and the fact that I was also working full time as a physician in a fellowship program, I initially thought these symptoms could be related to work-related stress and lack of sleep or relapse of my ocular cicatricial pemphigoid.
Experiencing vaginal bleeding daily since booster was received.  Please note, prior to getting the booster I was having infrequent vaginal bleeding due to polyps but it was only 2-4 days in addition to my normal period and very light, after booster it has been every day and more than what I had experienced in past.
This spontaneous report as received from a pharmacist refers to a 50 year old female patient. The patient did not have any medical history or drug reaction/ allergy to report. On 19-OCT-2015, the patient was vaccinated subcutaneously in the right arm with a dose of ZOSTAVAX 0.65 ml, once, lot # reported as K016323, expiration date 24-DEC-2015. Concomitant therapies included morphine sulfate (manufacturer unknown), PERCOCET and fentanyl. On an unspecified date in October 2015 (reported as on or after 19-OCT-2015), the patient developed redness at the injection site in her right arm after receiving the ZOSTAVAX dose. No treatment was given to the patient. No laboratory diagnostic studies were performed. The patient sought medical attention by visiting the pharmacist. At the time of the report, the outcome of injection site erythema was reported as not recovered. The relatedness between injection site erythema and ZOSTAVAX was not provided. No product quality complaint was involved. Additional information has been requested.
Information was received on 19-APR-2017 from a lawyer regarding a case in litigation concerning a female patient of unknown age. It is complained and alleged that the patient was inoculated with a dose of ZOSTAVAX vaccine, on or about 17-MAY-2012  at a health care facility, as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 12-NOV-2014, the patient was treated at a medical facility for a painful rash that was diagnosed as shingles that has spread into her eyes. On or about 18-NOV-2015, the patient was treated again for the shingles that had spread into her eyes, which is a more serious condition called herpes keratis (sic). On or about 16-DEC-2015, after experiencing continued severe pain, the patient was diagnosed with post herpetic neuralgia. While shingles and herpes keratis (sic) are incurable viral conditions, the patient has been prescribed  Gabapentin (manufacturer unknown) which has been ineffective in managing her symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. Upon internal review, shingles that had spread into her eyes/herpes keratitis was considered medically significant. Additional information has been requested.
Severe projectile vomiting, dehydration, head fog, loss of hair, flu like symptoms, dizziness
Pregnant/vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant/vaccine exposure during pregnancy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Pregnant.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 07-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant/vaccine exposure during pregnancy). On 07-Jan-2021, EXPOSURE DURING PREGNANCY (Pregnant/vaccine exposure during pregnancy) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant/vaccine exposure during pregnancy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Pregnant.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 07-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant/vaccine exposure during pregnancy). On 07-Jan-2021, EXPOSURE DURING PREGNANCY (Pregnant/vaccine exposure during pregnancy) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Due date was not reported.   The patient received vaccine while pregnancy/ vaccine exposure during pregnancy.  No treatment information was provided.  Company comment: This is a case of product exposure during pregnancy with no associated AEs for this female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Exposed on 9-18 by family members.  Began feeling tired on 9-19 tested 9-20 positive on 9 -21
This non-serious initial spontaneous case was received from a Pharmacist on 26-Sep-2017, concerning a female patient age less than 65 years (as reported). On 06-Sep-2017, the patient was administered with FLUAD (TIV) (dose: 0.5 ml, route of administration: intramuscular, batch number (as reported 178502), anatomical location, expiry date: not reported). It was reported that FLUAD was indicated individuals 65 years of age and older. No issues were reported since administration. The outcome of the event was not reported. The reporter assessed the event as non-serious.
See attached ER visit notes and SF 600 note. Labs, xray, CT results, EKG.
Got the vaccine, then got shingles/Suspected vaccination failure; Burning pain, living in extreme pain; Can't get comfortable, affected my whole life; I'm on fire all the time; Shingles, cause me I can't go to work; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a elderly patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, pain burning, discomfort and burning sensation. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was recovered/resolved and the outcome of the pain burning, discomfort and burning sensation were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, pain burning, discomfort and burning sensation to be related to Shingles vaccine.     Additional Information: GSK receipt date: 22-Dec-2022 Reporter's comment: The patient had the vaccine and got shingles for almost 4 months cause him/her. The patient could not go to work, had burning pain, could not get comfortable, it had really affected his/her whole life and did not know what to do because he/she was living in pain. The patient did not know the vaccine and should have had a mild this. The patient asked that he/she ever gonna get comfortable again as he/she was on fire all the time and was in extreme pain. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. As it was not clear for which event patient was reporting severity, therefore in worst approach, severity was captured as mild for all events.
I got my shot on Friday at 4 PM and that night I felt kind of OK but on Saturday I felt super sick with a bad headache, exhaustion, dizziness, body aches, and I was just super tired, and all of the places my bones were broken were hurting, and my entire left arm seized up and it was immobilized but I expected that. The next day I had some care and friends came and helped with the baby and I also still felt very bad, almost as bad as Saturday. Monday I woke up and had been having severe abdominal cramps and I felt terrible. I had to sleep a lot and I felt like my milk production had dropped and my baby wasn't seeming super satisfied and it was taking 2 boobs rather that 1 to keep her calm. Tuesday morning I woke up and I felt like I was menstruating and I wasn't expecting it and my period came gushing and when I squatted to pee a whole pool of blood would come out. I contacted my obgyn who delivered my baby and she had encouraged me to get the booster and I wanted to ask if she had any other patients that experienced it but she said not to worry about it and I don't think she realized how severe the bleeding was. Wednesday I was having extreme bleeding and I was using baby diapers instead of pads and was bleeding through them that day and I thought maybe it was because it was my first period after my baby. I had my baby via C-section on September 26. Thursday my bleeding was still bad and I was bleeding through my pad. I also became very dizzy and by the end of the day I was having trouble getting up from standing and I felt nauseous while turning, sort of like vertigo symptoms. I was walking my daughter around in a stroller because I was afraid of dropping her. Today (02/11/2022) I'm still bleeding through my pad after 3-4 hours and I'm still feeling dizzy but not as exhausted anymore. My milk production seemed to drop and I'm taking supplements for that. Throughout this whole thing, since Tuesday, I've also been having hot flashes/fever waves and extreme shifts of temperature in my body.
Fever, Tylenol Felt like someone with army boots danced on my back Slept 24 hours Entire body hurt, back the worst
Intermittent pain at left arm IM site traveled throughout (L) arm and (L) shoulder with on/off left arm weakness and/or limited range of motion x6 months. Plus, a one-time event of tingling sensation into left hand digits 1 and 2.
fast heartbeat; chest pain; This spontaneous case was reported by a patient and describes the occurrence of HEART RATE INCREASED (fast heartbeat) and CHEST PAIN (chest pain) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002821A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Apr-2021, the patient experienced HEART RATE INCREASED (fast heartbeat) and CHEST PAIN (chest pain). At the time of the report, HEART RATE INCREASED (fast heartbeat) and CHEST PAIN (chest pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: increased (High) Increased.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant and treatment information does not provided.   Reporter did not allow further contact
Redness, warmth, tenderness of left upper arm. Treated with antibiotic Zithromax and Prednisone.
For both of my vaccines, I had a noticeable dulling of my senses of taste/smell on the 3rd day following vaccination. Symptoms did not last longer than 12-24 hours
3 DAYS AFTER SHOT, LIP SWELL- NORMALLY FIRST STAGE FOR ANAPHYLAXIS  SHOT.  TREATED WITH CLARITIN  TO REMOVE SWELLING. HAD PREVIOUS REACTION BEFORE. STILL UNDETERMINED WHY I STILL GET THAT REACTION AFTER NOT TAKING LISINOPRIL FOR MANY YEARS.   6 DAYS AFTER-TONGUE SWOLLEN ON LEFT SIDE ONLY- TREATED WITH CLARITIN TO STOP SWELLING
Tingling in the lips within an hour of injection. Slight lightheadedness. Within 6 hours shivering and tiredness. redness to injection site. Day 2 after injection, continued occasional shivering, Injection site red, swollen, hot to the touch and painful approx 3x2" in measurement. fatigue and listlessness. Day 3 Pain and redness at injection site continues, Shivering resolved, but fatigue still present.  Day 4 Pain and redness at injection site present. Redness now expanded to 5x5" approx. Hot and tender to the touch.  Home treatment: Hot pack to injection site, Tylenol for pain.