chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Had a stroke on 7/13/21 which was later diagnosed as RCVS. No cause or trigger event discovered for the stroke, so I am reporting this as a possible link to the vaccine. I am healthy and without any factors which would normally contribute to a stroke.
Initial information has been received from an 85 year old female with spine and neck problems and a history of shingles (4 times in the past) who on 10-JUN-2008was vaccinated with a dose of ZOSTAVAX (Merck). The patient was also given tetanus toxoid at the same time. On 10-JUN-2008 post vaccination the patient experienced pain at the injection site, soreness all over her body and flu like symptoms. Follow-up information has been received form the patient concerning the patient had a "weakness in the head" prior to vaccination but never headache. After receiving a tetanus vaccine (unspecified manufacturer) and ZOSTAVAX (Merck) on the same arm at the same visit, the patient said that it became sore. The patient also experienced heart palpitations at times and headaches that came and went. the patient felt as if she had gotten weaker since vaccination. Concomitant therapy included LEVOXYL, LIPITOR, metoprolol, ALTACE, NORVASC and baby aspirin. At the time of this report the outcome were unknown. The patient spoke to pharmacist. No product quality complaint was involved. This is one of several reports received from the same source. Additional information has been requested.
First vaccine, he only had chills; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (First vaccine, he only had chills) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 022M20A) for COVID-19 vaccination.     The patient's past medical history included Surgery (Cataract surgery). Concurrent medical conditions included Drug allergy (Allergic to Versed Anastacia).   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CHILLS (First vaccine, he only had chills). At the time of the report, CHILLS (First vaccine, he only had chills) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-036258 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-036258:Dose 2
Information has been received from a nurse referring to unspecified number of patients of unknown age and gender. On unknown dates since 01-OCT-2015, the patients were vaccinated with improperly stored GARDASIL (lot # K016966, expiration date 10-MAY-2017) (dose and route were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Allergic reaction within 1-2 minutes.  My eyelid and upper lip started to swell and my face and lips became numb and tingly. I have had hives in the past and this is how it always starts. They were accompanied by the sensation of heat in my face as well. I drove myself to an urgent care and my BP was extremely elevated. I believe the highest was 190/114. The staff at Urgent Care waited to medicate me, perhaps due to my elevated BP. My forearms became very flushed, almost a purple hue, but no hives developed. My throat started to swell and they called an ambulance to take me to the hospital. In the minutes before the ambulance arrived, I was given epinephrine and Benadryl via injection in my right arm. I wish they had given me that more quickly. I started to feel better very quickly. By the time I was hooked up to monitors at the hospital, right across the parking lot, my BP had gone down to 123/71. There was never any sign of swelling of the tongue, but my throat felt tight the remainder of the evening and I had difficulty swallowing. I am still itchy in my legs today and my cheeks and eyebrows still feel numb. I am currently taking Prednisone for the next few days and was given an Epi Pen prescription. I was given the vaccine at 12, arrived at Urgent Care about 1:00 and was transported to the hospital around 2:30. I was discharged around 5:00.
Narrative: Patient received 1st dose of Moderna COVID-19 vaccine on 3/11/21 and second dose on 4/8/21. Patient seen at walk in clinic on 8/10 with complaint that she developed shortness of breath 2 days after her second dose which has since improved but not resolved completely. No interventions at this time.
This spontaneous report was received from a pharmacist via a company representative concerning an elderly (in early 70's) female patient. The patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies were unknown by the reporter. On 01-OCT-2017, the patient was vaccinated with PREVNAR 13 (dose, strength, frequency, route of administration, lot #, expiration date and indication were not provided). On 01-OCT-2018, the patient was vaccinated with PNEUMOVAX 23 0.5 ml, once, lot # reported as R018741, per intramuscular route (strength and expiration date were not provided) for prophylaxis. On an unspecified date in 2018, the patient went back and her arm was heavy swollen around the deltoid muscle and was slightly warm. The patient was recommended to take BENADRYL as treatment. It was unknown if laboratory diagnostics studies were performed. No product quality complaint (PQC) was involved. The causality assessment between the heavy swollen and slightly warm with the suspect vaccines was not provided.
Admitted to hospital with extremity numbness, tingling, back pain and unsteadiness-states 2 weeks ago first noted numbness/tingling in finger tips-Received H1N1 12/21/09; leg weakness. Feet flop when he walks; CSF unsuccessful due to arthritis; GBS.
The day of vaccine I developed headache, body aches all over, pain in left arm, restless legs, pain in legs off and on, out of body like experience, nausea, loss of appetite, fatigue, low grade fever. The day after I still had headache, body aches all over, pain in left arm - unable to raise above my shoulder, pain in arms and legs off and on,  nausea, loss of appetite, fatigue, weakness, loss of appetite, low grade fever.  The 2nd day I still had the same symptoms as the day before but also started developing a knot where the vaccine was given and was fevered, pain in the left arm (where the vaccine was given) feels like a ton of bricks and can't lift anything nor lift my arm to my shoulder nor above my shoulder. The 3rd day after I still had the same symptoms previously mentioned but now have a golf ball size knot where the vaccine was given and unable to use my arm and pain in the left arm (where the vaccine was given) feels like a ton of bricks and can't lift anything nor my arm to my shoulder nor above my shoulder.
On July 22, 2021, my daughter had a bloody stool.  This was the day after she recieved her first dose of the COVID-19  Pfizer shot.  The first bloody stool had the most blood.   She had three more bloody stools that were on different days (first one was Thursday7/22/21, then Saturday7/24/21, Monday7/26/21, and the last one was on Tuesday July 27, 20021.  The last three bloody stools had less blood each time.  Her first normal stool with no blood was on Thursday July 29, 2021.
The MMR and Varicella vaccine were mixed with sterile diluent that had an expiration date of 2022Jun02. Patient did not have adverse reaction to this nurses knowledge. MERK was contacted and gave the following information: Merk has in house data to support potency of the dose of Merk vaccine/sterile diluent that was inadvertently administered after its labeled expiration date. Stability data indicates that sterile diluent is expected to maintain all quality attributes within the label claim for up to 12 months beyond the labeled expiry. Merk does not make any recommendations on revaccination, that is up to the HCP.
Peripheral Neuropathy Numbness/Tingling in hands and feet Began 5/4/21 - still ongoing issue. Other possible causes have been ruled out - symptoms started after 2nd vaccine dose. Currently under care of Primary care doctor and neurologist and will be trying meds in an attempt for some relief from complete numbness in both hands and both feet.
Mother noticed hives that started this morning. Pt was evaluated and documented hives in office. Benadryl was administered and pt will follow up if symptoms continue/persist.
This case was reported by a pharmacist via sales rep and described the occurrence of influenza-like symptoms in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, unknown after receiving SHINGRIX, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was unknown. It was unknown if the reporter considered the influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected adult as per vaccine indication. The patient experienced flu like symptoms. No other details were provided. The pharmacist did not consent to follow up. The registered pharmacist (RPH) does not want to be contacted and did not want to report the adverse event.
11:45A -developed "hives" on BUES. 12:15P - BENADRYL 25mg po x 1 dose.
After receiving the 1st dose about 5 mins later I started getting cramps on my leg and arm on the opposite side of getting the injection. My leg and arm was shaking. I told the lady I was getting cramps. She asked if I had drunk any water and I told her I didn't so she went and brought me some. I had limped out of the vaccination site. The night that I went home I got a big bruise on my left arm. For a couple of days I was achy with night sweats. The arm that I got the shot in was a little pain and cramping. Then I had started to get a bruise on my left leg, and the one on my arm had went away. The bruise on my leg never went away. I still have the bruise on me to this day. I know I didn't hit my arm but maybe I hit my leg. The bruise will fade away and then flare up. When I got the second shot I had pain under my armpits. When I got the booster I started having a lot of asthma attacks. I went to an urgent care, and they switched my medications. They gave me an emergency pump, prednisone for 14 days, albuterol, and another medication. I made an appointment to see a doctor. The bruise hurts sometimes and then gets red sometimes. The doctor said I might have pre diabetes, heart issues, kidney failure, and/or malnutrition. He said that I could easily bruise if I am lacking vitamins, but I have been taking vitamins. I was also having stomach issues. I had flu like symptoms with the first and second shot. I can't go out and eat because I have to be close to the bathroom for using it or throwing up. The doctor told me to take Vitamin D 2,000 mg to see if that would help for the vitamin deficiency. When I wake up in the morning my body hurts with a burning sensation in different areas of my body. The doctor thinks it is arthritis. I am active. I had chills too.
After the vaccination I started experiencing higher blood pressure and swelling. At my 35 week appointment on 5/20/21 I was sent to triage in the labor and delivery department because it was so high. After being monitored for 2 hours I wasn't showing signs of recovery and was diagnosed with preeclampsia. It was severe enough that I was induced starting the 20th and I delivered on the 21st. I was on magnesium from the 20th and continued until at least the 22nd but it might have been finished the 23rd. My baby was born at 35 weeks, 2 days at 5 pounds 2 ounces. He was in the NICU for 2.5 weeks due to difficulty breathing.
This spontaneous report was received from a nurse refers to an unspecified number of unknown age and gender. Concurrent conditions, medical history and allergies were not reported. On an unknown dates, an unspecified number of patients were vaccinated with PROQUAD (strength, dose, route, anatomical location, lot number and expiration date were not reported), which were improperly stored. No adverse effects were reported and no product quality complaint (PQC) was involved. This is one of two reports received from the same reporter. Additional information has been requested.
The female subject received FLUBLOK intramuscular on 14Oct2015. On 16Oct2015, the subject called to report injection area redness and slight swelling at injection site. Reddened area was 5 cm by 7 cm. She denied any itching at site. At the time of the report, the outcome for the events was unknown. Concomitant medications were not reported. The company's assessment of the causal relationship between injection area and redness and FLUBOK and injection area swelling and FLUBLOK is a possible relationship. In light of the safety profile information, injection site erythema and swelling are expected events. In summary, this case report does not change the known safety profile of FLUBLOK.
amaurosis fugax.  Temporarily lost vision in top half of right eye - lasted about 15-20 seconds - blood clot in right eye.  No past history of blood clots
Right eye lid/eyeball feels numb and it was slightly lazy (that has resolved).  I noticed it first on 2/16/21 and my eye lid still feels "off" and kind of numb.  It seems like the right eye lid doesn't open all the way unless I use extra effort.
her LUPUS flare up/burning LUPUS; tremendous body pain; dizzy; migraine; A spontaneous report  was received from a consumer concerning a 46-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced tremendous body pain, a burning LUPUS, dizzy, LUPUS flare up, and migraine.  The patient's medical history was not provided.  Concomitant medications reported included Prednisone two weeks Synthroid, hydroxychloroquine every day, Pantoprazole, Famotidine, Xyzal, Byden, Tramadol.  On 3 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 012M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 21 Feb 2021, her LUPUS flare up. On an unknown date patient experienced events as tremendous body pain, dizzy, headache and migraine.  She has been under steroids treatment for a week and a half.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events experienced tremendous body pain, a burning LUPUS, dizzy, LUPUS flare up, migraine was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Gastritis starting within hours and still occurring 12/20/22 The injection site started itching and swelling with blistering on December 2, two weeks after the injection. It is still itching and swollen with blisters, 12/20/22
Pt said he felt like he had been hit by a truck- fever and severe muslce aches all over.
Patient was administered the second Pediatric Pfizer Covid 19 on 2/9/2022.  The first one was on 1/25/2022.  Patient's mom said that he felt a little bit tired after the shot.  Patient will come back on 3/2/2022 to be revaccinated.
NONE:  PATIENT IS 9.6 WEEKS PREGNANT AS CONFIRMED BY SONOGRAM.  PREGNANCY DX ON 18 MARCH, DATE OF LMP WAS 15 FEB 2003.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old male patient received BNT162b2 (BNT162B2), on 13Oct2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 37 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Relapsing Polychondritis" (unspecified if ongoing); "Tracheomalacia" (unspecified if ongoing). Concomitant medication(s) included: ACTEMRA; IVABRADINE; PREDNISONE; RASUVO; ROSUVASTATIN; METHOTREXATE SODIUM. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: Brand: Paxlovid Treatment start date: 02Dec2022 Treatment stop date: 06Dec2022 Indication: Treatment of COVID-19  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Pt brought to med obs #1 via stretcher after being monitored for 30 mins. Pt was brought laying down claiming to have "brain fog." Noticeably dazed for upward 20 mins. Reports of having negative reactions to first dose of pfizer vaccine. Pt gradually recovers over span of over 1 hour & 20 mins Orthostatic VS obtained. No s/s of distress noted. Pt refused wheelchair, opting to ambulate to exit with staff escort. Vs are as follow; Med Obs #2 1645: BP 162/97, HR 70, RR 22, O2 sat 95% on RA Med Obs #1 1702 (Laying): BP 144/96, HR 68, RR 16, O2 sat 97% on RA 1708 (Laying): BP 138/94, HR 67, RR 16, O2 sat 98% on RA 1715 (Sitting): BP 129/90, HR 65, RR 16, O2 sat 98% on RA 1725 (Sitting): BP 137/90, HR 71, RR 16, O2 sat 98% on RA 1730 (Standing): BP 135/98, HR 84, RR, 14, O2 sat 96% on RA  1735 (Standing): BP 141/96, HR 75, RR, 16, O2 sat 94% on RA
outbreak of shingles and tingling; Information was received from a lawyer regarding a case in litigation concerning a male patient (pt) of unknown age. The pt's medical history, concurrent conditions, or concomitant medication were not provided. On an unspecified date, he pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, frequency, route of administration, anatomical location, lot number and expiration date were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after zoster vaccine live (ZOSTAVAX) vaccination, the pt suffered an outbreak of shingles and tingling. As a result of these symptoms, the pt was seen and treated by medical providers in and is still under their care. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, the pt's symptoms have resulted in physical limitations not present prior to using the company's product. The pt also experience mental and emotional distress due to resulting physical limitations and seriousness of the pt's condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence of the company's wrongful conduct, the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, the pt suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of herpes zoster was reported as not resolved. The causal relationship of herpes zoster was reported as related to zoster vaccine live (ZOSTAVAX).   The reporter considered herpes zoster to be a disabling event.
Patient completed the Moderna Primary Series on 11/11/2021 but received Janssen for booster yesterday.
Dear Sir/Madam. 04/26/2023 Ever since the date of dose Pfizer Booster 04/26/2021, 04/24/2021 until 12/30/2021, I have been encountering series of problems both physically and mentally, including *Physical disability -- Permanent to the injury- related areas of my body caused by the accident. *Mental problems - constant stress deriving from the physical illness which leads to sexual dysfunction; hopelessness and lack of interest in social activvities. Is a chronic degeneration disorder primarily of the lower lip caused, identify studies assessing the long-term effects of COVID-19. "Balanitis xerotica obliterans (BXO), and KETOCONAZOLE 200MG TAB 04/3/2023 and CLOTRIMA/BETAME 1-0.05% CRM
Thinks the site of injection was too low; Injection also hurt; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (Thinks the site of injection was too low) and INJECTION SITE PAIN (Injection also hurt) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, the patient experienced PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (Thinks the site of injection was too low) and INJECTION SITE PAIN (Injection also hurt). At the time of the report, PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (Thinks the site of injection was too low) and INJECTION SITE PAIN (Injection also hurt) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       no relevant concomitant medications was reported. No treatment information was provided Med Info Agent: Maximiliano Cengarle Crosslink with Case MOD21-042058   Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: Non-Significant Follow up: AE contact information updated.
On observation after vaccine, patient reported swelling in her mouth and lips.  Patient took 2 benadryl 25mg  and stated she felt better. Advised patient to go to ER and patient refused.  Asked patient to stay for extended observation. About 30 min later, patient stated she was coughing and feeling slight tightness in her chest. At this point, patient was agreeable to go to the ER and patient was taken.
pt felt a little off; slow energy level, short tempered; 7JAN feeling sick, tired, achy, lightheaded, weak, stomach upset, nausea, vomiting, diarrhea, inc flatulence; 10JAN getting better still fatigued; 17JAN better but still faitgued;
Apparent cellulitis of right thigh - being treated with 7 day course of KEFLEX.
Dizziness with room spinning, facial numbness from cheekbones to top of head, head pressure in middle of head.
Unexplained prolonged twitching in neck.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58 year-old male patient received bnt162b2 (BNT162B2), administration date Apr2021 (Lot number: Unknown) at the age of 58 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MUSCLE TWITCHING (non-serious) with onset Apr2021, outcome "recovered", described as "Unexplained prolonged twitching in neck.". Therapeutic measures were not taken as a result of muscle twitching.  Additional information: Patient had never experienced this before in his life. It occurred 6 days after receiving the first dose of the Pfizer Covid-19 vaccine. Patient is a very healthy adult male with no significant medical issues in the past. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown, the patient was diagnosed with COVID-19 prior to vaccination. It was unknown, since the vaccination, the patient been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.