chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a pharmacist via call center representative and described the occurrence of injection site warmth in an unspecified number of patients who received SHINGRIX for prophylaxis. On an unknown date, the patients received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patients experienced injection site warmth, injection site swelling and injection site wheal. On an unknown date, the outcome of the injection site warmth, injection site swelling and injection site wheal were unknown. It was unknown if the reporter considered the injection site warmth, injection site swelling and injection site wheal to be related to SHINGRIX. Additional details were received as follows: The age at vaccination was not applicable. The pharmacist reported that other patients have experienced a warm raised welt at injection site after receiving SHINGRIX. This case was linked with case US2018123098, reported by the same reporter.
37 y/o/m without any medical history presented 2 days after vaccine with cardiac complaints. Found lying on boat dock extremely diaphoretic, pale, and weak, complaining of cardiac symptoms. Transported to ER.
I was sick with fever and body aches the next day. I was not concerned about that. It lasted for 4 days. But on the 4th day I became debilitatingly exhausted. It was hard just to keep my eyes open. I felt terrible. I could not drive my car when I needed for fear of falling asleep. I was falling asleep while  I was working. These things had never happened to me in my entire life before this. It was like I was narcoleptic. It was not just exhaustion though, I felt horrible too.  This lasted for 4 WEEKS. A couple weeks after that I had a  mystery illness that lasted for about 3 weeks, which included very high fever. I would have reported this sooner but I did not have a doctor at the time and the pharmacy where I got the shot could not tell me where to report my symptoms. I just learned about  this system so I am reporting what happened now. I am worried about what the shot did to me and  I am terrified of getting a booster. I will not get the booster.
No adverse effect reported; an 18-year-old female patient received the adult formulation of properly stored VAQTA in her left deltoid; This spontaneous report was received from a pharmacist concerning an 18 years old female patient of unknown race. The patient's pertinent medical history, concurrent conditions, drug allergies or reactions, historical and concomitant drugs were not reported.  On 24-JUN-2019, an 18 years old patient was vaccinated with the adult formulation of properly stored Hepatitis A Vaccine, Inactivated (VAQTA) (product use in unapproved population) 50 (units not reported), intramuscular in her left deltoid, lot number R014952 with expiration date on 09-AUG-2019 (dose and frequency were not reported) for prophylaxis. No adverse effects were reported. The outcome of product use in unapproved population was unknown.
Itching, hives, headache, sore throat, nasal stuffiness after receiving LAIV.  She took some Benadryl.  Hives are gone, but itching still present as of 9/18/09 at 10am.
Received shot on Friday.  Had flare up of chronic uveitis on Monday.  Still treating  Headache started on Sunday, and it has not resolved.  It gets better and worse, but is always there.  Does not go away with ibuprofen and Tylenol.  Appointment for eye doctor is scheduled.
PATIENT RECEIVED VACCINE THAT EXPERIENCED A TEMPERATURE EXCURSION, VACCINE WAS KEPT IN THE REFRIGERATOR FOR MORE THAN 30 DAYS. PATIENT REPORTED SORE ARM "LIKE ANY OTHER SHOT"
I've had about 18 adverse reactions, pain swelling on my nose first the right then the left and lasted about a week and 1/2, tremendous pain on my left shoulder unable to lay sown, about 2 weeks later the left shoulder started hurting tremendously, then about 4 days later my left elbow started to her. Then a couple days later my shoulders started hurting  again,  Then my left hand started to hurt. On  Oct. 13 of  2021 I was treated for left eye connectivity's. And and Oct 14th I had a left knee pain. Nov. 11 diagnoses with pharynges. on Dec, 10 my right wrist was inflamed, on Dec, 21 I had a sore throat, on Dec. 28th I went to the dentist to get a crown back an and my upper gums were bleeding. On  Jan. 23 2022 my right shoulder started hurting again. On Jan. 9th my left ring finger started hurting, on Jan 12, my right should was inflamed in the morning and the left shoulder was inflamed in the afternoon. On Jan. 27nmy left wrist and  then my right wrist started hurting. About that time I had a mild fever and sore throat but tested neg. for COVID, On Jan. 27 had blood work Feb. 3. had CT w/ contrast.  Fed. 4th I went to the hospital for shortness of breath, pneumonia, and, and kidney disease and vasculitis, on a high flow vent for about 8 days. I didn't feel any better until I had plasma paresis, ever since I was hospitalized until on dialysis, I have end stage renal disease and trying to get on the transplant list.
This spontaneous report as received from a healthcare worker refers to a 12 week old infant patient of unknown gender.  Patient's pertinent medical history, concomitant medication and drug reactions/allergies were not reported. On 12-APR-2016, the patient was vaccinated with VAQTA (strength, dosing details, anatomical location, lot #and expiration date unknown). No adverse symptoms were reported. No further information was provided. No product quality complaint was involved. The outcome of the events was unknown. Additional information has been requested.
9/12/2021: BAD HEADACHE, CHEST CONGESTION, STUFFINESS, COUGH, NOSE DRIPS, LOTS OF PRESSURE IN HER FACE
Patient was waiting for her family members to get vaccinated after she received hers. She was standing by her father and passed out.
50 days after receiving Zoster vaccine, patient developed right L5 radicular pain.  She spent 8 hours in ER, including MRI with contrast, and was discharged on Ultram and Valium for a diagnosis of osteoarthritis of the lumbar spine.  She was severely nauseated on the Ultram, just as she is with all codeine and hydrocodone meds.    Three days later she developed a papular rash on the right lateral calf and was diagnosed as shingles by the family physician (whose office administered the vaccine.)  She was prescribed 100-200 mg of GABA-pentin/day.       She had no relief and began to develop a right foot slap type limp, so was accepted by the neurosurgeon for consultation.  Dr.  said there was no problem with the spine, confirmed shingles and prescribed 300 mg Lyrica TID in addition to the ibuprofen she was taking.  There has been some relief but she is groggy and has pain every night that keeps her awake a couple of hours.   **Neither the doctor's office nor the pharmacy were willing to file a report of ineffective vaccine.  Telephone call to Merck was received graciously by RN; but the info received in response was only PDR and premarketing survey.  I do not know whether they are monitoring the reports or reporting them to you!
Information has been received from a nurse concerning a female patient who was vaccinated with GARDASIL. The patient came down with mono within one month of getting the vaccine. The patient sought medical attention. This is one of several reports from the same source. Additional information has been requested.
Dose #1 received on 04JAN2021 - Lot # EJ1685 - , Dose #2 received on 25JAN2021 - Lot # EL3302 and Dose #3 received on 18AUG2021 - Lot # FC3182; Dose #1 received on 04JAN2021 - Lot # EJ1685 - , Dose #2 received on 25JAN2021 - Lot # EL3302 and Dose #3 received on 18AUG2021 - Lot # FC3182; sick; This is a spontaneous report from a contactable other healthcare professional (patient). A 41-year-old female patient received third dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Left on 18Aug2021 09:00 (at the age of 41-year-old) (Lot Number: FC3182) as single dose for COVID-19 immunization. The patient medical history included currently at the hospital with mom who was in ICU with Covid (exposure to covid-19). The patient's concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), dose 1 on 04Jan2021 (Lot Number: EJ1685), dose 2 on 25Jan2021 (Lot Number: EL3302), both via an unspecified route of administration, administered in Arm Left at the age of 41-year-old as 3ml single dose for COVID-19 immunization. No other vaccines given the same days and none 4 weeks prior the booster dose. No problems with vaccines in past and states the last time she got vaccines was when she went on a mission trip and opted to get vaccines back in 2018. It was reported that the patient received the booster dose given on 18 August at 9am. States the booster dose made her sick. She got sick around 5pm that day. The patient underwent lab test which included antibody test after her first two doses of the Pfizer COVID-19 vaccine and she was positive for antibodies. Outcome of the event sick was unknown.
pt broke out in a fine pink rash all over body 1hr p/vax; itchy on face only; denies allergies to eggs & Neomycin; rx DPH; rash gone by 12JUN94;
This spontaneous report as received from a pharmacist refers to a 54 year old male patient with no pertinent medical history, drug reactions or allergies. On 05-SEP-2016, the patient was intramuscularly vaccinated with PNEUMOVAX 23 (dose was not reported, lot# M024673, expiry date on 17-NOV-2017). The patient was taking multiple unspecified concomitant medications. On 06-SEP-2016, the patient experienced pain at the injection site and he could not sleep at night. The patient also could not move the arm because of the pain. The patient did not have any laboratory test performed. The patient sought medical attention via calling pharmacy. The outcome of the events was reported as not recovered. Causality assessment was not provided. The reporter considered the events of pain at injection site, could not move the arm and could not sleep at night to be disabling. This is one of two reports received from the same reporter. Additional information has been requested.
Allergic vasculitis along the legs, thigs, and buttocks; Itchiness at injection site; Redness at injection site, red circles; A spontaneous report was received from a consumer concerning a 73-years-old female patient who experienced allergic vasculitis along the legs, thigs, and buttocks (hypersensitivity vasculitis), itchiness at injection site (vaccination site pruritus), and redness at injection site, red circles (vaccination site erythema).  The patient's medical history was not provided. Concomitant product use was unknown.  On 04 Feb 2021, prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (lot 013M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  It was reported that the injection site became itchy immediately upon injection and red circle developed afterwards (04 Feb 2021). Injection site reactions cleared up.  On 9 Feb 2021, about 5 to 7 days later, the patient experienced allergic vasculitis along the legs, thighs, and buttocks.(The diagnosis was from her doctor). Treatment for the events was unknown.  Action taken with mRNA-1273 in response to the events was unknown.   The event of allergic vasculitis along the legs, thigs, and buttocks (hypersensitivity vasculitis) recovered on 02 March 2021.  The events, itchiness at injection site (vaccination site pruritus) and redness at injection site, red circles (vaccination site erythema), were considered recovered.; 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.
Information has been received from a healthcare worker concerning a 67 year old female patient with diabetes; hypertension; hypercholesterolaemia and hypothyroidism and no known drug allergies who in November 2003, was vaccinated with the first 0.5 ml IM dose of PNEUMOUVAX 23. On 10-Mar-2009 the patient received the second 0.5 ml dose of PNEUMOUVAX 23 IM into her left deltoid (lot number 1161X. Concomitant therapy included QUINAPRIL HC1; SYNTHROID; ASPRIN and RANITIDINE. After receiving vaccine the patient developed redness; pain swelling and warmth in her left arm at the injection site. No lab diagnostics studies were performed. At the time of reporting the outcome was unknown. The patient sought medical attention via phone call. This is one of several reports from the same source. Follow up information was received from a physician concerning the female patient who on 10-Mar-2009 at 8:30 was vaccinated with the second 0.5 ml dose of PNEUMOVAX 23 IM into her left deltoid ( lot number 1161X). There was no illness at the time of vaccination on 11-Mar-2009 the patient developed redness; pain and swelling. At the time of reporting the patient recovered. The patient did not seek medical attention. Additional information is not expected.
In late December I had what appeared to be a cold.  I had a fever on 12/25/2022.  I tested positive for COVID-19 on 12/26/2022.  On the 29th I lost hearing in my left ear.  I went to urgent care and received prednisone and my hearing began to return on the 31st.  Hyperacusis.  That week I also began had heart palpitations.  I was having them a few times a day a few times an hour.   On January 1, 2023, they were frequent and caused chest pain.  I went to the emergency department. At the emergency department I was diagnosed with palpitations and tachycardia.   I saw my doctor on January 4th.  I wore a heart monitor January 16th and wore it for 36 hours. I saw a cardiologist on February 9th and I was diagnosed with having PVCs.  I had additional tests to confirm. I feel them enough to wake me up and taking beta blockers. Mid-January I began to have symptoms and diagnosed with Red Ear Syndrome.  My right ear turns bright red, and it is painful enough to wake me up.  I have not been given treatment for this.
Pfizer COVID-19 vaccine administered on 03/13/2023 expired on 03/09/2023.
Client presenting for assessment of new onset cough that occurred past 5 days, denies recent illness or known exposure, recently been started on lisinopril.   COUGH This is a new problem. Episode onset: 5 days. The problem has been unchanged. The problem occurs constantly. The cough is non-productive. Pertinent negatives include no fever, myalgias, rhinorrhea, sore throat, shortness of breath or wheezing. Nothing aggravates the symptoms. He has tried nothing for the symptoms.
About 3 hours after shot, I felt mild nausea, the feeling of a lump in my throat and a knot in my chest. When the latter two symptoms did not go away by 5/17/21, I went to my GP.  EKG was normal. Temp normal. BP normal. As my stomach was also upset, it was suspected that acid reflux might have been triggered by the shot response. I was prescribed Omeprazole 40mg 1x day. When the symptoms lingered into the following week, I went back to my GP on 5/25/21. After pushing on my chest, the doctor assessed that I had an inflammatory reaction to the first dose and recommended 3 Advil 3x a day.  When my chest remained tight I called my doctor on 5/28/21 and he prescribed Naproxen 500mg 2x/day.  I started feeling less pressure by 6/4/21 and was feeling good for my second shot on 6/8/21.
Vaccination adverse reaction; face flushing; bloodshot eye; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Vaccination adverse reaction), FLUSHING (face flushing) and OCULAR HYPERAEMIA (bloodshot eye) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) 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 VACCINATION COMPLICATION (Vaccination adverse reaction), FLUSHING (face flushing) and OCULAR HYPERAEMIA (bloodshot eye). At the time of the report, VACCINATION COMPLICATION (Vaccination adverse reaction), FLUSHING (face flushing) and OCULAR HYPERAEMIA (bloodshot eye) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 05-Feb-2021: Added events (face flushing, bloodshot eyes). suspect drug batch lot provided.
Nausea; I am nauseated; Feeling tired; Headache; Muscle pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NAUSEA (non-serious), outcome "unknown", described as "Nausea; I am nauseated"; FATIGUE (non-serious), outcome "unknown", described as "Feeling tired"; HEADACHE (non-serious), outcome "unknown"; MYALGIA (non-serious), outcome "unknown", described as "Muscle pain". Therapeutic measures were taken as a result of headache.  Additional information: NDC number of COVID-19 Vaccine, UPC number of COVID-19 Vaccine and Expiry Date of COVID-19 Vaccine was Unknown. Consumer stated, She was trying to find out if you had a side effect sort of from the shot (COVID-19 Vaccine) like nausea or you know feeling tired or headache, muscle pain can you take medication for that like Tylenol and nausea medication (Unspecified medication) or not. When probed to clarify if consumer already consumed the medications (Tylenol and Unspecified Medication): She want to know if you can take it. She did take Tylenol for the headache but now she was nauseated. Consumer was informed about the role of Pfizer Drug Safety and Pfizer Medical Information Department for the concern. Consumer was provided with the number of Pfizer Medical Information Department as (phone number), option 3 and timings as 8 am to 9 pm, Monday to Friday. In response to further probing, Consumer stated, She would rather want you to transfer. Attempt was made to transfer the call to Pfizer Medical Information Department however, it was unsuccessful. Consumer was requested to connect after some time to the department. Further probing could not be done. Hence, product details (LOT, Expiration date, NDC, UPC), purchase details and other details were unknown and limited information was available over the call.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
PT HAD REACTION AT INJECTION SITE: ITCHY RASH EXTENDING TO INSIDE OF ARM ABOUT 6IN X 4 IN
At 2AM on Saturday, March 13, 2021, I began passing blood into the toilet. That evening I went to the Emergency Department and was admitted as an inpatient. I was treated there and discharged to home on Tuesday, March 16. Over the next two days I passed substantial amounts of coagulated blood. My diagnosis was colitis.
Due to patients significant allergy history, patient was placed in a 30 minute waiting area.  Not long after being placed in the waiting area the patient started to get red, flushed, hot and itch.  EMS personnel helping to man the even gave the patient some injectable Diphenhydramine.  Patients symptoms resolved.
This spontaneous report was received from a medical assistant refers to a multiple unspecified patients of unknown age and gender. No pertinent medical history was reported. On an unknown dates, the patients were vaccinated with doses of improperly stored RECOMBIVAX HB (lot # L007558 and expiration date 10-NOV-2016) (dose and route were not reported). No adverse effects were reported. No Product Quality Complaint (PQC) was involved. This is one of the several reports received form the same source. Additional information has been requested.
Patient was given flu vaccine (Flulaval) which is meant for 18 years or older.  No adverse reactions occurred.
6 days after receiving the vaccine, the patient woke up feeling like her left arm was "hot". A few hours later she presented in the pharmacy. There was a bruise that she states was where the vaccine was injected and below that a palm-sized area of red. She said she thought it had expanded slightly since the morning.
Received telephone call from mother stating patient had swelling in L thigh beginning evening of 1/11/08.  States patient's "privates" are swollen today (1/14/08) and painful to the touch.  States no medical home. Instructed mom to go to ER since that is where she takes child when he is sick.  Asked mother to call RN back with followup information. On 1/17/08, phone call to mother to followup on what she was told when she was to have taken patient to doctor.  An adult female answered phone and stated mom not there and that she would have mom call RN.  Then on 1/18/08, phone call to mother. Message left with adult female for mom to call RN back.  1/23/08, phone call to mother.  Telephone has been "temporarily disconnected."
Moderna COVID?19 Vaccine EUA Approximately 8 days after the injection, I noticed that the injection site was a little bit itchy.  When I looked at the site, I discovered that there was a red circular area surrounding the injection site.  The redness of the area has been fading some over the past few days but is still slightly present.  The itchiness has been very minor.
- Fever (101 degrees) - 12 hours - Angioedema of the lips - 10 hours - Hives/rash on arms, body, scalp, shins,  and face - 12 hours - Extreme fatigue - 48 hours - Coughing - 48 hours - Pain at injection site - 48 hours
SEVERE! Headache for approximately 2 hours causing incapacitation. Swelling of a lymph node near left collar bone for 4 days (swollen to approximately 3x normal size.  Swelling in left harm and fever for 5 days (swelling occurred in the area of my first vaccine and was approximately 10" x 4"),  Still having mild pain in collar bone area.
STUFFY NOSE; RUNNY NOSE; SORE THROAT; This spontaneous report received from a parent concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total, administered on 09-MAR-2021 for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. On 10-MAR-2021, the subject experienced sore throat. On 11-MAR-2021, the subject experienced stuffy nose. On 11-MAR-2021, the subject experienced runny nose. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the stuffy nose, runny nose and sore throat was not reported. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard operating procedure as the case assessed as non-serious.
Patient got a headache and then  nausea. I asked if the patient had eaten anything today and she stated that she did not. I gave her some water and saltine crackers. Gave an ice pack for the back of her neck to help with the headache. I asked the patient if the water, crackers and ice pack were helping and she stated that they did help some. I asked the patient how she was feeling and she stated that she was feeling better than before. I took vitals at 8:39 am heart rate 90, o2 100 and BP 137/82, took again at 8:44 am heart rate 90, o2 100 and BP 135/82. I again asked how the patient was feeling to see if she was ready to go home. The patient stated that she was feeling better and was ready to go home. I released her to go home with her mother who was here with her today. They left at 8:56 am.