chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a 60-year-old female, with no pertinent medical history or allergies, who on 21-APR-2008 was vaccinated in the arm with a "single dose" of zoster vaccine live (Oka/Merck). Concomitant therapy included vitamins (unspecified), "WELCORE' and PAXIL. On approximately 28-APR-2008, "about 3 weeks ago," the patient developed two cold sores on her lip both in different locations. She developed the first cold sore three weeks ago and the second cold sore one week ago. The patient reported she has never had any cold sores in her lifetime until after receiving zoster vaccine live (Oka/Merck). The patient did not seek medical attention. No diagnostic labs or procedures were performed. At the time of the report the patient's status was not recovered. A product quality complaint was not involved. Additional information has been requested.
This spontaneous report was received from a nurse refers to 3 unspecified patients of unknown age and gender. No concurrent condition or medical history was reported. On 09-DEC-2015, the patient was vaccinated with PROQUAD (Merck) (lot # L039269, dose 1, subcutaneous, dose not provided) and VARIVAX (Merck) (lot # L005299, dose 1, dose and route not provided). No concomitant therapy was reported. No adverse effects were reported. The outcome of the event was unknown. No product quality issue was involved. Additional information has been requested.
VAXELIS administered since temperature excursion above 8.5° (10 mins)/Previous temperature excursion on 12-APR-22 above 8° (10 mins); This non-serious spontaneous report with reference numbers 02197725 / 02197588 was received by partner on 05-JUL-2022 and forwarded on 06-JUL-2022 from a consumer.    The causal relationship between Vaxelis and the reported event "multiple doses of VAXELIS administered since temperature excursion" was assessed as not applicable due to the nature of the event.    Further information is expected.  FOLLOW-UP INFORMATION was received by a partner on 01-AUG-2022 and forwarded on 03-AUG-2022, from a HCP. The case is maintained as non-serious.  The reporter confirmed that there were no Adverse Events following Vaxelis administration to the patient.  Due to the nature of the event, the causality between the event "VAXELIS administered since temperature excursion above 8.5° (10 mins)/Previous temperature excursion on 12-APR-22 above 8°C (10 mins)" and Vaxelis remained not applicable.  For reference purposes this case is linked to MCM-003724, MCM-003725, MCM-003726, MCM-003724, MCM-003734, MCM-003735, MCM-003737, MCM-003738, MCM-003739, MCM-003740, MCM-003741, MCM-003742, MCM-003743, MCM-003744, MCM-003747, MCM-003749, MCM-003751, MCM-003752, MCM-003753, MCM-003757, MCM-003759, MCM-003760, MCM-003763, MCM-003766, MCM-003767, MCM-003769, MCM-003770, and MCM-003772, due to same reporter.  No further information is expected.
Approximately 24 hours, post vax, pt developed severe local inflammation and fever to 102F, lasting several days, then subsiding. Also, got tinnitis in left ear which has persisted.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 66-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown, single (Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. No known allergies. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events Drug ineffective , Covid-19 and the use of suspect product cannot be fully excluded.
I have existing Tinnitus in my left ear, but it is hardly noticeable., On April 7, four days after my shot, I noticed  a substantial increase in my Tinnitus  in that ear, with a little  on again off again in my right, which I never had. Since then it has gotten worse in both ears and is quite  disturbing.
I was dry heaving at about 4:00 am and threw up once  muscle aches  chills  headache  blurry vision
Patient reports developing a fever (103 degrees), chills, and feeling disoriented.  Patient spent the night in the hospital. On the next day, patient reports overall improvement.
5/8" needle used. T101. 8"x4" upper anterior right thigh induration, itching at injection site.  Heat qid x 15 min followed by ice
bruise; tenderness on the arm; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a female patient of an unspecified age received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), via an unspecified route of administration on 04Mar2021 (lot number was not reported) as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unknown date in Mar2021, the patient experienced bruise and tenderness on the arm. The patient asked if it was a normal process from the vaccine and if she still needs to take the second dose that was scheduled on 25Mar2021. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
After 1st shot Felt light headed immediately after shot,   LOWER BACK PAIN DICOMFORT, pains GOES DOWN TO RIGHT LEG.  CaN FEEL PAIN MORE AT NIGHT,  TROUBLE SLEEPING,  After second shot within 3 hours I became numb in face and skin all over body. Lower Back (spine intensified)  and pain down  right leg.  Stiffness in walking movement. Also felt some pain in shoulders and upper back  muscles shoulder blades.
I had hallucinations. I thought it was vivid dreams but I could not wake myself. I even went to bathroom three times during the night and could not stop them while getting up and walking to bathroom. I would sit up in bed and even get out of bed but they would not stop. I?ve never had this happen ever in my life. I was crying out and sweating. I have also had severe fatigue, even much more than what I experience with CFS.
Patient called and stated that she was experiencing a rash spreading on her arm and groin. She stated that she did not have any swelling or difficulty breathing at that time. She was instructed to take Benadryl and go to her provider's office. The pharmacist called ahead to make them aware of the situation. Upon following up, the patient went to the ER because she started having mild swelling of the tongue. At the time of the call she had been given more Benadryl, Epinephrine, and a steroid and was being monitored.
Narrative: 69yo male with the following problem list: Nausea and vomiting (SCT 16932000) (ICD-10-CM 07/21/2021 R11.2) Hepatic encephalopathy (SCT 13920009) (ICD-10-CM 01/20/2021 G93.49) Ascites (SCT 38926000) (ICD-10-CM R18.8) 01/20/2021 Cirrhosis of liver (SCT 19943007) (ICD-10-CM 10/21/2021 K74.60) Esophageal varices (SCT 28670008) (ICD-10-CM 11/12/2018 I85.00) Coronary atherosclerosis (SCT 443502000) 08/29/2018 (ICD-10-CM I25.84) Arteriosclerosis of autologous coronary artery 08/29/2018 bypass graft (SCT 285151000119108) (ICD-10-CM Z95.1) Paroxysmal atrial fibrillation (SCT 282825002) 08/29/2018 (ICD-10-CM I48.0) Hypercholesterolemia (SCT 13644009) (ICD-10-CM 06/29/2017 E78.00) History of colonoscopy (SCT 851000119109) 06/29/2017 (ICD-10-CM R69.) 10/2013- tics, no polyps Other chronic nonalcoholic liver disease (SCT 01/27/2016 442685003) (ICD-9-CM 719.41); Pain in joint involving 04/09/2013  shoulder region (ICD-9-CM 719.41) (ICD-9-CM 302.72); Male erectile disorder 11/10/2010 (ICD-9-CM 302.72/607.84) (ICD-10-CM I10.); Essential hypertension (01/27/2016 59621000) (ICD-10-CM K21.9); Gastroesophageal reflux 01/27/2016 disease ( CT 235595009) (ICD-9-CM 724.2) (ICD-9-CM 305.1) Tobacco user 12/13/2006 received his first moderna covid vaccine dose on 7/21/2021. On 7/28/2021 pt went to ER outside of facility with chief complaint of Syncope and collapse. Pt was discharged on 7/30/2021 with the following diagnosis: DC dx: Cirrhosis, CAD, COVID 19. Pt had not been fully vaccinated. On 8/2/21 pt presented to ER at same facility with Chief complaint: Shortness of Breath. Pt remained inpatient with covid infection. Pt died on 8/9/21 at facility from complications associated with covid infection.
Hot, sweating, red face, hives on face and neck, closing/tightness in throat for approx 5 days following injection.  Low grade fever on day following injection, lasted 1 day.
After leaving pharmacy, had a headache within 5 min. site was pink, hot and sore and couldn't touch wake up in middle of night with severe pain even after TYLENOL. 10:AM next day had muscle aches, fever and chills. Went to urgent care, Pulse was 101 normally 80.
3 days after shot, constant itching at vaccination site on arm. 4 days after shot, thought it must be a bug bite. 6 days after shot a rash about 2" x 3" formed, and 7 days after shot I thought I either had poison oak or shingles. Cortisone cream barely made any difference. Was also somewhat painful. Took Benadryl in order to sleep. Read about the rash some people were getting from the shot and learned a friend also had it. Talked to nurse practitioner who gave me Rx for shingles in case it did turn out to be shingles. Two or three days later rash subsided. Itch lessened gradually but it still itched on 3/13/21.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 45 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 24Oct2021 (Lot number: 32030BD) at the age of 45 years as dose 1, single for Covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PARAESTHESIA (non-serious) with onset Nov2021, outcome "not recovered", described as "Pins and needles all through body". The event "pins and needles all through body" was evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of paraesthesia. Additional information included: The report was not related to a study or programme. Caller stated that, she was calling regarding the Pfizer shot, the first shot. She stated that it was mandatory for her job. Clarified that she was referring to the Pfizer Covid-19 vaccine. She was wondering why she had the shot 3 weeks ago and was put in the hospital because she was having pins and needles all through her body after the first shot. Pins and needles all through body: Caller states that it occurred 3 weeks after she got the first shot. She stated that, she was still experiencing it and it has stayed the same. Clarified that she was in the hospital for 4 hours on Saturday and it was clarified that she was referring to this past Saturday, 13Nov2021. Clarified that she was not admitted to the hospital overnight, that she was in the emergency room for 4 or 5 hours. Treatment: No, they did not give her anything in the hospital. She states that they did blood work. She stated that, she has had no other medications for treatment for the pins and needles. She visited to physician Office, right after the next day. Time of Vaccination Was Given: around 3:30 or 4:00 in the afternoon. History of all previous immunization with the Pfizer vaccine considered as suspect was reported as no. Additional Vaccines Administered on Same Date of the Pfizer Suspect was reported as no. The patient did not receive any vaccine prior to Covid-19 vaccine. Family Medical History Relevant to AE(s) was given as No. Relevant Tests: None. No follow-up attempts are possible. No further information is expected.
Swollen arm at injection site, nausea, fever and gagging. Patient was very ill looking and upset. She was a little better today, 10/13/2018, per her husband.
Fever, Diarrhea, 1/20/21 SYMPTOMS BEGAN. ADMITTED TO HOSPITAL & CONTACTED EOH 1/27/21 WITH FEVER, CHILLS,SOB, COUGH., DIARRHEA, BLOOD CLOTS, FLUID AROUND HEART. Narrative: Other Relevant History:
This spontaneous report was received from a registered nurse refers to a 6 month old male patient. The medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was inadvertently vaccinated with ROTATEQ, dose 1, oral. Additional information has been requested.
AFTER RECEIVING VACCINES, CLIENT EXPERIENCED SYNCOPE, REMAINED IN CHAIR, APPEARED TO FAINT FOR +/- 2 SECONDS, CAME TO QUICKLY. BY 20 MINUTES HAD RECOVERED FROM EVENT.  TOOK B/PX4 GAVE SNACK AND WATER.
Almost immediately affter vaccine injection, I experienced numbness and tingling in my left arm, then both arms, and then spread to face, lips, tongue and legs with numbness in all extremities accompanied by tingling.   These symptoms resolved after approximately 36 hours.
A sore arm a few days after vaccine and arm is still sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (A sore arm a few days after vaccine and arm is still sore) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced PAIN IN EXTREMITY (A sore arm a few days after vaccine and arm is still sore). At the time of the report, PAIN IN EXTREMITY (A sore arm a few days after vaccine and arm is still sore) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.
rash where I got the injection; rash / spread more along the side of my arm every day; itching on my left arm; This case was reported by a consumer via interactive digital media and described the occurrence of injection site rash in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced injection site rash, rash and itchy rash. The patient was treated with loratadine (Claritine) and cortisone (non-proprietary) (Cortisone Cream). On an unknown date, the outcome of the injection site rash, rash and itchy rash were not recovered/not resolved.   It was unknown if the reporter considered the injection site rash, rash and itchy rash to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by patient himself/herself. The age at vaccination not reported. The patient got the Shingle shot and had skin rash where got the injection, It goes away after taking Claritin for a day then it comes back again on the day of reporting. It's been going since he/she got the vaccine shot but the rash seemed to spread more along the side of arm every day. The reporter woke up itching on left arm now. They gave no papers and said nothing else after getting vaccine.  No follow up to see how he/she doing. The patient called clinic to see if it was normal and they told to put cortisone cream on it.
ACHES; CHILLS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's past medical history included covid-19. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced aches, and chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from aches, and chills. This report was non-serious.
pt recvd vax 26JUN92 & immed following vax devel a local reaction; approx 1wk later devel a low grade fever & exp arthralgias & myalgias; sx resolved; AUG92 devel cyst beneath breast; following day devel urticarial rash then devel hives;
Mild ache at site of injection; swelling at site of injection lasting about 3 days.  Redness, mild itching from just below the site of injection and extending downward over the lower deltoid muscle lasting 5 days.  No treatment required.
Patient began with inflammation and pain at injection site.  By 8:00 PM that same evening inflamed area was erythematous and measured approximatel 5 cm in diamete in an uneven roughly oval shape.  Patient was brought back into the office on 06/06/2019 at 1:15 PM for evaluation.  Inflamed area now measured approximately 12.5 cm erythematous, pruritic, and painful.  Patient diagnosed with cellulitis, placed on augmentin 400mg-57 mg/5 ml  with order of 5 ml twice daily via oral route x 10 days, prednisolone 15 mg/ 5 ml with order of 5 ml twice daily via oral rout x 5 days.  Will re-evaluate in office in 5 days or earlier as needed.
Mother noticed 11/16/2004 at morning time: vaccine given on 11/15/2004 right induration length 110 mm. Right arm circumference 210 mm total induration 110x100 of right arm vaccination reaction.
Flu like symptoms; This non-serious case was reported by a nurse via other manufacturer and described the occurrence of influenza-like symptoms in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Pfizer Covid-19 Vaccine with an associated reaction of malaise (also had experienced unwell).   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced influenza-like symptoms (Verbatim: Flu like symptoms). The outcome of the influenza-like symptoms was resolved.   It was unknown if the reporter considered the influenza-like symptoms to be related to Shingrix.     It was unknown if the company considered the influenza-like symptoms to be related to Shingrix.   Linked case(s) involving the same patient:  US2023AMR074925   Additional Information: GSK receipt date: 24-May-2023 The patient usually had some type of side effects with vaccines like Shingrix, 2 doses, both times I had flu like symptoms for a day or two; Covid the same thing I felt kind of tired and yucky and stuff like that. The reporter was a nurse anesthetist in hospital so was on the first round of getting Covid shots; every time, I have had malaise and did not feel good for a day or so that is how react to most vaccines.   Upon further discussion, the reporter called and stated that the physician recommended Prevnar 20 since I just turned years old.  The physician was recommended that get but reported that had issues with other vaccinations in the past including Shingrix and the Pfizer Covid-19 Vaccine. The reporter reported that had malaise and did not feel good for a day or so after receiving the Pfizer Covid-19 Vaccine.  There was planning to get it today, expecting same side effects as I have had with other vaccinations so ok to take Motrin. The reporter has always heard the debate whether or not I should take Motrin or to just allow the immune response to occur to have vaccine more effective.  After response, stated was a nurse anesthetist agreed to be transferred, but disconnected before successful transfer. Upon further clarification of which Covid vaccination, stated that, it was Pfizer's Covid 19 vaccine.  No additional information and response discussed per PI noting no specific information about impact of Motrin on efficacy of vaccination (reviewed section 7.2 Immunosuppressive Therapies).  Shared most commonly reported adverse reactions and referred to healthcare for further discussion on management recommendations as Pfizer is unable to make recommendations as may vary by individual patient.; Sender's Comments:  US-GSK-US2023AMR074925:Same patient/diffrent vaccine
Encephalitis. Lethargy, alt. conscious, personality, extreme irritability, hallucinations, stiff neck, ataxia, somnolence, focal neuro, URI, CV, rash.  A 60-day follow up report received 6/10/2003 adds no new info. Annual follow up on 03/17/04: "It is unknown if the pt recovered from the adverse events."
Pt had rash & hives on most of body, including arms, legs & torso. Starting using po BENADRYL & hydrocortisone cream.
Information regarding Prevnar was received from a nurse regarding a 2-month-old female patient who received the first dose along with a dose of Hib injection (manufacturer unknown) and a dose of Pediarix. On the same day, the patient experienced a local rash on the right leg. On 30-Jun-2006, the patient received a dose of Prevnar along with other childhood vaccines. Immediately after the injection, the child developed a local rash on the right leg that lasted for several hours. The rash "went away" and the patient recovered.  No additional information was available at the time of this report.
Patient came to our health department to be seen in our family healthcare services. Patient's mother showed the nurse her COVID card and asked if it was a mistake that she had received a Moderna vaccination.  The nurse questioned whether they had inadvertently written the wrong thing. Passed the information along to this nurse who then followed up with the clinic to see what vaccine had been given. Spoke with clinic on the phone and requested a copy of vaccination records from the day. Was later faxed the information which did not contain any lot number information but did state that the patient did receive a first dose Moderna vaccine at their site in their left deltoid on May 27th, 2021.
Immediately after I got the shot. My right arm stop being able to work, I woke up on the floor. Was super hot and dizzy. The right side of my chest has been hurting ever since along with my right arm.
ADULT OBSTRUCTIVE SLEEP APNEA 3/24/2023 SEVERE ALCOHOL USE DISORDER W ALCOHOL WITHDRAWAL, W PERCEPTUAL DISTURBANCE ACUTE NON ST ELEVATION MI 3/24/2023 SEVERE ALCOHOL USE DISORDER W ALCOHOL WITHDRAWAL, W PERCEPTUAL DISTURBANCE