chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Booster; Arm was killing me and couldn't move it.; Right arm is hurting, with red patches, itching, spread to the bicep; Right arm is hurting, with red patches, itching, spread to the bicep; her arm started to feel really sore and swollen; after the booster her arm started to feel really sore; This is a spontaneous report received from a contactable reporter(s) (Consumer) from medical information team. The reporter is the patient.  A 67 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 08Dec2021 (Lot number: FG3527, Expiration Date: 28Feb2022) at the age of 67 years as dose 3  (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (First dose: given on 17Apr2021 in the afternoon in the right arm, Lot: ER8731), administration date: 17Apr2021, when the patient was 67 years old, for Covid-19 Immunization, reaction(s): "right arm it hurt"; Bnt162b2 (Dose 2, The second on 08May2021 on right arm), administration date: 08May2021, when the patient was 67 years old, for COVID-19 Immunization, reaction(s): "right arm it was sore". The following information was reported: IMMUNISATION (non-serious) with onset 08Dec2021, outcome "unknown", described as "Booster"; MOVEMENT DISORDER (non-serious) with onset Dec2021, outcome "unknown", described as "Arm was killing me and couldn't move it."; PRURITUS (non-serious), ERYTHEMA (non-serious) all with onset Dec2021, outcome "not recovered" and all described as "Right arm is hurting, with red patches, itching, spread to the bicep"; PERIPHERAL SWELLING (non-serious) with onset Dec2021, outcome "not recovered", described as "her arm started to feel really sore and swollen"; PAIN IN EXTREMITY (non-serious) with onset Dec2021, outcome "unknown", described as "after the booster her arm started to feel really sore". Therapeutic measures were taken as a result of pruritus. Additional information: used a cream for the itchiness. No Emergency Room visit and Physician Office visit. None prior vaccinations (within 4 weeks).  No follow-up attempts are possible. No further information is expected.
Initial report received on 13 September 2012 from the Investigator participating in a post-marketing study under the reference number M5A16. A case of pertussis disease in an 2 year old, female subject was identified by the investigator based on review of data from the Electronic Disease Surveillance System (EDSS). The subject's vaccine history included 3 doses of PENTACEL received on 11 June 2010, 23 August 2010, and 06 October 2010 (route, site of administration, and lot numbers were not reported). Approximately 20 months after the last dose, on 14 July 2012, she developed a cough and a day later she developed cold-like symptoms. On 19 July 2012, the child developed paroxysmal cough with a whoop. She also experienced posttussive vomiting and sleep disturbance. Laboratory testing included positive PCR on 20 July 2012. Chest x-ray findings were negative for pneumonia. Corrective treatment consisted of azithromycin for 5 days starting on 19 July 2012. The subject was not hospitalized. At the time of final contact on 17 August 2012, the subject's cough was still present. At that time, the duration of the cough was reported as 34 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Headache, Myalgia, Arthralgia, chills, pain at injection site Narrative:
Patient experienced redness, warmth, pain, and swelling at site of injection. Patient was instructed to take ibuprofen and BENADRYL for treatment. Also recommended to see doctor in case symptoms worsen.
pain in right groin; difficulty walking; arm soreness; redness on the toe of his left foot; This is a spontaneous report from a contactable consumer (patient himself). An 86-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EL1284, expiration date was unknown), via an unspecified route of administration on the left arm on 16Jan2021 at a single dose for COVID-19 immunization; it was offered to him and he was in the Phase 1B category. Relevant medical history included ongoing type 2 diabetes mellitus, which was diagnosed 10-15 years prior reporting, had a watchman procedure on an unspecified date, and had used a cane to walk before. Concomitant medication included clopidogrel as a blood thinner from 15Jan2021 and ongoing, which he would take for 6 months. The patient previously took apixaban (ELIQUIS). It was reported that he had a watchman procedure and they took him off of apixaban and started him on clopidogrel. In 6 months, he would not have to take any blood thinners and would make an appointment with his physician. On 18Jan2021, at noon, the patient was experiencing pain in his right groin. As the day progressed it got worse. By night (18Jan2021), he was in extreme pain and had difficulty walking. He had to use a walker to walk. It had let up, but he still had pain in the groin of his right leg. The patient was asking if there were certain doctors that could assist him with this problem. He was no longer using a walker. He was using a cane instead. He used a cane to walk with before this, but not for this reason. He never had any real serious aching. He had a little soreness in his arm on an unspecified date in Jan2021, but nothing out of the ordinary. He didn't know his arm was sore until he rubbed it. He though it might have been on Sunday when he noticed it. He was not sure. Prior to this, he had redness on the toe of his left foot on an unspecified date in Jan2021. He was prescribed an antibiotic that he was still taking. He was unable to provide the name of the antibiotic. Therapeutic measures were taken as a result of "difficulty walking and redness on the toe of his left foot. The patient had no investigation assessment. The patient was recovering from the event "pain in right groin," he was not recovered from the event "difficulty walking," while the outcome of the events "arm soreness and redness on the toe of his left foot" was unknown.
On October 5th around noon noticed shoulder-blade area was sore. About a 1/2 hour later the area was swollen and tender. Sent a message to my dr. By the time they got back with me they didn?t have any openings so they sent me to urgent care. That dr didn?t know what was causing it, said it felt like fluid under my skin. I told him that I had had the booster shot on the same side two days before but he did not think it was connected. He advised me to go to the emergency room. I went to the emergency room.Dr there did ultrasound of area said it looked like fluid around the lymph node. She then had them do a CT scan.
I had the first dose on 2/26/21. On March 8, I began to develop painful and itchy hives on my arms and legs that woke me in the middle of the night. It happened for 3 nights in a row and then stopped.
Expired Twinrix Administered; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 58-year-old female patient who received HAB (Twinrix) (batch number DK23D, expiry date 8th February 2022) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 16th June 2022, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On 16th June 2022, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 19-OCT-2022 Reporter's Comments: The pharmacist called and wanted to know does expiration date move, how to proceed and would patient need to be revaccinated. The agency stated that they realized their Twinrix was expired and a few patients were administered. The agency reported that they inadvertently administered expired Twinrix doses to three separate patients.  All administered at their facility. The reporter did not consent to follow up. Additional Supportive Information: The patient received an expired dose of Twinrix, which led to expired vaccine used. This was 1 of the 3 cases reported by the same reporter.; Sender's Comments:  GSK-US2022150645:Same reporter GSK-US2022150647:Same reporter
11/9 to 11/23 Hospital Admission: While he was in the hospital, he was evaluated and treated for his COVID-19 pneumonia, was treated with IV remdesivir, evaluated by Infectious Diseases and Pulmonology, and also was treated for his E coli UTI and evaluated by Gastroenterology secondary to his peptic ulcer disease.  Suggested medical management.  As his symptoms were resolving gradually, he was discharged to subacute rehab in a stable condition.
On 6-28-11 pt developed a lump on (L) side of neck. On 6/29/11 pt developed a rash.
3/22/13 around 05:30 PM:  Tightness in chest, difficulty breathing (duration about 10 minutes), grade 1 pain in arm. 3/22/13 around 8:00 PM:  Grade 2 pain in arm.  3/24/13 around 02:00 AM: nausea & vomiting.  3/24/13 - present (it's presently 3/25/13):  nausea, swollen glands, grade 1 pain in arm.
Rash started 10 days after vaccination, started with fever 100.6, irritable. Rash on face and torso and legs.
Aprox. at 6:30 am on 09/13/2021, day after first vax, had a very severe vertigo episode that lasted aprox 5 min, after which a loud high pitched ringing began. This lasted for aprox 24hrs, unable to sleep or concentrate during this time. It has dimished to about 20 to 60 percent of the initial noise level. Still remains after 5 weeks. I am able to deal with it, thus far.  It fluctuates every day. Still there.
cellulitis left deltid a week after injection. Started today on Keflex 500mg Qid x 7 days. Site itchy hot with erythema
Headache/ He can't get rid of the headache and he has taken all sorts of Tylenol; This is a spontaneous report from a contactable consumer. This consumer reported similar event for 2 patients. This is the first of 2 reports.   A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported), via an unspecified route of administration on 10Jan2021 at single dose for COVID-19 immunization. Medical history included allergy to penicillin. The patient's concomitant medications were not reported. The patient took the Pfizer COVID at (Hospital name) on 10Jan2021 and experienced a headache and has been taking Tylenol since yesterday. It was so bad that he went to sleep at 7 and he was still in bed. The patient can't get rid of the headache and he has taken all sorts of Tylenol. The outcome of the event was not recovered.  Information on the Lot/Batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021026399 same reporter/drug/event, different patient
Rushed to emergency room with severe, severe pain left shoulder, arm, hand, underarm breast, upper back and midback (left side). Given morphine and nausea and sent home. Still in pain. Rushed back to emergency room exactly a week later with same symptoms plus blisters and rash (still left side).  Treated for symptoms of shingles, but no "classic" signs of shingles. Saw primary care doctor on 06/02/2021. Continued the treatment for shingles. Extremely limited function in left hand (holding, etc.) Future doctor visits schedule for August.
No adverse events noted. Client registered with birthdate of (unlisted) for appointment. Client's birthdate is (unlisted). Client received first dose of Moderna Vaccine. Father was notified by client. Client notified her physician. Client monitored for thirty minutes. No complications noted.
25AUG98 began being very tired (could sleep 20hr/day);27AUG98 firs noticed small bites, knees began to swell w/pain then feet & ankles;1SEP98 wrists especially painful-knees 90% better-ankles & feet better;never any fever-nausea or GI sx;
swelling in the arm after the injection; tendinitis and pain in the injected arm; tendinitis and pain in the injected arm; This spontaneous report was received from a physician referring to a 53-year-old female patient who was not pregnant. The patient had no known drug reaction/allergy. Information about pertinent medical history and concomitant medication was unknown.   On 10-DEC-2021, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (strength, dose, anatomical location, lot# and expiration date were not reported) intramuscularly for prophylaxis.         On 12-DEC-2021, the patient experienced swelling in the arm after the injection, tendinitis and pain in the injected arm. Information about treatment given for the event, lab diagnostics/studies and medical attention was unknown. The outcome of the events was unknown.   The causality between the events and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not provided.
injection site pain; experienced a fever of 102; Felt terrible; felt sick; This non-serious case was reported by a physician via sales rep and described the occurrence of injection site pain in a 70-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 08-SEP-2023, the patient received Arexvy. On 08-SEP-2023, immediately after receiving Arexvy, the patient experienced feeling unwell (Verbatim: felt sick). On an unknown date, the patient experienced injection site pain (Verbatim: injection site pain), fever (Verbatim: experienced a fever of 102) and feels awful (Verbatim: Felt terrible).The outcome of the injection site pain, fever, feeling unwell and feels awful were not reported.   It was unknown if the reporter considered the injection site pain, fever, feeling unwell and feels awful to be related to Arexvy.  It was unknown if the company considered the injection site pain, fever, feeling unwell and feels awful to be related to Arexvy.   Additional Information: GSK Receipt Date: 11-Oct-2023 The patient received a dose of Arexvy and reported that she immediately felt sick.  She had bad injection site pain but also experienced a fever of 102.  She felt so terrible that she did. The reporter did not think it was within the normal expectations.  She was going to report it herself but spoke to her so she told her she would start the process. She would be happy to speak to you about her experience in detail. The reporter agreed to follow up from GlaxoSmithKline.
This spontaneous report was received from a licensed practical nurse regarding a 21 year old female patient. The patient's medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not provided. On 13-APR-2017, the patient was vaccinated with first dose of GARDASIL 9 for prophylaxis (route, anatomical location, lot # and expiration date were not provided) and received the second dose on 14-MAR-2018. No adverse effects were reported. Sender's Comments: US-009507513-1803USA009618.
Right facial itching/burning/tingling, swelling, redness, blurred vision; later found to have shingles
Information was received 30-JUN-2017 via a phone call from a licensed practical nurse who reported that a patient (age and gender not specified) was administered an improperly stored dose of PNEUMOVAX 23 on an unspecified date. Lot number and expiration date were not provided. No adverse effects were reported. No additional information was provided. This is one of several cases from the same reporter. Additional information was requested. Sender's Comments: US-009507513-1707USA009867: US-009507513-1707USA009868: US-009507513-1707USA009869.
Redness and swelling at injection site. Started 48 hours after injection, and is still there 72+ hours later. Contacted medical professional through a telehealth visit, who recommended Benadryl as to not impact the vaccine's effectiveness, but suggested monitoring it incase it increased in severity.
THROBBING PAIN; UNABLE TO WALK (AFTER 4 HOURS OF VACCINATION); WAKE UP IN MIDDLE OF THE NIGHT (AFTER 4 HOURS OF VACCINATION); PAIN IN HIS SHOULDER AND ARM JOINTS; SEVERE HEADACHE/DULL PAIN ON TOP OF HEAD (AFTER 4 HOURS OF VACCINATION); FEVER; This spontaneous report received from a patient concerned a 57 year old male. The patient's weight was 182 pounds, and height was 165 centimeters. The patient's concurrent conditions included high cholesterol level, diabetic, high blood pressure, alcohol user, and non-smoker, and other pre-existing medical conditions included the patient had no known allergies. the patient did not have any history of drug abuse or illicit drug use. The patient received covid-19 vaccine  (suspension for injection, intramuscular, batch number: 1805020, and expiry: UNKNOWN) dose was not reported, administered on 30-APR-2021 for prophylactic vaccination. Concomitant medications included naltrexone for alcohol dependence.  On 30-APR-2021, the subject experienced throbbing pain. On 30-APR-2021, the subject experienced unable to walk (after 4 hours of vaccination). On 30-APR-2021, the subject experienced wake up in middle of the night (after 4 hours of vaccination). On 30-APR-2021, the subject experienced pain in his shoulder and arm joints. On 30-APR-2021, the subject experienced severe headache/dull pain on top of head (after 4 hours of vaccination). On 30-APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) burning, and Pain scale (NR: not provided) 10/10 pain level. On 01-MAY-2021, Laboratory data included: Pain scale (NR: not provided) 05/10 pain level. Laboratory data (dates unspecified) included: Blood glucose (NR: not provided) 160 mg/dL, and Blood pressure (NR: not provided) 145/110 mmHg. The action taken with covid-19 vaccine  was not applicable. The patient was recovering from severe headache/dull pain on top of head (after 4 hours of vaccination), and fever, had not recovered from pain in his shoulder and arm joints, and the outcome of throbbing pain, unable to walk (after 4 hours of vaccination) and wake up in middle of the night (after 4 hours of vaccination) was not reported. This report was non-serious.
Woke up with minor subconjuctival hemmorage in my right eye, went to urgent care, they noticed one blood vessel broken, no other symptoms, advised me if it didn't resolve within 2 weeks to follow up with ophthalmologist. It resolved within one week. I do have a suspicion that I may have whacked my eye when I slept with a sleep tracking ring I had been wearing. I only mentioned it on the V-Safe check-in because it was unusual.
Red, swollen, warm to touch at injection site. 5 cm induration. Itchy R arm Subq-MMR.
No additional AE; The patient was given an expired dose of GARDASIL 9; This spontaneous report has been received from a medical assistant, concerning a patient of unknown age and gender.  The patient's medical history, concurrent conditions, historical drugs, and concomitant therapies were not reported.  On 07-JUN-2023, the patient was vaccinated with an expired dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5 milliliter (lot number U007667 [also reported as "UU007667"] has been verified to be valid, expiration date reported and confirmed as 23-MAY-2023), as prophylaxis (route of administration and anatomical location were not provided) (Expired product administered). A healthcare professional (HCP) was the operator of the device. There were no known temperature excursions. The expiration was supported by Post MEMO Expiry. No adverse events (AEs) nor product quality complaints were reported.  This is one of two reports received from the same reporter. ; Sender's Comments:  US-009507513-2306USA007857:
One afternoon of heavy menstruation. I do not usually have periods due to my IUD Diarrhea and cramps for two days. Fatigue for two days  Cramps still ongoing
Localized reaction starting the following day. On 1/7/2021 this area was red, warm, slightly indurated and measured 9 cm x 5 cm
reported light headedness when First responder arrived.  stated she "always has this type of reaction" whenevery she gets an injection or has blood draw.  Also reports a h/o anxiety over getting vaccine due to her mother being "anti-vaccine"     TX - car heat immediately reclined mask removed for fresh air, emotional support.   OJ & pretzels.  Total observation time 30 mins.
headache  and nausea starting a few hours after shot. Nausea off and on since then, headache for the 8th day now, and not getting better
Became congested (lungs) then to ears, itching and headaches. Saw doctor 11/29/04 and tx as below.
Sharp shooting knifing pain originating at site spread over next few days to face, neck, down spine. sharps shoots in hip, knees, feet and ribcage.  Worst pain was spreading through out face and muscle rolling.   Still extremely sore in shoulder and face and wicked migraine.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Medical history, concurrent conditions, and concomitant medications were not provided. On or about 14-MAY-2012, the patient was inoculated (by an unspecified person) with ZOSTAVAX at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles (dose, route of administration, site of administration and lot # were not provided). The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 30-MAR-2016, she was treated (by an unspecified healthcare professional) at a medical group for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, or shingles. 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. The outcome of the events was unknown. The lawyer felt the events were related to ZOSTAVAX. Additional information has been requested.
Swelling and soreness in deltoid lasting three days; minor redness at site lasting two days.
Received vaccine on 09/20/2002. Has chicken Pox illness 06/26/2003
2 days sick with aches and weakness.  Arm swelling and rash with pain, headaches, fever, chills, tired.
pt vax on 10/23/98 & on 11/4/1998 pt exp a high fever, 104 with no rash reported.
numbness heaviness that started in my legs and spread up into my buttocks.  The following days it spread into may arms and  abdominal area including my head. Numbness feeling. I could still walk and had good strength, but was falling  and light headed.
I developed a rash a week after the dose.  Went to urgent care and diagnosed allergic reaction.  Gave me Prednisone 20mg tablet 3 tablets by mouth daily for 3 days and reacting correctly
fatigue, fever, chills, sharp pain behind eyes, ears, throughout head.  generalized severe body aches.