chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Within 6 hours of injection client complained of severe pain at upper right arm. At 3:00am went to ER with complaint of 10/10 pain at right arm. No redness or edema. Was admitted on observation from 3am-9:30am, 10/14/08, then discharged. Was given one Lortab for pain and blood was also drawn. Provider states blood work was WNL. By 4:00pm, 10/14, husband states she is resting with only a soreness at arm.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 55-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Sep2022 as dose 5 (booster), single (Lot number: GH9693) at the age of 55 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (07Dec2022) Positive; (unspecified date) Positive; (06Dec2022) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19. If vaccine received: Yes. Other medication in 2weeks: No. Anti-viral details: On 27Nov2022 patient received Paxlovid for COVID 19 treatment till 01Dec2022. Conclusion of Previously Completed Investigation: The complaint for "PFIZER-BIONTECH COVID-19 VACCINE" was investigated. The investigation included reviewing the involved batch records, deviation investigation, an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot GH9693. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. (withheld) concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The NTM process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed.
APPROX 15" POST VACCINATION CLIENT REPORTED SHE FELT "DIZZY" AND LIKE HER "HEART WAS RACING" "ALL OF A SUDDEN"   SHE WAS ASSISTED TO A BACK EXAM ROOM TO LIE DOWN, FAN TURNED ON.  BP STABLE  HR ELEVATED 120'S  COMPLAINTS OF DRY MOUTH, SHAKING.    SHE WAS GIVEN 50MG OF BENADRYL IM.....AFTER CONSULTATION WITH OUR MEDICAL DIRECTOR AND CONTINUED FEELING LIKE HER HEART WAS RACING AND FEELING SHORT OF BREATH. THIS CLIENT WAS TRANSPORTED TO THE LOCAL ER VIA EMS.   CLIENT REPORTS LATER THAT AFTERNOON THAT SHE WAS BETTER AND "FELT GREAT:"..... NEXT DAY WAS THE SAME REPORT, CONTINUING TO TAKING BENADRYL PO.
Initial itchiness at local injection site. Later that evening, spots were noticed on patient's face which later spread to both arms and face the next day. Spots became blister, hives and whelps also developed. The patient contacted her doctor, which he was out of town, but prescribed her steroid, which she did not take. She took BENADRYL and used CALADRYL lotion since the spots developed and it had helped. Symptoms have improved since then.
SEVERE CHILLS; BEING INCREDIBLY HOT; GENERAL LIGHT HEADEDNESS; THIRSTY ALL NIGHT; URINATED (PEED) A LOT AT NIGHT; PAINFULLY CHAPPED LIPS; TIREDNESS; HORRIFIC HEADACHE; MAYBE SLEPT FOR 4 HOURS; This spontaneous report received from a patient concerned a 33 year old male. The patient's height, and weight were not reported. The patient's concurrent condition included obesity.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular) .5 ml, administered on 07-MAR-2021, around 11:30 am for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On MAR-2021, the patient experienced maybe slept for 4 hours. On 07-MAR-2021, the patient experienced severe chills. On 07-MAR-2021, the subject experienced being incredibly hot. On 07-MAR-2021, the subject experienced general light headedness. On 07-MAR-2021, the subject experienced thirsty all night. On 07-MAR-2021, the subject experienced urinated (reported as 'peed') a lot at night. On 07-MAR-2021, the subject experienced painfully chapped lips. On 07-MAR-2021, the subject experienced tiredness. On 07-MAR-2021, the subject experienced horrific headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from tiredness, severe chills, horrific headache, general light headedness, and being incredibly hot, and the outcome of thirsty all night, painfully chapped lips, urinated (peed) a lot at night and maybe slept for 4 hours was not reported. This report was non-serious.
Initial report received from a healthcare professional on 05-Nov-2013. A 42 year-old female received ADACEL (batch number: unknown, expiry date: unknown) intramuscularly in 2009. The patient's medical history and concomitant medications were not reported. In 2009, within 24 hours of vaccination the patient felt her jaw was tight and had joint pain throughout her body. At the time of this report the outcome of the events were resolved. Documents held by sender: none.
Dizziness - lasted a couple of hours Joint aches - approximately 2 days Muscle pain - approximately 2 days Extremely swollen lymph node in armpit of arm in which injection received - four days and remains swollen Headache - approximately a couple of hours
in 1997 pt was vax & subsequently pt exp a case of breakthrough varicella.
Pain in arm; difficulty raising his arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in arm) and MOBILITY DECREASED (difficulty raising his arm) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003811A and 0114C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Apr-2021, the patient experienced PAIN IN EXTREMITY (Pain in arm) and MOBILITY DECREASED (difficulty raising his arm). At the time of the report, PAIN IN EXTREMITY (Pain in arm) and MOBILITY DECREASED (difficulty raising his arm) outcome was unknown. Not Provided          No concomitant medications and treatment information were reported.
The evening after receiving my fourth dose of Pfizer, I noticed that I was having some itching in my left deltoid at the injection site. I also noticed a lump around the size of a quarter. I went to bed and when I woke up the next morning, the area had doubled in size, was red, hot, and itchy. I was also running a low-grade fever of around 100.6. I was having headaches and tiredness as well. I stayed in bed taking 600 milligrams of ibuprofen every six hours as needed. I also applied ice packs to the injection site. The next day, the area continued to grow. I had outlined the area with a marker to monitor the size. I sought treatment that evening after work. I was prescribed 40 milligrams of prednisone for 7 days and clindamycin. The doctor advised that I only take the clindamycin if things got worse. As a nurse, I did not take the clindamycin because it is more of a site reaction than an infection. I continue to take the prednisone. The sight is only slightly warm now and the redness has gone down. It does still itch, however. I continue to apply ice to the sight and have switched to TYLENOL.
The evening of receiving vaccines, the patient developed a fever of 102. For the next 6 days, she spiked temperatures from 101-105. She developed vomiting on day 2 and swelling of the injection site of the MMR on day 5. She was asymptomatic by day 8.
lots of covid symptoms; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date at SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported.  The patient experienced lots of covid symptoms on an unspecified date with outcome of unknown. Caller mentioned that she had "lots of covid symptoms" and that when she "asked the other girl" where the covid vaccine was manufactured "they told me I had to ask you".   Information on lot number/batch number has been requested.
Patient reported redness and lumpy swelling at the site of injection including occasional itching. Patient was advised to apply ice pack to the site and report to ER if symptoms get worse. Patient reported decrease in swelling and redness the following day.
09/15/2022 Awakened with moderate to severe headache, joint popping (crepitus) in all joints large and small including wrists and fingers bilaterally. Difficulty moving around, sleepiness. I also had a fever of 38.4 c. By mid-day had a hard lump about 5 to 7 cm diameter and redness larger than that over the injection area. That increased each day and finally today, 9/19/2022 the size of the hard lump is smaller. On Saturday 09/17/2022 my spleen was very enlarged and caused me a lot of pain when I would bend forward and my ribs put pressure there. I've had this happen other times and know it is my spleen. The size got smaller on Sunday. I can't feel it today. (I'm a healthcare provider and know how to assess this). The redness over upper left arm increased ever day, and now is a dark red color with several satellite papules, most of which popped open and drained (clear?) fluid. Four of them extended to my back. I have photos of my arm.
I wanted to pass along symptoms I had from the recent Shingles vaccination (dose one). We had the shot on Wednesday, March 7. Thursday I was fine, other than my arm was a little sore. Thursday night I had a severe case of shivers but did not check my temperature. Friday I felt fine other than a sore arm, but found that I also had a rash at the site of the shot. Do we expect similar results with the second dose scheduled for May?
Patient received Zostavax vaccine 10-15-07. Was seen in office 10-22-07, 10-25-07 for other medical symptoms, no report of difficulty from vaccine. On 10-29-07, pt. seen in our office for c/o rash @ (L) waistline, has L L2 dermatome red patches, vesicles. Was started on Valtrex 1.0gm tid, Vicodin, and tapering prednisone, to be f/u in 2 days.
A report has been received from a Pharmacist concerning a 53 year old, Male subject, who had been receiving FLUMIST QUADRIVALENT (intranasal). FLUMIST started on an unknown date. On 06-Jan-2014, the patient received expired FLUMIST QUADRIVALENT. The outcome of the event of patient received expired FLUMIST is unknown. The report was considered to be non-serious.
Client said she had fever and chills all night.  Did didn't notice anything at injection site but does have redness down arm today (10/21/10).  States she did not get out of bed to check actual temp and did not take any meds to relieve temp.  She did finally take an Aleve today.  Arm is no longer painful and she said it never did itch.  Encouraged her to see her doctor in case he wanted to give meds for potential cellulitis.
RASH ON WRIST; TIREDNESS; This spontaneous report received from a patient via a company representative concerned an elderly female. 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, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On MAR-2021, the subject experienced rash on wrist. On MAR-2021, the subject experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from rash on wrist on MAR-2021, and the outcome of tiredness was not reported. This report was non-serious.
Sudden hearing loss/loud ringing in right ear about 1 week to 10 days after 2nd injection
Redness on arm; hands numb/feet numb; swelling; right arm pain.
She was having headaches and dizziness the night after getting the shot. She also experienced pain at the injection site.
I am the treating Emergency Physician.  Patient received the new Dip/Tet/Pertussis booster vaccine from PCP at about 1630 on 1/17/07.  Then went to gym to work out.  Became weak and shaky w/sense of swelling in throat, anxious.  Came to ER for eval at 1906.  Found to be a physicially and mentally healty female with obvious tremor accompanied by mild myoclonic jerk.  Remainder of exam negative. Responded completely to Benadryl 12.5 mg IV.  Patient had vaccine name, but I did not copy it.  Records apparently available from PCP.
Approx. 4 hrs. after receiving Td booster (left deltoid), individual unable to lift left arm to manuever car. Next morning (8/19)arm swollen and tender to the touch. During the day (8/19)noticed enlarged left axillary lymph node with tenderness radiating to left breast.  That evening (8/19) individual experienced nausea, lethargy, chills and profuse clammy sweat and a temp of 102.6.  The next morning (8/20) individual awoke with a migraine-like headache (in addition to all of the afore named symptoms)unable to go into work.  This individual took alternating tylenol and ibuprofen throughout the day (8/20).  By bedtime, fever reduced to 99.0.  Individual returned to work today (8/21), still c/o left axillary and breast tenderness; left deltoid is swollen, warm and hard to the touch. Individual advised to notify physician if symptoms do not continue to resolve, or if immunization site becomes red and tender to the touch.
Patient was given Tdap instead of Dtap. Attempt to phone parent to inform that the dose needs to be repeated with the correct vaccine ASAP. No answer and VM was not set up to take messages. This writer will attempt to contact parent again today.
pt recv vax 20NOV96 & 11APR97 pt devel a severe case of chickenpox that consisted of several hundred vesicles on face, chest, back & arms;21APR97 pt recovered;
Mother called 9/7/06. Stated child had many hives. No difficulty breathing advised to give Benadryl.
This case was reported by a nurse to a sales representative and described the occurrence of arm pain at the injection site in a 54 year old female subject who was vaccinated with influenza virus vaccine (Fluarix) for prophylaxis. On 25 October 2005, the subject received the first dose of Fluarix (lot AFLUA154AA). Information regarding previous immunization with influenza virus vaccine was not provided. One day later, on 26 October 2005, the subject experienced arm pain at the injection site. As of 10 November 2005, the event remained unresolved. In the reporting nurse's opinion, the event was probably related to vaccination with Fluarix. Follow up - This case was reported by a nurse and described the occurrence of arm pain at the injection site in a 54-year-old female subject who was vaccinated with FLUARIX, GlaxoSmithKline. On 25 October 2005, the subject received a dose of FLUARIX in the right arm (lot AFLUA154AA). Information regarding previous immunization with influenza viruenza virus vaccine was not provided. At an unspecified time following the administration of FLUARIX. On 25 October 2005, the patient experienced arm pain at the injection site. The subject was seen at a physician's office. On an unspecified date in 2005, after 25 October 2005, the subject underwent "a CT scan and ultrasound." The results of these tests were not provided. The event was ongoing as of 19 December 2005. In the reporting nurse's opinion, the event was probably related to vaccination with FLUARIX. The nurse also reported that the injection of FLUARIX was "possibly administered too high."
This case was reported by a healthcare professional, via a GSK representative and described the occurrence of swelling injection site in a 4-month-old male subject who was vaccinated with PEDIARIX, (GlaxoSmithKline). Concurrent vaccination included HIB (non-gsk); Sanofi given on 9 March 2010; ROTARIX; GlaxoSmithKline given on 9 March 2010; pneumococcal vaccines (non-gsk); Wyeth labs given on 9 March 2010. On 8 March 2010 the subject received 2nd dose of PEDIARIX (.5 ml, unknown route, right thigh). On 9 March 2010, 1 day after vaccination with PEDIARIX, the subject experienced swelling injection site. The subject's right leg swelled to approximately twice the normal size. The subject was seen by a physician on 10 March 2010. On 11 March 2010, the event was resolved. The healthcare professional considered the event was probably related to vaccination with PEDIARIX.
felt dizzy, skin was cold; couple of hrs later had fever 102.8; Monday temp is back to nl; This happened w/1st odse;
A 7 month old baby was unintentionally given FLUARIX, intended for ages 3 years and older.
Facial numbness, tingling, and warming sensation on left side of face, neck, and down left arm. The symptoms lasted for two days.
Tested positive for COVID-19; Tested positive for COVID-19; This is a spontaneous report received from a contactable consumer.  A 67-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing), notes: Underlying issues; "High blood pressure" (unspecified if ongoing), notes: Underlying issues. The patient took concomitant medications. The patient takes unspecified medicines for diabetes, high blood pressure, and other medicines. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Tested positive for COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included nirmatrelvir/ritonavir (PAXLOVID) from 06Oct2022. Per clinical course, the patient and his wife had been so sick with whatever variant they got, and the wife successfully did not get COVID-19 (patient's wife was healthy). The patient and his wife were due for the booster and on the day, they were to get the vaccine, the patient got positive for COVID-19. The patient didn't know what was making him feel so bad. The patient needed the booster (as he is a PharmD in a hospital and university). When the patient's wife reported to her doctor's office last Thursday, the patient was positive the day before. The patient's wife stated why the hospital was not even worried and everyone in the pharmacy is coming down with COVID-19. The patient's coworker has this now and the people that worked here. The patient's wife was waiting for the Bivalent and the hospitals should vaccinate employees; she was waiting for the Bivalent and wasn't worried about COVID-19. The patient was 13 months out from his last booster and that didn't do him any good and the patient's wife was 10 months out. The patient has his vaccination card and probably had different vial. That's how the patient's wife got her vaccinations and don't think have same lot. The patient might have had 2 boosters and the wife was not sure.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient received 2nd dose of Pfizer vaccine on 04/02/2021. She then developed symptoms of runny nose, chills, and cough on 07/30/2021. Patient tested positive for Covid-19 on 08/02/2021.
Information has been received from a registered nurse concerning a 32 year old female consumer who on 16-APR-2008 was inadvertently vaccinated with zoster vaccine live (Oka/Merck) (lot # 659762/1874U) instead of with varicella virus live (Oka/Merck) (MSD). Concomitant vaccination included measles-mumps-rubella vaccine (Oka/Merck) (MSD). It was reported this was not product confusion, but human error. It was unspecified if medical attention was sought or if lab studies were performed. At the time of the report the patient's status was unknown. There was no product quality complaint involved. Follow-up information from the registered nurse indicated that the vaccine was administered to the patient at the end of the day and the nurse was tried. It was noted that the nurse was distracted because the patient had many questions. It was also noted that the nurse did not perform the triple verification of the label that is required by the facility. The registered nurse reported that she has spoken to the patient and the patient was "doing fine." Additional information has been requested.
pt recv vax & had a crying spell for 3hr;on the day p/vax pt was breastfeeding & presented w/head shaking & body shaking for 15-20seconds, became drowsy, fell asleep & as awoke about 5min later & behavior nl;
This spontaneous report was received from a registered nurse referring to an 11 year old male patient. The patient's concomitant medication, pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On 05-OCT-2017, the patient was vaccinated with either GARDASIL lot # N000326, expiration date 14-OCT-2019 or GARDASIL 9 lot # N000326, expiration date: not reported (strength, dose, dose number and route of administration were not provided) for prophylaxis which were improperly stored. This is one of several reports received from the same source. Sender's Comments: US-009507513-1709USA008666.
MD received a call from patient 1/2hr after receiving PNEUMOVAX in (R) deltoid that he is experiencing increasing pain in that area that is now excruciating. Describes dry, pins and needles in hand and fingers. Having trouble lifting arm. No rash, redness or swelling. No breathing problems and notes good color in tips of fingers. Provider advised pt to take hydrocodone for pain, and go to ED if symptoms worsen. Arm swelling occurred the next day. Pt to ice pack arm and go to ED if symptoms worsen. Range of motion in (R) shoulder reported decreased 2 days later. Symptoms fully resolved 9 days later.
Moderate headache, back pain, R arm muscle soreness, moderate fatigue, loss of appetite, hot flashes/chills alernating
Rapid Heart Beat Blurry Vision High Fever - Approaching 2 weeks Strong Dizziness/Vertigo Rashes Week long Headaches Hard to breath Ringing in ears Deep ache/pain in leg & arm with leg swelling
Patient noted the next day (Saturday 4-28-18) that her right arm was swollen, red, stinging and hurting.
Dizziness, Myalgia, lightheaded Reported that on 01/13/2021 he had lightheadedness, dizziness, and myalgia
This initial spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. There was no pertinent medical history, concurrent conditions, or drug allergies/drug reactions described. On 26-OCT-2015, the patient was vaccinated with improperly stored (Oka/Merck) VARIVAX (lot # L006386 with expiration date 25-FEB-2017; dose and route were not reported). No adverse symptoms were reported. It was unknown if the patient sought medical attention. Product quality complaint (PQC) was not involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Pt reports pain at site of injection (left arm; PNEUMOVAX 23) that radiates down his arm and across his shoulder blades.