chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Intense lethargy; tightness in chest; exertion/Some difficulty in breathing upon exertion; injection site bicep is still red; impairment prevented me from working; Muscle soreness at the site; extreme shaking; Could barely walk; Severe chills; This case was reported by a consumer and described the occurrence of injection site muscle pain in a 62-year-old male patient who received Herpes zoster (Shingrix) (batch number 3R45T, expiry date September 2022) for prophylaxis.   On 22nd December 2020 10:30, the patient received Shingrix (intramuscular) .5 ml. In December 2020, 14 hrs 30 min after receiving Shingrix, the patient experienced chills, tremor and walking difficulty. On 22nd December 2020, the patient experienced injection site muscle pain, injection site erythema and activities of daily living impaired. On 23rd December 2020, the patient experienced lethargy, chest tightness and exertional dyspnea. On an unknown date, the outcome of the injection site muscle pain, tremor, walking difficulty, lethargy, chest tightness, exertional dyspnea, injection site erythema and activities of daily living impaired were recovering/resolving and the outcome of the chills was recovered/resolved.   It was unknown if the reporter considered the injection site muscle pain, chills, tremor, walking difficulty, lethargy, chest tightness, exertional dyspnea, injection site erythema and activities of daily living impaired to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient administered the Shingrix vaccine at 10:30 AM. Initially experienced muscle soreness at the site but not much else. The patient went on a 7 mile hike without any issues.  The patient woke up at 1:00 AM (14.5 hours later) to severe chills. The patient reported that worst chills ever experienced. The patient could barely walk into bathroom due to chills and had difficulty opening Advil bottle due to extreme shaking.  Extreme chills lasted for 2 hours and then subsided. The patient experienced intense lethargy on 23rd December 2020. The symptoms included tightness in chest and some difficulty in breathing upon exertion. The degree of impairment would have prevented the patient from working. On 24th December 2020 at 3:04 PM after more that 52 hours, still the patient's injection site bicep was red 60 cm in all directions. Other symptoms were reduced, but still present at the time of reporting. The patient suggested increasing patient warning regarding possible side effects. The case was linked with the case US2020AMR256584 (wife's case).; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR256584:Wife's case
Approx. 20-25 minutes following flu shot, she experienced nausea, dizziness and tachycardia.
Pt received dose 1 of PfizerBiontech COVID Vaccine AT 1318. He was observed 30min without complaint and left without incident. He returned at 1356 c/o" throat and chest tightness." Upon assessment, wheezing is noted bilaterally. Resp Rate and Work of Breathing Within Normal Limits. Denies any other complaints and exhibits no further signs or symptoms. Albuterol/Atrovent Neb as well as IV Benaryl 50mg administered on scene and patient states his tightness is improving/resolving. Continues to denye further Complaints. Responding units Fire Department  and Ambulance arrive on scene and care handed over to crew. Assessments, care, and treatment continued enroute and patient transported to ED
Seriousness criteria- Medically significant event. Initial information received on 29-Mar-2019 regarding an unsolicited valid serious case received from a non healthcare professional by phone. This case involves a 56 years old female patient who was vaccinated with 0.5 ml once dose of FLUZONE QUADRIVALENT (Batch number: UJ011AG, expiry date, dose in series, route and site of administration were not reported) on 17-Jan-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported. On 24-Mar-2019, the patient developed a serious symptoms of flu which found to have Influenza type A (influenza) 2 months 7 days following the administration of FLUZONE QUADRIVALENT. This event was assessed as medically significant. On an unknown date, today is the first day the patient could get out of bed since falling ill (bedridden) following the administration of FLUZONE QUADRIVALENT. It was also a case of vaccination failure.These events was assessed as medically significant. It was reported that the patient went to urgent care last evening (28-Mar-2019). A rapid influenza nasal swab was done and she was found to have Influenza, type A. Corrective treatment was not reported. The patient outcome is reported as Recovering/Resolving for all the events. Documents held by the sender: none. Sender's Comments: This case involves a 56 years old female patient who developed Influenza A virus infection and was not able to get out of bed despite vaccination with FLUZONE QUADRIVALENT. Time to onset is not compatible and patient was tested positive for Influenza A, hence it was assessed as vaccination failure. The Patient's condition before vaccination or other underlying risk factors for influenza have not been reported. As with any vaccine, vaccination with Influenza vaccine may not protect 100% of susceptible individuals. Additional information regarding patient's immune status, infection status at the time of vaccination, confirmatory investigation results (details of specific strain identified in PCR) are needed to fully assess the case. Based upon the available information, the role of the vaccine or a case of vaccination failure cannot be assessed.
diluent used past expiration date, T014588 11/25/2022. No known ADR
Numbness in left arm where shot was administered.  Sensation started as a pinprick and now, the area is completely numb.
02/12/22 presents "as a direct admit" "for evaluation of R knee infection". PMHx of "ESRD on HD T,Th,Sat" "subclavian stenosis" "CAD w prior MI" "bradycardia" "PVD on low dose Xarelto 2.5 mg daily, prior DVT,  IDDM, BPH, HTN, HLD"
I started getting chills; my whole body was sore; Felt like the Flu minus the respiratory stuff.; Had arm pain that night; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received his second dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 vaccine; lot number: EL1283; expiration date: unknown), via an unspecified route of administration on 11Jan2021 at a single dose for covid-19 immunization. The patient received his first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 vaccine; lot number: EL0140; expiration date: unknown), via an unspecified route of administration on 22Dec2020 at a single dose for covid-19 immunization.  The patient's medical history concomitant medications were not reported. The reporter stated that the second dose was much worse. The patient had arm pain that night (11Jan2021) then about 16 hours post shot (12Jan2021), the patient started getting chills and his whole body was sore. The patient felt like the flu minus the respiratory stuff. The patient got home from work, did zoom meetings in bed, then slept until this morning and still feel kinda like crap but he was starting to feel better. It was mentioned that it was not reported if the patient had covid prior vaccination, if covid tested post vaccination was done or if treatment was received. The outcome of the events was recovering.
Vaccine given in Clinic on the 18th. No pain no issues then on 21 st started having nerves on my left leg firing during the day like I had a pinched nerve. Later that night I had lower back pain like sciatica nerve pain like 10/10 Tylenol 500 could not help added 400 md Motrin still no help got to 8/10. and also right hand finger next to the thumb was numb occasionally. I felt tightness on left hamstring area. Massaged it and all pain disappeared on the back  after a while. But since that incident I have been having lower leg bil never firing and occasionally same numbness on the same finger . Today got slightly worse as seems like my right  hand getting a bit more numb.
7 days after injection developed a tennis ball sized raised, red circle at injection site. Area is raised and warm to touch. Nausea and slight vomiting noted with this.
12 or so flea bite like non-blistered lesions on trunk. 2 or 3 on arms.
Information has been received from a pharmacist concerning a 79 year old male with drug allergies to RISPERDAL and LOVENOX who on 28-JUN-2012 was vaccinated intramuscularly with a 0.5 ml dose of PNEUMOVAX 23 (Lot# not reported). On 28-JUN-2012 the patient developed rash after receiving PNEUMOVAX 23. The patient saw physician to seek medical attention. No treatment was given. At the time of this report, the status of the patient was not known. No further information is available.
Information has been received from a physician concerning a 10 year old male who on 11/4/97 was vaccinated with a dose of varicella virus vaccine live. Subsequently, the patient experienced breakthrough chicken pox with 10 to 200 lesions and coinciding strept pharyngitis and cellulitis. Unspecified medical attention was sought. No product quality complaint was involved. No other information was available at this time. Follow up information indicated that there was no adverse event rather breakthrough disease (varicella) years after immunization - (as) with cellulitis and strep throat. The report indicated that a rapid strep test was positive. It was also reported that in March 2004 the patient developed disease with typical lesions > 100 and some with cellulitis - mild to moderate. Because the child had a high fever, a strep test was done and was positive. The reporter stated that the strep throat was incidental. He was treated with antibiotic and the patient recovered. The reporter considered the patient's varicella, cellulitis and pharyngitis to be other important medical events (OMIC). Information received on 4/30/04 contained the following adverse experiences: strep throat (March 2004).
Information has been received concerning a pt who on 1 day post vaccination complained of a swollen arm at the site of injection, welt in the same area which grew to the size of a golf ball. She complains of aches over entire body and fever of 100 F. The pt stated that she reported this to her physician.
Initial report was received 25 June 2009 from another manufacturer (document number 45220797), who received the report from a health care professional. A female patient had developed Guillain-Barre Syndrome and paralysis of her legs after she had received an unspecified influenza vaccination when she was a child. The patient's recovery status was not reported. No further information was available at the time of the report. Documents held by sender: None.
Tinnitus -----    both ears.  High pitched squeal around 8500 HZ.  all the time. Scheduled  to see an ENT on March 16.
Hives/swelling around eyes a little more than 48 hours from vaccine administration. Hives and swelling relieved by zyrtec (taken at 6:30PM) and completely disappeared the next morning after taking Benadryl at night before sleep.
Administration to a 76 year old patient; 1st dose on 7 july 2021 and 2nd dose on 21 sep 2021; Administration to a 76 year old patient; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 76-year-old male patient who received DTPa (Infanrix) (batch number 49tm3, expiry date 28th May 2022) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa (Infanrix) (batch number 49tm3, expiry date 28th May 2022) for prophylaxis and dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 21st September 2021, the patient received the 2nd dose of Infanrix and Infanrix Pre-Filled Syringe Device. On 7th July 2021, the patient received the 1st dose of Infanrix and Infanrix Pre-Filled Syringe Device. On 7th July 2021, not applicable after receiving Infanrix and Infanrix Pre-Filled Syringe Device and unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On 21st September 2021, the patient experienced inappropriate age at vaccine administration and drug dose administration interval too short. On an unknown date, the outcome of the inappropriate age at vaccine administration, inappropriate age at vaccine administration and drug dose administration interval too short were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The 76 year old male patient received 1st and 2nd dose of Infanrix, which led to inappropriate age at vaccine administration. The patient received 2nd dose later than the recommended time interval, which led to shortening of vaccination schedule. No further events were reported. The reporter consented to follow up.
Patient experiemced a severe migraine headache and chills approximately 12 hours after administration of vaccine. Continued until 4/6/2021 in the morning and was most severe 24 hours after administration. Patient no longer experieces headache ache or chills. Tingling sensation that feels like equilibrium is off started 4/6/2021. Also has tingly arms which started 4/6/2021.
diagnosed with COVID; fever; headache; fatigue; a little cough; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (a little cough), COVID-19 (diagnosed with COVID), PYREXIA (fever), HEADACHE (headache) and FATIGUE (fatigue) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     Concomitant products included ATORVASTATIN CALCIUM (LIPITOR) and ANASTROZOLE for an unknown indication.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jan-2021, the patient experienced COUGH (a little cough), PYREXIA (fever), HEADACHE (headache) and FATIGUE (fatigue). On 15-Jan-2021, the patient experienced COVID-19 (diagnosed with COVID). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, COUGH (a little cough), COVID-19 (diagnosed with COVID), PYREXIA (fever), HEADACHE (headache) and FATIGUE (fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Jan-2021, SARS-CoV-2 test: (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No laboratory details were  provided.  No treatment medications were reported.
pain in left arm on 6th day horrible tinnitus in left ear. went to doctor on 7th day. no ear infection doesn't know why its happening. also starting 6th day I was very exhausted for 4 more days. I'm on day 16 and the tinnitus is still really bad.
This spontaneous prospective pregnancy report was received from a nurse prescriber and a nurse, and refers to a 14 year old female patient. The patient had no concomitant or historical therapies, historical conditions neither drug reactions or allergies. Information regarding the patient's concurrent conditions was not provided. The patient's last menstrual period was on 30-SEP-2018. On an unknown dates, the patient was vaccinated with two separate doses of GARDASIL (route, anatomical location, lot # and expiration date were not provided) for prophylaxis. The patient became pregnant on approximately 14-OCT-2018. On 25-OCT-2018, the patient received GARDASIL 9 as the third dose in the vaccination series, 0.5 ml, intramuscular, once, lot # R016970, expiration date 22-MAR-2021, for prophylaxis (interchange of vaccine products) (wrong product administered)(exposure during pregnancy). On the same date, an urine pregnancy test was performed and the result was positive. The gestation period at exposure was 3 weeks. It was reported that on an unknown date, the patient was in a medical office for well child check. The estimated date of delivery (EDD) was on 07-JUL-2019. The pregnancy outcome was outcome pending.
red circle; itchy; heavy; stiff; warm; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (heavy), MUSCULOSKELETAL STIFFNESS (stiff), INJECTION SITE WARMTH (warm), ERYTHEMA (red circle) and PRURITUS (itchy) in a 93-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     Concomitant products included METOPROLOL, ROSUVASTATIN and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced LIMB DISCOMFORT (heavy), MUSCULOSKELETAL STIFFNESS (stiff) and INJECTION SITE WARMTH (warm). On 25-Jan-2021, the patient experienced ERYTHEMA (red circle) and PRURITUS (itchy). At the time of the report, LIMB DISCOMFORT (heavy), MUSCULOSKELETAL STIFFNESS (stiff), INJECTION SITE WARMTH (warm), ERYTHEMA (red circle) and PRURITUS (itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. Treatment details included Advil.   Reporter did not allow further contact
Orthostatic Intolerance; dizziness; headache; fatigue; This initial spontaneous report was received from a lawyer regarding a case in litigation referring to a 23-year-old female patient. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On an unknown date, the patient was vaccinated with Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) (exact dose, lot#, expiry date, route of administration and anatomical location were not provided) for prophylaxis. On an unknown date, the patient experienced orthostatic intolerance, fatigue, dizziness and headache. Reported date of injury was unspecified date in 2013. The outcome of the events was not reported. The lawyer considered all events to be related to Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL).   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2301USA006946:
Looked like I had some bruising; This case was reported by a consumer via interactive digital media and described the occurrence of swelling arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced swelling arm and contusion. On an unknown date, the outcome of the swelling arm and contusion were recovered/resolved.   It was unknown if the reporter considered the swelling arm and contusion to be related to Shingles vaccine and Shingles vaccine.     Additional details were reported as follows: Age at vaccination was not reported. The reporter received both dose of Shingles vaccines and reported to look bruised and the bruising took 3 months to go away. Consent to follow up was not possible as no contact details available.
Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Shakiness-Mild, Systemic: Tachycardia-Mild, Additional Details: Shortly after vaccine administration(~12 noon), pt had some SOB and \"tongue felt fat\", felt hot, dizzy. She had some Benadryl tabs and I told her to take 25mg DPH and she did.  She felt better, but I recommended that she should go to the ER or a walk in clinic.  She had a friend drive her home.  I called her at 3pm and she said she felt bad again on the drive home and she took another 12.5mg of Benadryl.  I recommended she go to the ER or walk-in clinic, again.  Called next day, she was OK>
On 8/21/21 with sore throat, cough, fever, chilld, body ache, headache, runny nose. Will quarantine for 10 days.
lower leg numbness from hips down; nerve damage on legs; muscle weakness; coordination problems; he is tripping; experiencing imbalance; uncontrollable muscle twitching all over body; This spontaneous case was reported by a consumer and describes the occurrence of NERVE INJURY (nerve damage on legs), MUSCULAR WEAKNESS (muscle weakness), COORDINATION ABNORMAL (coordination problems), GAIT DISTURBANCE (he is tripping) and BALANCE DISORDER (experiencing imbalance) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018B21A and 045B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure. Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Mar-2021, the patient experienced NERVE INJURY (nerve damage on legs), MUSCULAR WEAKNESS (muscle weakness), COORDINATION ABNORMAL (coordination problems), GAIT DISTURBANCE (he is tripping), BALANCE DISORDER (experiencing imbalance) and MUSCLE TWITCHING (uncontrollable muscle twitching all over body). On an unknown date, the patient experienced HYPOAESTHESIA (lower leg numbness from hips down). At the time of the report, NERVE INJURY (nerve damage on legs), MUSCULAR WEAKNESS (muscle weakness), COORDINATION ABNORMAL (coordination problems), GAIT DISTURBANCE (he is tripping), BALANCE DISORDER (experiencing imbalance), MUSCLE TWITCHING (uncontrollable muscle twitching all over body) and HYPOAESTHESIA (lower leg numbness from hips down) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient reported he was taking blood pressure medication.  No treatment medication was reported by patient.
Heavier period, longer period; More intense cramps; Lower back pain; Significantly higher ovarian cyst pain; Increase cyst pain in left breast; This is a spontaneous report received from a contactable consumer (patient herself). A 29-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0167, at the age of 29-year-old), dose 2 via an unspecified route of administration, administered in arm left on 08Apr2021 as single for covid-19 immunisation in pharmacy or drug Store. Medical history and concomitant medications were not reported. The patient had no known allergies sulfa. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on unknown date 13:45 (Batch/Lot Number: EW0153) as single for covid-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient did not receive any medications the patient received within 2 weeks of vaccination. On 17May2021, the patient experienced heavier period, longer period, more intense cramps, lower back pain, significantly higher ovarian cyst pain (on both sides now instead of just one) and increase cyst pain in left breast more frequent and intense. The patient did not receive the treatment. Post vaccination, the patient had not tested for COVID-19. The outcome of the events was not resolved.