chrisvoncsefalvay/vaers-outcomes huggingface dataset:
her legs were loose; feet tingling; Itching; leg pain; High blood pressure; like a chills wave from her feet upwards; body pain; injection site pain for 2 days; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (her legs were loose), PARAESTHESIA (feet tingling), PRURITUS (Itching), PAIN IN EXTREMITY (leg pain) and HYPERTENSION (High blood pressure) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No reported medical history.  Concomitant products included LEVOTHYROXINE, PRAVASTATIN, ALENDRONATE SODIUM (ALENDRONATE), TAMSULOSIN, METHENAMINE HIPPURATE, VITAMIN D3, VITAMIN B12 [VITAMIN B12 NOS], VITAMIN C [ASCORBIC ACID], MULTIVITAMIN [VITAMINS NOS] and PROBIOTICS NOS for an unknown indication.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced VACCINATION SITE PAIN (injection site pain for 2 days). On 27-Feb-2021, the patient experienced ASTHENIA (her legs were loose), PARAESTHESIA (feet tingling), PRURITUS (Itching), PAIN IN EXTREMITY (leg pain), HYPERTENSION (High blood pressure), CHILLS (like a chills wave from her feet upwards) and MYALGIA (body pain). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event NOS, at an unspecified dose and frequency and DESLORATADINE for Adverse event NOS, at an unspecified dose and frequency. On 27-Feb-2021, VACCINATION SITE PAIN (injection site pain for 2 days) had resolved. At the time of the report, ASTHENIA (her legs were loose), PARAESTHESIA (feet tingling), PRURITUS (Itching), PAIN IN EXTREMITY (leg pain), HYPERTENSION (High blood pressure), CHILLS (like a chills wave from her feet upwards) and MYALGIA (body pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
FEVER; WEAK LIKE GOING TO PASS OUT; DIZZY/CANT TURN HEAD; PALPITATIONS; SLIGHT BLURRED VISION; SLIGHT DIFFICULTY BREATHING; EXTREME JOINT PAIN; UNCONTROLLABLE CHILLS; HEADACHE; This spontaneous report received from a patient concerned a 44 year old male. The patient's height, and weight were not reported. The patient's past medical history included: brain tumor, and concurrent conditions included: migraine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211D21A, expiry: 11-APR-2022) dose was not reported, administered on 17-NOV-2021 for prophylactic vaccination. No concomitant medications were reported. On 17-NOV-2021, the patient experienced dizzy/cant turn head. On 17-NOV-2021, the patient experienced palpitations. On 17-NOV-2021, the patient experienced slight blurred vision. On 17-NOV-2021, the patient experienced slight difficulty breathing. On 17-NOV-2021, the patient experienced extreme joint pain. On 17-NOV-2021, the patient experienced uncontrollable chills. On 17-NOV-2021, the patient experienced headache. On 17-NOV-2021, the patient experienced weak like going to pass out. On 18-NOV-2021, the patient experienced fever. Laboratory data included: Body temperature (NR: not provided) 102 C. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from uncontrollable chills on 18-NOV-2021, was recovering from extreme joint pain, and had not recovered from dizzy/cant turn head, slight difficulty breathing, headache, slight blurred vision, fever, weak like going to pass out, and palpitations. This report was non-serious.
Dizziness especially in the morning; This is a spontaneous report received from a contactable consumer, the patient. A 63-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: EN6198) via an unspecified route of administration in the left arm on 05Mar2021 at 10:30 (at the age of 63-years-old) as a single dose for COVID-19 immunisation. Medical history included prothrombin gene mutation; being treated with warfarin 5 milligram. The patient did not have any allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included warfarin (MANUFACTURER UNKNOWN) 5mg for prothrombin gene mutation. The patient did not receive any other vaccines within four weeks prior to the vaccination. Since the vaccination, the patient had not been tested for COVID-19. On 20Mar2021 at 08:00, the patient experienced dizziness especially in the morning. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the adverse events. The clinical outcome of dizziness especially in the morning was not recovered. No follow-up attempts are needed. No further information is expected.
A patient received an expired vaccine , no AE; Initial information regarding an unsolicited valid non-serious case was received from other healthcare professional (Reference number- 00527670) and transmitted to Sanofi on 19-Mar-2021.  This case involves a one-year-old female patient who received an expired 0.5 mL of 3rd dose of IPV (VERO) [IPOL] (lot R1B251M and expiry date: 13-Mar-2021) via an intramuscular route in the thigh for prophylactic vaccination on 19-Mar-2021 (Expired product administered).  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   This was a case of actual medication error case due to expired vaccine used (latency same day).  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Fever of over 100. Chills, nausea. Over a 12 hour period.
itchy hands; itchy eyes; feels prickly; vision: car lit looks spikey with a lot of radiance; increase heart rate to 100bpm; BP reading of 90/52; O2 sat 92%; possible fever; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 07-Mar-2021 and was forwarded to Moderna on 08-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchy hands), EYE PRURITUS (itchy eyes), PARAESTHESIA (feels prickly), VISUAL IMPAIRMENT (vision: car lit looks spikey with a lot of radiance) and HEART RATE INCREASED (increase heart rate to 100bpm) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included Xorelto                                                        blood thinner, Benicar                                                        for hypertension, Hydrochlorothiazide                                            diuretic, Naproxen                                                       for inflammation, Paroxetine                                                     for depression, Crestor                                                        for cholesterol, Vitamin D                                                      supplemental and Calmeg + Zinc                                                  supplemental for an unknown indication.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced PRURITUS (itchy hands), EYE PRURITUS (itchy eyes), PARAESTHESIA (feels prickly), VISUAL IMPAIRMENT (vision: car lit looks spikey with a lot of radiance), HEART RATE INCREASED (increase heart rate to 100bpm), BLOOD PRESSURE DECREASED (BP reading of 90/52), OXYGEN SATURATION ABNORMAL (O2 sat 92%) and PYREXIA (possible fever). On 07-Mar-2021, PRURITUS (itchy hands), EYE PRURITUS (itchy eyes), PARAESTHESIA (feels prickly), VISUAL IMPAIRMENT (vision: car lit looks spikey with a lot of radiance), HEART RATE INCREASED (increase heart rate to 100bpm), BLOOD PRESSURE DECREASED (BP reading of 90/52), OXYGEN SATURATION ABNORMAL (O2 sat 92%) and PYREXIA (possible fever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Chest pain; Headache; muscle fatigue; joint pain; muscle pain; muscle cramps; arm soreness; dizziness; vertigo; blurry vision; tingly sensation in arm and leg; sharp toe pain; out of body experience; brain fog; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration in the right arm on 02May2021 at 14:15 (at the age of 41-years-old), as a single dose for COVID-19 immunisation. Medical history included hypertension and acid reflux. The patient did not take any concomitant medications. The past drug history was reported as no. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 02May2021 at 18:45, the patient experienced chest pain, headache, muscle fatigue, joint pain, muscle pain and cramps, arm soreness, dizziness, vertigo, blurry vision, tingly sensation in arm and leg, sharp toe pain, out of body experience and brain fog. The clinical outcome of the events chest pain, headache, muscle fatigue, joint pain, muscle pain, muscle cramps, pain in arm, dizziness, vertigo, blurry vision, tingling sensation, pain in toe, out of body experience and foggy feeling in head were not recovered at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Quite severe pain in neck, shoulders, and hips partially relieved by  Ibuprofen  and or Tylenol.
Symptoms acute onset day following vaccine administration (11/27/2021)  Presented to clinic with fever, shortness of breath, body aches, joint pain  on 11/29/2021 and found to have negative flu, strep and COVID rapid swabs. CXR obtained - positive for new pulmonary infiltrate.  Treated with steroids beginning on 11/30/2021 x 5 days  Patient to return on 12/3/2021 for repeat labs and evaluation
Incorrect route of product administration; The patient has complained of no other issues; This spontaneous report was received from a pharmacist referring to a male patient of 54 years old. Information about patient's pertinent medical history, concomitant medication and drug reactions/allergies was not provided.      On 17-AUG-2020, the patient received a dose of varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 ml  (lot # T000344 and expiration date 05-JAN-2022) via intramuscular route (Inappropriate route of vaccination) for prophylaxis. The patient did not complain of any other issues (No adverse event).
Myalgia, Fever, Chills, Back pain Narrative:  Other Relevant History:
Received Moderna vaccine on Moderna 1/12/2021  and 2/9/2021. MD note: 77M PMH COPD, AV block s/p dual-chamber PM, HTN, HFpEF, GI bleed w/ Mallory-Weiss tear, prior Tobacco use (60 pack-year), and BPH who presented with progressive SOB for ~2 weeks and was admitted on 8/29/2021 for acute hypoxic respiratory failure due to COPD exacerbation and COVID-19 PNA. Increasing o2 requirement 9/5, increase steroid dose 2/2 COPD exacerbation complicating picture w prolonged expiratory phase. BCx almost certainly contaminant d/c vanco. 9/6 increasing o2 requirements, increase steroid dose, escalate o2 tx as needed, if worsening over next 1-2days, consider palliative consult. 9/7 o2 requirements improving today cont high do Additional information for Item 18: 9/7 o2 requirements improving today cont high dose steroids and taper as pt improves, cont encourage IS and oob ambulation and proning as tolerated. 9/8 o2 requirements cont to improve, cont encourage proning and oob ambulation, titrate steroids as tolerated. 9/9 documented increase o2 needs overnight, however this morning pt v comfortable and satting well on NC, cont monitor o2 requirements cont steroids high dose, pt subjectively feeling much better today, hopefully cont to improve and wean to NC o2 low dose for d/c home in 3-4 days. 9/10 pt's strength cont to improving, cont encourage oob ambulation and self proning, o2 requirements remain high but intermittently can be tapered, would benefit from trial cpap at night for likely OSA. 9/11 o2 requirement cont improve today, still not on cpap at night, repeat request for trial cpap as pt likely w osa and confirming that he does not require high amt of O2 at night is imperative before d/c home. cont encourage oob ambulation/proning. 9/12 o2 requirements cont improve, pt w desats to 70s on ambulation, encourage oob ambulation ok to go home once out of 70s on exertion, likely tomorrow. 9/13 ambulating well w/o c/o, only minimal desats on room air with exertion (high 80s) acceptable to d/c w home o2 until desats resolve, d/w pt regarding staying in house vs o2 at home, o2 in place at home now, recommend pulse ox and slow weaning as tolerated, needs o2 at night 2-3L, close f/u PCP phone visit; pulse ox on d/c, return precautions discussed at length. cont prednisone taper, f/u pcp.
Flu like symptoms; Running a fever/feverish; Achy; nose issue; hurt really bad in my joints; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration in upper right arm on 29Mar2021 (at the age of 63-years-old) as dose 1, single for COVID-19 immunization. The patient's medical history was not reported. It was stated that patient has not taken anything else other than the vaccine and her daily medicine. The patient experienced flu like symptoms, running a fever/feverish, achy, nose issue and hurt really bad in my joints on 30Mar2021 14:00. Patient gave herself a Tylenol at night. Outcome of events was not resolved.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021376042 similar report from same reporter
Patient fainted, stopped breathing momentarily. She turned white, then red and her eyes rolled to the back of her head. The patient then became rigored and slid out of the chair. When she "came to" she started screaming and crying and was very disoriented and didn't know where she was.
2JUN93 pt began crying in the evening lasting all noc off & on; mom states gave pt APAP & called MD; mom states MD said no more pertussis;
Initial report received from a patient on 17 August 2007. A 46 year old, female (with a history of allergies to trees, grass, shellfish, mycins, sulfa, PCN) complained of sweating, chills, the night after she received her first dose of IMOVAX (lot number A0208-2, route of administration not reported) in the left deltoid and IMOGAN (lot number, route and site of administration not reported) on 08 August 2007. She did not have any illness at the vaccinations and was not any medications. She had not recovered. The patient also experienced adverse events after receiving the second and third dose of IMOVAX - these are detailed in cases 2007-02827 (second dose) and 2007-02828 (third dose). Follow-up information was received from a health professional on 24 September 2007, which included details and dates of administration for the patient's other IMOVAX vaccination. It was unknown if the patient had recovered from the events.
fever; bone pain; very strong reaction; temperature goes down but at times it shoots up strongly; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), BONE PAIN (bone pain), ADVERSE EVENT (very strong reaction) and BODY TEMPERATURE FLUCTUATION (temperature goes down but at times it shoots up strongly) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     No medical history was provided by reporter.  No concomitant medication reported.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PYREXIA (fever), BONE PAIN (bone pain), ADVERSE EVENT (very strong reaction) and BODY TEMPERATURE FLUCTUATION (temperature goes down but at times it shoots up strongly). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 500 milligram every four hours. At the time of the report, PYREXIA (fever), BONE PAIN (bone pain), ADVERSE EVENT (very strong reaction) and BODY TEMPERATURE FLUCTUATION (temperature goes down but at times it shoots up strongly) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant product was provided.
Redness at injection site, itching and swelling. The itching has gotten progressively worse over time?one week later and it is constant. I have put Benadryl cream on the arm and taken Benadryl tablets..
w/in 1 hrs of vax pt reported feeling lethargic, devel a h/a & backache; c/o all muscles in body hurt; having difficulty breathing & swallowing; temp rose to over 101;
Starting on day of immunization had pain post + ant. L shoulder, which has progressively worsened.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 69-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Sep2022 as dose 5 (booster), single (Lot number: Gj2524), in left arm and on 13May2023 as dose 6 (booster), single (Lot number: Gj3268) at the age of 68 years for covid-19 immunisation; bnt162b2 (BNT162B2), on 19Feb2021 as dose 1, single (Lot number: EL9264), in left arm, on 19Mar2021 as dose 2, single (Lot number: EN6207), in left arm, on 01Oct2021 as dose 3 (booster), single (Lot number: FE3592), in left arm and on 29Mar2022 as dose 4 (booster), single (Lot number: FJ9943), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hyperlipidemia" (unspecified if ongoing); "calcified coronary atherosclerosis w/o angina" (unspecified if ongoing). Concomitant medication(s) included: CRESTOR, start date: 04Feb2010, stop date: 19Sep2023. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Sep2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Patient received Paxlovid treatment from 19Sep2023 to 23Sep2023 and had no known allergies.; Sender's Comments: The efficacy of a vaccine varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine product to the reported events Vaccination failure and COVID-19 cannot be ruled out.,Linked Report(s) : US-PFIZER INC-202300314845 Same patient different drug/event;
pt had 2nd shingrix vaccine on 8/4/21 and contacted pharmacy 8/5 to inform us they had sore arm and it was red and swollen
After administration and returning to the waiting area, the patient's mother  called for my attention. She mentioned it looked like he was twitching but it didn't last more than 2 seconds. Patient said he began feeling lightheaded about 2 minutes after the administration of the vaccine. Patient looked pale but was responsive and talking. I had him lower his head between his legs for about 5 minutes. He was conscious the whole time. After about 10 minutes his color was looking better and he acknowledged he was feeling better. He had been sweating as well and his shirt was showing the sweat. After 20 minutes his color had fully returned and he said he was feeling much better. The patient left under his own power  with his mother and said he was good.
Patient received a COVID -19 vaccine and after vaccine had muscle spasm for more than 24 hours.
Developed a rash on 4/21/2021 after several days of muscle pain.  Was diagnosed with Shingles on 4/23 and prescribed Valtrex (took for 2 weeks).  Experienced significant pain associated with shingles from roughly 4/25 to 5/1.  Rash is still healing but largely scarred over.
Didn't feel well; Was achy for a couple of days/A sharp pain in her hand, her shoulders will have some pain, then eventually it goes away; it increased after the second dose as in the beginning it was in her feet and now it has increased to all over her body/a "nervey, numby, zapping, and tingling feeling" that she feels all the time; Miserable night and day/Constantly very uncomfortable; A little temperature; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Didn't feel well), MYALGIA (Was achy for a couple of days/A sharp pain in her hand, her shoulders will have some pain, then eventually it goes away), PARAESTHESIA (it increased after the second dose as in the beginning it was in her feet and now it has increased to all over her body/a "nervey, numby, zapping, and tingling feeling" that she feels all the time), FEELING ABNORMAL (Miserable night and day/Constantly very uncomfortable) and PYREXIA (A little temperature) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and 012M20A) for COVID-19 vaccination.     No Relevant Medical History was provided.  Concomitant products included VITAMIN D [VITAMIN D NOS], VITAMIN B12 NOS and SIMVASTATIN for an unknown indication.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MALAISE (Didn't feel well), MYALGIA (Was achy for a couple of days/A sharp pain in her hand, her shoulders will have some pain, then eventually it goes away), PARAESTHESIA (it increased after the second dose as in the beginning it was in her feet and now it has increased to all over her body/a "nervey, numby, zapping, and tingling feeling" that she feels all the time), FEELING ABNORMAL (Miserable night and day/Constantly very uncomfortable) and PYREXIA (A little temperature). The patient was treated with GABAPENTIN at a dose of 100 microgram. At the time of the report, MALAISE (Didn't feel well), MYALGIA (Was achy for a couple of days/A sharp pain in her hand, her shoulders will have some pain, then eventually it goes away), PARAESTHESIA (it increased after the second dose as in the beginning it was in her feet and now it has increased to all over her body/a "nervey, numby, zapping, and tingling feeling" that she feels all the time), FEELING ABNORMAL (Miserable night and day/Constantly very uncomfortable) and PYREXIA (A little temperature) outcome was unknown.