chrisvoncsefalvay/vaers-outcomes huggingface dataset:
excruciating headache; Fever; Chills; Muscle and joint aches; Muscle and joint aches; Weakness; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 49 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 27Aug2021 (Lot number: FC3183) at the age of 49 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Covid-19" (unspecified if ongoing), notes: I had previously had COVID. Concomitant medication(s) included: ZYRTEC. The following information was reported: HEADACHE (non-serious) with onset 2021, outcome "recovered" (2021), described as "excruciating headache"; PYREXIA (non-serious) with onset 2021, outcome "recovered" (2021), described as "Fever"; CHILLS (non-serious) with onset 2021, outcome "recovered" (2021), described as "Chills"; MYALGIA (non-serious), ARTHRALGIA (non-serious) all with onset 2021, outcome "recovered" (2021) and all described as "Muscle and joint aches"; ASTHENIA (non-serious) with onset 2021, outcome "recovered" (2021), described as "Weakness". Therapeutic measures were not taken as a result of headache, pyrexia, chills, myalgia, arthralgia, asthenia.  Additional information: The patient was not pregnant at the time of vaccination. After first dose the patient had excruciating headache, fever, chills, muscle and joint aches, weakness. These lasted about 14 hours. The patient had these symptoms after each dose even though she had previously had COVID. The patient did not received treatment for adverse event. The patient had no prior covid vaccination. The patient had not covid tested post vaccination.  No follow-up attempts are possible. No further information is expected.
Lymph nodes in my right armpit became swollen the day after my shot. It's now 3 days after my shot and my lymph nodes are still swollen.; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 19 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 27Aug2021 22:00 (Lot number: EW0191) at the age of 19 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose1, single, lot number= EW0191), for Covid-19 immunization. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 28Aug2021, outcome "not recovered", described as "Lymph nodes in my right armpit became swollen the day after my shot. It's now 3 days after my shot and my lymph nodes are still swollen.". The event "lymph nodes in my right armpit became swollen the day after my shot. it's now 3 days after my shot and my lymph nodes are still swollen." was evaluated at the physician office visit. Therapeutic measures were not taken as a result of lymphadenopathy.  Additional information: Patient had no known allergies. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.   No follow-up attempts are possible. No further information is expected.
weak; tired; feeling "generally unwell"; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 69 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 12Apr2021 (Lot number: EN6205) at the age of 69 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Blood pressure" (ongoing); "Gout" (ongoing). Concomitant medication(s) included: AMLODIPINE BESILATE taken for blood pressure measurement; ALLOPURINOL taken for gout. The following information was reported: ASTHENIA (non-serious) with onset Apr2021, outcome "unknown", described as "weak"; FATIGUE (non-serious) with onset Apr2021, outcome "unknown", described as "tired"; MALAISE (non-serious) with onset Apr2021, outcome "unknown", described as "feeling "generally unwell".  Additional Information: Patient reported that he received his first dose on Monday, 12Apr2021, and he has been feeling "generally unwell". He also reported that this feelings seems to "come and go". Stated he started feeling weak and tired about 2-3 days after he got the vaccine, maybe Tuesday or Wednesday. She is taking concomitant Amlodipine since 4-5 years and Allopurinol since about 5 years or more.  No follow-up attempts are possible. No further information is expected.
DIFFICULTY WALKING; DIFFICULTY MOVING; AFFECTED SPINE; AFFECTED VISION; AFFECTED ARMS AND LEGS; This spontaneous report received from a consumer concerned a female of unspecified age. 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, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced difficulty walking, difficulty moving, affected spine, affected vision, and affected arms and legs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from difficulty walking, difficulty moving, affected spine, affected arms and legs, and affected vision. This report was non-serious.
soreness; sinus headache; hyperglycemia; fever; Angioedema; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ANGIOEDEMA (Angioedema) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 immunization. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes since 01-Jun-2016, Hypertension, GERD since 2001 and Cholesterol since 2018. Concomitant products included PANTOPRAZOLE for GERD, HYDROCHLOROTHIAZIDE, VALSARTAN (VALSARTAN & HCTZ) for Hypertension, EMPAGLIFLOZIN (JARDIANCE) for Product used for unknown indication, ATORVASTATIN CALCIUM (ATORVASTIN), LYSINE, VITAMIN D3 and MELATONIN for an unknown indication, ZINC.    On 02-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ANGIOEDEMA (Angioedema) (seriousness criterion medically significant), FATIGUE (fatigue), ARTHRALGIA (soreness), PYREXIA (fever), SINUS HEADACHE (sinus headache) and HYPERGLYCAEMIA (hyperglycemia). At the time of the report, ANGIOEDEMA (Angioedema), FATIGUE (fatigue), ARTHRALGIA (soreness), PYREXIA (fever), SINUS HEADACHE (sinus headache) and HYPERGLYCAEMIA (hyperglycemia) had resolved.            Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
01/29/21 early AM shaking, fever chill, cough, fatigue.
1 week after administration patient has pain in arm at site of injection. She describes as muscle pain and sometimes a "shooting" pain that does not affect her all the time but with certain movements.
High fever (103 for 3.5 days), sensitive to light, tiredness  Same symptoms of FMF disorder
Pt received 1st dose Pfizer COVID vaccine on 4/20/21. Presented for 2nd dose on 5/12/21. Reports that 2 days after 1st dose, she developed a "fine, red, itchy rash on both arms". Reports she also had "swelling around the face and some rash". Denies any SOB or difficulty breathing or swallowing. Reports s/s lasted about 4 days and she did not seek medical care or take any OTC medications for s/s. Discussed risks of receiving 2nd dose. Advised to seek evaluation and discuss with PCP. Note requesting provider evaluation given to patient to bring to her PCP. Pt left facility on 5/12/21 without receiving 2nd injection.
Approx 7 days post vaccine, I developed a small jelly bean sized lump near my left clavicle.  Im not sure when it appeared, but I noticed it on 1/20/22 in the evening due to pain in that location and on the front on my shoulder near injection site. My seatbelt was rubbing on it.
Patient was given COVID Bivalent booster instead of COVID monovalent 2nd dose. Nurse contacted Nurse manager who spoke to Vaccine Coordinator who states patient can be given monovalent 2nd dose in 8 weeks to complete the series. Patient can then be given Bivalent booster (if desired) 2 months after 2nd dose. Patient was informed of error and understood. Patient will return to clinic in 8 weeks to get Monovalent 2nd dose. Patient left office.
Rotateq administered 4/4/08. Pt hospitalized 4/25/08 with intussusception which was reduced nonsurgically. Hospitalized x 3 days. 5/13/08-clinic notes received for DOS 4/4/08-well baby visit. DOS 5/5/08-F/U visit for past hospitalization for intussusception. Successfully reduced with 2 air contrast enemas which demonstrated successful reduction of intussusception. In clinic no C/O.  5/22/08-records received for DOS 4/23/08-Impression: Intussusception status post reduction air contrast barium enema. Presented to ED with vomiting began on day of seen in ED, vomitus is bilious and blood stained. Some bloody diarrhea. Lethargic and tired, decreased oral intake and normal urine output.
Swelling and redness around injection site.  Roughly the size of a baseball.  Along with pain and fever at injection site.
onset of fever same day as vax, fussiness, & cont crying & some lethargy;temp reached 107 the next day & then gradually receded;afeb 13AUG97 (1st day) rash onset 12AUG97 erythematous palpable, blanching lesions from scalp-legs;sl urticaria
31JUL92 pt recvd 1st dose of Engerix-B & that noc devel flu-like sx, high fever, dizzy & stumbling; took APAP & had recovered by the evening of 1AUG92;
Regionalized rash and hives, very itchy and raised looking like bug bites around injection site, down and under arm, down side, spreading to chest and stomach. Turned to raised, hard, dry bumps almost "scab" like within a week. Still slightly present as of 11/17/2009.
Patient called and reported her arm had a red welt at injection site and was slightly painful. She noticed it the night after the flu shot and it remained through the next day (this is when she called the pharmacy). I advised her to use and ice pack on the injection site to help with swelling and take an otc pain medication such as tylenol or ibuprofen if she needed.
DURING THE 20 MINUTE WAIT AFTER THE VACCINE, PATIENT REPORTED A TIGHTNESS IN HER CHEST AND WAS HAVING DIFFICULTY BREATHING.  WE CALLED 911 AND HAD THE PARAMEDICS CAME OUT.  WE KEPT OUR EYES ON HER BUT DID NOT ADMINISTER ANY MEDICATIONS AS SHE WAS TALKING TO US AND STILL ABLE TO BREATH ON HER OWN.  PARAMEDICS TOOK HER TO THE HOSPITAL FOR OBSERVATION.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown gender and age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 12-NOV-2016, the patient was inoculated with ZOSTAVAX by a healthcare provider as recommended for permanent prevention and protection against shingles and zoster-related conditions (dose, route, and lot # not provided). On an unknown date, the patient was diagnosed with shingles and/or zoster related injuries after and despite being inoculated with ZOSTAVAX vaccine and suffered serious mental and physical pain and suffering and required extensive medical care and treatment. On or about 14-NOV-2016, the patient was treated by a healthcare provider for shingles. As a further proximate result, the patient had suffered and would continue to suffer significant medical expenses, and pain and suffering, and other medical related expenses which includes but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was unknown. Causality assessment was related.
Patient reported tightness in lower midline jaw.  Vitals were taken : 15:40 BP was 157/91 (Right arm), pulse 79, and O2 sat 95%, BP taken again on L arm 175/119, BP taken again on right 154/96. Swapped cuff and vital taken again at 15:55 Right arm BP 164/105 and taken on Left arm 171/115, pulse was 63 and O2 sat 95%, Vitals were taken again at 16:05 with Blood pressure 179/131 on right arm and 70 pulse and 95% O2 and EMS was called for transport to Hospital. During this time destress techniques were utilized however pt appeared not to be in an anxious state.
After vaccination, felt tightness in throat, similar to GERD, and then had an anxiety reaction. Skin appeared flushed. BP elevated and pulse was regular, 120 beats. O2 saturation= 98%. With relaxation techniques pulse and BP came down, but skin remained flushed. Benadryl 50mg IM given in left deltoid by APRN.  At 5:30 pm, pulse was 85. Parents were contacted and arrived to clinic to drive the patient home. Advised to come accompanied by parent for dose #2.
Right side of face freezes (possible Bell's palsy) upon awakening from sleep; This is a spontaneous report from a contactable consumer (patient). A 57-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: ER20150), via an unspecified route of administration in right arm, on 12Apr2021 at 07:00 PM (19:00), at a single dose, for COVID-19 immunization. The patient had no medical history and concomitant medications. No other vaccine was administered in four weeks. On 13Apr2021 at 06:30 AM, the patient's right side of face freezes (possible Bell's palsy) upon awakening from sleep. No treatment was administered for the event. The patient has not been tested for COVID-19 post-vaccination. The outcome of the event was unknown.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 67 year-old patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 02Mar2021 15:45 (Lot number: EN4205) at the age of 67 years as dose 1, single for Covid-19 immunisation. Relevant medical history included: "Liver Resection Surgery", start date: 17Mar2008 (unspecified if ongoing), notes: Liver Resection Surgery: To remove Liver stones; "Ventral Hernia Surgery", start date: 12Nov2008 (unspecified if ongoing), notes: Ventral Hernia Surgery; "Ventral Hernia Surgery", start date: 04Feb2017 (unspecified if ongoing), notes: Ventral Hernia Surgery. There were no concomitant medications. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "recovered", described as "pain on the injection site". Relevant laboratory tests and procedures are available in the appropriate section. Additional Information: Prior Vaccination (within 4 weeks): None. Concomitant Drugs: None. Specific Relevant Test for Thromboembolic Events with Thrombocytopenia: None. Patient received the first dose of the Pfizer vaccine for the Corona-19 virus on left arm on 02Mar2021, patient felt some mild pain on the injection site afterwards for a few days but it went away. No follow-up attempts are possible. No further information is expected.
Positive for Covid-19; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of COVID-19 (Positive for Covid-19) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, the patient experienced COVID-19 (Positive for Covid-19). The patient was treated with Immunotherapy (MONOCLONAL ANTIBIOTICS) for COVID-19. At the time of the report, COVID-19 (Positive for Covid-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Apr-2021, SARS-CoV-2 test: positive (Positive) POSITIVE.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  The patient received treatment on 05 Apr 2021.
Event-Dizzy, unstable, vision blury, alomost lost vision in left eye complely, PTP5 cerebral artery blocked almost100% when previously was only 50% - 75% blocked  Treatment-Changed meds, added Eliquis and Repatha Outcome-Unknown for 3 monthes when he gets re-checked
doses administered after more than 1 temperature excursion; doses administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 014M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Feb-2021 at 11:27 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 27-Mar-2021 at 11:26 AM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 27-Feb-2021 at 11:27 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 80.73 for dose administered on 27-Feb-2021 and 80.81 for dose administered on 27-Mar-2021.  No concomitant medications were reported.  Batch number 019B21A underwent temperature excursion on 27-Mar-2021 with temperature 35 degrees Fahrenheit from 12:00 PM to 01:00 PM. This vial was moved to fridge on 23-Mar-2021 and beyond use date for the vial was reported as 22-Apr-2021. Product moved to clinic on 27-Mar-2021.  Batch number 014M20A underwent temperature excursion on 27-Feb-2021 with temperature 35 degrees Fahrenheit from 01:00 PM to 02:00 PM. This vial was moved to fridge on 24-Feb-2021 and beyond use date for the vial was reported as 26-Mar-2021. Product moved to clinic on 27-Feb-2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a traceable temperature monitor at every hour.  No treatment medications were reported.   This case was linked to MOD-2022-566976 (Patient Link).
30 minutes after injection Tingling in fingers  30 minutes after injection Feel cold 3.5 hours after injection  Sore arm 16 hours after injection Fever   19.5 hours after injection  Fever 102.2 22 hours after injection Congestion  23.5 hours after injection Joints: elbows fingers Knees hips back  24 hours after injection. Fever 103.6 24 hours after injection Cold hands  24 hours after injection  joints: Ankles  9 days after injection arm is bothering below injection site.
pt c/o SOB, throat closing;lungs were clear, color & temp nl, had labored breathing;pt completely alert & oriented;dx acute severe allerg rxn poss secondary to MMR vax;tx EPI & DPH, susphrine;
Per NP, when he looked back on yesterday, patient thinks he had difficulty with coordination for about one hour later in the day after getting vaccinated.  Patient states today had a black spot in visual field.  NP administered Acetaminophen, 500mg tabs x 2 for c/o mild headache.  Referred patient to Immediate Care for further evaluation and treatment.
Confirmed Breakthrough Case   COVID-19 (Pfizer) 1  02/11/2021 local County Health Department Pfizer EM9810   COVID-19 (Pfizer) 2  03/04/2021 local County Health Department Pfizer EN6201   COVID-19 (Pfizer) 3  09/28/2021 Pharmacy  Pfizer 301558A   COVID-19 (Pfizer-BNT 30mcg) 4  04/10/2022  Pharmacy  Pfizer FM0698
Diffuse  and somewhat linear raised papules and plaques on bilateral forearms, right worse than left. Color is pink to fleshy. rash is non-pruritic at this time and appears consistent with mild eczema/atopic dermatitis
12cm x 12cm area of redness, and induration at site of Prevnar + 4.
01/17/22 presents to ED for "low hemoglobin". PMHx of "ESRD on PD due to FSGS and on transplant list, HTN, cirrhosis, chronic anemia"
This spontaneous report as received from a nurse via Pfizer refers to a 4 month old male patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date the patient was vaccinated with PNEUMOVAX 23 (lot, expiry date, dose, frequency and route were not reported) instead of PREVNAR 13 for prophylaxis (wrong product administered). It was reported that, event did not take place after use of the product (no adverse event).
Found to have varicella zoster today when came in for rash.  Zoster present in C3 dermatome on left neck and posterior auricular area.
I received my Covid-19 10/29/2022. I started feeling sinus pressure on 01/16/2023. I also experienced body ache. Symptoms were severe for a few days. I contacted my doctor on 01/19/2023. I was diagnosed with Covid-19. I was prescribed PAXLOVID however I did not take it. Symptoms lasted about 4 days. Tested negative for Covid-19 on 01/28/2023.
Pt. had severe pain in (R) arm X 1-2 hrs post inj. Progressively delt started to swell and then pt noticed red, hard, raised areas around inj site. - No fever - Given SOLUMEDROL 125 mg inj in office and BACTRIM DS x 10d.
This spontaneous report as received from an administrator refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 09-MAR-2017, the patient was vaccinated with the improperly stored dose of M-M-R II (dose, route of administration, lot # and expiration date were not reported) for prophylaxis. No adverse symptoms were reported. The vaccines were exposed to the light varying from 1 to 6 hours. The administrator confirmed that only 3 patients received the vaccines (captured in MARRS # 1705USA002114 and 1703USA005830) and the rest of the doses were discarded. This is one of several reports received from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1703USA005830: US-009507513-1705USA002114:
The pt received the vaccine on 8/15/00. The pt notified the health department on 8/29/00 that she just learned that she is pregnant. She is concerned about possible side effects to the baby. She has no adverse events at this time.