chrisvoncsefalvay/vaers-outcomes huggingface dataset:
even though I had all my shots, I develop the COVID Virus; even though I had all my shots, I develop the COVID Virus; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 87 year-old patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "even though I had all my shots, I develop the COVID Virus". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  Reaction event as reported by primary source for translation: taking the Paxlovid; I see on the list that may be a reaction, it says something about simvastatin; Unknown if patient is taking both medications  Additional Context: Concern: Consumer stated, "I was prescribed the Paxlovid by my doctor because I develop, even though I had all my shots (Further clarifications unknown hence captured as Unspecified Shot), I develop the COVID Virus. I am 87 years old (Not clarified hence not captured) and I have been taking the Paxlovid but one of the medication I see on the list that may be a reaction, it says something about simvastatin (Further clarifications unknown if patient is taking both the medications hence Paxlovid and Simvastatin captured as suspect conservatively), Am I correct?" Consumer was informed about role of Pfizer Drug Safety. Consumer was informed about the Pfizer Medical Information department and telephone# was shared as withheld, option 3, 8 AM to 9 PM, Monday to Friday, as per EST. Further Questions: Consumer stated, "Right now I have some company here and I have just (incomplete sentence)." Product details (Expiration date, NDC# UPC# and Treatment) and Pharmacy details could not be probed as consumer was unwilling to share further information. Hence further probing could not be done. Limited information available over the call.QR Comment: Reporter type  could not be probed hence captured by default as Consumer or other non-health professional in tab.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
Patient received Pneumovax injection on 10/11/06. He called in on 10/12/06, reporting he woke up with left arm swelling and soreness. Patient thinks arm is "almost twice normal size". No redness or fever. MD recommended acetaminophen for pain, diphenhydramine and ice pack. Patient was advised to come to ER/UCU for evaluation if no better/worse.
Initial unsolicited report received from a consumer (herself) on 28-Nov-2017. This case involves a 63-year-old female patient, who was vaccinated with 0.5 ml dose of ADACEL injection once (batch number, expiry date, dose in series were not reported) via intramuscular route in the left deltoid on 01-Sep-2017. Patient medical history and concomitant medications were not reported. On an unknown date, the day after the vaccination, the patient was tired, had flu symptoms, fever, headache, drowsiness and pain in left arm down to hand. She felt a lump in the shoulder at injection site. Also reported that no other vaccines were given on that day. Lab data and corrective treatment were not reported. Outcome of all the events was not recovered at the time of reporting. List of documents held by sender: none.
As reported, the recipient/patient who is approximately 7 months pregnant, collapsed while in the shopping mall which resulted in death.
Approx 11 hrs after vaccination pt ha a 1st time generalized tonic-clonic seizure of upper extremities x 10 minutes. Admitted to hospital x 24 hrs. EEg negative, blood work normal. Will be scheduled to have x 24 hr video EEg and seen again by peds neurology.
Initial pregnancy report received from a healthcare professional on 18 April 2013. A 18-year-old female patient, had received intramuscular first dose ADACEL vaccine batch number U4384AA, in right deltoid on 17 April 2013. The patient's health during pregnancy and risk factors (e.g.: alcohol, tobacco or recreational drugs) were not reported. The patient received vaccine during pregnancy. The patient's last menstrual period date was not reported. The expected date of delivery (EDD) is unspecified date in June 2013. On 17 April 2013, the gestational age was 30 weeks and 6 days IUP. The patient did not experience any adverse event. Follow up information received from a healthcare professional on 26 August 2013: The patient had on pregnancy previously and had delivered one live birth. The patient had taken multi prenatal vitamins tablets daily and had no illness at the time of vaccination. The patient was treated for positive Chlamydia on 27 February 2012. Father's health status was not disclosed. The patient was healthy with no concerns during pregnancy. The patient's last menstrual period date was on 10 September 2012 and the estimate4d date of delivery was reported as 17 June 2013. The laboratory test results were within normal limits. No genetic testing/screening were done or noted in patient's medical record. No treatment for infertility was done. On 18 June 2013, the patient delivered a single male baby (at 39th week of gestation of unknown weight and unknown height) with no congenital abnormality. The mode of delivery was vaginal. The Apgar score was 8 at 1 minute and 9 at 5 minutes. List of documents held by the reported: None.
chills, fever, congestion, extreme tiredness, swelling and pain at injection site, swelling of fingers, swelling under arm
Fatigue after 3 hrs. Then Starting about 10 hrs after shot. Severe Body aches,  fever ( not high and only lasted 2-3 hrs), nausea,. The body aches lasted 3 days and the worst were the first 48 hrs. Fatigue lasted over a week.
Vaccine administered after temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion). On 02-Apr-2021, PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that there was a power outage on 02-Apr-2021 and vials were in freezer and refrigerator where Temperature dropped to -13.79 C for 47 minutes and 12 C for 59 minutes respectively.  No concomitant products were reported.  No treatment information was provided.
Chills, fatigue, headache, muscle contraction, muscle soreness, weakness , nausea , lightheaded.
They worsened after my second dose; Swollen lymph node right axilla; This spontaneous case was reported by a consumer and describes the occurrence of CONDITION AGGRAVATED (They worsened after my second dose) and LYMPHADENOPATHY (Swollen lymph node right axilla) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A and 011M20A) for COVID-19 vaccination.     Concurrent medical conditions included Spider bite, Drug allergy (Uribel), Drug allergy (Ciprofloxacin), Drug allergy (Propofol), Tendonitis (Biceps Tendonitis) since June 2019, Impingement syndrome since June 2019, Blood pressure increased (elevated blood pressure) since 2003, Constipation (Occasional Constipation), Fibrocystic breast and Shoulder arthritis (Left shoulder issues) since June 2019. Concomitant products included LISINOPRIL for Blood pressure increased, MACROGOL 3350 (MIRALAX) and DOCUSATE SODIUM (COLACE) for Constipation, MULTIVITAMIN [VITAMINS NOS] for Vitamin supplementation.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CONDITION AGGRAVATED (They worsened after my second dose) and LYMPHADENOPATHY (Swollen lymph node right axilla). At the time of the report, CONDITION AGGRAVATED (They worsened after my second dose) and LYMPHADENOPATHY (Swollen lymph node right axilla) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Mar-2021, Ultrasound scan: two lymph nodes under my right axilla (abnormal) two lymph nodes under right axilla.. On 04-Jun-2021, Mammogram: one lmph node had gone away while one lymph node r (abnormal) one lmph node had gone away while one lymph node remained on ultrasound that had shrunk in size. On 04-Jun-2021, Ultrasound scan: one lymph node had gone away (abnormal) one lymph node had gone away while one lymph node remained on ultrasound that had shrunk in size when compared to ultrasound done on 3/4/21..         On June 04, 2021 Mammogram was done.  No treatment medications were provided.   This case was linked to MOD-2021-240549 (Patient Link).
He received the J&J vaccine on 8/16/21. After this he developed constipation and  then diarrhea. He also had severe pain in his neck and back. This was so painful  it prevented him from sleeping. Two weeks later he developed sudden weakness in  his legs and arms and difficulty walking. He also developed numbness in his  hands and feet. He was very unstable on his feet and fell multiple times. This  did not progress. He also notes tremor when he moves his arms and feet. About one month  ago he presented to an outside ED with worsening left neck numbness and left  facial droop. He had double vision as well. These symptoms self-resolved and he was not admitted. The weakness and  numbness did not resolve though. Lower extremities are weaker. He states  whenever he moves them he has painful paresthesias that travel up his limbs.
Patient experienced vasovagal syncope following administration of Trumenba (Meningococcal Serogroup B) vaccination into his right deltoid. After lying with his feet in the air and taking sips of water, the patient was able to leave.
pt with anxiety after vaccination c/o sensation of palpitaitons  and dizziness . pt brought to observation where vital signs were  pulse of 111 and blood pressure of 198/109. pt reclined in slight trendelenburg  and monitored in a quiet low lit room. exam by physician pt with good coloration  cardiac reg rate and rhythm  peripheral pulse strong. .  pulse and blood pressure decreased without need for medication of fluids. pt at time of discharge feel well. final pulse 80 and final blood pressure 178/95 (pt with h/o hyptension) no orthostatic changes
Complained of not feeling well am of 09/25/03 - Had a temp of 101 degrees along with dizziness and slightly swollen left arm.  patient stated left arm was warm to touch - stated symptoms only lasted 24 hours.  Took 2 Extra Strength Tylenol tabs for fever.
pt recv vax;itchy;rash noted behind ears,upper arm & around neck;pt will take DPH & pred;lips chapped;rt arm sl reddened at inject site; lt arm feels sore & tongue feels funny;denies resp problems; instructed to seek med attention;
dizziness, lightheaded, chills in head and body, nausea, elevated blood pressure, frightening odd feeling all over, fatigue
At the injection on day 2, the area was raised, red and warm to touch. At day 3 it was no longer raised. At day 4, it was better.
Pt came to clinic to consult of her reaction to varicella vaccine. She has 3" X 4" size redness, swelling and pain on left upper arm. Claims size of redness is smaller today. Applied Caladryl for itching and relief. Advised cold compresses, cortisone cream to site and observe for severity of symptoms.
pt recv vax 950AM;around 10:02 AM pt observed to be very pale;pt stated not well;color was poor & rapidly changing placed on mat;BP very low & not recorded around 64/40;unable to get radial or brachial pulse;911 called;epi given;
Vaccinated with AFLURIA 2009-2010 formula noon 09/16/09. By early evening hard 4 inch x 2 inch by 1 inch swollen area on deltoid an upper arm left. Next AM swollen lymph node left clavicle area 3. 5x2. 25 inch. tender to touch. No fever. Same afility 3 others have reported arm reactions with soreness, redness and warmth post injection.
Swelling/redness at site of Dtap right arm IM 4x5 cm induration - itchy and burning. Feels hot to touch.
One hour after receiving the vaccine, the patient started feeling poorly with some anxiety and what appears to her to be some involuntary body movements she has no history of ms/neuro issues.
Red at injection site and warm (hot) and achy, hard red area 3" diameter around injection site. 11-14-15 stills wollen, hard, and itching.
Dose received: 3/dose number = 3; Fever; Symptoms of rigors; Headache; Fatigue being more severe this time around; This is a spontaneous report received from a contactable reporter (consumer). The reporter is the patient.  A 47 year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administered in left arm, administration date 28Apr2021 at 18:00 (Batch/Lot number: EW0175) at the age of 46 years as dose 2 and BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administered in left arm, administration date 28Nov2021 at 09:30 (Batch/Lot number: 33038BD) at the age of 47 years as dose 3 (booster); for COVID-19 immunisation.  The patient's medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, DOSE 1, SINGLE, Lot number: ER8729, Route of administration: Unspecified, Anatomical site: left arm, administration time: 18:15), administration date: 07Apr2021, when the patient was 46 years old, for COVID-19 immunisation. The following information was reported: PYREXIA (non-serious), CHILLS (non-serious), HEADACHE (non-serious), FATIGUE (non-serious) all with onset on an unknown date in 2021, outcome "recovered" on Nov2021 and all described as ''fever, symptoms of rigors, headache and fatigue being more severe this time around''. Therapeutic measures were not taken as a result of events pyrexia, chills, headache and fatigue.  Additional Information: The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Fever, rigors, headache and fatigue did not happen with 1st dose. It happened after 2nd dose, but completely resolved in a day. With 3rd booster, completely resolved after day and half. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.
High temperature (100 degrees) and fatigue for 5 weeks. Temperature finally left but fatigue remains to this day. Then on May 22nd 2021 I had a severe attack of paracarditis. Had to go to emergency room. Could not breath terrible pain in head and chest and could not bend over with out feeling like I would pass out. Refered to cardiologist am now waiting on stress tests and echo cardiogram. Cardiologist not sure what's wrong or if I have heart or lung damage or if can be traced to the Covid episode with out further tests. Any suggestions?
Dizziness & Headache Narrative:  missed one day of work following second dose due to the above symptoms
Inflamed, sore, hot to touch, large raised knot at injection site and spanning across entire width of upper arm. Numbness, tingling, and pain in left arm and shoulder radiating to neck. Headache, fatigue, nausea, diarrhea, fever/chills.
Fever, projectile vomiting, diarrhea, rash in hair & all over torso, back, arms, legs & between toes, dehydration. Diarrhea for 3 days, vomiting x1. Rash x3.
Discharge Provider: DO Primary Care Provider: DO Admission Date: 6/5/2022 Discharge Date: 06/06/2022  DISCHARGE DIAGNOSES 1. COVID-19 positive 2. Toxic metabolic encephalopathy 2° #1. 3. HTN 4. BPH 5. ASHD 6. Mass or cystic lesion at the left T1-2 neural foramen.  MRI of the cervical and thoracic spine with and without contrast recommended outpatient.  HOSPITAL COURSE 88-year-old gentleman presented 6/5 with increasing fatigue and unsteady gait for two days.  Baseline is being very active and working full-time providing line care and delivering food.  Home COVID test positive 6/4.  Family noted that he appeared short of breath.  Seemed somewhat confused compared to his baseline.  Family brought him in for evaluation.  CTA head and neck was unremarkable.  CT head showed age-related atrophy but no stroke.  Chest x-ray negative.  He was not hypoxic.  Due to his weakness and some confusion he was admitted.  Admitting physician chose not to start antiviral therapy.  Did not require steroids.  The following day he was up and ambulating about the room independently.  No chest pain or shortness of breath.  Felt well and wanted to go home.  He is stable for discharge at this time.   Family asked about antiviral therapy.  I explained that the oral antiviral medications are not available to inpatients within Spectrum.  First day of symptoms was 6/4, and if his PCP feels that oral antivirals are appropriate, he is still within the window to get this.
Headache, Sedation, Myalgia, Arthralgia, Rash,  Chills Narrative:  Other Relevant History:
Patient presented to the ED and was subsequently hospitalized for GI hemorrhage with melena within 6 weeks of receiving covid vaccination.
small amount of pain at the injection site of left shoulder; experienced small amount of pain at the injection site of left shoulder; not going to be a very productive day and that was the case; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 58-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number: ER8735, Expiry date: unknown ) (age at the time of vaccination was 61 years), via an unspecified route of administration, administered in Arm Left on 22Apr2021 around 13:00-13:30 as dose 1, single for COVID-19 immunization. Medical history included, had positive COVID-19 test from exposure that occurred between best guess 25Nov2021-30Nov2020. Had no symptoms and had digital thermometer was periodically taking temperature even though had no symptoms, works from home-took test because it was close by at the apartment complex, but was completely asymptomatic. Acute Bronchitis as a child from an unknown date and unknown if ongoing. Other vaccine prior to COVID vaccine with in 4 weeks was reported as second dose of Shingrix Vaccine shot, 2 weeks and 1 day prior to first Pfizer COVID-19 Vaccine. Lot/NDC/Expiry: Unknown, caller does not have this information on hand, unknown if lost the paperwork. Shingrix Vaccine second dose vaccine hurt a lot, but he was fully recovered from the Shingrix Vaccine and feeling fine by the time he got the first Pfizer COVID-19 Vaccine. Shingrix Vaccine first dose caller thinks was administered on 30Dec2020 or 31Dec2020: Lot/NDC/Expiry: Unknown, caller does not have this information on hand, unknown if lost the paperwork. The patient's concomitant medications were not reported. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number: EP7533, Expiry date: unknown ) (age at the time of vaccination was 58 years), via an unspecified route of administration, administered in Arm Left on 02Apr2021 around 13:00-13:30 as dose 1, single for COVID-19 immunization. On 23Apr2021, when he woke up, the patient was anticipating that and told his manager basically not going to be a very productive day and that was the case. That was more than just a little bit of pain at injection site, it was not being able to work the entire next day. The patient completely recovered and would say by a day later. Treatment received included Advil, may be he should have taken Tylenol. The patient underwent lab tests and procedures, which included Covid-19 test in Nov2020: showed positive. The outcome of the event experienced small amount of pain at the injection site of left shoulder that was bypassed by his having felt achy the entire day like flu-like achy was resolved in Apr2021, and outcome of the events should pain and work problem was unknown.  No follow-up attempts were needed. No further information was expected.
low grade fever; chills; fatigue; This spontaneous case was reported by a nurse and describes the occurrence of PYREXIA (low grade fever), CHILLS (chills) and FATIGUE (fatigue) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M204) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Feb-2021, the patient experienced PYREXIA (low grade fever), CHILLS (chills) and FATIGUE (fatigue). In February 2021, PYREXIA (low grade fever), CHILLS (chills) and FATIGUE (fatigue) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were provided. The patient experienced low grade fever, chills, and fatigue which lasted for 36 to 48 hours.  No treatment medications were provided.   This case was linked to MOD-2021-023951, MOD-2022-580236 (Patient Link).
After monitoring patient for 15 mins he then returned to his office. Called around 30 mins or so later and stated he was experiencing itching all over body and extreme nausea. Employee health went to office to check on patient. Face did appear flushed, but no rash seen. Stayed with patient until he stated he felt better and no further issues.
Pt received first dose of Pfizer COVID-19 vaccine on 2/9/2021.  Pt developed COVID symptoms and presented to hospital, tested positive 2/25/2021 via SARS-CoV-2 PCR NP.   Symptoms: generalized fatigue and malaise, max temp 103, confusion with hallucinations, needed supplemental O2.  Admitted on 2/25/2021.
Petechial rash on left side of face and both sides upper back region with itching, worse on right side than left.
Information has been received from a nurse concerning an 82 year old male pt who on 21Oct03 was vaccinated SC with a dose of pneumococcal 23v polysaccharide vaccine. The nurse reported that the pt received a larger than 0.5ml dose of pneumococcal 23v polysaccharide vaccine. The exact amount is not known. The pt also developed an injection site reaction. The injection site became red, his arm swelled up, and he had difficulty sleeping. It was noted that his current state of health was unknown. Unspecified medical attention was sought. This report did not involved a product quality complaint. Additional information has been requested.
I sought chiropractic care, I lost range of motion in my left arm after my vaccine. I wake up in middle of night due to pain. Nothing natural has worked on my arm.
My average heart rate was between 60-70BPM, but two days after the second does of Pfizer, it elevated to 90-110 BPM accompanied with tiredness. No other symptoms as of now.
Redness, slight swelling, slight numbness extending ~3 inches around injection site. Noticed on 2/9, 8 days after vaccination. Took 25mg Benadryl on 2/9, symptoms began to lessen 2/10 and are almost gone at time of reporting (2/11).