chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pfizer Covid-19 vaccine administered on 04/01/2022 date has been determined to be outside of the recommended stability guidelines by Pfizer and the CDC and a repeat dose is recommended.
Pt complained of headache, lower back pain, left upper quadrant abdominal pain, nausea and fever of 102F by 16:00 on day of injections. Treated with ibuprofen or Tylenol for fever increase to 101F. Developed rash, 5 days, post vax.
Sore arm; fatigue; This is a spontaneous report from a contactable pharmacist (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced sore arm and fatigue in Jan2021 lasting 24 hours with outcome of recovered.  No follow-up attempts are possible. Information about Lot or Batch Number cannot be obtained. No further information is expected.
The next day pt felt very "sick", achy.  Took Tylenol.  2 days later arm became very tender, red, swollen, the size of a baseball.  One week later arm is still swollen & tender but redness is abating.
his left foot and left calf area and it looked like chickenpox / area on the right side of his torso that looked like chickenpox / chickenpox on the patient's left foot, leg and torso; itching on his left foot and left calf area; This case was reported by a consumer via call center representative and described the occurrence of varicella in a 63-year-old male patient who received Herpes zoster (Shingrix) (batch number 75P7G, expiry date 17th April 2022) for prophylaxis.   On 8th September 2020, the patient received the 1st dose of Shingrix (intramuscular). On 9th September 2020, 1 days after receiving Shingrix, the patient experienced varicella and pruritus. On 11th September 2020, the outcome of the varicella and pruritus were recovered/resolved.   It was unknown if the reporter considered the varicella and pruritus to be related to Shingrix.   Additional details were provided as follows: The patient reported himself. The patient reported that he received the first dose of Shingrix vaccine in the left arm.  The patient reported the second night after receiving the vaccine he started itching on his left foot and left calf area and it looked like chickenpox in those areas. On the following day the patient reported he had an area on the right side of his torso that looked like chickenpox. The patient reported he went to the doctor and the doctor confirmed it appeared to be chickenpox on the patient's left foot, leg and torso. The patient reported the chickenpox and itching resolved after about 2 days. The reporter consented to follow up with HCP.
Patient got Flucelvax on 10/17/2022. Expiration day of the vaccine was on 06/30/2022. RN failed to check expiration day before provided to patient. patient has no adverse effects, no discomfort or distress. Close monitor patient at dialysis clinic
"I" developed a dry cough /fatigue/congestion within 12 hrs of getting this vaccine; "I" developed a dry cough /fatigue/congestion within 12 hrs of getting this vaccine; "I" developed a dry cough /fatigue/congestion within 12 hrs of getting this vaccine; This is a spontaneous report from a non-contactable healthcare professional, the patient. A 25-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 30135BA) via intramuscular route of administration in the right arm on 15Sep2021 at 11:00 (at the age of 25-years-old) as a single dose for COVID-19 immunisation. It was unknown if the patient was pregnant at the time of vaccination. The patient had no medical history reported. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported.  On 15Sep2021, at 20:00, the patient developed dry cough, fatigue and congestion within 12 hours of getting this vaccine. It was also reported that these symptoms were still going on and it had been 4 days after receiving it. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures included treatment with benzonatate (MANUFACTURER UNKNOWN) 200MG capsule to help relieve the cough. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events developed a dry cough, fatigue and congestion within 12 hours of getting this vaccine was not recovered at the time of this report.    No follow-up attempts are possible. No further information is expected.
Numbness in hands and feet, dehydration, healthcare provider has given fluid for dehydration, constant headaches, constant urination.
noticed his fingers and toes turning red; itchy; peeling; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (noticed his fingers and toes turning red), PRURITUS (itchy) and SKIN EXFOLIATION (peeling) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-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 ERYTHEMA (noticed his fingers and toes turning red), PRURITUS (itchy) and SKIN EXFOLIATION (peeling). At the time of the report, ERYTHEMA (noticed his fingers and toes turning red), PRURITUS (itchy) and SKIN EXFOLIATION (peeling) had resolved.            No concomitant medication information provided.  It was reported after the first dose everything was fine and the adverse events resulted from the second dose got cleared up within 6 months.  No treatment information provided.   This case was linked to MOD-2022-568088 (Patient Link).
Information has been received from a registered nurse referring to a patient of unknown age and gender. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions reported. On 30-SEP-2015, the patient was vaccinated with ZOSTAVAX (0.65 ml, Lot#L024997, expiration date: 06-OCT-2016), which was improperly stored for 16 days (Incorrect product storage). The outcome was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Patient up to date on COVID vaccinations who admitted with encephalopathy likely r/t COVID.  Provider d/c note below:  "Patient came in with acute metabolic encephalopathy and sepsis.  Etiology likely COVID, but she also had sides of a urinary tract infection.  Patient was started on antibiotics and fluid.  Family came in and felt that since she had been bed ridden for at least the last 3 years that she should be made comfort care.  All treatment was stopped except for her treatment for bipolar disorder.  She was given Roxicodone and Ativan p.r.n..  Hospice was notified and family signed papers for her to return to the extended care facility with hospice.  The patient became much more alert despite not having treatment but agreed to go back to the extended care facility.  Her other baseline medications were continued on discharge since she was more alert and able to interact.  She was not given any further antibiotics though per family's request."  Of note, patient has since died, with date of death 03/28/22 on hospice services.
patient was given incorrect vaccine, Pediatric Bivalent Pfizer vaccine non-diluted 0.3ml IM rather than standard Grey top Pfizer Bivalent vaccine. No adverse effects have been reported.
NOSE BLEEDING; FEVER; This spontaneous report received from a parent concerned a 22 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, and batch number: 043A21A expiry: UNKNOWN) dose was not reported, administered on 03-APR-2021 14:00 to left arm for prophylactic vaccination. No concomitant medications were reported.  On 03-APR-2021, the subject experienced fever. On 05-APR-2021, the subject experienced nose bleeding. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on 04-APR-2021, and the outcome of nose bleeding was not reported. This report was non-serious.; Sender's Comments: V0:  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Right arm pain radiated to subclavian area. Burning sensation. BP 140/85 (pulse 65), O2 sat 99%.
J96.21 ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 5/14/2021 CKD STAGE 4 (GFR 15-29) J96.21 ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 5/14/2021 PULMONARY HTN J96.21 ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 5/14/2021 ASTHMA, UNSPECIFIED
Pt was discharge from the facility before second dose. Facility failed to provide patient with their vaccination card upon discharge. Pt is now lost to follow-up
Shot at 1:05pm, reaction at 1:15pm warmth down arm, tingling in forearm, numbness in ring finger, 1:35pm 97.9f, 169/100mmHg, 102bpm. 1:44pm 158/104mmHg, 99bpm. 1:58pm 160/103mmHg, 93bpm, 98% o2 sat. 2:07pm headache starting.
This spontaneous report was received from a physician refers to a patient of unknown age and gender. On 23-JUN-2015, the patient was vaccinated with improperly stored PROQUAD (Merck) lot # K025766, expiry date 08-JUN-2015. This one of the several reports received from the same reporter. Additional information has been requested. +
Systemic: Allergic: Rash Generalized-Medium, Additional Details: patient daughter reported adverse effects on the phone and they already spoke to a doctor. pt was prescribed zyrtec.
I was mildly nauseous for about 1 entire week after the vaccine, mainly in the mornings; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the left arm on 07Apr2021 at 11:00 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure and coarctaion of the aorta (repaired). The patient had known allergies to avocado and pineapple. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medication included hydrochlorothiazide (MANUFACTURER UNKNOWN); taken for unknown indication from an unknown date and unknown if ongoing. On 09Apr2021, the patient was mildly nauseous for about 1 entire week after the vaccine, mainly in the mornings. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event was mildly nauseous for about 1 entire week after the vaccine, mainly in the mornings was resolved on an unknown date in Apr2021.  No follow-up attempts are needed. No further information is expected.
Resident complained of being unable to move his right arm approx 10 minutes after receive vaccine.  Resident was able to move both arms and had equal strength in both hands. When asked about his arm pain, resident retracted and stated that he had chest pain. Facility staff was notified immediately and vitals taken and recorded as HR 78, BP 122/72, RR 20, SPO2 98%. Facility nurses resumed care if resident.  I have not yet received a call back from the facility for follow up. Left messages on 3/23/23, 3/24/23 and 3/27/23.
2hr p/vax pt noted by mom to be lethargic, limp, hypotonic & bluish color;
received the COVID-19 vaccine on 19Dec2020 and then contracted COVID-19/positive COVID-19 test after receiving COVID-19 vaccine; received the COVID-19 vaccine on 19Dec2020 and then contracted COVID-19/positive COVID-19 test after receiving COVID-19 vaccine; This is a spontaneous report from a Pfizer sponsored program Pfizer First Connect via a contactable consumer. A 22-year-old female patient receive bnt162b2 (BNT162B2, also reported as PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date were not reported), via an unspecified route of administration in left arm/deltoid on 19Dec2020 at 0.3 mL, single for Covid-19 immunisation (as protection). Medical history included ulcerative colitis. The patient's concomitant medications were not reported. On 28Dec2020, the patient was positive for COVID-19 test after receiving COVID-19 vaccine. She informed she contracted COVID-19 due to an exposure from a co-worker. The outcome of events was not recovered.  Information about lot/batch number has been requested.
Had a very strong, not anaphylactic reaction but, strong reaction to the Moderna vaccine; uncomfortability; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (Had a very strong, not anaphylactic reaction but, strong reaction to the Moderna vaccine) and DISCOMFORT (uncomfortability) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017F21A) for COVID-19 prophylaxis.     The patient's past medical history included Cancer (cancer survivor) in 2021. Previously administered products included for Product used for unknown indication: Pfizer (First Shot LOT: EL1283 NDC, EXP: Unknown) on 26-Feb-2021, Pfizer (Second shot LOT: EN6208 NDC and EXP: Unknown) on 19-Mar-2021. Past adverse reactions to the above products included No adverse event with Pfizer; and Sleep excessive with Pfizer.    On 26-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Had a very strong, not anaphylactic reaction but, strong reaction to the Moderna vaccine) and DISCOMFORT (uncomfortability). At the time of the report, IMMUNISATION REACTION (Had a very strong, not anaphylactic reaction but, strong reaction to the Moderna vaccine) and DISCOMFORT (uncomfortability) outcome was unknown.            No Concomitant medication was reported. Patient had some issues with Moderna and the Pfizer vaccines.  No treatment information was reported.   This case was linked to MODERNATX, INC.-MOD-2023-705591 (E2B Linked Report). This case was linked to MOD-2023-705318 (Patient Link).; Sender's Comments:  MODERNATX, INC.-MOD-2023-705591:Case for Most People
Significant teeth chattering, body shaking chills starting about 3:45 am  lasting about 1 1/2 hours and then fever of 101 next morning. Body aches and lethargic most of day
Pt. received Fluzone and Pneunovax on 11/16/07 both in Left Deltoid due to previous Right Mastectomy.  Approximately 5 AM on 11/17/07 Patient noted edema, increased warmth, pain, and redness to Left Deltoid, along with malaise, stiffening of elbow and shoulder joints and fever.  This continued throughout 11/17/07 and 11/18/07.  Patient presented to Health Dept today for evaluation of area.  Erythma extends to an area approx. 10cm X 15cm on L upper arm, with warmth and redness noted to area.  Patient states she feels slightly better today, and was instructed to take OTC Tylenol as needed for pain and/or fever, and to apply a thin layer of neosporin to area and cover with warm compresses to help decrease pain/edema.
Presented to hospital. Over the last month he noted some difficulty with some word finding.  States that it feels like the words on the tip of his tongue but he cannot find what he needs to say.  Additionally feels that his cognitive processing is a bit slower than normal.  Over the last 3-4 days he noted progressive foot numbness which was ascending.  This was described as ?cold and like my fingers were asleep ?.  Yesterday this significantly worsened with weakness all over that he could not work through.  Has had some spasticity in the upper extremities, poor coordination and now cannot do his ADLs or walk without assistance.  Also notes that his right eye feels delayed and motion though he has had no specific visual field deficit or blurred vision.  No other constitutional symptoms including fever chills or diarrhea.  Lumbar puncture was performed and IVIG was ordered.  Patient to receive a total of 2 grams/kilogram of IVIG over 5 days (400 milligrams/kilogram x5 days) Intubated during hospital stay. Diagnosed with Guillain Barre.
Myalgia, Arthralgia, Diarrhea Chills Narrative:
The same day of vaccination, about 8 hours later, soreness at injection site, fever above 100.4 - reaching 101.8 at the highest. Headache also started around the same time, the same day of vaccination. The next day, experienced full-body muscle soreness, continued fever and headache.
PT RECEIVED SHINGRIX ON 9/6/23 IN LEFT ARM AND WHEN HER CALLED US ON 9/12 HE STATED A FEW DAYS AFTER THE INJECTION HIS LEFT ARM SWELLED UP WHERE THE SHOT WAS GIVEN AND GOT HARD AND WAS WARM TO THE TOUCH. HE TOOK BENADRYL AND PUT ICE ON HIS ARM AND WHEN HE CALLED ON 9/12 HE STATED HE FELT FINE NOW
Information has been received concerning an 11 year old white male with no known allergies or past medical history on on 16-OCT-2006 at 18:00 was vaccinated SC in the right arm with a second dose of Varivax (lot # 654528/1044F). Concomitant vaccination included a first dose of Boostrix (lot # AC52b011BA) given IM in the left arm. There was no illness at the time of vaccination. On 18-OCT-2006 at 09"00 the patient developed redness and swelling at the site (actual site not specified), also reported as a localized allergic reaction. Unspecified medical attention was sought. No diagnostic tests or labs were performed. It was reported that the patient had not had any adverse events following prior vaccination. The patient recovered on 22-OCT-2006. Additional information is not expected.
had recent cad which could not be stented.  to er 4-25-23 and admitted with pneumonia, covid, cad, sepsis, ischemic cardiomyopathy deceased 5-9-23
Hospital with fracture of tibia COVID + 1/7 but not symptomatic at this time.   BOOSTER: 10/26/2021 Moderna LOT 036C21A L arm Intramuscular
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 26-JUN-2017, the patient was vaccinated with an improperly stored dose of GARDASIL 9 lot # M042853, expiration date: 17-JUL-2019 (dose, strength, route of administration was not reported) for prophylaxis. There were no adverse effects reported. The administered dose of vaccine experienced the temperature excursion of 47 to 77 degrees Fahrenheit for 105 hours. Data logger was not involved. There were no previous excursions reported. Additional information has been requested.
Headache, fever at 100 degrees per wife, started 2/26/2013.
Single seizure lasting about 15 mins. "Body stiffened, arms and legs were jerky and eyes went in different directions," and sleepy afterwards.
COVID-19; SEVERE STOMACH BURNING; DIARRHEA; REVACCINATION WITH DIFFERENT COVID-19 VACCINE; This spontaneous report received from a patient via other manufacturer (Pfizer) concerned a 20 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient was not pregnant at time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin, and batch number and expiry date were not reported) dose was not reported, 1 total administered at left arm on APR-2021 for covid-19 prophylaxis. The batch number was not reported and has been requested. Age at time of vaccination 19 years old. It was unknown whether patient had any adverse events following vaccination with first dose covid-19 vaccine ad26.cov2.s (dose number in series 1). The patient additionally received non-company suspect vaccine included: Pfizer and BioNTech(tozinameran) (dose number in series 2) ( form of admin, route of admin, and batch number and expiry date were not reported) dose was not reported, administered at left arm on NOV-2022 for covid-19 prophylaxis which was revaccination with different covid-19 vaccine. Concomitant medications included Mucinex (guaifenesin). On an unspecified date, the patient experienced covid-19 (dose number in series 2) and received non-company suspect drug Paxlovid for treatment (form of admin, route of admin, and batch number and expiry date were not reported) dose was not reported, administered from 04-JAN-2023 to 08-JAN-2023. On 04-JAN-2023 17:00, the patient experienced severe stomach burning, and diarrhea while taking Paxlovid (dose number in series 2). She went a few hours without taking her morning dose and felt relief from the gastrointestinal (GI) symptoms which she experienced. The action taken with covid-19 vaccine ad26.cov2.s, tozinameran was not applicable and for Paxlovid was drug discontinued.  The patient recovered from severe stomach burning, and diarrhea on 08-JAN-2023, and the outcome of covid-19 and revaccination with different covid-19 vaccine was not reported. This report was non-serious.
Pfizer-BioNTech COVID-19 Vaccine EUA Received Pfizer-BioNTech COVID Vaccines on 7/13/2021 and 8/10/2021. Arrived to ED 7/12/22 c/o progressively worsening SOB. Previously seen 7/7/22, dx'd w/COVID-19 PNA, and was COVID+ 10 days prior to ED visiti on 7/7/22. Placed on non-rebreather mask en route to hospital by EMS and hypoxia improved. Admitted to ED, O2 requirements progressed to Airvo. Pt removed Airvo and was found with O2 in 50s. Went into cardiac arrest and underwent compressions. Family decided to remove resuscitative measures. Pt expired 7/12/22. Pt given zosyn.
Pt reports that her menstrual cycles were thrown completely off and still are, (3 cycles in less than 1 month), and She had near psychosis, with ongoing mood disturbance. She is certain it isn't menopause
Rash; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series completed; unknown manufacturer), for COVID-19 immunization.  The following information was reported: RASH (non-serious), outcome "unknown".  Additional information: This report was not related to a study or program. Reason for no lot number: of COVID-19 vaccine: Complainant hung up abruptly/transfer incomplete. Consumer stated, "I just have a rash, I took the Pfizer booster (Pfizer COVID-19 vaccine) and then I got a rash. I was wondering how long rash last? will it go away?" Consumer was informed about the role of Pfizer Drug Safety department and Pfizer Medical Information department. Further probing could not be done as the consumer hung up the call abruptly. Hence, limited information available over the call. Reporter type could not be probed over the call hence captured by default as Consumer or other non-health professional.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.