chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a medical assistant reporting on behalf of a physician. This Medical assistant reported similar events for two patients. This is the first of two reports. A patient of unspecified age, ethnicity and gender received PREVNAR 13, via an unspecified route of administration on an unspecified date as single dose for immunization. The patients medical history and concomitant medications were not reported. The patient experienced fever and swelling on an unspecified date. The outcome of fever and swelling was unknown. Sender's Comments: Linked Report(s): US-PFIZER INC-2016596236 similar events and product, different patient.
This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Solution for injection, lot no. and expiry date not reported), via an unspecified route of administration on 13Jan2021 17:00 at a single dose (first dose) on left arm for covid-19 immunization.  The patient medical history was not reported.  There were no concomitant medications reported as well.  Patient has not received other vaccine in four weeks. Patient has no COVID prior vaccination.   Patient stated:"I received the shot (13Jan2021) at 5 pm and I could not sleep that night. I felt fine, but was awake until 9 pm the next day". The outcome of the event recovered on unspecified date. The patient has not tested COVID positive since vaccination. Information on the Batch/Lot number has been requested.
This spontaneous report as received from a physician refers to an approximately 25 year old female nurse with no pertinent medical history. On 01-SEP-2013 the patient was vaccinated with a dose of GARDASIL, injection (lot #, expiration, dose unspecified), intramuscularly in the lower aspect of the lateral side of an unspecified leg. In September 2013 the patient complained of pain and swelling when walking. Physician stated after the injectio non 01-SEP-2013, the nurse stated the injection site hurt and the pain had progressively been getting worse along with swelling. The reporter also stated that the patient had experienced a rash from amoxicillin (manufacturer unknown) and LEVAQUIN. No lab diagnostics studies performed. The patient sought medical attention via office visit. No treatment was given. The event outcome was reported as not recovered. Additional information has been requested.
Pain immediately at injection site. Tiredness, chills to the point I was shaking, using hand warmers and comforters with heat turned way up, pain in my arm that goes to my fingers and into my neck, head pain, then getting so hot I felt like I was burning, then freezing again, nausea and multiple trips to the bathroom.
Exhaustion starting around 7 pm and lasting until 4:00 pm the following day. Insomnia starting around 9:30 pm and lasting as long. Headache from 9:30 pm to 5 pm the next day. Tenderness around vaccination site from 2.5 hours after shot until present. Stabbing pain in muscle on other arm from 5 pm to 8 pm the following day. Nausea and lack of appetite for the whole day after the shot.
Flu Like Symptoms; Chills; Fever; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced influenza-like symptoms, chills and fever. On an unknown date, the outcome of the influenza-like symptoms, chills and fever were recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms, chills and fever to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced flu like symptoms, chills and fever that lasted for about 3 days after receiving dose of Shingrix. No further details were provided.  The patient was reporting event for herself, her friend, and her friends husband. This was 1 of the 3 cases, reported by same reporter.
pt recv vax 19DEC96 & 10JAN97 pt exp redness @ the inj site;no fever was noted;pt mom, who was not vaccinated w/vax also devel shingles (WAES 97012176);
This spontaneous report as received from a pharmacist (pharmacy manager) refers to a 66 year old female patient. The patient had none pertinent medical history. The patient had none drug allergies. On 31-MAY-2013 the patient was vaccinated with ZOSTAVAX (lot # J000495, expiry date 14-APR-2014) (strength and total daily dose not reported). The vaccine was administered by the pharmacist. Concomitant medications were reported as none. The pharmacist reported that on 06-JUN-2013, he received a phone call from the patient's physician stating that patient had an active case of shingles when patient received the ZOSTAVAX vaccination on 31-MAY-2013. Pharmacist reported that physician stated that patient had "full blown shingles" at the time of reporting. The patient sought for medical attention by visiting physician. Lab diagnostics studies performed were reported as none. The patient was not recovered. Additional information has been requested.
Fever: -resolved 4/1/17 Rash: -ongoing/improving Runny nose: Prior to immunization - resolved 4/3/17 Diarrhea: -resolved 4/3/17
Received TdaP vaccine instead of DtaP that was ordered. Office staff realized the error the next morning.
Muscle aches and heavy menstrual flow 3 weeks after 3rd dose; Muscle aches and heavy menstrual flow 3 weeks after 3rd dose; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  An adult female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (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: Bnt162b2 (Dose Number: 2, Brand: Pfizer Covid-19 Vaccine, Batch/Lot No: Unknown), for Covid-19 Immunization; Bnt162b2 (Dose Number: 1, Brand: Pfizer Covid-19 Vaccine, Batch/Lot No: Unknown), for Covid-19 Immunization. The following information was reported: HEAVY MENSTRUAL BLEEDING (non-serious), MYALGIA (non-serious), outcome "unknown" and all described as "Muscle aches and heavy menstrual flow 3 weeks after 3rd dose". The events "muscle aches and heavy menstrual flow 3 weeks after 3rd dose" required physician office visit. It was unknown if therapeutic measures were taken as a result of heavy menstrual bleeding, myalgia. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Received booster shot at 33 weeks pregnant. Symptoms included body aches, chills, sweats, sore throat, headache, and constricted chest. No issues with prior Moderna shots received at 3 weeks and 7 weeks pregnant.
Pt recv vax on 11/12/98;on 11/13/98 pt exp shortness of breath, LA pain, swollen/red eyes, tight chest, dizzy
Around 7pm left arm was sore and warm. At 3 AM woke up in excruciating pain on left side that was under ribs. Lowered the bed flat. Tried to get comfortable, couldn't. Had a hydrocodone tablet left over from a prescription given in March. Took one. No relief. Got up at 5:20 tried to eat my cereal and jaw hurt too much to chew and room started spinning. My husband had too almost carry me back to bed because I was in so much pain on left side. Took an Excedrin migraine, no relief, got up at 10AM in pain. Husband gave me one of his tramadol. Pain eased somewhat. Took a Tylenol at 2pm. Pain on left side only, lower ribs, inside body cavity to around the side to back.
No adverse event; 0.25ml dose administered instead of 0.5ml; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL UNDERDOSE (0.25ml dose administered instead of 0.5ml) and NO ADVERSE EVENT (No adverse event) in a 60-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 030G22B) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .25 milliliter. On 11-Oct-2022, the patient experienced ACCIDENTAL UNDERDOSE (0.25ml dose administered instead of 0.5ml). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (0.25ml dose administered instead of 0.5ml) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (0.25ml dose administered instead of 0.5ml).    No concomitant product was reported.  This case contains information for the 4th of the 14 patients described by the reporter.  No treatment information was reported.
Patient reports feeling lightheaded and hot. Patient noted to be sweating on his head. Denies sob, tongue swelling, or closing of throat. No rashes or hives noted. Patient initially denied pain. Initially BP is 144/96, HR99, O2 saturation is 95% on room air. Patient reports being diabetic and last time eaten was this morning. He states he also took Metformin and Glipizide. No glucometer available at this site. Patient given 3 bottles of 8oz water and small hard candy. Patient lightheadedness did not improve. And now he's feeling sleepy. 911 called. Paramedics and fire department arrived after a few minutes. Fire department checked patient's blood sugar and it was 280. Patient left via gurney with paramedics afterwards.
FEVER , CRYING STARTING AT 102 AT  5 PM 10/14/17 PROGRESSING TO 105. TAKEN TO ER, FEVER CONTROLLED WITH ALTERNATING MOTRIN & TYLENOL.
Chills, fever, severe pain in arm, aches all over, tired; Chills, fever, severe pain in arm, aches all over, tired; Chills, fever, severe pain in arm, aches all over, tired; Chills, fever, severe pain in arm, aches all over, tired; Chills, fever, severe pain in arm, aches all over, tired; This is a spontaneous report from a contactable consumer. A 63-Year-old male consumer (patient) reported that patient received Bnt162b2 (BNT162B2; Formulation: Solution for injection; LOT#: ew0183) via unknown route of administration from 20May2021 09:30 2nd dose on left arm for COVID-19 immunization, and Bnt162b2 (BNT162B2; Formulation: Solution for injection; LOT#: ew0175) via unknown route of administration from 29Apr2021 09:45 1st dose on left arm for COVID-19 immunization. Patient's medical history includes stroke 36 years ago, and no known allergies reported. Facility type vaccine includes doctor's office/urgent care. If covid prior vaccination no, no if covid tested post vaccination. It was reported that Chills, fever, severe pain in arm, aches all over, tired and no treatment received. The outcome of the events was recovered.  Follow-Up (12Jul2021): Follow-up attempts are completed. No further information is expected.  Follow-Up (27Jul2021): Follow-up attempts are completed. No further information is expected.
The patient has high pitch crying for 4 hours after his shots. Persistence of crying for 20 hours.
Migraine  Swollen axilla lymph nodes  Low grade fever 100 Chills
Entire left arm (side of vaccination) numb, including hand and fingers (unable to move), progressively worse over 10 minutes
Dose was a "booster" and not an "additional" 3rd dose. 0.5 ml of Moderna was given instead on 0.25 ml of Moderna
pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (pregnancy) in a female patient of an unknown age (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 19-Feb-2021 and the estimated date of delivery was 26-Nov-2021. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  first week of the pregnancy.  At the time of the report, EXPOSURE DURING PREGNANCY (pregnancy) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Received vaccine on 8/10/05. On 8/24/05 noticed cold symptoms. On 8/25/05 noticed rash.
Patient experienced being fidgety the following day after administration, then the day after experienced neck pain that progressed to the shoulder of the opposite arm that he received the vaccine. Patient stated since the, the pain keeps alternating from the right to the left side of his neck that shoots down to the same side of shoulder/arm, but not the same side daily, either one or the other side.
RECEIVED ONLY 2.5ML OF THE JANSSEN COVID-19 VACCINE; OFF LABEL USE; This spontaneous report received from a health care professional concerned a 22 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822809 and expiry: 07-MAR-2022) 2.5 ml, administered on 21-NOV-2021 for prophylactic vaccination. No concomitant medications were reported.  On 21-NOV-2021, the patient experienced received only 2.5ml of the janssen covid-19 vaccine. On 21-NOV-2021, the patient experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the received only 2.5ml of the janssen covid-19 vaccine and off label use was not reported. This report was non-serious.
Throat swelled; Knees started to swell; Blood pressure increased; Immune system has been compromised; Can not work and she can not do anything; Allergic reaction; This is a spontaneous report from a contactable consumer reporting for herself. This 67-year-old female patient received on 15May2019 pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13, lot X39675) at single dose as she had pneumonia. Medical history included pneumonia, allergy and allergic to cats. Concomitant medications were none. In May2019 the patient experienced throat swelled that recovered in May2019 (serious for hospitalization) and blood pressure increased with outcome of unknown. On 10Jun2019 knees started to swell. This event recovered in Jun2019. Patient was in hospital for knees started to swell from 16Jun2019 to 20Jun2019. On an unknown date in 2019 patient had immune system compromised, allergic reaction and cannot work and she cannot do anything, all with outcome of unknown. Treatment was provided for the events of allergic reaction, blood pressure increased, and throat swelled. Laboratory data included blood pressure increased in May2019. Course of the events were reported as follows: She had pneumococcal 13-val conj vac (dipht crm197 protein) after having pneumonia. The Saturday after she got the shot, her throat swelled up and went to a physician on the following Monday. They thought it was a salivary gland and was told to eat lemons. When she was going to the doctor to have tests read, the ENT told her that it was an allergic reaction and gave her steroids. She cannot work, and she cannot do anything. She has been hospitalized. She had high blood pressure. She was taking medication before but then her dose was increased. Her knees started to swell up. She is supposed to see an immunologist on 25Jun2019 as her immune system has been compromised. The steroids have reduced the swelling.
It was reported that a pt (2 of 2) received an Imovax Rabies ID vaccination on 3/27/01. Immediately, post vax, the pt developed redness and itching at the site.
I was fine. I donated blood at a blood drive on April 20, 2021. In May, I received a letter from the organization stating I could not donate blood again. They found something in my blood: Human T-cell lymphotropic virus (HTLV), type one and type two was reactive for antibodies. They stated I have an infectious disease and can never donate again.
Strong stomach pain about five days after first shot. Lasted a couple days.  On third day after second shot, painful cold sores all over lower lip.
This is a spontaneous report based on the information received by Pfizer from Sanofi PVPortal, (Local reference no: 20210222000002). A contactable consumer reported for herself. A female patient of an unspecified age received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 25Jan2021 (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced tingling in both legs and feet 2-3 days later. She stated to neurologist. They are aware. Neurologist stated it was patient decision, as to whether she chooses to get 2nd COVID-19 (Pfizer) vaccine. (Patient stated she has opted not to get). The patient did not receive any treatment for event. The outcome of event was unknown. No follow up attempts are possible. Information about Lot/batch number cannot be obtained.
This case was reported by a nurse via call center representative and described the occurrence of injection site pain in a 18-year-old male patient who received BEXSERO (batch number 151401, expiry date 30th December 2016). On 25th July 2016, the patient received the 1st dose of BEXSERO .5 ml. On 27th July 2016, 2 days after receiving BEXSERO, the patient experienced injection site pain, tingling of extremity and pain in hand. On an unknown date, the outcome of the injection site pain, tingling of extremity and pain in hand were not recovered/not resolved. It was unknown if the reporter considered the injection site pain, tingling of extremity and pain in hand to be related to BEXSERO. Additional details were provided as follows: The reporter stated that, after administration of BEXSERO the patient experienced pain and tingling in both hands and pain at the injection site, which was persisted till the time of reporting. On a pain scale of 1-10, the pain was at a scale of 3 and annoying.
Patient transferred from a nursing home due to right hip pain. Patient is lethargic but arousable, oriented to name only, does not appear to be in any acute distress. Does complain of right hip pain. No family at bedside, no comparable labs, entire history obtained through EMR and ER staff. Patient had a fall approximately 7 days ago, x-ray shows extensively comminuted and displaced right hip fracture. Orthopedics consulted. Patient has anemia 6.5, transfusing 1 unit packed red blood cells, FOBT pending. EKG pending. Chest x-ray shows cardiomegaly with pulmonary edema, will give IV Lasix, echo pending to evaluate for CHF and for preoperative evaluation. Patient is on Eliquis for AFib, will hold. Acute kidney injury, creatinine 2, unsure of baseline. Patient is COVID positive, unsure of vaccination status, no respiratory symptoms at this time, denies chest pain, cough, shortness of breath. Patient is sating high 90s on 2 liters nasal cannula.  1/31 at 9.30 am with worsening breath difficulty, with fluid infusing, suspected volume overload, given hx of Diastolic CHF , BNP 11900, CXR with interstitial pulmonary edema pattern, Discoutinue IV fluid, for suspected fluid overload, Lasix for volume overload status from acute D chf at 1325 Nursing reported patient expired. Given patient communited Hip fracture 7 days prior to admission, likely etiology acute cardiopulmonary arrest secondary to Fat embolism vs acute diastolic heart failure. Patient hospitalization also complicated with acute anemia requiring Blood transfusion, AKI on CKD unknown baseline, hyponatremia hypervolemic, positive covid status with 2L BNC requirement. afib on eliquis. Patient was pronounced dead at 1330 on 1/31/22 family members informed
Administered HPV and influenza vaccine at 9:00 AM. Patient had immediate reaction upon administration of influenza and gardasil vaccine. Presented first with difficulty breathing then mild facial swelling and mild right arm swelling occurred shortly after. Patient was instructed to lay flat on the bed, take her mask off,  and use deep breaths. Instructed mom to stay with patient. Went into the hallway and grabbed Dr. immediately to come in and assess patient. Dr. instructed me to then obtain epinephrine. Spoke with staff, another nurse, about dosage needed. Drew up 0.5 mL of epinephrine per instructions on box. Lot # 335174 and Exp # 03/2021. Took epinephrine and a pulse/pulse oximetry meter into the room. Obtained patient's oxygen saturation at 98% and pulse at 72 bpm at 9:15 AM. Administered dose of epinephrine into patient's left deltoid at 9:18 AM per Dr.'s instructions. Patient laid flat again and was monitored for 15 minutes after injection. Patient's oxygen saturation was 99% and pulse was 80 at 9:30 AM. Patient feeling better at that time and showing no signs of distress.  No further doses of epinephrine needed or given per Dr. Patient dismissed and advised to contact us or seek emergency services if symptoms reappear. Patient also given a steroid by Dr. for home use. Spoke with staff, nursing manager, about excess epinephrine. Discarded remainder of epinephrine down the sink.
Unconsolable crying, found crying in crib, stiff positive head & limbs, stiff x 30 seconds then limp, lack of coordination.  Right side weakness lasted 48 hours now resolved.  Infant with normal exam today.  (Possible seizure activity) Afebrile.
Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Hyperventilation-Mild, Systemic: Weakness-Mild
Had a stroke 4 hours after vaccine; This is a spontaneous report from a contactable consumer (Patient). A 49-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), first dose via an unspecified route of administration, administered in right arm on 25Mar2021 at 10:30 (at the age of 49-year-old) as a single for COVID-19 immunisation at public health clinic facility. Medical history included multiple allergies from an unknown date and unknown if ongoing known allergies were reported as yes. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did receive other unspecified vaccines within 2 weeks prior to the COVID vaccine. The patient did not diagnose with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. On 25Mar2021 at 13:30, the patient experienced had a stroke 4 hours after vaccine. The patient was hospitalized for had a stroke 4 hours after vaccine (cerebrovascular accident) for 2 days. Adverse event had not resulted in for death, life-threatening, prolonged hospitalisation or Congenital anomaly/birth defect but resulted in hospitalization, disability, or permanent damage. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 25Mar2021. The outcome of the event was reported as resolving.  Information on the lot/batch number has been requested.