chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a RN concerning a 12 month old male birth triplet with no known allergies who on 02/03/04 was vaccinated in the left leg with a dose of varicella virus vaccine live (Lot # 644789/0329N).  The nurse reported that the pt experienced a local site reaction and developed hives at the site immediately post vaccination. The pt was observed for 45 minutes and was treated with oral Benadryl.  The reporter has requested a lot check. The records of testing prior to release of this lot have been checked by Quality Assurance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. Additional information has been requested. The nurse also reported that the pt's brother and sister experienced a similar reaction after therapy with varicella virus vaccine live (WAES # 0402USA01540 & 0402USA01541).  The nurse reported two other children who experienced a similar reaction after therapy with varicella virus vaccine live (WAES # 0402USA01546 & 0402USA0547).  It was noted that the triplets had the worst reaction. The nurse also reported two other children who experienced a similar reaction after therapy with MMRII (WAES # 0402USA01554 & 0402USA01555).
During the evening on the same day as immunization administered she began having left arm pain, states she had difficulty sleeping both Thursday and Friday evening and difficulty raising arm more than level with chest. Arm red, she marked area with black marker on Sunday, and the redness has traveled down arm outside of marking. Area red, hot to touch.
Body Aches, headache, nausea, dizzy ness, feeling unwell, fatigue Pfizer-BioNTech COVID-19 Vaccine EUA
32 weeks pregnant. 2nd pregnancy. EDD 10/09/23. Starting 3 days after vaccine, experienced severe diarrhea throughout the day - liquid, at least 5x. Extreme fatigue and heart racing throughout the afternoon.
fever; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 14Sep2021 08:00 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), on an unspecified date as dose 1, single for covid-19 immunisation and experienced nausea which lasted for a day. The patient experienced fever on 14Sep2021 20:00 which he classified as mild fever. However, patient did not have a thermometer to verify the temperature. The patient underwent lab tests and procedures which included body temperature: unknown results on 14Sep2021. Patient took Tylenol last night (14Sep2021) and today (15Sep2021) around 12:00 to treat post vaccination symptoms. Caller wanted to know if it was safe to take them. Caller also wanted to know if it was recommended to drink plenty of water to help alleviate the symptoms. The outcome of event fever was not recovered.  The lot number for [BNT162B2], was not provided and will be requested during follow up.
aching all over;fever 102.5 APAP has brought it down currently w/fever;seen @ clinic;
102.0 fever and chills, hallucinations for 4 days, pt reports feeling FMF was exacerbated  Reports cutaneous burning and rash diagnosed as a lichenoid drug eruption
There was no allergic reaction, I vaccinated patient after the deadline of April 1, 2022. But unexpired vaccine.
Patient died from unknown causes 7/25/2007 following syncopal episode playing soccer. Similar episode of syncopal like events in 5/2006 playing soccer however he received typhoid vac in 5/2006 not AVA. Someone asked if AVA vaccine may be an underlying cause.  3 AVA vac received 3/9/2004, 5/13/04, 7/7/04.  Typh received 5/1/06  4/18/08 Reviewed medical records from HC which included vax records & autopsy report.   FINAL COD: cardiac arrhythmia.  Summary diagnoses: pulmonary congestion & edema; mild cerebral edema; passive visceral congestion.  Tox screen neg.  Manner of death natural. Vax records indicate patient received Typhoid VI lot # Z0042, Aventis on 5/1/2006.  Narrative reports patient received influenza vaccine 1/10/2007 but is not recorded on vax record.  Received Anthrax #1 FAV082 on 3/9/2004; #2 FAV084 on 5/13/2004; & #3 FAV 084 on 7/7/2004 & was medically exempted from remainder of anthrax series.  Records reveal patient had been ill w/flu-like symptoms for approx 1 week prior to death.  Same type symptoms had recurred several times since 12/2006.  Work-up s/p vaso-vagal syncopal episode in 8/2006 playing soccer while deployed reported as: x-rays, EKG, labs all WNL. No seizure activity or postictal state at that time. Records reveal patient experienced feeling ill, collapsed, had seizure & died on 7/25/2007 while playing soccer.  Patient had been d/c from military 05/05/2007 in good health.
I was administered the injection in my left shoulder, and was directed to sit down on a bench. Within 30 seconds I started to feel strange, followed by a fuzzy sound and I started to get tunnel vision. I then began to have what were described to me as muscle spasms, with all of my muscles tensing, my mouth open and eyes open the entire time. I also trembled lightly. I came to with various people and the administering doctor around me, and I was sweaty and pale, and had to lay down for half an hour. Afterwards I felt slight pangs of motion sickness-like nausea, which subsided after a few hours, perhaps 3. The following day I felt very fuzzy, and a bit incoherent, with a very strong soreness in the injected arm and shoulder.
Fever (103), extreme lower back pain, extreme leg pain, muscle spasms in legs, tremors, swollen lymph nodes in rd underarm, headache, sensitivity to light, exhaustion
Swelling, redness, pain of left lower extremity (thigh) x2 days after administration of DTaP.
Tingling sensation all over the body. Pins and needle sensation all over the body. Parestheshia of all extremities . Abdominal pain, chills/rigors
Patient had local injection site reaction. Redness, swelling, and rash about 1 inch lower and interior to injection site. Patient has had similar reaction the last 3 years she has gotten flu shot. Patient had little to no complaints of soreness or pain.
Dose 2: bizarre dreams; Difficulty sleeping; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, lot number: EW0191), via an unspecified route of administration on 27Jun2021 11:00 at left arm (at the age of 55-years-old) as Dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient did not receive any other medication within 4 weeks prior to vaccinations. The patient previously received first dose of BNT162B2 (Lot number: EW0191) on 06Jun2021 11:00 at right arm for COVID-19 immunization and experienced neck pain, headache, thirst, diarrhea, kidney pain, burning in the back of the neck, sadness on 08Jun2021, congestion on 08Jun2021, cough, dizziness on 07Jun2021, difficulty sleeping. For dose two patient was not having any real side effects, not as bad. The only thing that she was still experiencing was the difficulty sleeping in 2021. However she thinks it was because of the dreams. Patient was having really bizarre dreams which began Sunday night, 27Jun2021. Patient was dreaming about everybody that has passed away in her life. Patient was just like, what does this mean. She clarified the events happened mainly in the morning and the things that were at night, were at night, however, the majority were in the morning. There were no additional Vaccines Administered on Same Date of the Pfizer Suspect. The adverse events did not require emergency room or physician's office. No relevant tests. The outcome of the events were not recovered.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021816851 similar report from same reporter
No additional adverse events reported; the patient was administered a dose of VARIVAX on 12/19/2019, that had been improperly stored; This spontaneous report was received from a vaccine coordinator (also reported as an office manager) and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 19-DEC-2019, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection, (lot number S021926 has been verified to be a valid lot number, expiration date 15-JUL-2021) (exact dose, dose number, route and site of administration were not reported) for prophylaxis. The varicella virus vaccine live (oka/merck) (VARIVAX) was reconstituted with a properly stored sterile diluent.   Administered dose of vaccine was exposed to the temperature excursion of 1.2 degrees Celsius for 3 hours and 9 minutes incorrect product storage Data logger was involved. There was no previous temperature excursions. No adverse events were reported.
my head still feels a little strange; got sick at 3am; soreness at the arm; so weak she could not get out of bed; a little dizzy in the head; could hardly work without help; pain at the injection site; slight fever; headache; extremely fatigued; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (got sick at 3am), PAIN IN EXTREMITY (soreness at the arm), ASTHENIA (so weak she could not get out of bed), DIZZINESS (a little dizzy in the head) and HEAD DISCOMFORT (my head still feels a little strange) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history reported by the patient.  Concomitant products included CALCIUM, CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) and CLOBETASOL for an unknown indication.    On 22-Jan-2021 at 11:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced PAIN IN EXTREMITY (soreness at the arm), ASTHENIA (so weak she could not get out of bed), DIZZINESS (a little dizzy in the head), MYALGIA (could hardly work without help), VACCINATION SITE PAIN (pain at the injection site), PYREXIA (slight fever), HEADACHE (headache) and FATIGUE (extremely fatigued). On 23-Jan-2021 at 3:00 AM, the patient experienced ILLNESS (got sick at 3am). On 25-Jan-2021, the patient experienced HEAD DISCOMFORT (my head still feels a little strange). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form. On 25-Jan-2021, PAIN IN EXTREMITY (soreness at the arm) had resolved. At the time of the report, ILLNESS (got sick at 3am), ASTHENIA (so weak she could not get out of bed), DIZZINESS (a little dizzy in the head), HEAD DISCOMFORT (my head still feels a little strange), MYALGIA (could hardly work without help), VACCINATION SITE PAIN (pain at the injection site), PYREXIA (slight fever), HEADACHE (headache) and FATIGUE (extremely fatigued) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Pyrexia: 99.6 (High) 99.6.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2021: Follow up received on 08-Jun-2021 did not contain any new information.
got Covid-19 on 18JAN2022; got Covid-19 on 18JAN2022; itching at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of DRUG INEFFECTIVE (got Covid-19 on 18JAN2022), COVID-19 (got Covid-19 on 18JAN2022) and VACCINATION SITE PRURITUS (itching at the injection site) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004F21A and 009C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Aug-2021, the patient experienced VACCINATION SITE PRURITUS (itching at the injection site). On 18-Jan-2022, the patient experienced DRUG INEFFECTIVE (got Covid-19 on 18JAN2022) and COVID-19 (got Covid-19 on 18JAN2022). At the time of the report, DRUG INEFFECTIVE (got Covid-19 on 18JAN2022), COVID-19 (got Covid-19 on 18JAN2022) and VACCINATION SITE PRURITUS (itching at the injection site) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Jan-2022, COVID-19: positve (Positive) positive.         No concomitant medications was provided by the reporter. No treatment medications was provided by the reporter.  The patient didn't not take booster dose company comment This spontaneous case reported by a consumer, concerns a 43 year old female patient with no medical history reported, who experienced the unexpected, non-serious AESI of Covid 19 with a positive covid-19 test, about 5 months after receiving the 2 dose of mRNA-1273 vaccine in the covid 19 vaccination series. Drug Ineffective (Lack of Drug Effect) was noted. The patient had received the 2 primary doses with Moderna vaccine at an interval of about 27 Days and it was reported that he did not take any booster dose. Details of treatment were not provided. Event outcome was unknown. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.; Sender's Comments: This spontaneous case reported by a consumer, concerns a 43 year old female patient with no medical history reported, who experienced the unexpected, non-serious AESI of Covid 19 with a positive covid-19 test, about 5 months after receiving the 2 dose of mRNA-1273 vaccine in the covid 19 vaccination series. Drug Ineffective (Lack of Drug Effect) was noted. The patient had received the 2 primary doses with Moderna vaccine at an interval of about 27 Days and it was reported that he did not take any booster dose. Details of treatment were not provided. Event outcome was unknown. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.
Received vaccine in left deltoid  within minute felt throat tighten self administered personal epi pen.
100.4 fever (at 2am). arm pain other than inj site, severe chills all night until approx. 7am (Sunday) 99.2 fever at  8am and 1pm (Sunday) Temperature 98.6 (Monday)
With first shot.  Extreme pain on arm of immunized arm. Swelling  and decreased mobility. same day of injection 01/07/21 around 6pm. Next day Friday January 08 2021  missed work due to mild body aches, head ache, severe pain on arm, decreased mobility.  Under arm pain and swelling on arm of vaccine given. Temp of 99.5-99.9 Had symptoms for 2 full days.   2nd shot. Same day of immunization of 02/04/21 right arm mildly ached. Later on that day around 7-8 pm still had mild pain on arm . Moderate body aches, headache, nausea. The next day 02/05/21 Extreme body aches, horrible headache concentrated on eyes. 100.1 -100.5 temp for 2 days. Symptoms of dizziness and extreme body aches lasted for 4 days and then slowly left.
Site: Swelling at Injection Site-Medium, Systemic: swelling and pain in leg-Severe, Additional Details: Patient stated that they were experiencing swelling and pain when walking in leg
Intermittent chills, left axillary pain, tenderness and lymphadenopathy
Within 24 hours had blurred vision. Have to close one eye to be able to focus good enough to read close up work and work on the computer.
Pt started with swollen red spots all over body which progressed to severe painful hives over the next two days.  Pt's family discussed treatment with local urgent care et was referred on to primary care provider.  Pt does not have a primary care provider or insurance.  Pt's daughter phoned health department 5/21/2012 et was referred to NEW Clinic (free clinic). Phone number and address given.  Appt made by daughter for 5/22/2012.  Inst daughter to seek immediate medical attention if needed.  Daughter verbilizes understanding.  Request daughter to call HD to update after appt.
I have a dime sized blister about 1.5 inches from the injection site.  The blister is yellow and fluid filled. I noticed it today, but it could have appeared sooner.
Extreme soreness after administration on 10.17.15 went to MD 11/12 - given meloxicam. As of 12.1.15 no improvement. Patient concerned portion of needle remains in her arm.
Rash localized to near the injection site.  It looks like poison ivy bubbles and is red and itchy
Pt seen for headaches on 1/21/09 - Seen again on 2/7/09 when mother told dr she is concerned this is related to the HPV vaccine. got related information from the internet  2/13/09 Received PCP medical records of 1/21-2/10/2009. FINAL DX: tension/stress HA Records reveal patient experienced HA on 1/21 occurring 4-5x/wk over 2 mo period.  Usually starts in afternoon.  Tiredness, stomach pain.  Tx w/meds.  RTC 2/7 w/worse HA unrelieved by meds along w/joint pain, low energy, stomach ache.  CT scan & labs ordered.
Got PNEUMOVAX and less than 12 hours later developed cellulitis in right arm with fever. Admitted to hospital, IV vancomycin and KEFLEX.
4/2-Patient's mother  stated her son collapsed on 4/1/2021 approx. 2pm. He was tested for COVID-19 at the hospital and the result came back positive. Patient was not able to eat or drink, diarrhea, have muscle aches and weaknesses, and fever. Caller also stated patient is having coughs (she stated this could be due to him being a smoker). Patient is still experiencing these symptoms at time of call. Patient temp was taken at 5pm with a reading of 101 degree. When patient was in the hospital on 4/1/2021 he was given IV fluid. Since he was released from the hospital he has only been taking Tylenol to reduce his fever. Patient prescribed cough medication by ER doctor but he has not yet taken it since released from the hospital. Due to his positive COVID-19 test result, he was instructed to quarantine for 2 weeks by ER doctor.
Patient reported trouble breathing after evaluation. Epipen was given and 911 was called. Patient was evaluated by paramedics.
Site: Pain at Injection Site-Mild, Systemic: Cardiac Disorder (diagnosed by MD)-Severe, Systemic: Chest Tightness / Heaviness / Pain-Severe, Systemic: DEATH-Severe, Systemic: Heart Attack-Severe
7:30 PM- headache, took Tylenol 325 mg x 2  + Benadryl 50mg + 1 packet of Emergen-C next day, 5AM: felt tired, headache persisting throughout the day, when got home at 8PM, took Tylenol 325 mg x 2  + Benadryl 50mg  5AM, woke up and noticed rash on chest while in the shower. Took Benadryl 50mg.   11AM:  noticed lump on L arm on the injection site.  Took Tylenol  325 mg x2 + Benadryl 50mg and it resolved the next day.  As of today, 4/15/21: headache still persisting but nowhere near as bad, "not enough to take a Tylenol"
inflammation; hives head to toe; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the parent. A 12-year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient relevant medical history and concomitant medications were not reported. The following information was reported: INFLAMMATION (non-serious), outcome "recovered", described as "inflammation"; URTICARIA (non-serious), outcome "recovered", described as "hives head to toe". Additional information Reporter stated, looks like it was FE3592. (Further clarification unknown hence, not captured in tab). Expiry Date of COVID-19 Vaccine: Unknown. Reaction/event as reported by primary source: My son had an adverse reaction to the COVID vaccine. He had inflammation and hives head to toe for about 4 days. Reporter stated, my son had an adverse reaction to the COVID vaccine, and I was looking at the website, so I looked that he should not receive the second dose, but I just wanted to confirm now with someone. Reporter was unwilling to complete the report, further probing could not be done. Hence, limited information was available over the call.  Information about lot/batch number cannot be obtained. No further information expected.
Bells Palsy right facial droop, eye droop.  12/03/09 MR received for DOS 10/30/09. DX: Asthma exacerbation. Pt c/o asthma exacerbation, wheezing, hoarseness, coughing, nasal congestion, HA, body pain, nausea and muscle ache. On examination increased temperature, wheezing inspiratory and expiratory on both lung fields. Tx steroids.  12/09/09 MR received for DOS 11/03/09  11/04/09: Consult notes received for DOS 10/30/09 DX: Bell's palsy. Pt c/o R side facial paralysis, drooping of lips on R side. Pt diagnosed with Bell's palsy.
This spontaneous report was received from a licensed practice nurse concerning to a 14 year old female patient. Information regarding the patient's medical history, concurrent conditions or concomitant medication was not provided. On 17-JUL-2015, the patient was vaccinated with the first dose of GARDASIL injection (strength, dose and route of administration were not provided) (lot # K007828 with expiration date of 02-MAR-2017). It was reported that on an unspecified date after the patient received the vaccine, she was discovered to be pregnant with a last menstrual period in an unspecified date in June 2015. At the time of this report, the outcome of the pregnancy was pending. The due date would be probably in March 2016. No adverse event or product quality complaints were reported. Additional information has been requested.
Per nursing report: "took 2nd Moderna vaccine today  [2/22] about 10:30. C/o headache and lightheadedness. States going to  go home for the rest of the day"
No adverse event; 6 month old - 5 yr old Moderna Monovalent dose given to a 20 yr old.; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (6 month old - 5 yr old Moderna Monovalent dose given to a 20 yr old.) and NO ADVERSE EVENT (No adverse event) in a 20-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Question:Describe relevant medical history/conditions, allergy, concomitant diseases and risk factor.Answer:HCP declined to share recipient's initials or DOB. Preference for contact: Phone or email.     On 12-Jan-2023, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Jan-2023,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced WRONG PRODUCT ADMINISTERED (6 month old - 5 yr old Moderna Monovalent dose given to a 20 yr old.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (6 month old - 5 yr old Moderna Monovalent dose given to a 20 yr old.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (6 month old - 5 yr old Moderna Monovalent dose given to a 20 yr old.).    No concomitant medication information was provided. No treatment medication were provided.
Deep aching pain, not swollen or red. Muscles on arm hurting badly since then. Pain comes and goes. Take anti-inflammatory to relief pain, enough to go to sleep. Site of injection still very tender. Pain began 3/4 days after shot (11/20/05), pain was from elbow to shoulder, sometimes up my neck, now. Worse when I'm horizontal [so intense I can't sleep or I wake up] Pain in ranging from dull ache to sharp jabs-sore to the touch, also
Fever to 104+ developed @ 0200. Pt also has ear infections - uncertain if high fever due to infection or vaccines