chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient presented without a card stating that she was due for her Booster dose of Moderna.   This PHN looked her up # 5608291 observing the following documentation:              1/22/21            MODERNA    LOT# 012L20A          0.5 ML             2/19/21            MODERNA    LOT# 013L20A          0.5 ML             8/16/21            MODERNA    LOT# 017E21A          0.5 ML  Patient stated to have received full doses and was eligible for BOOSTER MODERNA DOSE at 0.25 mL based on Immunocompromised status.  Patient stated did not have her vaccine card with her. PHN created a new card with the above dates and adding 1/12/22 0.25 mL Moderna dose as Booster.  *This PHN neglected to observe the 12/27/21 noted as HALF DOSE but documented as 0.5 mL. Given at the clinic  This PHN realized later when inputting consents:  1) Upon closer inspection the consent was not signed and immune compromised box not checked although PHN discussed both with patient. 2) Dose documented as given on 12/27/21.  This PHN attempted to reach patient by phone x 2. No answer or VM.  On 1/13/21 PHN went to vaccination site and spoke with patient directly. Who signed the consent. Patient stated she did not have her old card but when asked directly had she received a dose of Moderna at Clinic on 12/27/21 patient denied stating, ?I didn?t get it that day. I changed my mind.? There is a record in the form of a signed consent which indicated patient did receive a dose of Moderna on 12/27/21 at the clinic. Patient continues to deny that she received the vaccine that day.
Chills, fever (101-102F), muscle aches, extreme fatigue, headache. Ie, flu-like symptoms but this was not a mild reaction. It felt like full blown flu for 24 hours (symptoms were as severe as the actual active flu virus I had last year).   Onset was 10 hours after flu shot (Sanofi Fluzone QIV MDV). Fever lasted about 12 hours, headache lasted 24 hours.
reports sore arm, more than usual, after receipt of vaccination 2; tiredness; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50 year-old male patient received bnt162b2 (BNT162B2), administration date 18Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose), for COVID-19 immunisation. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "reports sore arm, more than usual, after receipt of vaccination 2"; FATIGUE (non-serious), outcome "unknown", described as "tiredness".  Additional Information:Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Was in 30 minute monitoring d/t hx of anaphylaxis to wasp sting.  At 20 minutes post injection, developed tight cough and wheezing.  States it felt like a film in her throat and her tongue felt "weird."  Placed on O2, administered 0.3 mg Epi pen to right VL and 50 mg Benadryl IM to RD. Began improving immediately.  States she always has a low BP and pulse.  Medical hx includes liver disease, bipolar, dementia, arthritis. Accompanied by son.
Sore arm about 7 hours after injection. Achy, chills, fever 101.8 about 12-14 hours after injection. Fever went down every couple of hours throughout the night 100.3, 99.3, 98.3 then normal for me 97.6. Next day had a headache and was weak (couldn't stand up for more than 10 minutes at a time) for the whole day. Took ibuprofen for headache. Woke up next day (48 hours after shot) feeling 85-90% normal. Was back to normal later that day.
Rapid pulse of 120, face, cheeks and neck very flushed. Eyes felt funny. She felt a little weak and shakey. 50mg of liquid BENADRYL given and observed client for one and half hours. After that time she was feeling normal and her pulse was down to 80 and  she was no longer flushed or feeling weak or shakey. BP was normal. Recommended to Mom that she call her MD to see if he/she wants to see her. Client left school clinic with her mother.
Pt stated that she was pregnant at the time of her last set of immunizations but had not realized it at the time.  She stated after receiving the vaccines, she took a pregnancy test and learned she was "a few weeks pregnant."  She reported that she had then miscarried at 9 weeks.
stroke; This is a spontaneous report from a contactable consumer (patient self).  A 51-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) Solution for injection, via an unspecified route of administration, administered in Arm Left in Apr2021 (Batch/Lot number was not reported) as dose 2, single (at the age of 50-year-old) for COVID-19 immunisation. The administration time was 10:00 AM.  Medical history included arthritis and gastrooesophageal reflux disease (GERD). Concomitant medications included ASA; celecoxib; esomeprazole sodium (NEXIUM).  The patient previously received BNT162B2 dose 1 in Mar2021 at the age of 50-year-old for COVID-19 Immunization. There was no other vaccine in four weeks.  The patient did not have Covid prior vaccination.  No known allergies.  The patient suffered a stroke on 23Jun2021, with very little to other known risk factors which resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event).  The patient was hospitalized in Jun2021 for 2 days.  Treatment received inluced hospitalization, multiple tests, and new Rxs.  Outcome of the event was resolving.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Information has been received from a licensed practical nurse concerning a patient who on 22-OCT-2009 was vaccinated with a PO dose of ROTATEQ (Lot number unspecified) (It was not known which dose in th series this was). The licensed practical nurse reported that the patient may have received a partial dose of ROTATEQ. The patient vomited soon after the dose was administered. At the time of the report the status of the patient was unspecified. It was unknown if the patient sought medical attention. Additional information has been requested.
This case was reported by a consumer via call center representative and described the occurrence of joint pain in a 54-year-old female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included no adverse effect. On 12th June 2018, the patient received the 1st dose of SHINGRIX. In June 2018, 7 days after receiving SHINGRIX, the patient experienced joint pain, influenza and injection site pain. On an unknown date, the outcome of the joint pain was not recovered/not resolved and the outcome of the influenza and injection site pain were recovered/resolved. It was unknown if the reporter considered the joint pain, influenza and injection site pain to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on left arm. At vaccination night or the day after vaccination, the arm where she received the shot hurt and she also felt like she was coming down with the flu. It lasted a day. However, about the following week she started noticing severe joint pain. She has joint pain in her knuckles of both hands and both knees. She said that she was not recovered till the time of reporting and the pain was about the same since then. The patient was concerned about getting her second SHINGRIX dose. She did not have her physician's name with her at the time of the call.
This spontaneous report was received from a medical assistant (also reported as nurse prescriber) referring to a currently 4 year old patient of unknown gender. The patient's medical history, concurrent conditions or concomitant medication were not informed. On an unknown date, the patient was vaccinated with a dose of PROQUAD (lot # N025929, expiration date 18-MAR-2019, subcutaneously), for prophylaxis (dosage information was not informed), following a temperature excursion. No adverse effects were reported. It was also informed that the temperature was -10.97C, time frame 35 minutes, There was no previous temperature excursion. A "data logger" was involved. This one of two cases from the same reporter. Sender's Comments: US-009507513-1805USA001406.
2" x 2" area of redness and tenderness at site of flu vaccine. Improved by AM 10/20/2017.
Sore, elevated, erythematous, warm tissue at (R) deltoid injection site.
On 12/14/2022, patient presented to the emergency department from facility with chief complaint of weakness. She had a 3-day history of illness with cough, congestion, intermittent fevers, malaise/fatigue. Upon arrival in the ED, she was hypoxic and required oxygen, and had a positive COVID-19 NAA test; No shortness of breath; Chest X-ray showed mild left basilar opacity may represent atelectasis or pneumonia. CT of Chest was negative for pulmonary embolism and there were no acute findings. Diagnoses: Pneumonia due to COVID-19 virus, Hypoxia, Respiratory distress. Patient was treated with Decadron along with albuterol and Atrovent. She was admitted to the hospital for further treatment.   Submitter does not have access to further medical information on this case. If more information is needed, please contact the admitting hospital:
pt recv 2 dose of vax & diagnostic lab tests revealed that pt did not seroconvert;
Patient states she had some pain and a "lump" at the injection site, although that has resolved now.  She states now that she has a rash that covers the majority of her scalp but is "splotchy".  It is itchy and in places, "crusty".  She said they rash started about 5 days ago which was 5 days post injection.  Patient has scheduled a dermatology appointment in 3 days  but was told to seek medical treatment if neccessary before that day.
About 24 hours after I got the shot I had joint and muscle pain . By Sunday swollen lymph nodes and it's gotten progressively worse since. I've also been running a low-grade fever of 99 to 100 since Sunday.
TDAP injection site left deltoid.  Area is raised & red with heat.  Approx size of golf ball.  Advised symptomatic tx with MOTRIN.
p/ pt recv vax 4/97 in 6/98 pt devel chickenpox that consisted of ``pustules, pruritic rash on face & neck, upper extremities, back, legs, buttocks, & thighs'' , multiple lesions, temp 101.3f
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age. On an unknown date, an unspecified number of patients were vaccinated with improperly stored PNEUMOVAX 23 lot # L003227 expiration 13-OCT-2016. Other therapies included ROTATEQ L047158 expiration 17-SEP-2017 (MARRS# 1608USA007206). The temperature was reported as 34F and time frame 15 hours 20 minutes. No symptoms were reported. No further information was provided. This is one of several reports from same reporter. Additional information has been requested.
This spontaneous case was reported by an other caregiver and describes the occurrence of COVID-19 (COVID-19) in a 57-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis. Co-suspect product included non-company product TOFACITINIB CITRATE (XELJANZ XR) for an unknown indication. The patient does not have any known allergies. Concomitant products included LEVOTHYROXINE, FOLIC ACID, CALCIUM, CURCUMA LONGA (TURMERIC [CURCUMA LONGA]) and COLECALCIFEROL, FISH OIL (FISH OIL + VITAMIN D3) for an unknown indication. In 2021, the patient started TOFACITINIB CITRATE (XELJANZ XR) (Oral) 11 milligram once a day. On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) outcome was unknown. The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown. It was reported that the patients husband stated that the patient had COVID-19 at the end of July and stopped medication for 1 to 2 weeks. The husband also stated that the prescribing doctor was not aware of this but primary doctor was. The husband stated that wife was doing well now. The patient husband also stated that patient was no longer taking the medication. Company comment: This spontaneous case was reported by an other caregiver and describes the occurrence of COVID-19 (COVID-19) in a 57-year-old female patient in the context of a dose of mRNA-1273 vaccine. Co-suspect product included non-company product TOFACITINIB. Very limited information is available in source document regarding data of the event, diagnostic work-up to support the current diagnosis and treatment received. Temporal association cannot be assessed due to lack of information on onset date of the events  and vaccination date. The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report. Treatment information was not provided. Reporter did not allow further contact. Sender's Comments: This spontaneous case was reported by an other caregiver and describes the occurrence of COVID-19 (COVID-19) in a 57-year-old female patient in the context of a dose of mRNA-1273 vaccine. Co-suspect product included non-company product TOFACITINIB. Very limited information is available in source document regarding data of the event, diagnostic work-up to support the current diagnosis and treatment received. Temporal association cannot be assessed due to lack of information on onset date of the events and vaccination date. The benefit -risk relationship of mRNA -1273 (Moderna Covid-19 Vaccine) is not affected by this report.
Pregnant with second child at first and second dose of the covid vaccine. Due date was 10/15/2011. I experienced a miscarriage at 9 weeks pregnant on 3/17/2021.
Headache, left side of face felt funny around 8:30pm on May 15th; went to Emergency Room at 10pm May 16th, was diagnosed with Bell's palsy.
6cm x 5cm diam & raised 0.5 cm - warm, firm, tender, no lesions or eruptions, c/o itchy & shoulder joint tender. Located (R) deltoid.
Redness of skin formed on scalp Sunday AM.  Sunday afternoon the condition went to her forehead and both sides of ears. The pain increased Sunday afternoon.  Monday morning the red areas turned to welts and her arm in area of vaccination became hot to the touch and swollen.  Tuesday morning at about 9:35 patient says that she is feeling better after recieving doses of valtrex and clindamycin
No side effects reported; HCP calling to report AE for ROTATEQ. Vaccine administered experienced a temperature excursion. No side effects reported. No other medical information known. See additional AE cases 02475713, 02475789, 02475811, 02475849, 02475861, 02475818, 02475985; This spontaneous report was received from Other Health Professional and refers to a patient of unknown age and gender.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 19-JUN-2023, the patient started therapy with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, unk, lot #W026137, expiration date: 05-FEB-2024, administered for prophylaxis (strength, and route of administration were not provided).  On 19-JUN-2023, HCP called to report AE for ROTATEQ. Vaccine administered experienced a temperature excursion (7.74 C for 35 minutes). No side effects reported. No other medical information known. See additional AE cases 02475713, 02475789, 02475811, 02475849, 02475861, 02475818, 02475985. No PQC.
Elevated temp, then had sz on 27JAN90; Hospitalized for 2 days; Had "several" szs; Appears well now; Normal growth & developement, actually is bigger than normal;
Unknown illness with neurologic signs and symptoms: unilateral left sided numbness and tingling, trouble thinking, episodic difficultly with coordination with arms and legs, tingling and shock sensation down spine, staring spells, severe fatigue/lethargy, episodic difficulty speaking, trouble swallowing, tingling on head, neck stiffness and pain, seizure like activity.
The patient received a Flu vaccine 12 2009 at a Pharmacy with an irritated erythematous area that evolved into a papular nodular lesion. A biopsy in March 2011 revealed a cutaneous marginal zone lymphoma CD20 (+), CD3 (+), CD23 (+) with a clonal light chain gene rearrangement.
Well I had a reaction to both of them. The first dose my blood pressure went up immediately and had to sit there till it came down. After the second dose I woke in the middle of the night and my face was tingling and I thought I was having a stroke. But when I reviewed the stroke symptoms I didn't have anything else so I went to the doctor the following Monday. And my left side of my face was still tingly. They sent me for a CT scan and everything was fine. I was never prediabetic and 4 months ago was diagnosed as diabetic. I'm not taking any medications for it right now. My face still gets tingly every now and then.
Information has been received from a 75 yr old female with cancer and a history of urinary tract bacteria, splenectomy and no allergies, who on approx 18Aug05 last week was vaccinated SC with a dose of pneumococcal 23v polysaccharide vaccine. Concomitant therapy included (Leboxyl), esomeprazole magnesium (Nexium), (Prevachol) and pancreatic enzymes. Last week, the pt developed vomiting and diarrhea. Unspecified medical attention was sought. No lab diagnostic studies were performed. The consumer reported that she was feeling better but she had not recovered. No product quality complaint was involved. Additional information is not expected.
This infant had a fever of 100 - 103 from 02/17/01 to 02/19/01. She had diarrhea on 02/18/01 and 02/19/01.
Patient received vaccine April 2, 2021 and initially had low-grade fever up to 100 and myalgias, mild symptoms.  However, patient then had intermittent shortness of breath for the next few days and on April 12, 2021 developed wheezing and shortness of breath.  Patient presented to the clinic on April 13 due to significantly worsening respiratory distress.  She was seen at our affiliated walk-in Center.  She was given Benadryl and IM steroids but then went on to develop swelling of the face and vocal cords.  EMS was called.  Patient was transported to a local emergency room bayonet point where she was admitted, given more steroids and nebulizers, however, patient ended up intubated and transported to the intensive care unit for the next 4 days.  On exam, it was noted patient had subglottic angioedema. Patient does have a history of asthma and allergic reactions
Red, itchy, watery eyes, fatigue, headache, body aches, chills, fever (101.1 F) fast heart beat 1130 pm.
pt recv vax 10JUL97 & w/in 4 days pt devel a rash described by MD as erythematous lacy;
Rash and mild swelling over (L) deltoid (urticarial rash) upper 1/3 of arm. Treated w/BENADRYL.
Significant left ear pain that woke me up from sleep 3x last night when I would lay on that side; left ear pain; Right ear pain; Outer ear pain on rest and highly tender on palpation, most severe around the tragus area; left unilateral left axillary lymphadenopathy; Moderate systemic symptoms; This is a spontaneous report from a contactable other health professional (patient). A 26-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection via an unspecified route of administration in left arm on 23Jan2021 03:30 PM (Batch/Lot Number ELA262) single dose for COVID-19 immunization at hospital. The patient's medical history was none, and concomitant medications were not reported. The patient had no allergic history. Patient had not received any other vaccines within 4 weeks prior to the COVID vaccine and patient was not diagnosed with COVID-19 prior to vaccination. 12 hours after the vaccination the patient had moderate systemic symptoms and persisted for 36 hours. 24 hours after the vaccination, the patient developed left unilateral left axillary lymphadenopathy and improved. On 24Jan2021 at 06:30 AM the patient had outer ear pain on rest and highly tender on palpation, most severe around the tragus area. 48 hours after the vaccination the patient had right ear pain (now resolved) and after 72 hours pain started in left side (persisting). It was reported that about 5 days after vaccination, the patient had significant left ear pain woke her up from sleep at night if she lay on that side. No cervical or preauricular lymphadenopathy. Events were not treated. Events resulted in doctor or other healthcare professional office/clinic visit. On 25Jan2021, the patient was tested (Nasal Swab) negative for COVID-19. Outcome of "Outer ear pain on rest and highly tender on palpation, most severe around the tragus area", left ear pain, was not recovered. Outcome of right ear pain and Moderate systemic symptoms was resolved. Outcome of "Significant left ear pain that woke me up from sleep 3x last night when I would lay on that side" was unknown. Outcome of "left unilateral left axillary lymphadenopathy" was unknown.  Follow-up attempts are completed. No further information is expected.
Temperature of 103.6 - Vomiting, Lower abdomen pain, Cold Sore outbreak on 7/27 at eyes, nose, mouth Complaint of ear ache. Cold sore eruption increase to around both eyes, under nose, bottom lip. Bottom lip swollen, eyes puffy
Vaccine was expired as of 02/04/2022 when it was given. We called Pfizer and they stated that the vaccine has a shelf life of 14 days after expiration date so no intervention was needed, and no repeat dose was needed. Patient reported no adverse reactions.
Systemic: Bell's Palsy-Mild, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: OTHER-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Shakiness-Mild, Systemic: Tinnitus-Mild, Systemic: Weakness-Mild
no additional adverse event reported; expired dose of vaccine was administered; This spontaneous report was received from a medical assistant 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 30-SEP-2019, the patient was vaccinated with expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) 0.5 milliliter, lot # N028443 has been verified to be a valid lot number, expiration date was reported as 09-APR-2019, albumin status rHA (formulation, strength, frequency and route of administration were not reported) for prophylaxis. No additional adverse event was reported. The medical assistant noticed the event going through records. No temperature excursion was for this lot #.
Patient received a dose of Dtap and should have received Tdap due to over age 7. No treatment needed and no adverse reactions noted.
Child developed a rash. Rash looked like small blisters on his hands, legs, feet, and diaper area.
Information has been received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, current condition and concomitant medication were not provided. On 26-SEP-2018, the patient was vaccinated with VARIVAX (dose, frequency and route were unknown, lot number N020013 and expiration date 17-JUL-2019) for prophylaxis. On the same day, the patient was also vaccinated with M-M-R II rHA (recombinant Human albumin) (dose, frequency and route were unknown, lot number M047302 and expiration date 30-NOV-2018) for prophylaxis. Both VARIVAX and M-M-R II were reconstituted with sterile diluent (manufacture unknown) (lot number reported as R010090 and expiration date 29-NOV-2018), respectively. It was reported that "medication drawn into plastic syringe (which was supplied by HCP) had needle and barrel of syringe come apart during injection. So the reporter was unsure the amount of medication received. Product quality complaint (PQC) was ruled out as the nurse reported using needle supplied by HCP and did not use prefilled syringe. No adverse effects were reported.