chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial unsolicited report received from a pharmacist on 12-Oct-2016. This case was linked with 2016SA189772, 2016SA189781, 2016SA189791, 2016SA189792, 2016SA189793, 2016SA189794, 2016SA189795, 2016SA189796, 2016SA189797, 2016SA189798, 2016SA189799, 2016SA189800, 2016SA189801, 2016SA189802, 2016SA189803, 2016SA189804, 2016SA189805, 2016SA189806, 2016SA189807, 2016SA189808, 2016SA189809, 2016SA189810, 2016SA189811, 2016SA189812, 2016SA189813, 2016SA189814, 2016SA189815, 2016SA189816, 2016SA189817, 2016SA189818, 2016SA189819, 2016SA189820, 2016SA189821, 2016SA189822, 2016SA189823, 2016SA189824, 2016SA189825, 2016SA189826, 2016SA189827, 2016SA189828, 2016SA189829, 2016SA189830, 2016SA189831, 2016SA189832, 2016SA189833, 2016SA189834, 2016SA189835, 2016SA189836, 2016SA189837, 2016SA189838, 2016SA189839, 2016SA189840, 2016SA189841, 2016SA189842, 2016SA189843, 2016SA189844, 2016SA189845, 2016SA189846, 2016SA189848. (same vaccine and reporter) This case involves a patient (age, gender unknown) who was vaccinated with a dose of FLUZONE Quadrivalent via intramuscular route (batch number- UI669AA, expiry date: 30-Jun2016, dose and site of administration was not reported) on 04-Oct-2016. The patient's medical history and concomitant medications were reported as none. On an unknown date, after the vaccination the patient had achiness, nausea, fever and headache. Patient required Emergency room or doctor visit. The patient's lab tests was not reported. It was reported that patient did not seek treatment. The patient was not recovered from the events (it was reported that events was ongoing on 06 October 2016). List of documents held by sender: none.
administered undiluted Pfizer pediatric dose (0.2ml)  to child.  no adverse reaction at time of injection and yet.
Patient presented for second dose of the Pfizer vaccine, but was given the incorrect formulation for patient age (patient received formulation intended for 12 and older).  Error was realized on day of vaccination.  Contacted patient's parent and explained error and possible adverse reactions that could be experienced.  Parent reported no significant reaction.  Follow-up call placed 2 days later, with no significant reactions noted.
Patient returned to site about 30 minutes after injection with symptoms- tongue/ cheek tingling, increased BP/ HR and uneasy feeling. Also labored breathing. Symptoms decreased after about 45 minutes, then patient went home. Later she felt worse and went to ER!
SWELLING OF ARM, REDNESS AND PAIN, CRYING FOR GREATER THAN 3 HRS , FEVER FOF103.5 AND VOMITING
This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received bnt162b2 (Formulation: Solution for injection; Batch/Lot number was not reported), dose 2 via an unspecified route of administration on an unspecified date Aug2021 as dose 2, single for covid-19 immunisation. The patient medical history was not reported. There were no concomitant medications. The patient previously received first dose of bnt162b2 on an unspecified date for covid-19 immunisation. The patient experienced feeling bad, unspecified, after second vaccine. Caller states he is calling about the Covid 19 shot, reclarified as Pfizer. Caller states he took the second shot on Tuesday. Caller states ever since, he is feeling bad. Caller states he takes no medicine. The outcome of the event was unknown. Information on the lot/batch number has been requested.
A Flublok was given to a 12 year old. The appropriate age for Flublok is 18 years and up. The client did not have an adverse event.
I experienced an overwhelming amount of itching and right after getting vaccinated I experienced extreme swelling in my fingers my right ankle and underneath my feet. I was told to take Zyrtec. It helped but I still experienced itchiness and swelling. I consulted a dermatologist who diagnosed me with dermatographism and concluded my skin responds to the excessive itching by a trauma response known as petechiae. I also have gained a lot of weight since become vaccinated and rapidly. I have not changed my eating habits.
Client received vaccine 6/07. Client mother called Health Department this AM c/o child with bumps on back. Slight temperature. Instructed mom to take child to Pediatrician. Received phone call from doctor office with child diagnosed with chickenpox. This was child's second vaccine no complaints with earlier vaccine at 1 year old.
Missed recommended interval between doses; Weird chest sensation; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Missed recommended interval between doses) and CHEST DISCOMFORT (Weird chest sensation) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Missed recommended interval between doses) and CHEST DISCOMFORT (Weird chest sensation). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Missed recommended interval between doses) had resolved and CHEST DISCOMFORT (Weird chest sensation) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication were not reported Treatment medication were not reported
Small bowel obstruction. Acute care surgery. Discharged to home. ED visit to hospital admission. This visit was within 6 weeks of receiving the COVID vaccine.
Day 1-4 was pronounced fatigue, day 5-9 was intense GI distress and stabbing stomach pain, following these significant events and continuing are fatigue and general malaise. Most problematic has been the re-emergence of a long dormant auto-immune disorder (12+ yrs), bullous pemphigus. This disorder, when active, causes blistering and sloughing skin in soft tissue areas. It can be very painful and uncomfortable. It usually emerges when I have a significant event that causes my immune system to plummet. I fully believe this vaccine precipitated this occurrence.
pt recvd vax 30JUL93 & w/in 6 hrs devel fever of 102-103, irritability, sl swelling @ site; rx'd w/APAP; 31JUL fever 104 taken to ER; pt pale & irritable; hospitalized 3 days; CBC: HCT 23, HGB 7.8, WBC 3.1; dx hemolytic anemia;
pain on one side of his body; he could not sleep; he experienced numbness; first dose of the vaccine just hurt the caller's arm and he was in pain; It felt like something was crawling inside of the caller; This is a spontaneous report from a contactable consumer(patient) via Pfizer-sponsored program COVAX US Support. A 70-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), dose 1 via an unspecified route of administration on 23Feb2021 as dose 1, single for covid-19 immunisation. Medical history included chronic sinusitis (he experiences it year round everyday). The patient's concomitant medications were not reported. On an unspecified date the patient experienced pain on one side of his body, he could not sleep, he experienced numbness, first dose of the vaccine just hurt the caller's arm and he was in pain, it felt like something was crawling inside of the caller. Patient stated, His doctor advised him not to take the second dose. He received his second dose on 20Jul2021 and is scheduled for a third dose on 10Aug2021. He is to receive the third dose because we are restarting. The patient took the second shot on 20Jul2021. It has been so long they scheduled the caller for a third dose on 10Aug2021. Should the patient do that since he's already had two doses? He thinks it was more scaring him and he's not trying to blame Pfizer. The outcome of event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
booster; Have taken both covid shots and had booster 3 weeks ago/just tested positive; Have taken both covid shots and had booster 3 weeks ago/just tested positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (003110). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: IMMUNISATION (medically significant) with onset 2021, outcome "unknown", described as "booster"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2021, outcome "unknown" and all described as "Have taken both covid shots and had booster 3 weeks ago/just tested positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (2021) positive.  The lot number for bnt162b2 was not provided and will be requested during follow up.
felt a little colder than usual; trouble falling asleep; general feeling of malaise; pressure building in my head and abdomen; pressure building in my head and abdomen; left shoulder became increasing sore over 24 hours; This is a spontaneous report from a contactable consumer reported for himself that: 43-years-old male patient started to receive the second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) , via an unspecified route of administration on 16Feb2021 15:45 at single dose at left arm  for covid-19 immunisation.  The patient previously took the first dose bnt162b2 on 26Jan2021 at 43 years old for covid-19 immunization. The patient medical history was not reported.  The patient's concomitant medications were not reported.  The patient experienced left shoulder became increasing sore over 24 hours on 16Feb2021 15:45, trouble falling asleep on 17Feb2021 04:00, general feeling of malaise, pressure building in my head and abdomen on 17Feb2021, felt a little colder than usual on 17Feb2021 08:30. No treatment was received for the adverse events. Under the tongue temperature reading was 97.9 (The patient was usually 97.5 with this thermometer) on 17Feb2021. The outcome of events was not recovered. No other vaccine in four weeks; No covid prior vaccination; No covid tested post vaccination  Information on the lot/batch number has been requested.
Chest pain shortness of breath for days, still on going. Went to cardiologist and went to ER. I was not admitted but said I had a positive d dimer indicating blood clot in the body so they checked my lung for blood clot and it was negative. But I still have chest painnand shortness of breath
1/3/2020, 8pm: 101 degree fever. Large (4"dia), painful, hot lump at injection site. Body aches. Took Tylenol. Fever gradually came down overnight. 1/4/2020, 1pm: 100.3 degrees. Lump on arm has spread out, gone down,  and is not as painful. Still taking Tylenol.
Three days after receiving vaccination I developed pronounced Tinnitus in both ears. A loud high pitched background noise that remains to this date.
I suddenly felt the right leg from the hip on down a rubbery feeling as if the leg was about to give way. Very weak. Within 30 seconds it went away. I went to the hospital because it felt as a TIA, Ct scan of my head to rule out bleeding. CTA of artery. Place mine on cholesterol medication. Also had to get an MRI of the head. Also notice numbness on spots on my right leg.
Pt recvd 1st dose Hep B vax 22MAR91 & 2 days later devel fever 101 to 102 & on 6APR91 devel a rash & seen by MD; tx DPH & Pred; On 7APR90 devel joint pains; MD felt exp was allergic rxn to vax;
Child noted to have tactile temp at home and had trouble latching onto bottle and then noted to be staring at ceiling and not moving. Had periodic episodes of shaking of tongue, hands and legs. Lasted about 5 hours and brought to the ER. Returned to baseline neuro status in ER- Had CT of brain and infectious workup including LP, blood culture and urine culture. LP neg to date and urine and blood cultures pending. EEG pending.
Patient received Moderna #1 vaccine (Lot 026L20A) on 12/29/2020 and Moderna #2 vaccine (Lot 029L20A) on 1/24/2021. Side effects with dose 1 - sore arm. Side effects with dose 2 - began 12 hours after vaccine (chills, myalgias, night sweats).  Resolved by 24 hours after the vaccine.  Patient tested positive for SARS-CoV-2 on 3/9/2021 via PCR testing through routine surveillance testing.  Patient is asymptomatic.  No known exposures and no recent illnesses.
bumpy arm; feels warm to the touch; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAPULE (bumpy arm), SKIN WARM (feels warm to the touch) and PAIN IN EXTREMITY (sore arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAPULE (bumpy arm), SKIN WARM (feels warm to the touch) and PAIN IN EXTREMITY (sore arm). At the time of the report, PAPULE (bumpy arm), SKIN WARM (feels warm to the touch) and PAIN IN EXTREMITY (sore arm) outcome was unknown.            For the second dose of mRNA-1273, the action taken was not applicable.  No concomitant medications were reported. No treatment was reported for these events.   This case was linked to MOD-2021-058178 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: Follow-up received 13-May-2021 included updated dates for both dose 1 and dose 2.
From telephone call received, it was reported : Patient received Fluzone vaccine administered 10/21/01 in her left deltoid. Within 2-3 days, congestion started. She reported large clumps of mucus. In the middle of the night, she couldn't breathe. Her doctor saw her to evaluate and put her on Clariton 10mg daily and Flonase once a day. Albuterol Inhaler PRN. Her doctor told her she had an allergic reaction to something in the Fluzone. Then she saw on TV last evening that this year's flu was causing 'Flu-Like symptom" and feels that this exacctly what happened to her. One month later she is still experiencing these problems.
Erythema, swelling, itching of anterior left thigh extending between L hip and L patella.
A very sore left arm with deep hematoma at injection site, developed by around 9pm. Overnight more pain and fever, hard to sleep.  Took Tylenol but the last few hours before the next dose were very painful. 10 am this morning temp 99.9º with headache and muscle aches. At 2pm temp 101º. Arm got better slightly after Tylenol but waiting for the next dose it is very painful again.
Site: Pain at Injection Site-Mild, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: eyelid swelling-Medium
Red marks down (R) leg (rash) has pain in R Leg off/on when playing felt warm to touch but no fever. TYLENOL and warm compress for pain.
Patient started experiencing covid symptoms on 5/28/21 starting with cough, runny nose and cold symptoms. The patient then took an at home covid test and got a positive result so she went to her doctor and was confirmed positive with lab test.
Patient received vaccine on 9/19/13, called 9/20/13 said her body was sore and she wouldn't do any thing. She took ADVIL and 9/21/13 said feel better.
Crohn's disease flare ups; Felt achy; This is a solicited report from a Non-Interventional Study (FACILITATED COLLECT) based on information received by Pfizer from Company (manufacturer control number: 21K-163-3912380-00). A contactable 68-year-old female consumer (patient) reporter for herself that a 68-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1, dose 2 and dose 3 (booster), all via intramuscular on an unspecified date at single dose for COVID-19 vaccination; adalimumab (HUMIRA, Solution for injection in pre-filled pen), via subcutaneous from an unspecified date (Lot Number: 1138116) and from an unspecified date (Lot Number: 1150237) at citrate free for moderate to severe adult Crohn's disease. Medical history included were none and no known allergies. The patient's concomitant medications were not reported.  The patient experienced Crohn's disease flare ups and felt achy on an unspecified date. The action taken in response to the events for adalimumab was unknown. The outcome of Crohn's disease flare ups was resolved in 2021, the outcome of felt achy was unknown.   Causality for Humira (Adalimumab): The reporter's causality for the event(s) of Crohn's disease flare ups with Humira (Adalimumab) was no reasonable possibility. The reporter's causality for the events of Felt achy was not provided.  The reporter's assessment of the causal relationship of the events with the suspect product bnt162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the event Crohn's disease and pain and the suspect drug cannot be excluded. The case will be reassessed once new information is available.   The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
The patient's husband stated she woke up after receiving her second dose of the Moderna shot &  she couldn't move her fingers on left hand.  Also, she says her arm was very weak,  She called her doctor which preceded to tell her to go to the hospital. The patient arrived at  hospital & was admitted for 2 days.  Upon her discharge the doctors told her they believe she had a minor stroke. She starts rehab next week. I tried to reach out to patient several times about retrieving her current medication list but there was no answer.
Red warm tender left arm 8x3cm. Red warm tender right arm 12x3cm. KEFLEX 500mg 1Q6 hours x1 wk. BACTRIM DS 2 BID x1wk. ZYVOX 600mg 1 BID x7 days.
Severe, intense pain, cold sweats alternating with fever and chills, with extreme pain and malaise and nightmares for greater than 48 hours post vaccination.  I reported it to the vaccination clinic and they refused to submit on my behalf and told me it was all normal.
Muscle aches; Fatigue; Extremely heavy menstrual bleeding (abnormal).; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in the left arm on 12Apr2021 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. The patient's medical history included COVID-19. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any medication within two weeks of the COVID-19 vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the left arm on 22Mar2021 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 12Apr2021, with the second dose of vaccine, the patient experienced muscle aches, fatigue and extremely heavy menstrual bleeding (abnormal). Since the vaccination, the patient had not been tested for COVID-19. The events 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 events. The clinical outcome of the event's muscle aches, fatigue and extremely heavy menstrual bleeding (abnormal) were not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
pt recvd vax;mom said infant lump in lt thigh @ site of shot;no redness or swelling;no fever;lump size of quarter;will see MD monday
16 month old female inadvertently given Fluarix Quadrivalent dose of Influenza vaccine.
Gave patient less dosage. The patient was contacted and aware that she can get re-vaccinated.
Redness (the size of a hand) at the site of the injection  (some redness remained after almost 3 weeks); swelling and pain at site of injection lasted 2 weeks; extreme fatigue (3 days); fever (100 degrees, 2 days); stomach upset (some gastric distress, some diarrhea ); itching at site of injection; headache (off and on over several days); shivering (2 nights)  All these side effects were mentioned and none required a visit to the ER (i.e., no hives, no trouble breathing or swallowing, etc.) HOWEVER, the effects lasted much longer than the 3 days I was led to believe.  I called the pharmacy and they said to expect the redness/soreness to last a week ? not 3 weeks.  I?m wondering whether I had so many side effects because I previously had the the Zostavax vaccine and I previously had a mild case of shingles.
12:15 Client became hypotensive while having blood drawn in the Lab and approximately 1 hour after her Pfizer booster. Bandaid called, provider RT present, unable to obtain BP for about 15 minutes, then obtained BP of 76/40 Rt arm sitting. Client initially was unresponsive with eyes open X 30 seconds, then regained full consciousness. Color pale. Blood sugar 134, pulse 54, SpO2 SAT 98%. Client placed in a second chair and reclined to 180 degrees. Facial color returned to pink, rash appeared on client's arms chest and abdomen. Red non-raised, client states this happens when she gets hot, describes as "heat rash". 911 called and EMS here by 12:20, EMS placed client on a heart monitor, V/S taken, BP remains low at 78/4
This area had remained somewhat sore after the initial soreness the day of and the day after the vaccination. Red, welp, itching, stinging, burning, "hot" to touch after waking up this morning.  Redness patch/area approximately 4" x 3" Took extra dose of my allergy medication and applied Benadryl cream locally At 4:25 (time of this report) the area is not as "red" but still "hot" to touch and itching periodically.  Reddish/pink patch still the same measurement
hospitalized for 5 days for seizure-like activity, incidentally found to be positive for COVID
Started feeling lethargic a couple of hours after the vaccine on Friday. By Friday evening, I was aching and running a low-grade fever. On Saturday, I was still lethargic and running a low-grade fever. I felt like I was probably 20 years older than I am, with knees, back and other joints hurting really bad. Started feeling better by Sunday evening. Today (Monday), I am feeling about 100%.