chrisvoncsefalvay/vaers-outcomes huggingface dataset:
1. First dose, July 28th, 2021 at 12:30 pm:   a. While injection administration:     i. Immediately acquired metal taste in mouth that lasted for 5 days     ii. Super sensitive and painful teeth to even the air that also lasted for 5 days   b. 7 minutes after injection:     i. Entire body started uncontrollably trembling, which lasted for approximately 2 hours     ii. Fingers and toes became numb and tingly, also lasted for approximately 2 hours   c. Next morning, July 29th, 2021, upon waking, 4 am:     i. Sore, bruised feeling fingers, like I had been punching the walls, which lasted 10 days   d. 2 days after injection, July 30th, 2021, upon waking 4 am:     i. Folliculitis outbreak on my torso that I haven?t had in over 9 years.  It started to lessen 2.5 weeks after the first dose, but then the second dose made it even worse.  At this time, September 3rd, I am still combatting the folliculitis.  I have been treating with known, effective treatments since the day of outbreak. 2. Second dose, August 18th, 2021 at 11:30 am:   a. While injection administration:     i. Immediately acquired metal taste in mouth that is still haunting me as of September 3rd.  The severity has lessened after 8 days, but still remains with me today.     ii. Super sensitive and painful teeth to even the air that is still haunting me as of September 3rd.  The severity has lessened after 8 days, but still remains with me today.   b. 7 minutes after injection:     i. No body trembling this time.     ii. Fingers and toes became numb and tingly and still lingering to this day, September 3rd, even though, there has slightly improved.  But still far from normal.   c. Next morning, August 19th, 2021, upon waking, 4 am:     i. Herpes, Simplex 1, outbreak, which I was able to treat and mitigate within 5 days.  I haven?t had any signs of outbreak in over 11 years.     d. 16 hours after injection:     i. Received all the normal expected reactions, besides fever:  entire body soreness, aches, bad headache, super weak, nausea, etc.  All which lasted approximately 6 hours     ii. Sore, bruised fingers, like I had been punching the walls, which lasted consistently for just over 2 weeks (September 1st), but now comes & goes throughout every day  It is obvious that many of these symptoms are nervous system symptoms.  There is no evidence that any of these symptoms are due to stress either.  When my husband was diagnosed and underwent chemotherapy and radiation for his stage 4 throat cancer and my father and closest best friend passed away two years ago, that is when I experienced extreme stress without any of the symptoms/reactions listed above.   Maybe the vaccine reacted to my nervous system or maybe it lowered my immune system that allowed some of these reactions to happen or maybe it was a combination of both.  My major concern, at this time, is that any additional, future COVID-19 vaccines will cause or setoff something much worse than what is already described above that may become permanent damage to my health.  Also, there is no idea that some of these issues already aren?t permanent.
but thinking that she is a covid positive.; but thinking that she is a covid positive.; This is a spontaneous report from a contactable consumer (patient) reported that a female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: UNKNOWN) via an unspecified route of administration on 25Feb2021 as a single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. After 1st dose she was thinking that she was a covid positive on an unspecified date in 2021. The patient 2nd dose vaccine was scheduled on 19Mar2021. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Injection site is sore and very tender to the touch. Swelling and hardness surrounding injection about a 2 Inch square. Also random itching throughout the body including ankles and back of neck
Patient reports having unexpected menstruation one week after the second and third dose of the COVID-19 vaccine. Additionally c/o breast swelling beyond one bra cup size.
This spontaneous report was received from a nurse referring to multiple unspecified patients of unknown age and gender. The patients' pertinent medical history, drug reaction/allergies or concomitant information was not reported. On an unknown date the patients were vaccinated with improperly stored doses of GARDASIL 9 lot #: M028323 with expiration date: 26-SEP-2018, lot #: M023169 with expiration date: 13-JUN-2018 and lot #: M009378 with expiration date: 23-APR-2018 (dose and route were not provided). The reporter stated that the GARDASIL 9 vaccines were exposed to -2.2 C for 41.4 hours and 11.6 C for 149 hours. Additionally, the improperly stored doses were administered from 15-SEP-2016 thru 01-NOV-2016. No adverse event was reported. There was no product quality complaint (PQC) involved. This is one of several reports received from the same reporter. Additional information has been requested
feels really weird; cannot sleep and would wake up every hour; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FEELING ABNORMAL (non-serious), outcome "unknown", described as "feels really weird"; SLEEP DISORDER (non-serious), outcome "unknown", described as "cannot sleep and would wake up every hour".  Additional information: The patient wanted to know the vaccine's side effects. This was because 4 days after her vaccine shot, she felt really weird. She cannot sleep and would wake up every hour. She wanted to know if this was a possible side effect of the vaccine.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
The patient received a dose of the vaccine following temperature excursions on unknown dates; No adverse event; This spontaneous report as received from a medical assistant refers to a current 1-year-old patient of unknown gender.  The patient's concurrent conditions, medical history and concomitant medications were not provided.   On an unknown date, the rotavirus vaccine, live, oral, pentavalent (ROTATEQ)  (lot # S013439 with expiration date 03-MAR-2021, lot # S013436 with expiration date 30-JAN-2021, and lot # S006050 with expiration date 12-DEC-2020) underwent a temperature excursion.   Temperature Total Time and LOWEST Temperature BELOW 36°F/2°C (0C) Time frame 7 hours 30 minutes Previous temperature excursion? yes, Total Time and LOWEST Temperature BELOW 36°F/2°C (0C) for 8 hours 30 minutes Was call because of a "data logger"? yes  On an unknown date, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) at a dose of 2 ml (route not provided) as prophylaxis. No adverse events were reported.  This is one of several reports received from the same reporter  This spontaneous report as received from a other health professional refers to a patient of unknown age.    On an unknown date the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # S006050, 2 milliliter for prophylaxis.       On an unknown date the patient experienced product storage error and no adverse event.    The outcome of product storage error and no adverse event is unknown.   The reporter considered product storage error and no adverse event to be not assessed to Rotavirus Vaccine, Live, Oral, Pentavalent(ROTATEQ).     {Additional information has been requested. / Additional information is not expected.}; Sender's Comments:  US-009507513-2005USA003382: US-009507513-2005USA004545: US-009507513-2005USA004950: US-009507513-2005USA004951: US-009507513-2005USA004953: US-009507513-2005USA004954: US-009507513-2005USA004955: US-009507513-2005USA004956: US-009507513-2005USA004957: US-009507513-2005USA004958: US-009507513-2005USA004959: US-009507513-2005USA004960: US-009507513-2005USA004961: US-009507513-2005USA004962: US-009507513-2005USA004963: US-009507513-2005USA004964: US-009507513-2005USA004965: US-009507513-2005USA004966: US-009507513-2005USA004967: US-009507513-2005USA004968: US-009507513-2005USA004969: US-009507513-2005USA004970: US-009507513-2005USA004971: US-009507513-2005USA004972: US-009507513-2005USA004973: US-009507513-2005USA004974: US-009507513-2005USA004975: US-009507513-2005USA004976: US-009507513-2005USA004977: US-009507513-2005USA004978: US-009507513-2005USA004979: US-009507513-2005USA004980: US-009507513-2005USA004981: US-009507513-2005USA004982: US-009507513-2005USA004983: US-009507513-2005USA004984: US-009507513-2005USA004985: US-009507513-2005USA004986: US-009507513-2005USA004987: US-009507513-2005USA004988: US-009507513-2005USA004989: US-009507513-2005USA004990: US-009507513-2005USA004991: US-009507513-2005USA004992: US-009507513-2005USA004993:
PFIZER purple top vial reconstituted with 0.18 ml of diluent instead of 1.8 ml. Patient received only dose from this vial. Next morning reports mild body aches and moderately sore arm. Reports arm of injection site is more sore than with first two doses.
Within an hour of the injection developed pain at the injection site (treated w/ ice and ibuprofen) -- no notable redness or swelling. Approximately 48-hr later began to notice pain in left upper back area. The pain worsened and by another 24-36-hr, the pain was significant and lying down was very uncomfortable and trying to get up even more so. The pain felt deeper than muscular and I became concerned that something was affecting my lungs (did not experience any breathing problems -- no SOB or added discomfort when inhaling or exhaling). I had a viral induced pleuritis and pericarditis several years ago from Coxsakie B and was becoming concerned that was happening again. Treated with 800mg ibuprofen and topical pain relieving rub. By the next morning, pain was lessened enough that I did not seek medical treatment. The pain continued to lessen each day and by one week following the injection, was back to normal.
Vaccine Symptoms 8/27/21 @ 2:38 pm, Initial dose-Pfizer: 2:43pm dizzy/light headed, like something pushing on chest; 2:48pm increased heart rate to 120bpm, left eye twitching; 2:53pm same symptoms as above; 2:58pm itching in left arm and chest; 3:03pm minor full body shakes; 3:08pm same symptoms; 3:13pm same; 3:18pm same; 3:23pm same; 3:28pm same; 3:33pm same; 3:38pm same released home; 4:00pm feel drained, arm sore, same symptoms as above; 4:30pm shaking eased up; 5:00pm heart rate returning to normal; 5:30pm muscle pain intensifying, pain across chest, feels tight, face pain across cheeks, forehead, orbital areas; 6:00pm neck and base of skull feel tight, painful, jaw pain and same face pain symptoms, right eye twitching; 7:00pm neck stiffness worse, could fall asleep now, muscle pain still getting worse, face pain; 8:00pm muscle pain includes back now, almost like kidney/upper abdominal pain; 9:00pm same; 10:30pm same; 8/28; 2:30am kidney/upper abdominal pain getting worse, slight cough; 5:30am diarrhea, coughing increased; 6:15am left kidney/upper abdominal area pain intensifying, like a stabbing pain now, not just an ache; 8:00am stabbing pain not as bad. Body aches and joint pain; 11:00am stomach/mid abdominal pains, body/muscle/joint aches; 12:00pm stomach pains back, right side; 12:45pm horrible side pains, diarrhea; 1:00PM diarrhea, abdominal pains; 1:30PM abdominal pains; 2:00PM self administered epi pen, Albuterol, called 911; 2:15PM In ambulance, morphine, Zofran, no relief; 2:40PM @ SFH; Blood work, CT, confirmed appendix inflamed; 10:30ish pm appendectomy and repair of internal bleeding; 8/29; 2:00am released to home.
Feeling of lightheadedness/Dizzziness; Loud tinnitus; Sensitivity to lights; Limited ability to live; Walking is very unpleasant; Vestibular system compromised; Feels brain is floating off-balance inside my skull; Difficulty to focus on anything for any length of time; cant drive more than 20 minutes; Anxiety; Life altering and debilitating; Fatigue; Headaches; Violent vertigo; Flu like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (Violent vertigo), DIZZINESS (Feeling of lightheadedness/Dizzziness), TINNITUS (Loud tinnitus), PHOTOPHOBIA (Sensitivity to lights) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Limited ability to live) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004C21A and 040B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In May 2021, the patient experienced VERTIGO (Violent vertigo) and INFLUENZA LIKE ILLNESS (Flu like symptoms). On an unknown date, the patient experienced DIZZINESS (Feeling of lightheadedness/Dizzziness), TINNITUS (Loud tinnitus), PHOTOPHOBIA (Sensitivity to lights), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Limited ability to live), GAIT DISTURBANCE (Walking is very unpleasant), VESTIBULAR DISORDER (Vestibular system compromised), FEELING ABNORMAL (Feels brain is floating off-balance inside my skull), DISTURBANCE IN ATTENTION (Difficulty to focus on anything for any length of time), IMPAIRED DRIVING ABILITY (cant drive more than 20 minutes), ANXIETY (Anxiety), ASTHENIA (Life altering and debilitating), FATIGUE (Fatigue) and HEADACHE (Headaches). In May 2021, INFLUENZA LIKE ILLNESS (Flu like symptoms) had resolved. At the time of the report, VERTIGO (Violent vertigo), DIZZINESS (Feeling of lightheadedness/Dizzziness), TINNITUS (Loud tinnitus), PHOTOPHOBIA (Sensitivity to lights), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Limited ability to live), GAIT DISTURBANCE (Walking is very unpleasant), VESTIBULAR DISORDER (Vestibular system compromised), FEELING ABNORMAL (Feels brain is floating off-balance inside my skull), DISTURBANCE IN ATTENTION (Difficulty to focus on anything for any length of time), IMPAIRED DRIVING ABILITY (cant drive more than 20 minutes), ANXIETY (Anxiety), ASTHENIA (Life altering and debilitating), FATIGUE (Fatigue) and HEADACHE (Headaches) had not resolved.            Concomitant product information and treatment information was not reported. Patient had a worst random vertigo episodes
sore arm; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm". Additional information: The person reported having a sore arm after the vaccine was administered. 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.
I got my fourth Pfizer shot a couple of weeks ago, and I got a big hematoma at the site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 4 (booster), single for covid-19 immunisation. Relevant medical history included: "immunocompromised" (unspecified if ongoing), notes: She said she's an immunocompromised person . The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series complete, MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (Dose number unknown, MANUFACTURER UNKNOWN), for Covid-19 immunization. The following information was reported: VACCINATION SITE HAEMATOMA (non-serious), outcome "unknown", described as "I got my fourth Pfizer shot a couple of weeks ago, and I got a big hematoma at the site".  Additional information: Patient explained that, explained that she had hematoma after getting her 4th dose of Pfizer covid vaccine. She said she was an immunocompromised person and she worries that maybe the shot did not go into the muscle and that she did not get the whole benefit of the vaccine. she wants to thank Pfizer for making a life-saving vaccine. She was truly grateful for our product.  The lot number for bnt162b2 was not provided and will be requested during follow up.
She is still freezing to death; Sick as a dog; Fever; Chills; cannot eat and have no appetite; nauseous; This is a spontaneous report from a contactable nurse (patient). A 79-year-old female patient received first dose of bnt162b2 (also reported as Pfizer Covid vaccine, lot number: EK4176), intramuscular into left arm on 05Jan2021 16:00 at single dose indicated as presentation because she is a nurse/Covid-19 immunization. Medical history included Type 2 Diabetes, about 2 years ago in 2019 in which she takes metformin 1,000mg twice daily. Concomitant medication included metformin on unspecified date at 1,000mg twice daily for Type 2 Diabetes. There was no history of all previous immunization with the Pfizer vaccine nor there were additional vaccines administered on same date of the Pfizer Covid vaccine. The patient received the Pfizer COVID vaccine last Tuesday and since 06Jan2021 at 06:00, she has been sick as a dog. She is running a fever, has chills, can't eat and has no appetite because she is nauseous; all on 06Jan2021 at 06:00. This is the third day of it.  She would like to know what she can she do. She said that it all started Wednesday morning when she got up. It just gets worse every day.  It looks like it would get better by now, but it hasn't.  She never runs a temperature, but she has now (unspecified date).  She is still freezing to death on unspecified date. She usually has a good appetite.  Even the thought of food makes her sick. She further reported that she has had nothing but chills, fever, and nausea and states it will not go away. She is treating it with ibuprofen. She confirms she already talked to a nurse in this department to report this and she was transferred to see what she could do and states they never answered. This is her first dose and she does not know if she should get the second dose. The patient can't calm down since she has been sick since last Wednesday. She stated that she needed some help because she is so sick. She was suggested to call again calling Pfizer medical information department. She stated that she had called back three times, but there is no such number. The events sick as a dog, fever, chills, can't eat and has no appetite, and nauseous were considered serious (Other medically important condition). The outcome of the events sick as a dog, fever, chills, can't eat and has no appetite, and nauseous was not recovered, and the outcome of the remaining event was unknown.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be completed based on known safety profile and a compatible temporal relation between vaccination and onset of events.  The impact of this report on the benefit/risk profile of the Pfizer product 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 RAs, Ethics Committees, and Investigators, as appropriate.
1ST DOSE MODERNA VACCINE GIVEN TO 12 YEAR OLD FEMALE ON 8/3/2021.  NO NEGATIVE OUTCOME TO PATIENT AS PER GRANDMOTHER. NOTICED THE ERROR ON 8/17/2021 WHEN SUBMITTING VACCINE FORM. CALL PLACED TO GRANDMOTHER NOTIFIED AND SHE REPORTS THE CHILD IS FINE AND NO ISSUES AFTER THE VACCCINE.  SHE REPORTED THAT HER GRANDAUGHTER'S FRIENDS ALSO RECEIVED THIS VACCINE AT ANOTHER CLINIC AND THIS WAS HER PREFERRED VACCINE.
Patient received vaccines x2 in RIGHT arm via injection by MA. After administered, patient began to zone out and brief LOC. Easily aroused. N/V, low BP noted. Ice packs applied, monitored BP. As BP increased, patient's color returned. Patient was A&O x4 upon leaving clinic via wheelchair. Parent drove patient home.  All resolved within 10 minutes
Tested positive for COVID-19 at urgent care in Aug2023.; sinus and congestion issues/Tested positive for COVID-19 at urgent care in Aug2023.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 72-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; bnt162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "AFib" (ongoing), notes: before 2007, cardioversion didn't work, so lives with AFib now. Tried a medication for a year or so.; "Patient had sinus and congestion issues in the fall", start date: 2007 (unspecified if ongoing); "cardioversion" (unspecified if ongoing), notes: didn't work, lasted 2 or 3 weeks, back in AFib. The patient's concomitant medications were not reported.The following information was reported: DRUG INEFFECTIVE (medically significant) with onset Aug2023, outcome "unknown", described as "Tested positive for COVID-19 at urgent care in Aug2023."; COVID-19 (medically significant) with onset Aug2023, outcome "unknown", described as "sinus and congestion issues/Tested positive for COVID-19 at urgent care in Aug2023.". The events "tested positive for covid-19 at urgent care in aug2023." and "sinus and congestion issues/tested positive for covid-19 at urgent care in aug2023." required emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Aug2023) Positive. Additional information:Clarified and confirmed had prior Pfizer COVID vaccines, had first 2 doses and then a booster and maybe another booster. Confirmed all doses were the Pfizer COVID vaccine. Tested positive for COVID-19 at urgent care in Aug2023. Patient had sinus and congestion issues in the fall. Patient didn't test at that time, then 2 days later was getting worse, clearly had COVID, didn't get a positive COVID test until 2 days after caller did. Patient had lingering sinus things  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5, bnt162b2 has been requested and will be submitted if and when received.