chrisvoncsefalvay/vaers-outcomes huggingface dataset:
feel my heart pound really fast/her heart felt like it was pounding out of her chest; feeling of severe doom or dread; felt very bizarre/felt like she was going to lose her breath/felt like she was going to hyperventilate; began to become very tachycardic; This is a spontaneous report from a contactable nurse (patient). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot Number: EW0130, expiry date not reported), via an unspecified route of administration on 01Apr2021 as a single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient received the first dose of the Pfizer COVID-19 vaccine on 01Apr2021 and she would like to know if she should proceed with getting the second dose based on the nature of her reaction to the first dose. The patient stated, she received the vaccine and then 90 minutes later she began to feel her heart pound really fast and it started to feel like it was pounding out of her chest, accompanied by feeling of severe doom or dread. It felt very bizarre, felt like patient was going to die. She felt like she was going to lose her breath but she didn't. Her throat did not close up. She did not have a rash, and was not itchy anywhere. Patient took some Benadryl right away and it subsided. It lasted about a total 5 minutes, it felt like a very long 5 minutes. The anxiety was the worst she had every experienced. She had never experienced anything like that before. She would like some guidance regarding her second dose. She would like to know any information regarding the efficacy after one dose of the Pfizer COVID-19 vaccine. She also said she began to become very tachycardic on 01Apr2021 and felt extreme anxiety and it was the worst anxiety that came over her. She felt like she was going to die and might call it that and she did not really have trouble breathing but felt like she was going to hyperventilate. Therapeutic measures were taken as a result of the events "feel my heart pound really fast/her heart felt like it was pounding out of her chest" and "felt very bizarre/felt like she was going to lose her breath/felt like she was going to hyperventilate". The patient recovered on an unspecified date in Apr2021 from the events "feel my heart pound really fast/her heart felt like it was pounding out of her chest" and "felt very bizarre/felt like she was going to lose her breath/felt like she was going to hyperventilate". The outcome of the other events reported was unknown.; Sender's Comments: Considering the plausible drug-event temporal association, a contributory role of the suspect product bnt162b2 to the reported events cannot be excluded. 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 Regulatory Authorities, Ethics committees and Investigators, as appropriate.
The pt experienced widespread muscle and joint pain (chronic). Chronic fatigue and muscle weakness with activities, muscle tightness and spasms. Elevated anxiety and depression, mood swings that are sudden and severe. Chronic GI problems were also experienced. The pt states that all of the complications experienced were not listed only the most chronic and debilitating here.
Fever of 101; Feel crappy; Tired; Seeing spots; Pulse up to 120; B/p was 160; Light headed; Tingly; This is a spontaneous report from a contactable nurse, the patient. A 56-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown) via an unspecified route of administration in the left arm on 24Mar2021 at 11:00 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. Medical history included obesity and known allergies as blotchy and sensitive skin. Concomitant medications included cetirizine hydrochloride (ZYRTEC) 1 per day, 2000 units of colecalciferol (VITAMIN D3) and 500mg of ascorbic acid (VITAMIN C); all from an unknown date for unknown indication. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 24Mar2021, 10minutes after the shot, the patient was driving and started seeing spots, pulse was up to 120, blood pressure was 160 at the fire station. Light headed and tingly. Done in 3 hours and left ED. Next day (25Mar2021), the patient experienced just tired. On day 5, (29Mar2021), the patient experienced fever of 101 and felt crappy. The patient took ibuprofen. The patient would talk to an allergist before taking the second one. Her risk factor was obesity BMI of 40. The events seeing spots, pulse was up to 120, blood pressure was 160, light headed and tingly resulted in emergency room/department or urgent care. Therapeutic measures were taken as a result of fever of 101, felt crappy and included treatment with ibuprofen (MANUFACTURER UNKNOWN). The clinical outcomes of spots, pulse up to 120, blood pressure was 160, light headed, tingly were recovered with sequelae on 24Mar2021. The clinical outcomes of tiredness, fever of 101, felt crappy were recovered with sequelae on an unknown date in 2021.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Fever 103 deg-improved at visit 9/8/02 100.2 degrees. Blotchy rash 12 hrs duration. Current vesicular-papular rash.
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 67-year-old male patient received BNT162b2 (BNT162B2), on 25Jan2021 as dose 1, single (Lot number: EL9261), in left arm, on 19Feb2021 as dose 2, single (Lot number: EN6200), in left arm, on 08Oct2021 as dose 3 (booster), single (Lot number: 30125BA), in left arm and on 05May2022 as dose 4 (booster), single (Lot number: FK9894) at the age of 67 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Moderate hypertension" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL, start date: Mar2022.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 27May2022, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results; (04Jun2022) Negative; (11Jun2022) Positive; (13Jun2022) Positive; (unspecified date) Negative; (27May2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: The patient received anti-viral product for COVID 19 Treatment, brand Pfizer, treatment start date: 27May2022, treatment stop date: 01Jun2022. The patient had a rebound of COVID-19 after testing negative with a rapid test. The patient contracted COVID from a colleague on 24May2022. The patient began to feel symptoms on 26May. The patient tested positive with a rapid test on 27May and was prescribed Paxlovid which he began to take the evening of 27May. The patient did not miss any treatments. The patient tested every day and was negative on 04Jun. His moderate symptoms also had disappeared. Moderate symptoms returned on June 8, and tested positive again on 11Jun. the patient still positive as of 13Jun.
Fully vaccinated patient admitted for COVID PNA.  Treated with Remdesivir and decadron.  Discharged to facility on 08/20/21.  Returned to ED on 08/22/21 with hypoxia and weakness, discharged back to facility with O2.  Returned to ED again on 08/30/21 with hypoxia and started on Bipap.  CTA showed extensive infiltrates and was negative for pulmonary emboli.  Started on empiric antibiotics with concerns for secondary infection/PNA, diuresis, and steroids.  Continued to decline and became comfort care on 09/02/21.   Went into cardiac arrest on 09/04/21 and died.
Information has been received from a pharmacist referring to unspecified numbers of patients with unknown age and gender. There was no information about the patients' medical history and concurrent condition. On unknown dates, the patients were vaccinated with improperly stored VAQTA (dose, lot# and route unknown). There was no information about concomitant therapy. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report was received from a physician assistant and refers to 1-month-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient was accidentally vaccinated with a dose of VAQTA lot # N030286 and expiration date: 10-NOV-2018 (dose and route of administration were not reported) instead of getting a pediatric dose of hepatitis b vaccine (recombinant) (manufacturer unknown), possibly due to product confusion. There were not adverse reactions reported.
I broke out in shingles on 4/25/22. I had it a week before I went to the doctor because I thought I had poison oak. I had a lump in my arm pit after my 3rd dose and it came back when I broke out in shingles and it's still there. I also had blurred vision in my right eye. I an still dealing with this at this time.
RECEIVED LESS THAN 0.5ML (APPROXIMATELY AROUND 0.3ML) OF VACCINE AS A BOOSTER DOSE; OFF LABEL USE; This spontaneous report received from a health care professional concerned a 60 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. On an unspecified date, the patient was previously treated with covid-19 vaccine ad26.cov2.s from unspecified manufacturer (suspension for injection, route of admin not reported, batch number: Unknown expiry: Unknown) dose was not reported (dose number in series was 1), 1 in total administered for prophylactic vaccination. It was unknown whether patient had any adverse event following vaccination with covid-19 vaccine ad26.cov2.s. The patient received covid-19 vaccine ad26.cov2.s (dose number in series was 2) (suspension for injection, route of admin not reported, batch number: 213D21A, expiry: 11-APR-2022) with dose less than 0.5 ml (approximately around 0.3ml), 1 total, administered on 01-DEC-2021 to right arm for prophylactic vaccination which was an off label use as patient received less than 0.5 ml of the Janssen covid-19 vaccine as a booster dose (LLT: Vaccine underdose)(both events dose number in series was 2). No concomitant medications were reported.  "As per the report, the health care professional (HCP) withdrew 8 doses of the Janssen Covid-19 vaccine from 5 vials and 7 doses from 1 vial which injected into 48 individuals. When the caller had a discussion with that HCP, mentioned that he/she injected 0.5 mL but the caller mentioned that the math (she arrived at that by dividing 2.5 mL by 5 doses) did prove that they received approximately around 0.3 mL." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the received less than 0.5ml (approximately around 0.3ml) of vaccine as a booster dose and off label use was not reported. This report was non-serious. This case, from the same reporter is linked to 20211210197, 20211209551, 20211210067, 20211209976, 20211210058, 20211210160, 20211210588, 20211210112, 20211209775, 20211210610, 20211210159, 20211210409, 20211210555, 20211210733, 20211210408, 20211209880, 20211210133, 20211209816, 20211209782, 20211212088, 20211212082, 20211210662, 20211209679, 20211209740, 20211210670, 20211210824, 20211210350, 20211209912, 20211210141, 20211210585, 20211210107, 20211209921, 20211210684, 20211210590, 20211210334, 20211210165, 20211210143, 20211210106, 20211210019, 20211209843, 20211209706, 20211209884, 20211209874, 20211209798, 20211210549 and 20211210180.
This case was reported by a nurse via sales rep and described the occurrence of injection site erythema in a 4-year-old female patient who received FLULAVAL TETRA 2018-2019 season (batch number 4DY9K, expiry date 7th June 2019) for prophylaxis. On an unknown date, the patient received FLULAVAL TETRA 2018-2019 season. On an unknown date, less than 2 months after receiving FLULAVAL TETRA 2018-2019 season, the patient experienced injection site erythema, injection site swelling and injection site itching. On an unknown date, the outcome of the injection site erythema, injection site swelling and injection site itching were unknown. It was unknown if the reporter considered the injection site erythema, injection site swelling and injection site itching to be related to FLULAVAL TETRA 2018-2019 season. Additional information was reported as follows: On 18th September 2018, the patient's mother called and stated that the patient experienced redness and swelling at the injection site and the patient in care of, also experienced itchiness to the injection site area. On 19th and 20th September a call was attempted in order to contact the patient's mother but haven't heard here back till the time of reporting.
I awoke at 3:30 AM the following morning after vaccine with aches, headache mild and fever 99.8.  I took extra strength Tylenol and a glass of water.  By 7 AM aches gone, no headache and fever down to 99.1.
Right after shot , pain in arm , some reddening but disappeared after 3 day s.  The 2 days later it started again and has been sore ever sinc e.. upper arm sore , red and quite hard; shoulder area and neck also very painful
Arm is real sore/Can not lift and hold arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Mar-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY. At the time of the report, PAIN IN EXTREMITY outcome was unknown. Not Provided.          Treatment details includes Biofreeze, Heating Pad, Trying exercise it. No concomitant medication was reported.
Headache, Malaise, Extreme fatigue, Loss of appetite, somnolence, mood chages (lasted 48 hours)  Severe redness and swelling of injection arm all the way from the shoulder to the elbow. Redness and swelling still persists on day 3 (Dec 30th).
Information has been received from a 63 year old male patient concerning himself who was involved in a patient assistant program. The patient's medical history includes herpes. The patient was allergy to penicillin. On 27-APR-2015 the patient was vaccinated with ZOSTAVAX (dose, lot #, and route were not reported, strength: 19400 PFU). Concomitant therapies included FLOMAX. On 27-APR-2015, the patient was itchy after receiving ZOSTAVAX. No treatment was given for the event. No lab diagnostics studies were performed. The patient had not sought medical attention. The outcome of the event was reported as recovered on 28-APR-2015. Additional information has been requested.
This case was reported by a healthcare professional and described the occurrence of a red circle around the injection site in a subject of unspecified age and gender who was vaccinated with Flulaval (GlaxoSmithKline) for prophylaxis.  On 30 October 2007 the subject received a one time dose of Flulaval at 0.5 ml in the left arm.  On 30 October 2007, at an unspecified time after vaccination with Flulaval, the subject experienced an injection site reaction.  The subject developed a 1.5 inch circular, red, hot injection site reaction.  At the time of reporting the outcome of the events was unspecified.
Initially had lump and pain at the site of the Tdap injection which according to the patient lasted until approx. 11/18/2009 when some liquid came out of the area of the injection site.  Seen by Dr. on 11/19/2009 and culture of the serous fluid from the wound performed and approx. 1-2 mm small hole was observed at the injection site on the right deltoid.
In the evening of the vaccine shot, I felt a slight body temperature rise and a dull headache, these lasted throughout the next.  By the  next day (two days after the shot), these effects were gone.  The subsequent day I also felt fine.  But on the next day (the fourth day since the shot), I felt very tired, slightly nauseated, and had a mild headache.  These are all not normal and very strange.  The next day, these effects were still present but less so.  The next day (6 days since the shot), they were diminished again and almost gone.  It seemed very strange that I had side effects that started on the day of the shot, but then these were resolved within 48 hours.  However, two days later, side effects returned and new effects came.
Stomach aches, chills then had black black stools.   Followed by vomiting, body aches, headache.   2nd day extreme tiredness, unable to stay awake then slept 10 hours.    Injection site stopped hurting on 3/1/2021
Information has been received from a consumer concerning her 8 year old son who on an unspecified date was vaccinated with PNEUMOVAX 23 (lot # not reported). The mother reported that her son, who could skid down the sidewalk on his face with barely a tear, was curled up in a fetal position in horrible pain and throwing up every ten minutes, because of this vaccine. On 21-SEP-2010, the patient required an emergency room visit secondary to side effects experienced as a result of PNEUMOVAX 23. He and his father spent almost six hours at the emergency room. His pain was so intense, so they gave him VICODIN and they had to give him a medicine for cancer patients to stop the dry heaves and stomach convulsions. The reporter was angry that PNEUMOVAX 23 resulted in unnecessary pain and misery for the patient. At the time of report, the outcome was unknown. Additional information has been requested.
Patient say since received FLUZONE HD vaccine on 11/9/15 she is having problem with sore arm. States loss of strength in arm that has increased in last 2 months.
She showed signs of a staff infection at the site (redness, 4 inch circumference swelling, very hot at site, lethargic), was treated on 2/11/12 with multiple antibiotics and it improved. The lymph nodes on the back of her head were very swollen and she had a mild fever. On 2/21/2012 her cheeks swelled up and by the next day, her body was covered head to toe in an itchy, bumpy rash.
Right thigh slight redness,swelling, warm to the touch. Treatment: Tylenol, apply warm compress to area.
A red, oval rash near the injection site that appeared 7 days after receiving the moderna vaccine.  The rash is neither painful nor itchy.  There is no soreness or tenderness when touched. The rash first appeared this morning.  I am closely watching it to see if it spreads or goes away.   My left arm was sore after receiving the vaccine but the soreness decreased each day and was gone by the 3rd day after receiving the vaccine. I expected something like that to happen.  I did not expect to see a rash a week after receiving the vaccine.
About 1 hour after vaccination given patient felt tired and had just enough time to lay down before she passed out for 6 hours. When she came to she attempted to stand up and fell hitting her face and head. She had a bruise on her forehead and chin but no cuts. Patient has continued to be shaky, dizzy, and nauseated with her symptoms getting a little better with each day. She has also had a bad headache since 8/6 but it is improving.  She is still not back to normal. She did not seek medical attention.
Pt recv vax on 8/20/97; on 8/26/97 pt exp herpes zoster.
Top of left arm swollen very tight from shoulder to elbow and broke out with a rash, almost looked like blisters (but was not). That night I was very ill. Took 5 or 6 days for arm to be back to normal.
3 1/2 hours after receiving 2nd dose.  Extreme abdominal pain that lasted 1 1/2 hours.    I had the same pain after the 1st dose-but it happened 6 days after receiving the dose.  Exactly the same pain and lasting 45 minutes.
severe irritability, crying 3:30AM-6PM; adm to hosp 5/19/99;no fever, discharged 5/21/99;sepsis w/u completed;
Five days after the initial dose, I noticed swollen lymph nodes near the armpit of my left arm.  I received the injection in my left arm.  The lymph nodes were tender and I experienced pain in the armpit area.  Seven days after the initial dose, I woke up in the middle of night feeling like my body was on fire with pain on my left side.  I took my temperature and it was 99.3.   Upon waking up in the morning one week after the initial dose, the swelling was gone in lymph nodes.  However, a red  rash appeared near the injection site on my left arm.  The rash was tender and warm to the touch.  My left arm was tight and painful.  As of day nine after the injection, the rash is itchy and has moved slightly down my arm.  Pain has diminished but there is still tightness in my upper left arm.
its been 2 months since my first dose; the county I live in doesn't have any second doses; the county I live in doesn't have any second doses; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (its been 2 months since my first dose), PRODUCT AVAILABILITY ISSUE (the county I live in doesn't have any second doses) and PRODUCT ADMINISTRATION INTERRUPTED (the county I live in doesn't have any second doses) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (its been 2 months since my first dose), PRODUCT AVAILABILITY ISSUE (the county I live in doesn't have any second doses) and PRODUCT ADMINISTRATION INTERRUPTED (the county I live in doesn't have any second doses). At the time of the report, PRODUCT DOSE OMISSION ISSUE (its been 2 months since my first dose), PRODUCT AVAILABILITY ISSUE (the county I live in doesn't have any second doses) and PRODUCT ADMINISTRATION INTERRUPTED (the county I live in doesn't have any second doses) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant drug was not reported. Treatment medication was not reported.
swelling all over the left side of her body which is the side she got it on. She went and saw her PCP who gave her a steroid pack and told her to take Advil and Benadryl. She is still having problems today with arm pain. They are saying that there is possibly nerve involvment
Pt was given flu shot on Saturday 9/21/13 and when she woke up the next day her left arm was swollen and red. She use ice for the inflammation and has since gone down but still red.
Red spots that are hot to the tough on left arm below and on side of injection site.  Fatigue
Dose 1 - About 12 hours after, a rash appeared. At 20 hours, it had grown 6 times in size. I contacted the online dr and was told to take Claritin or Benadryl. I took Claritin and it cleared up.  Dose 2 - About 6 hrs later, I got diarrhea. An hour later, I had a headache. I went home and took Melatonin and Excedrin Migraine. At around 5 am, I started having full body muscle aches in addition to the headache. I threw up around noon the next day. Around 7 or 8 that evening, I started to feel better.   Around March, I was presumed positive for COVID.