chrisvoncsefalvay/vaers-outcomes huggingface dataset:
loss of appetite; spontaneous bleeding under skin by right eye; severe pain under arm in armpit with swelling; severe pain under arm in armpit with swelling; hot feeling on skin; extreme fatigue; had some itchy skin and redness an hour after shot, especially on both arms; had some itchy skin and redness an hour after shot, especially on both arms; Extremely nausea/Often nauseous; insomnia; mild diarrhea; This is a spontaneous report from a contactable Other HCP (patient). A 48-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EM9809; expiration date not provided), via an unspecified route of administration (anatomical location: arm right) on 09Feb2021 18:00 at SINGLE DOSE for COVID-19 immunisation. Medical history included asthma and known allergies to sulfa drug both from unknown dates and unknown if ongoing. The patient has no COVID prior vaccination. Patient is not pregnant. The patient's concomitant medications were not reported. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL9262; expiration date not provided) on 19Dec2020 02:30 pm (vaccination location: left arm) and experienced dizziness, extreme itchy skin, headache, and fatigue reported as 'After 1st shot had dizziness and extreme itchy skin 1 hour after shot for approx 2 hours before it ended, then headache and fatigue for 1-2 days. However, after 48 hours all effects from the 1st shot were gone'. The patient experienced spontaneous bleeding under skin by right eye on 14Feb2021. Patient's clinical course is as follows:  After 2nd shot, patient had some itchy skin and redness an hour after shot, especially on both arms that lasted a couple hours (started at 7PM and stopped at 9PM). Patient also had extreme fatigue everyday since 11Feb2021, as well as insomnia especially during the first 48 hours. Also had total loss of appetite the past 8 days (17Feb2021), extremely nauseous and mild diarrhea everyday since immediately after 2nd shot until now (8 days later) with no improvement. Often nauseous until close to the point of vomiting. 2 days after 2nd shot started having severe pain under arm in armpit area with swelling and hot feeling on skin. Developed some spontaneous bleeding under skin by right eye about 5 days (14Feb2021) after shot which has now gone away. Fatigue and health is poor with no improvement; most effects seem to be getting worse instead of improving each day. Patient was not COVID tested post vaccination. It was reported that no treatment was provided for the events. Outcome of the event 'had some itchy skin and redness an hour after shot, especially on both arms' was recovered on 09Feb2021; outcome of the event 'spontaneous bleeding under skin by right eye' was recovered; outcome of the remaining events was not recovered.
Temp at 8:30pm 99deg. F. Parent states child vomited at 6:30pm, vomited three more times (last tiem at 4:30am 02/28/2002). Parent gave child Prosoghe six times since 6:30pm 02/27/2002 about 8ox each bottle. No more vomiting since 4:30am.
Patient presented to her primary care provider on 2/11/2021 with right ear pain, numbness on right side of face and head, full feeling on right side of throat and right eye dryness. Patient had received 2nd dose of Pfizer COVID19 vaccine on 2/2/2021 and started feeling itchy from head to tow that lasted 24 hours. Was diagnosed with Bell's Palsy at this visit.  She then presented to the Emergency Department on 2/13/2021 with shortness of breath.
Vaccine given  at roughly 11:40 am. Client  went unresponsive at 11:45 am. Epi given in right thigh at 11:46 am, client responded well to Epi.  Vitals at 11:48 am: BP:  122/78, P:83, O2: 97% . Vitals at 1150 am : BP: 124/72 P: 97, O2: 85 %.  911 was called and client left via ambulance.
After looking at the billing of the vaccine, we have noticed that the vaccine was given prior to the three weeks recommended 2nd dose date. The patient has not called to report an adverse event, but we are trying to contact that patient at this time. We have had no luck getting the patient on the phone, but will continue to try to reach the patient.  We are still awaiting the return call from the patient to determine if there was an undo side effects.
Pt reported to ER for possible inadvertent inoculation of left eye with smallpox vaccine. Seen by Dr and treated wit Trifluridine Opt 1% gtt soln and Ciloxan 3% and referred to optometry for confirmation. Seen by Dr on 8Aug at 0730. Diagnosed with viral conjunctivitis with source unk. Dr unable to determine if conjunctivitis was due to an Atenovirus or Vaccinia. Unable to do culture due to antibiotics. Viral conjunctivitis.
Patient was administered shot by RN and he immediately stiffened up and eyes became distant and twitched. He was like this for 10 sec and was disoriented when he became aware of surroundings. EMS was contacted. They assessed him and took him to the hospital
Patient resided at  a LTCF.  He received the vaccine at this facility on 12/29/2020 and 2/23/2021.  He recently moved to  Assisted Living and only records of his initial dose on 12/29/2020 was forwarded to the new facility.  Patient received a third dose on 3/8/2021 at  Assisted Living Facility , which was intended to be his second dose of the vaccine.  The new LTCF was informed of this error on 3/8/2021 and no side effects have been reported as of 3/9/2021.
Tue 11/09 - Lymph Nodes left armpit swallow. Fever 101.5. Pain in moving left arm Wed 11/10 - Lymph nodes more swallow. Muscular pain everywhere. Fever 103.5. Headache. Stomachache. Vomit. Thu 11/11 - Lymph nodes very swallow. Muscular pain. Fever 101/102. Headache. Stomachache. Fri 11/12 - Lymph nodes swallow. Fever 101. headache. Sat 11/13 - Lymph nodes swallow. No more fever. headache.  Sun 11/14 - Lymph nodes swallow Mon 11/15 - Lymph nodes swallow
Otic pain Narrative: Left ear pain, similar to ear infection pain. More pain with jaw movement.
I experienced fever, fatigue, body aches, chills, and this lasted for 24 hour to 36 hours.
I woke up this AM with a stomach ache. I normally dont have one and I thought it was gas. By lunch I felt very Nauseated and my stomach hurts.
Just before 2 PM, I went to pharmacy for my 2nd Moderna shot.  I was due for my 2nd one on the 15th, however I was out of town and rescheduled the 2nd dosage, CT three days later.  The woman who gave me the shot made a noise when she injected me, something like "oh or oops" and suddenly I felt the vaccine run quickly down my arm.  She reached for something to dry it up and said nothing.  I said, was that vaccine running down my arm?  She said yes, but they put more than enough in the syringe so you are fine.  I asked how do you know that?  She didn't respond, told me to wait 15 minutes and that everything would be fine.  The next day, concerned because I have underlying conditions, I called pharmacy back.  The pharmacy manager was unaware of the event and took down my information.  Someone called me back a few minutes later and said they had no direction on what to do next, that they needed to reach out to pharmacy Corporate to report it and the CDC for guidance.  2 days later and I have heard nothing.  I called them back and pharmacy told me that they were waiting on direction, when I asked when I would hear back from them, they had no answer.  I then called the CDC number on the internet and spoke to someone who transferred me to a nurse who read information to me  and gave me directions to fill out an incident report on this website.  Part of what she read me (and then subsequently emailed me) stated that if 1/2 the dosage was given, that is fine, but if less than 1/2 (or if it can not be determined), that an additional vaccine should be given immediately in the opposite arm.  There is no way that the woman who gave me the shot knew how much went in my arm, her verbal reaction and the fact that she rushed me out of there is more than a little concerning.  I now don't know how well I am vaccinated, or what to do next.  Pharmacy told me that there is no data available on the adverse impacts of getting a 3rd vaccine at this point.  WHAT do I do now?
Temperature excursion at 48.3 Fahrenheit for 2 hours due to a power outage with no reported adverse event; Vaccine administered post excursion with no reported adverse event; Initial information received on 20-Sep-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 4 months old female patient who was administered vaccine post temperature excursion at 48.3 Fahrenheit for 2 hours due to a power outage with no reported adverse event while receiving vaccine IPV (VERO) [IPOL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HIB VACCINE CONJ (TET TOX) (ACTHIB), PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13), DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP) and ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ).  On an unknown date, the IPV (VERO) was exposed to a temperature excursion at 48.3 Fahrenheit for 2 hours due to a power outage with no reported adverse event (product storage error).  On 19-Sep-2022, the patient received 0.5 mL dose of suspect IPV (VERO) (formulation and strength not reported; lot V1A121M and expiry date: 15-Feb-2024) via intramuscular route in the right thigh for prophylactic immunization.  On 19-Sep-2022, (latency: same day) the patient was administered vaccine post excursion with no reported adverse event (poor quality product administered) following the administration of IPV (VERO).  Action taken was not applicable.  At time of reporting, the outcome was Unknown for both the events.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Mom states PT had fever of 107 & had szs; had not had Tylenol in 8-9hrs a/szs; @ 5AM had szs & was hospitalized; rx: Phenobarbitol; wk of 13SEP91 had fever of 104 & more szs; 17SEP91 PT placed on phenobarbital 'til age 3;
Feels a  little bit woozy; Lingering fatigue; Occasional chills; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Feels a  little bit woozy), FATIGUE (Lingering fatigue) and CHILLS (Occasional chills) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012F21(B or 6), 037K20A and 023M20A) for COVID-19 vaccination.     The medical history was not provided by the reporter.  Concomitant products included SERTRALINE for Anxiety, AMLODIPINE for Blood pressure, ATORVASTATIN for Cholesterol, LEVOTHYROXINE for Hypothyroidism, ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DIZZINESS (Feels a  little bit woozy), FATIGUE (Lingering fatigue) and CHILLS (Occasional chills). The patient was treated with NAPROXEN SODIUM for Adverse event, at a dose of 1 dosage form. At the time of the report, DIZZINESS (Feels a  little bit woozy), FATIGUE (Lingering fatigue) and CHILLS (Occasional chills) outcome was unknown.            This case was linked to MOD-2021-371333 (Patient Link).
p/vax pt devel small vesicular papules on arms, abd & neck which have become infected;rx for keflex, hydrocortisone;
Chills during the night; fatigue the next day, nausea , redness around injection site (still there after five days). Did not seek medical attention
Temperature elevated- 4:30 Watering of eyes- 4:45 Shortness of breath-5:00 Hives- everywhere- 5:15 Swelling around face and neck- 5:30 (times are approximated)
Patient came to office with swelling on (R) side of neck/jaw. No complaint of pain or visual signs of trauma.
School nurse call to report child was crying due to pain in left arm.  Redness and swelling from shoulder to elbow.  Treated in school with ice and Motrin.  Mom reports rash-like redness almost to elbow (+) movement.  02/13/04: decreased edema; mom gave Benadryl, child returned to school. NOTE: Mother reports child received these same 3 shots (DTAP, IPV, HEP B) at PMD's somewhere else, but for some reason they were not recorded.  She states child's father took the child for those shots in Sept/Aug 2003.
Renal infarct--admit 12/23/21 to 12/24/21 at Hospital  Re-eval ER 12/29/21
Pt received flu vaccine on 10/21/02. On 10/24/02 the pt returned to the clinic complaining of a headache and dizziness, room was spinning and loss of concentration.
Case number PHEH2014US022564, is an initial spontaneous report received from a pharmacist on 07 Nov 2014. This report refers to a patient of unknown identifiers. The patient's medical history and concomitant medications were not reported. The patient was vaccinated with only Men C, Y, W-135 liquid component of MENVEO (batch number: not reported) intramuscularly on 15 Aug 2014 without being reconstituted with Men A lyophilized component of vaccine on unspecified date. No adverse event reported after the maladministration (inappropriate preparation of medication). No additional information was available at this moment.
The patient is an 83-year-old female with multiple medical problems including heart disease, heart failure, CVA, chronic renal failure and type 2 diabetes, along with a lifelong speech impediment (not related to her stroke), who presents to the emergency department with family members for evaluation of multiple complaints. The patient did recently test positive for COVID earlier in the week on Tuesday, December 14, and she also received monoclonal antibodies yesterday  Inpatient
This spontaneous report as received from a nurse refers to a 4-month-old patient of unknown gender. The patient's relevant medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 15-SEP-2017, the patient was vaccinated with improperly stored ROTATEQ (dosing details were not reported) (lot # M042170, expiry date: 22-JUN-2018) orally for prophylaxis. No adverse effects were reported. Temperature excursion was from 0 degree Celsius (C) to 1 degree C (0.8 degree C) for 52 minutes. The previous temperature excursion was reported as from 9 degree C to 25 degree C (10.9 degree C) for 3 hours 17 minutes. The call was because of a data logger. No product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA000054.
Pt vaccinated with MMR 24 hrs later child began shaking, became disoriented, school nurse reported "seizure like" activity. No fever. No urination. Electrolytes, Glucose, CBC checked. All normal.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Apr2022 as dose 4 (booster), single (Lot number: FR9895) at the age of 77 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: sulfa drugs" (unspecified if ongoing), notes: Known allergies: sulfa drugs. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 18Aug2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: COVID 19 Treatment; (15Aug2022) Positive, notes: On day 10 tested positive; (16Aug2022) Negative, notes: day 11 tested negative; (18Aug2022) Positive, notes: Day 13 tested positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional Information: Patient received vaccine. There was no any other medication received in 2 weeks. Therapeutic measures taken Anti viral details: for COVID 19 Treatment, Brand: Paxlovid Treatment start date: 05Aug2022, Treatment stop date: 09Aug2022, indication Treatment of COVID-19. Took paxlovid as prescribed for five days. On day 10 tested positive, day 11 tested negative, having milder symptoms for next couple of days. Day 13 tested positive, still having mild symptoms. Patient think patient having a rebound reaction.  No follow-up attempts are possible. No further information is expected.
This spontaneous report as received from a registered nurse refers to a patient of unknown age (gender unspecified). On 12-JAN-2012, the patient was vaccinated with the first dose of RECOMBIVAX HB, (lot number, expiry date and route was not reported). On 26-MAR-2012, the patient was vaccinated with the second dose of RECOMBIVAX HB, (lot number, expiry date and route was not reported). On 29-MAY-2012, the patient was vaccinated with the third dose of RECOMBIVAX HB, (lot number, expiry date and route was not reported). Concomitant medications were not reported. No adverse event was reported. Additional information is not expected.
dang shot made me  so sick/ Deathly ill with The FLU; Initial information regarding an unsolicited valid serious case was received from a non-healthcare professional (patient) via social media on 07-Dec-2020.  This case involved a patient of an unknown age and gender for whom it was reported that dang shot made so sick/ Deathly ill with The FLU (Illness) after receiving INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by an unknown manufacturer (lot number and expiry date were not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date (unknown latency), it was reported that the dang shot made the patient so sick that the patient was in the hospital for 2 weeks and was deathly ill with the flu (Illness). The patient further reported to stop it as the laboratory did not know how it reacted on people.  No relevant laboratory details were provided.  The event of influenza was reported as serious due to event caused hospitalization by the reporter. The patient was hospitalized for 2 weeks (14 days).  It was not reported if the patient received a corrective treatment.  Outcome of the event was unknown.  There will be no information available on the batch number for this case.; Sender's Comments: This case involved a patient of an unknown age and gender who presented with Illness after receiving  INFLUENZA VACCINE from unknown manufacturer. Time to onset is unknown. Although, medical history, concomitant medications, additional information on investigations ruling out other etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.
This spontaneous report was received from a registered nurse referring to a 3 year old patient of unknown gender. The patient's pertinent medical history and concurrent conditions were not provided.    On 13-DEC-2017, the patient was vaccinated with an improperly stored dose of M-M-R II lot # M040558, expiration date on 03-OCT-2018, for prophylaxis (strength and route were not reported). Concomitantly, the vaccine was reconstituted with a properly stored sterile diluent (MERCK STERILE DILUENT). The vaccine was also stored at a temperature of 50°F for a time frame of 2 hours. No adverse effects  neither previous temperature excursions for the improperly stored vaccine were reported. The call was because of a data logger. This case was one of several reports received from the same reporter.; Sender's Comments: US-009507513-1801USA002510: US-009507513-1801USA002511: US-009507513-1801USA002512: US-009507513-1801USA002513: US-009507513-1801USA002515: US-009507513-1801USA002516: US-009507513-1801USA002517: US-009507513-1712USA010085: US-009507513-1801USA002519: US-009507513-1801USA002520: US-009507513-1801USA002521: US-009507513-1801USA002522: US-009507513-1801USA002509: US-009507513-1801USA002508: US-009507513-1801USA002514:
Patient complaints of itching, redness, and heat to touch with a moderate-sized circle around the injections site.
After each Covid-19 injection, I experienced terrible pain in both arms, that eventually went to a soreness in my upper arm muscles that never went away. Around November 2022, I could hardly use my right shoulder or move my arm. This had happened earlier that year in my left shoulder/arm, somehow subsided. Not knowing what to do, as no one I knew or heard about was experiencing this continued pain after the vaccine injections. I was in so much pain with the right shoulder and arm that I went to Dr., Orthopedic, who diagnosed me with Frozen Shoulder after taking an x ray (11/10/22), of my right shoulder. He ordered me an MRI to confirm Bursitis, but I became claustrophobic and could not do the test. I saw Dr., Orthopedic who gave me a cortisone shot in my right shoulder on 12/16/2022, which did not appear to help, other than place me back several months to pain again.  When that went away about 5 days later, I went back to the progress I had already been making in physical theraphy. PA ordered Physical Therapy which I did from 12/06/2022 to 03/20/2023.  I had to stop the theraphy because I began hearing a wind noise in my head, went to PA, diagnosed with a double ear infection, which I have never had in my life. Although I continue to do my daily exercises, my arms and shoulders remain sore, and I do not have full range of motion. This has been a life changer for me, feeling like an invalid getting dressed, undressed, & showered.  The swishing noise continues in my ears even though the ear infections are gone.  I was always pretty healthy.
I afterward noticed 2 weeks or so after the booster shot that I had a shortness of breath while playing golf. It continued to get worse causing me to stop shopping and "catch my breath." I then made my first visit to my GP doctor who after an abnormal EKG sent me to ER. There my EKG was again abnormal but chest x-ray and blood work were fine. See below.
1 day p/vax pt devel fever of 103.6;also stopped playing & began crawling which was unusual for this child;pt recovered;
Severe pain right side of back, the following day red swollen bump in right side of back, the following day ER treatment for pain and the red bump now has blisters..... ER diagnosed shingles, herpes zoster.