chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 37 years, in right 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: "Bmi 30.8 (obese)" (unspecified if ongoing), notes: Bmi 30.8 (obese); "known allergies: penicillin" (unspecified if ongoing), notes: known allergies: penicillin; "known allergies: Sulfa" (unspecified if ongoing), notes: known allergies: Sulfa. The patient's concomitant medications were not reported. Past drug history included: Amoxicillin, reaction(s): "known allergies: amoxicillin", notes: known allergies: amoxicillin; Cipro, reaction(s): "known allergies: Cipro", notes: known allergies: Cipro. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (14Dec2022) Negative; (16Dec2022) Positive; (21Dec2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: other medication in 2weeks product was LoLoestrin fe and stop date was 09Dec2022. It was reported that on 09Dec: first day of covid. Sore throat, aches (like a flu) 10Dec: first day of paxlovid. Got pax mouth, so gross 14Dec: finished paxlovid, tested negative 16Dec: tested positive. Stopped isolation and went to wearing n95 at all times around others. 17Dec: different symptoms - runny nose, congestion, cough (more like a cold than a flu.) 21Dec: still testing positive, still masking with an N95 and sleeping separate from my spouse Congestion only at night, primary symptom is a dry cough. 27Dec: No moee congestion or symptoms, tested positive.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Patient given adult dose of Hepatitis A 19+ vaccination,  and is only 17 years old.  Incorrect vaccine given.
Patient developed heart palpitations, tachycardia, chest tightness, dyspnea, and exhaustion approx. 16 hours after receiving her vaccine. Continued to have intermittent episodes and ended up in the ER 5 days later to evaluate and treat symptoms.
Facial swelling, legs swelling, severe vertigo, irregular heart rhythm problem- too fast and then too slow, irregularly pulse with sharp and steady heart pain), numbness in left shoulder, numbness behind the neck, can't feel the right half of my head, severe headache, chest pain, stomach pain, severe abdominal pain, blurry vision, can't stand on my feet.
HYPOTENSION RIGHT FACIAL MUSCLE WEAKNESS 11/29/2022  &  3/14/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
39 y/o W M with COVID. Daughter brought it home from camp. He started with symptoms over late last week and was tested on Friday. He was treated by doctor through his insurance. He is on day 4 of Ivermectin. He c/o cough disrupting his sleep. He has not has SOB, but his wife has been mildly.         Tested ER- PCR- positive. 7/16/2021        Doctor also prescribed Zpack, Symbicort, and prednisone.
he has these spots on his body/showed her a red spot; circular spots on the other arm and there is a deep one the one arm and in the other leg and all over the body; This is a spontaneous report from a contactable pharmacist.  A 26-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), dose unknown via an unspecified route of administration on 09Jul2021 (at the age of 26 years old) (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 13Jul2021 14:00, the patient has these spots on his body. The patient came in and it looks like he has these spots on his body. He got the vaccine 09Jul2021. He showed her a red spot near where it would have been given, that looks like it is likely from it. But then there are bullet spots on the other arm and down on his foot. They almost look like targets and are pretty circular. The patient is there now. The reporter clarified the spot that she thought was where it was given was actually on his other arm. It looks like circular spots on the other arm and there is a deep one the one arm and in the other leg and all over the body. The spots first occurred not shortly after lunch time, yesterday, around 2:00PM. He had gotten the vaccine last Thursday and a few days had passed since then. Patient clarifies they were all on the arm, in both arms. The reporter considered the events as non-serious. The outcome of the events was unknown.  Information regarding the lot/batch number has been requested.
This spontaneous report was received from a healthcare worker refers to a patient of unknown age and gender. Medical history was not reported. The healthcare worker informed that on 11-AUG-2014 the patient was vaccinated with an improperly storage (Oka/Merck) PROQUAD injection, 0.5ml, subcutaneous, (lot number, expiration date were not reported). That was exposed to 36F for 13 hours. Concomitant therapy was not reported. No adverse effect was reported. Additional information has been requested.
On 7-3-07 client received MMR 3 Dtap with 100 pm. that evening client arm got red and itching. Fever 995 Tylenol given. Mom put ice on arm 7/3/07 pm and 7//7/07. Red area on L upper arm measured 3"x2 1/2".
Patient presented to the ED on 4/15/21 and was subsequently hospitalized within 6 weeks of COVID vaccination.
Right shoulder pain the next day, pt was prescribed two steroid dose packs and eventually had an MRI and cortisone shot that has now worn off he is now being treated with CELEBREX and still having pain.
Left arm swollen from inject site past elbow to middle forearm, redened, feverish at inject site. Inject site fine on 3/1/03 after returning from dad's house 3/2/03 above noted.
Headache, fever, chills, body aches for 16-24 hours. Took Zquil at onset of symptoms to attempt to sleep. Took 2 Tylenol roughly 12 hours after start on symptoms. Took hot Epsom salt bath approximately 16 hours after symptom onset.
Patient presented with nausea and feeling "light headed". Pt laid on left side on cot to recover. Pt recovered within 10 minutes of adverse reaction. Alert and oriented x3 at all times.
Pt started having severe upper arm pain with large area of redness that is warm and tender to the touch. Symptoms started early am following the vaccine administration and gradually worsened. Diagnosed with cellulitis of arm and given Clindamycin 300mg four times daily for ten days.
Within 24 hours of injection the pt experienced a fever of 104 for 3 days. Lips and tongue were swollen. The pt was treated with Tylenol and fluids.
macular erythematic rash LUE 15-20 min p/vax;no resp problems;tx DPH;rash spread to other 3 extremities following morning;tx DPH;
muscle aches; Joint aches; Chills; feels fatigue; Diarrhea; Stomach upset; 4" x 4" injection site swelling; 4" x 4" injection site redness; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE SWELLING (4" x 4" injection site swelling), INJECTION SITE ERYTHEMA (4" x 4" injection site redness), MYALGIA (muscle aches), ARTHRALGIA (Joint aches) and CHILLS (Chills) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced INJECTION SITE SWELLING (4" x 4" injection site swelling) and INJECTION SITE ERYTHEMA (4" x 4" injection site redness). On 31-Jan-2021, the patient experienced MYALGIA (muscle aches), ARTHRALGIA (Joint aches), CHILLS (Chills), FATIGUE (feels fatigue), DIARRHOEA (Diarrhea) and ABDOMINAL DISCOMFORT (Stomach upset). At the time of the report, INJECTION SITE SWELLING (4" x 4" injection site swelling), INJECTION SITE ERYTHEMA (4" x 4" injection site redness), MYALGIA (muscle aches), ARTHRALGIA (Joint aches), CHILLS (Chills), FATIGUE (feels fatigue), DIARRHOEA (Diarrhea) and ABDOMINAL DISCOMFORT (Stomach upset) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
This spontaneous report received from a patient via a company representative concerned multiple patients. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced terrible side effects. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of terrible side effects was not reported. This report was non-serious. This case, from the same reporter is linked to 20220609828.
Patient called pharmacy the night of receiving vaccination. Right arm was swollen and looked very inflamed. Patient was referred to ER and given a MEDROL Dose pack and BACTRIM DS.
This spontaneous report has been received from a medical assistant referring to a 20 patients of unknown age and gender. Information regarding medical history, drug reactions, allergies and concomitant therapies was not provided. On an unknown date, the patients were vaccinated with an improperly stored ROTATEQ, oral (dose, strength, and frequency were not provided), lot # reported as M025571 and expiration date 19-JAN-2018 for prophylaxis. The reporter stated that the temperature range  of the vaccine  was 0 Celsius (C) and 2 Celsius (C), the time frame was 15 hours and 42 minutes, also stated that there was no previous temperature excursion, this information was registered in a digital data logger. No adverse effect was reported nor product quality complaint was not involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1701USA013142: US-009507513-1701USA013143:
This spontaneous report as received from a certified medical assistant to a 16 year old patient of an unknown gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. Approximately in 2015 (reported as 27-AUG-2015 to 03-SEP-2015) the patient was vaccinated with improperly stored dose of GARDASIL lot # K010215 with expiration date 05-MAY-2017 or lot # K011562 with expiration date 08-APR-2017; dose and route of administration were not reported). No adverse experiences were reported. This is one of the several reports received from same reporter. Additional information has been requested.
approx 30 mins p/vax pt broke out in red rash on lt arm & rt fingertips; rash itched; no SOB on 17FEB93; pt was now getting a rash on face & neck @ 9AM; pt went to MD & was told it was an allergic rxn to vax;
NO AE REPORTED, HOWEVER, ADMINISTERED IM INSTEAD OF SQ, PER BAVARIAN NORDIC MANUFACTURER, NO REPEAT DOSE IS REQUIRED
GUILLAIN-BARRE Syndrome - lost ability to crawl, dysphagia, back pain. Also had URI, patchy airspace opacities on CXR, mycoplasma IgM positive. Discharged on Zithromax.
At 0830, RRT was called for a 19 y/o F with c/o dizziness, lightheadedness, pain in neck area, and difficulty with vision. At initial meeting, client was pale and stated she had difficulty breathing and had blurry vision, per client, like in ?hyperspace?.  Head-to-toe assessment completed. Client was diaphoretic and cool and clammy. Pulse was thready. AA0x4 and tachypneic but has clear breath sounds. PERRLA. Vitals: BP: 100/60, HR: 55, 02: 95% on RA. Mother and father present during this time. No PMH, NKA. Did not take any medications today, only ate a small breakfast. Not pregnant. Client states she had a similar reaction like this with the HPV vaccine 1 year ago. During monitoring/observation time, client?s status improved. Client insisted for EMT/ambulance assistance. 911 called. EMT arrived at 0845. During EMT evaluation, client vomited about 70 ml of clearish/yellow emesis. After paramedic explained options of going home or transportation to the hospital, client opted to be transported to the hospital. Client left facility with paramedics (AMR 332), accompanied by mother and father. Patient transported to Hospital via ambulance.
Patient received vaccine 11/28/16. Next day developed warm, tender hard, indurated area at site of shot; no fever, chills or night sweats just pain 5/10. Area of redness has not spread passed initial area of inflammation. Some pain when lifting arm.
Information has been received from a registered nurse referring to a patient of unknown age and gender. Concurrent condition and medical history were not reported. On an unknown date the patient was vaccinated with improperly stored GARDASIL (lot # J011272, expiration date 21-APR-2016, dose and route were unknown). No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested.
LD warm swollen and fever and slight pain, mother said she did not take temp she felt warm I took temp 98.7.
excruciating bone pain only in the places which have osteoporosis; My muscles were just as bad; I felt a little off the rest of the day; Dose 1: administration date Mar2021/ had my second dose of Pfizer on March 18th; Had minor headache the evening of vaccine; woke up nauseous during the evening; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 61 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 18Mar2021 (Batch/Lot number: unknown) at the age of 61 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Fibromyalgia" (unspecified if ongoing); "Cyclic vomiting syndrome" (unspecified if ongoing); "depression" (unspecified if ongoing); "osteoporosis" (unspecified if ongoing); "Anxiety" (unspecified if ongoing). Concomitant medication(s) included: ZOLOFT taken for anxiety, depression. Vaccination history included: Bnt162b2 (Dose 1; LOT number: Unknown; Administrator route: Intramuscular; vaccine location:Left arm), administration date: Mar2021, when the patient was 61 years old, for COVID-19 immunisation. The following information was reported: HEADACHE (non-serious) with onset 18Mar2021, outcome "recovering", described as "Had minor headache the evening of vaccine"; NAUSEA (non-serious) with onset 18Mar2021, outcome "recovering", described as "woke up nauseous during the evening"; MALAISE (non-serious) with onset 19Mar2021, outcome "recovering", described as "I felt a little off the rest of the day"; BONE PAIN (non-serious) with onset 20Mar2021, outcome "recovering", described as "excruciating bone pain only in the places which have osteoporosis"; MUSCLE DISCOMFORT (non-serious) with onset 20Mar2021, outcome "recovering", described as "My muscles were just as bad"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 18Mar2021, outcome "unknown", described as "Dose 1: administration date Mar2021/ had my second dose of Pfizer on March 18th". Therapeutic measures were not taken as a result of headache, malaise, bone pain, muscle discomfort. Therapeutic measures were taken as a result of nausea.  Additional information: Patient being weaned off Amitriptyline which took for nausea. It was interacting with the 50mg Zoloft I have been put on for anxiety and depression. I am now seeing a therapist for depression. With the loss of (name withheld) 6 years ago and the loss of my mother this past year plus the virus I can't say life has been joyous. Working on my mental health. The pain was so bad patient was in tears. My muscles were just as bad. It lasted about six hours and then subsided. When patient woke up Sunday by bones felt better, but muscles have been horrible since that time. The patient did not have allergies to medications, food, or other products. Patient was not diagnosed with COVID-19 prior to vaccination. Patient not been tested for COVID-19 since the vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I have ha-mrsa and the skin had a rash; Left arm swollen and red; Left arm swollen and red; I have ha-mrsa and the skin had a rash; Cellulite looking swelling and now skin extremely flaky and dry; Cellulite looking swelling and now skin extremely flaky and dry; Cellulite looking swelling and now skin extremely flaky and dry; This is a spontaneous report from a contactable consumer reporting for herself. A 49-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: not provided), via an unspecified route of administration, on 09Apr2021 at 17:30 (at the age of 49 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: not provided), via an unspecified route of administration, on 17Mar2021 at 04:30 PM (at the age of 49 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION. Relevant medical history included HA-MRSA/asthma, and had known allergies: sulfa. The patient was not pregnant at the time of vaccination. Concomitant medication included amoxicillin and doxycycline. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 11Apr2021 at 08:00, the patient reported she has ha-mrsa and the skin had a rash, Left arm swollen and red, Cellulite looking swelling and now skin extremely flaky and dry. The patient did not receive treatment for these events. The outcome of the events was not recovered. Since the vaccination, the patient had not been tested for COVID-19.  Information on the lot/batch number has been requested.
The patient had initially received dose #1 of PFIZER vaccine on 09/16/2021 however, the chart completed in the office was labeled MODERNA.  The patient received PFIZER  and it was documented as MODERNA for first dose w/ a PFIZER LOT number.  When the patient came into the office on 10/14/2021 for his second vaccine, he claimed he lost his vaccine card and needed a new card.  His chart was accessed by our front desk team member, which showed a MODERNA vaccine documented.  He was escorted to the vaccination area and greeted by the MA who confirmed with the patient chart that he had Moderna, but did not notice the that the lot numbers for the initial vaccine belonged to the PFIZER vaccine.  She proceeded to confirm his identity and his review of his PRE vaccination checklist and vaccinated the patient with MODERNA for his second dose on 10/14 on the understanding that the note in his chart was accurate.   As his COVID-19 card was being rewritten and updated for the patient, I was called as the discrepancy in LOT number from dose 1 was noted (noted to be Pfizer lot # w/ Moderna documented in the chart). Upon review of paper documentation from his initial day of service on 9/16 and databse it was confirmed that he received a PFIZER vaccine for his first dose on 9/16.  Therefore, the patient received his first dose of vaccine as Pfizer on 9/16 and his second dose on 10/14/21 as Moderna. The patient was notified of this and sent home after his post vaccination wait time was completed.
Transient ischemic attack; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of TRANSIENT ISCHAEMIC ATTACK (Transient ischemic attack) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced TRANSIENT ISCHAEMIC ATTACK (Transient ischemic attack) (seriousness criterion hospitalization). The patient was hospitalized from 15-Apr-2021 to 16-Apr-2021 due to TRANSIENT ISCHAEMIC ATTACK. At the time of the report, TRANSIENT ISCHAEMIC ATTACK (Transient ischemic attack) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Treatment information was not provided.  Very limited information regarding the event has been provided at this time and is insufficient for causality assessment. Further information has been requested.; Sender's Comments: Very limited information regarding the event has been provided at this time and is insufficient for causality assessment. Further information has been requested.
pretty significant arm pain; fever; muscle aches; little bit of nausea; This spontaneous case was reported by a physician and describes the occurrence of PAIN IN EXTREMITY (pretty significant arm pain), PYREXIA (fever), MYALGIA (muscle aches) and NAUSEA (little bit of nausea) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A and 015M20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 on 30-Nov-2020.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Jan-2021, the patient experienced PAIN IN EXTREMITY (pretty significant arm pain), PYREXIA (fever), MYALGIA (muscle aches) and NAUSEA (little bit of nausea). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency and HYOSCINE HYDROBROMIDE (SCOPOLAMINE PCH) for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (pretty significant arm pain), PYREXIA (fever), MYALGIA (muscle aches) and NAUSEA (little bit of nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) tested negative for COVID before vaccination..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided.   This case was linked to MOD-2021-030149 (Patient Link).
Patient felt dizzy, flush and was about to faint. She complained of a lower back pain.