chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Started having reaction on both elbows. Started as pain, then redness then itching.  There after reaction moved to neck, with hives that were extremely itchy.  Then after, hives were all over body. Lip started swelling, hands were very swollen, red, itchy. Was treated in ED with prednisone, antihistamine, Benadryl, and Pepcid.   Went to see allergist after PCP appt due to 2 ER visits.  They prescribed more medications.  Meds in the morning were:  Prednisone 40mg, Zyrtec 10mg, Pepcid 20mg, and Benadryl 50mg.  Meds in the evening were:  Zyrtec 10mg, Pepcid 20mg, Benadryl 50mg and Singular 10mg.
Have not yet seen doctor.  Moderate to severe shoulder pain with onset 4 days following vaccination.  Pain is the shoulder that did not receive the vaccination.  No other cause has been identified, and the pain has now lasted almost 3 full days. Following vaccine there was pain in the shoulder where the vaccine was administered.  However, that pain has since resolved.
This case was reported by a nurse via call center representative and described the occurrence of hives in a patient who received RABAVERT. On an unknown date, the patient received the 3rd dose of RABAVERT. On an unknown date, unknown after receiving RABAVERT, the patient experienced hives. On an unknown date, the outcome of the hives was unknown. It was unknown if the reporter considered the hives to be related to RABAVERT. Additional details were provided as follows: The patient received RABAVERT as a pre exposure schedule. The health care professional had no product or patient information and stated that she would call back to give the information.
pt described swelling of tongue and difficulty breathing administered 25mg liquid Benadryl and 0.3mg EpiPen emergency services was called, emt check out pt, advised likely anxiety related reaction
after his 2nd dose his COPD improved, as far as his breathing goes; This spontaneous case was reported by a consumer and describes the occurrence of PRE-EXISTING CONDITION IMPROVED (after his 2nd dose his COPD improved, as far as his breathing goes) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     The patient's past medical history included Panic attacks and COPD. Concomitant products included FLUTICASONE FUROATE, VILANTEROL TRIFENATATE (BREO ELLIPTA) for an unknown indication.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PRE-EXISTING CONDITION IMPROVED (after his 2nd dose his COPD improved, as far as his breathing goes). At the time of the report, PRE-EXISTING CONDITION IMPROVED (after his 2nd dose his COPD improved, as far as his breathing goes) outcome was unknown.            No treatment information was provided.
Unable to sleep on 9/16.  Malaise, myalgias, arthralgias, severe headache, escalating fever to 103.7 with shivering, rigor, diffuse sweating by 5 PM 9/17.  Persistent symptoms and fever to 101-102 on 9/18.  Fever 101 on 9/19.  No fever 9/20-9/21 but fatgue, malaise.
received the first dose of the Pfizer Covid-19 vaccine on 02AUG2021 and was diagnosed with Covid-19 on 12AUG2021; fever for the past three days/ran a temperature for 7 days with a cough; ran a temperature for 7 days with a cough; This is a spontaneous report from a contactable consumer (Patient). A 62-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0170), dose 1 via an unspecified route of administration on 02Aug2021 (Age at vaccination: 62 years) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced received the first dose of the pfizer covid-19 vaccine on 02aug2021 and was diagnosed with covid-19 on 12aug2021 (covid-19), fever for the past three days and ran a temperature for 7 days with a cough in Aug2021. The patient underwent lab tests and procedures which included sars-cov-2 test was positive on 12Aug2021. Reporter received the first dose of the Pfizer Covid-19 vaccine on 02Aug2021 and was diagnosed with Covid-19 on 12Aug2021 (caller stated "we got the vaccine" but did not specify the other person or persons). Reporter stated that she was previously running a fever but has no complaints of fever for the past three days. She was scheduled to get her second dose of the Pfizer Covid-19 vaccine on 25Aug2021. She was asking "should we get our second dose" of the Pfizer Covid-19 vaccine. The outcome of the event received the first dose of the pfizer covid-19 vaccine on 02aug2021 and was diagnosed with covid-19 on 12aug2021 (covid-19), ran a temperature for 7 days with a cough was unknown. The outcome of fever for the past three days was recovered in Aug2021.  Follow-up (19Aug2021): This is a follow-up spontaneous report from Pfizer Sponsored Pro-gram. Reporter says she and her husband got their first dose of the Pfizer COVID-19 vaccine on 02Aug2021, then they both tested positive on 12Aug2021 which is merge in above as combine follow up.
Tele call from Mother to clinic stating patient has aching and swelling in her feet and legs that indents since about 2 days after receiving vaccines on 08/08/2017. Mom instructed to contact PMD, and to have patient seen at after hours clinic or Urgent Care if unable to see PMD. Mom will relay results of visit.
Pt began to feel a slowly worsening  painful edema at the injection site 2 days after injection which worsened markedly between d#8-9. she came to our clinic for evaluation on post injection d#9. Left arm exam notable for 14x10cm warm erythematous area of tense edema overlying the entire left deltoid region with central induration but no fluctuance. No externally obvious hematoma.
Patient had left the office and she had called EMS from her car on Highway as she was experiencing shortness of breath and her heartrate was 180bpm. (Per telephone call by the Patient's mother) 11/4/2022
Red hot lumpy site painful sore , like a sunburn  Bones ache , redness spreading
Had a feeling like "falling into the vacuum"/ They felt like they were going to die; Heart was a bit raced; Palpitations; Blood pressure elevated; Could not breathe, had like asthma; Mouth was dry, completely dry; Headache; This spontaneous case was reported by a physician and describes the occurrence of FEELING ABNORMAL (Had a feeling like "falling into the vacuum"/ They felt like they were going to die), HEART RATE INCREASED (Heart was a bit raced), PALPITATIONS (Palpitations), BLOOD PRESSURE INCREASED (Blood pressure elevated) and DYSPNOEA (Could not breathe, had like asthma) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M207) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Cancer (.) and Lymphadenectomy (Cancer removed from left arm and they got their lymph nodes removed). Concurrent medical conditions included Asthma. Concomitant products included DOXAZOSIN, ATORVASTATIN and METOPROLOL for an unknown indication.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2021, the patient experienced FEELING ABNORMAL (Had a feeling like "falling into the vacuum"/ They felt like they were going to die), HEART RATE INCREASED (Heart was a bit raced), PALPITATIONS (Palpitations), BLOOD PRESSURE INCREASED (Blood pressure elevated), DYSPNOEA (Could not breathe, had like asthma), DRY MOUTH (Mouth was dry, completely dry) and HEADACHE (Headache). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. On 21-Feb-2021, FEELING ABNORMAL (Had a feeling like "falling into the vacuum"/ They felt like they were going to die), HEART RATE INCREASED (Heart was a bit raced), PALPITATIONS (Palpitations), BLOOD PRESSURE INCREASED (Blood pressure elevated), DYSPNOEA (Could not breathe, had like asthma), DRY MOUTH (Mouth was dry, completely dry) and HEADACHE (Headache) had resolved. Not Provided      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.
lymphedema; This is a spontaneous report received from a contactable other healthcare professional (who is also the patient). A male patient of an unspecified age (reported as 47, unit not provided, pending clarification) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration, on 08Jan2021, at single dose, for COVID-19 immunization, in the hospital. The patient's medical history and concomitant medications were not reported. The patient received his second dose of the COVID19 vaccine on Friday (08Jan2021) and experienced lymphedema as a side effect in Jan2021. The patient would like to know if there is anything he can do for it. The outcome of the event was unknown.  Information on lot/batch number has been requested.
UNSPECIFIED SIDE EFFECTS; This spontaneous report received from a patient concerned multiple patients. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) 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 02-APR-2021, the subject experienced unspecified side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of unspecified side effects was not reported. This report was non-serious. This case is a duplicate of 20210417740.  Additional information was received from patient on 08-APR-2021. It was determined that Manufacturer Case Number 20210417740 was a duplicate of this case. All relevant information regarding this case will be submitted under Manufacturer Case Number 20210417339.
61-year-old male with past medical history of COPD, hypertension, prostate cancer, current tobacco use, history of cocaine use presented to emergency room with multiple complaints.  Patient states he was walking today and fell however he does not recall the events leading to a preceding the fall.  He states that he has been having back pain for 3 weeks however also states that he was admitted to the hospital in December and went to rehab facility for this back pain.  He states his legs give out.  He also states he has pain all over, chest pain, fever (described as sweating), chills, nausea, vomiting, diarrhea.  He also complains of difficulty urinating and is concerned that his prostate cancer is back.
nausea - 6hrs post shot; headache -10hrs; body aches-14hrs; chills - 14hrs; This is a spontaneous report from a non-contactable consumer (patient). A 35-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247), via an unspecified route of administration on left arm on 16Feb2021 11:30 AM at single dose for covid-19 immunisation. Patient was not pregnant at the time of vaccination. Medical history included hypothyroid, Allergies to amoxicillin and sulfa drugs. Concomitant medication (received within 2 weeks of vaccination) included levothyroxine sodium (SYNTHROID), buspirone hydrochloride (BUSPAR) and vitamin D. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for covid-19 immunisation on 26Jan2021 at age of 35 years old. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 16Feb2021, the patient experienced nausea - 6hrs post shot, headache - 10hrs, body aches and chills - 14hrs. The outcome of events was not recovered. No treatment received for the adverse events. All events reported as non-serious.   No follow-up attempts are possible. No further information is expected.
She called me yesterday (7 days after receiving the vaccine) and said that the previous night she noticed some redness and then yesterday morning it grew to 2 or 3 inches and was very red and warm. She didn't really have any other symptoms. I told her to see her physician which she did this morning and they told her it was mostly likely an allergic reaction to PREVNAR and to go home and take Benadryl and rest. She did that and it improved rapidly.
BLUE NAILS; CHILLS; FEVER; HEADACHE; SORENESS ON INJECTION SITE; This spontaneous report received from a patient via a company representative concerned a 26 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 202A21A expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced blue nails. On 08-APR-2021, the subject experienced chills. On 08-APR-2021, the subject experienced fever. On 08-APR-2021, the subject experienced headache. On 08-APR-2021, the subject experienced soreness on injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from blue nails on 09-APR-2021, and had not recovered from fever, chills, headache, and soreness on injection site. This report was non-serious.
I do not know exactly which Meningococcal vaccine was given. The sheet the Dr supplied says "Meningococcal ACWY Vaccine" High fever. Highest was 101.4 before patient rested.
High fevers that began approx. 48 hrs after FLUZONE and Hep A vaccines that ranged between 104-105.2 rectally for 9 days including a 60-120 sec period of blue infant and non-responsiveness en route to hospital. No other cause for fevers found. My daughter had brief desats in hospital requiring blow by O2 for 10-15 minutes. She had complained of (L) thigh pain and abdominal pain with no other symptoms.
Woke up about 12 hours after receiving shot feeling like my heart was racing.  Tried to relax thinking it was anxiety from receiving the vaccine. Wouldn't go away, checked heart rate on pulse ox. Read 130. Went to Er to be checked out to be safe. They did a cardiac work up, chest xray, checked urine & gave me IV fluids. Heart rate was in the 120's at the hospital & came down to the 90's after awhile. Didn't feel the racing anymore. Was released from hospital. After about 3 hours, heart rate was back in the 70's. Haven't felt any racing since. Did a follow up with PCP a couple weeks later. No issues since.
all over body pain; fatigue; injection site is very painful; Initial information was received on 08-Oct-2021 regarding an unsolicited valid non-serious case from a consumer/non-healthcare professional.  This case involves a 65-year-old male patient who had all over body pain (pain), fatigue and injection site is very painful (vaccination site pain), after receiving INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  It was unknown if the patient had any medical history, concomitant disease or risk factor.  The patient's past medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On 07-Oct-2021, the patient received a dose of 0.7mL suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (once, injection, lot number and expiry date were not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On 08-Oct-2021, the patient developed non-serious all over body pain (pain), fatigue and injection site is very painful (vaccination site pain) (one day) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  It was reported "next day after receiving shot woke up with all over body pain and fatigue. Also, injection site is very painful. Could not sleep on the arm."  It was unknown if the patient experienced any additional symptoms/events.  There were no lab data/results available.  It was not reported if the patient received any corrective treatment for the events.  At time of this report, the patient was recovering from all the reported events.  There will be no information available on the lot number for this case.
Fever of 100.2-101, headache, sweats/ chills, fatigue, swelling in arm. Muscle sore
Chilld x 2d, vomited x 1, anorexia x 2d after vaccine
This is a spontaneous report from a contactable consumer reporting for herself. A 69-years-old female patient received PREVNAR 13 , via an unspecified route of administration on 24Oct2016 at single dose for immunization in right arm.  On the same day the patient received influenza vaccine in her butt. The patient medical history was not reported, and unspecified concomitant medication were ongoing.   The patient previously took influenza vaccine and experienced injection site pain. The patient experienced joint pain in both knees and  joint pain in both thumbs in Nov2016 a week to 10 days after vaccination, with outcome of not recovered.  Doctor prescribed Diclofenac SOD EC 75mg to take one tablet twice a day.  Was advised to take it for 3 days, but she took it for 4 days.  While taking it, things got much better, so she stopped it.  Within a couple of days, the pain came back.
Moderna Covid-19 Vaccine second dose given too early.  Patient did not inform he had vaccine and vaccinator noticed after vaccine was given. Patient had first dose given 2/5/21 at same clinic.
Slight soreness date of injection. 7 days later swelling, redness, sore and intense itching at injection site.  Also itching on face, neck and scalp. Similar to reactions to medications in the past.
vaginal bleeding; lethargic; upper and lower back pain/pain in her upper back; didn't feel good; general aches and pains like she had the flu; a little nauseous; pain around her shoulders; chills; injection site was tender to the touch/injection site pain/tender to the touch; injection site was raised/raised bump at the injection site; injection site bruised/bruising around the injection site; bled a lot after the injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (injection site was raised/raised bump at the injection site), VACCINATION SITE BRUISING (injection site bruised/bruising around the injection site), VAGINAL HAEMORRHAGE (vaginal bleeding), LETHARGY (lethargic) and BACK PAIN (upper and lower back pain/pain in her upper back) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 091D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 03-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Aug-2021, the patient experienced VACCINATION SITE MASS (injection site was raised/raised bump at the injection site), VACCINATION SITE BRUISING (injection site bruised/bruising around the injection site), VACCINATION SITE HAEMORRHAGE (bled a lot after the injection) and VACCINATION SITE PAIN (injection site was tender to the touch/injection site pain/tender to the touch). On 04-Aug-2021, the patient experienced VAGINAL HAEMORRHAGE (vaginal bleeding), LETHARGY (lethargic), BACK PAIN (upper and lower back pain/pain in her upper back), MALAISE (didn't feel good), PAIN (general aches and pains like she had the flu), NAUSEA (a little nauseous), ARTHRALGIA (pain around her shoulders) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 06-Aug-2021, PAIN (general aches and pains like she had the flu) had resolved. In August 2021, BACK PAIN (upper and lower back pain/pain in her upper back) and ARTHRALGIA (pain around her shoulders) had resolved. At the time of the report, VACCINATION SITE MASS (injection site was raised/raised bump at the injection site), VACCINATION SITE BRUISING (injection site bruised/bruising around the injection site), LETHARGY (lethargic), MALAISE (didn't feel good), VACCINATION SITE HAEMORRHAGE (bled a lot after the injection), NAUSEA (a little nauseous), VACCINATION SITE PAIN (injection site was tender to the touch/injection site pain/tender to the touch) and CHILLS (chills) outcome was unknown and VAGINAL HAEMORRHAGE (vaginal bleeding) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. Treatment includes Ice and Tea   This case was linked to MOD-2021-336033 (Patient Link).
Info has been received from an LPN concerning a 4 year old male with no medical history or allergies who on 8/30/01 was vaccinated with a dose of varicella virus vaccine live. There was no concomitant therapy. There was no illness at the time of vaccination. The LPN reported that on 4/20/05, the pt developed breakthrough characterized by a rash consisting of 50 lesions. No fever or other symptoms were noted. The pt was seen on 4/21/05, but no lab/diagnostic tests were performed. Subsequently, the pt recovered. Additional info is not expected.
After both shots. About 1-2 minutes after I started feeling nauseous, shaky, dizzy and then my heart pounding out of my check for 30-40 seconds. My heart settled down and I was shaky and jittery the rest of the day.
This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 03-SEP-2014 the patient was vaccinated with VARIVAX (dose, units, route of administration, anatomical location were not reported) which was exposed to a supported temperature excursion on 15-AUG-2014. No adverse events had been observed or reported. Follow-up information has been received from certified medical assistant who stated she did not have any further information available at that time. This is one of several reports from the same reporter. Additional information has been requested.
Information has been received from a physician concerning a "16-17" year old female patient with no pertinent medical history and no known drug reactions/allergies who in April 1994, was vaccinated with VARIVAX (Merck). The physician believed that the date was incorrect since the vaccine was not released until May 1995 and mentioned that the patient may not had received the vaccine since the date was incorrect. There was no concomitant medication. On approximately 29-MAR-2010, "two weeks ago", the patient developed chickenpox with a fair amount on her arms and hands. The patient sought medical attention by an office visit. At the time of the report, the patient was recovering. No laboratory or diagnostic studies were performed. Follow up information has been received from a physician who indicated that he was questioning the date reported by a parent that her daughter had received VARIVAX (Merck) in 1994. The physician stated that he really questioned the patient actually got the vaccine but that the parent had merely given a fictitious date; possibly no vaccine was ever given. The physician also mentioned that the patient contracted chicken pox in March 2010. The case was full blown with a significant number of vesicles that scabbed in the classic manner. It was also reported that the patient's sister experienced chicken pox after receiving VARIVAX (Merck) (WAES# 1007USA01141). Additional information is not expected.