chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a health professional concerning a 60 year old female nurse who was vaccinating a patient with a dose of Zostavax (Oka/Merck).  It was reported that the vaccine was splashed on her arm and she washed the arm off.  Three hours later she developed a chickenpox looking rash on her arm.  The patient was enrolled in the VZVIP program: the Varicella Zoster Virus Identification Program enables biologic samples to be analyzed by PCR to identify if VZV is present and if it is present to identify whether it is associated with the wild-type VZV strain or with the Oka/Merck vaccine VZV strain.  It was reported that the source of specimen for VZVIP program was collected from arm.  A VZV DNA and B-globin DNA amplification was not done.  The specimen collected was insufficient for analysis.  Additional information has been requested.
Hot, cold, things like that; Shooting pain, like on my side and different spots on my body/shooting pains all over my body, just like random/achy; Slight fever; This spontaneous case was reported by a consumer and describes the occurrence of FEELING OF BODY TEMPERATURE CHANGE (Hot, cold, things like that), MYALGIA (Shooting pain, like on my side and different spots on my body/shooting pains all over my body, just like random/achy) and PYREXIA (Slight fever) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 009C21A and 039B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ATORVASTATIN (UNITOR) for Thyroid disorder NOS.   On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-May-2021, the patient experienced FEELING OF BODY TEMPERATURE CHANGE (Hot, cold, things like that), MYALGIA (Shooting pain, like on my side and different spots on my body/shooting pains all over my body, just like random/achy) and PYREXIA (Slight fever). The patient was treated with PARACETAMOL (TYLENOL) for Ache, at a dose of 1 dosage form. On 17-May-2021, MYALGIA (Shooting pain, like on my side and different spots on my body/shooting pains all over my body, just like random/achy) had resolved. At the time of the report, FEELING OF BODY TEMPERATURE CHANGE (Hot, cold, things like that) and PYREXIA (Slight fever) had resolved.            Action taken with mRNA-1273 in response to the events were not applicable.
pt recvd vax 3FEB & rash around neck breaks out 5FEB w/sl fever; fever & rash progressively worse w/higher fever 8FEB & worst rash 9FEB; APAP given for fever;
Patient states that she started having trouble feeling tired, having difficulty concentrating/making decisions, vision problems, and dizziness/lightheadedness after the first vaccine dose on 1/26/21.  She was not very clear on timeframe of onset of individual symptoms.  She received her second dose on 2/26/21.  She was diagnosed with A-fib during the time between her 2 doses.  She did not notify pharmacy where vaccine was administered of her suspected side effects until 4/20/21.  Patient states she has seen several of her healthcare providers to see if they could find any reason for her to be experiencing these things other than the vaccine but she says they haven't found anything.
My daughter has a stutter in her speech now after talking very well before her shot, the day after she began talking with the stutter.
Pt states sharp pain in arm at injection site. Has diminished in severity over 2 weeks, but pain persists. Pt has not had reaction in past. Takes MOTRIN. Difficulty moving left arm.
Lungs feel worse or congested; one to 3 bloody noses a day; bruising easily; clotting from nose mouth. And sometimes just clotting; headache; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY CONGESTION (Lungs feel worse or congested) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   In May 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PULMONARY CONGESTION (Lungs feel worse or congested) (seriousness criterion medically significant), EPISTAXIS (one to 3 bloody noses a day), CONTUSION (bruising easily), COAGULOPATHY (clotting from nose mouth. And sometimes just clotting) and HEADACHE (headache). At the time of the report, PULMONARY CONGESTION (Lungs feel worse or congested), EPISTAXIS (one to 3 bloody noses a day), CONTUSION (bruising easily), COAGULOPATHY (clotting from nose mouth. And sometimes just clotting) and HEADACHE (headache) had not resolved.            Concomitant product use was not reported. Treatment information was not provided.  Very limited information regarding these events has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding these events has been provided at this time.  Further information has been requested.
Pfizer Covid-19 vaccine that was administered to her has been ineffective; Pfizer Covid-19 vaccine that was administered to her has been ineffective; This is a spontaneous report from a non-contactable pharmacist.   A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown, Expiration date: Unknown), via an unspecified route of administration on 17Mar2021 as dose 1, single, and received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown, Expiration date: Unknown), via an unspecified route of administration on an unspecified date, as dose 2, single for Covid-19 immunization. Medical history was not reported. Concomitant medications included methotrexate taken for an unspecified indication, start and stop date were not reported; and rituximab (RITUXAN) taken for an unspecified indication, start and stop date were not reported. On an unspecified date, Pfizer covid-19 vaccine that was administered to her has been ineffective. Patient said that she was under the medication of methotrex-ate and rituxan (rituximab) before and after the Covid-19vaccine shots. She said that her doctor advised her to take another shot of Covid-19 vaccine either Johnson and Johnson or Pfizer Covid-19 vaccine because her doctor told her that the Pfizer Covid-19 vaccine that was administered to her has been ineffective due to the medications that she was currently taking. The outcome of the event was unknown.  Information about lot/batch number could not be obtained. Additional information had been requested.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the Lack of efficacy, Suspected Covid-19 Positive and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE)
pt recvd vax 25APR94 & mom called 410PM on 27APR94; area @ inject site was swollen, red & hot to touch per mom; pt had fever x 36 hrs post inject; pt seen in ER:
This spontaneous report as received from a nurse refers to unspecified number of patients. Their pertinent medical history, concomitant medications, drug reactions and allergies were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 lot# M026317, expiration date 11-JAN-2018 (dose and route of administration were not reported). Vaccines were stored at the temperature of 8.5 Celsius degrees for 30 minutes. There was no previous temperature excursion. Digital data logger was involved. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Tightness in chest and shortness of breath. Increase heart rate.  Most notice more the day after second shot. Colchicine and 600mg of Ibuprofen
Info has been received from a physician concerning a 4 year old female who on 5/14/02 was vaccinated with a dose of varicella virus vaccine live (lot 641266/1293L). On 9/26/05, the pt developed mild breakthrough chickenpox characterized by approximately 10 lesions. Unspecified medical attention was sought. A product quality complaint was not involved. Additional info has been requested.
19OCT93 vomiting, fever (100), achiness, dizziness, nausea to present 21OCT93 820AM; states redness & swelling below inject sites dec; area has 5 blotchy red areas no longer swollen; muscle aches, h/a, n/v dec;
Diagnosed as an upper respiratory infection (low grade fever, chest congestion, trouble getting a very deep breath, sinus congestion).
Acute pulmonary embolism without acute cor pulmonale. She was treated with supplemental oxygen, valacyclovir, Xarelto and was briefly treated with antibiotics (Zosyn and vancomycin) until the result of the respiratory pathogen panel was known (positive for human metapneumovirus).  She responded well, but was still requiring supplemental oxygen at 2 liters via nasal cannula at the time of discharge.  See home oxygen qualification performed by RT on 12/16.  Right flank Zoster lesions were all healing without discharge or signs of secondary cellulitis. Patient was discharged to Home with home oxygen and supply of medications. ED visit and hospital admission within 6 weeks of receiving the COVID vaccine.
None- vaccine given 13 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (None- vaccine given 13 days post expiry) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 041L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (None- vaccine given 13 days post expiry). On 19-Nov-2021, EXPIRED PRODUCT ADMINISTERED (None- vaccine given 13 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient did not experience any adverse event- vaccine given 13 days post expiry  No concomitant medications were reported No treatment drugs were reported   This case was linked to (Patient Link).
After my second Moderna shot on May 4th 2021, I got the "Covid arm" response on my left arm 8 days after the second injection. This was a localized red/itchy and circular rash that went away within a week.  I received my COVID19 Moderna booster shot on November 11th, 6 months after my second Moderna shot. Nine days later, on 11/19 through 11/20 night, I was flying and experienced strong itchiness on the back of my legs, and in the mirror saw that I had lots of raised white bumps (hives). I took Benadryl, but within 6-8 hours these white bumps had turned to red splotches.   The next day (Sunday 21st), I developed intense itchiness on my neck and upper back, and a large rash in those areas and also on my hips. I bought Zyrtec and continued to take that, but itchiness continued.  Monday the 22nd, the rash spread to my arms and my wrists and hands started to swell. I can usually clasp my thumb and pinky finger around my wrist, and by Monday evening there was a 1cm gap between these fingers. I also experienced muscle soreness in my quads. My heart rate was in the 80s according to my smart watch, but it is usually 60-65. I had no fever according to a thermometer I used.  By Tuesday morning my hands continued to swell and the rash had spread to about 30% of my body. I had no fever according to a thermometer I used, but my heart rate was 100-120 all of the afternoon and evening according to my smart watch. By evening, my wrist was so swollen that there was about a 1 inch gap between my pinky finger and thumb, and the skin on my forearms felt very hard/ did not compress. My hands felt throbbing and warm. My travel group planned to fly that evening, and I decided to fly because medical care is better where we were going.  Landing on Wednesday 2am, I went to the emergency room. They measured my BP at 133/77 and heart rate at 125, temperature at around 38. My BP is usually 90-100 and heart rate is usually 60-65. They gave me a hydrocortisone injection, and could barely put the IV in because my hands and arms were so swollen. They could not take my BP in my arm because it was too painful -- they had to use my leg.  Wednesday throughout the day the swelling in my hands started to go down, gradually back to only about a 1cm gap when clasping my hand around my wrist by 6pm. However, I experienced six bouts of diarrhea on Wednesday and a slightly increased temperature (99.1 degrees), in addition to feeling general malaise.  Thursday the 25th (today), my hand swelling is almost completely gone and I can once again clasp my hand around my wrist with no gap. The rash has gone down significantly since I started taking Allegra last night, but my eyelids and face are very puffy today.
Mild injection site pain and headache; Mild injection site pain and headache; This is a spontaneous report from a contactable physician (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced mild injection site pain and headache on an unspecified date. Outcome of events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pt did not have a reaction to this Vaccine was past beyond use time in refrigerator but not expired on lot number.
Patient states the next day approximately 5 inch circular area appeared at vaccination site which was sore to touch with no movement issues reported. One month later a 2 inch light pinkish circular area remains with no soreness or movement issues reported.
Afebrile. Got shingles vaccines on 6/6/13 - (L) arm SQ inject. Sl. redness/soreness which worsened by 6/7/13. Went to MD on 6/8/13 who sent me to ER due to increased erythema/swelling/hot to touch - cellulitis sx. ER visit and given IV ANCEF and labs done. Sent home on KEFLEX 500mg qid x 7 days and f/u MD appt.
This case was reported by a pharmacist and described the occurrence of injection site redness in a pt who received Engerix-B for prophylaxis. On an unknown date, the pt received vaccination with Engerix-B. At an unknown time after receiving Engerix-B, the pt had "deep red" coloration at the injection site. The outcome of the events is unknown.
Patient accidently received a bivalent booster dose instead of a monovalent dose for their 1st primary series dose.
Moderna COVID?19 Vaccine EUA I have a welt at the injection site. It continues to be itchy and warm to the touch
Febrile seizure due to spiking fever that he had no sign of when put to bed at 9:30PM.  Taken to Pediatric ER to be monitored.  Given ibuprofen and acetaminophen at ER as well as at home because fever remained high for another day.
patient is having shoulder pain and attributes it to getting the vaccine  - she stated that she had an arthritic neck & upper back/shoulder blade pain prior to the vaccine.  Also said that she was doing exercises before and after the vaccine but never noticed any pain from it.
chest pain; no hungry; no energy; chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (chest pain), DECREASED APPETITE (no hungry), FATIGUE (no energy), CHILLS (chills) and PYREXIA (fever) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M204) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, the patient experienced CHEST PAIN (chest pain), DECREASED APPETITE (no hungry), FATIGUE (no energy), CHILLS (chills) and PYREXIA (fever). The patient was treated with MORPHINE at a dose of UNK, bid. At the time of the report, CHEST PAIN (chest pain), DECREASED APPETITE (no hungry), FATIGUE (no energy), CHILLS (chills) and PYREXIA (fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: normal (normal) normal. On an unknown date, Electrocardiogram: normal (normal) normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitants were reported. No Medical History information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: NNI On 11-May-2021: TCR added
SORENESS IN THE ARM; SWOLLEN GLANDS IN THE NECK; REALLY NAUSEOUS; COULD NOT GET OUT OF BED FOR 3 DAYS; REALLY SICK; VERY LETHARGIC; This spontaneous report received from a parent concerned a 19 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 201A21A, expiry: UNKNOWN) dose was not reported, administered on 08-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-SEP-2021, the patient experienced could not get out of bed for 3 days. On 09-SEP-2021, the patient experienced really sick. On 09-SEP-2021, the patient experienced very lethargic. On 09-SEP-2021, the patient experienced swollen glands in the neck. On 09-SEP-2021, the patient experienced really nauseous. On 10-SEP-2021, the patient experienced soreness in the arm. The action taken with covid-19 vaccine was not applicable. The patient recovered from could not get out of bed for 3 days, really sick, very lethargic, soreness in the arm, swollen glands in the neck, and really nauseous on SEP-2021. This report was non-serious. This case, from the same reporter is linked to 20200314674.
Within 24 hours after receiving flu mist became very nasal congested, ears burning, sinus congestion.
At approximately 4:15 PM, a pt stated feeling light-headed and clammy.  Pt was assisted to a wheelchair and moved to a cot.  Pt's vital were assessed. HR:120, RR:20, SaO2: 98.  Ot appeared flushing and pale.  Lung sound were clear and equal bilaterally.  Pt sat for 30 minutes and stated she wanted to go to the hospital POV.  Pt's VS were reassessed.  HR: 106, BP: 136/86, RR: 20, SaO2: 98%.  Pt signed  form.  Pt was assisted out of the clinic by wheelchair.
Dtap, Polio, Varivax, and MMR all given at 5yr Check up on July 24, 2006. Pt showed no immediate reaction. Mom called on July 25, 06 to report swelling, tenderness, to both legs at injection sites. Advised to use Motrin and ice packs. Mom called again on July 26, 2006 to report Right leg having warmth and redness and swelling still, appt made. MD checked and noted local reaction to the Polio SQ injection site.
Due to a scheduling error, patient received his 2nd dose of the Pfizer vaccine too early - at 13 days.  Patient received first dose on 2/6/2021.  After error was discovered, patient was observed in the vaccination clinic for 30 mins and had no adverse reactions during that time. He was informed of the error and notified that he would not need to repeat the second dose.
After 1 1/2 could not stay awake till sunday.  Body aches. Chest pain. Headache.
Patient received the PREVNAR 13 on Friday and began to feel fatigued by that evening. By Saturday she began experiencing chest and nasal congestion, coughing, fever, chills, headache, and nausea with 3 episodes of vomiting. These symptoms have continued through Monday (the present time), although she reports that the fever and chills have abated.
I am going through excruciating pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Lot number: EW0169) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN (non-serious), outcome "unknown", described as "I am going through excruciating pain". Relevant laboratory tests and procedures are available in the appropriate section. The reporter considered "i am going through excruciating pain" not related to bnt162b2.  Additional Information: The patient just took the Pfizer first dose of Pfizer vaccine on "Friday" and the day of report was Monday. The patient had some dental work done while the patient had an implant, and was going through excruciating pain. However, the patient heard it was not supposed to be, but the patient's prescription was for 800 mg of ibuprofen, and was asking if it can be taken. The patient was waiting to take the second dose in the first week of May. The patient reported to have no side effect from the vaccine but the patient had some dental work done; the patient had an implant some dental work done in morning of the report and the patient needed to take pain killers and was prescribed 800 mg of ibuprofen and was asking if it can be taken.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the current available information, the event of pain is not related to suspected drug of bnt162b2, but related to dental implant. The case will be reassessed if additional information becomes available.
This spontaneous report as received from a nurse refers to a 12 month old patient, gender unknown. On 22-AUG-2001 the patient was vaccinated with M-M-R II HSA (dose 1, route, dosage and lot number unknown). On 01-AUG-2001 the patient was vaccinated with VARIVAX (dose 1, route, dosage and lot number unknown). The nurse reported the two vaccines were placed too close together. No adverse effects were reported. On 25-AUG-2004, the patient received the second dose of M-M-R II HSA (dose 2, route, dosage and lot number unknown), and on 12-AUG-2013 the second dose of VARIVAX (Merck) (dose 2, route, dosage and lot number unknown). This is one of two reports on the same reporter link (1312USA003821). Additional information has been requested.