chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Narrative:  COVID infection following COVID vaccine series 04/28 Janssen, dose #1 08/24 pt cc: cough, diarrhea, fatigue, headache, myalgias, rhinorrhea exposure: unknown 08/25 SARS-COV-2 Variant Sequencing result: 09/02 COVID swab, result: detected SARS-COV-2 Variant Sequencing result: pending
Moderna bivalent formulation was administered with a lower dose than recommended. Appt has been scheduled for pt to revaccinate.
By the next morning, her arm swelled to 3 times normal size and red all the way around from elbow up to shoulder. Also had pain to touch on arm including around the shoulder to the back shoulder blade. She went to ER and doc told her he'd give her a steroid shot but she didn't want one. He said it was her immune system responding and that she should never get one again.... that she was to use ice and rest it to decrease the swelling ie. not overuse it. She had an ALLEGRA (OTC?) in her system from am of 11/16/17 and took another one on 11/17/17 in am as well. She came in to pharmacy 11/20/17 and swelling had gone down.
I got my booster and I currently have a rash all over my chest and my face is swollen and today looks the same as yesterday except I'm getting little white bumps on my face now.
Headache, muscle aches, fever over 100. Lasted one day. No treatment, only rest. Day two symptoms were gone.
Uncontrollable crying 3 days after.  No recognition of parents.  New arm twitch shoulder raises to cheek uncontrollably.
a little itchiness; ear tinnitus, hear sounds; diarrhea; thinking is not clear; arm of injection hurts; rash at the site of injection; nausea; vomiting; fatigue, energy low; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (a little itchiness), TINNITUS (ear tinnitus, hear sounds), DIARRHOEA (diarrhea), THINKING ABNORMAL (thinking is not clear) and VACCINATION SITE PAIN (arm of injection hurts) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.  Concomitant products included ESTROGENS CONJUGATED (PREMARIN), PANTOPRAZOLE, CALCIUM and MAGNESIUM for an unknown indication.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, the patient experienced PRURITUS (a little itchiness), TINNITUS (ear tinnitus, hear sounds), DIARRHOEA (diarrhea), THINKING ABNORMAL (thinking is not clear), VACCINATION SITE PAIN (arm of injection hurts), VACCINATION SITE RASH (rash at the site of injection), NAUSEA (nausea), VOMITING (vomiting) and FATIGUE (fatigue, energy low). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PRURITUS (a little itchiness), TINNITUS (ear tinnitus, hear sounds), DIARRHOEA (diarrhea), THINKING ABNORMAL (thinking is not clear), VACCINATION SITE PAIN (arm of injection hurts), VACCINATION SITE RASH (rash at the site of injection), NAUSEA (nausea), VOMITING (vomiting) and FATIGUE (fatigue, energy low) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medications included allergy medicine and supplements for the tinnitus. Concomitant medications included vilest 7.5 mg, 5Hpt, multivitamins and vitamin B.   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: Follow up received Included Event tinnitus still severe.
Vaccinee experienced severe skin rash (like shingles) from neck to her waist (little on arms) 2 days post inject.
large black bruise devel a sore muscle that didn't go away;MD ordered anti-inflammatory med & hot packs;
My back's hurting; Bones and everything was hurting; Hurting all over / aching all over, Bones and everything was hurting; Joint pain,; Fever of 100.9°F,101 fever; Chills; Headache; Nauseated; felt like going to vomit, only could drink tea; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (My back's hurting), BONE PAIN (Bones and everything was hurting), PAIN (Hurting all over / aching all over,Bones and everything was hurting), ARTHRALGIA (Joint pain,) and PYREXIA (Fever of 100.9°F,101 fever) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 035C21A, 025L20A and 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Lumpectomy on 07-Apr-2021, Radiation therapy (First 3 weeks in May 2021.) in May 2021 and Mammogram on 27-Jan-2021. Concurrent medical conditions included Breast cancer since 15-Mar-2021.   On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Sep-2021, the patient experienced BACK PAIN (My back's hurting), PAIN (Hurting all over / aching all over,Bones and everything was hurting), ARTHRALGIA (Joint pain,), PYREXIA (Fever of 100.9°F,101 fever), CHILLS (Chills) and HEADACHE (Headache). 02-Sep-2021, the patient experienced BONE PAIN (Bones and everything was hurting), NAUSEA (Nauseated) and NAUSEA (felt like going to vomit, only could drink tea). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of q6h. At the time of the report, BACK PAIN (My back's hurting), BONE PAIN (Bones and everything was hurting), PAIN (Hurting all over / aching all over,Bones and everything was hurting), ARTHRALGIA (Joint pain,), PYREXIA (Fever of 100.9°F,101 fever), CHILLS (Chills), HEADACHE (Headache), NAUSEA (Nauseated) and NAUSEA (felt like going to vomit, only could drink tea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Sep-2021, Body temperature: 101 (High) fever of 101.         No concomitant medication was reported. The patient reported she would take ibuprofen when the 6 hrs is up.  Patient thought patient was going to die.   This case was linked to MOD-2021-305899, MOD-2021-305824 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Sep-2021: Significant follow up received  Event added.; Sender's Comments: Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded.
Pt returned approx 2 1/2 hours after appointment complaining of ear pressure, "lung pressure", arms and legs tingling, weakness, whole body feeling heavy, eyes watering. Possible reaction to pneumovax which lists potential adverse side effects - malaise, arthralgia, paresthesia.
Lip and mouth numbness; hoarseness; chest pressure; lightheadedness; This is a spontaneous report from a contactable nurse.   A 46-year-old nurse reported that she received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number unknown), at single dose in the Left arm on 15Jan2021 at 11:30 am for COVID-19 immunization.Medical history included allergy to latex.  The patient's concomitant medications were not reported.  On 15Jan2021 at 12:00 am the patient experienced lip and mouth numbness, hoarseness, chest pressure and lightheadedness. Since the vaccination, the patient has not been tested for COVID. No treatment was received. The outcome of the events was unknown.   Information on the lot/batch number has been requested.
Developed Pityriasis Rosea, rashes on the chest and back since 2 months after the vaccine shots. Doctor prescribed a steroid cream
FIRST DOSE: SORE ARM AT INJECTION SITE SECOND DOSE: HEADACHE, FEVER, MUSCLES ACHE, SKIN SENSITIVE TO TOUCH, JOINT ACHES, STIFFNESS RESOLVED AFTER 24 HOURS
This spontaneous retrospective pregnancy report as received from a healthcare worker refers to a 26 year old female patient with none pertinent medical history and no drug reactions or allergies. On 06-NOV-2012 the patient was vaccinated with the first dose of GARDASIL injection (route, strength, lot number and expiration date not provided). In January 2013 (reported as 2 months later) the patient was vaccinated with the second dose of GARDASIL injection (route, strength, lot number and expiration date not provided) while the patient was assumed to be pregnant. Also was reported that the patient became pregnant with Last Menstrual Period (LMP) of 01-FEB-2013 and Estimated Delivery Day (EDD) of 08-NOV-2013. No concomitant medication was reported. The patient sought medical attention and contacted physician. The sonogram for pregnancy was performed. The patient never had the third injection of GARDASIL because a baby was delivered via caesarian section shortly after (in 2013, date and detailed information not specified). The pregnancy outcome was unknown). The relatedness between vaccination with GARDASIL and caesarean section was not reported. Additional information has been requested.
Patient presented to clinic on 1/25/05 with rhinorrhea and congestion; was afebrile. Was given Extex. Was given FluMist vaccination on 1/28/05. Patient had worsening URI symptoms over weekend. Symptoms improved early the following week but worsened again by Friday, 2/4/05. Patient presented to clinic on 2/4; was diagnosed with rhonchi in right lung base. Was given Azythromycin and released. Patient became acutely ill later the same evening; had fever of 102. Taken to civilian ER and admitted to ICU step down unit. Treatment with Azythromycin, Rocephin, and IV fluids. Patient currently still admitted.Information from Discharge summary states dehydration, hypotension, cough, chills, tachycardic, nausea, vomiting. msv
Patient experienced significant swelling and pain in the right arm. Symptoms occurred approximately 2-3 hours after injection was given. Patient did not take any medication or obtained medical care.
chest tightness; I had difficulty breathing; profusely sweating; This is a spontaneous report from a contactable consumer. A 21-years-old non pregnant female patient received second dose of bnt162b2 (Solution injection; Batch/Lot Number: EW0182), via an unspecified route of administration, administered in Arm Left on 04May2021 at 16:45 (at the age of 21-years-old) as DOSE 2, SINGLE for covid-19 immunisation. Patient previously received first dose of bnt162b2 (Solution injection; Batch/Lot Number: ER8733), via an unspecified route of administration, administered in Arm Left on 06Apr2021 at 18:15 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient had no known allergies. Patient did not receive any other vaccine in four weeks. Patient was not diagnosed with covid prior to vaccination. On 12May2021 12:00, patient experienced an episode where she had difficulty breathing, was profusely sweating, and had chest tightness a few minutes after vaccine was administered for around 30 minutes, but it slowly subsided after that. On the same day, she took a video appointment with a doctor that was available. Therapeutic measures were not taken due to the events. Patient was not tested for covid post vaccination. The outcome of all the events was unknown.  Follow-up attempts are completed. No further information is expected
Received first Pfizer Covid19 vaccine on 2/28/21. Developed fever 102.8, chills, SOB on 3/2/21 and was transported by EMS to ER and admitted. He was tested 3 times for COVID 19 and found to be negative.  CT scan was concerning for viral pneumonia and suspected COVID. He was treated and released to home on 3/4/21.  Followed by pulmonologist.  Received second Pfizer COVID19 vaccine on 3/21/21. On 3/23/21 developed fatigue, weakness, shakiness, nausea and vomiting. had significant decline over the week. Has acute event on 3/27/21 and was pronounced dead at home.
Immediate swelling at upon injection with subsequent bruising and now, periodic arm pain/ache and slight weakness and numbness/tingling.
seen 13AUG93 fever 102, h/a & pain in chest on inspiration & movement legs feel weak; CXR done & nl; seen 16AUG93 neck pain, fever, sore throat;
Diarrhea, vomiting X 1 day, fever (100-102F) X 5 days.
Smallpox vax administered 11/23/2004.  Patient remembers touching around eye- left eye swollen 12/2/2004.  Patient seen in ER,  Incision and Drainage of lesion of left side near eye brow.  Treatment cefalexin, novisil. Follow up with ocular.  Cerfial to skin area.
Had respiratory symptoms, coughing and sneezing, on 07/07/2022.
Hand rash/hand rash after covid vaccine; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Hand rash/hand rash after covid vaccine) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    No known allergies were reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced RASH (Hand rash/hand rash after covid vaccine). At the time of the report, RASH (Hand rash/hand rash after covid vaccine) had resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No concomitant medication details were provided. No treatment medication details were provided.   The reporter's causality for the event of rash with SKYRIZI(RISANKIZUMAB) was no reasonable possibility.  It was unknown if patient was enrolled in a COVID-19 vaccine trial.   This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Member was administered an expired vaccination. Vaccine expiration is 2022 NOV 03 @ proximatley 1000. Member notified by 1200.
Client developed right upper arm pain with inflammation and redness. Pt was seen by doctor 2 days after administration of vaccines. Pt was given prescription for Augmentin and Atarax with diagnosis of immunization reaction.
severe nausea, anorexia, epigastric pain. Symptoms lasted 10 hours are required 4L NS IV, 16mg zofran IV, 50mg phenergran IV
Vesicle formation at injection site after 2 wks along with pain x2 weeks starting from date of injection.
Information has been received from a physician concerning an 11 year old Caucasian male who on 5/1/00 was vaccinated IM with 1 dose of Hep-B vaccine. On 5/15/00, the pt experienced urticarial rash. A visit to a physician was required. Subsequently, the pt recovered. No further information is available.
No adverse event known.  Pt given 2nd dose of Moderna from a vaccine bottle which had been refrigerated, but expiration date had passed by 13 days.
Left arm swollen. Red and white, tender to touch. 3.5 inches wide and 6 inches tall.
Subsequently pt developed injection site reaction characterized by redness extending from the shoulder to the elbow, swelling and warmth. The patient recovered. There are 6 patients from facility who developed an reaction.
Patient was administered the MMRII vaccine as a child and a low tier for mumps; This spontaneous report was received from a physician assistant referring to a child of unknown gender. No information was provided regarding the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant medication.  On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) for prophylaxis  (dose, route of  administration, anatomical location, lot number and expiration date were not reported) with water sterile diluent for prophylaxis  (dose, route of administration, anatomical location, lot number and expiration date were not reported). On an unknown date, after the vaccination the patient had lo titer for mumps (mumps antibody test negative).  At the time of the report, the outcome of mumps antibody test negative was unknown. The reporter did not provide causality assessment between the event and vaccination with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II).
Ear pain 2 minutes after injection  Left arm completely numb 8 minutes after injection  Hot flashes 10 minutes after injection  Chest pain and tightness 15 minutes after injection  Brain fog delayed movement thyroid meds left my system 20 minutes after injection
Multiple red pustules with surrounding erythema starting 13-14 days after receiving multiple vaccines. Follow-up Information 05-SEP-2008: Client states approx. 1 hour after receiving imms on 8/19/08 both arms became swollen and painful. Client states this lasted 4 days then resolved. Then on 9/1/08 client reports she had swelling and black and blue marks in her upper arms with approx 20-30 "pimples" on her arms, face, and head. She states they were painful to the touch. Client visited the health center 9/3/08 for evaluation. PP gave client a prescription for Bactrim, took culture of her "pimples" that are now scabbed over and made a follow-up appt for next week.
muscle is in pain, not sore , but really painful. different movements create different levels of pain. ever present not intermittent
Redness to R forarm - C/O itch to arms, back only, no hives @ 4:55. 5:10 C/O tongue itch - able to swallow no Rx issue. 5:15 - itch - no redness, no hives. 50 min post-op no hives no issue D/C with parents home.
Swollen lymph node/big bump under her arm; This spontaneous case was reported by an other health care professional and describes the occurrence of LYMPHADENOPATHY (Swollen lymph node/big bump under her arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LYMPHADENOPATHY (Swollen lymph node/big bump under her arm). At the time of the report, LYMPHADENOPATHY (Swollen lymph node/big bump under her arm) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment information was not provided.
tiredness on the evening of day 0.  Tiredness after exercise on day 1.  Sleep for 13 hours.  Woke up with blood shot eyes--the whites-- redness on the innerside of the lids.  Not noticeably inflamed, not itchy, just bloodshot.  It looked like conjuctivitis without the goo or the itch.   It lasted about 8 hours then slowly improved.  Took 72 hours to return to normal
1 of 2 pts who exp swelling @ the site of inject (arm 2 x nl size) from deltoid to elbow; appeared as cellulitis; pt was treated w/Keflex & Pred; pt recovered;
Slight headache within an hour of dose.; This is a spontaneous report from a contactable consumer. A 48-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection, Batch/Lot Number: EL3247), via an unspecified route of administration, administered in Arm Left on 09Feb2021 08:15 as single dose at Workplace clinic for COVID-19 immunisation. Medical history included none. Concomitant medication included cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]). On 09Feb2021 09:30, The patient experienced slight headache within an hour of dose. The action taken in response to the event for BNT162B2 was not applicable. The outcome of event was not recovered.
This spontaneous report has been received from a medical assistant concerning multiple patients of unknown demographics. The patient's pertinent medical history, drug reactions, allergies, concurrent conditions and concomitant therapies were not informed. On unknown dates, the patients were vaccinated with improperly stored doses of  GARDASIL 9, lot # M011117, expiry date: 17-DEC-2017, (dosages and therapy routes were not provided), for prophylaxis. No adverse effects were reported. The doses of GARDASIL 9 were exposed to a temperature of 9C and 11C, and were out of range for 30 minutes. A data logger was used to track the temperature and there were no prior excursions. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. As of 14-DEC-2016, it was reported that all telephone attempts to obtain follow-up information have been unsuccessful. On 20-DEC-2016, a call was received from the medical assistant who stated that he/she was unable to provide any further information. Additional information has been requested.; Sender's Comments: US-009507513-1610USA004694:US-009507513-1610USA010044:US-009507513-1610USA010046:US-009507513-1610USA010048:US-009507513-1610USA010049:US-009507513-1610USA010050:,MERCK 1610USA010047:Mfr number.
PT was sitting with guardian and started to have seizure like activity for him which consists of audible and visual auras and Right arm twitching. This lasted about 1 min.  Once we got him into a dark room he started having slurred speech and Left sided weakness that lasted about a min.  He was A&OX1.  Pt had a right sided slant in his eyes.  His pupils were dilated to a 9 and were equal and non reactive.  he became sluggish and kept starring off to the right side.  This lasted about 2 mins and 45 sec.  His pupils returned to 6 and were equal and reactive and he became less lethargic.  He started to complain of a head ache.  At 1302 he stated that he stated tapping his face and trying to speak.  He began to have a right sided glance again and his pupils dilated to an 9 again and we equal and non reactive. he did not respond to his name.  This lasted for almost 2 mins. He then stated he was foggy and his pupils returned back to a 6 and were equal and reactive.  He was struggling to find sounds in the room. His Vital signs were initial B/p 138/98 resp 22 HR-78.   at 1320 his B/P was 128/68 Resp 20 HR 80.  Pt was transported by EMS for medical evaluation by his neurologist.
Client complained of pain, swelling and erythema at injection site. Onset 4/7/01 and duration 4/9/01. Treatment: none required.
Had been sick the week before vaccine with a 'virus'. Day of vaccine was feeling ok, day following vaccine (11/21/08) thought she had burner her tongue and could not taste. 11/22/08 developed headache and ear ache.  11/24/08 had headache behind eye and low grade temp.  11/25/08 eye felt swollen, later lips not working, taste off, rt. side slightly drooping - went to ER.
Started with itching, erythema and edema @ injection site. Coughing and wheezing. Self Treated with Ice @ injection site, Benadryl cream, Clarinex, Singulair, and Advair inhaler. Noted improvement with self treatment approximately 2 hours later.
stopped breathing 24 hrs p/immun-brought to ER; temp was nl & breathing OK; mom did not observe any of this since was @ hosp w/another child @ time; sitter revived child by rubbin chest; MD felt had sz;
vaccine administered to a patient that is 6 months pregnant on 5/13/2019; Information has been received from a physician referring to a 19 years old female pregnant patient. The patient's medical history, concurrent condition and concomitant medication were not reported.    On 13-MAY-2019, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (dose, lot # and expiration date unknown) subcutaneously for prophylaxis (reported as measles) when she was 6 months pregnant (Vaccine exposure during pregnancy).  The patient's  last menstrual period (LMP) and estimated date delivery (EDD) was not reported. The outcome of the patient's pregnancy was not reported.
CHILLS, FEVER, MUSCLE AND JOINT ACHES, DIZZY, HEADACHE, EXHAUSTION AND TIGHTNESS IN LUNGS.  LASTED ABOUT 20 HOURS.  TOOK 800MG IBUPROFEN 3 TIMES.