chrisvoncsefalvay/vaers-outcomes huggingface dataset:
dizziness; tiredness; fever; soreness in the injection arm through the back of the arm; chills; rash all over body/ looking like mosquito bits/very itchy; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), FATIGUE (tiredness), PYREXIA (fever), VACCINATION SITE PAIN (soreness in the injection arm through the back of the arm) and CHILLS (chills) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021C214) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included B COMPLEX [AMINOBENZOIC ACID;CALCIUM PANTOTHENATE;CYANOCOBALAMIN;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RIBOFLAVIN;THIAMINE HYDROCHLORIDE], TOCOPHEROL (VITAMIN E [TOCOPHEROL]), VITAMINS NOS (DAILY VITAMINS) and CALCIUM for an unknown indication.    On 20-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (dizziness), FATIGUE (tiredness), PYREXIA (fever), VACCINATION SITE PAIN (soreness in the injection arm through the back of the arm), CHILLS (chills) and RASH PRURITIC (rash all over body/ looking like mosquito bits/very itchy). At the time of the report, DIZZINESS (dizziness), FATIGUE (tiredness), PYREXIA (fever), VACCINATION SITE PAIN (soreness in the injection arm through the back of the arm) and CHILLS (chills) outcome was unknown and RASH PRURITIC (rash all over body/ looking like mosquito bits/very itchy) had not resolved.            Treatment drug includes ointment NOS   This case was linked to MOD-2021-253193.
Patient called to say she woke next morning with "severe complete body aches", an "incredible Headache",  "severe and intense nausea and dry heaving" with vomiting and then finally diarrhea. She also had fatigue.  Unknown if she had a fever, she did have chills. This was mainly on Saturday and Sunday, then improved on Monday, May 3rd. She is recovered now.
Information has been received from a physician concerning a 9-year-old white female who on 13-JUL-2005, at approximately 14:00 was vaccinated SC in the right arm with the first dose of varicella virus vaccine live (Lot #647264/0437P). The physician reported that on 13-JUL-2005, right after vaccination, the patient developed a welt at the site. The physician also reported that on 22-JUL-2005, the patient's injection site area became red, swollen and with a rash. The patient was treated with amoxicillin (250mg/5mL, 3 12 tsp. BID x 10 days). As of 28-JUL-2005, the patient's injection site area was noted to be healed. No further information is available.
Information has been received from a physician concerning a male who was vaccinated with a dose of hepatitis B virus vaccine rHBsAg (yeast) Subsequently the patient developed HBsAG during the series. The physician reported that the patient tested positive for HBsAG while in  the midst of the series. Unspecified medical attention was sought. there was no product quality complaint. Follow up information indicated that on 11/27/2001 the patient donated blood which was  HBsAg positive. It was noted that he had "just received a dose of hepatitis B virus vaccine rHBsAg (yeast). No additional information is expected.
Itching at the site of the injection in left arm; Swelling at the site of the injection in left arm; Redness at the site of the injection in left arm; Pain at the site of the injection in left arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itching at the site of the injection in left arm), VACCINATION SITE SWELLING (Swelling at the site of the injection in left arm), VACCINATION SITE ERYTHEMA (Redness at the site of the injection in left arm) and VACCINATION SITE PAIN (Pain at the site of the injection in left arm) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Psoriatic arthritis. Concomitant products included ADALIMUMAB (HUMIRA) for Psoriatic arthritis.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (Itching at the site of the injection in left arm), VACCINATION SITE SWELLING (Swelling at the site of the injection in left arm), VACCINATION SITE ERYTHEMA (Redness at the site of the injection in left arm) and VACCINATION SITE PAIN (Pain at the site of the injection in left arm). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form. At the time of the report, VACCINATION SITE PRURITUS (Itching at the site of the injection in left arm) was resolving and VACCINATION SITE SWELLING (Swelling at the site of the injection in left arm), VACCINATION SITE ERYTHEMA (Redness at the site of the injection in left arm) and VACCINATION SITE PAIN (Pain at the site of the injection in left arm) had not resolved.        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.   Treatment included  ice packs.
Cellulitis in upper right arm at injection site ; initial site hard and tender 24 hours after injection; 1 week post injection site is red and itching
Information has been received from a physician concerning a 4 month old patient who on 28-SEP-2006 was vaccinated with an oral first dose of rotavirus reassortant vaccine live (human-bovine). The physician reported no side effect or problems after the first dose. No product quality complaint was involved. Additional information has been requested.
7-9pm started feeling flush and extremely tired, injection site extremely painful 9-11pm temperature around 100, progressive chills and shivering, muscle cramping, joint tightness, injection site red and swollen 11-6am temperature up to 101.5, severe chills, uncontrollable shivering, extreme headache, vomiting 6-11am temperature returns to 98-99, most symptoms considerably less, injection site still red and swollen Rest of 2/3 feel like recovering from a bad flu, injection site still red and swollen 2/4 feel very rundown but longer sick, temperature 97-98, injection site still red and swollen 2/5 feel normal, injection site less red and less swollen 2/6 no symptoms, feel fine
sore muscles all over; Initial information received on 12-Nov-2020 regarding an unsolicited valid non-serious case received from a consumer via social media.  This case involves patient (unknown demographics) who experienced sore muscles all over (myalgia), while he/she received vaccine INFLUENZA VACCINE.  The patient had no medical history, concomitant disease or risk factor.  Medical treatment, vaccination, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date: not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious sore muscles all over (myalgia) (unknown latency) following the administration of INFLUENZA VACCINE.  It was also reported that patient got really sore muscles all over for about a week when got mine. Patient was really under the weather. Hope it affects you differently.  It is unknown if the patient experienced any additional symptoms/events.  There were no lab data/results available.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome of event was reported as unknown.  There will be no information available on the batch number for this case.
Client complaining of headache and feeling of throat closing immediately after receiving vaccine. RN and MD responded. BP 100/60 HR 95. 50MG IM Benadryl given in R arm. Shortly after administering Benadryl, client reported feeling much better. Continued to monitor. Client left site without further incident.
Information has been received from a physician concerning a 74 year old female patient who on 29-NOV-2007, was vaccinated IM into the left deltoid with a first 0.5 mL dose of pneumococcal 23v polysaccharide vaccine (Lot# 658075/0962U). Concomitant therapy included (therapy unspecified), ASPIRINE, calcium (unspecified) and vitamin D (unspecified). On 29-NOV-2007 within 6 hours of the vaccination, the patient experienced pain at the injection site. 24 hours after the vaccination the patient experienced induration, redness and warmth at the injection site. At 36 hours, 3/4th circumference of the upper arm and the middle upper arm was affected. Unspecified medical attention was sought. A diagnosis of cellulitis was reported. The patient was treated with (BACTRIM) and (DOXYCYCLINE). No laboratory diagnostic studies were performed. At the time of this report, the patient's outcome was unknown. No product quality complaint was involved. Additional information is not expected.
This case was reported by a pharmacist via patient support programs and described the occurrence of pain in arm in a 61-year-old female patient who received FLUARIX QUADRIVALENT 2018-2019 season) (batch number M73CE, expiry date unknown) for prophylaxis. On 3rd October 2018 11:30, the patient received FLUARIX QUADRIVALENT 2018-2019 season .5 ml. On 4th October 2018, 1 days after receiving FLUARIX QUADRIVALENT 2018-2019 season, the patient experienced pain in arm, localized erythema, tenderness and skin warm. On an unknown date, the outcome of the pain in arm, localized erythema, tenderness and skin warm were unknown. It was unknown if the reporter considered the pain in arm, localized erythema, tenderness and skin warm to be related to FLUARIX QUADRIVALENT 2018-2019 season. Additional details were provided as follows: The reporter stated that he would say it was a product complaint. However, she did not know how to classify it as she was experiencing an adverse reaction. The reporter could not find anything to indicate that was typical. The patient stated on the morning of reporting date, her entire arm was sore. There was a red tender hot circle an inch below the injection site was a red hot tender circle. She did not indicate an exact time. She consulted her primary care and they referred her to the reporting pharmacist who administered the vaccine. The reporter stated that they had administered several hundred vaccines and this was the first such event.
% year old girl given Pfizer COVID19 vaccine for age group 6 months to 4 years in error. Have left message for mother to call back so can be reported to her.
having headaches every day for the past 10 months; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset 2022, outcome "unknown", described as "having headaches every day for the past 10 months".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300076188 same reporter, product and event; different patients;
Bruising (Fri- Wed.), welts (Fri - Wed), itching arm (Thurs), pain in shoulder (Thurs - Sat.), and a blotch of redness (Fri 1 Oct - Sun) at site. Treatment was antihistamines and zyrtec.
Muscle soreness; Arm is killing him; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Muscle soreness) and VACCINATION SITE PAIN (Arm is killing him) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (Muscle soreness) and VACCINATION SITE PAIN (Arm is killing him). At the time of the report, MYALGIA (Muscle soreness) and VACCINATION SITE PAIN (Arm is killing him) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.
Information has been received from a physician concerning an 18 year old female who in approximately April 2008, was vaccinated IM with a first dose of GARDASIL.  Subsequently, the patient experienced breathing difficulties and was taken to the emergency room where she stayed for 12 hours.  The specifics were unknown.  At the time of the report, the outcome of the patient was unknown.  Upon internal review the breathing difficulty was considered to be an other important medical event.  Additional information is not expected.
About 12 hours after vaccine I had Uncontrollable shivering and mild  body aches. Only lasted about 2 hours
Felt like did not sleep; Totally wiped out; Totally exhausted; This spontaneous case was reported by a consumer and describes the occurrence of POOR QUALITY SLEEP (Felt like did not sleep), FEELING ABNORMAL (Totally wiped out) and FATIGUE (Totally exhausted) in a male 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Apr-2021, the patient experienced POOR QUALITY SLEEP (Felt like did not sleep), FEELING ABNORMAL (Totally wiped out) and FATIGUE (Totally exhausted). At the time of the report, POOR QUALITY SLEEP (Felt like did not sleep), FEELING ABNORMAL (Totally wiped out) and FATIGUE (Totally exhausted) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
This is a spontaneous report from a contactable nurse via a Pfizer sales representative. This nurse reported similar events for 3 patients. This is the second of three reports. A 19 year-old female patient of an unspecified race and ethnicity received the first dose of TRUMENBA via an unspecified route of administration in Jul2016 at 0.5 ml single for immunisation.  Relevant medical history included abdominal pain (problem stress related) from 30Nov2012, gastrointestinal (GI) FU in Feb2013 and endoscopy on an unspecified date were within normal limit, symptoms resolved in Apr2013. Negative tuberculin test with 0 mm induration was performed on 22Jul2016.  Concomitant medications were not provided. The patient experienced swelling and pain in Aug2016 a couple of days after vaccination. The outcome of the events was unknown. Follow-up (07Oct2016): Follow-up attempts are completed. No further information is expected. Follow-up (13Oct2016): New information reported from a contactable nurse includes: reporter occupation updated from medical assistant to nurse, updated patient age, suspect vaccine administration date and dose number, medical history and relevant tests. Sender's Comments: Linked Report(s): US-PFIZER INC-2016383049 similar report from same reporter; US-PFIZER INC-2016383050 similar report from same reporter.
Received vaccination 11/18 woke up 11/19 at 0300 with fever, body aches. Continued with fever of 102, redness, swelling, tenderness to Rt deltoid, symptoms continued through 11/24/11.
Headache, Myalgia, Arthralgia, NauseaVomiting, extreme soreness in right arm Narrative:
She received her first dose of the Moderna COVID-19 vaccines, bivalent, on 20Mar2023; Had COVID-19 in Dec2022; Had COVID-19 in Dec2022; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): MOD-2023-716765 (Moderna).  A 68-year-old female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) at the age of 68 years for covid-19 immunisation; BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) at the age of 68 years for covid-19 immunisation; davesomeran, elasomeran (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), on 20Mar2023 as dose 1 (booster), single (Batch/Lot number: unknown) for covid-19 prophylaxis. The patient's relevant medical history included: "bipolar disorder" (unspecified if ongoing), notes: Hx of bipolar disorder. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "Had COVID-19 in Dec2022"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 20Mar2023, outcome "unknown", described as "She received her first dose of the Moderna COVID-19 vaccines, bivalent, on 20Mar2023".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Started having mild dizziness, foggy headed, and ringing in ears (more in the right ear).  This resolved after a few days but periodically  it would reoccur lasting  2-3 days.  This went on for about 7 months.  At random intervals (could be days or weeks) I would become dizzy and foggy headed for a few days and then it would go away.  After about 7 months  when a recurrence wound happen I started loosing hearing (especially low frequency hearing) in my right ear along with the dizziness and foggy headedness.  I went to ENT and was tested and was given a probable diagnosis of menier's  disease.  Diagnosis cannot be final until there is permanent hearing loss. I also developed some heart irregularities several months after taking the Jansen shot.  I was referred to Dr.  Heart monitor was place and irreqularities  were noted but this appears to have resolved.
BODY ACHES; EXCESSIVE FATIGUE/EXCEEDINGLY TIRED; FEVER; HEADACHES; PAIN AT INJECTION SITE; This spontaneous report received from a patient concerned a 54 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, route of admin not reported, batch number: 1805022, and expiry: unknown) dose was not reported, administered on 07-MAR-2021 (vaccinated at left arm) for prophylactic vaccination. No concomitant medications were reported. On 07-MAR-2021, the subject experienced pain at injection site. On 08-MAR-2021, the subject experienced body aches. On 08-MAR-2021, the subject experienced excessive fatigue. On 08-MAR-2021, the subject experienced fever. On 08-MAR-2021, the subject experienced headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, and fever on 09-MAR-2021, pain at injection site on 10-MAR-2021, and headaches on 14-MAR-2021, and had not recovered from excessive fatigue. This report was non-serious.
pt recv vax 17MAR97 & 48hr later devel migratory joint pain (arthritis);the sx still persists;
Patient experienced a vasovagal response to HPV. Duration was 4-6 seconds. BP at 09:30 60/40 pulse-50, at 9:45 62/40 p-52, BP at 10:00 72/40 p-60 and at 10:15 80/44 p-68.
higher than normal blood pressure; pain in arm; no energy/slept for 12 hours; headache; pain at injection site; This spontaneous case was reported by a physician and describes the occurrence of BLOOD PRESSURE INCREASED (higher than normal blood pressure), PAIN IN EXTREMITY (pain in arm), LETHARGY (no energy/slept for 12 hours), HEADACHE (headache) and INJECTION SITE PAIN (pain at injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 032L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced BLOOD PRESSURE INCREASED (higher than normal blood pressure), PAIN IN EXTREMITY (pain in arm), LETHARGY (no energy/slept for 12 hours), HEADACHE (headache) and INJECTION SITE PAIN (pain at injection site). At the time of the report, BLOOD PRESSURE INCREASED (higher than normal blood pressure), PAIN IN EXTREMITY (pain in arm), LETHARGY (no energy/slept for 12 hours), HEADACHE (headache) and INJECTION SITE PAIN (pain at injection site) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant and treatment medications were not reported.  The action taken with the drug was Not applicable.   This case was linked to MOD-2021-089937 (Patient Link).
Patient presents to the ED and admitted to the hospital for evaluation of fever, chills, body aches, abdominal pain, nausea, and decreased appetite.  Symptoms ongoing for the past few days.  Patient states her mother tested positive for COVID-19 one week ago, and her mother currently lives with her.
Too Much dizzy; Headache; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Too Much dizzy) and HEADACHE (Headache) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2021, the patient experienced DIZZINESS (Too Much dizzy) and HEADACHE (Headache). At the time of the report, DIZZINESS (Too Much dizzy) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 09-May-2021: TCR Form  received on 09-MAY-2021 and it doesn't have any new information
No additional AE; Patient was administered expired PNEUMOV AX 23 on 10/07/2021; This spontaneous report as received from a nurse practitioner and refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, previous drug reactions or concomitant medications  On 07-OCT-2021, the patient was vaccinated with and expired dose of  pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot # T021329 with expiration date on 03-OCT-2021 (Confirmed to be a vial formulation), for prophylaxis (strength, dose, frequency and route of administration were not reported). No additional adverse events and no temperature excursion reported.
SOB, WHEEZING, COUGH W/ MILD PRODUCTION, AND ASSOCIATED CHEST PAIN, FEVER, BODY ACHES