chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reaction or allergies and concomitant therapies were not reported. On 25-OCT-2017, the patient was inadvertently vaccinated with an expired dose of VARIVAX (lot # L041204, expiry date: 20-OCT-2017) which was reconstituted with sterile diluent (MERCK) (lot # N023308, expiry date: 04-FEB-2020) for prophylaxis. Dosing details and route of administration were not reported. No adverse effects were reported. No product quality complaint (PQC) was involved. Lot # N023308 has been verified to be a valid lot number for varicella virus vaccine live (oka/merck).
Pfizer-BioNTech COVID-19 Vaccine EUA: after seoncd dose of vaccine patient reported fatigue then axillary lymph nodes swelled to the size of a golf ball. Affected area uncomfortable but no erythema. At clinic visit one week after vaccination patient states symptoms improving and no new symptoms developed. Patient discahrged to home from clinic stable.
moderate soreness at injection site; swelling and soreness of infraclavicular lymph node; swelling and soreness of infraclavicular lymph node; Dose: 4 Moderna, Dose: 5 Pfizer; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Sep2022 as dose 5 (booster), single (Lot number: GH9694) at the age of 71 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE: 3, Lot Number: FC3181), administration date: 21Aug2021, when the patient was 70-year-old, for COVID-19 Immunization, reaction(s): "swelling and soreness of infraclavicular lymph node", "swelling and soreness of infraclavicular lymph node", "moderate soreness at injection site"; BNT162b2 (DOSE: 2, Lot Number: EN6200), administration date: 17Feb2021, when the patient was 70-year-old, for COVID-19 Immunization, reaction(s): "swelling and soreness of infraclavicular lymph node", "moderate soreness at injection site", "swelling and soreness of infraclavicular lymph node"; BNT162b2 (DOSE: 1, Lot Number: EL9262), administration date: 28Jan2021, when the patient was 69-year-old, for COVID-19 Immunization, reaction(s): "moderate soreness at injection site", "swelling and soreness of infraclavicular lymph node", "swelling and soreness of infraclavicular lymph node"; moderna coviD-19 mrna (Dose: 4, Lot Number: 002M21A), administration date: 04Apr2022, when the patient was 71-year-old, for COVID-19 Immunization, reaction(s): "swelling and soreness of infraclavicular lymph node", "moderate soreness at injection site", "swelling and soreness of infraclavicular lymph node". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 09Sep2022, outcome "unknown", described as "Dose: 4 Moderna, Dose: 5 Pfizer"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "moderate soreness at injection site"; LYMPHADENOPATHY (non-serious), LYMPH NODE PAIN (non-serious), outcome "unknown" and all described as "swelling and soreness of infraclavicular lymph node".  Additional information: Vaccination Facility Type: Doctor's Office/Urgent Care. Vaccine was not administered at Military Facility. Moderate soreness at injection site. Swelling and soreness of infraclavicular lymph node experienced with each of the 6 COVID injections. Prior vaccinations, relevant tests and specific relevant test for thromboembolic events with thrombocytopenia were reported as none. No one in family has had adverse reaction to vaccines of any kind.
This case meets vaccine breakthrough criteria review.  SxS cough, intermittent fevers, myalgias, SOB, increased O2 needs, fatigue, diarrhea
3-4" by 1" raised rash migrating from injection site. Pt c/o pruritis associated with rash. MD gave antivirals PO at f/u visit.
only the arm where I got the shot was sore.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administered in arm (Batch/Lot number: unknown) 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 IN EXTREMITY (non-serious), outcome "unknown", described as "only the arm where I got the shot was sore.".  Additional information: Subject: Patient Assistance Customer Verbatim: patient  had received two shots of the Pfizer COVID vaccine. After receiving the first shot, patient  had minimal symptoms only the arm where got the shot was sore. After receiving the second shot, I had flu-like symptoms and a fever for approximately ten days. Patient went to personal physician and received negative results for a flu test and COVID test. Does Pfizer recommend that patient get the booster shot. Patient should not get the COMIRNATY (COVID-19 Vaccine, mRNA) or the Pfizer BioNTech COVID-19 Vaccine if had a severe allergic reaction after a previous dose of this vaccine or if  had a severe allergic reaction to any ingredient of this vaccine. Patient should get a booster: At least 6 months after completing your primary COVID-19 vaccination series.Referred to HCP to assess and give recommendations for booster shot.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This case was reported by a pharmacist via call center representative and described the occurrence of muscular dystrophy in a female patient who received Shingrix for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, immediately after receiving Shingrix, the patient experienced muscular dystrophy. On an unknown date, the outcome of the muscular dystrophy was not recovered/not resolved. It was unknown if the reporter considered the muscular dystrophy to be related to Shingrix. Additional details were provided as follows: The patient received Shingrix in the left arm approximately 2 months ago. The patient reported to the pharmacist that shortly after receiving the vaccine, she experienced muscle dystrophy in her left arm. The patient reported that her left arm looked smaller than her right arm. The patient went to see her physician and had an X-ray and the physician did not see anything unusual on the X-ray. The reporter did not have patients initials, patient's date of birth or lot number at the time of the call, however, he stated that he would call back tomorrow and provide this information.
UrticariaPruritus, HYPERtension, itching Narrative: after 30 minutes, redness resolved, elevated blood pressure returned to normal
10 HRS AFTER SHOT, MOM GAVE TYLENOL FOR TEMP. OF 99.5, CHECKED ON CHILD @ 10PM TEMP=100.1. MOM GAVE JUICE AND COOL RAG TO HEAD. 1 A.M., NO FEVER. 2:45A.M.,CHILD SCREAMED ONCE, MOM FOUND CHILD "DAZED AND UNRESPONSIVE". MOM CALLED 911, AMBULANCE ARRIVE GAVE O2 CHILD CAME OUT OF "SEIZURE". TAKEN TO ER. PT. SAW DR W NO OTHER PROBLEMS. MOM CALLED NURSE TODAY, STATES THAT CHILD SAW HIS PEDIATRCIAN ON 080305, RULED THAT CHILD COULD HAVE IMMIES @ 4 YEARS OLD.
Feeling feverish and achey, hot but not registering any high temperature.  Headache.  Nauseous and itching at injection site. This all started at 12 hours after the shot, almost to the minute. I have been taking Ibuprofen for the aches and headache, drinking water and eating small meals, trying to rest.
Marked local pain for 3 days.  Approximately 3 weeks later regional painful skin to upper left chest , left scapula and then left upper outer arm and upper left back, all very sensitive to touch.  This was CRPS reaction to shot, or shingles without rash. I had previously been vaccinated with Zostavax and both Shingrix shots.  Now over three months later, my left upper back remains with dysphasia.  There developed some intensely pruritic and painful papules to my left upper back. Never vesicles. I got a little relief from topical lidocaine and oral Gabapentin.  My neurologist and I came to same opinion that ?something triggered by COVID shot?. Second COVID shot no big deal at all....just malaise hangover in first 12-48 hours.
Pt. states sudden chills, fever, headache and vomited once starting approx. 5 hours after getting the shot on 10/25. Called 10/26 to report. Pt states she is still have issues but not bound to the bed.
Covid-19 breakthrough. Vaccinated on 04/12/2021. 68 y/o PMH COPD, GERD, HTN, HLD, OSA, DM2 presents with 4-5 day history of increasing upper quadrant abdominal pain. CT showed pancreatic lesion so patient referred to AHWP for evaluation. Incidentally found to be Covid +.  Patient denies c/o N/V, fever, chills, cough, congestion, CP.  One episode of diarrhea. Treated with Pepcid, Zofran, and Morphine.
Vaccine given 11/29/04 redness and swelling noted to arm next day and progressively getting larger. Was seen at hospital in the evening on 11/30/2004 and was given Keflex. Seen in office today 12/01/2004 and sent back to hospital for IV abx. Child alert and happy. No fever noted.
Night terror; Sweating; This spontaneous case was reported by a consumer and describes the occurrence of SLEEP TERROR (Night terror) and HYPERHIDROSIS (Sweating) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2021, the patient experienced SLEEP TERROR (Night terror) and HYPERHIDROSIS (Sweating). At the time of the report, SLEEP TERROR (Night terror) and HYPERHIDROSIS (Sweating) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication included.  No treatment medication included.  Patient reported that after the second shot, her arm/shoulder started to hurt, she started feeling poorly around 12 hours in, she had a fever, aches, and a horrible headache that lasted for about 12 hours. She also tested positive for COVID-19 on 23May2021.   This case was linked to MOD-2021-168596 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Follow up received and contain no new information. On 27-Jul-2021: Follow-up received and contain non-significant information
Patient became lethargic several hours after shot administered. Then developed a fever of 104. Taken to ER by parents and treated with ibuprofen. Fever coming down now after 24 hours.
Arm pain started at 4:30pm the day of the injection. As the evening continued, I had muscle and joint aching of left side of my neck, shoulder, breast and felt very fatigued. During the night, I fell asleep quickly but woke up between 12-2 am sweating, with chills and muscle and joint aching all over my body specifically in my spine. The next morning I woke up with severe left arm pain and was unable to lift my left arm but I believe that is possibly due to the location of the injection site. (They injected me much closer to the AC joint rather than in the bulky part of the muscle.) The arm pain lasted 2 nights. I continued feeling fatigued and drained through the first full day and woke up after the second night feeling better. I had mild headaches on and off starting the second day after the injection and lasting about 5 days.
Pt developed a papular rash within 24 hours, post vax, that developed into hives. Cleared and reappeared the next day but no episodes since.
This is a spontaneous report from a contactable Nurse. A 9-year-old female patient received a dose of PREVNAR 13, (Batch/lot # W51762, exp date 30Jun2020) IM at 0.5 ml, single at deltoid right  on 01Oct2018 at 15:30 at 9 years and 10 months for immunisation, for low pneumococcal antibody titers, administered at Physician Office. She was recommended having an additional dose after receiving 5 previous doses of PCV7 since titers were still low. Medical history and concomitant medications were none. The patient previously received pneumococcal polysaccharide vaccine on 15Dec2010 (Lot: 1246Y, Expiry 21Jan2011) and 5 doses of pneumococcal 13-val conj vac (dipht crm197 protein) (PCV7) intramuscular at 0.5 ml, single: 1st on 06Jan2009 at 1 month (58 days) (No lot/expiry), 2nd on 17Jul2009 at 8 months (Lot: D75884, Expiry: Feb2012), 3rd on 29Aug2009 at 9 months (Lot: D92436, Expiry: Apr2012), 4th on 02Nov2009 at 11 months (Lot: D67170, Expiry: Jan2012), 5th on 22Feb2010 at 15 months (Lot: E20366, Expiry: Oct2013) for pneumococcal infection, all IM for immunisation. Regarding PCV7 injections, the caller could not determine from the records if there was a lack of effect or another reason for receiving 5 doses of PCV7. No adverse event occurred following prior vaccinations. No prior vaccinations (Within 4 weeks). On 03Oct2018 the patient experienced fever, itchiness at injection site, with redness, and pain. The events required a visit to Physician Office. The events were considered serious as important medical events. The outcome of the event fever was recovered 0Oct2018, the other events were recovering. Course of events: After receiving the PREVNAR 13 on 01Oct2018 the patient developed a fever and local reaction of itchiness at injection site, with redness, and pain on 03Oct2018 and was seen back at the office that morning. The patient was prescribed Cephalexin on 03Oct2018 for a suspected allergy versus infection following the PREVNAR 13 administration. On 04Oct2018 the patient was seen again and was given a topical steroid and told to stop the Cephalexin, as the provider did not feel it was necessary. On 04Oct2018 the patient was afebrile and the painfulness of the injection site has improved but the redness has increased. States it was about 32 hours after injection that the reactions occurred. Relevant tests were none. A Product Complaint was filed. The reporter considered there was a reasonable possibility that all events were related to the vaccine. Sender's Comments: A possible contributory role of the suspect product cannot be excluded for the reported events
Vaccine breakthrough case. Patient received 2nd dose of Moderna vaccine on 4/3/2021. Tested positive for COVID on 4/20/21 (negative for COVID via PCR on 4/8/2021). Patient was admitted to Hospital for infected right groin wound. Tested via routine admission screening. Asymptomatic for COVID-19 symptoms. Chest Xray/CT not performed.
aches; fever; tiredness; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (aches), PYREXIA (fever) and FATIGUE (tiredness) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 632L20A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Flu shot (Flu shot) in 2006. Past adverse reactions to the above products included Guillain-Barre syndrome with Flu shot. Concurrent medical conditions included Cholesterol since 1999, Diverticulitis since 2002 and Premature ventricular contractions since 2007. Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID] for Cardiac disorder, ROSUVASTATIN, ROSUVASTATIN CALCIUM (CRESTOR) and PRAVASTATIN SODIUM (PRAVACHOL) for Cholesterol, PLANTAGO OVATA (METAMUCIL [PLANTAGO OVATA]) for an unknown indication.    On 05-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MYALGIA (aches), PYREXIA (fever) and FATIGUE (tiredness). At the time of the report, MYALGIA (aches), PYREXIA (fever) and FATIGUE (tiredness) outcome was unknown. Not Provided          No treatment medication was reported.   This case was linked to MOD-2021-011434 (Patient Link).
This spontaneous report was received from a nurse referring to unspecified patients of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On unknown dates, the patients were inadvertently administered with VAQTA (lot # N008823, expiration date 26-MAY-2018) that had been improperly stored (incorrect product storage) for prophylaxis. The temperature was 1 centigrade degree (°C), and the time frame was 2 hours 23 minutes. There was no previous temperature excursion. Data logger was involved. No adverse effects reported. This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1708USA007006: US-009507513-1708USA007034:
Covid; Graves' disease; This spontaneous case was reported by a consumer and describes the occurrence of BASEDOW'S DISEASE (Graves' disease) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Heart rate high (elevated heart rate) in October 2020.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced BASEDOW'S DISEASE (Graves' disease) (seriousness criterion medically significant). On 08-Jan-2022, the patient experienced COVID-19 (Covid). At the time of the report, BASEDOW'S DISEASE (Graves' disease) outcome was unknown and COVID-19 (Covid) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Jan-2022, SARS-CoV-2 antibody test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were reported.  Patient received his first dose of the Moderna vaccine and does not have specific dates or lot numbers It was reported that prior to getting his second dose patient was diagnosed with Grave's disease and patient's mother reported that no healthcare professional said it was related to the vaccine because it showed he had elevated heart rate dating back to oct-2020 which is a symptom of Grave's disease. He has not received his booster.  No treatment details were reported.  Company comment-This spontaneous case concerns a 27-year old, male patient with relevant medical history of  increased heart rate, who experienced the unexpected serious (medically significant) event of Basedow's disease which occurred at an unknown interval after receiving the first dose of mRNA-1273 vaccine. He also experienced unexpected non-serious AESI event of Covid-19 at an unknown interval and recovered from the same. The outcome of the event Basedow's disease was not known at the time of this report. Medical history of elevated heart rate could be a confounder to the event Basedow's disease.  The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report..   This case was linked to MOD-2022-495556 (Patient Link).; Sender's Comments: This spontaneous case concerns a 27-year old, male patient with relevant medical history of  increased heart rate, who experienced the unexpected serious (medically significant) event of Basedow's disease which occurred at an unknown interval after receiving the first dose of mRNA-1273 vaccine. He also experienced unexpected non-serious AESI event of Covid-19 at an unknown interval and recovered from the same. The outcome of the event Basedow's disease was not known at the time of this report. Medical history of elevated heart rate could be a confounder to the event Basedow's disease.  The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report..
Hives all over face and neck some of body Very red and itchy  Swollen tongue Numbness in throat, tongue, hands, legs  Pins and needles over whole body Very faint, disorientated
shortly after vaccination patient experienced tingling/itchy sensation on her tongue and the top of her head. within 20 minutes symptoms resolved.
Swelling of the throat; Puffy eyes; My skin, my face and neck was like jelly; I get the allergic reaction to shot, Pfizer.; This is a spontaneous report from a contactable consumer or other non hcp (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date at dose number unknown, single for covid-19 immunisation. Medical history and concomitant medications were not reported. On an unspecified date the patient experienced swelling of the throat, puffy eyes, my skin, my face and neck was like jelly, i get the allergic reaction to shot, pfizer. Reporter stated that, I was told to call this number and report. I get the allergic reaction to shot, Pfizer. Is this where we call to report an adverse reaction to the shot, Pfizer. Adverse reaction: Reporter stated that, swelling of the throat, puffy eye and my skin, my face and neck was like jelly. Outcome of the events was unknown.   Information about lot/batch number has been requested.
This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with doses of improperly stored RECOMBIVAX HB (dose, route of administration, injection site, lot number and expiration date were not reported). No adverse experiences were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Fever, body aches, fatigue, upset stomach, diarrhea, rash on trunk, face, and thighs, loss of smell
Initial report received on 02 December 2009 from a health care professional. The case involves a 52-year-old female who is one of two cases on a cluster reported by the same reporter. The other patient's information is reported in case 2009-05288. A 52 year old female with no known allergies received in the left arm and injection (route not reported) of ADACEL (lot number not reported) on 06 November 2009. On 01 December 2009 (twenty five days after vaccination) the patient reported swelling and a lump at the injection site. The patient was seen in the doctor's office the following day. A lump, swelling and "purplish" discoloration was noted at the injection site. The patient had no reported illness at the time of vaccination. The patient's recovery status was reported as unknown. Follow-up information received on 08 January from a healthcare professional. The patient's recovery status was reported as recovered. List of documents held by sender: none
Pt recvd vax on 29MAY92 & for the next 3 days pt felt lethargy & devel sore arm;
Eyes burning, fatigue, soreness at injection site, muscle aches (not manifest until following day).
About 15 mins after injection my legs started itching, and I felt slightly disoriented, dizzy. I did feel like it wouldn't be smart to drive so my husband drove me home. I had a slight fever that night and next day, I felt super tired. I scheduled an ultrasound for 1 week following the shot, My ears kind of freaked out after the ultrasound and was itching and burning, I also got a rash around my neck after ultrasound. The rash felt like fire. Allegra helped with the itching. Faint rash traveled down my arms. The Dr. put me on prednisone the rash spread to my back and upper legs. Benadryl was not helpful. It lasted approximately 2 weeks.
Soreness beginning at the time of the injection (routine) then a day later, more pain and loss of ROM L shoulder that persists 6days after the vaccine.