chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial-arm soreness at injection site followed by lymph node in same arm swelling-duration 2 weeks. 2weeks after 1st dose tension headaches began moderate to severe, began menstrual cycle 2 weeks early along with other pms symptoms (fatigue, headaches, breast swollen and tender, fluid retention. Have continued on menstrual cycle for about 2 weeks, bleeding has lessened and headache still present. After 2nd dose, arm began slight swelling and tender, 2 hours after 2nd dose brief double vision, the night of 2nd dose fever, chills, body aches, nausea lasting 24 hours, now at 48 hour and slight chills, some body aches, no fever, arm tender, mild headache, extreme fatigue
Child started breaking out with welts (hives) on trunk, arms and face. No difficulty breathing speaking or swallowing.  Dr gave patient Benadryl.
5 min after administration- lleft arm pain described as nerve pain near shoulder. worsened over the next 30 minutes, ibuprofen ddidn't help. lasted days and has progressed further down arm. ER gave gabapentin, no relief. X ray and ultrasound came back normal
PAIN IN RIBS WHILE BREATHING IN; SHORTNESS OF BREATH/HUFFING AND PUFFING; FEELS CONSTRICTING; This spontaneous report received from a patient concerned an elderly female. The patient's height, and weight were not reported. The patient's concurrent conditions included metastatic breast cancer. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 09-JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 09-JUL-2021, the subject experienced pain in ribs while breathing in. On 09-JUL-2021, the subject experienced shortness of breath/huffing and puffing. On 09-JUL-2021, the subject experienced feels constricting. On 10-JUL-2021, treatment medications included: ibuprofen. Laboratory data (dates unspecified) included: X-ray (NR: not provided) Patient had a spot in ribs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from shortness of breath/huffing and puffing, pain in ribs while breathing in, and feels constricting. This report was non-serious.; Sender's Comments: V0. Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
Symptoms lasted for 3 days - chronic  Extreme and persistent muscles and joint aches, mostly upper body  Mild fever difficulty sleeping fatigue  took an ibuprofen once a day - lessened but never took away the aches and pain
blood sugar went down to 80 and is now normal without medications; This spontaneous case was reported by a consumer and describes the occurrence of HYPOGLYCAEMIA (blood sugar went down to 80 and is now normal without medications) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Handicap. Concomitant products included INSULIN HUMAN (NOVOLIN R) and INSULIN HUMAN INJECTION, ISOPHANE (NOVOLIN N) for an unknown indication.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HYPOGLYCAEMIA (blood sugar went down to 80 and is now normal without medications). At the time of the report, HYPOGLYCAEMIA (blood sugar went down to 80 and is now normal without medications) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Mar-2021, Blood glucose: 80.         Action taken with mRNA-1273 in response to the events was not applicable. Treatment details were not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-069694 (E2B Linked Report). This case was linked to MOD-2021-069694 (Patient Link).
Tightening of throat, itchiness in throat, dizziness, confusion, light headed, increased heart rate.   Emergency room treated me with  steroid, Benadryl, and epinephrine.   I was sent home with a steroid pack, Benadryl, and an epipen.
got it from medication side effects/suspected vaccination failure; got it; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: got it from medication side effects/suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: got it). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 20-MAR-2023 The case  was received from the patient via interactive digital media. The patient got it from medication side effects. The patient had the Shingles shot some years ago and thought that helped him/her.  This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
On 08/12/2020 Patient was given a Proquad and Varicella injection. (Totality not seen clearly on paper submitted to ). Mother notified and Patient did well throughout the night. Patient was a little fussy per mother and received a dose of Tylenol at night.
hives; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, lot number and Expiry date: not provided) (age at the time of vaccination was 71 years), via unspecified route on an unspecified date as dose number unknown, single for COVID-19 immunization. On an unknown date, the patient experienced after three weeks of vaccination. The patient still have hives and they were getting worse. No further details provided. The outcome of the event was not resolved.   No further information was provided. Batch/lot number not obtained.
Vomiting approximately 30 minutes after vaccination, chest pain beginning around 1:13 am on 8/17/2022 that prevented sleep; severe vaccine site pain extending to right hand.
slight pain on shoulder where injection made, pain went away 2 days later.  pain came back (tolerable), itches and is slightly swollen
This spontaneous report as received from a registered nurse refers to unspecified number of patients of unknown age and gender. On an unknown date unspecified number of patients were vaccinated with a dose of ROTATEQ (lot number expiration date, dose were not reported), route default as oral for prophylaxis that underwent post supported temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
The patient had Nausea, started Today in the morning, Called pharmacy. The patient was provided some OTC Meclizine to prevent/treat  Nausea.  Patient also has some complaint of Joint pain. Patient was prescribed Meloxicam. So, suggested to continue taking it, which could be helpful to Joint pain. Suggested if symptoms getting worsen Call 911 and report to pharmacy.
103 degrees F temp, hives, myalgia, body pain, minor throat swelling. BENADRYL, EPI.
Late menstrual cycle after 2nd dose.  Currently 7 days late. No chance of pregnancy.  No treatment. Outcome is that I?m still waiting for my cycle.  This is totally irregular.
Pt developed autoimmune hemolytic anemia and states she started to feel her symptoms shortly after flu vaccine (24-48 hrs after).  04/24/2007 MR received from OBGYN which includes several hospital records as well. Pt initially presented to the hospital on 11/23/2007 with a drop in the patient's Hct and Hgb noted on 11/22/2007. This hemolytic anemia followed on the heels of passing tea colored urine, nausea, vomiting, icterus  and elevated LFTs which pt. was being f/u for. Txd with steroids and discharged on PO prednisone. Final DX:  IUP at 21 weeks with hemolytic anemia of uncertain etiology. F/U with Heme/Onc MD 11/29/06. Doing well on steroid tx.  Hct increasing. DX: Autoimmune Hemolytic Anemia.
Information has been received from a literature article concerning a 17 year old female patient developed uveitis following administration of GARDASIL. A total of 24 cases of uveitis occurred following administration of GARDASIL; the gender in all cases was female. The median age was 17 (range 12-29). The median time from vaccination to onset of ADRs was 30 days (range 0-476); time to onset was unknown in this case; the time to onset in this case was 7 days from vaccination. There was one reported rechallenged of the GARDASIL vaccine. In 13 of the 24 cases other ocular side effects were noted including 3 case reports of papillitis, 2 case reports of retinitis and 1 case report of papilledema. Systemic side effects were noted in 9 of the 24 cases and included 2 cases of arthralgia. In 2 case reports multiple vaccines were administered simultaneously. According to World Health Organization Causality Assessment Guide of Suspected Adverse Reactions, the relationship between human papilloma virus vaccine and uveitis was "possible". Causality assessments are based on the time relationship of drug administration, uveitis development and rechallenge data. This is one of several reports from the same literature source. Additional information has been requested.
A nurse reported that a 5 month old infant received Acel-Immune and IPV vaccines in May 2000. The infant developed an injection site reaction characterized by redness and swelling at the site of Acel-Immune administration. The infant recovered. This is 1 out of 4 patients from this facility who had an adverse experience following receipt of Acel-Immune lot 469-396 or the concomitantly administered vaccines.
It came on like cough when I had sinus irritation. I had a terrible headache, and my sinuses was really runny. I started talking Paxlovid that Monday and by Tuesday, I was feeling much better. Tested negative 3/6/2023.
Sore arm; Rash; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; lot/batch number and expiry date were unknown), via an unspecified route of administration on 08Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had his/her 1st Pfizer vaccine on 08Jan2021, and the reaction is just sore on the arm (on unspecified date in Jan2021). And then last week on unspecified date in Jan2021 (started a week ago), it came out like rash. The patient is asking whether there is anybody reported that they start looking out in rash, couple weeks later. The patient reported that he/she is not sure whether this rash is from the vaccine. The patient is also asking if he/she should get the 2nd vaccine, because his/her 2nd vaccine is this Friday. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Redness and swelling around injection site on day two (day one being day of injection). Redness and swelling on day three decreased to just small red dot. No other complaints.
warm arm; pink arm; swollen arm; injection site itching; "flu like" illness; flushing; headache; injection site redness; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swollen arm), FEELING HOT (warm arm), INJECTION SITE DISCOLOURATION (pink arm), INFLUENZA LIKE ILLNESS ("flu like" illness) and FLUSHING (flushing) in a 67-year-old female 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 Rheumatoid arthritis and Osteoarthritis. Concomitant products included METHOTREXATE, HYDROXYCHLOROQUINE SULFATE (PLAQUENIL S), PARACETAMOL (TYLENOL), HYDROCORTISONE, CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY), POLYCARBOPHIL CALCIUM (FIBER), TOFACITINIB CITRATE (XELJANZ), PANTOPRAZOLE, OMEPRAZOLE, FOLIC ACID, METOPROLOL, MONTELUKAST SODIUM (SINGULAIR), ATORVASTATIN, ACETYLSALICYLIC ACID (ASPIRIN 81), MULTIVITAMIN & MINERAL, PROBIOTIC 10, UBIDECARENONE (COQ) and TRAMADOL for an unknown indication.    On 02-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS ("flu like" illness), FLUSHING (flushing), HEADACHE (headache) and VACCINATION SITE ERYTHEMA (injection site redness). On 04-Mar-2021, the patient experienced INJECTION SITE PRURITUS (injection site itching). On 07-Mar-2021, the patient experienced PERIPHERAL SWELLING (swollen arm) and INJECTION SITE DISCOLOURATION (pink arm). On 08-Mar-2021, the patient experienced FEELING HOT (warm arm). The patient was treated with HYDROCORTISONE (HYDROCORTISONE CREAM) for Injection site redness, Injection site itching and Swelling, at an unspecified dose and frequency. On 03-Mar-2021, INFLUENZA LIKE ILLNESS ("flu like" illness), FLUSHING (flushing), HEADACHE (headache) and VACCINATION SITE ERYTHEMA (injection site redness) had resolved. At the time of the report, PERIPHERAL SWELLING (swollen arm), FEELING HOT (warm arm), INJECTION SITE DISCOLOURATION (pink arm) and INJECTION SITE PRURITUS (injection site itching) outcome was unknown.            Patient concomitant medicines include nasal saline spray but unknown as well  taken cool compress treatment to relieve the symptoms.
Heart raced; Allergic reaction; Bad headache; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Heart raced), HYPERSENSITIVITY (Allergic reaction) and HEADACHE (Bad headache) 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 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced PALPITATIONS (Heart raced), HYPERSENSITIVITY (Allergic reaction) and HEADACHE (Bad headache). At the time of the report, PALPITATIONS (Heart raced), HYPERSENSITIVITY (Allergic reaction) and HEADACHE (Bad headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
under the weather for a day or two; dizziness; headache; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (under the weather for a day or two), DIZZINESS (dizziness) and HEADACHE (headache) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 032M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MALAISE (under the weather for a day or two), DIZZINESS (dizziness) and HEADACHE (headache). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, MALAISE (under the weather for a day or two), DIZZINESS (dizziness) and HEADACHE (headache) had resolved.            No Concomitant product use was reported.  The reporter was calling on behalf of their wife who was the patient and reported that the patient felt under the weather for a day or two and experienced headache and dizziness, after dose 2. Reportedly, by the morning it was gone.
pt recv vax 13FEB96 & on 27MAR97 pt devel a moderate, disseminated, vesicular varicella-like rash consisting of greater than 50 lesions;
Next day pt. states lump under left armpit, Neck and stiffness on right side of shoulder.
pt recvd vax & devel fever of 102.9 R approx 5 hrs p/vax; pt then started to shake & eyes rolled back; sz; t104.7; flushed face; devel febrile seizure;
she developed like a cold; teary eyes; congestion; chills; checked temperature and it was 90; body aches; woke up in the middle night all sweaty; her body was cold; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (body aches), HYPERHIDROSIS (woke up in the middle night all sweaty), PERIPHERAL COLDNESS (her body was cold), NASOPHARYNGITIS (she developed like a cold) and LACRIMATION INCREASED (teary eyes) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) 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 LOSARTAN and PRAVASTATIN for an unknown indication.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced PAIN (body aches), HYPERHIDROSIS (woke up in the middle night all sweaty), PERIPHERAL COLDNESS (her body was cold), BODY TEMPERATURE (checked temperature and it was 90) and CHILLS (chills). On 06-Mar-2021, the patient experienced NASOPHARYNGITIS (she developed like a cold), LACRIMATION INCREASED (teary eyes) and NASAL CONGESTION (congestion). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 06-Mar-2021, PAIN (body aches), HYPERHIDROSIS (woke up in the middle night all sweaty), PERIPHERAL COLDNESS (her body was cold), NASOPHARYNGITIS (she developed like a cold), LACRIMATION INCREASED (teary eyes) and NASAL CONGESTION (congestion) had resolved. At the time of the report, BODY TEMPERATURE (checked temperature and it was 90) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 08-Mar-2021: Follow-up received on 9-mar-2021 which include Events Chills and checked Temperature and it was 90  and the Outcome of event was unknown .
Patient states she received Hep B shot on 11/12/15 and has since developed a generalized rash 11/14/15 that began from her abdomen and spread to neck and is now arms, hands and legs. Patient states she had taken OTC BENADRYL and applied some type of OTC ointment (unable to recall name of ointment. Patient denies any other symptoms. Patient requesting a waver or recommendation from PCP Dr. Innocent regarding 3rd and final Hep B inoculation. Patient requesting to be contacted by clinic with Plan of Care regarding this matter. Rash and Urticaria Pruritus. Diphenhydramine, Methylprednisolone.
Mother noticed increased tantrums, length of tantrums, and significant increase in their severity a few days after her MMR vaccine
Patient received first shot of Moderna COVID-19 vaccine while under the age of 16; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient received first shot of Moderna COVID-19 vaccine while under the age of 16) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-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 PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient received first shot of Moderna COVID-19 vaccine while under the age of 16). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient received first shot of Moderna COVID-19 vaccine while under the age of 16) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication use was unknown Treatment information was unknown
Information has been received from a licensed practical nurse concerning a 15 month old male pt, with no allergies and no medical history, who on 29APR2003 at 9:30AM was vaccinated SC in the right leg with a first dose of  measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation). Concomitant therapy included vaccination IM  in the left leg on 29Apr03 at 9:30AM with a fourth dose of HIB conjugate vaccine (ACTHIB) and vaccination IM in the left leg on 29Apr03 at 9:30AM with a fourth dose of Streptococcus pneumoniae vaccine (PREVNAR). On 06May2003 the pt experienced a red itching rash at site of injection. No medical attention was sought. It was reported that there were no diagnostic tests or laboratory data. The pt recovered on an unspecified date. No further information is available.
The vaccination was was dripping down her arm; lure lock system wasn't completely closed; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE DISCHARGE (The vaccination was was dripping down her arm) and PRODUCT DISPENSING ERROR (lure lock system wasn't completely closed) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 040A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Mar-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. On 24-Mar-2021, the patient experienced VACCINATION SITE DISCHARGE (The vaccination was was dripping down her arm) and PRODUCT DISPENSING ERROR (lure lock system wasn't completely closed). At the time of the report, VACCINATION SITE DISCHARGE (The vaccination was was dripping down her arm) and PRODUCT DISPENSING ERROR (lure lock system wasn't completely closed) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported No treatment medications were reported
Amenorrhea starting in June and continuous until today.  Since getting the second dose of the vaccine, she has not menstruated.  Prior to the vaccine, she had a regularly occurring period for the last 2+ years.
This spontaneous prospective pregnancy report as received from a physician refers to a 15 year old female patient. The patient's pertinent medical history and drug allergies were not reported. On 24-MAR-2016, the patient was vaccinated with third dose of GARDASIL 9, 1 shot intramuscularly. It was mentioned that they were sexually active. The doctor administered a pregnancy test, which came back positive after the vaccine had been administered. The stage of pregnancy was not stated, as it is believed to be in the very early stages. No treatment was provided. No product quality complaint was reported for GARDASIL 9. Outcome was unknown (also reported as not recovered). Additional information has been requested.
Patient developed severe Bell's Palsy beginning approximately 8 days after 2nd dose of Pfizer COVID19 vaccination. Patient with near complete paralysis of left facial nerve. Unable to close eye.