chrisvoncsefalvay/vaers-outcomes huggingface dataset:
40 patients administered vaccines that have undergone temperature excursion; Patient was administered with vaccines that had undergone temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (40 patients administered vaccines that have undergone temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccines that had undergone temperature excursion) in a 41-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059H21A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Feb-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Feb-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccines that had undergone temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (40 patients administered vaccines that have undergone temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (40 patients administered vaccines that have undergone temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccines that had undergone temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was reported.  On 30-Jan-2022, the patient received the booster dose of Moderna COVID-19 Vaccine   Vaccines were thawed on 28-Jan-2022.  It was reported Maximum or minimum temperatures reached as on 28-Jan-2022 temp range positive 34.7F to positive 41.2F, on 30-Jan-2022 temp range positive 34.7F to positive 41.2F which occurred for 48 hours; on 31-Jan-2022 temp range positive 34.7F to positive 41.2F for 12 hours and on 04-Feb-2022 temp range positive 35.2F to positive 41.7F for 12 hours.  It was reported that the patient did not experience any adverse event.  No treatment medications were provided.   This case was linked to MOD-2022-539812 (Patient Link).
a major inflammation on the arm that impaired its movement; a major inflammation on the arm of the injection; chills; started felling body aches; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (a major inflammation on the arm that impaired its movement), VACCINATION SITE INFLAMMATION (a major inflammation on the arm of the injection), CHILLS (chills) and MYALGIA (started felling body aches) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022C21A and 046B21) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-May-2021, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (a major inflammation on the arm that impaired its movement), VACCINATION SITE INFLAMMATION (a major inflammation on the arm of the injection), CHILLS (chills) and MYALGIA (started felling body aches). At the time of the report, VACCINATION SITE MOVEMENT IMPAIRMENT (a major inflammation on the arm that impaired its movement), VACCINATION SITE INFLAMMATION (a major inflammation on the arm of the injection), CHILLS (chills) and MYALGIA (started felling body aches) outcome was unknown.            No concomitant medication was reported.Treatment medication was not provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable.
Immunization given with hive like reaction over area of immunization 10cm. Observation only.
All over itching- no rash.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 18Sep2022 at 12:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 34 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "COVID-19" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Amoxicillin, reaction(s): "Allergy". Vaccination history included: Covid-19 vaccine (DOSE 1, UNKNOWN MANUFACTURER.), for Covid-19 Immunization; Covid-19 vaccine (DOSE 2, UNKNOWN MANUFACTURER.), for Covid-19 Immunization; Covid-19 vaccine (DOSE 3, UNKNOWN MANUFACTURER.), for Covid-19 Immunization. The following information was reported: PRURITUS (non-serious) with onset 18Sep2022 at 12:00, outcome "not recovered", described as "All over itching- no rash.". Therapeutic measures were not taken as a result of pruritus.   Additional information: the patient did not received other vaccine in four weeks or covid tested post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Platelet count of zero; This spontaneous case was reported by a physician and describes the occurrence of PLATELET COUNT DECREASED (Platelet count of zero) in an 82-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced PLATELET COUNT DECREASED (Platelet count of zero). At the time of the report, PLATELET COUNT DECREASED (Platelet count of zero) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine), the reporter did not provide any causality assessments.   Treatment and concomitant medications were not provided.
vaccine has triggered asthma; Breathlessness; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 25832536) on 22-Aug-2021 and was forwarded to Moderna on 22-Aug-2021.    This regulatory authority case was reported by a consumer and describes the occurrence of DYSPNOEA (Breathlessness) in a male patient of an unknown age who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.  Concurrent medical conditions included Asthma. Concomitant products included PARACETAMOL for COVID-19.    On 20-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 21-Aug-2021, the patient experienced DYSPNOEA (Breathlessness) (seriousness criterion medically significant). On an unknown date, the patient experienced ASTHMA (vaccine has triggered asthma). At the time of the report, DYSPNOEA (Breathlessness) had not resolved and ASTHMA (vaccine has triggered asthma) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Jul-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown.       The report mentioned that the vaccine has triggered the patient's asthma.  No treatment information was provided.  Based on the current available information and temporal association between the use of the product and the start date of the event Dyspnoea, a causal relationship cannot be excluded. Very limited information regarding the event Asthma has been provided at this time. No further information is expected at this time. Of note, the patient's medical history of Asthma is a confounding factor that may play a possible contributory role. Moreover, the event Dyspnoea was assessed as serious by the Regulatory Authority. However, based on medical judgement and the lack of evidence of seriousness from a clinical or regulatory standpoint, the event is not considered serious.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event Dyspnoea, a causal relationship cannot be excluded. Very limited information regarding the event Asthma has been provided at this time. No further information is expected at this time. Of note, the patient's medical history of Asthma is a confounding factor that may play a possible contributory role. Moreover, the event Dyspnoea was assessed as serious by the Regulatory Authority. However, based on medical judgement and the lack of evidence of seriousness from a clinical or regulatory standpoint, the event is not considered serious.
Loss of appetite, mild fever and lethargy began first at around 5:30 PM. Fever spiked around 10 PM including rapid heartbeat, lowered consciousness, lethargy, staring and confusion and a sore throat and a raspy, voice with difficulty swallowing and talking. Her fever has continued (at about 103.4 degrees F) for the past 68 hours, brought down 4 times- every 4 to 6 hours- with Children's Tylenol. We visited the doctor's office at 2:30 PM on March 22 and she was tested for Strep Throat which came back negative. Today, March 24 at 12:57 PM, she is experiencing fussiness, stomach pain (possibly from constipation), mouth and tooth pain and leg muscle aches along with a mild fever and is still lethargic but taking in more fluids than she has the past few days.
Vomiting, nausea, neck muscle tightness, throat tightness and muscle soreness of back of tongue,  severe disorientation, blurred vision, neck soreness, diarrhea
At approximately 2:30AM on 6/3, onset of high fever (101+), body aches, chills/sweating, arm pain, nausea, fatigue. This continued for approximately the next 30 hours; at 30 hours, fever reduced to just below 100 (took Advil/Tylenol every 4 hours during the entire course of issues). Most symptoms subsided or were minimal by 6/5.  Weeks later however, I am still feeling extremely fatigued (the slightest exertion causes exhaustion - which prior to the vaccine I did not seem to have).
pain in the back at both kidney areas appeared suddenly in less than an hour after vaccination, the pain in that area continues for days and it is still present. After covid19 vaccine pfizer first dose in November 2021, pain in the same area appeared and lasted for more than six months. On 6/28/2023 join pain suddenly appeared in finger joints and shoulder in right arm this pain still continue and did not improved after more than a week. Headache and light temperature that lasted for one week.
This case was reported by a other health professional via sales rep and described the occurrence of shingles in a 62-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included COVID-19 VACCINE (COVID-19 BOOSTER) for prophylaxis.     On an unknown date, the patient received the 2nd dose of Shingrix and COVID-19 BOOSTER. On an unknown date, more than 2 years after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.       Additional Information: tareceipt date: 3-Feb-2023 Reporter's comment: The patient received the 2nd dose of Shingrix vaccine in 2019 just before COVID began. The patient had second occurrence of Shingles in 2022, 1 year later receiving a COVID booster. The reporter clarified to be sure that it was Shingrix (not Zostavax) that the patient received and whether he had previously reported it. It was definitely Shingrix, he said, and commented that it was never reported.  The reporter was happy for it to be reported and willing to provide any additional information, should any be needed.  The reporter commented that 3 independent seasoned clinicians confirmed the diagnosis to be shingles as he was very much an advocate of Shingrix (and still was) for his patients.  The reporter was surprised at the reoccurrences but believe them both to be true, fairly mild cases of shingles. Lots numbers were not available but the information was complete, per the form. The reporter consented to follow-up. Additional supportive information: It was unknown if the reporter considered the shingles to be related to Covid-19 booster. As 1 year later Covid-19 booster the patient had second occurrence of shingles therefore Covid-19 booster was coded as suspect in this case.
This is a spontaneous report from a contactable nurse via a Pfizer sales representative. A 16 year-old female patient received TRUMENBA via an unspecified route of administration, on unknown date, at single dose. The patient also received and tuberculin ppd (unknown manufacturer). Relevant medical history and concomitant medications were not reported. The patient felt faint and needed support to stand on unknown date after received the products. The action taken for tuberculin ppd was not reported. The outcome of the events was unknown. No follow up attempts possible. No further information expected.
I have visited and shown him my PCP on 9-30-16, 1:30 pm and same as above. Dermatologist on 10-12-16 at 9:30 am.
severe severe severe pain in my legs/severe severe severe pain in the back of my thigh; for months I could hardly walk/for months I could hardly sit down and get up/it went into my shoulders; severe severe severe pain on the top of the joint; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (severe severe severe pain in my legs/severe severe severe pain in the back of my thigh), HYPOKINESIA (for months I could hardly walk/for months I could hardly sit down and get up/it went into my shoulders) and ARTHRALGIA (severe severe severe pain on the top of the joint) in a 77-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-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 PAIN IN EXTREMITY (severe severe severe pain in my legs/severe severe severe pain in the back of my thigh), HYPOKINESIA (for months I could hardly walk/for months I could hardly sit down and get up/it went into my shoulders) and ARTHRALGIA (severe severe severe pain on the top of the joint). At the time of the report, PAIN IN EXTREMITY (severe severe severe pain in my legs/severe severe severe pain in the back of my thigh), HYPOKINESIA (for months I could hardly walk/for months I could hardly sit down and get up/it went into my shoulders) and ARTHRALGIA (severe severe severe pain on the top of the joint) had not resolved.            No concomitant medications provided. No treatment medications provided.
Extreme Fatigue - Temp that ranged from 102 to 105F.  Took 4 baby aspirins    -  Ten hours later, Took 1000 mg acetaminophen (generic tylenol)  ... temp eventually broke Subsided 30 to 36 hours later.
Mom in on 8/20/01, and states injection site developed blister-like area and had a hardened area and was warm to the touch. Pt was seen in ER and told it could be a reaction to bandaid or vaccine. Site open and red on 8/20/01 but no knot felt. Mom is using ice to site.
Pt stated had HBV #1 on 6/27/02. Then developed circular hives on L arm above elbow size of nickel x 2 size of dime on R elbow and x 1 size of nickel on R forearm, itching pinkish red in color. Seen at clinic on 7/2/02 by a health provider does not able to determine the reason for hive and prescribed 1% H C TID, without relief. No other sx. Advised to follow up with his MD. 8/28/02 several attempts to contact client to follow-up status has been unsuccessful. Letter sent 9/3/02.
This case was reported by a other health professional and described the occurrence of rash in a patient who received FLUARIX (batch number LY2F5, expiry date 30th June 2015). On an unknown date, the patient received FLUARIX. On an unknown date, immediately after receiving FLUARIX, the patient experienced rash, injection site pain and discomfort. On an unknown date, the outcome of the rash was not recovered/not resolved and the outcome of the injection site pain and discomfort were unknown. The reporter considered the rash, injection site pain and discomfort to be probably related to FLUARIX. Additional information: The physician assistant reported that there had been several patients (about 6) that have reported inflammatory reactions with more than normal (unusual) pain and discomfort after receiving the FLUARIX TIV vaccine. In 2 of the 6 patients they developed a rash which was indurated hard and painful. One of the 2 patients that developed the rash it was in size about 10-15cm. All of these patients are reporting these adverse events immediately upon receiving the vaccine and reported that it gradually worsened over time. About 5 patients came back in the office to be evaluated. The PA believes these reactions have resolved but is not sure.
Chicken pox disease. Pt awoke with spots, sister developed spots night before 06/25/02. pt has chicken pox 20+ spots on 06/26/02.
Noted onset of rash beginning on abdomen, 3 days, post vax/HBIG, gradually spread over trunk, proximal extremities, small erythematous non-pruritic papules.
Fever x 3 days T-max 102. Sore arm x 2 days. Red welt 4cm diameter around site of injection (R) arm.
FEVER OF 101 DEGREES; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included cancer. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 12-MAR-2021, the subject experienced fever of 101 degrees. Laboratory data included: Body temperature (NR: not provided) 101 deg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of fever of 101 degrees was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment not required as per standard procedure as the case assessed as non-serious
Patient received her first COVID-19 vaccine on 11/11/21.  Presented to our clinic on 11/16/21 for bruising and rash.  Rash subsequently identified as petechiae.  CBC showed thrombocytopenia, with platelets of 27,000.  Repeat CBC showed platelet count of 15,000.
Redness / hot induration at the site of TDAP and MENACTRA. Mom had to take him to ER as he started to have fever also. Reaction 2" circle around the site.
L thigh swollen area-received immunization on 10/21/02 at 11am in left upper thigh. Pt same on 10/23/02 at 10am.
On 10/29/19, patient called pharmacy to report sore left arm, redness and swelling at the injection site of Shingrix on 10/28/19. On 10/30/19, patient saw his primary care doctor, who recommended putting a cold compress on left arm to ease swelling and pain.  Patient reports that the pain is easing up from when he first got the vaccine.
Left side of mouth (teeth) started hurting....extremely painful, lasting for 45 mins. Weakness started after 30 mins. then headache came on lasting for 2 hours.  Took 200 mg. Motrin. Teeth pain, weakness, were over in 1 hour, while the headache lasted about 2 hours.
Starting from 04/07/21, Sudden waist and back pain, cannot straighten up the body. When straighten up the body feels breathing difficulties . After 3-4 days there?s a continuous  pain in both thigh and the calf, and red marks are spawning on the legs.
Left arm in severe pain, still can't lift it all the way up without struggle, the injection site has a lump (cyst like in feel) and a wide area around is swollen and stiff/sore. No treatments yet....but if still bad after this weekend, will seek medical help.  Left eye swelling started at 2pm today, with pain. the eye lid and the area around the left eye are painful and swollen. I have been using hot compresses.  Difficulty catching my breath today durning a morning walk. I have been walking for months on the same path and can hold a conversation, but today, I could barely walk and talk. Once I stopped talking I eventually was able to catch my breath, but we had to walk a much slower pace as well.
Right deltoid (arm) red and swollen, mother of patient stated that kid had a low grade temp. of 99.4 the day after vaccine administered.
The temperature went up to 103 degrees F. after immunization with prevnar (12 hours later).
Perscribed Losartan late December 2020 for hypertension due to problems with HCTZ.  By early January 2021, noted mild persistent tinnitus (previously only very minor and occasional).  I reduced the dose of Loartan from 50mg to 25 mg per day and did note some minor improvement in the tinnitus, as clinic does report ear noise and tinnitus as a side effect from Losartan.   However, the longer I continued Losartan the worse the tinnitus became such that in February it was moderate and in March was severe, such that I discontinued Losartan the day after the 2nd Pfyzer vaccine shot due to the extreme severity of the tinnitus thinking that it was Losartan related.  I am now 2 1/2 months since that last covid vaccine shot and the discontinuation of the Losartan and the tinnitus has gone from 9-10+ (1-10 scale) to 6-8,  but  has not resolved.   My hearing test compared to that of 2 years ago is unchanged and shows minimal hi frequency hearing loss which is inconsequential to any day to day living activities.
Last night around 10 pm she achey, muscle and joint pain, and then a headache and then chills, lips bluish, but not SOB, blood pressure 185/78  usually  it's lower like 120 or 130, pulse ox 85 low. Suggested to go to ER or call 911 She called her DR.
Pt received Pfizer monovalent as a booster instead of Pfizer Bivalent
This spontaneous report as received from a pharmacist refers to a 61 year old female patient with no concurrent condition or medical history. The patient had no drug reactions or allergies. The pharmacist reported that the patient received a dose of a tetanus vaccine (manufacturer unknown) on 11-JUN-2015 in her right arm. On 14-JUL-2015, the patient was vaccinated with a dose of ZOSTAVAX 19400 PFU (lot # L013546, expiration date 17-JUL-2015) 0.65 ml, subcutaneous in the posterior right arm (dose not reported). The pharmacist reported that on 16-JUL-2015, the patient consulted him to show her injection site where she received ZOSTAVAX. The pharmacist stated that site was red, swollen, and warm to the touch in a 4-inch diameter around the injection site. The patient reported that she noticed the symptoms developing "last night," (on 15-JUL-2015). The pharmacist stated that she had not notified her primary healthcare provider at this time, and that he cannot determine whether or not she was developing a rash. No treatment was given to the patient and on laboratory diagnostic studies were performed. The outcome of injection site erythema, rash, injection site warmth and injection site swelling was reported as not recovered/not resolved. The reporter did not assess the relatedness between ZOSTAVAX and the events above mentioned. Additional information has been requested.