chrisvoncsefalvay/vaers-outcomes huggingface dataset:
lump in my arm that wont go down; lump kept growing and growing at the site of injection; Hard; Big, round like base ball; Red; Itchy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (lump in my arm that wont go down), VACCINATION SITE MASS (lump kept growing and growing at the site of injection), VACCINATION SITE INDURATION (Hard), VACCINATION SITE SWELLING (Big, round like base ball) and VACCINATION SITE ERYTHEMA (Red) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE MASS (lump in my arm that wont go down), VACCINATION SITE MASS (lump kept growing and growing at the site of injection), VACCINATION SITE INDURATION (Hard), VACCINATION SITE SWELLING (Big, round like base ball), VACCINATION SITE ERYTHEMA (Red) and VACCINATION SITE PRURITUS (Itchy). At the time of the report, VACCINATION SITE MASS (lump in my arm that wont go down), VACCINATION SITE MASS (lump kept growing and growing at the site of injection), VACCINATION SITE INDURATION (Hard), VACCINATION SITE SWELLING (Big, round like base ball), VACCINATION SITE ERYTHEMA (Red) and VACCINATION SITE PRURITUS (Itchy) outcome was unknown.        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.   No concomitant medication details was reported. No treatment medication details was reported.
Chronic diarrhea with no remission since the vaccine. Dry mouth. Dizziness. Chest tightness
Swelling, redness, pain, itching at the injection site. Symptoms started approximately 48 hours after injection.
Patient did not report adverse reaction. However, patient received Moderna vaccine when he is under 18.
This spontaneous report as received from a Physician Assistant refers to a 42 years old female patient with allergy to penicillin. The patient's medical history included migraines and vertigo. The patient was vaccinated with PNEUMOVAX23 (0.1 ml, intradermal, left forearm, lot # was reported as H013847, expiration date was 15-MAR-2014) on 14-NOV-2012. No other co-suspects were reported. Unspecified medication for migraines as needed. On 14-NOV-2012 the patient received 0.1 ml of PNEUMOVAX23 administered intradermally. PNEUMOVAX23 was inadvertently administered instead of a tuberculin purified protein derivative (PPD) related to an error by a staff member. The patient was experiencing significant left hand and left arm swelling (on 14-NOV-2012). The outcome of significant left hand and left arm swelling was reported as not recovered. No lab diagnostics studies performed. The patient sought medical attention via visiting office. Additional information has been requested.
Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021; Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2021 at 8:56 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 31-Mar-2021 at 8:56 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 27.53   Concomitant products were not provided.  On 31-Mar-2021 Excursion time was reported at 08.00 A.M  with  temperature as 32 degrees Fahrenheit, total doses given for the day was 199, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 23-Mar-2021 , vial was moved to clinic on 31-Mar--2021. 4 vials were sent to clinic. Vaccine BUD date was 22-Apr-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a Fisherbrand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
Arm (injection site) began to swell, become hot to the touch, and become noticeably sore to touch/movement.
Very strong headache, very high blood pressure, Chest Pain, Fever, Nauseas, Dizzy, Vomiting, Fatigue,  Leg Pain
autoimmune condition symptoms aggravated; underlying conditions aggravated; she felt it is difficult for her to normally breath because of lymph nodes pressure on her throat; she kept on getting flu symptoms on and off; Her face feels hot; achy body/muscle pains somedays it resolves quickly but for some days it can last hours; Bad headache; joint pain; lymph nodes in the neck swelled up; This spontaneous case was reported by a consumer and describes the occurrence of AUTOIMMUNE DISORDER (autoimmune condition symptoms aggravated) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046A21A and 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Sjogren's syndrome, Peripheral neuropathy, Graves' disease, Atrial fibrillation and Thyroid disorder.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Mar-2021, the patient experienced LYMPHADENOPATHY (lymph nodes in the neck swelled up). On an unknown date, the patient experienced AUTOIMMUNE DISORDER (autoimmune condition symptoms aggravated) (seriousness criterion medically significant), CONDITION AGGRAVATED (underlying conditions aggravated), INFLUENZA LIKE ILLNESS (she kept on getting flu symptoms on and off), HOT FLUSH (Her face feels hot), MYALGIA (achy body/muscle pains somedays it resolves quickly but for some days it can last hours) and ARTHRALGIA (joint pain). an unknown date, the patient experienced DYSPNOEA (she felt it is difficult for her to normally breath because of lymph nodes pressure on her throat) and HEADACHE (Bad headache). At the time of the report, AUTOIMMUNE DISORDER (autoimmune condition symptoms aggravated), CONDITION AGGRAVATED (underlying conditions aggravated), DYSPNOEA (she felt it is difficult for her to normally breath because of lymph nodes pressure on her throat), INFLUENZA LIKE ILLNESS (she kept on getting flu symptoms on and off), HOT FLUSH (Her face feels hot), LYMPHADENOPATHY (lymph nodes in the neck swelled up), MYALGIA (achy body/muscle pains somedays it resolves quickly but for some days it can last hours), HEADACHE (Bad headache) and ARTHRALGIA (joint pain) outcome was unknown.            Concomitant medications reported as unspecified thyroid and atrial fibrillation medication. Treatment included acetaminophen.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-139250 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
8 Days after each  vaccine I had redness, swelling, fever and a lot of pain at injection site. Most importantly I also got a UTI. I have never had a urinary tract infection in my life.
This spontaneous report was received from a certified medical assistant and refers to a 4 months old, male patient. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 23-APR-2016 at 12:39, the patient was vaccinated with improperly stored first dose of ROTATEQ lot# L033543, expiry date 30-MAY-2017, orally (dose was not reported). No adverse symptoms were reported. The patient had no illness at the time of vaccination. Administered vaccine experienced temperature excursion of 34 degrees Fahrenheit for a total time of 65 hours. There was no previous temperature excursion. Digital data logger was not involved. This is one of several reports received from the same source. Additional information is not expected, as all scheduled correspondence was received.
2 red, circular spots discovered 7/11/15 by patient's mother.  Spots located adjacent to subcutaneous site of injection on the left upper arm.  One circular spot is approx. 3" diameter; the other is approx. 5" diameter.  Spots appear to be enlarging.  Advised a doctor/ER visit stat.
This spontaneous report as received from a registered nurse refers to a 10 week old patient. The patient's concurrent conditions, medical history and drug allergies were not reported. On 15-DEC-2016, the patient was vaccinated with improperly stored ROTATEQ, oral, (dose not reported) from lot # M007311 (expiry date: unspecified) for prophylaxis. Concomitant medications were not reported. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information is not expected as all correspondence has been received. Follow-up information indicated that suspect product with the lot# M007311 had not actually involved in the previously reported temperature excursion. Therefore, case # 1612USA012740 is being deleted from our files on generic rotavirus vaccine, live, oral, pentavalent. This is an amended report, as corrected. The reference type for the number US-009507513-1610USA014706 has been changed from Company Number to Linked Report. Sender's Comments: US-009507513-1610USA008140: US-009507513-1610USA014705: US-009507513-1610USA014706.
Pt recvd 3 doses of Engerix-B & did not respond; no tx given;
Patient's arm became red, sore, and swollen the same day getting the vaccine on 9/3/21 which was resolved by 9/6/21.  She had a fever and lethargy which resolved on 9/6/21.  On the morning of 9/9/21 patient said her arm was hot and swollen (4 to 5 inches wide) at the injections site and there was a red streak going around to the inside of her arm.  She also said she had severe aching and cramping in her joints.
fever; chills; weakness; This case was reported by a consumer via call center representative and described the occurrence of fever in a 71-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26th November 2019, the patient received the 1st dose of Shingrix. On an unknown date, 6 weeks after receiving Shingrix, the patient experienced fever, chills and weakness. On an unknown date, the outcome of the fever, chills and weakness were recovered/resolved.   It was unknown if the reporter considered the fever, chills and weakness to be related to Shingrix.  Additional details were provided as follows: The reporter was the wife of the patient. The patient received Shingrix and approximately 6 weeks later, the patient experienced fever, chills and weakness.   The events had resolved.  The reporter did not wish to provide contact information for provider until after discussion with her husband and the doctor. She provided a case number if the decision was to allow contact with the doctor. For tolerances of 2nd dose, refer case US2020AMR086626, reported by same reporter for the same patient.
Cellulitis developed over the area where varicella and PCV 13 were given.
Tingling and numbness in the arm where injection occurred; Tingling and numbness in the arm where injection occurred; This is a spontaneous report from a contactable consumer reported for a female patient. A female patient of unspecified age (unknown if pregnant at the time of vaccination) received her first dose of bnt162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: UNKNOWN) via an unspecified route of administration on 28Jan2021 as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 28Jan2021, the patient had tingling and numbness in the arm where injection occurred. It was unknown if the patient received any other vaccines within four weeks prior to the Covid vaccine. It was unknown if the patient was diagnosed with Covid-19 prior to vaccination nor has the patient been tested for Covid-19 since the vaccination. Outcome was unknown for the events.  Information on the lot/batch number has been requested.  Follow-up (15Apr2021): This follow-up is being submitted to notify that the batch/lot number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.  No follow-up attempts are possible. No further information is expected.
significant edema/erythema/cellulitis requiring steroids and antibiotics at site of injection with headache.
This spontaneous report as received from a nurse refers to multiple unspecified patients. On unknown dates the patients were vaccinated with PNEUMOVAX 23 (lot #, expiration date, dose, frequency, route unspecified) that were improperly stored. No adverse effect was reported. This is one of several reports from the same source. Additional information has been requested.
The patient experienced redness, warm to touch and slight swelling at the vaccine site in an area approximately 2 1/4" x 1 1/2" approximately 30 hours.
This spontaneous prospective pregnancy report has been received from a 32 year old female nurse referring to herself. The patient had no pertinent medical history or drug reactions/allergies. Concomitant therapy included VITERGAN PRE NATAL. The patient's concurrent condition was not reported. The patient reported that she was currently 22 weeks pregnant and "was stuck in her thumb by a needle that was attached to a syringe containing M-M-R II (lot # M048036; expiration date 08-DEC-2018; therapy type rHA) reconstituted with sterile diluent (MERCK) (lot # N000383; expiration date 26-JUN-2019)" at 9:50 AM on 04-OCT-2018. The pregnancy outcome was pending. The patient's estimated date of last menstrual period (LMP) and due date were 03-MAY-2018 and 07-FEB-2019 respectively. Trimester of exposure was the second. No treatment was given. No lab diagnostics/studies were performed. The patient did not seek medical attention. No cancer or overdose. The outcome of the events was unknown. The causality assessment was not reported.
pt developed 3" stretch marks under left arm pit.  It is very noticeable and still looks the same as it did a couple of months ago.
reported that doses of GARDASIL9 had been administered following a temperature excursion; This spontaneous report has been received from a health professional, referring to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, concomitant medications, previous drug and/or allergy reactions were not reported.  On 09-AUG-2021, the patient was vaccinated with an improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) at a dose of 0.5 milliliter (vaccination scheme, route and anatomical location of administration were not provided; lot # T026167 has been verified to be a valid lot number, and expiration date reported and established upon internal review as 04-DEC-2022) as prophylaxis.   The administered vaccine underwent a temperature excursion below 2 degrees Celsius (°C) of -40.0 °C for a time frame of 15 minutes; and an excursion above 8°C of 9.6 °C for a time frame of 1 hour. No previous temperature excursion was reported. No information about the use of a datalogger was reported.   This is one of several cases, from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.  devicelotnumber: T026167; expirationdate: 04-DEC-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Nausea, vomiting, dry mouth, headache, slightly elevated temperature.  Unable able to sit up or get out of bed except to vomit.  Unable to eat or drink, even water.  I tried sitting up around 11 p.m. but after less than 5 minutes I felt nauseous.  Slept fitfully through the night but felt more normal when I got up at 7 a.m.  on 03/20 (next e morning)
Received moderna 3/1/21 5:30pm, while waiting in post obs @ ~13 min - daughter rushed to our door said they thought patient was having reaction (543pm). Per wife - patient became clammy, very warm, unresponsive, gurgling at the mouth. I ran out to check on patient Pharm.D.  They asked if they could remove his mask , i told them YES! he had a cloth mask over an n95 mask! Upon inspection, patient was not talking to me like he was prior to vaccine. They said patient gets tired and can become out of it, so they were not sure if this was a rxn to vaccine or just one of his episodes.  Patient has prior hx of 3 times stroke and is on dialysis. He did not appear to be in anaphylaxis and was breathing (when looking at chest). We called code white to pharmacy, and  Manager called EMS 5:44pm. Pharm.D came out to assist me 5:45pm. It was difficult to get a pulse using fingers, so we used BP cuff and got 83/57, with 87 BPM 547pm. I had epi pen ready to go in case we needed to use it but wanted to wait since patient was still breathing. While waiting for EMS, patient became responsive and began to talk. EMS showed up and took over. At this time Patient was talking and joking. 550 pm We decided we wanted patient to be checked out prior to sending him on his way. EMS asked us what we had done, and we discussed the above. EMS took over from there 555pm. Everything turned out ok, EMS left without further intervention. Before they left, I went to speak to family, and they were very happy due to the care they received. Event ending @ 6:15pm
Dizzy, lost consciousness for approximately 5seconds and fell to floor. Aroused alert x 4. Perrla. Refused transport to hospital.
Patient received first dose of Pfizer vaccine at approx 1:30pm. Approx 1:40pm patient layed down on floor of waiting area complaining of feeling nauseous and faint. Patient did not pass out. Provided patient with cool compress, water, and ice pack. After 5 minutes patient sat up and stated that she felt better. Patient was moved to nurse office approx 1:55pm which had air conditioning and was seen by EMS who was called for patient's sister who also had a similar incident but almost fainted. Patient was cleared by EMD and walked out to car with father and 2 siblings.
Based on additional information received on 19 January 2016, this case became medically confirmed. Initial unsolicited report received from non-healthcare professional on 23 October 2015. This case involves a 66-year-old female patient who was vaccinated with a dose of Fluzone HD (batch number: UI458AA, expiration date: 24 April 2016, dose, dose number and route were not reported) in left arm on 16 October 2015. The patient's medical history includes allergy of spinach, kale and marijuana and the patient had previously received vaccination with Fluzone HD which was well tolerated. Patient's concomitant medication was not reported. On 16 October 2015 same day following the vaccination, the patient experienced reddened, hot to touch, area with burning sensation extended to below her elbow of her left arm. Then the red, hot to touch, burning sensation extended to below her elbow to wrist and her elbow was very swollen and skin felt hard. Then over next few days her right arm also became red, hot to touch, swollen, and same burning sensation from her upper arm to her wrist. The patient required ER/doctor visit. Laboratory investigations were not reported. The patient received Benadryl as a corrective treatment. The outcome of the events were not recovered. Patient's arms were much less hot with burning sensation, stated "almost back to normal", although skin still feels rough. As of 23 October 2015, the swelling and redness had resolved. List of documents held by sender: none. Follow up information received from a health care professional on 19 January 2016. It was reported that patient had a medical history of tobacco use disorder -1/2 ppd since 10 years of age, back pain due to work related injury, depression, asthma, RT torn rotator cuff, overweight. Patient had concomitant medications of aspirin lite coat 325 mg tablet 1 tablet once a day, Cymbalta 60 delayed release capsule taken one capsule by mouth every day, albuterol sulfate CFC free 90mcg/inh aerosol 2 puffs q4h prn, Ambien 10 mg tablet 1 tab qhs prn insomnia, chondroitin- glucosamine 1500/1200 mg 2 tabs once a day, lorazepam 0.5 mg tablet 1 tab TID prn, hydrochlorothiazide 12.5 mg capsule 1 cap once a day, Soma 350 mg tablet 1 tab QID, Norco 325 mg-7.5 mg tablet 1 tab every 6 hours prn, Ambien 10 mg tab 1 tab qhs prn insomnia on 16 October 2015. It was also reported that patient received dose 1 of 0.5 ml of FLUZONE HD vaccine and had allergic reaction and her arm was red and swollen by the afternoon of 16th October 2015. Patient was treated with refill soma tablet 350 mg, 1 tab, orally, QID, 30 days, 120 tablets, refill gave 3 rx's, refill Norco tablet, 325 mg-7.5 mg, 1 tab, orally, every 6 hours prn, 30 days, 90, refills gave 3 rx's.
I have not been able to have any meat protein since the day of the shot. The smell of meat, cooked or uncooked smells so bad. It makes me vomit, if I try and eat any lunch meat, or cooked meats then I vomit it back up with in minutes. This has now been 3 days, I am only able to keep down plant base proteins, cheese and milk. Starting today I have had incontrollable diarrheic. About every 15 mins I am in need to use the bathroom. Being in a car is also making me sick.