chrisvoncsefalvay/vaers-outcomes huggingface dataset:
didn't felt good; had a breath treatment; has have no energy since the first vaccine; felt tired; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (didn't felt good), RESPIRATION ABNORMAL (had a breath treatment), ASTHENIA (has have no energy since the first vaccine) and FATIGUE (felt tired) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Non-smoker and Abstains from alcohol. Concomitant products included VITAMINS NOS for an unknown indication.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, the patient experienced MALAISE (didn't felt good), RESPIRATION ABNORMAL (had a breath treatment), ASTHENIA (has have no energy since the first vaccine) and FATIGUE (felt tired). At the time of the report, MALAISE (didn't felt good), RESPIRATION ABNORMAL (had a breath treatment), ASTHENIA (has have no energy since the first vaccine) and FATIGUE (felt tired) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       They patient stated that after the first dose they felt tired and didn't felt good, had a breath treatment, and had have no energy since the first vaccine, and these symptoms were ongoing.  They also reported that they don't smoke, drink, or do drugs.  It was also reported that the patient had a breath treatment.   This case was linked to MOD-2021-435962, MOD-2021-435966 (Patient Link).
This spontaneous report as received from a Nurse refers to unspecified number of patients of unknown age. The reporter stated that RECOMBIVAX HB, which might have gone out of range sometime in April 2013, but nurse was unable to provide the worst case time frame or temperature. The nurse additionally stated that an unspecified number of people have been administered this product. No adverse effects have been reported. Lot numbers and expiration dates unavailable for this product. On 10-JUN-2014, a phone call was placed to the nurse. The phone call was answered by other reporter. The reporter stated there was no one by that name at their facility/office. She checked with other nursing/office personnel concerning vaccine storage issues from April 2013. There was no information available to share with company concerning this report. This is one of several reports. The case is linked to 1309USA013801, 1406USA007117, 1406USA007118, 1406USA007119, 1406USA007120, 1406USA007121 (same reporter link). Additional information has been requested.
Patient developed hives and lip swelling after PROQUAD; Patient developed hives and lip swelling after PROQUAD; This spontaneous report was received from a nurse and referred to a 5-year-old female patient. The patient's concomitant medications, pertinent medical history and drug reactions/allergies were unknown by reporter.  On an unknown date, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection (strength, dose, lot #, expiry date anatomical location and route of administration were not provided) for prophylaxis.  On an unknown date, the patient developed hives and lip swelling after measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (urticaria; lip swelling). It was not sure when it happened.  Whether the patient had sought medical attention was unknown. No other issues or concerns noted.  At the time of reporting, the outcome of all events was resolved. The causal relationship between all events and suspect vaccine was not provided.
The week before the November holiday while on a trip with tour group and one of the people were sick. Went home the end of November and tested and I was negative. My symptom mimicked a sinus infection. On Dec 7, I still wasn't feeling well and I had a dentist appointment and hair, and I had no sense of smell, so I tested again and was positive. I then called my doctor and will a fever they prescribed (azithromycin, cetirizine, montelukast) something for the symptoms she didn't give the routine meds based on the timing. I only had the fever that day and then I just continued with the slight symptoms and on the 12 of Dec, I tested again and was negative. I had fatigued a couple of weeks after.
One week post vax, the pt developed erythema chronicum migrans rash at the injection site. The rash was brownish in color, 3 cm, and centrally clear. The rash faded after one week.
Rash on left arm developed 7 days after vaccine administration on the site of the injection.  Rash was itchy, swollen and warm to the touch, about 3 inches in diameter.
At 8pm, patient started with hives on scrotal area, and inguinal area and rectal area. Hives increased to legs. Hives progressed to chest, abdomen , feet, ankles, chin and cheeks of face. Hives worsened over the weekend, and was taking Benadryl at night. Also placed Lotrimin AF on scrotal rash and rash worsened.
1st dose Dec2021, forgot to get 2nd; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 56-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on December 2021).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.     Additional Information: GSK receipt date: 03-OCT-2022 Reporter's comment: The patient self reported the case. Patient reported that he forgot to get the 2nd dose. Patient inquired when should get the 2nd shingles vaccine.  Not all information was available. No additional information was provided for this first dose (lot or site of injection). Patient consented to follow up with HCP, but did not have the information available at the moment. Additional supportive information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
ANGIONEUROTIC OEDEMA; PYREXIA. Information has been received from a health professional concerning a 13 week old male with no allergies and no medical history who on 18-DEC-2003 was vaccinated with a second dose of hepatitis B viurs vaccine rHBsAg(yeast)(thimerosal free) (lot #645479/0215N). There was no concomitant medication. It was reported that there was no adverse symtoms with the first vaccination. ON 18-DEC-2003, in the evening, the patient experienced angioedema with his face swollen and a low grade fever. He was seen by a physician on 19DEC2003 and mild swelling was noted. No treatment was given. No product quality complaint was involved. Additional information from a health professional indicated that concomitant vaccines on 11/19/2003 included a first dose IM in the right thigh of diphtheria toxoid (+) pertussis acellular biken vaccine (+) tetanus toxoid (Tripedia) (lot 01606AA), a first dose dose IM in the left thigh of poliovirus vaccine inactivated (Vero) (IPOL) (lot X0148), a first dose IM in the right thigh of Hib conj vaccine (tet toxoid) (ACTHIB) (lot UE064AA) and a first dose IM in the left thigh of pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine (CRM197) (Prevnar) (lot 492-388).  There were no other concomitant medications.  There was no illness at the time of vaccination.  It was reported that "on 12/19/2003, at 7:00 AM," the patient experienced angioedema of the left side of the face.  He recovered on 12/21/2003. Additional information is not expected.
4x4cm area erythema left thigh. No fever. Benadryl and Ibuprofen
10 mins after the shot pt felt dizzy,  chilly and starting to have a hard time to breath stated feeling throat closing  gave hydroxyzine 30mg liquid, after a few minutes patient state he lost his complete vision,   but breathing was better,  after a couple of minutes was only to see outlines not detailed nor color  black and white then after 5 mins the complete vision patient came back to full and felt better.  In the mean time the parents contacted the pediatrician.   lost vision  for 5 mins.  Pediatrician will call them back later nurse took information while this was occurring.
While sitting, patient felt a severe pain on L side of head about 8.5 hours after injection. Then the L foot started throbbing and pt wasn't able to move L foot. Pain traveled from L foot up to the L thigh. Next R entire leg started out with a grabbing, throbbing spastic unbearable pain that lasted for about 30 minutes. Predominant pain was on the R thigh and continued to seize up and  caused incredible pain, every bit of a 10 on the pain chart.  Pt took salt and 1000 mg acetaminophen. Pt states that if she hadn't been sitting  she would've gone down and not been able to walk or move
Patient had local reaction.  Hives at site, redness on neck and face.  Benadryl 25mg given po.  Patient monitored about30 minutes.
Admission CXr concerning for pulmonary edema and appeared fluid overloaded on exam likely 2/2 recent IVF for sepsis, additionally noted mild right effusion. He was diursesed and started on IV Zosyn.  CT chest later showed stable small right effusion. ED visit and hospital admission within 6 weeks of receiving the COVID vaccine.
No adverse effect; inadvertently administered the adult dose of VAQTA; This spontaneous report was received from a nurse practitioner regarding an 18 year old patient. The patients' medical history, concurrent conditions and concomitant medications were not reported. On 31-AUG-2019, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) (lot # R031045, expiry date: 18-NOV-2019) dose 1, intramuscular route, for prophylaxis. The patient was considered to be an adolescent, however he/she received an adult dose of hepatitis a vaccine, inactivated (VAQTA) (product administered to patient of inappropriate age). No adverse effects reported.
Pt developed fever and had several episodes of staring and jerking that lasted for seconds but recurred multiple times.
Pt presented to the office on 10/2/01 with a diffuse, macular, evanescent rash all over.
Foggy head; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Foggy head) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hashimoto's disease (Patient was diagnosed with Hashimotos 2 years ago).   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (Foggy head). At the time of the report, FEELING ABNORMAL (Foggy head) outcome was unknown. Not Provided          The patient had been feeling foggy head which is the side effect of hashimoto's disease.  Relevant concomitant medications were not reported. Treatment medication was  not reported. Action taken with mRNA-1273 in response to the event was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jun-2021: Additional information received on 14 JUN 2021 and does not contain any new information.
left arm turned red, very sore, itchy.erythema medial aspect left uppr arm, none at outer deltoid at sited of  pneumovax injextion.Area tender, erythematous and warm, no axillary nodes
Received Moderna COVID vaccine at 2pm on 3/4/2021. At 5pm of the same day, developed a fever of 101 degrees. At around 6pm of the same day, I had slight heart palpitations. At 9pm (same day) while sitting in bed, I developed tachycardia (Heart Rate 170) and shortness of breath. I laid down and also breathed in a brown paper bag, got my heart rate down to 150. Then, my parents took me to the Emergency Department. Today is 3/12/21 (8 days after receiving vaccine), but my tachycardia, palpitations, and shortness of breath has continued. Heart rate continues to be anywhere from 85-135 bpm while I am at rest. Palpitations have also continued and are worse at night. Shortness of breath has also continued, but is not as bad as before.
Patient presented with croup cough, fever, and nasal congestion. Another patient presented with similar symptoms following varicella vaccine.
Watery eyes, running itchy nose, sinus headache, partial loss of taste and smell, loss of appetite. Severe symptoms for 36 hours, less severe for another 2 days. No treatment.
This spontaneous report was received from a pharmacist refers to a 66 year old male patient. The patient's concurrent conditions were not reported. The patient's drug reactions, allergies and concomitant medications were not reported. On 17-OCT-2017, the patient was vaccinated with PNEUMOVAX23 (dose, units and frequency not reported) (lot # N012127 and expiration date: 20-JAN-2019) intramuscularly on right upper arm. It was reported that the patient had Flu shots before, at the same time, on the opposite side. The patient went to emergency room. On an unknown date in October 2017, patient experienced excruciating pain, the patient could not event shake hand or put clothes on, patient could not get dressed (injected limb mobility decreased). It was reported that the patient could not sleep. The patient was treated with ice and Tylenol for the event injected limb mobility decreased. The patient took 7 days to be able to function (injected limb mobility decreased) and 10 days for pain to go away (injection site pain). The outcome of the event insomnia was unknown and other events had resolved. The reporter did not provide the causal relationship for the events with suspect therapy PNEUMOVAX23. This is one of the 4 cases received from the same reporter. Sender's Comments: US-009507513-1710USA009526: US-009507513-1805USA007660.
fatigue Narrative: arm sore, fatigue, diarrhea for 1 week
Patient developed painful itchy rash on neck, back, and hairline this morning after getting Zostavax and flu shot yesterday.  Patient took Benadryl and then was prescribed prednisone and Zantac by her Dr.
Day after 4 m/o vaccines, child went to ER with fever increased 106 (reported per mother), 102 in ER, runny nose, no injection site redness/swelling fever x1 day, possible sore throat.
finger flange was broken; No additional AEs were reported; finger flange was broken / an unspecified patient was administered with the syringe and possibly received less than the recommended dose but she was not sure.; an unspecified patient was administered with the syringe and possibly received less than the recommended dose but she was not sure.; This spontaneous report was received from an office manager regarding a patient of an unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 01-MAY-2023, the patient was vaccinated with a dose of hepatitis a vaccine, inactivated (VAQTA) prefilled syringe, product quantity 1, lot #X004813, expiration date: 28-JUL-2024, administered as prophylaxis (strength, dosage regimen, and route of administration were not provided). It was reported that it was possible that the finger flange was broken while the nurse was administering the vaccine (Poor quality product administered) and that the patient possibly received less than the recommended dose (Incorrect dose administered). Product Quality Complaint (PQC) was filed. The syringe was broken into 2 o more pieces and the syringe tray was intact and undamaged on receipt. It was not difficult trying to attach the syringe needle to the syringe, the syringe tip cap was attached properly prior to use, the product was administered, and the cellophane cover of the syringe tray was intact and completely sealed. On 12-MAY-2023, it was reported that the product was returned. No adverse events were reported.  This is one of two cases received from the same reporter.  This is a Non-valid case due to lack of patient's identifiers. ; Sender's Comments:  US-009507513-2305USA001992:
Rash - vesicular, appearance similar to shingles, beginning on bilateral lower extremities about 2 weeks after vaccine given with lesions developing on arms & trunk over ensuing 2 weeks.
I started to feel really tired, and I had an appointment with my doctor and I went to him and he ran some more tests to see what was going on and why I was experiencing tiredness. And he saw that the level of the muscle breakdown enzymes had gone up high. And after he took blood work, he prescribed more medication which was Prednisone. And then after I began taking the steroid, that elevated my blood sugar more, and they had to prescribe insulin Basaglar 25 IU for the elevated blood sugar. I started with 40mg of Prednisone, and now I'm taking 30mg of it because I'm tapering off. I have a follow up appointment in the next month or so. In the meantime, I am still having two visits per month where I'm getting IVIG treatments. I also have increased urine incontinence.
Pt is 14 weeks pregnant with twins, EDD 15 Jul 2021 Pt reporting chills, body aches, and headache.
Approx. 20 minutes post injection, child pale felt dizzy and had rapid heart beat. Child sat down took water symptoms resolved in five minutes.
Moderna vaccine used past the 12-hour window of use time once bottled punctured. Stored in refrigerator entire time of use and cleaned between each use with alcohol. Contacted the patient and no adverse reaction reported. States, " My arm was sore for 1 to 2 days like when you get a shot, but no problem with vaccine or injection site. ?
N93.9 - Abnormal vaginal bleeding N93.9 - Abnormal uterine and vaginal bleeding, unspecified
pt was given expired vaccine. label  expiration read  2/22/22 but was refrigerated on 12/1/21 and expired on 12/31/21 there is a 32 day max pt has no adverse effects pt does not want re-vaccinated for 2nd pifizer
Severe head ache; nausea/vomiting; chills; muscle aches; injection site pain and swelling
Transient left-sided headache and LUE/LLE numbness lasting for 1 day after COVID vaccine administration (Pfizer)
Fever and body aches especially in the legs the night of vaccine. Swelling, redness, and pain at the site of the injection.
Patient was seen on 9/15/20 and mother reports rash started yesterday 9/14/20. Patient had immunizations including MMR immunization 14 days ago (9/1/20), fever which started a few days after immunization and ended 3-4 days ago (9/13/20). Pt diagnosed with Erythema multiforme minor by provider.
Pt stated the area where the vaccine was administered became itchy, swollen and painful. The swelling started spreading to his whole upper arm and trapezius. Pt also began having bilateral shoulder pain. Pt reported to the urgent care and was examined by the provider working. Provider determined it was widespread intramuscular edema. Provider prescribed pt a MEDROL DOSE PAK and ATARAX and told to follow up in 24 hours or sooner if the area gets worse.
ACUTE LACUNAR STROKE, UNSPECIFIED TYPE AND ARTERY ACUTE STROKE, UNSPECIFIED TYPE AND ARTERY LEFT FACIAL MUSCLE WEAKNESS
mmediately after administration lhe patient had some redness and swelling at lhe insertion site; Immediately after administration The patient had some redness and swelling at lhe insertion site; The patient was administered a dose of improperly stored VARIVAX; This spontaneous report was received from a study coordinator referring to a 1 year old female patient. There were no pertinent medical history, concurrent conditions nor drug allergies/drug reactions.  On 15-JUL-2020, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot  S007963, expiration date 02-AUG-2021 for immunisation (strength, dose, frequency and route of administration were not provided).    The improperly stored suspect vaccine had a temperature of -14 degrees Celsius (°C)  to -10°C  ( average -12 .8°C) during 46 minutes. There was no previous temperature excursion and the Merck sterile diluent used to reconstitute the vaccine was properly stored.   On 15-JUL-2020, immediately after administration the patient had some redness (injection site erythema ) and swelling at the injection site.   It was reported that the patient's mother sought medical attention by contacting the physician office and paracetamol (TYLENOL) was provided as treatement.   The outcome of injection site swelling and injection site erythema was reported as recovered on the same day. The call was made because of a data logger.  The causality between the events and varicella virus vaccine live (Oka/Merck)(VARIVAX) was not provided.   Lot number S007963 is an invalid lot number for varicella virus vaccine live (Oka/Merck)(VARIVAX).  This is one of several cases from the same reporter. ; Sender's Comments:  US-009507513-2008USA000665:01664542 US-009507513-2008USA000429:
Wheezing, shortness or breathe, tired, fever, runny nose, muscle cramps, uterine cramps, achy joints, chills, migraine
Bifrontal headache; This is a spontaneous report from a contactable consumer and contactable physician.  A 56-year-old female received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown), via an unspecified route of administration at left arm on 17Dec2020 at 15:15 at single dose for COVID-19 immunization.  The patient medical history and concomitant medications were not reported.  The patient previously took cephalexine and experienced allergies. On 18Dec2020 at 06:00, the patient experienced bifrontal headache. The patient outcome of the event was recovered. Therapeutic measures were taken as a result of bifrontal headache and included treatment with MIDRIN.
Patient reports having  pain, tingling and shaking in his left arm and hand. He reports it later progressed to his whole left side.  He has been experiencing this since  after his vaccination date (9/29/22) until today (10/18/2022). He reported going to the ER and a chiropracter for help with no relief.
had not experienced an erection after the last shot; the left arm that they shot him in the vein had swollen up and was burning; the left arm that they shot him in the vein had swollen up and was burning; the left arm that they shot him in the vein had swollen up and was burning; This is a spontaneous report from a non-contactable consumer (patient himself). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), intravenously, administered in the left arm on an unspecified date (Batch/Lot number and Expiration date were unknown) as the 1st dose, single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that women had no clue what he was talking about, but he just heard about children and young  adult having problem with heart and heart was connected to the penis. On an unspecified date, on the 20th, the patient took the shot and he went woken up or he had not experienced an erection after the last shot. He further described that the first shot he took, it didn't do any thing for like 3 hours. The patient woke up and the left arm that they shot him in the vein had swollen up and was burning on an unspecified date and he would have to rub and it went down; it still didn't do anything, it kept coming up and going back down. The patient thought that "it must be the time release, that's the only reason what it's doing." The outcome of the events was unknown.  No follow-up attempts are possible, information about batch/lot number cannot be obtained. No further information is expected.
sx began about 10hrs p/vax;fever of 102 x 2 days;lt upper arm,shoulder area very warm,swollen,red;15APR erythema measured @ 8.5cm x 14cm on lt deltoid;fever 99.5;deltoid very sore