chrisvoncsefalvay/vaers-outcomes huggingface dataset:
really intense hives for 10 days now./ hives now spread to her body; woke up with really intense itching on her head / really intense itching behind her ears; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (really intense hives for 10 days now./ hives now spread to her body) and PRURITUS (woke up with really intense itching on her head / really intense itching behind her ears) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A, 018B21A and 013F21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE, ETHINYLESTRADIOL, NORETHISTERONE ACETATE (LOESTRIN), SPIRONOLACTONE and METFORMIN for an unknown indication.   On 24-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) (unknown route) dosage was changed to 1 dosage form. On 16-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Nov-2021, the patient experienced URTICARIA (really intense hives for 10 days now./ hives now spread to her body) and PRURITUS (woke up with really intense itching on her head / really intense itching behind her ears). At the time of the report, URTICARIA (really intense hives for 10 days now./ hives now spread to her body) and PRURITUS (woke up with really intense itching on her head / really intense itching behind her ears) outcome was unknown.            Treatment medication include two oatmeal baths a day to calm the skin ,two urgent care and two allergist.
Patient was admitted to the hospital on November 13, 2021, and tested positive for COVID-19.  Patient was asymptomatic as a patient in a long-term care facility.  Patient was discharged back to the nursing home a few days later.  Community talk indicated that patient died on November 24, 2021.
At 1:53 pm the patient received her COVID vaccine in her left deltoid and was told to wait in the parking lot for 30 minutes. At 1:58 pm the patient reported to the NG medic her throat felt tight and was swelling.  EPI auto injector was administered at 1:58 pm by NG medic in her right thigh. Sat 97% and HR 96. At 2:00 patient reported she was feeling better. O2 sats 98% and HR 95. Notified EMS and they arrived at 2:05. Patients BP 160/82,  O2 sats 99% and HR 84. Pt refused transport to the ER and left at 2:20pm with a friend who had drove her.
Got adol vaccines, Tdap, HPV #2, Ckpox #2 - c/o just not feeling well day later, nausea, slight diarrhea; swelling at site of injection, itching all over - c/o just not being able to concentrate. Got ibuprofen et BENADRYL started taking Wed - Th saw dr Th 11/21/13 - Dr feels rx to HPV. Informed to me receive 3rd dose.
Pt recvd vax & approx 6 months afterward, pt began to exp a serum sickness type react consisting of joint pain, weakness, &/or diarrhea; workup has included numerous tests for collagen vascular diseases, & has been non-diagnostic;
At the day of the vaccination, just got the usual arm soreness but on 12/31 I felt a pain in my arm pit (left) and the day after I felt itching at the injection site around noon and by the time looked at the site around 3/4 PM there was redness of the size of a quarter. But the next morning it doubled in size. Consulted with my employee health who suggested me being seeing at the UC or doing TELADOC they were fear it could be cellulitis. The Teladoc MD prescribed me antibiotics (doxycycline), steroid (prednisone), naproxen and Benadryl and called it cellulitis. My arm pit pain went away by my second dose of prednisone. The itching stopped also with the prednisone. I took the doxycycline for 3 days only instead of a week as prescribed. Also took the prednisone only for 2 days once the itching and the arm pain went away I stopped. All symptoms were resolved by 4 days.
Injection site swelling and bruising that has gotten worse every day since vaccine. Site is red and warm to the touch and visibly enlarged and goes from elbow up to neck and continues to spread as time goes on. Patient observed by pharmacist 2 day after injection and instructed patient to do compress for swelling and bruising, otc pain reliever for fever and inflammation. Continue to observe for improvement or worsening. 3 days after vaccine, no improvement, site continues to get worse, patient instructed to see medical doctor for follow up.
Swelling erythema warmth at shot site 1.5cm x 3.5cm at L upper arm. Keflex 200/5 1 tsp BID x 5d.
pt recvd vax; 48 hrs later exp n & vomit; complaints that he does not have any appetite;seen by M on 18aug95; T 101.2;
This spontaneous case reported by a consumer, describes the occurrence of syringe issue (broken syringe) and underdosage (insufficient dose administered) in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On Apr 20, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Apr 20, 2021, patient experienced syringe issue (broken syringe) and underdosage (insufficient dose administered). At the time of the report, syringe issue (broken syringe) and underdosage (insufficient dose administered) resolved. No concomitant medication or treatment information provided. The action taken for mRNA-1273: not applicable.
Pfizer-BioNTech Coiv-19 vaccine EUA- HA and dizziness that morning, mid morning nauseated and diarrhea by noon vomiting. Wednesday evening fever 103.7 with body aches, chills, \weakness fever did not get below 100.4 until Friday afternoon,
Initial report was received from the Nurse on 17 Feb 2010: This patient (under four years of age) was vaccinated with 0.5 ml of FLUVIRIN (batch number 102138P1A) intramuscularly on 16 Feb 2010. The outcome of patient's condition was not reported. The seriousness criteria of the patient was not reported.
Pfizer 8/28/21, 9/18/21. Positive on 7/19/22
1st day after the shot, I experienced Muscle aches throughout my whole body, chills, arm pain (couldn't lift my arm), fatigue, and nausea.  2nd day after the shot: fatigue, arm pain (hot to the touch), diarrhea, and headache.  3rd day after the shot: Arm pain fading away, fatigue. 4th day no bruise left and no pain. 8th day after the shot: itchy, pain, hot to the touch 9th day after the shot: itchy, pain, hot to the touch (getting larger in diameter) 10th day after the shot: itchy, pain, hot to the touch (getting larger in diameter) - Today's date 3/20/2021
Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial(10 mcg) instead of blue cap vial(25 mcg), when blue cap was indicated.; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial(10 mcg) instead of blue cap vial(25 mcg), when blue cap was indicated.) and NO ADVERSE EVENT (No adverse event) in a 7-month-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch nos. 216K22A and 214K22A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 01-May-2023, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 10 microgram. On 03-Jun-2023, received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 10 microgram. On 03-Jun-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced WRONG PRODUCT ADMINISTERED (Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial(10 mcg) instead of blue cap vial(25 mcg), when blue cap was indicated.) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial(10 mcg) instead of blue cap vial(25 mcg), when blue cap was indicated.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial(10 mcg) instead of blue cap vial(25 mcg), when blue cap was indicated.).    The route of administration of dose 1 and dose 2 was reported as BI. Concomitant medications were not reported.  No treatment information was provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-730780 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-730780:Master case
Pain after each injection; Extra dose; This case was reported by a pharmacist via call center representative and described the occurrence of pain in a 78-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on December 2018) and Shingrix (2nd dose received on February 2019).   In October 2019, the patient received the 3rd dose of Shingrix. In October 2019, less than 3 months after receiving Shingrix, the patient experienced pain and extra dose administered. On an unknown date, the outcome of the pain and extra dose administered were unknown.   It was unknown if the reporter considered the pain to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient came for a pneumonia vaccine in October 2019 but was accidentally given a third dose of Shingrix, which led to extra dose administered. The reporter stated that the patient had pain after each injection. The reporter did not have more specific details available at the time of reporting. The reporter consented to follow up.
Pt vaccinated with DTP/OPV awake and seemed shaky. Laying down pulled head back & went limp. No jerking of the extremities not responsive for about 10 seconds then quiet, sleepy x 10-15 mins.
Initial misuse report received from a healthcare professional on 16 October 2013. The case was received on 21 March 2014. 3 years and 5 months old patient had received FLUZONE 0.25 ml instead of 0.5 ml. No adverse event was reported. List of documents held by sender: none.
w/in min of vax noted hives low back, posterior neck & rt thigh (site of inj);pt recv DTAP #1 2mo prior w/o rxn;
Feel very warm; Arms were tingling; Felt she was going to passout and dizziness; This is a spontaneous report from a non-contactable healthcare professional. A 35-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration on 22Mar2021 (at the age of 35-year-old) as a single dose for COVID-19 immunisation. Medical history included vasovagal response when getting vaccines or donating blood in the past. Concomitant medications were not reported. On 22Mar2021, (during 15-minutes) the patient experienced very warm and her arms were tingling. The patient felt she was going to pass out (laid on the floor in the observation area) and dizziness. She was wheel chaired to observation bay. The patient denied rash, hives, difficulty breathing, difficulty swallowing and facial swelling. The patient received treatment for the events which included water. Follow up response to treatment was good. The patient stated she felt normal prior to discharge. She was escorted out of the facility and denied any symptoms with ambulation. The patient was discharged and was stable to go home and was asked to follow up with Primary care provider (PCP). The clinical outcome of the events began to feel very warm, arms tingling and dizziness were recovered on 22Mar2021.    No follow-up attempts are needed. No further information is expected.
I have a rash on my arm at the injection site, eight days after receiving the first shot. Day eight the rash was bumpy. Today is day nine. It is larger, flat and not bumpy. It is an oval about 3 inches high and 2 inches wide. It is not itchy or painful. I am not worried, just reporting it.
Fever went up to 104.7 Welts /bumps all over her face Dizziness/weakness Took her to urgent care then to the hospital...she never gets a fever.  Her fever went up quickly...within a couple of hours and she got welts all over her face (I have pictures).  Urgent care had us take her to the hospital.  They tested her for a bunch of stuff which turned out negative.  They gave her IV's and released her a few hours later when her fever came down.    In the end we believe it was the HPV shot.  A few OB/GYNs tell us that they have seen this with the HPV Vaccinations.
Almost immediate - upset stomach and tired, became progressively tired through the afternoon, loud noises made me irritable and I wanted everyone to be quiet. Around 9 pm I began having severe  joint/muscle pain, severe chills - shaking, and a persistent, dull headache. I woke up through the night feeling the same.   The next morning all symptoms had improved except the persistent, dull headache, slight tiredness and soreness.
pt recv vax & post vax exp gen itching;tx w/DPH;sx cont as of 10MAY96
Patient developed pericarditis with pericardial effusion and pleuritis with pleural effusion starting about 3 weeks later and no othewr cause besides PCV20 was identified.
Fever :  100 at 7:30 am after Advil at 3:30 am; fever now 99.7 Headache Cold/ achy Very slight cough (normal)
This non-serious spontaneous case, was initially received from other health professional on 28-Sep-2017, concerns a 56-year-old, adult female patient. The patient's medical history and concomitant medications were not reported. On 27-Sep-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, batch number: 185286, expiry date: 30-Apr-2017, route of administration, anatomical location: not reported). The reporter assessed the report as non-serious. Non-significant case correction received 28-Sep-2017: Batch number (185286) was added on the screen and updated expiry date. The narrative was amended accordingly.
Pfizer-BioNTech COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer Vaccines on 1/19/2021 and 2/2/2021. Patient was recently hospitalized for COVID 8/11/2021 to 8/17/2021. Patient presented to ED on 9/9/2021 with complaints of shortness of breath with increased oxygen requirements. Medications administered: levofloxacin and aspirin. Patient became unresponsive with no palpable pulse. Patient expired at 01:55 on 9/9/2021.
Within 4 hours a rash between my inner thighs appeared.; This is a spontaneous report from a contactable consumer (patient).  A 39-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number and expiration date were unknown), via an unspecified route of administration in the left arm on 04Feb2021 at 14:15 (02:15 PM) at a single dose for COVID-19 immunization. The vaccine was administered to the patient at a hospital. The patient had no other vaccine in four weeks. The patient's medical history included diabetes, and the patient had Covid prior to vaccination. The patient had no known allergies. Concomitant medication included ascorbic acid (VITAMIN C), colecalciferol (VITAMIN D), semaglutide (OZEMPIC), and prenatal vitamin. Within 4 hours (on 04Feb2021 at 06:30 PM) a rash between her inner thighs appeared. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the event which included steroid cream and diphenhyramin HCl (BENADRYL). The patient has not been tested for Covid post vaccination. The outcome of the event was not recovered.   Information on the batch/lot number has been requested.
Significant arm soreness at injection site; body aches; chills; mild headache; restless night's sleep; This is a spontaneous report from a contactable nurse. A 46-year-old female patient received BNT162B2 vaccine (Lot number EH9899) intramuscular in the left arm on 16Dec2020 at 08:45 at single dose for immunisation. Relevant medical history included recent Urinary Tract Infection (UTI), treated and recovered. Concomitant medications included sulfamethoxazole/trimethoprim (BACTRIM), famotidine (PEPCID) and melatonin. Past drug reaction included allergy to doxycycline. On 16Dec2020 at 14:00, the patient experienced significant arm soreness at injection site, body aches, chills, mild headache and restless night's sleep. Corrective treatments taken as a result of the events included ibuprofen (ADVIL). The patient was not pregnant. Facility type vaccine: Hospital. The patient did not receive other vaccines in four weeks. The patient did not have COVID-19 prior to vaccination, and she was not tested after vaccination. At the time of the report, the patient was recovering from the events.
the patient began to experience weakness in her hands and legs; The patient was found to have decreased grip strength; This spontaneous report was received from a physician via company representative, referring to a 21-year-old female patient. Information regarding the patient's pertinent medical history, concomitant therapies and previous drug reactions or allergies were unknown by the reporter.  On 07-SEP-2021, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) at a dose of 0.5 milliliter (ml) as prophylaxis (formulation, vaccination scheme frequency and anatomical location were not reported; route of administration, lot number and expiration date were unknown by the reporter). On the same date, at an unspecified time after the administration, while the patient was still in the office, the patient began to experience weakness in her hands and legs (muscular weakness) and was found to have decreased grip strength. The patient declined to remain in the office for observation and that evening the patient reported that her symptoms had not decreased.  On an unknown date in September 2021, the patient was hospitalized and it was reported that she would be in the hospital for 5 days. The patient saw a neurologist who did not believe that the patient's condition was caused by the hpv rl1 6 11 16 18 31 33 45 52 58 vlp (yeast) vaccine (GARDASIL 9). According to the reporting physician, the neurologist stated that "it should not have happened that fast from the vaccine". No treatment was administered for adverse events. It is unknown if laboratory studies or diagnoses were performed.  The outcome of the events muscular weakness and grip strength decreased was reported as not recovered. The reporting physician did not provide the causality assessment between the events muscular weakness and grip strength decreased and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9).; Sender's Comments:  US-009507513-2109USA002610:
Shot given around 8:00 pm. Juvenile woke up about 3:00 am shakey. He states "uncontrolled muscle spasm". Severe headache, dizzy, metallic taste in mouth. Temp 101.8. TYLENOL for fever and headache.
Parent reported child was not acting herself at preschool that morning, as reported by her teachers. Parent reported paying special attention for a possible fever per instructions from nurse administering vaccine. Parent denied child had any temperature to her knowledge; however, went on to have a febrile seizure approximately 21 hours following vaccination. Child was taken to ER where a CT scan was done and parent was given instructions for Tylenol and Motrin alternating schedule usage.
First the site of the injection was firm and red approx 2 days after admin, then target lesions developed on shins, spreading to body and face and palms.  I diagnosed her as erythema Multiforme.  Consistent with a reaction to herpes and it was the ZOSTAVAX vaccine
Headaches, body aches, fever, chills, stomach cramps, nausea, local pain and rash. She came to see yesterday. I ordered Tylenol, Zofran, Zantac, benadryl and lidocaine patch. I think she will get better.
Developed fatigue, myalgia, headaches, polyarthralgia and paresthesias 1-1.5 week after immunization   first dose 1/19/21
Rotarix vaccine reconstituted with incorrect diluent. No adverse event reported. Immunization to be repeated per CDC.
swelling all on the site; a little bit of soreness/her arm was sore; This is a spontaneous report from a contactable consumer or other non-health care professional. A 60-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: ER8727) via an unspecified route of administration in right upper arm on 18Mar2021 around 15:00 PM as single dose for COVID-19 immunization (at 59 years old). Patient received the second dose of (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: ER8731) via an unspecified route of administration in right upper arm on 08Apr2021 as single dose for COVID-19 immunization. Medical history included ongoing COPD; Unsure of diagnosis date but it was maybe 10 years ago, ongoing Chronic kidney disease stage 3; Unsure of diagnosis date but probably more than 20 years ago and it is stable. They check it every 3 months and it is stable. Historical vaccine included flu shots and pneumonia shots; she has had flu shots and pneumonia shots and has never had any reaction to anything before. Patient mentioned that she is on medication (unspecified) but she has been on them all her life there is just about nothing new that was taken at all. On 18Mar2021, patient experienced swelling all on the site and a little bit of soreness/her arm was sore. Outcome of the events was recovered on 19Mar2021.  Follow-up (20Apr2021): This is a follow up spontaneous report received from a contactable consumer reported that no new AE was reported.   No follow-up attempts are needed. No further information is expected.
pt recv vax 28MAR96 & pt varicella antibody IgG w/less than 15;No further details were provided;
pt devel rash & purpura following vax w/Engerix-B;no further details are available;
Safety needle stuck in patient's arm after injection. Was unclear whether first dose was given so RPh on duty advised to re-dose. Patient experienced fever and chills a day later (103-104 F fever). She went to ER. The ER doctor advised that dose should have been held for 21 days.
Severe pain to shoulder, arm, and clavicle region with and without movement. Not improving with ibuprofen.
Between 7 -10 days, I noticed itching in the site of the vaccine shot. Also then noticed a pinkish red area about 2 inches in diameter.  Also, have noticed that range of motion on that arm is less than prior to shot. Pain at the site, very much dismissed but still have some tenderness almost 2 weeks after shot.
I contracted COVID sometime after taking the vaccine. My symptoms included a severe runny nose, congestion, a sinus headache. My voice and throat were ok, and my temperate was 99.2 which was the highest it ever got. I took a COVID test and it read as negative, and I just thought it was a sinus infection. I woke up the next day and just did my daily routines, but the nose was relentless. The day after I was more stuffed up and my nose felt like glue. I felt miserable but I went to work anyway, and that lasted 30 minutes before I left and went to the doctor. And that is where I tested positive. I was given PAXLOVID, and took the regime and felt better and no rebound.
SUDDEN WAVE OF BEING HOT, EXTREME DIZZINESS TO THE POINT OF FALLING TO HANDS AND KNEES