chrisvoncsefalvay/vaers-outcomes huggingface dataset:
hives; Itching; Rash/Hives; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives), PRURITUS (Itching) and RASH (Rash/Hives) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006MZ0A) for COVID-19 vaccination.     The patient's past medical history included Hay fever (she has a history of hay fever, but that was 40 years ago.).    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Apr-2021, the patient experienced URTICARIA (hives), PRURITUS (Itching) and RASH (Rash/Hives). The patient was treated with PREDNISONE at a dose of 1 dosage form and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at a dose of 1 dosage form. At the time of the report, URTICARIA (hives), PRURITUS (Itching) and RASH (Rash/Hives) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details updated.   Most recent FOLLOW-UP information incorporated above includes: On 29-May-2021: TCR received on 29-may-2021 Patient stated that she had no more symptoms and she declinedfurther follow up
A week ago, her arm started itching; it started getting warm; there is a little red spot; Her arm was sore for 3 days after getting 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Her arm was sore for 3 days after getting 1st dose), PRURITUS (A week ago, her arm started itching), INJECTION SITE WARMTH (it started getting warm) and RASH MACULAR (there is a little red spot) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ESTRADIOL and CABERGOLINE for an unknown indication.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced PAIN (Her arm was sore for 3 days after getting 1st dose). On 30-Mar-2021, the patient experienced PRURITUS (A week ago, her arm started itching), INJECTION SITE WARMTH (it started getting warm) and RASH MACULAR (there is a little red spot). The patient was treated with HYDROCORTISONE at an unspecified dose and frequency. At the time of the report, PAIN (Her arm was sore for 3 days after getting 1st dose), INJECTION SITE WARMTH (it started getting warm) and RASH MACULAR (there is a little red spot) outcome was unknown and PRURITUS (A week ago, her arm started itching) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments
Developed anxiety 2days after shot, 1 -2 episode per day lasts about 15-20minutes feels like I?m going to go crazy then it subside. I don?t have history. My husband is is too. He went to ER & can?t take the episode starts crying.
c/o severe h/a, vomiting, & elevated temp 103; mom also stated child was limp & pale; Seen in ER
From telephone contact received at manufacturer on 6/3/02 it was reported that a 1 year old male received Tripedia on 5/30/02. Patient developed a large local reaction from knee to upper thigh on 6/3/02. Area red, warm to touch, swollen and itchy. Nurse stated that cellulitis developed. Child scheduled for follow up visit with doctor's office on 6/4/02.
Client received Tdap (Boostrix), Menactra and HPV 9 injections. About 5 minutes after vaccines were administered, the client had a change in facial color to pallor and became diaphoretic. The client lost consciousness and her body began to shake. The client also was incontinent of urine. The client responded after about 45 seconds to her name and was oriented to time and place. Cold compresses were applied. Parent informed that the client would be ok with plenty of fluids and adequate nutrition.
Patient received influenza vaccine at an offsite vaccine clinic at 12 noon. She stated that she had never had an influenza shot in the past. At 12:30 pm she visited the school's nurse with a chief complaint of numbness on the left side of her face/cheeks saying it felt like being numbed at dentist's office.  She also had a blunt/blank affect (nurses' description), tunnel vision, double vision. He contacted me at 12:32 pm and I went to nurses' office and sat with patient and nurse until 2 pm when her husband picked her up to take her to the MD. During that 1.5 hr time period we observed her and noted symptoms.  Her blood pressure was taken at 12:40pm and read as 128/80 and she commented that it was high per her normal readings of usually 80-60 or so. Patient seemed to have some jerky spasms originating in her back/upper body.  Once she went to MD, he sent her to the emergency room at the hospital.  She was assessed for a stroke which came back negative. She was placed under observation overnight. The following day she was admitted due to continued feelings of "heaviness" in her left arm and leg.  A neurologist consulted with her and diagnosed this reaction as being caused by the influenza vaccine possibly interacting with any Covid-19 antibodies patient may have.
Soreness in left arm for 2-3 days after injection. Swollen lymphnode in axillary region of left arm beginning 4-5 days after injection.
The patient received the Moderna Bivalent booster within 90 days of having Covid. Patient was monitored. No adverse effect within 15 observation time.  Notified of vaccine administration error. Provided with patient education. Clinic Manager and Pharmacy were notified
On day 2 there is a smell of metal in nose / stuffy; On day 2 there is a smell of metal in nose / stuffy; In day 2 there is a couple inch welp forming close to injection site in right shoulder; This is a spontaneous report from a contactable other healthcare professional, the patient. A 48-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration in the right arm on 11Aug2021 at 14:30 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medications. On 13Aug2021 at 13:15, on day 2 there was a smell of metal in nose/stuffy and there was a couple inch welp forming close to injection site in right shoulder. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events on day 2 there was a smell of metal in nose/stuffy and in day 2 there was a couple inch welp forming close to injection site in right shoulder was unknown at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Vaccine #1 was received January 14,2021 with second dose on February 11,2021. On March 3, 2021 Patient was taken to the hospital via EMS after experiencing severe tremors of both upper extremities and slurred speech. He was subsequently diagnosed with Uro-sepsis and due to reported neurological signs was taken for CT scan to rule out stroke. Stroke was ruled out but a brain mass was noted. Further investigation required brain MRI which determined the mass was a tumor. At his advanced age of 86, he declined a biopsy but accepted the plan of repeat MRI in one month. At the one month interval the second scan revealed the tumor had doubled in size from initial scan and was presumed, due to lack of biopsy, glioblastoma, based on radiologic description and rate of enlargement. Patient passed away on June 17, 2021.
Swelling in the lymph nodes (lymphadenopathy); Very bad headache (headache); This is a spontaneous report from a non-contactable pharmacist. A 33-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via intramuscular route of administration on 09Apr2021 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. It was unknown if the patient had any relevant medical history and known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. It was unknown if the patient received any concomitant mediations. On 10Apr2021, the patient developed swelling in the lymph nodes (lymphadenopathy) and 'very bad headache' (headache) shortly after the 1st dose of the COVID-19 vaccine. Both events lasted for about a week and a half and have resolved. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events swelling in the lymph nodes (lymphadenopathy) and very bad headache (headache) was resolved on an unspecified date in Apr2021.  No follow-up attempts are possible. No further information is expected.
The pt experienced respiratory distress and congestive heart failure. The pt was hospitalized in ICU on a ventilator and CTB on 10/15/00. Interstitial infiltrates noted on chest x-ray by Pulmonologist.
The same night I received the injection, I developed a pain under my left shoulder blade and could not lay flat. This lasted a little over a month. Then about 2 months later, when I was packing boxes to move, the shoulder pain returned.; it finally went away by August. Then I got a flu vaccine in the same left arm in November and the shoulder pain returned again, even worse and I could not lay down for a month. This time the shoulder pain was accompanied by pain that radiated down my arm and up to my neck. It cause all my fingers on my left hand to have numbness and tingling. I went to the Dr. who didn't do any tests and told me to exercise the arm. I did not do any of the exercises, but, then the numbness in the fingers and the shoulder pain gradually went away after about a month and a half. I feel that the covid vaccine first shot has sensitized my left arm to vaccines and will not get any vaccines in that arm in the future. I did take about 800 mg of ibuprofen and 500 mg Tylenol each day for a month from December to January. I am afraid that I will have even a worse shoulder/arm pain if I get another vaccine in the left arm.
5 months after dose 3 vaccination, I started having fatigue, upper resp. cough and sinus drainage. I took a home Covid test on 5-9-2022 and it was positive so I had a telehealth visit with my PCP that same day. They prescribed PAXLOVID. I took all of that medication. I am feeling a lot better today. There is a lingering cough but it is not limiting my ability to function. I am reporting my breakthrough case of Covid.
Fever, chills, night sweats, nausea.  Took zinc, Ibuprofen and symptoms were gone in 3 hours.  I just felt tired the next day then good as new.
redness, swelling, hot to touch, the area was 15 cm in diameter at the injection site; a circular bubble in the middle, the area was 15 cm in diameter at the injection site; itching at the injection site, the area was 15 cm in diameter at the injection site; redness, swelling, itching, a circular bubble in the middle, hot to touch, the area was 15 cm in diameter at the injection site; Initial and additional information received on 27-May-2021 regarding an unsolicited valid  non-serious case received from a physician via Agency (Reference number- 00618732).  This case involves a four years old male patient who experienced redness, swelling, hot to touch, the area was 15 cm in diameter at the injection site (inflammation), circular bubble in the middle, the area was 15 cm in diameter at the injection site (blister), itching at the injection site, the area was 15 cm in diameter at the injection site (pruritus) and redness, swelling, itching, a circular bubble in the middle, hot to touch, the area was 15 cm in diameter at the injection site (vaccination site reaction), while he received DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].  The patient's medical history, medical treatments, vaccinations and family history were not provided.  Concomitant medications included POLIO VACCINE for prophylactic vaccination on 13-May-2021 at the same visit.  On 13-May-2021, the patient received a 0.5 ml dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot C5743AA, expiry date: 06-JUN-2022 via intramuscular route in the left thigh for prophylactic vaccination.  On 14-May-2021, the patient developed a non-serious redness, swelling, hot to touch, the area was 15 cm in diameter at the injection site (inflammation), circular bubble in the middle, the area was 15 cm in diameter at the injection site (blister), itching at the injection site, the area was 15 cm in diameter at the injection site (pruritus) and redness, swelling, itching, a circular bubble in the middle, hot to touch, the area was 15 cm in diameter at the injection site (vaccination site reaction) one day following the administration of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE.  Description: Health Care Professional called to report DAPTACEL has been causing chemical reaction in four patients. The caller stated that she has had four patients that developed the same injection site reaction after a vaccination with Daptacel and Doctors nurse called back stating they would like a replacement. Three of the patient received the same lot number for sure, the caller was not sure about the fourth patient. She will send pictures of the reaction areas of all of these patients. Product used, Still using product: No  No laboratories details reported.  The patient was treated with BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE] and cool compresses for all the events.  At time of reporting, the patient was recovered from all the events after five days.
No adverse event; They received a 0.2mL dose from the vial with the pink cap. They were supposed to receive the blue cap at a 0.25mL dose.; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (They received a 0.2mL dose from the vial with the pink cap. They were supposed to receive the blue cap at a 0.25mL dose.) and NO ADVERSE EVENT (No adverse event) in a 10-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 201L22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 06-Jul-2023, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .2 milliliter. On 06-Jul-2023, the patient experienced WRONG PRODUCT ADMINISTERED (They received a 0.2mL dose from the vial with the pink cap. They were supposed to receive the blue cap at a 0.25mL dose.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (They received a 0.2mL dose from the vial with the pink cap. They were supposed to receive the blue cap at a 0.25mL dose.) 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 (They received a 0.2mL dose from the vial with the pink cap. They were supposed to receive the blue cap at a 0.25mL dose.).    Patient  did not received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Concomitant medication details not reported by the reporter. Treatment details was not reported by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-732484 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-732484:Linked to Master case MOD-2023-732484, same reporter
After the boost shot on 12/14/21, I started having nerve pain in my legs and an itchy spot was happening on my back. The itching progressed to pain like shingles. This spread around my right side, under my armpit then to the front of my chest. It affected my breasts and nipples causing discomfort and periods of pain. No visible markings on my body. I still have discomfort on my right side.
12 month old previously healthy presents with lip swelling. Received 12 mo immunization this am around 10.30. Took once dose of PO Tylenol right after. Went home right after, no other suspected environmental exposure, no different foods or anything topical. Around 1630 developed lip - upper and lower swelling, tugs at his  lips - maybe itchy. No generalized rash or itching. Tugging a little at his ears. No noisy breathing or wheezing. Tolerating PO, no vomiting. Has been having a mild URI symptoms with low grade fever, T-99 for the past week. No known allergies - Not allergic to egg, or any kinds of food. No fam hx of angioedema like illness. This has never happened in the past or related to any immunization or Tylenol.
The morning after receiving vaccine, the injection site was warm but not red. Afebrile. Left axilla was edematous secondary to lymph nodes swollen and tender. Had sharp pains experienced in axilla on arm movement (non-radiating). Edema worsened and saw MD on 12/14/01. Placed on Relafen. MD dx'd rxn to the flu vaccine. Pain and edema resolving by 12/18/01.
Information has been received from an office administrator referring to an unspecified number of patients of unknown age and gender. The patients were vaccinated with improperly stored doses of VARIVAX (lot # M003439, expiration date 19-JAN-2018, dose and route not provided) on unspecified dates. No adverse effects had been reported. There was no product quality issue (PQC) involved. Temperature and Time frame: 9.7F for 1 hour and 18 minutes. Was it administered (AE)? Yes. Was previous temperature excursion? No. Was call because of a "data logger"? Yes. This is one of several reports received from the same reporter. Additional information has been requested.
About a week after the shot my arm started itching and a rash spread around my arm. It was about 6 inches around, welted, hot and itchy. It stayed that way for about 7 days and then started to get better and lighten up.
Late Dose/did not taken 2nd dose; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received years ago).   On an unknown date, the patient received 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 details were reported as follows: The case was reported by the patient. The age at vaccination was not applicable for this report. The patient did not take 2nd dose of Shingrix till the time of reporting which led to incomplete course of vaccination. The patient called to see if he need to take 2nd vaccine or do he had to start over.  The patient could not answer most of the safety question due to getting vaccines years ago and he could not remember. The reporter consented to follow up.
Every time I eat something for the last 2 days develope hives/rash everywhere in my mouth.
Moderna vaccine was opened on 5/16/22 at 930a, dose should of been discarded after 930p on 5/17/22.  Patient  came in on 5/17/22 at 230p to get Moderna vaccine patient was given a dose that was expired.  No adverse reaction noted, pt was notified.
This is a spontaneous report from a contactable consumer reported for herself. A 19-year-old female patient received TRUMENBA, via an unspecified route of administration on MAR2016 at 0.5 ml single dose. The patient medical history and the patient's concomitant medications were not reported. On unknown date in MAR2016 the patient experienced muscle ache, headache and fever. The outcome of the events was reported as recovered. No follow-up attempts are possible. No further information is expected.
Painful lower extremity joints - knees lumbar, bilat 14 days after MENVEO. No joint inflammation, AF, no rash. On labs, microscopic hematuria. EJR = = 36. Labs nl/ Sx resolved 5-7 d.
Scratchy and lumpy throat, face swelling, lips tingling, breathing felt tighter.
Admitted at medical center x 1 day then transferred to hospital for bilious vomiting. Dx-Intussusception of Intestine (560.0) 10/6/08-records received for DOS 7/23-7/24/08-DC DX:Instussusception. Successful reduction of ileocecal intussusception by air enema. Presented with 2 day history of vomiting bilious in last 24 hours, abdominal pain and lethargy. Unable to tolerate feedings. Irregular bowel movement with constipation, no blood.
2 days after administration of vaccine, patient had numbness and tingling in his feet, unable to walk and was hospitalized. Patient came to me on day 5.
patient stated he is always hungry; This spontaneous report was received from a physician via company representative refers to a male patient of unknown age. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies, historical drugs, familial history and concomitant medications were not reported.   On an unknown, date the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (strength, dose, route of administration, anatomical location, lot/batch # and expiration date were not reported) for prophylaxis. On an unknown date, the patient started therapy with ertugliflozin(STEGLATRO) (strength, dose, frequency, route of administration, lot/batch # and expiration date were unknown) for an unknown indication.   On an unknown date, the patient reported that he was experiencing hunger always (increased appetite). No product quality complaint was involved.   The therapy with ertugliflozin(STEGLATRO) was discontinued and also reported that the patient will restart ertugliflozin(STEGLATRO) in 1 week. The outcome of increased appetite was unknown. The reporter's causality assessment was unknown.
(Right arm)site is erythematous, hot, painful X 6 days.  Pain into shoulder joint of right arm.
Information has been received from a physician concerning her son who "a couple of years ago," in approximately 2004, was vaccinated with MMR II. Subsequently, the patient developed a fever and rash. Unspecified medical attention was sought. At the time of the report the patient had recovered. There was no product quality complaint involved. The patient's brother (WAES#0607USA03942) had a similar experience following vaccination with MMR II. No further information is available.
I had COVID-19. I was really tired and exhausted. By Sunday, I had a bad throat pain. By Monday, My body started aching. I didn't have a thermometer but I knew I had a fever. I also had night sweats. These symptoms lasted for about 2-3 days. The congestion and cough lasted for about 10 days. I felt short of breath as well. I was also extremely congested. I also had a really bad headache.
Felt like I had a deep muscle bruise. No redness to the area, but hot at the injection site. 12 hours after the shot - right at bed time - my body temperature dropped and I was freezing. I couldn't get warm, especially my feet. Had to turn off all fans and AC to try to get warm. Didn't sleep well. Couldn't lay on my left side because of the pain from the injection. Woke up hot but the pain in my arm was minimal. Still sore, but no longer a deep bruise pain. Slight "hurt/bruised" feeling through Wednesday. No pain or bruised feeling on Thursday.