chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Several hours after the injection patient started to have  pain ,tingling and numbness up into upper back and down to the fingers. Patient put ice on the site. The following morning the swelling had increased  the site on the arm was about a 5 inch diameter circle . It was hot , hard and red. Patient went to the doctor. The doctor recommended the patient take ibuprofen. The ibuprofen has helped some and the swelling is retreating
1st shot administered to 16yr old; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (1st shot administered to 16yr old) in a 16-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (1st shot administered to 16yr old). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (1st shot administered to 16yr old) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was provided by the reporter. No treatment was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: Follow up was received. No new information was provided.
Information has been received concerning a 12 year old male with no allergies who was vaccinated with varicella virus vaccine (Oka/Merck). There was no illness at the time of vaccine. The patient developed five-six lesions on the chest, with vesicles, and one lesion on the arm and abdomen for 24 hours. At the time of this report, the outcome was unknown. Additional information has been requested.
Shortness of breath, large raised welt oni injection site, painful breathing, pinprick pain all over body, slight headache,,lasting 2day ,starting 10 days after injection.
Client was to young to receive the Moderna vaccine and was give the second dose on 05/01/2021. The first dose was given on 04/3/21 (First dose of Moderna was given on 04/03/21). Per the Chief Medical Director the second dose has to be given to complete the series. Following the guidelines of Administration and error documentation and deviation and error (recommendations as off label use)  No adverse effects known.
Pt had a feeling like his bp had gone up as well as flushed feeling. He was sent to lie down and administered zyrtec 10 mg PO. Pt then began to have tingling in his fingers. Pt was evaluated by ems. Denied wanting to go to hospital. Pt observered for 1 hr when symptoms resolved. Pt was turned over to wifes care with instructions to f/u with md as well as if symptoms occurr again or worsen to follow up with EMS/ER.
Swollen lymph node; Low-grade fever/100.6 fever; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Swollen lymph node) and PYREXIA (Low-grade fever/100.6 fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    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, the patient experienced LYMPHADENOPATHY (Swollen lymph node) and PYREXIA (Low-grade fever/100.6 fever). At the time of the report, LYMPHADENOPATHY (Swollen lymph node) and PYREXIA (Low-grade fever/100.6 fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100.6 (High) 100.6 fever.         The  concomitant medications on use were not provided. No treatment information was provided.   This case was linked to MOD-2021-435190 (Patient Link).
After administering flu vaccine pt stated to smell something strong, then administered the shingrix vaccine. Pt felt burning sensation on back and throughout body. Pt could breathe, but pain was unbearable. Gave patient water. Denied ambulance. Pt stated that she felt it was the influenza vaccine. Checked BP after pt was calm 137/67 with pulse of 83. Patient sat for about 45 more minutes, checked BP again 127/73 w/ pulse 73. Pt felt fine to leave.
Arm swelling; Severe arm redness; Unable to use arm; This case was reported by a nurse via call center representative and described the occurrence of extensive swelling of vaccinated limb in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced extensive swelling of vaccinated limb, erythema of extremities and injected limb mobility decreased. On an unknown date, the outcome of the extensive swelling of vaccinated limb and erythema of extremities were unknown and the outcome of the injected limb mobility decreased was recovered/resolved.   It was unknown if the reporter considered the extensive swelling of vaccinated limb, erythema of extremities and injected limb mobility decreased to be related to Shingrix.  Additional information received were as follows: The age at vaccination was not reported. The patient experienced severe arm redness and extensive swelling of vaccinated limb following the first injection of Shingrix. The reporter's collaborative doctor and reporter did not know if this patient could receive the second injection safely. The reporter asked what do they thought. The patient's whole arm had reddnes swelling and she was not able to use her arm for one month. The reporter consented to follow up. The visitor stated that she was busy seeing patients and did not provide patient demographics.
C/O REDNESS AND SWELLING IN RIGHT ARM FROM SHOULDER TO ELBOW.  Area, upon inspection, was red, swollen, and warm to touch.
Information was received from a pharmacist concerning an approximately 66 year old female with sulfa and penicillin allergy, TB active positive test and an allergy to bee stings who was vaccinated with the first dose of PNEUMOVAX 23 (manufacturer unknown) in 2006.  It was reported that the patient experienced redness, swelling at site after the vaccine. The patient subsequently experienced redness at site administration, hardness under skin and warmness to touch while on therapy with ZOSTAVAX (Merck) (MSD, WAES 0908USA04736). No further information is available.
Felt feverish and achey starting 12 hours after injetion, lasting a total of 54 hours. At 36 hours after injection I felt like I was going to faint. I sat down and put my head on the table. According to my husband, my eyes briefly rolled back into my head and I was convulsing for a brief period of time (5 seconds). I then sat straight up, sweating profusely, white a sheet and with a terrified look on my face started hyperventilating for a short period of time. My husband said I never actually fainted, but I don't have memory of this incident. After this episode passed I continued to feel feverish and achey. Temp about 100.7. Started to feel a little better 54 hours after injection.
Information has been received from a health professional concerning a 64 year old female received a dose of PNEUMOVAX 23 vaccine (lot # 662020/0614X). The patient experienced lump, size of "dollar", and redness at injection site. Patient administered ice packs and BENADRYL for event. Patient recovered. This is one of several reports received from the same source. Additional information is not expected.
pt recv vax 28FEB96 & 5min p/vax pt fell to the ground hitting head very hard & proceeded to have tonic/clonic sz;MD treated w/in 5min & was awake & responsive;MD felt it was a vasovagal response;had another sz @ home;vasovagal sz;
Vaccine Administration error Patient arrived for 2nd dose Moderna, upon review of the patient's birthdate the patient should have received Pfizer for the 1st dose vaccine due to age. 2nd dose Moderna was administered as off label use because Moderna is not authorized in the age group.
15-year old patient received the 1st dose of the Moderna vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (15-year old patient received the 1st dose of the Moderna vaccine) in a 15-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 078C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jul-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (15-year old patient received the 1st dose of the Moderna vaccine). On 16-Jul-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (15-year old patient received the 1st dose of the Moderna vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were provided.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Additional information received included no new significant information.
This spontaneous report as received from a Licensed Practical Nurse refers to a patient of 14 years old adolescent patient and unknown gender. On 29-AUG-2014 the patient was vaccinated with a dose of an improperly stored GARDASIL (lot J015378, expiration date 09-APR-2016) (dose, route, were not reported). No adverse effect was reported. The outcome of events reported was unknown. No product quality complaint was involved. This is one of several reports received from the same source. Additional information has been requested.
30 hours of hiccups/abdominal spasms/ Myalgia/Headache/Mild fever.
Had a Stroke 4 days after 2nd dose of vaccine.  Passed away April 10.
Itching all over body/Itching on hands; This case was reported by a consumer via call center representative and described the occurrence of generalized pruritus in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th December 2019, the patient received the 2nd dose of Shingrix (intramuscular). On an unknown date, less than 2 weeks after receiving Shingrix, the patient experienced generalized pruritus. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the generalized pruritus was unknown.   It was unknown if the reporter considered the generalized pruritus to be related to Shingrix.  Additional case details were reported as follows: The patient received Shingrix and experienced itching all over her body, most predominant on her hands, and without signs of rash or hives.    The caller reported that her physician advised her to use Benadryl and that it has not really helped. The reporter consented to follow up.
Admitted to Hospital 11/10/2022 for COVID-19 treatment, deceased 11/16/2022.
This case was reported by a consumer via call center representative and described the occurrence of generalized rash in a 65-year-old female patient who received SHINGRIX. Concomitant products included CALTRATE, Multi Vitamin and SYMBICORT. On 21st April 2018, the patient received the 1st dose of SHINGRIX. On 21st April 2018, 10 hrs after receiving SHINGRIX, the patient experienced generalized rash. On an unknown date, the patient experienced raised rash. The patient was treated with Steroids and BENADRYL. On an unknown date, the outcome of the generalized rash was recovering/resolving and the outcome of the raised rash was unknown. The reporter considered the generalized rash and raised rash to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. Ten to twelve hours after receiving SHINGRIX, the patient experienced rash all over which was more pronounced and inflamed on Sunday and Monday. The physician prescribed steroids and the patient took BENADRYL and the rash was not as inflamed. The patient reported that the rash was more prominent on her trunk and arms which was very slight, raised and inflamed and the rash spread to both of her thighs.
4/13/12 received DtaP 5 (R) & IPV 4 (L) - developed very large local reaction 20 x 26 cm w/lots of redness, induration, micro vesicles.
Sore throat     Hoarseness  Encounter Date:  6/16/2021 Patient here for Bamlanivimab and Etesevimab infusion. Patient tolerated infusion well and was monitored for 1 hour post. Upon discharge, patient was provided a pulse ox, thermometer, after visit summary and follow up instructions. No adverse events noted during this visit.
1/17/23 mom contacted office to inform that 48 hours after injection on 12/229/22, patient developed red, itchy palms and palms were still red at time of call. Applied fluticasone cream and no improvement. Dad called to inform rash on feet as well. Has previously scheduled appt with pediatric dermatologist, Dr. on 01/19/23. Virtual visit with Pediatric dermatologist, Dr. who advised they apply hydrocortisone to the LT palm and toes and not the RT side to see if any change. No change after 1 week.  Pedi derm informed them that he has seen COVID toes before but uncertain if this is related to the COVID vaccine and no diagnosis was made. Dr. pediatrician advised postponing 2nd dose of the COVID vaccine at this time.
sudden onset of ringing in ears 15 minutes after the vaccination, persisting to the present date
Reported shortness of breath & dizziness at 4:30 PM, fever onset 10:00 PM.
2 hours after vaccination, sudden onset of fatigue, stomach upset, headache, whole body ache. Symptoms lasted for 3 days and patient could not get up to leave home. Patient did not experience these symptoms after 1st dose of Shingrix 2 months earlier.
second vaccine not given\from the first vaccine given, and today would have been day 45; headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) and PRODUCT DOSE OMISSION ISSUE (second vaccine not given\from the first vaccine given, and today would have been day 45) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     Concomitant products included AZITHROMYCIN from 20-Aug-2021 to 24-Aug-2021 for an unknown indication.    On 27-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jul-2021, the patient experienced HEADACHE (headache). On 27-Aug-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (second vaccine not given\from the first vaccine given, and today would have been day 45). On 27-Aug-2021, PRODUCT DOSE OMISSION ISSUE (second vaccine not given\from the first vaccine given, and today would have been day 45) had resolved. At the time of the report, HEADACHE (headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Chest X-ray: normal (normal) Results were negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       X-ray of the left lung to check for Pneumonia, the results were negative  Concomitant medications also include Nitro used for unknown indication.  No Treatment information was reported.   Reporter did not allow further contact
my arm started hurting; Little bit of diarrhea; Headache; ca't smell; I felt bad; I was not feeling well; Nasal congestion; I felt tired immediately; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (my arm started hurting), NASAL CONGESTION (Nasal congestion), FEELING ABNORMAL (I felt bad), DIARRHOEA (Little bit of diarrhea) and MALAISE (I was not feeling well) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure high and Stomach discomfort. Concomitant products included LOSARTAN for Blood pressure high, HYDROCHLOROTHIAZIDE and VITAMINS NOS for an unknown indication.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, the patient experienced FATIGUE (I felt tired immediately). On 28-Feb-2021, the patient experienced NASAL CONGESTION (Nasal congestion) and MALAISE (I was not feeling well). On 01-Mar-2021, the patient experienced FEELING ABNORMAL (I felt bad). On 04-Mar-2021, the patient experienced ANOSMIA (ca't smell). On an unknown date, the patient experienced PAIN IN EXTREMITY (my arm started hurting), DIARRHOEA (Little bit of diarrhea) and HEADACHE (Headache). On 02-Mar-2021, FEELING ABNORMAL (I felt bad) outcome was unknown. At the time of the report, PAIN IN EXTREMITY (my arm started hurting), NASAL CONGESTION (Nasal congestion), DIARRHOEA (Little bit of diarrhea), MALAISE (I was not feeling well), ANOSMIA (ca't smell), FATIGUE (I felt tired immediately) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No laboratory data was provided. Treatment included pseudoephedrine and two paracetamol.   This case was linked to MOD-2021-035159 (Patient Link).
Headache, Myalgia, Fever, Fatigue, Chills, Pain on the injection site. Narrative:
Excessive heavy bleeding with menstrual period lasting several days. Also numbness on her left side From jaw to leg) starting on 8/31/21
This spontaneous report was received from a physician, via a company representative, referring to an unknown number of infant patients between 6-11 months, of unknown gender. The patients' pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On unknown dates, the patients were vaccinated with diphtheria toxoid (+) hepatitis B virus vaccine rhbsag (yeast) (+) HIB conj vaccine (ompc) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (vero) (+) tetanus toxoid (manufacturer unknown) for prophylaxis (strength, dose, route, anatomical location, lot # and expiration date were not reported). On unknown dates, the patients developed pertussis. At the reporting time, the outcome of pertussis was unknown. The causality assessment was not provided. Upon internal review, pertussis was considered a medically significant event. Sender's Comments: US-009507513-1904USA013391; US-009507513-1905USA004180; US-009507513-1905USA004179; US-009507513-1905USA004178; US-009507513-1905USA004182; US-009507513-1905USA004177.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Sep2022 at 16:00 as dose 5 (booster), single (Lot number: GJ5342) at the age of 73 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: pistachio nuts" (unspecified if ongoing); "Known allergies: sulfa" (unspecified if ongoing); "COVID-19" (unspecified if ongoing), notes: If covid prior vaccination: Yes. Concomitant medication(s) included: ATORVASTATIN; OMEPRAZOLE; VIT D3; MAGNESIUM. Past drug history included: Isoniazide, reaction(s): "Known allergies: isoniazide". Vaccination history included: Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE, COVID-19 VACCINE [Manufacture unknown]), for Covid-19 immunization; Covid-19 vaccine (Primary immunization series complete  , COVID-19 VACCINE [Manufacture unknown]), for Covid-19 immunization. The following information was reported: NAUSEA (non-serious) with onset 22Sep2022 at 08:00, outcome "recovered", described as "I became nauseated"; LOSS OF CONSCIOUSNESS (medically significant) with onset 22Sep2022 at 08:00, outcome "recovered", described as "blacked out"; COLD SWEAT (non-serious) with onset 22Sep2022 at 08:00, outcome "recovered"; DIZZINESS (non-serious) with onset 22Sep2022 at 08:00, outcome "recovered", described as "dizzy". The events "blacked out", "i became nauseated", "dizzy" and "cold sweat" required physician office visit. Therapeutic measures were taken as a result of loss of consciousness, nausea, dizziness, cold sweat.  Clinical course: Patient became nauseated, dizzy, cold sweat and blacked out and fell to the floor (her husband caught her head before she hit the floor), but remained conscious. Lasted a few minutes. Same thing happened after the 4th shot. Had electrophysiology study after the first black out episode and now after this second episode, patient was having a loop recorder implanted for monitoring. Patient has not been tested for COVID-19 since the vaccination.
Initial misuse report received from a healthcare professional on 28 June 2013. A staff member inadvertently received an eye splash while drawing up ACTHIB. The reporter was unsure whether it occurred while drawing up diluent regarding the patient. No adverse event was reported. Documents held by sender: none.
Soon after receiving the vaccination my daughter has had 3 plantar warts. GARDASIL shots x 3 Lot # 0558X, June 17, 2009, Aug. 19, 2009, Dec 26, 2009.
sore injection site left arm; Headache; Fever; body aches; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore injection site left arm), HEADACHE (Headache), PYREXIA (Fever) and MYALGIA (body aches) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, the patient experienced VACCINATION SITE PAIN (sore injection site left arm), HEADACHE (Headache), PYREXIA (Fever) and MYALGIA (body aches). At the time of the report, VACCINATION SITE PAIN (sore injection site left arm), HEADACHE (Headache), PYREXIA (Fever) and MYALGIA (body aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication provided. No treatment details were reported.   This case was linked to MOD-2021-285675 (Patient Link).
Tingling, first legs then arms and legs.  Weaknesses,  Dificulty to walk , talk,  cramps ( legs, hands), Numbness, bowel problems, Tiredness
Around 645 am the patient stated that she was starting to feel a little itchy on her body when she was waiting for the vaccine.  715 am her itching was all over her body, no trouble with breathing, gave 50 mg of benadryl which the patient states has worked for itching before. 745 am patient was feeling fine, and left. Counseled on what to look out for, to go to ER if any issues.
I have been diagnosed with chronic hives(Urticaria) and angioegema. I suffer daily with hives and itching all over my entire body. This started while I was at work in early January 2022. My face, lips and eyes started to swell and I went to emergency at the Hospital. That is the first of many emergency visits due to the covid 19 vaccination.  I have been referred to a specialist. He has done extensive testing on me. Blood tests, allergy tests and an abdominal ultrasound. All of these tests have come back clear and he has no answers as to why I am having these terrible outbreaks. I believe this all stems from the covid 19 vaccine.  He has perscribed me many different medications and none of them give me any relief.