chrisvoncsefalvay/vaers-outcomes huggingface dataset:
17 year old received their first dose of the Moderna vaccine; Aches; A spontaneous report was received from a pharmacist concerning a 17-year-old patient who received their first dose of Moderna's COVID-19 vaccine (mRNA-1273)/ product administered to patient of inappropriate age and developed aches/myalgia.  The patient's medical history was not provided. Concomitant product use was not provided.  The patient received their first of two planned doses of mRNA-1273 (Batch number: 011L20A) between 11 Jan 2021 and 21 Jan 2021 (date not specified) intramuscularly for prophylaxis of COVID-19 infection.  Treatment information was not provided.  The patient was scheduled to receive the second dose in Feb 2021. Action taken with mRNA-1273 in response to the events was not provided.  The event, 17-year-old received their first dose of the Moderna vaccine, was considered resolved on the same day of vaccine administration (date not specified). The outcome of the event, aches, was not reported.; Reporter's Comments: This case report concerns a 17-year-old female patient who was administered mRNA-1273 vaccine Lot# 011L20A (inappropriate age at vaccine administration) and experienced aches. The event of aches is temporarily associated with the product use and a causal association cannot be excluded. The event of inappropriate age at vaccine administration is assessed as not applicable.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-011594:
Patient states she has increased eye pressure (described symptoms as distorted vision, inflammation, pain). Currently undergoing treatment with eye drops to lower inflammation. Outcome, patient is working with eye specialist.
This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (no appetite), ASTHENIA (weakness), HEADACHE (Headache), MYALGIA (muscle aches) and FATIGUE ( tired) in an elderly 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced DECREASED APPETITE (no appetite), ASTHENIA (weakness), HEADACHE (Headache), MYALGIA (muscle aches) and FATIGUE ( tired). At the time of the report, DECREASED APPETITE (no appetite), ASTHENIA (weakness), HEADACHE (Headache), MYALGIA (muscle aches) and FATIGUE ( tired) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided by the reporter. The Patient was over 60 years old and was tired,no appetite, weakness, muscle aches, and headache. Treatment information was not provided. This case was linked to MOD21-085592, MOD21-085383, US-MODERNATX, INC.-MOD-2021-101650 (E2B Linked Report).; Sender's Comments:  MOD21-085592: MOD21-085383: US-MODERNATX, INC.-MOD-2021-101650:
Injection site pain, tiredness, severe headache for two days, muscle pain, chills, joint pain, low grade fever, mild nausea
W/in 6-8 hours notices small red spot that has progressively gotten worse each day. Larger, red, warm. 2/27 is 10 1/2 cm x 7 cm. Dr visit dx as a cellulitis.
Had Menactra and Boostrix on 4/16 at 11 am. Went to sleep that evening and woke up at 3 AM on 4/17 with low grade fever, headache, neck pain and joint muscle pain. Parent gave Tylenol at 3 AM and again in early AM on 4/17. Pediatrician contacted and recommended Advil 600 mg Q 6 hrs. Parent contacted on 4/19. Child returned to school today after missing 2 days of school.
Case number PHEH2013US022624 is an initial spontaneous report received from a nurse on 25 OCT 2013. This report refers to a 34-year-old male patient. He was given only MenCYW-135 liquid component of MENVEO (batch number: M12024) intramuscularly on 25 OCT 2013. No adverse event was reported following this administration error (inappropriate preparation of medication).
1 week post injection, I have redness, warmth, swelling and itching at injection site.
first vaccination in 1/2020 pre pandemic; This case was reported by a other health professional via (Shingrix GSK Chatbot) interactive digital media and described the occurrence of social problem in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in January 2020 pre- pandemic).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.  Additional details were provide are as follows: The age at vaccination was not reported. The patient received 1st Shingrix vaccination in January 2020 pre-pandemic and now wanted to get the 2nd shot which led to social problem. The reporter advised to get them both again or could he just get the 2nd shot.
12 weeks pregnant, due May 21, 2022. Had severe nausea the next morning (about 13/14 hours after shot). Had not been nauseous from pregnancy and also took diclegis the same night as shot. Had body aches, sore arm throughout the day and a severe headache. Nausea subsided after a few hours. All other side effects were completely gone the following morning
High blood pressure, fluctuating for one hour, anxiety, racing heart immediately following vaccine.  Headaches, anxiety, tiredness continue 1 week after vaccine.
2nd Covid Vaccination reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (2nd Covid Vaccination reaction) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027L20A and 011M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Mar-2021 at 5:00 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION COMPLICATION (2nd Covid Vaccination reaction). On 11-Mar-2021, VACCINATION COMPLICATION (2nd Covid Vaccination reaction) had resolved.            No concomitant medication provided. No treatment medication provided.   This case was linked to MOD-2022-453316 (Patient Link).
Patient seen 7NOV08 for asthma visit but also complaint of 1 week h/o raised erythematous rash that began 1 day after vaccinations, 6x4 in. notable papular rash over trunk and extremities, reassurance given, no medical treatment required.
Mother reports client developed redness and knot at site of injection. Mother described redness as "streak" around injection site. Client taken to doctor 10/10/2001. Diagonal with local reaction to second Hep B shot per MD and will be reevaluated in the next 2-3 months (see attached copy).
Immediately after receiving the vaccine the patient complained of numbness in her fingers in the arm the vaccine was administered.  This persisted through the day, and her numbness spread to the arm injected.  The following day, the patient stated her numbness became widespread, she began itching, and she stated she had difficulty breathing.  She went to the emergency room, and according to the patient, the physician stated she had an allergic reaction to the vaccine.  She was released from the emergency room.  The following day (2 days after the vaccine) the patient stated she was feeling better and was referred to an allergist to undergo testing for different allergies.  The patient was unaware of any allergies she has.
Vaccine mistakenly given via IM route.  Pt developed malaise and a vesicle on upper lip.
complained of left arm increase swelling redness after vaccine. 6/13/2005 eval at clinic Patient currently is on aloe treatment for pain hypersensitivity start dry 06/13/2005
vaccine recipient complained of itching/tingling in her throat after receiving vaccine.  states this is similar to other allergen/medication reactions she has had.  treated with benadryl and observed in clinic.
Within a few seconds of receiving vaccine, patient had a seizure last approx 10 sec.  Code blue called, transferred to ED for evaluation.  Stable and discharged home following event.  Mom later reported previous hx of seizure following vaccination.
This case was reported by a pharmacist and described the occurrence of rash spots in a 7-month-old female subject who was vaccinated with PEDIARIX (GlaxoSmithKline), PREVNAR (non-gsk) and Hib (non-gsk). On 17 April 2013 the subject received 3rd dose of PEDIARIX (unknown, left thigh), 3rd dose of PREVNAR (unknown), 3rd dose of Hib (Non-GSK) (unknown). On 20 April 2013, 3 days after vaccination with Hib (Non-GSK), PEDIARIX and PREVNAR, the subject experienced rash-like spots. The subject developed rash-like spots on her face three days after receiving vaccinations. The subject was evaluated at the clinic on 01 May2013 and the spots were now all over her body. The physician prescribed BENADRYL to treat the subject. It was reported that there were no changes in the subject's food or laundry detergent. The immunization series with PEDIARIX was not discontinued or delayed. At the time of reporting the event was unresolved. The pharmacist considered the event was possibly related to vaccination with PEDIARIX, PREVNAR and Hib (Non-GSK). Follow up information received from the pharmacist on 22 July 2013. The pharmacist reported that no action was taken with PEDIARIX, PREVNAR and Hib (Non-GSK). The pharmacist confirmed that PEDIARIX, PREVNAR, and Hib were all suspect and the event started on 20 April 2013. At the time of the follow up report, the outcome of the event was unknown.
Pt recv vax on 11/12/98; on same day pt exp right thumb swelling/ red/ hot/ pain; tx=ice applied
Started experiencing shortness of breath and coughing on May 27, 2021.  Noticed shortness of breath as walking up hill.  Breathing issues continues to get worse over time.  Went to urgent care doctor on June 4th.  They said my oxygen level was low and could hear wheezing in chest.  They did a chest x-ray and thought I might have pneumonia.  Gave me antibiotics.  Recommended to see primary care doctor.  Went to HCF on 6/7/2021.  Saw FNP.  She did blood work.  Scheduled me for a cat scan on  6/8.  Blood tests indicated d-dimer level was high.  Cat scan showed pulmonary embolisms in both lungs.  Went to hospital.
HIB was mixed with Sterile Diluent in lieu of Diluent for HIB.
11:00 - Arm around injection site started to feel sore 18:00 - slight headache began in conjunction with driving home from work 06:30 - awoke with a headache that felt like I was severely dehydrated Throughout the day felt extremely tired and dehydrated despite drinking water and having nearly clear urine All soreness, exhaustion, and headache issues ceased after second night of sleep
maternal exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (maternal exposure during pregnancy) in a 34-year-old female patient (gravida 3, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     The patient's past medical history included Supraventricular tachycardia in 1998 and Abortion spontaneous (Miscarriage was reported) on 02-Jan-2020. Concurrent medical conditions included Asthma since 2006. Concomitant products included PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE] for Pregnancy, CLOMIPHENE CITRATE from 05-Jun-2020 to an unknown date for Subfertility, ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 08-Feb-2021 at 9:45 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 19-Mar-2021. On 08-Feb-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (maternal exposure during pregnancy). The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Unknown. At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (maternal exposure during pregnancy) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Jul-2020, Pregnancy test: positive (Positive) Positive. On 12-Jan-2021, Ultrasound foetal: normal (normal) normal. On 26-Jan-2021, Ultrasound foetal: normal (normal) normal. On 05-Feb-2021, Ultrasound foetal: normal (normal) normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient reports having 2 previous pregnancies.  In 18-Mar-2018, the pregnancy outcome was Live, full-term birth.  The patient's estimated date of conception for the current pregnancy was 29-Jun-2020. Treatment medication was not reported.
8/21/12 Extreme soreness in left arm, difficult to move. Called again at 2:30 pm 8/21/12, she was feeling better. Advised to keep putting ice & taking TYLENOL.
approx 3-5min p/vax pt collapsed became ashen & sl cyanotic lowered to floor sl sz like activity regained consciousness on floor placement;pulse slow BP good in 15 min;
Recurrent vomiting, low grade fever, muscle pains, leg numbness and weakness.
Rash from face to arms to trunk within seconds of receiving vaccines. Given Benadryl and resolved within 30 min.
Slightly feverish; Had a red spot on her arm that is about the size of a baseball; Red spot is generating heat; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Slightly feverish), ERYTHEMA (Had a red spot on her arm that is about the size of a baseball) and SKIN WARM (Red spot is generating heat) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced PYREXIA (Slightly feverish), ERYTHEMA (Had a red spot on her arm that is about the size of a baseball) and SKIN WARM (Red spot is generating heat). The patient was treated with IBUPROFEN (oral) at an unspecified dose and frequency. On 02-Apr-2021, PYREXIA (Slightly feverish) had resolved. At the time of the report, ERYTHEMA (Had a red spot on her arm that is about the size of a baseball) and SKIN WARM (Red spot is generating heat) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The fever subsided after 24 hours, but the other side effects are still present and have not begun to subside. Treatment for the events:  ice pack.
Swelling, redness, itching, soreness around injection site lasting 6 days; Swelling, redness, itching, soreness around injection site lasting 6 days; Swelling, redness, itching, soreness around injection site lasting 6 days; Swelling, redness, itching, soreness around injection site lasting 6 days; Swollen lymph nodes in left armpit; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 12Nov2021 (Lot number: 3230BD) at the age of 39 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Excedrin, reaction(s): "Allergy". Vaccination history included: Bnt162b2 (Dose 2, Batch/Lot No: EN5318, Location of injection: Arm Left), administration date: 10Feb2021, when the patient was 38 years old, for COVID-19 immunization; Bnt162b2 (Dose 1, Batch/Lot No: EL1283, Location of injection: Arm Left), administration date: 20Jan2021, when the patient was 38 years old, for COVID-19 immunization. The following information was reported: VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE SWELLING (non-serious), VACCINATION SITE PRURITUS (non-serious), VACCINATION SITE PAIN (non-serious) all with onset 13Nov2021, outcome "recovered" (2021) and all described as "Swelling, redness, itching, soreness around injection site lasting 6 days"; LYMPHADENOPATHY (non-serious) with onset 13Nov2021, outcome "recovered" (2021), described as "Swollen lymph nodes in left armpit". Therapeutic measures were taken as a result of vaccination site erythema, vaccination site swelling, vaccination site pruritus, vaccination site pain, lymphadenopathy.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and not received any other medications the patient received within 2 weeks of vaccination. Prior to vaccination the patient was not diagnosed with COVID-19 and Since the vaccination the patient has not been tested for COVID-19. Patient received treatment with Hydrocortizone cream, Tylenol for events. Seriousness was reported as non serious.  No follow-up attempts are possible. No further information is expected.
Joint pains; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Joint pains) in a patient of an unknown age and 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 ARTHRALGIA (Joint pains). At the time of the report, ARTHRALGIA (Joint pains) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD21-082687, MOD21-082724, MOD21-082726 (E2B Linked Report).; Sender's Comments:  MOD21-082687:cross linked id MOD21-082724:cross linked id MOD21-082726:cross linked id
3/10/21?first shot.  Felt fine.   3/19/21?started to get rash on upper left arm?shot arm.  3-20-21?rash spread to upper right arm and a few spots on my knees 3/23/21?blood draw.  Platelets almost doubled since my last count three weeks prior.  Increase anagrelide to two pills twice a day. 3/31/21?second dose. Shot again the left arm   Felt fine that day. 4/1/21?felt tired. 4/2/21?really feel tired and skin feel tingly like a rash coming on.  Had chills.  By evening upper arms were red, sore, swollen, rash covered and warm to the touch.    4/3/21---Slept a lot of the day and still in a fair amount of pain.  Upper arms and hands red, sore and swollen.  Took an over the counter antihistamine Zyrtec, which helped with the swelling. 4/4/21?Continued with Zyrtec 4/5/21?Continued with the Zyrtec.  Skin in my arms seems to be ?drying out? a bit and swelling down. 4/6/21?Arms and hand still red but swelling down.
Right arm swelling and itching at site of injection 12 hours after injection. Treatment 5/26/047: oral diphenhydramine.
About one to two weeks after getting the second dose I started hearing this high pitched ringing in my hear almost like a high pitched dog whistle. I have always had a this low ringing that I hear sometimes but not like this and not constant. I tried a bunch of home remedies after researching, cleaning my ears, Debrox, ear ringing drops and nothing worked. I finally July 17th went to the ER and they had me try a decongestant, Flonase Mucinex, and a nasal rinse and said if it is not better in a week to see an ENT. We did a hearing test and checked different things about my ears and the Dr. gave a diagnosis of Dysfunction of the Estuation Tubes. It still happens to this day and it a nightmare.
Muscle Aches, Chills, Teeth Chattering, Fever, Headache, Extreme Fatigue, Soreness at the site.
Case number PHEH2013US016944, is an initial spontaneous report received from nurse on 07 Aug 2013. This report refers to an 11 year old female patient. Her medical history and concomitant medication was not reported. Nurse reported that the patient received MENVEO (batch number: X11042/A12013), at a dose of 0.5 ml subcutaneously on 07 Aug 2013. No adverse event was reported. No further information was provided.
This spontaneous report was received from a retired physician, referring to a female patient of unknown, who is a retired nurse also. The patient's medical history included bilateral hips replacement on an unspecified date. Concurrent conditions included back pain. Concomitant medications included ibuprofen and naproxen sodium (ALEVE) as needed for back pain. The patient's dug reactions/allergies were not reported. On 25-JAN-2017, the patient was vaccinated with a dose of ZOSTAVAX 19400 Plaque-Forming Units (PFU), 1 dose, subcutaneously, for prophylaxis (lot # and expiration date were not reported). On 26-JAN-2017, the patient experienced injection site redness. It was stated that the redness was "the size of a cupcake top and raised but there was not pain". No treatment was given for the adverse event as the patient stated "we did not really like to take medicine and I was sure it would subside". At the time of reporting, the outcome of the event was reported as recovering. A product quality complaint was not involved. The causality assessment between the event and ZOSTAVAX was not provided. Additional information is not expected because the reporter refused additional contact.
Left deltoid 13X14 CM Swollen, Redness, warm to touch. Apply cold compress (ice) every 2 hrs for 15 min. Then warm.
CLIENT STATED ON QUESTIONNAIRE THAT SHE WAS NOT PREGNANT.  STATE ALSO THAT SHE HAD READ THE QUESTIONS.  WAS GIVEN NASAL H1N1 (LAIV).  CLIENT IS PREGNANT.
Patient experienced swollen tongue and throat about 3 hours following vaccine. had severe chills. Almost resulted in hospitalization.
Pain at injection site, worse than normal.  As of phone call on 9/8/2020,  patient said her arm did not hurt during the day, but was waking her up in the morning with excruciating pain.  She had placed a phone call to her primary care doctor and left a message.
administered the adjuvant without using the powder portion.; administered the adjuvant without using the powder portion.; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate dose of vaccine administered in a 57-year-old female patient who received Herpes zoster (Shingrix) (batch number EG3A3, expiry date 10th December 2021) for prophylaxis.   On 13th July 2021, the patient received the 1st dose of Shingrix. On 13th July 2021, unknown after receiving Shingrix, the patient experienced inappropriate dose of vaccine administered and inappropriate preparation of medication. On an unknown date, the outcome of the inappropriate dose of vaccine administered and inappropriate preparation of medication were unknown.  Additional details provided were as follows: This case was reported by the medical assistant. The patient received 1st dose of Shingrix but they only administered the adjuvant without using the powder portion which led to inappropriate dose of vaccine administered and inappropriate preparation of medication. The reporter consented to follow-up.