chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; All doses were given at a 0.2mL dosage from the presentation with the dark pink cap with yellow border instead of the dark blue cap and label with gray border presentation; This spontaneous case was reported by a consumer and describes the occurrence of WRONG PRODUCT ADMINISTERED (All doses were given at a 0.2mL dosage from the presentation with the dark pink cap with yellow border instead of the dark blue cap and label with gray border presentation) and NO ADVERSE EVENT (No adverse event) in a child patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 215K22A) for COVID-19 prophylaxis.     The patient did not received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     In April 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) .2 milliliter. In April 2023, the patient experienced WRONG PRODUCT ADMINISTERED (All doses were given at a 0.2mL dosage from the presentation with the dark pink cap with yellow border instead of the dark blue cap and label with gray border presentation). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (All doses were given at a 0.2mL dosage from the presentation with the dark pink cap with yellow border instead of the dark blue cap and label with gray border presentation) 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 (All doses were given at a 0.2mL dosage from the presentation with the dark pink cap with yellow border instead of the dark blue cap and label with gray border presentation).    No concomitant medications were provided. It was reported that 12, 1st doses of bivalent Moderna were administered from 24-28APR2023.  Patients between 6m-5y of age were involved.  Dosage text reported as unknown. No reported symptoms. No treatment medication was provided. This case contains information for the 2nd of 12 child patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-722123 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-722123:
Got Sick; Sore; This spontaneous case was reported by a patient family member or friend and describes the occurrence of ILLNESS (Got Sick) and PAIN (Sore) in a male patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (Got Sick) and PAIN (Sore). At the time of the report, ILLNESS (Got Sick) and PAIN (Sore) had resolved.            No concomitant medication was reported.  It was reported that patient got sick and sore for about 2 days.  No treatment medication was reported.
Pain in arm (L). Blister at injection site, purple area around site. On 7/4/14, burning sensation. 7/6/14 - came to pharmacy instructed to use cortisone cream, applied 2-3 x a day. Redness decreased, and injection site improved.
Strange bruise; Overlying skin became leathery; Skin started peeling off revealing white tissue underneath; This is a spontaneous report from a contactable healthcare professional, the patient. A 49-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FL3181) via an unspecified route of administration in the left arm on 21Aug2021 at 14:00 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. 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 COVID-19 vaccine. On 21Aug2021 at 14:00, the patient developed strange bruise within 30 minutes of vaccination which persisted for 2 weeks and the overlying skin became leathery. Then, the patient's skin started peeling off revealing white tissue underneath. The patient had no cavitation and pain. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the reported events. The clinical outcome of the events strange bruise, overlying skin became leathery and skin started peeling off revealing white tissue underneath was not resolved at the time of this report.
7-22-10 Day 1: C/o "pain at site of injection". 7-23-10 Day 2: "approx @ 3pm fever 101 - later that day (T) 102 - No med taken. Whelps to upper (L) arm above injection site." Generalize weakness with pain in fingertips and joints. 7-24-10 Day 3: "Went to Emergency Room in the afternoon after husband got off work: MD prescribed ibuprofen; LORTAB; ciprofloxacin.
Information has been received from a registered nurse concerning a 77 year old female with unspecified medical history who was vaccinated with pneumococcal 23v polysaccharide vaccine (lot #650329/0747P) (0.5ml), intramuscularly. Concomitant therapy included unspecified medication. Subsequently, the patient experienced cellulitis. The patient was seen in the emergency room and was treated with antibiotics. The patient was reportedly "doing well". The reporting nurse considered cellulitis to be disabling. It was also reported that two other patients experienced cellulitis after being vaccinated with pneumococcal 23v polysaccharide vaccine (WAES#0511USA01525 & 0511USA02279). The reporting nurse requested a lot check. Additional information has been requested.
she had arthritis, extreme pain in her shoulder after her first dose; she had arthritis, extreme pain in her shoulder after her first dose; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A female patient of an unspecified age received the first dose of bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number and Expiration date: Unknown) via an unspecified route of administration on 14Feb2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced arthritis, extreme pain in her shoulder after her first dose on an unspecified date. The outcome of both events was unknown.  Follow-up (13May2021): Follow-up attempts completed. No further information expected.
Patient is an 89-year-old with a history of CHF, COPD, hypertension who is oxygen dependent (3 L) all the time at home.  Patient states yesterday he felt weak and today has had some increased shortness of breath.  He states he is more short of breath if he moved around.  No chest pain.  No fever.  No chills.  No urinary symptoms. Associated Symptoms: chills, cough, shortness of breath, weakness
She got her vaccine at 9:00 AM and felt weird. Then by 9:00 PM when it started hitting her. She started having chills, chattering teeth, and then started running a fever to 101.6, could not lift her arm. She took Tylenol and drank some water, and had a low grade fever of 99.9. Around 8:00 she started vomiting profusely and drank Gatorade which calmed it down some, and still continued to vomit. Then around 11:00 yesterday she started to feel clammy and then the weirded thing ever, her hands drew up like she had arthritis and she could not move her hands, they were numb and tingling. After about 10-15 minutes it subsided and started having chest pains. She called her daughter who is a nurse and she had severe chest pains. She told her to go to the hospital, which she did not.   After about 30 minutes they subsided. Her temp then went up to 102, and was lifeless and kept vomiting. This morning around 5:00 AM all her symptoms went away other than weakness. She has no fever, and feeling better.  She called her PCP who informed her that she had an AE and to report it.
Fever that did not go down with Panadol, severe pain in joints, heart and at the moment she could hardly breathe. she use to come and go  for the moment and rolled her eyes. She also went super white and her lips extremely white. Her eyes were very small and she hardly slept  the day of the vaccine. The second dose also hit such a small girl extremely hard. I don't understand why so strong.  I thought my daughter was dying. The situation was not easy.  she could barely move. Her body ached to the point that she wouldn't stop crying. Find no safety in those vaccine. I am worried about the situation. I would like you to call me and guide me as to why this reaction is so strong  that it nearly killed her. And the chest and breathing overwhelmed me the worse. i need help with respect. I did not find the process of these vaccines favorable for my daughter.
Vaccine given @ 0945 ; began feeling dizzy and developed chills around 1700 ; Temp of 101 degrees - relieved by TYLENOL. Symptoms persisted until 0300 10-16-09. Fever controlled after TYLENOL.
got vaccinated for shingles / shingles/ suspected vaccination failure; awful case of shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, several years after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The reporter stated that, got vaccinated for shingles and a couple of years later, got an awful case of shingles. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization for shingles, time to onset for event and laboratory confirmation for shingles were not provided.
Pt reported, 2 weeks later, that, one day after receiving the injection, his R hand & all his fingers in the R hand got swollen, red & stiff, couldn't open or close his hand which would lead to pain if he tried.  Right arm was spared.
Per mom: seizure like activity observed by mom day after. 2 month immunizations given.  Hi fever, held and observed 2 quick jerks, inconsolable crying with drowsy sleep. No Rx needed.
My husband was driving me home and said that I passed out about 4 minutes after shot. Seized up for approximately 8 seconds and my eyes went to the back of my head. Threw up 4 times within 20 minutes of getting the shot. Throat got tight. Extreme weakness and fatigue starting only a few minutes after getting the vaccine and lasting all day. Got headache about 1 hour later but that subsided as the day went on.
rash all over her body; itching; Rash/blotches in her mouth; This is a spontaneous report from a contactable consumer or other non hcp (patient herself). A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number, and expiration date not reported), via an unspecified route of administration on 06Mar2021, as first dose, single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced rash all over her body, itching, and rash/blotches in her mouth on 09Mar2021. She said a dermatologist has looked at the rash. She also received a copy of the Fact Sheet for Recipients and Caregivers. Patient inquired on what to do to get the second dose. She doesn't know if she need to see somebody or if there is a need to get tested. She wants to get her second dose. Patient was looking to find out what she needs to get the vaccine, what kind of doctor, and what kind of prophylactic so she won't get itching again. Patient also inquired if there is someone that will do this kind of thing with Pfizer who will be able to give her permission to get this. The outcome of events was unknown.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
On 6/30/21 patient had first covid-19 vaccination.  Initially had typical immunization symptoms (fatigue, chills,  right arm  heaviness and headache).  On 7/21/21- present day she developed symptoms starting Bell's Palsy (pain in top of head, right side facial dropping, difficulty speaking, difficulty closing right eye).   She is still symptomatic today, taking valcyclovir and prednisone.
Patient stated his face turned red and he ran 102 degree fever the evening after getting the flu shot.  States he wasn't sure if it was the shot or something else he may have gotten into that caused the reaction.  Stated the reaction was gone by the next day.
Drive thru flu clinic, 8 year old child received adult formulation. No phone number provided, mailed letter for patient to call our office to notify.
Fever over 100, chills, cold sweats, muscle aches, headache, nausea, injection site pain, whole arm pain. My fiancé had same symptoms as well in the same time frame - he got his at the same time.
No additional AE reported; HCP reporting VAQTA, PEDVAXHIB, and ROTATEQ were administered after a temperature excursion. Caller stated she did not have the exact dates of administration nor the names of the patients involved. No additional information provided. No additional AE; This spontaneous report was received from a Health Care Professional and refers to a 15-month-old female patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 08-DEC-2022, the patient was vaccinated with the third dose of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) intramuscular injection, in right thigh, lot #U031544, expiration date: 23-JUN-2024, administered intramuscularly for prophylaxis (strength was not provided).  The administered dose of the vaccine experienced a temperature excursion (product storage error) since 01-DEC-2022. The vaccine administered were stored at temperatures excursion of 47.9 Fahrenheit (storage in clinical practice) for 47 minutes. Data logger was involved.  No adverse event was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2301USA001175: US-009507513-2301USA009088: US-009507513-2301USA009024: US-009507513-2301USA009110: US-009507513-2301USA009878: US-009507513-2301USA009918: US-009507513-2301USA009933: US-009507513-2301USA009943: US-009507513-2302USA000403:
A LITTLE DIZZINESS AND FELT LIKE HEARTRATE INCREASED A BIT BUT WAS ABLE TO SIT A LITTLE LONGER THAN THE 15 MIN AND WAS OKAY DIDNT NOTIFY ANYONE THEY WERE ALREADY DEALING WITH A PATIENT WHO WAS HAVING ISSUES
The child had DTAP and IPV vaccine to left thigh. Mother reports the next day that child had reddened spot at injection site and a large nodule with a red spot. This was dx'd as a local reaction to immunizations and is resolving. The pt was treated with Tylenol with codeine syrup 1/4 tsp q 6 hours prn for pain and continue warm compresses.
They are so stiff; Trigger finger; legs were aching / hands were predominantly worse / hand pain; Joint pain in legs and hands; Felt off; And was red in a large area; Arm was sore; Had a raised area; Feverish / fever of 101.4; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (They are so stiff), TRIGGER FINGER (Trigger finger), PAIN IN EXTREMITY (legs were aching / hands were predominantly worse / hand pain), VACCINATION COMPLICATION (Felt off) and ERYTHEMA (And was red in a large area) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Mar-2021, the patient experienced VACCINATION COMPLICATION (Felt off), ERYTHEMA (And was red in a large area), PAIN IN EXTREMITY (Arm was sore), VACCINATION SITE SWELLING (Had a raised area) and PYREXIA (Feverish / fever of 101.4). On 06-Mar-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (They are so stiff), TRIGGER FINGER (Trigger finger), PAIN IN EXTREMITY (legs were aching / hands were predominantly worse / hand pain) and ARTHRALGIA (Joint pain in legs and hands). The patient was treated with PARACETAMOL (TYLENOL EXTRA STRENGTH) ongoing since an unknown date for Adverse event, at an unspecified dose and frequency. On 07-Mar-2021, VACCINATION COMPLICATION (Felt off), ERYTHEMA (And was red in a large area), PAIN IN EXTREMITY (Arm was sore), VACCINATION SITE SWELLING (Had a raised area), PYREXIA (Feverish / fever of 101.4) and ARTHRALGIA (Joint pain in legs and hands) had resolved. At the time of the report, MUSCULOSKELETAL STIFFNESS (They are so stiff), TRIGGER FINGER (Trigger finger) and PAIN IN EXTREMITY (legs were aching / hands were predominantly worse / hand pain) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Mar-2021, Body temperature: 101.4 (High) 101.4.         Concomitant drugs were not reported. Treatment included hot pads.
Patient history is normotensive, prior to vaccination currently takes  no prescription or otc medications. Vaccine given 4/5/2021 at 11:30am and at 4:30pm patient felt like she was about to have a nose bleed and took her blood pressure at home and reports a blood pressure of 220/112. Patient reports to the ER and is monitored with a blood pressure of 245/110 as reported by the patient.  Family Physician has placed patient  on Losartan 50mg daily and is going to see her again in one week.
very itchy; Rash reappeared; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (very itchy) and RASH (Rash reappeared) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023C21A and 001C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Jun-2021, the patient experienced RASH PRURITIC (very itchy) and RASH (Rash reappeared). At the time of the report, RASH PRURITIC (very itchy) and RASH (Rash reappeared) had not resolved.            No relevant concomitant medications were reported.  No treatment information was provided.  No relevant Lab Data was provided.  No relevant medical history was provided.   This case was linked to MOD-2021-240450 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: Additional information received contain no significant information.
Rash appeared 5-20-18 itchy and spreading but on trunk only. Had MMR, Varicella and PCV13 on 5-3-18. No cough, congestion or runny nose. No fever, slightly fussy. Initially had a little redness at shot site office visit 5-23-18. Skin-multiple erythematous macules with small papule on top on the chest, 1 lesion on the back. Discussed suspect viral rash however cannot exclude atypical chicken pox. Patient is a 12 m.o. female who is here with mother for a chief complain of Rash, all over body x5days., here with mom.
Employee have a history of  a seizure disorder received vaccine 1030 seizure started at 1047
needle and the hub got detached, and some liquid leak; needle and the hub got detached, and some liquid leak; This spontaneous case was reported by a pharmacist and describes the occurrence of DEVICE CONNECTION ISSUE (needle and the hub got detached, and some liquid leak) and UNDERDOSE (needle and the hub got detached, and some liquid leak) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037F21A, 045B21A and 031B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Nov-2021, the patient experienced DEVICE CONNECTION ISSUE (needle and the hub got detached, and some liquid leak) and UNDERDOSE (needle and the hub got detached, and some liquid leak). On 18-Nov-2021, DEVICE CONNECTION ISSUE (needle and the hub got detached, and some liquid leak) and UNDERDOSE (needle and the hub got detached, and some liquid leak) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
No further AE reported / No additional AEs reported; VARIVAX underwent a temperature excursion and was then administered to a patient; This spontaneous report was received from a physician referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported.   On 28-SEP-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) 0.5 milliliters (ml) (route of administration, anatomical site of vaccination, and vaccine scheme were not reported; lot number U002397 has been verified to be valid, expiration date reported and established as 22-JAN-2023) as prophylaxis.   The vaccine underwent a temperature excursion of minus 14 degrees Celsius (-14 C) to minus 10 degrees Celsius (-10 C) during a time frame of 1 hour and 30 minutes; minus 10 degrees Celsius (-10 C) to 8 degrees Celsius (-9.68 C) for 15 minutes. There was no previous temperature excursion (product storage error). No further adverse event reported (no adverse event).
Pt reports had rash all over for 5 days post vaccine (of Td) on 02/13/08.  Pt took Benadryl and did not seek medical care.  Pt reports on 02/20/08 is much improved. Asked that we report the incident to Vaers.