chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Had the vaccine ready and as I was injecting and the needle in his muscle , his muscle twitched and most of the dose came out of the syringe and started dripping . Not sure If he ended up getting any drops or not but it seems that most if not all the vaccine was lost . Thinking it is probably a bad syringe .
Tachycardia, palpitations, increased blood pressure, hotness, excessive sweating, day of dizziness, nausea. Given beta blocker for treatment. Outcome: dizziness and nausea only happened for one day. The rest of the symptoms haven?t gone away but the tachycardia and palpitations have mildly improved.
Information has been received from a nurse practitioner concerning a female who on an unspecified date was vaccinated with a second dose of GARDASIL vaccine (yeast) 0.5 ml IM. On 23-JUL-2008 the patient experienced a temperature and body aches. The patient's temperature and body aches persisted. The patient did not seek medical attention. Additional information has been requested.
Cough  Fatigue  Muscle or body aches  Headache  New loss of taste or smell  Congestion or running nose  Nausea or vomiting
I woke up early in the middle of the night with sharp pain in my right abdomen that would not go away. I went to the emergency room. Upon arriving at the emergency room, they did an MRI and found that I had a kidney stone. I was given medication for nausea, pain and to help pass the kidney stone. I was referred to a urologist, we has discussed removing the stone surgically if I could not pass the stone myself. Upon my second visit to the urologist to set the surgery date I was able to pass the stone on my own, no surgery was necessary.
this person jabbed her so hard with the shot and the caller jumped; pain around the injection site for 7 weeks; Arm hurts; It's very hard for her to open her car door or lift her up/ hard to lift or move her arm; This is a spontaneous report from a contactable consumer (the patient). A 67-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246) intramuscular in left arm on 29Jan2021 in the morning at age of 67-year-old at single dose for COVID-19 immunisation. The vaccine was not administered at military facility. The patient had no medical history. There were no concomitant medications (reported as no other products received). The patient previously took the first dose of BNT162B2 intramuscular in left arm on 08Jan2021 at age of 67-year-old for COVID-19 immunisation and experienced no adverse event (reported as "she was fine"). The patient experienced arm hurts and pain around the injection site for 7 weeks on 29Jan2021. The events did not require a visit to Emergency Room or Physician Office. The caller was calling in regard to the Pfizer COVID-19 vaccine. She didn't know who the person was who gave her the shot, she didn't know if she was a nurse or what she was, but the person had a nurse beside her who told her to give the shot. The caller explained she recognized the nurse, beside the person that actually help administered the second dose. The nurse was the people who help administered the first dose, but she let this other lady gave the second dose to her, she did not know why. Caller explained this person jabbed her so hard with the shot and the caller jumped. The nurse knew something was wrong and asked "what did you do to her". She stated it's been 6 weeks at the time of report, and her arm still hurts. When she pressed down on her arm, it hurts. It hurts on top of her arm, underneath her arm. She didn't know what this is. It's been a long time her arm has felt this way, her arm should be getting better by now. She stated she felt the pain right away and her arm didn't get better. It's very hard to lift or move her arm. When she pressed down where she received the shot (injection site), it still hurts all along there. It's very hard for her to open her car door or lift her up. It should have gone away already. She mentioned seeing "MR" on her vaccine record card and also the date 27Jan, but she clarified this was the date of when she could have received it. She could have received it between the time frame of 27Jan- 31Jan 2021. She got it on 29Jan2021. She further explained she just kept touching the injection site and it just hurts. It's very hard to lift her arm and underneath arm. She didn't understand what this was, and she hoped there was no hematoma or anything. No relevant test was taken for the patient. The outcome of event "arm hurts" was not recovered, of other events was unknown.
This spontaneous report as received from a registered nurse refers to a patient of unknown demography. Patient's concurrent conditions and relevant medical history was not reported. On 20-JAN-2015, the patient was vaccinated with improperly stored PROQUAD (dose, frequency and route unspecified) (lot number: K011314 with expiry date of 14-FEB-2016). Concomitant medications were not reported. The reporter stated that, between 07-JAN-2015 through 19-FEB-2015, PROQUAD was exposed to 34.4 Fahrenheit temperature which was outside the recommended condition. No adverse effects were reported. The outcome of the events was unknown. The causality of the events with PROQUAD was not reported. Product quality issue was not involved. This is one of the several reports from the same reporter. Additional information has been requested.
Injection site  swelled , was sore, became itchy, and was hot to the touch. It began the evening of 1/8/21 as tenderness and itchy but increased in size, temperature, and increased tenderness and itch the evening of 1/9/21. I took 3 ibuprofen and iced for 30 minutes. By morning, swelling was down and not as sore. Site still remains itchy at times.
stress would make the headaches come back; never had headaches before this, Headache moved from the back of his neck to the front of his forehead; a little fatigue; soreness around the injection site; couldn't sleep on that arm, it would wake him up; felt like someone was holding a candle inside of my head; there was a pressure inside my brain; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (couldn't sleep on that arm, it would wake him up), FEELING ABNORMAL (felt like someone was holding a candle inside of my head), HEAD DISCOMFORT (there was a pressure inside my brain), STRESS (stress would make the headaches come back) and HEADACHE (never had headaches before this, Headache moved from the back of his neck to the front of his forehead) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21A and 020B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Mar-2021, the patient experienced INSOMNIA (couldn't sleep on that arm, it would wake him up), FEELING ABNORMAL (felt like someone was holding a candle inside of my head), HEAD DISCOMFORT (there was a pressure inside my brain), HEADACHE (never had headaches before this, Headache moved from the back of his neck to the front of his forehead), FATIGUE (a little fatigue) and VACCINATION SITE PAIN (soreness around the injection site). On an unknown date, the patient experienced STRESS (stress would make the headaches come back). At the time of the report, INSOMNIA (couldn't sleep on that arm, it would wake him up), FEELING ABNORMAL (felt like someone was holding a candle inside of my head), HEAD DISCOMFORT (there was a pressure inside my brain), STRESS (stress would make the headaches come back), HEADACHE (never had headaches before this, Headache moved from the back of his neck to the front of his forehead), FATIGUE (a little fatigue) and VACCINATION SITE PAIN (soreness around the injection site) outcome was unknown.            This case was linked to MOD-2021-104324 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 11-Jun-2021: Non-Significant Follow-up
Lack of drug effect; Lack of drug effect; lot of damage to elbows and was in a lot of pain; Pain in elbow; This is a solicited report (Mfr. Control No.: 21K-163-4053360-00). This female consumer (patient) reported for herself.   A 74-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 1 via  unknown route on 20Feb2021 (Batch/Lot number was not reported), dose 2 intramuscular in 2021 (Batch/Lot number was not reported) both as single dose for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at unknown dose for an unspecified indication. Medical history was none.  The patient's concomitant medications were not reported. The patient experienced Lack of drug effect, Humira was not helping elbows and lot of damage to elbows and was in a lot of pain, pain in elbow on unknown dates. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The action taken in response to the events for adalimumab was unknown.  Causality for HUMIRA(ADALIMUMAB): The reporters causality for the events of lot of damage to elbows and was in a lot of pain, Humira was not helping elbows and lot of damage to elbows and was in a lot of pain was not provided.   The reporter's assessment of the causal relationship of the events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on known drug safety profile and temporal relationship there is reasonable possibility of causal association between the events elbow injury, arthralgia and other reported events and the suspect drug BNT162B2.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
pt recv vax;having nose bleed on 12jun95 on awakening at 6am lasting approx 1 1/2 hr & cont spitting out bloody sinus drainage daily to this time 20jun95;
Fell; Hurt their leg; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of FALL (Fell) and PAIN IN EXTREMITY (Hurt their leg) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced FALL (Fell) and PAIN IN EXTREMITY (Hurt their leg). The patient was treated with PREDNISONE for Adverse event, at a dose of 10 mg and DOXEPIN HYDROCHLORIDE (ADAPIN) for Adverse event, at a dose of 800 mg. At the time of the report, FALL (Fell) and PAIN IN EXTREMITY (Hurt their leg) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.  Patient fell and hurt the leg. Doctor advised him not to drive very far.
This spontaneous case, initially received from other health professional (nurse) on 06-Nov-2018, concerns a 64-year-old, adult male patient. On 31-Oct-2018, the patient was administered expired FLUCELVAX QIVc [dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 195216, and expiry date: 30-Apr-2018]. The patient did not experience any adverse events after vaccine administration. The reporter assessed the case as non-serious. This case was linked to 201805215 due to same reporter. Non-significant follow-up received from the nurse on 21-Nov-2018: The reporter confirmed that, the patient did not experience any adverse reactions after administration of the expired vaccine. The narrative was amended accordingly.
Possible Anxiety attack; Patient experienced covid; This spontaneous case was reported by a patient and describes the occurrence of ANXIETY (Possible Anxiety attack) and COVID-19 (Patient experienced covid) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. In 2022, the patient experienced COVID-19 (Patient experienced covid). On an unknown date, the patient experienced ANXIETY (Possible Anxiety attack). At the time of the report, ANXIETY (Possible Anxiety attack) outcome was unknown and COVID-19 (Patient experienced covid) was resolving.      Concomitant drugs were not reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.The reporter's causality for the events of Possible Anxiety attack and Patient experienced covid with Humira was not provided. Treatment details were not given.  Company Comment: This is a Spontaneous case reported by a patient, concerning a 63-year-old female patient, with no relevant medical history, who experienced the unexpected and non-serious AESI of COVID-19,  which occurred after an unspecified dose of mRNA-1273 vaccine. Since no vaccination dates were provided, temporal association and latency cannot be properly assessed. Co-suspect product included non-company product Adalimumab for rheumatoid arthritis. No information disclosed about diagnostic tests performed or treatments received. At the time of the report, the event was resolving. The benefit-risk relationship of mRNA-1273 vaccine, is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This is a Spontaneous case reported by a patient, concerning a 63-year-old female patient, with no relevant medical history, who experienced the unexpected and non-serious AESI of COVID-19,  which occurred after an unspecified dose of mRNA-1273 vaccine. Since no vaccination dates were provided, temporal association and latency cannot be properly assessed. Co-suspect product included non-company product Adalimumab for rheumatoid arthritis. No information disclosed about diagnostic tests performed or treatments received. At the time of the report, the event was resolving. The benefit-risk relationship of mRNA-1273 vaccine, is not affected by this report.
At 0400 in the morning the day after the flu shot injection, I woke up feeling that the left upper arm (deltoid area) started to ache, and I noticed swelling and, felt warm to touch. I think it is a reaction to the flu shot.
Patient came in for #2 Monovalent Pfizer vaccine, instead, patient received Pfizer Bivalent vaccine for #2 dose. Staff member stated she knew patient needed #2 but pulled the wrong vial. Informed management of outcome.  No symptoms or side effects at time vaccine was administered.
saw some rashes on my chest and back; headache; lightheadedness; that night I had an itching on my back; This spontaneous case was reported by a nurse and describes the occurrence of DIZZINESS (lightheadedness), PRURITUS (that night I had an itching on my back), RASH (saw some rashes on my chest and back) and HEADACHE (headache) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced DIZZINESS (lightheadedness) and PRURITUS (that night I had an itching on my back). On 16-Jan-2021, the patient experienced HEADACHE (headache). On 17-Jan-2021, the patient experienced RASH (saw some rashes on my chest and back). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, DIZZINESS (lightheadedness), PRURITUS (that night I had an itching on my back), RASH (saw some rashes on my chest and back) and HEADACHE (headache) had resolved.        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.   No Concomitant medications were provided
This child has a rapidly enlarging erythematous induration, tender, and firm on the left thigh, 10 x 9 cm.
Contracted Covid.  Contracted 102 fever on 5/3. Other minor symptoms  Received Monoclonal antibodies on 5/4 (Lilley)  Symptoms improved starting 5/5.  Back to work 5/9
Pain at the injection site; Hives at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13th September 2022, the patient received the 1st dose of Shingrix. In September 2022, less than a week after receiving Shingrix, the patient experienced injection site pain and injection site hives. On an unknown date, the outcome of the injection site pain was unknown and the outcome of the injection site hives was not recovered/not resolved.   It was unknown if the reporter considered the injection site pain and injection site hives to be related to Shingrix.     Additional Information: GSK Receipt Date: 19-SEP-2022 Reporter's Comment: The reporter reported that the patient received a dose of Shingrix vaccine. The reporter stated that after Shingrix vaccine the patient experienced pain at the injection site. In Sep 2022, few days after receiving Shingrix patient had hives at the injection site. The reporter did consent to follow up.
Vomiting, nausea, diarrhea that has lasted over three weeks. It lasted only one week after the first shot.
My throat began to feel uncomfortable when I swallowed, different from my "normal " cold would start with. Then after about 7 hours the throat felt better followed by mild cold symptoms followed by a dry throat and cough. At present, I am  constantly clearing throat and having bouts of coughing and using cough drops and liquids. No fever
Partial blind spot in lower left eye. It lasted about 60 minutes. It appeared as a moving wavy line. I had to shift my focus to read the print on my laptop screen. It went away after about an hour.  The condition has not returned since.
Red, swollen and warm to touch at injection site. Swelling size about the size of baseball shadow. Advised to use BENADRYL and cool packs.
She complained of wrist and elbow pain that started a couple days after the injections.  She reported the joint pain on 11/4/13 and it had not yet resolved.  Unknown date of resolution (not reported).
The Vaccine was expired on 19-May-2023, and vial was initially stored in the refrigerator thawed and injected on 31-May-2023.; No adverse event; Pharmacist is calling to report that several nursing home patients received expired Bivalent booster dose of Moderna COVID-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Pharmacist is calling to report that several nursing home patients received expired Bivalent booster dose of Moderna COVID-19 vaccine), PRODUCT STORAGE ERROR (The Vaccine was expired on 19-May-2023, and vial was initially stored in the refrigerator thawed and injected on 31-May-2023.) and NO ADVERSE EVENT (No adverse event) in an elderly 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. AS7147B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 31-May-2023, 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 31-May-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Pharmacist is calling to report that several nursing home patients received expired Bivalent booster dose of Moderna COVID-19 vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The Vaccine was expired on 19-May-2023, and vial was initially stored in the refrigerator thawed and injected on 31-May-2023.) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Pharmacist is calling to report that several nursing home patients received expired Bivalent booster dose of Moderna COVID-19 vaccine), PRODUCT STORAGE ERROR (The Vaccine was expired on 19-May-2023, and vial was initially stored in the refrigerator thawed and injected on 31-May-2023.) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (Pharmacist is calling to report that several nursing home patients received expired Bivalent booster dose of Moderna COVID-19 vaccine) and PRODUCT STORAGE ERROR (The Vaccine was expired on 19-May-2023, and vial was initially stored in the refrigerator thawed and injected on 31-May-2023.).    No concomitant medications were reported. They were all in intact carton. Vial size was 2.5 ml and the vial did not underwent any temperature excursions. No adverse reactions were reported. All the patient were qualified the age and or immunocompromised. No treatment medications were reported.  This case contains information for the 9 of 20 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-727268 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-727268:Patient 3 out of 20 (Master case)
itchy off and on days 2-9.  On day 9, itch is fairly  constant and area warm, distracting but not uncomfortable.  Site is red, about size of dime , later in day below the site( about 2 inches) another red itchy area,  about size of quarter,  developed.  Today, day #10 ,a larger red itchy, warm area is spreading below injection site.
Sore arm; This case was reported by a consumer via other manufacturer and described the occurrence of pain in arm in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included immunosuppression. Concomitant products included etanercept (Enbrel).   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.     Linked case(s) involving the same patient:  US2022AMR163747   Additional Information: GSK Receipt Date: 07-NOV-2022 Reporter's comment: The patient was taking an immunosuppressive medication (Enbrel). The patient received dose of Shingrix vaccine and experienced just a sore arm. The reporter did not consent to follow-up.; Sender's Comments:  US-GSK-US2022AMR163747:Same reporter