chrisvoncsefalvay/vaers-outcomes huggingface dataset:
10 minutes after the shot she reported feeling sick stating " the shot is making me feel sick...I feel funny"  she was somewhat disoriented and her face/ lips were very pale. After sitting down she recovered and looked more like herself. She was not upset/crying at the time of the shot so her symptoms were not stress induced. The next day her entire upper arm is hot, hard and swollen.
Vaccination adverse reaction; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION COMPLICATION (Vaccination adverse reaction) 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 VACCINATION COMPLICATION (Vaccination adverse reaction). At the time of the report, VACCINATION COMPLICATION (Vaccination adverse reaction) outcome was unknown. Not Provided      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.   Concomitant medication list was not provided. Treatment information was not provided.    This case was linked to MOD21-081072.; Sender's Comments:  MOD21-081072:
Red arm; big swollen arm; Vaccination site pain; vaccination site pruritus; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Red arm), PERIPHERAL SWELLING (big swollen arm), FATIGUE (fatigue), VACCINATION SITE PAIN (Vaccination site pain) and VACCINATION SITE PRURITUS (vaccination site pruritus) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. unk and unk) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Jan-2021, the patient experienced FATIGUE (fatigue). On an unknown date, the patient experienced ERYTHEMA (Red arm), PERIPHERAL SWELLING (big swollen arm), VACCINATION SITE PAIN (Vaccination site pain) and VACCINATION SITE PRURITUS (vaccination site pruritus). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, ERYTHEMA (Red arm), PERIPHERAL SWELLING (big swollen arm), FATIGUE (fatigue), VACCINATION SITE PAIN (Vaccination site pain) and VACCINATION SITE PRURITUS (vaccination site pruritus) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included heart medicines and blood pressure pills.   This case was linked to MOD-2021-033898 (Patient Link).
Large, local, reaction with subcutaneous, nontender nodule.  Left thigh 2 by 2 and a half centimeter nodule (Pediarix site).  Right thigh 3.5 by 4 centimeter nodule (questionable PCV-7 site). Expected to recover fully.
Patient was given refrigerated Moderna that was expired beyond it's 'Beyond Use Label' date of 01/27/2022.  Vial was placed into fridge on 12/28/2021.  Vial was not removed from fridge in time for 'Beyond Use' expiry date and inadvertently administered.  Manufacturer's expiry date is March 25, 2022.  Provider informed.  Moderna informed and stated that 'the vaccine administered on January 28 to February 7, 2022 from lot number 033H21A maintained the activity necessary to protect against the SARS-CoV-2 (covid 19) virus at time of administration'.  Writer called patient to inform of adverse event, but no answer, unable to evaluate adverse effects.
Swelling, redness, tender to touch, hot to touch, restricted movement, aching, some nausea, headache, weakness & fatigue
Shortness of breath, injection site soreness, fever, weakness, night sweats first night following injection and progressively worsened.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), in Sep2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 49 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162B2 NOS has been requested and will be submitted if and when received.
jaw pain on right side; face pain in nasal region; Left arm numbness; back of neck pain; flush of heat; numbness in left side of face; left jaw pain; This is a spontaneous report from a non-contactable consumer, the patient. A 28-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EW0170), via an unspecified route of administration in the left arm on 06May2021 at 11:30 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. Medical history included heart murmur and septorhinoplasty. Concomitant medications included etonogestrel (NEXPLANON IMPLANT) from an unknown date and unknown if ongoing for an unknown indication. The patient did not have any allergies to medications, food or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 06May2021 at 12:30, the patient experienced left arm numbness, back of neck pain, flush of heat and numbness in the left side of the face, left jaw pain all on day one. On 07May2021, the patient experienced jaw pain on the right side and face pain in the nasal region on day two. The patient also reported that she still had on and off numbness in her left arm but other symptoms have subsided thus far. Therapeutic measures were not taken as a result of the events. The events resulted in a visit to the doctor or other healthcare professional office/clinic visit. The clinical outcome of the events back of neck pain, flush of heat and numbness in the left side of the face, left jaw pain, jaw pain on right side and face pain in nasal region was recovering. The clinical outcome of the event left arm numbness was not recovered at the time of the report.  No follow-up attempts are needed. No further information is expected.
3 days with fever off and on-up to 101; severe headache; chills, joint aches in knees, shoulders and hips; large red swelling at injection site a bit larger than the size of a large grapefruit Treatment:  continued dosage of Tylenol and Ibuprofen; contacted doctor on call at my local physician and they suggested to continue taking the over the counters meds I was already taking
I experienced sweating, chills, fatigue and sore at the injection sight. I was sore at the injection site right after it was administered. I then experienced severe chills in the evening, starting at about 7pm. The next morning I woke up fatigued and alternated between sweating and having the chills and shaking.
An individual was inadvertently vaccinated with 1.0 mL of Moderna COVID-19 vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of ACCIDENTAL OVERDOSE (An individual was inadvertently vaccinated with 1.0 mL of Moderna COVID-19 vaccine) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 milliliter. On an unknown date, the patient experienced ACCIDENTAL OVERDOSE (An individual was inadvertently vaccinated with 1.0 mL of Moderna COVID-19 vaccine). At the time of the report, ACCIDENTAL OVERDOSE (An individual was inadvertently vaccinated with 1.0 mL of Moderna COVID-19 vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   no Concomitant products were provided.  no treatment medications were provided
A non-serious, spontaneous report of administration to 14 month old has been received from a nurse regarding a male patient who received FLUMIST. On 09 Dec 2009, the patient received FLUMIST. After administering FLUMIST, the nurse realized she had erroneously given FLUMIST to a 14 month old male patient. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST.
I received my second vaccination Friday Oct 8 at 0800 after my night shift. I was ok for the 15 min I was monitored, went home and went to bed, since I had to work Friday night. I woke up at around 3pm to use the restroom, upon sitting up in bed, I had a massive headache, that I had to lie down. I took Motrin 800mg with no effect. I had to call out from work that night.
Severe sudden headache squeezing and vibrating of the brain, spikes blood pressure,dibilitizing headache. Gets headache when doing anything even peeing and ejaculating and just sleeping l. Tried two medications from doctor nothing helping. Please advise what to do.
Information has been received regarding a female pt who, as an infant, received Orimune, DTP, Hib and Hep-B vaccines on 7/25/96. According the her mother, the pt developed a "high" fever, bruised thighs and "high-pitched" crying on the day of vaccinations. Reportedly, the pt has experienced "recurring infection and fever ever since". The mother indicated that her daughter has received a total of 4 doses of DTP vaccine, the last dose of which was administered in 11/97. The mother has refused all vaccinations in her daughter since 11/97. The mother indicated that in 6/98, her daughter presented with "signs and symptoms of leukemia," which was subsequently ruled out. Reportedly, the pt was dx'd with hemolytic anemia, splenomegaly and a platelet disorder; the mother attributed these events to DTP administration. Follow-up information from a physician, provided the pt's name as well as a birth month and year of May, 1996. The physician indicated that the pt has an autoimmune disease requiring weekly lab testing; however, no test results were reported. The events were considered to be "Other Important Medical Events". No further information was available at the date of this report.
shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 85 year old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   On or around 18-NOV-2013, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions.   On an unspecified date, the patient experienced shingles. On an unspecified date, the patient was treated by a physician for shingles. The outcome of the event was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): NVSC2022US167203 (Novartis). A 24-year-old female patient received COVID-19 Vaccine - Manufacturer Unknown, as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete, Unknown Manufacturer), for COVID-19 Immunization. The following information was reported: HYPOAESTHESIA (non-serious) with onset 2022, outcome "unknown", described as "Numbness"; SUNBURN (non-serious) with onset 2022, outcome "unknown"; VERTIGO (non-serious) with onset Jul2022, outcome "unknown". Additional information: Patient experienced vertigo after a sunburn in Jul and a couple months ago had numbness after COVID-19 booster shot. The information on the batch/lot number for COVID-19 Vaccine - Manufacturer Unknown has been requested and will be submitted if and when received.
Sinus Tachycardia, Shortness of Breath, Anxiety, Chest Pain, Tremors, Numbness, Fever, General Pain
body aches; headache; nausea; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (body aches), HEADACHE (headache) and NAUSEA (nausea) 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 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Mar-2021, the patient experienced MYALGIA (body aches), HEADACHE (headache) and NAUSEA (nausea). At the time of the report, MYALGIA (body aches), HEADACHE (headache) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication information not provided.  Treatment information not provided.
feeling really bad; hurts really bad; Swollen arm; he went to the ER room due to the pain in the Left arm; Pain in the left shoulder; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of FEELING ABNORMAL (feeling really bad), PAIN (hurts really bad), PERIPHERAL SWELLING (Swollen arm), PAIN IN EXTREMITY (he went to the ER room due to the pain in the Left arm) and ARTHRALGIA (Pain in the left shoulder) in a 90-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.    Co-suspect product included non-company product PNEUMOCOCCAL VACCINE for an unknown indication.    No medical information was provided by the reporter.  Concomitant products included THYROID for an unknown indication.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient received dose of PNEUMOCOCCAL VACCINE (unknown route) unknown. On 07-Mar-2021, the patient experienced FEELING ABNORMAL (feeling really bad), PAIN (hurts really bad), PERIPHERAL SWELLING (Swollen arm), PAIN IN EXTREMITY (he went to the ER room due to the pain in the Left arm) and ARTHRALGIA (Pain in the left shoulder). The patient was treated with KETOROLAC on 07-Mar-2021 at a dose of UNK dosage form. At the time of the report, FEELING ABNORMAL (feeling really bad), PAIN (hurts really bad), PERIPHERAL SWELLING (Swollen arm), PAIN IN EXTREMITY (he went to the ER room due to the pain in the Left arm) and ARTHRALGIA (Pain in the left shoulder) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient was prescribed with meloxicam 7.5mg but he didn't taken them  due to the possible side effects the pill could cause. The patient was told in the emergency room this was due to arthritis or arteriopathy, he could not remember well.
tingling on  lips; This spontaneous case was reported by an other health care professional and describes the occurrence of PARAESTHESIA ORAL (tingling on  lips) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, the patient experienced PARAESTHESIA ORAL (tingling on  lips). At the time of the report, PARAESTHESIA ORAL (tingling on  lips) outcome was unknown. Not Provided      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.
Patient is a 2 month old male born at 29 weeks and 1 day complcated by bronchopulmonary dysplasia and pulmonary artery stenosis. Patient had been intubated multiple times for hypoxic and hypercapnic respiratory failure. Patient was extubated on 09/16/23 had had been doing well per mothers report. Patient received his two month vaccination on 09/28/23. Two hours after receiving vaccines  patient developed respiratory distress requiring intubation. Patient was unable to be oxygenated on mechanical ventilation and was transitioned to oscillation. He is a current candidate for ECMO as of 10/2/23
This spontaneous report was received from a physician, via company representative, and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant therapies, drug reactions or allergies were not reported. On 31-AUG-2015, the patient was vaccinated with an improperly stored PNEUMOVAX 23 10 PK, lot #L002310, expiration date 08-JUL-2016, at a dose of 0.5 ml, (route and anatomical location of administration were unspecified). The vaccine underwent a total temperature excursion, of 144 hours. The lowest recorded temperature was 27 Fahrenheit degrees (-2.777777778 Celsius). The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator (R)". No adverse effects were reported. No Product Quality Complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
I was starting to feel a little off in thirty minutes and about 9 PM that night I had body aches. My body and joints hurt and really really tired. Those lasted until Sunday at 09:00. It just abruptly stopped. I woke up with rash all over my face and itchy and swollen eyes on Saturday and I went to the eye doctor on Saturday. I was given eye drops and and an anti-histamine; That is helping. I am still a little bit itchy on my face but it's better.
Only had a sore arm; her heart rate was a little faster; A spontaneous report was received from a consumer concerning a 71-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced sore arm/pain in extremity, and her heart rate was a little faster/heart rate increased.  The patient's medical history was not provided. Concomitant medication included baby aspirin everyday for heart beat.    On an unknown date, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch number:unknown)in the right arm for prophylaxis of COVID-19 infection.  On 18 Feb 2021,the patient received their second of two planned doses of mRNA-1273 vaccine for prophylaxis of COVID-19 infection.   After the first dose of vaccination , the patient only had a sore arm. Also, her heart rate was a little faster.  Treatment information was not provided.  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events were not applicable.  The outcome of events, sore arm and heart rate was little faster, were unknown.
Patient was instructed to wait 15" post vaccination because he seemed anxious. Upon leaving he said he fell dizzy and was moved to a chair where he continued to have a syncopal episode. His face was pale, skin clammy and was not verbally responsive for 30 seconds to 1 minute. Episode began at 1610. After he responded to ice pack on neck hew was transferred to the table. At 1615 BP 88/47 P 45. At 1625 BP 203/54 p. 52. Ambulated to bathroom, said felt better. 1645 BP 2200/55 p65. color returned. Said he wanted to leave. Ambulated with supervision to vehicle. (mother drove. Instructed to rest and call physicians if symptoms do not subside.
Abdominal Upper quadrant x 2 rash  with flat spots , erythema, intermittent rash.  Neosporin and cortisone  cream for eight days.
Drug ineffective; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 73-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 73 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Remote treatment for lung cancer" (unspecified if ongoing), notes: Other medical history: Remote treatment for lung cancer; "NSCLC" (unspecified if ongoing), notes: Other medical history: NSCLC. There were no concomitant medications. Patient had no known allergies.  The following information was reported: COVID-19 (medically significant) with onset 2023, outcome "not recovered", described as "COVID 19 Treatment"; DRUG INEFFECTIVE (medically significant) with onset 2023, outcome "not recovered". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: COVID 19 Treatment; (10Feb2023) Negative, notes: Antigen test one day after completion of the 5 day treatment course was Negative; (15Feb2023) Positive, notes: Mild symptoms continued and 5 days later a repeat antigen test was positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 from 04feb2023 to 09Feb2023. Clinical course: The reporter stated that Covid Rebound. Antigen test one day after completion of the 5 day treatment course was Negative. Mild symptoms continued and 5 days later a repeat antigen test was positive.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the drug ineffective (LOE) and  Covid 19 cannot be ruled out.
This case was reported by a physician via sales rep and described the occurrence of muscle pain in a 65-year-old female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, 2 days after receiving SHINGRIX, the patient experienced muscle pain and general body pain. On an unknown date, the outcome of the muscle pain and general body pain were recovered/resolved. It was unknown if the reporter considered the muscle pain and general body pain to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient received a dose of SHINGRIX 6 months prior to October 2018. After vaccination, the patient experienced body/muscle aches and the first symptoms began 2 days after vaccination. The event was continued for 6 months. The reporter agreed to be follow up from GlaxoSmithKline.