chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician and a practice manager via company representative referring to a patient of unknown age and gender. On 18-MAR-2015 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23-10PK-0.5mlSD-PFS LLokwTip) (lot # K019386, expiration date 09-JUN-2016). This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time was 216 hours with the lowest recorded temperature of 27 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Sore arm at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore arm at injection site) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, the patient experienced VACCINATION SITE PAIN (Sore arm at injection site). At the time of the report, VACCINATION SITE PAIN (Sore arm at injection site) 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 product use was not provided. Treatment information was not provided.    For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.    This case was linked to US-MODERNATX, INC.-MOD-2021-079996 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-079996:dose 2
Severe arm and underarm pain and swelling. High fever of 104. Dizziness. Headache. Feeling faint when standing. Change in urine color. Pain all around left breast on chest wall.
ADR = Elevated heart rate, fever, injection site pain.  History follows. Day 1, prior to vaccine administration, BP 132/80 mmHg, Pulse 56 bpm, and temp 98.2 F.  1st dose of vaccine was about 7:30 PM on day 1 (January 7, 2021.) On day 2, at 8:40 AM, approximately 12 hours post vaccination, experienced low grade fever (99F), injection site  became very sore and lasted for nearly a week, headache, and myalgias.  SPO2 was 97%.  Pulse was 69 bpm, which is a bit higher than my usual of 50 bpm or so.   Approximately 18 hours post vaccination, fever was up to 101.8F.  Took acetaminophen 1000 mg. While trying to rest I experienced palpitations, with a heart rate of 92-95 bpm.  About 20 hours post-vaccination, fever was 101.5F.  Took acetaminophen 500 mg.  3 hours later, fever was down to 99.1F and pulse was down to 74 bpm. On day 3, at 8:15 AM, BP was 106/61, SPO2 was 96%, pulse 71 bpm, and temperature of 99.5F. Day 4, at 11:40 AM, BP 112/65, pulse 58, and SPO2 96% and temp was 98.0F.
Information has been received from a registered nurse concerning a 12 month old patient of unknown gender. Patient's medical history, concurrent condition and concomitant therapy were not reported. On 23-SEP-2014, the patient was vaccinated with the first dose of PROQUAD, lot # K008871, expiration date 19-DEC-2015 (dose and route not reported), which was improperly stored. No adverse event was occurred. This is one of several reports received from the same reporter. Additional information has been requested.
Information has been received from a nurse practitioner concerning a 7 yr old white female with a penicillin allergy who on 08Mar01 was vaccinated in the left arm with a first dose of varicella virus vaccine live (lot632719/1241K). There was no illness at the time of vaccination. On 12Oct05 the pt was diagnosed with breakthrough chickenpox. The child had about 40 lesions that have crusted over. No fever was present. The outcome was reported as recovering. There was no product quality complaint. No further information was available. Follow up information indicated that the pt recovered on 20Oct05. There were no relevant  diagnostic test or laboratory data. There were no adverse events following prior vaccinations of the pt. No additional information is expected.
Patient felt light headed and dizzy "as if the room was spinning." Patient did not disclose that he was hypoglycemic until after he was vaccinated and 10 minutes into observation. He said he had only eaten a "sausage and egg thing and a Body Armor" to eat. He said he was starting to feel shaky. He was given a water, a fruit snack, and a protein drink. He was told to go eat a good meal. He was observed for an additional 5 minutes. He then said his legs and then knees started to lock up, and said his heart started to race. Staff put the patient in a wheelchair and took him to the University health clinic. The Head Nurse took patients vitals. Patients father then showed up. Nurse said patients vitals were stable. Patient and his father left prior to EMS arriving, which was Against Medical Advise.
Diarrhoea; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhoea) and VOMITING (Vomiting) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017B21A and 024M20A) for an unknown indication.     The patient's past medical history included No adverse event (No medical history reported.).   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Apr-2021, the patient experienced DIARRHOEA (Diarrhoea) and VOMITING (Vomiting). At the time of the report, DIARRHOEA (Diarrhoea) and VOMITING (Vomiting) outcome was unknown.            Products known to have been used by the patient, within two weeks prior to the event , included ezetimibe, losartan, metoprolol and levothyroxine. Treatment information included Pedialyte and Tylenol. Action taken with mRNA-1273 in response to the events was  not applicable.
Severe vertigo; I had very little sleep; neck ache/severe pain in my neck, head (forehead, specifically), and upper shoulders; Headache/severe pain in my neck, head (forehead, specifically), and upper shoulders; shoulder ache/severe pain in my neck, head (forehead, specifically), and upper shoulders; nausea; sweats; chills; This is a spontaneous report received from a contactable consumer (Patient). A 61-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), Solution for injection, via an unspecified route of administration, administered in Arm Left on 16Feb2021 09:30 (at the age of 61-year-old) as single dose for covid-19 immunisation. The patient medical history was not reported. Concomitant medications included acebutolol (ACEBUTOLOL), primidone (PRIMIDONE), atorvastatin calcium (LIPITOR [ATORVASTATIN CALCIUM]), losartan (LOSARTAN), fexofenadine hydrochloride (ALLEGRA). The patient previously took codeine in Tylenol 3 and experienced codeine in Tylenol 3 allergy. Patient did not receive any other vaccine with four weeks of Pfizer COVID vaccine. Patient was not diagnosed with COVID-19 prior to vaccination. Patient was not tested for COVID-19 since vaccination. Patient historic vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number unknown), Solution for injection, via an unspecified route of administration, administered in Arm Left on 26Jan2021 09:30 as single dose for covid-19 immunisation. On 17Feb2021 00:30, the patient experienced severe vertigo, had very little sleep, neck ache/severe pain in my neck, head (forehead, specifically), and upper shoulders, shoulder ache/severe pain in my neck, head (forehead, specifically) and upper shoulders, nausea, sweats and, chills. It was reported that, he received his 2nd dose of the vaccine at 9:25 am on 16Feb2021, yet did not exhibit adverse effects until shortly after midnight (12:30 am, 17Feb2021). He had very little sleep the remainder of the night, and then experienced severe pain in his neck, head (forehead, specifically), and upper shoulders until around 9:30 pm that same day (17Feb2021). Two doses of acetaminophen (1.25 g) were taken that day, about 8 hr apart, to help reduce severity of symptoms. The remainder of the evening of 17Feb2021 were uneventful with no side effects. The events were recovered on 17Feb2021.  Follow-up attempts completed. No further information expected.
Red rash on arm; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (Red rash on arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH ERYTHEMATOUS (Red rash on arm). At the time of the report, RASH ERYTHEMATOUS (Red rash on arm) outcome was unknown.            Concomitant medication was not reported. No treatment medication was provided. Patient called to report a possible adverse event. She called on 03-Mar-2021 and got her first vaccine on 24-Feb-2021. She had red rash on her arm. She didn't state when she had her second dose of the Moderna vaccine but she also had a red rash on her arm with the second dose. She was suppose to get a form to fill out from one of our representative but never did. Before the call was connected the patient disconnected the line.   This case was linked to MOD-2021-020916 (Patient Link).
I was in observation for about 45 min due to the symptoms I had with the first dose. About 10 min after vaccination, I felt itching on my face, and it progressed to my back and hands. I also started coughing,  no rash. In the evening, at home I started feeling shortness of breath and started using my albuterol inhaler and symbicort.  I had a feeling like someone was sitting on my back, squeezing my left side, my left lung. I also experienced chest pain. I had to use symbicort and albuterol for about 5 days and the symptoms persisted for at least 3 days, itching, cough, chest pains. The symptoms went away and they returned 3 days ago. Now I am once again starting to experience cough and shortness of breath.
I began to notice an enlarged cyst on Oct. 7th.  I felt nauseated and dizzy occasionally during the day.  On Oct. 8th I went to the doctor because I felt worse and the cyst was much larger.   The doctor opened it to start the draining, I was given Doxycycline for 14 days,  and told how to treat it with epson salt baths.       I had had this cyst under the skin for many years.  It was about the size of a pea.  Two different doctors had told me it was nothing to worry about.  When it was infected it swelled to about the size of a small egg.  A week later my dermatologist told me it did not need to be removed, but I needed to use Mupirocin for 2 weeks.
Patient arrived at our COVID vaccination site for her scheduled "first dose" appointment. A Pfizer assessment sheet was filled out, and the patient answered "No" to all assessment questions. When asked "Has the person to be vaccinated ever received a COVID-19 vaccine" the pt stated "no". The pt was also asked " has the person to be vaccinated received any vaccine in the past 14 days" and the pt stated "no". Based upon the pts responses to the standard questions asked on the assessment sheet, a Pfizer vaccine was administered to the pt. The pt never let on that she had previously received a COVID vaccine.  Upon entering the pt vaccination information into the system, it was discovered that the pt had in fact already received a dose of the Moderna vaccine on 1/06/2021.
2/8/10-had Zoster vaccine on 2/16 developed a rash on arm, itchy, raised, red 3" round on 2/16.
Lymph node under left arm swelled significantly (tennis ball sized) (swelling increased over 2 days, stayed steady for 2 days, and then began decreasing. Has not yet fully subsided after 11 days)  Hives on head, neck, chest, back, and abdomen  Face & throat swelling  Hives & face/throat swelling improved after 24 hours and treatment with Benadryl.
red mass on her left shoulder deltoid region; Mass is itchy; Mass is painful; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE ERYTHEMA (red mass on her left shoulder deltoid region), VACCINATION SITE PRURITUS (Mass is itchy) and VACCINATION SITE PAIN (Mass is painful) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, the patient experienced VACCINATION SITE ERYTHEMA (red mass on her left shoulder deltoid region), VACCINATION SITE PRURITUS (Mass is itchy) and VACCINATION SITE PAIN (Mass is painful). At the time of the report, VACCINATION SITE ERYTHEMA (red mass on her left shoulder deltoid region), VACCINATION SITE PRURITUS (Mass is itchy) and VACCINATION SITE PAIN (Mass is painful) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   patient is on concomitant medication opioids.   Reporter did not allow further contact
Fever body aches, fever, lumps under arm & sharp left lower leg pain. Narrative:  Reported today 2/11/21. Body aches, fever, left leg pain, and lumps under arms appeared a coupe of days after 2nd dose but have subsided except for  leg pain. Employee c/o pain to left lower leg starting Jan 30-31. Denies edema or erythema to left lower leg. Employee continues to have 3/10 sharp pains to left lower leg when weight bearing. Seeking medical attention from PCP today for leg  pain.  Other Relevant History:
Information has been received from an approx. 50 year old female nurse who in 2002 was vaccinated with a first dose of varicella virus vaccine live. Subsequently, for the following six months, the pt experienced malaise, aches, and lesions around her mouth, inside her mouth, and around her eyes. It was unknown if treatment was given. The condition had resolved. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.
This case was reported by a nurse via sales rep and described the occurrence of feeling hot in a female patient who received Shingrix for prophylaxis. On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than a year after receiving Shingrix, the patient experienced feeling hot and pain. On an unknown date, the outcome of the feeling hot and pain were recovered/resolved. It was unknown if the reporter considered the feeling hot and pain to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported. The patient felt feverish and achy for approximately 6 hours post vaccination with Shingrix.
facial flushing; neck pain; fuzziness; confusion; nausea; headache; hard time doing her job; patient received an expired dose of VARIVAX; varivax; route of administration: intramuscular; This spontaneous report as received from a nurse practitioner refers to a 47-year-old female patient. The patient's medical history was not reported, her concurrent conditions included: hypothyroidism, dyslipidaemia, sleep apnoea syndrome and seasonal allergies. Concomitant therapies included dexlansoprazole (DEXILANT) and levofloxacin(LEVAQUIN).   On 18-JAN-2019, the patient was vaccinated with expired dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot # M044347, expiration date: 04-NOV-2018, 0.5 milliliter (strength and dosing schedule were not reported) intramuscularly (considered as inappropriate route of administration) for prevention of varicella. On the same date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II)(recombinant Human albumin rHa), lot #R002049, expiration date 22-JAN-2020, 0.5 ml (strength, dosing schedule and route of administration were not reported) for prophylaxis. The patient reported she had side effects back when these doses of vaccines were given. She sought for medical help and had gone to the emergency room (ER) the next day- 19-JAN-2019, with symptoms of facial flushing, neck pain, fuzziness, confusion, reported having a hard time doing her job, nausea, and headache. The doctor had mentioned it could had been from the vaccines she had been given and advised her to check on them. The patient stated she felt fine on 20-JAN-2020, (reported as: on the next day) and was then back at baseline, the events were considered to be resolved. Action taken with vaccines was not applicable.   The causality assessment between varicella virus vaccine live (oka/merck)(VARIVAX) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was not reported.
sore arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (sore arm) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced MYALGIA (sore arm). At the time of the report, MYALGIA (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
pt recvd vax 4AUG93 & later that day pt devel hives; hives were transient in nature, pt recovered p/several wks; No further info is provided;
Psoriasis and psoriatic arthritis flare; Psoriasis and psoriatic arthritis flare; Period with iud for 3 months which is abnormal; This is spontaneous report from a contactable consumer (Patient). A 44-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number and expiration date were not reported) via an unspecified route of administration in the left arm on 23Apr2021 11:00 (at the age of 44-years-old) at single dose for covid-19 immunisation. The patient medical history included psoriasis, psoriatic arthritis, rheumatoid arthritis,depression and iud (Intra-uterine contraceptive device). The patient was not pregnant. The patient was not pregnant at time of vaccination. The patient did not have COVID-19 prior to vaccination. The patient had no known allergies. The patient concomitant medication taken in two weeks included citalopram and leunomide. The patient did not receive any other vaccines within 4 weeks. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number and expiration date were not reported) via an unspecified route of administration on 02Apr2021 10:30 (at the age of 44-years-old) at single dose for covid-19 immunisation. On 03May2021, the patient experienced psoriasis and psoriatic arthritis flare, period with iud for 3 months which was abnormal. Treatment was received for the events with estrogen pills and steroid added to infusions. The patient had not tested positive for COVID-19 since the vaccination. The outcome of events was recovering.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Bright red splotchy rash all over that showed up within the two hour span; fever spiked to 102 and has stayed about high 99s up to 100.7 as of 11/22/2016. Continued to monitor the fever. He hasnt ate much or drank much so we have pushed fluids and tiny amoints of pedialite. We gave one dose of tylenol however it didn't help except take the edge off of fever to about 101 degree Fahrenheit. He has begun puking more since the vaccinations as well.
Approximately 10-15min after injection pt began c/o "difficulty breathing."  Also c/o feeling "stiff arms," dry mouth, and racing heart.  BP at 0902 187/116, HR 136, pulse ox 100% on RA.  Pt didn't appear to have any difficulty breathing or be in distress.  Used rescue inhaler before being transported to Urgent Care and was feeling better.
DIZZINESS; This spontaneous report received from a consumer concerned a 52 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1816027, and expiry: UNKNOWN) dose was not reported, administered on 23-SEP-2021 13:30 for prophylactic vaccination. No concomitant medications were reported. On 23-SEP-2021, the patient experienced dizziness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from dizziness. This report was non-serious.
Soreness at injection site about 5 hours after injection; Chills; joint aches; headache about 10 hours; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old male patient received BNT162b2 (BNT162B2), on 04May2022 at 11:15 as dose 4 (booster), single (Lot number: FL3197) at the age of 60 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "sulfa and ceftan based antibiotics" (unspecified if ongoing), notes: Known allergies: sulfa and ceftan based antibiotics. Concomitant medication(s) included: NASONEX; ESOMEPRAZOLE; LORAZEPAM; CENTRUM SILVER +50. Past drug history included: Sulfa and ceftan based antibiotics, reaction(s): "Known allergies: sulfa and ceftan based antibiotics", notes: Known allergies: sulfa and ceftan based antibiotics. Vaccination history included: Bnt162b2 (Dose 1, Lot No.: EL3247, Anatomical Location: Arm left), for COVID-19 immunization; Bnt162b2 (Dose 2, Lot No.: EP6955, Anatomical Location: Arm left), for COVID-19 immunization; Bnt162b2 (Dose 3, Lot No.: FH8027, Anatomical Location: Arm left), for COVID-19 immunization. The following information was reported: CHILLS (non-serious) with onset 04May2022, outcome "recovering"; VACCINATION SITE PAIN (non-serious) with onset 04May2022, outcome "recovering", described as "Soreness at injection site about 5 hours after injection"; HEADACHE (non-serious) with onset 04May2022, outcome "recovering", described as "headache about 10 hours"; ARTHRALGIA (non-serious) with onset 04May2022, outcome "recovering", described as "joint aches". Therapeutic measures were not taken as a result of vaccination site pain, chills, arthralgia, headache. Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and patient received Nasonex, Esomeprazole, Lorazepam, Centrum Silver 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.