chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pt says she when she woke up she was dry heaving and severe headache.  She had chills, diarhea, nausea, skin was slightly red and peeling.  She had vertigo, sore throat, dry mouth, loss of taste, fatigue, muscle aches and pains.  Her right arm hurt more than the left arm where she had the arm that was injected.  She had major hair loss and trouble focusing and feels like she has a sinus infection.   Patient is taking cold and flu meds.  She does feel some better but still has a headache and feels like she has a cold.
Starting around 05/30/2022, I developed allergy symptoms (sore throat, runny nose, cough which devolved into sticky mucous/saliva and thin mucus). Also, I developed a sticky throat sensation as if something was stuck in my throat. After a few nights of almost no sleep (~2-4hrs a night) and treating myself for cold symptoms, I went to see the Dr. He gave me recommendations for medicine to take and prescribed me an antibiotic, and recommended I continue taking the anti-mucous OTC and OTC sleep medicine.  So far, the medicine has been helping me sleep (~6-7 hours of sleep) and I have only had 2 nights where I couldn't sleep since then but have self treated in hopes to go back to sleep. I asked the doctor if I could have medicine to help me sleep and I was given lorazepam but I haven't had to use it yet.
Within 24 hours, there was a hard golf ball sized lump at the injection site. It was feverish and itchy.  As of today, 10/3/21, the lump is approximately the size of a jelly bean and is still itchy, but the fever is gone.
Warmth, pain, edema at injection site; Warmth, pain, edema at injection site; Warmth, pain, edema at injection site; This spontaneous case was received on 30-Sep-2020 from other health professional (nurse) via Health Authority (reference number: SEQW20-02593) and concerned a patient of an unknown age and gender.   The patient's medical history and concomitant medications were not reported.    On an unknown date in Sep-2020, the patient was vaccinated with Flucelvax QIV (influenza vaccine, subunit influenza virus vaccine polyvalent, indication, dose, route of administration and anatomical location: not reported). The batch number reported was 279838.     On the same day, a few hours after receiving Flucelvax QIV, the patient experienced warmth, pain and edema at injection site.   The outcome of events was not reported.   The reporter did not provide a causality assessment.  This case is linked to 202004882, 202004883, 202004884 and 202004885 (the same reporter).  Company comment:The patient developed vaccination site warmth, vaccination site pain and vaccination site oedema a few hours after vaccination with the suspect product, Flucelvax QIV. Chronology is suggestive. No information regarding concomitant medications and medical history was provided. Based on this information, causal relationship for all events is assessed as possibly related. (defaults to ''related'' in the safety database for reporting purposes).; Sender's Comments: The patient developed vaccination site warmth, vaccination site pain and vaccination site oedema a few hours after vaccination with the suspect product, Flucelvax QIV. Chronology is suggestive. No information regarding concomitant medications and medical history was provided. Based on this information, causal relationship for all events is assessed as possibly related. (defaults to ''related'' in the safety database for reporting purposes).
A small rash was noticed on the stomach and Aveno lotion was applied to soothe. The rash slowly progressed to cover the all body parts excluding the face and head. Benadryl was given and hydrocortisone was applied. He was taken to Dr. on 5/30/15 at 11:30 AM. She looked at the rash and said it was viral and prescribed Predinisone 20 mg for 5 days. On Monday the rash had increased and he had a low fever and felt weak. He was taken to another Dr. She looked at his rash and checked his ears and throat. She believed it was most likely an allergic reaction but did not rule out the possibility of it being viral. She gave him a Depomedrol 60mg IM and prescribed Prednisone 40 mg for 2 days, 35 mg for 2 days, and has him tapering down by 5 mg until he reaches 10mg for 2 days. As of today his rash is still present and he had a fever of 100 F.
R09.02 HYPOXIA 1/13/2023 AORTIC VALVE STENOSIS R09.02 HYPOXIA 1/13/2023 TACHYCARDIA
Pt was given two injections one in each arm IM. Tdap given in (L) arm and MCV given in (R) arm. Pt shortly after the MCV injection, pt had a seizure.
Pronounced immune response; Beat me up, Kicked my ass, Felt horrible; This case was reported by a consumer via interactive digital media and described the occurrence of immune system disorder in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In November 2021, the patient received the 1st dose of Shingles vaccine. On an unknown date, less than 3 months after receiving Shingles vaccine, the patient experienced immune system disorder and feels awful. On an unknown date, the outcome of the immune system disorder was unknown and the outcome of the feels awful was recovered/resolved.   It was unknown if the reporter considered the immune system disorder and feels awful to be related to Shingles vaccine.  Additional details were provided as follows: The patient self- reported this report. The age at vaccination was not reported. The patient got 1st shingles vaccine 3 months ago and get a pronounced immune response and felt horrible for a few days.  The patient stated that Antibiotics did not work on shingles as it was a virus.  However, the patient would get the 2nd vaccine as getting full blown shingles was much worse than the side effects of the vaccine. The patient stated that the 1st one beat him/her up, but he/she guess it's better than getting shingles. The follow-up could not be possible as no contact details were available.
Pt fainted moments after receiving vaccine. After he received vaccine he started to say he is feeling weak then with in a minute his fainted in the chair. He was out for a minute then started to come out of it. He pulse was 90, bp 115/80 Pul Ox 999 sugar 90. Pt stated he did not eat in the morning before receiving the vaccine pt was also restless and anxious prior to vaccination. He was fine at 10:45 after EMT also checked him over and all clear was given. Called pt at 12:45 pm to recheck on him and he was still filling okay at this time.
Patient had immediate itchy rash, facial swelling and limb swelling, given benedryl to treat symptoms, and symptoms subsided. Itchiness persisted until 9/19/22.
Patient reported being very weak and in bed.  She reports that she experienced nausea, vomiting, fever, chills, and a headache as well as a localized reaction at the injection site which included hives, redness and swelling.
This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (Arm felt hot in the shoulder area), VACCINATION SITE ERYTHEMA (Red blotch about the size of patients' hand where patient received vaccine), VACCINATION SITE PAIN (Minor pain) and VACCINATION SITE SWELLING (Little bit swollen) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-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 FEELING HOT (Arm felt hot in the shoulder area), VACCINATION SITE ERYTHEMA (Red blotch about the size of patients' hand where patient received vaccine), VACCINATION SITE PAIN (Minor pain) and VACCINATION SITE SWELLING (Little bit swollen). At the time of the report, FEELING HOT (Arm felt hot in the shoulder area), VACCINATION SITE ERYTHEMA (Red blotch about the size of patients' hand where patient received vaccine), VACCINATION SITE PAIN (Minor pain) and VACCINATION SITE SWELLING (Little bit swollen) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
Received 2nd dose of COVID vaccine 1/23/2021.  On 3/21/2021 developed sore throat and cough.  Tested positive for COVID.
6 days after vaccine developed painful lymphadenopathy, bilateral axillary, and left anterior cervical lymphnodes
My due date was 07/16/2022, and I had a really smooth pregnancy with no complications until I contracted COVID-19. I contracted COVID-19 05/30/2022 with symptoms of scratchy chest, congestion, and on 06/01/2022 I began having contractions. I was admitted to the hospital on 06/01/2022 for my early labor contractions, and they were able to stop the labor. I was released after 2 nights in the hospital on bedrest. Due to low amniotic fluid which resulted due to my illness and my son being breach I had to have a C-Section. I was hospitalized for 3 days.  My son was born weighing 4lbs 10 oz and he was in the hospital for 8 days before being release. We are both healthy and doing well.
Information has been received from a health professional concerning a 5 year old female who on 09/13/2004 was vaccinated with a first dose of measles virus vaccine live, mumps virus vaccine live, rubella virus vaccine live.  Subsequently the patient experienced mumps.  It was reported that the patient was seen in the ER, but not hospitalized.  No laboratory diagnostic tests were done and no medications were given.  The patient recovered on an unspecified date.  There was no product quality complaint involved.  Follow up information from the health professional indicated that the patient's mother stated that the patient was given vaccine and within 24 hours her neck was swollen.
This case was reported by a healthcare professional (nurse) via a sales representative and described the occurrence of fever in a 4-month-old female subject who was vaccinated with PEDIARIX (GlaxoSmithKline). Concurrent vaccination included haemophilus influenzae type b vaccine (non-gsk); non-GSK manufacturer; unknown; unknown given on 25 September 2013; pneumococcal vaccines (non-gsk); non-GSK manufacturer; unknown; unknown given on 25 September 2013; rotavirus vaccine (non-gsk); non-GSK manufacturer; unknown given on 25 September 2013. On 25 September 2013 the subject received a dose of PEDIARIX (unknown details). In 2013, less than one week after vaccination with PEDIARIX, the subject experienced fever and high white cell count. The reporter described the white cell count as "very high" and no further details were provided. The subject was hospitalised. Relevant test results included white cell count taken in 2013 which was "very high." The subject was also reported to have a "103 degree fever" in 2013. At the time of reporting the outcome of the events were unspecified. The nurse documented 2 other cases with PEDIARIX. See cases A1044386A and A1044385A for details on the other cases.
Nausea; Diarrhea; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm right on 14Apr2021 at 08:15 (at the age of 34-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient's medical history and known allergies reported were not applicable. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. On 14Apr2021 at 09:30, the patient experienced nausea and diarrhoea. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events nausea and diarrhoea was recovering at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Erythematous area of soft, non indurated swelling 9x10 cm (local reaction).
This case was reported by a nurse and described an 84 year old female pt who tested positive for hepatitis B e antigen following the administration of Engerix B. The pt's history was notable for renal failure (cause not specified) requiring hemodialysis, diabetes mellitus (type not specified), coronary artery disease, hypertension and Parkinson's disease. On 02 July 2004, the pt received the fourth dose of Engerix B (lot ENG5589A4). The reporter stated that, "five days after receiving Engerix B, on 07 July 2004, laboratory findings indicated that the pt developed hepatitis B e antigen."  A repeat laboratory test performed on 12 July 2004 for hepatitis B e antigen was "non-reactive." The nurse considered the event to possibly be related to vaccination with Engerix B.
Patient felt light headed, dizzy, then extremely cold. We laid her down, gave her an ice pack, then blanket & pillow. We monitored BP and pulse
This spontaneous report was received from a physician and refers to a multiple unspecified patients of an unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided. On an unknown dates between August 2016 and November 2016, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # M004116 with expiration date 12-OCT-2017 (dose, route of administration and anatomical locations were not reported). No adverse effect was reported. Administered doses of GARDASIL 9 experienced temperature excursion of 0 degrees Celsius for 285 hours and 20 minutes in August 2016, 285 hours and 20 min in September 2016, 223 hours and 20 minutes in October 2016 and 200 hours in November 2016. There was no previous temperature excursion. Digital data logger was involved. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has requested.
COVID-19 VIRUS TEST POSITIVE; This spontaneous report received from a patient via other manufacturer (AbbVie) concerned a 63 year old female. The patient's height, and weight were not reported.  The patient's concurrent conditions included: non-infectious intermediate posterior and panuveitis, and moderate to severe rheumatoid arthritis. The patient previously received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, intramuscular, batch number was not reported) dose, start therapy date were not reported, 1 total for covid-19 prophylaxis.  The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine (Dose number in series 1). Non-company suspect drug included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number: 1160291) dose, frequency, and therapy dates were not reported for moderate to severe rheumatoid arthritis, and non-infectious intermediate posterior and panuveitis.  The patient received booster dose with non-company suspect vaccine: tozinameran (Pfizer vaccine, Dose number in series 2) (form of admin unknown, intramuscular, batch number was not reported) dose, start therapy date were not reported, 1 total for covid-19 prophylaxis.  On an unspecified date in JUL-2022, the patient experienced covid-19 virus test positive (Dose number in series 2). Laboratory data included: COVID-19 virus test Positive. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab, and tozinameran was not reported. The patient recovered from covid-19 virus test positive on JUL-2022. This report was non-serious.
Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient was administered the Pfizer Covid Vaccine. A few minutes later, while watching her mom receive the vaccine she fainted. Patient was unresponsive for less than a minute. Upon regaining consciousness patient seemed to recover fully after resting and drinking some water.
Fever to 102.5, myalgias, arthralgias, fatigue started 8-10 hours post vaccine lasting for about 36 hours and mostly resolved at 48 hours post vaccine. Despite Tylenol, fever only decreased to 100.4 at best.  Worst symptoms were between  20 hours post vaccine until 40 hours post vaccine. After that only mild fever and chills persisted until around 48 hours post vaccine, then it resolved.  I noticed my upper arm was red just distal to the vaccine site about 3 days after the vaccine. It was a little warm and tender/itchy  but resolved after a couple days.
Acid bath going down in her stomach; Stomach was upset and squishy; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Stomach was upset and squishy) and GASTROOESOPHAGEAL REFLUX DISEASE (Acid bath going down in her stomach) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     The patient's past medical history included Surgery. Concurrent medical conditions included Allergy to grains.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced ABDOMINAL DISCOMFORT (Stomach was upset and squishy). On 30-Mar-2021, the patient experienced GASTROOESOPHAGEAL REFLUX DISEASE (Acid bath going down in her stomach). At the time of the report, ABDOMINAL DISCOMFORT (Stomach was upset and squishy) and GASTROOESOPHAGEAL REFLUX DISEASE (Acid bath going down in her stomach) outcome was unknown. Not Provided      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.
Pt began to feel light headed after receiving covid vaccine did not eat breakfast, was feeling nervous about getting shot.  Did not take her HTN medication this AM.  1130 Pt felt fine after 15 min.  1130 BP 138/90, HR 52, RR 10; 1145 BP 138/88, HR 55, RR 10, O2 99%
After pneumonia shot in left arm, was unable to move it for 5 days. Call Dr on Oct 22 at 330 AM he was not concerned. Slowly recovering with limited use. Went to see Dr on the 26 with lots of pain still in arm and left side of body. I am still in a lot of pain on left side of body.
flu; Initial information received on 21-Jan-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp via digital media.  This case involves Adult of an unknown gender patient who experienced flu, while receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (unknown dose, formulation, via unknown route in unknown administration site) as prophylactic vaccination.  On an unknown date, the patient developed a non-serious event " flu" (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported"Nothing like getting the hypochondriacs riled up again. I had the flu shot twice in my life. Had the worst case of flu both times. The rest of the time, I haven't had the flu. Imagine that. Decided by using critical thinking that I don't need a flu shot ."  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (flu).  At time of reporting, the outcome was Unknown for the event flu.
On January 29 I had itching on my left arm, where the shot was given.  I had splotches of redness.  My am was swollen.  During the day it felt hot and the itching increased.  It was sensitive to my touch. It was not comfortable sleeping on my left side.   On January 30 I now have a circle of redness (like the pictures of people on the internet, called Covid arm).  My arm still itches.  It is still sensitive to my touch.  It is not as warm as yesterday.
Pt recvd vax & had t39.5C for next 2 days;
7 hours after injection I developed chills, fever (100 F), fatigue. dizziness, fatigue, weakness, nausea, loss of appetite, and a headache. These symptoms lasted for the next 24 hours and gradually subsided over the next 8 hours.  On 8/28/20 I woke up feeling normal again.
vomiting, lethargy, restless, disoriented, can't walk, stiff discoloration of feet & hands
Adverse effect of other vaccines and biological substances, initial encounter on 2021-01-06.
Consumed one dose of Vivotif which was left unrefrigerated for three days; Spontaneous report received on 24AUG2020.  Based on the information obtained from the female consumer two individual case safety reports 20000452SP (wife) and 20000453SP (husband) were created and cross-linked in the database.  The female consumer reported that her husband "consumed one dose of Vivotif which was left unrefrigerated for three days" (PT: Product storage error). He was receiving Vivotif (lot number: 3003320 and expiry date: Nov 2020) for immunisation. She reported that Vivotif was left unrefrigerated for three days (Tuesday to Friday) at 72-degree Fahrenheit. She put back Vivotif in the refrigerator on Friday. On 24AUG2020, her husband took one dose of the unrefrigerated Vivotif. She also informed that her husband took only one dose of Vivotif so far. Action taken with Vivotif with respect to the reported event was not applicable. The outcome of the reported event was unknown.  Company Comment: It was reported that a consumer consumed one dose of Vivotif which was left unrefrigerated for three days (product storage error). Vivotif should always be stored in the refrigerator at the recommended temperatures. The causality of product storage error is assessed as not applicable to Vivotif due to the nature of the event which was due to human error.; Sender's Comments: It was reported that a consumer consumed one dose of Vivotif which was left unrefrigerated for three days (product storage error). Vivotif should always be stored in the refrigerator at the recommended temperatures. The causality of product storage error is assessed as not applicable to Vivotif due to the nature of the event which was due to human error.
Vaccine caused my genital herpes to re-emerge. I have not had a breakout in 7 years prior to this and now I have one that will not heal up. Flu like symptoms (fatigue, fever, aches and pains in left leg) Pain, itching and clusters of sores on left side of vagina. Clusters of sores have have white heads, the white heads fell off and the sores are leaking  pus and blood, Difficulty walking & sleeping.   Have been taking Valtrex & Naproxen to combat Herpes outbreak since August 17th to no avail. Epsom salt baths. Sitting on ice packs. I can't wear panties as it rubs the site and makes the pain worse.
Donor had completed a plasma donation and then received a tetanus immunization. After the immunization, the donor experienced hypotensive LOC.
Patient reports experiencing the following symptoms in a period after vaccination of 4 days. Body heat. Itching throughout the body. Tiredness. Pain when ejaculating (the pain prevails for a period of one hour).
This is a spontaneous report from a contactable other healthcare professional (HCP) via a Pfizer sales representative. A patient of unspecified age, ethnicity and gender received a single dose of TRUMENBA, via an unspecified route of administration, on an unspecified date. The patient medical history and concomitant medications were not reported. The patient experienced arm pain on an unspecified date after the vaccination. The outcome of the event was unknown at the time of this report. Follow-up (19Aug2016): Follow-up attempts are completed. No further information is expected.