chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a pharmacist refers to a female patient of unknown age. About a month ago on an unknown date in January 2013 the patient was vaccinated with PNEUMOVAX 23 (lot # was not reported. Please add: Route of administration was not provided). On an unknown date in 2013 the patient developed a swollen arm which hurt up to her armpit. It was not reported whether the patient sought medical attention. The outcome of the adverse event was unknown. Additional information will be requested.
injection site is more sensitive; red; swollen; discomfort in the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOMFORT (discomfort in the injection site), VACCINATION SITE PAIN (injection site is more sensitive), VACCINATION SITE ERYTHEMA (red) and VACCINATION SITE SWELLING (swollen) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced VACCINATION SITE DISCOMFORT (discomfort in the injection site). On 11-Feb-2021, the patient experienced VACCINATION SITE PAIN (injection site is more sensitive), VACCINATION SITE ERYTHEMA (red) and VACCINATION SITE SWELLING (swollen). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency and FEXOFENADINE HYDROCHLORIDE (ALLEGRA) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, VACCINATION SITE DISCOMFORT (discomfort in the injection site), VACCINATION SITE PAIN (injection site is more sensitive), VACCINATION SITE ERYTHEMA (red) and VACCINATION SITE SWELLING (swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant details were not reported by the reporter. Treatment included also ice.   Reporter did not allow further contact
Left deltoid redness, warm to touch, swelling, occurred (noticed this morning), cool compresses.
Mom phoned MD reported child began shaking about 2.5 hrs following vax, eyes rolled back, became cold & cyanotic; Taken to ER temp 103;
This case was reported by a other health professional and described the occurrence of inappropriate age at vaccine administration in a 13-month-old male patient who received FLUARIX. Co-suspect products included FLUARIX. On 29th September 2014, the patient received the 1st dose of FLUARIX .5 ml and the 2nd dose of FLUARIX .5 ml. On an unknown date, an unknown time after receiving FLUARIX and FLUARIX, the patient experienced inappropriate age at vaccine administration, accidental overdose and inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration, accidental overdose and inappropriate age at vaccine administration were unknown. It was unknown if the reporter considered the inappropriate age at vaccine administration to be related to FLUARIX. It was unknown if the reporter considered the accidental overdose and inappropriate age at vaccine administration to be related to FLUARIX. Additional information received on 29 September 2014: 2 doses of FLUARIX was administered to a patient on the same day. Both doses were meant for his siblings. No other information was provided.
Lip swelling; This is a spontaneous report from a contactable physician. A 48-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9264) via intramuscular route of administration in the right arm on 08Feb2021 at 11:30 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history included multiple sclerosis. The patient was allergic to fluoroquinolones (unspecified). The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via intramuscular route of administration in the right arm on 17Jan2021 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Concomitant medications included glatiramer acetate (COPAXONE) taken for unspecified indication from an unknown date. Prior to the vaccination the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. On 01Mar2021, after three weeks of the second dose of vaccine (as reported), the patient experienced lip swelling. The event resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Treatment received with unspecified steroids. The clinical outcome of the event lip swelling was resolved on an unknown date in 2021.  No follow-up attempts are needed. No further information is expected.
Patient developed wheal - like reaction at injection site the evening of receiving the vaccine.  Not tender to touch.  Not warm to touch.  Approximate size of 4.5cm in length and 5.5cm in height.  No other systemic symptoms.
On 9/17 rash developed, 9/18 hives, chest welts, runny nose, cough, swallowing difficulties. Patient took BENADRYL for a few days and symptoms are improving. No distress, minimal runny nose, still has splotchy rash, but has improved per patient, some fatigue. If worsens, patient will contact pharmacy for follow-up and appropriate care through PCP.
Patient was experiencing rash and chills after her second dose of COVID19 vaccine, treated herself with benadryl to resolve. Rash re-appeared following day, presented to the ED received solumedrol, fluids and benadryl, and she was discharged with ranitidine and hydroxyzine (2/21). She returned on 2/23 to ED, presented with rash, tachycardia and c/o abdominal pain . She was treated with methylprednisolone 15mg, 1L of LR, 1L of NS, and 50 mg IV diphenhydramine, 0.3 mg IM Epinephrine, and 20 mg of famotidine IVx1. Patient was continued on prednisone 40 mg po bid and famotidine 20mg po bid.
This spontaneous report was received from a medical assistant regarding a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On 04-SEP-2015, the patient was vaccinated with an improperly stored dose of VAQTA (dose and route were not reported, lot # L009445, expiration date 01-JUN-2017). There were no adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Presyncope- diaphoresis, left hand parethesia- self- resolvedNone EMS, pharmacist, and MD (me) on site.  Vitals taken. Laid down, observed, oj and chips given. Appt made at Health Center for tomorrow. Advised to rest today, alert friend of event.
ELEVATED HEART RATE STARTED A FEW HOURS AFTER VACCINATION AND HAS LAST MULTIPLE HOURS ALONG WITH FEVER, TIREDNESS, SORENESS AND HEADACHE.
This spontaneous report as received from a pharmacy technician refers to a 5 year old patient of unknown gender. Patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 29-JAN-2018, the patient was vaccinated with improperly stored dose of VARIVAX (lot # N022979, expiry 23-AUG-2019) for prophylaxis. No adverse effect was reported. The VARIVAX temperature excursion occurred on 14-DEC-2017 and 30-DEC-2017. On 14-DEC-2017, the vaccine was exposed to the temperature of 16.9 degree Fahrenheit (F) for 30 minutes. On 30-DEC-2017, the vaccine was exposed to the temperature of 6 degree Fahrenheit (F) to 14 degree F for 30 minutes. It was reported that the event was because of data logger. No product quality complaint was involved. This is one of the several reports received from the same reporter source. Sender's Comments: US-009507513-1802USA001558.
11/10/2005 about 10:15 pt telephone corpworx to report taking 2nd dose oral typhoid at about 06:00 - 6:30 today. Now she experiencing urticaria, tingling lips, mouth has a coding feeling, denies SOB or hives. Suggested PO Benadryl not to complete typhoid doses (2). See medical attention PRN.
Given a flu shot on Tuesday. Called Thursday afternoon to report that it was sore & the pain has been on into her shoulder & neck. She also developed some bumps in her neck. It sounded to me like these were probably lymph nodes but I asked her to please come in for me to view what she was talking about. She was not able to come until today. She said things have improved & there was only one lump left about size of a pea - hard, tender & mobile in low neck just above clavicle. I told her I would report it & also check back with her next week. I said there was no way to know if this was due to the shot or something else but it was good things were improving. She has had no fever or other symptoms. Told her to see her MD if things got worse or if this didn't resolve in a couple weeks, though I did say that lymph nodes to take a while to get make to normal. Called again 1/24/11. Lump gone - disappeared over weekend.
The left side of my face went a little numb for the rest of the day following my first shot. It lasted 2 days following my second shot.; This is a spontaneous report from a contactable consumer, the patient. A 23-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9264) via an unspecified route of administration in the left arm on 18Mar2021 at 10:00 (at the age of 23-year-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the left arm on 15Apr2021 at 14:00(at the age of 23-year-old) as a single dose for COVID-19 immunisation. Medical history included birth control. Concomitant medication included birth control (MANUFACTURER UNKNOWN) from an unknown date. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient had not been diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 18Mar2021 at 10:00, the patient's left side of the face went a little numb for the rest of the day following the first shot. It lasted two days following the second shot. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event left side of the face went a little numb for the rest of the day following the first shot and lasted two days following the second shot was recovered on 16Apr2021.    No follow-up attempts are needed. No further information is expected.
GUILLAIN BARRE Syndrome Dx 10/2010 by Dr. Tx at hospital.
Started to feel sick while on vacation on 9/13, I started to get a fever, a headache and was very achy and had a dry cough. Never got a sore throat fever and the achiness less than 2 days. I have had colds that made me feel worse. I went to a 24-hour Care clinic. I showed them a picture of my self-care test and she gave some advice. I was just sent be isolate because they only give medication if people need to be admitted. I did consult another doctor a few days later. On the 15th I got back and on 16th I had a zoom doctor appointment. The zoom doctor sent me to give antibody?s the next week and I did. I as completely recovered by the 16th but I did still have the dry cough but that was it. I was feeling find but still testing positive.
Initial and follow-up information has been received from a registered pharmacist concerning a 53 year old female patient who on 15-DEC-2008 was vaccinated with a dose of PNEUMOVAX (lot # 661529/0868X) and had previously been vaccinated with a dose of the same vaccine.  Within 24 hours of vaccination, the patient developed swelling and warmth down her injection arm and was seen by the doctor.  PREDNISONE was prescribed for her.  At the time of the report the patient was recovering.  This is one of three reports received from the same source.  Additional information has been requested.
26JUN 1 day post vax pt exp painful joints w/swelling, some redness & heat felt  eg. feet, ankles, elbows, knees, hands was unable to sleep through the noc because of sx;
On 10/9/2013 15 minutes after the injection I became nauseated, warm, itchy, and had difficulty breathing.  I used my inhaler and took Benadryl.  I continued to be short of breath over night and my arm became very sore with a hard spot at injection site.  I ended up in the Emergency room the next day with anaphalaxis.
Patient was given 0.3 ml of undiluted Pfizer Covid Vaccine. Patient was advised to watch for side effects, especially injection site reactions.
Had BP of 150/100 after 2nd dose in April. Went back to normal after 5 days. Was proactive to check after booster after feeling slightly fatigued.
Under age administration of Pfizer Pfizer vaccine (17 years old - booster dose approved for 18 years and above - even if age approved, does not meet criteria for at risk group) Signs and symptoms: none Diagnosis and treatment: Patient accompanied by parent. Patient observed for 15 minutes per CDC protocol, no adverse reaction observed. Patient released from mobile vaccination clinic in unremarkable, stable condition. No treatment required. Diagnosis: vaccine error related to age of minor child, does not quality for booster Supervisor reported event to site manager  for VAERS reporting
cardiac issues.; This is a spontaneous report received from non-contactable reporter(s) (Physician).  An adult patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CARDIAC DISORDER (non-serious), outcome "unknown", described as "cardiac issues.".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
second day after receiving vaccine I was fairly sick.  Then I was fine.  5 days after receiving vaccine (yesterday 1/13/2021) I started developing Bell's palsy
Swelling, redness, and tenderness to left upper arm at injection site. Began one hour after vaccine administered. Treated with MEDROL dose pack.
stomach flu; diarrhea.; no appetite; nausea; Sore arm; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced stomach flu, diarrhea, no appetite, nausea and sore arm on an unspecified. It was reported that patient was due to receive her second dose of COVID vaccine on 06May2021. She has been having symptoms of what she believes to be a stomach flu for the past 1-2 weeks. Patient reported that symptoms were "off-and-on" over the time period and included diarrhea and no appetite.  She was asking if she should still receive her second dose as scheduled. Patient did not attribute symptoms to her first dose of vaccine, she noted that she did fine with the first shot and only reported a sore arm. Patient was not thinking her symptoms and the first dose of vaccine are related. The patient would like to speak to the nurse who would be administering the shot. The patient had previous stomach virus with diarrhea and nausea and stuff like that and has had it for the past week. She wanted to know would this bring any more harm to her by getting second shot. Outcome of event stomach flu and diarrhea was not resolved. Outcome of remining events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on the temporal relationship, the association between the events stomach flu, diarrhea, no appetite, and nausea with BNT162b2 can not be fully excluded. There is a reasonable possibility that the event sore arm was related to BNT162b2 based on known drug safety profile.  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.
After 2nd. shot on Tuesday:  early on Thursday morning woke up 102+ degree temp, extreme nausea, sweating, severe headache, joint stiffness and head felt like I was in a fog. Severe systems lasted for four days. Today (6/17/21) still having headaches, head fog, and severe joint stiffness in hands elbows and ankles. Taking Tylenol and Advil for relief.
This spontaneous report was received from a physician referring to 12-month-old patient of unknown gender. Pertinent medical history or concurrent conditions were not reported. On 01-AUG-2017, the patient was vaccinated with improperly stored doses of VAQTA (lot # N005274, expiration date 03-APR-2018) (dosage information and route were not informed). Information regarding concomitant medication was not provided. Additionally, it was reported that the lowest temperature was 32°F and the higher was 54°F for 70 hours. Data logger was not involved.  No adverse effects were reported. There was no product quality complaint involved. This is one of several cases from the same reporter. Sender's Comments: US-009507513-1709USA012768: US-009507513-1709USA007325.
This is a spontaneous report received from a contactable consumer or other non-HCP (patient). A 36-year-old female patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), on Mar 25, 2021, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient had dysgeusia (strong metallic taste in her mouth, which lasted only 30 seconds to 1 minute), onset 2021, with outcome of recovered (2021). Clinical course: Reportedly, patient experienced a strong metallic taste in her mouth, which lasted only 30 seconds to 1 minute. It went away afterwards. Patient wanted to know this was normal, and if it is ok to receive the second dose. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
The night before last I had and itch in the middle of my upper left are at the vaccination site. And that?s when I noticed and elevated circular bump, which is red, hard and warm to the touch. It was exactly 7 days since I was vaccinated. Today it?s a little bigger and more itchy. It is sore also. I had mild side effects the day after the vaccine. Just muscle pain and a head ache off and on.
Injection site is red, very sore, very itchy.  Body aches all over.
pt recv vax 17JAN97 & on 24JAN97 pt exp a rash on chest, which lasted for a few hr;
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies was provided. On 21-MAR-2017 at 16:29, the patient was vaccinated with improperly stored VARIVAX injection (lot # M035142) (expiration date, dose and route of administration were not reported). The vaccine underwent previous temperature excursions. The number of previous excursions, time frames and values of incorrect temperature were unknown. No adverse effects were reported. Digital data logger was used. Product quality complaint was not involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA008441: US-009507513-1704USA000389: US-009507513-1704USA000390: US-009507513-1704USA000391: US-009507513-1704USA000392: US-009507513-1704USA000393: US-009507513-1704USA000394: US-009507513-1704USA000395: US-009507513-1704USA000396: US-009507513-1704USA000397: US-009507513-1704USA000398: US-009507513-1704USA000399: US-009507513-1704USA000400: US-009507513-1704USA000401: US-009507513-1704USA000402: US-009507513-1704USA000403: US-009507513-1704USA000404: US-009507513-1704USA000405: US-009507513-1704USA000406: US-009507513-1704USA000407: US-009507513-1704USA000408: US-009507513-1704USA000409: US-009507513-1704USA000410: US-009507513-1704USA000411: US-009507513-1704USA000412: US-009507513-1704USA000413: US-009507513-1704USA000414: US-009507513-1704USA000415: US-009507513-1704USA000416: US-009507513-1704USA000417: US-009507513-1704USA000418: US-009507513-1704USA000419: US-009507513-1704USA000420 US-009507513-1704USA000421: US-009507513-1704USA000422: US-009507513-1704USA000423: US-009507513-1704USA000424: US-009507513-1704USA000426: US-009507513-1704USA000427: US-009507513-1704USA000428: US-009507513-1704USA000429: US-009507513-1704USA000430: US-009507513-1704USA000431: US-009507513-1704USA000432: US-009507513-1704USA000433: US-009507513-1704USA000434: US-009507513-1704USA000435: US-009507513-1704USA000436: US-009507513-1704USA000437: US-009507513-1704USA000438: US-009507513-1704USA000439: US-009507513-1704USA000440: US-009507513-1704USA000441: US-009507513-1704USA000442: US-009507513-1704USA000443: US-009507513-1704USA000444: US-009507513-1704USA000445: US-009507513-1704USA000446: US-009507513-1704USA000447: US-009507513-1704USA000448: US-009507513-1704USA000449: US-009507513-1704USA000450: US-009507513-1704USA000451: US-009507513-1704USA000452: US-009507513-1704USA000453: US-009507513-1704USA000454: US-009507513-1704USA000455: US-009507513-1704USA000456: US-009507513-1704USA000457.
Cried for 2.5 hour straight with fever to 101.5, screaming very to move either leg. Seen in Emergency Room continued screaming crying intermittently x 12 hrs, still f/u - on 10/4.
The shot was given 7/26/04 at 1 pm. After the shot he started having fever, headaches, some dizziness, unable to concentrate completely, causing him to become unable to make conscience decisions, muscle weakness, fatigue, memory loss, depression, seizure which resulted in mental and physical hospitalization, as a result of the shots he has now hypothyroidism (loss of his thyroid) resulting in life time medication.  Nurse follow up on 09/22/04 states: "Final diagnosis was myxedema due to Hashimoto's thyroiditis with psychotic features.  Other findings include hallucinations, suicidal ideation, elevated liver function tests, dry skin, pruritis." Per annual report- Pt has hypothyroidism now and have to take synthroid for the rest of his life, as long as he is on the medication he is fine but of course if one day he does not take his medication he has unbalance, paranoid, unable to think. Per annual report-But he lost his thyroid and have to stay on synthroid for the rest of his life.  Sometimes he is still paranoid but we are not sure if it is the thyroid or still the adverse reaction or allergies.
Redness and edema 2.5 to 3 inches in diameter at inject site left upper arm.