chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16May2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 63 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 20Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 02Apr2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 09Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm and on 22Jan2022 as dose 4 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "known allergies: shellfish" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Iodine, reaction(s): "Drug allergy"; Sulphur, reaction(s): "Drug allergy". 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 including Paxlovid from 06Apr2023 to 10Apr2023.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Dizziness, Headache, CoughWheeze, NauseaVomiting, HYPERglycemia,  site pain, red, swelling fatigue  Narrative:
Patient experienced redness, swelling, itching and rash near injection site and on full arm where injection was given. Parent said they had treated arm with hydroocortisone for itch. Symptoms had started to get better over time according to parent.
Fever; chills; headaches; sore throat; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the right arm on an unknown date in Apr2021 at 16:00 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies. Concomitant medications included hydrochloride (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 16Apr2021 at 06:30, the patient experienced lymph node armpit, fever, chills headaches and sore throat. On 18Apr2021, the patient underwent nasal swab and the result was pending. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of events and included treatment with amoxicillin 875 (MANUFACTURER UNKNOWN). Since the vaccination, the patient had been tested for COVID-19. The clinical outcome of the events lymph node armpit, fever, chills headaches and sore throat was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL OVERDOSE (Gave 0.5ml third full dose instead of half shot booster.) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 ml. On 02-Nov-2021, the patient experienced ACCIDENTAL OVERDOSE (Gave 0.5ml third full dose instead of half shot booster.). On 02-Nov-2021, ACCIDENTAL OVERDOSE (Gave 0.5ml third full dose instead of half shot booster.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported. No treatment information was provided.  The reporter stated that the patient received 0.5ml full third dose instead of the booster half shot on 02-Nov-2021.   This case was linked to MOD-2021-374683, MOD-2021-374919, MOD-2021-374922, MOD-2021-374933, MOD-2021-374578, MOD-2021-374706 (Patient Link).
Dizziness, fatigue, sore neck, visual changes at 2pm all at once.
Narrative: COVID infection following completion of COVID vaccine series 02/25/21 COVID vaccine dose #1 03/18/21 COVID vaccine dose #2 07/31/21 Pt presents to screening reporting exposure to COVID positive wife: asymptomatic; COVID POSITIVE 08/01/21 Pt reports chills, cough, nausea 08/09/21 Pt reports feeling fine but had diarrhea 08/16/21 Pt reports feeling fine the past two weeks
This spontaneous report as received from a nurse refers to a 7-month-old patient of unknown gender. The patient's relevant medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 28-SEP-2017, the patient was vaccinated with improperly stored ROTATEQ, orally, lot # M042170, expiry date: 22-JUN-2018, and RECOMBIVAX HB lot# N006321, expiry: 08-NOV-2019, both for prophylaxis. No adverse effects were reported. Temperature excursion was from 0 degree Celsius (C) to 1 degree C (0.8 degree C) for 52 minutes. The previous temperature excursion was reported as from 9 degree C to 25 degree C (10.9 degree C) for 3 hours 17 minutes. The call was because of a data logger. No product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA007014.
Patient received second dose of Pfizer shot. Diluent added to the vial was less than 1.8 ml, therefore, dose patient received was more concentrated than typical. Patient has not reported any adverse events as of yet.
Patient received all kindergarten boosters on 7/16/13 and that evening began with "low grade" fever which progressed to 102.7 within 24 hrs of vaccination. Also with (L) arm pain.
Hypertensive Crisis-3/4/21 Patient taken to ER for monitoring and possible future tests-3/4/21
Pt states that a rash appeared the day after pt was given the PNEUMOVAX injection; pt had been treating a different rash prior to injxn and was not certain if injxn was cause of current rash.
sore arm; I had a cold; it feels tight but I can breathe; it is still hurting, I may be go in to the emergency room; my throat feel strange; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 66-year-old male patient received bnt162b2 (COMIRNATY), administered in arm right, administration date 02Nov2021 14:30 (Lot number: FE3590) at the age of 66 years as dose 1, single for covid-19 immunization. Relevant medical history included: "cholesterol" (unspecified if ongoing); "Acid reflux" (unspecified if ongoing). Concomitant medication(s) included: MIRALAX taken for faeces soft; PRILOSEC [OMEPRAZOLE]; MYLANTA 11 taken for gastrooesophageal reflux disease; MYLANTA 11 taken for gastrooesophageal reflux disease; LOVASTATIN taken for blood cholesterol increased. The following information was reported: CHEST DISCOMFORT (non-serious) with onset 02Nov2021, outcome "unknown", described as "it feels tight but I can breathe"; OROPHARYNGEAL DISCOMFORT (non-serious) with onset 02Nov2021, outcome "unknown", described as "it is still hurting, I may be go in to the emergency room; my throat feel strange"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm"; NASOPHARYNGITIS (non-serious) with onset 02Nov2021, outcome "unknown", described as "I had a cold". Therapeutic measures were not taken as a result of chest discomfort, oropharyngeal discomfort, pain in extremity, nasopharyngitis.  Additional information: Consumer stated, "Of the Pfizer I had the first vaccine today was it normal for the, I do not see it on the list they gave me, but it was side effects that was why I am talking like that. My side effect has badden from the last two hours or more and it felt tight, but I can breathe because I was talking, I have a doctor visit assistance, but I cannot reach her, I think she was in a medical seminar on product convention, so I was reading this paper they gave me that is how I got your number. Do you have any information with quality was that a side effect or It feels like I was holding it, my lymph nodes well for my lymph node my doctor before might may be two year ago just checked in my lymph node, I had a cold, (further clarification unknown) I do not know it is like inside the 'cervix' (further clarification unknown)."  No follow-up attempts are possible. No further information is expected.
could not stop shaking; weakness; rash behind knees and in groin area; feverish; had chills; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (could not stop shaking), ASTHENIA (weakness), RASH (rash behind knees and in groin area), PYREXIA (feverish) and CHILLS (had chills) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included METFORMIN for an unknown indication.    On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Jan-2021, the patient experienced TREMOR (could not stop shaking), ASTHENIA (weakness), RASH (rash behind knees and in groin area), PYREXIA (feverish), CHILLS (had chills) and VACCINATION SITE PAIN (sore arm). On 25-Jan-2021, VACCINATION SITE PAIN (sore arm) outcome was unknown. At the time of the report, TREMOR (could not stop shaking), ASTHENIA (weakness), RASH (rash behind knees and in groin area), PYREXIA (feverish) and CHILLS (had chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2020, COVID-19:.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
Hot, erythematous, three inch diameter macular rash on area of vaccination (posterior deltoid of left arm).  She also had accompanying burning sensation along the ventral forearm and weakness in the hand.  All symptoms and signs resolved completely within four days.  She was treated with cold packs.  She refused benadryl P.O.
Patient came into pharmacy on 2/11/2019 around noon. Her left arm 2 inches above her elbow was red and warm to the touch. The patient did not complain of pain or discomfort. She said the rash appeared the next day after the immunization and appeared to expand the following day.
After administration of Moderna COVID vaccine to left arm, patient reported itchy throat and tingling from left arm to back of neck.
C/o of itchiness of face and neck.  No rash or hives.  Redness where she was scratching with nails  Respirations without distress.  Lungs clear.  VS normal with diastolic 90 (hypertension hx and on meds)  O2 rebreather mask applied by EMT.  Remained to c/o of itchiness after 10 minutes.  Transferred to local hospital.  Received Benadryl po in transit.
had fever approx 100 or 101 on 24DEC95;devel rash on 26DEC95 per t/c mom reports lt is a flat rash-a bit itchy-did not see MD;
palpitations; Fatigue; chills; Malaise; Heat at the injection site; Local discomfort / Injection site; Sinus arrhythmia; Possible right bundle branch block; Thickened endometrium; Dysrhythmia; This case was reported by a nurse via call center representative and described the occurrence of dysrhythmias in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included palpitation (during menopause). Concurrent medical conditions included eyeglasses wearer, endometrial cancer and ovarian adenocarcinoma.   On 10th July 2020, the patient received the 1st dose of Shingrix (intramuscular). On 10th July 2020, less than a day after receiving Shingrix, the patient experienced injection site warmth and injection site discomfort. On 11th July 2020, the patient experienced fatigue, chills and malaise. On 12th July 2020, the patient experienced palpitation. In July 2020, the patient experienced dysrhythmias (serious criteria GSK medically significant), sinus arrhythmia, right bundle branch block and endometrial thickening. In July 2020, the outcome of the injection site warmth, injection site discomfort, fatigue, chills and malaise were recovered/resolved. On 14th October 2020, the outcome of the palpitation was recovered/resolved. On an unknown date, the outcome of the dysrhythmias, sinus arrhythmia, right bundle branch block and endometrial thickening were unknown.   It was unknown if the reporter considered the dysrhythmias, injection site warmth, injection site discomfort, sinus arrhythmia, right bundle branch block, fatigue, malaise, palpitation and endometrial thickening to be related to Shingrix. The reporter considered the chills to be related to Shingrix.  Additional information was provided as follows: The case was reported by patient her self who was a retired nurse. The patient received vaccine intramuscularly in the left deltoid. The patient experienced local discomfort and heat at the injection site which resolved. On Saturday 11th July 2020 the patient experienced chills and fatigue/malaise. On Sunday evening 12th July 2020 the patient began experiencing palpitations. She mentioned that she was not sure if the palpitations were related to the Shingrix or not because she had other stressors (she learned that her husband had cancer). On 28th July 2020 she learned the results of her Dilation and Curettage which was that she had a thickened endometrium which required a hysterectomy. An EKG  (Electrocardiogram) was done which showed dysrhythmia, sinus arrhythmia and possible right bundle branch block. Due to the results of the EKG and because the palpitations had not yet resolved her hysterectomy surgery had to be postponed. She did have the hysterectomy surgeryon 14th October 2020. The palpitations had stopped by 14th October 2020. There were no complications during surgery, there was no dysrhythmia during the surgery. The patient had endometrial cancer and possible adenocarcinoma of the ovary as well. She might require chemotherapy. She had not yet had a follow up EKG but she was scheduled to have one. The reporter consented to follow up.
I woke up and my entire body was sore, my entire right arm is painful and my hands feel tingly. I?ve had a weird feeling in my chest, fast heartbeat, and anxiety since I woke up.  Migraine, sore neck, tiredness but I?m not able to fall asleep because of the anxiety, it?s like my body won?t relax.
chills; stomach cramps; watery diarrhea all day and through the evening; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection (lot number EK9231 and expiry date unknown) via an unspecified route of administration in the left arm on 07Jan2021, 12:15PM at a single dose for COVID-19 immunization. The patient's medical history included allergy to scallops. Concomitant medications included metoprolol, omeprazole, simvastatin, magnesium chloride (SLOW MAG), and colecalciferol (VITAMIN D); patient also receive these medications within 2 weeks of vaccination. The patient had previous allergies with Erythromycin. The patient was not pregnant; did not receive any other vaccines within 4 weeks prior to BNT162B2; and was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient had not been tested for COVID-19. On Sunday, 10Jan2021, 1200AM, reported as three days after vaccine, the patient developed chills, stomach cramps, and watery diarrhea all day and through the evening. No therapeutic measures were taken in response to the events. Outcome of the events at the time of last observation was recovering. The report was considered as non-serious; the events did not result in death, were not life threatening, did not caused/prolonged hospitalization, were not disabling/ incapacitating, and did not caused any congenital anomaly/birth defect.
Narrative:  Patient is presenting to covid vaccine clinic today for first dose covid vaccine. Ten minutes after vaccine, patient began to experience shortness of breath, throat swelling and chest redness. Patient reports history of allergic reactions in which she has had to use an epi pen. An ambulance was called. She was also given benadryl 25mg IM left deltoid and Epi pen IM in left upper thigh. Her vital signs were 143/104, 179/98, heart rate 73 and pulse oximeter 100% on room air. Her respiratory status remained stable. She remained alert and oriented x3. Her husband was by her side. She was taken by ambulance to Medical Center with her belongings in good condition.
Swelling in arm, redness, itchiness.  Facial flushing and puffiness.
FLU LIKE SYMPTOMS (BAD CHILLS, FEVER, FATIGUE, BODY ACHES AND CONSTANT HEADACHE); TINGLING FEELING THROUGH THE BACK ON THE SPINE AND ON THE STOMACH; This spontaneous report received from a patient concerned a 34 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.  The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 023A21A expiry: UNKNOWN) dose was not reported, administered on 20-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 20-MAY-2021, the subject experienced flu like symptoms (bad chills, fever, fatigue, body aches and constant headache). On 20-MAY-2021, the subject experienced tingling feeling through the back on the spine and on the stomach. The action taken with covid-19 vaccine  was not applicable. The patient recovered from flu like symptoms (bad chills, fever, fatigue, body aches and constant headache) on 22-MAY-2021, and had not recovered from tingling feeling through the back on the spine and on the stomach. This report was non-serious.
A couple came in to receive Pfizer COVID boosters and the wife requested a flu shot at the same time. I got both patients ready and scanned their forms into the handheld, and scanned the correct items (flu shot box QR code and manual input for the pfizer shot). When all info was input into the system, I went to give the shot to the husband first, and misakenly grabbed the prefilled flu syringe instead of one of the pfizers I had drawn up. I had an intuition I made the mistake and asked the couple who wanted the flu shot to confirm. They also noticed that I gave the odd vaccine to the husband instead of the wife who requested it.  The husband states that on 10/25 at pharmacy he received this year's flu shot. I confirmed it was this year's afluria. He was not concerned and stated getting a double vaccine should not hurt him. I confirmed this and said he should be fine, but asked them to stay around for 15 minutes to ensure there was no side effect and to get any extra info from them while I filled out the error reporting forms.
Small spots on left arm 1st week. Week 1-7 large spots all over body. Scaly rash.
patient was administered a dose of improperly stored PROQUAD; 15 year old patient was vaccinated with PROQUAD; This spontaneous report as received from an office manager refers to a 15 year old patient. On 23-FEB-2021, the patient was vaccinated with an improperly stored 0.5 mL dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # T027111 exp date 07-FEB-2022). The vaccines were through the temperature excursion on 16-FEB-2021. There was no data logger issue. The temperature of excursion was -10 °C for a time frame of 1 hour 15 minutes.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Mast cell disorder" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "Migraines" (unspecified if ongoing); "Heating loss" (unspecified if ongoing); "Connective tissues disorder" (unspecified if ongoing); "Known allergies: Fibrin glue" (unspecified if ongoing); "Known allergies: Bees" (unspecified if ongoing); "Known allergies: Wasps, fire ants" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Oxycodone, reaction(s): "Known allergies: oxycodone". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken (Paxlovid) as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
a patient received a dose of ROTATEQ at 2 months old and again at 8 months 9 days; No other adverse effects were reported in the patient.; This spontaneous report was received from a registered nurse, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, or concomitant medications were not reported.  On an unspecified date, the patient received the first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally administered, as prophylaxis (dosage regimen, vaccination scheme, lot number and expiration date were not reported), at the age of 2 months old.  On an unspecified date, the patient was vaccinated with the second dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 2 milliliter (ml) orally administered, as prophylaxis (lot number 1684151 which has been verified to be valid, expiration date reported and validated as 23-JUN-2021) (vaccination scheme was not reported), at the age of 8 months and 9 days old (inappropriate schedule of product administration). No other adverse effects were reported in the patient.
Vaccine had been administered in left deltoid. Patient subsequently developed enlarged lymph nodes along the left side of his neck. One enlarged node was noticed on Friday August 19th and another noted Sunday August 21st. They were tender to touch. By Monday morning August 21st 3 supraclavicular nodes were noted and the largest measured 1.5 cm. He was seen by a physician 8/21 where diagnostic labs and imaging were performed.