chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sore Arm; Sore Throat; Fatigue; Nausea; Sugars running high; This is a spontaneous report from a contactable consumer. A 57-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the left arm on 03Apr2021 at 16:15 (at the age of 57-year-old) as a single dose for COVID-19 immunisation. Medical history included type 1 diabetes mellitus. Concomitant medications included levofloxacin (LEVOXIN), insulin lispro (HUMALOG) and insulin glargine (LANTUS), all from an unknown start date for an unknown indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an unspecified route of administration in the left arm on 13Mar2021 at 16:00 (at the age of 57-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 04Apr2021 next day after the vaccine, the patient experienced sore arm, sore throat, fatigue, nausea and sugars were running high (patient type 1 diabetic). 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. The clinical outcome of events sore arm, sore throat, fatigue, nausea and sugars were running high was recovered on an unknown date in Apr2021.   No follow-up attempts are needed. No further information is expected.
Narrative: Patient contacted PCP via phone to report experiencing swollen, itch, tenderness, and redness on his left arm after receiving COVID booster dose on 6/7/22. Patient declined triage at this time. all has improved besides the redness.
p/vax pt felt itching;noticed red prickly bumps over arms & legs;all body even eyes itchy;DPH given;
This spontaneous report as received from a health professional refers to a 17 year old patient of unknown gender. On 20-JAN-2016, the patient was vaccinated with a third dose of GARDASIL lot # K008931 (expiration date 04-MAR-2016) in the right arm (dose and route were not reported), which was stored for 15 hours and 15 minutes in a 33 Fahrenheit (F) degrees. There was no previous temperature excursion and the call was not because of a data logger. Additional information is not expected, as all required correspondence was received.
soreness in arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 85 year-old female patient received bnt162b2 (BNT162B2), administration date 18Oct2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "deafness" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Cortisone injections, notes: cortisone injections. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunization; Bnt162b2 (Dose 2), administration date: Mar2021, for COVID-19 immunization; Flu shot, for Immunization, reaction(s): "rash". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Oct2021, outcome "unknown", described as "soreness in arm".  Additional information: Reporter states she received her second dose of the Pfizer BioNtech covid 19 vaccine in Mar. States that she received her booster shot yesterday, reports soreness in arm and no other side effects. Reporter reports history of cortisone injections as well as deafness. Reporter Seeking information on the difference between the booster shot and the 3rd shot and the 3 criteria for immunocompromised could be addressed. Reporters son who is very active received his booster shot and experienced side effects of headache and fatigue. Reporter states that she had a side effect of a rash after receiving her flu shot.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
The patient developed urticaria approximately 18 hours after vaccination. The patient developed large raised hives around the neck, on the chest, abdomen and in the perineal upper thigh diaper area. The patient was seen in the ER and given an injection of Phenergan. 24 hours later the hives were less and had moved to the arms and legs. The patient was in no distress.
RECEIVED GARDASIL 9, TDAP AND MENVEO THEN STOOD UP, BECAME DIZZY, FELL AND BUMPED LEFT TEMPLE ON WALL IN EXAM ROOM
dimpling; serum sickness; swelling; redness; This spontaneous report was received from a medical assistant and refers to a 75-year-old female patient with hypertension, hyperlipidaemia, hypothyroidism and atrial fibrillation. The patient did not have drug reactions or allergies.   On 25-SEP-2019, the patient was vaccinated intramuscularly with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot # S021740, expiration date 25-MAR-2021 (exact dose was not reported) for prophylaxis. Concomitant therapies included atorvastatin, diltiazem hydrochloride (DILT XR) and apixaban (ELIQUIS).  On 26-SEP-2019, the patient experienced serum sickness, along with swelling, redness and dimpling at injection site. She sought medical attention. She was treated with prednisone. None lab diagnostics were performed.  The outcome of the events and the relatedness between the events and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not reported.
Information has been received from a nurse referring to an unspecified number of unspecified patients. Nurse reported on unspecified dates since 24-DEC-2014, the patients were administered an unspecified number of improperly stored doses of VAQTA (dose, route and lot # not reported). No adverse effect reported. This is one of several reports from the same source. Additional information has been requested.
Info has been received from an RN concerning a 6 year old white female with no known medical history or allergies who in the PM of 8/13/99, was vaccinated, SC in the right upper arm with 0.5ml, 1st dose of varicella virus vaccine live. Concomitant vaccination that day included a 1st dose of MMRII. The RN reported that the morning of 4/21/05 (also reported as 4/28/05), the pt developed chickenpox, it was reported that the mother phoned the office, but the pt was not seen. It was also noted that the pt "had recent exposure". Unspecified medical attention was sought, but no lab/diagnostic tests were performed. At the time of this report, the pt had recovered. Additional info is not expected.
The morning after MENACTRA and BEXSERO were given the patient awoke feeling confused and with slurred speech. He also had inappropriate affect and a headache. He was seen at urgent care and referred to ER. He did not go however and the symptoms resolved by the next morning.
lethargic the day after vaccine that I cant keep eyes open; hives; This is a spontaneous report from a contactable consumer. This 52-year-old female consumer reported. A 52-year-old non pregnant female patient received second dose of bnt162b2 (Comirnaty, formulation: solution for injection, batch/lot number: unknown) via unknown route of administration in left arm on 26Mar2021 at 08:00 AM (at the age of 52 years old) as DOSE 2, SINGLE for COVID-19 immunisation. The patient medical history included trigeminal neuralgua, bipolar, high cholesterol, allergies, type 2 diabetes. Concomitant medication included tizanidine hydrochloride (ZANAFLEX) for spasticity, pregabalin (LYRICA) for anxiolytic, hydrocodone for severe pain, rosuvastatin calcium (CRESTOR) for cardiovascular disease and trazodone as antidepressant therapy. Historical vaccine included first dose of bnt162b2 (Comirnaty, formulation: solution for injection, batch/lot number: unknown) via unknown route of administration in left arm on 05Mar2021 at 08:00 AM (at the age of 52 years old) as DOSE 1, SINGLE for COVID-19 immunisation and experienced numb upper arm for one week and joint pain so badly she could barely move. Patient did not receive other vaccine in four weeks. Patient did not covid prior vaccination and did not covid tested post vaccination. On 27Mar2021 at 09:00 AM, After vaccination patient was lethargic the day after vaccine that she could not keep eyes open and broke out in hives. The patient did not receive the treatment. The outcome of the events were not recovered.  No follow-up attempts were possible. Information about Lot/Batch number cannot be obtained.
contact dermatitis; significant rash which is very itchy; bruise; Afibrillation; A Spontaneous report  was received from Consumer concerning 49-year-old of male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and afibrillation, noticed a significant rash which was very itchy on his hips where he got a bruise, stated his wife thought it was contact dermatitis.  The patient's medical history was not reported. The concomitant medication included Zoloft, Aspirin, Fish oil and Vitamins.  On 11 Mar 2021, 1 day prior to the onset of the event, the patient received their first dose mRNA-1273 (Lot number: 038A21A, Expiration date: not provided) via intramuscular route in the right arm for prophylaxis of COVID-19 infection.  On same day, patient experienced afibrillation which was resolved on 13 Mar 2021.  On 15 Mar 2021 he noticed a significant rash which was very itchy on his hips where he got a bruise and he stated his wife thought it was contact dermatitis.  Action taken was unknown with respect to events.  The outcome of other events were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events,  a causal relationship cannot be excluded
Very enlarged lymph nodes in left arm pit. Swollen to almost double the size of my normal right arm pit. Very very painful; Very enlarged lymph nodes in left arm pit. Swollen to almost double the size of my normal right arm pit. Very very painful; Very enlarged lymph nodes in left arm pit. Swollen to almost double the size of my normal right arm pit. Very very painful; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31 year-old female patient (unknown if pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 30Dec2021 12:30 (Lot number: FT1611) at the age of 31 years as dose 3 (booster dose), single for covid-19 immunisation. Relevant medical history included: "Penicillin" (unspecified if ongoing). Concomitant medication(s) included: SERTRALINE. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EN6207, Location of injection: Arm Left, Vaccine Administration Time: 12:00 PM), administration date: 03Mar2021, when the patient was 31 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6303, Location of injection: Arm Left, Vaccine Administration Time: 12:00 PM), administration date: 20Feb2021, when the patient was 31 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 30Dec2021 12:30, outcome "unknown", described as "Booster"; LYMPHADENOPATHY (non-serious), LYMPHADENOPATHY (non-serious), LYMPH NODE PAIN (non-serious) all with onset 30Dec2021 20:00, outcome "not recovered" and all described as "Very enlarged lymph nodes in left arm pit. Swollen to almost double the size of my normal right arm pit. Very very painful". Therapeutic measures were not taken as a result of lymphadenopathy, lymphadenopathy, lymph node pain.  Additional information: Patient has no COVID prior to vaccination and patient having known allergies to penicillin's.  No follow-up attempts are possible. No further information is expected.
Rash on arm lasting from 02/23/2021 and is still there today 04/09/2021
On 12/24/20  I received the vaccine at Pharmacy, later that night I woke up feeling very cold. My temperature for the first 2 days of 103.1, chills, body aches, veins in my eyes busted. The fever has continued, today 12/28/20, 100.8, I feel dizzy, tired. Due to the holiday, will be seeing my PCP today.
Initial information received on 17-Jan-2019 regarding an unsolicited valid non-serious case received from physician. This case involves a 13 years old male patient who received a dose vaccine FLUZONE QUADRIVALENT (lot UI078AA and 30-Jun-2019) via unknown route in the right deltoid on 17-Jan-2019. It was also reported that the patient also received the same vaccine 2 weeks ago at a pharmacy. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient didn't receive any other vaccinations or medications. It was a case of actual medication error due to Extra dose administered. It was not reported if the patient had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
The vial expired on 19MAY2023 and located in the freezer, thawed and injected on 31MAY2023; No adverse event; Pharmacist is calling to report that several nursing home patients received expired Bivalent booster dose of Moderna COVID-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Pharmacist is calling to report that several nursing home patients received expired Bivalent booster dose of Moderna COVID-19 vaccine), PRODUCT STORAGE ERROR (The vial expired on 19MAY2023 and located in the freezer, thawed and injected on 31MAY2023) and NO ADVERSE EVENT (No adverse event) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 31-May-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 31-May-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Pharmacist is calling to report that several nursing home patients received expired Bivalent booster dose of Moderna COVID-19 vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial expired on 19MAY2023 and located in the freezer, thawed and injected on 31MAY2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Pharmacist is calling to report that several nursing home patients received expired Bivalent booster dose of Moderna COVID-19 vaccine), PRODUCT STORAGE ERROR (The vial expired on 19MAY2023 and located in the freezer, thawed and injected on 31MAY2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Pharmacist is calling to report that several nursing home patients received expired Bivalent booster dose of Moderna COVID-19 vaccine) and PRODUCT STORAGE ERROR (The vial expired on 19MAY2023 and located in the freezer, thawed and injected on 31MAY2023).    The case was for patient 15 out of 20 patients.  No concomitant medications were reported.  Pharmacist was calling to report that several nursing home patients received expired Bivalent booster dose of Moderna COVID-19 vaccine, initially located in the freezer, thawed and injected on 31-May-2023.  Dose administered after 30-day use by date or after manufacturer date of expiry products. The vial did not undergo any temperature excursions.  Moderna vaccines was still effective. There have been no adverse reaction for patient. All booster dose.  Treatment medication was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-727268 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-727268:Master case
This consumer report (initial receipt 27-Nov-2013) concerns a 54 year old female patient. Concomitant medications included a low dose estrogen. On the 14-Nov-2013, the patient received AFLURIA injection (batch number 08549211A) 0.5 mL in the left deltoid. On an unspecified date, right after receiving the injection, the patient developed some soreness at the injection site. Then two hours later, the patient experienced severe stomach pains. The patient stated that she could barely walk and was bowling over. Thirty minutes later, the patient started wheezing, having breathing problems and coughing problems. The patient was taken to the emergency room where she was treated with albuterol and BENADRYL injection. She stated that having these medications she felt really shaky but could breathe again. The patient continued to use her albuterol. Outcome was reported as recovering.
The adverse events were unusual paleness and weakness, fast heartbeat and dizziness, low blood pressure, low temperature, the time of course was for 5-10 minutes, sodium chloride was administered as a treatment into venoses.
Left hand loss of function, left arm weakness & pain, & epigastric discomfort following receiving the Pfizer comirnaty vaccine
Pain at injection (L) when lifting; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Pain at injection (L) when lifting) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     Previously administered products included for an unreported indication: ANORO (COPD). Concurrent medical conditions included Hypertension and COPD.    On 14-Jan-2021 at 5:03 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced INJECTION SITE PAIN (Pain at injection (L) when lifting). On 15-Jan-2021, INJECTION SITE PAIN (Pain at injection (L) when lifting) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment medications were provided by the reporter.
One day subsequent to receiving vax, pt woke up rubbing injection site and complaining of pain. Pt refused to walk on leg when taken to day care. Pt is a twin and sibling also suffered leg pain following vax.
Left deltoid, area were DTaP administration very red and swollen, hot. Father states child has no fever, doing fine, no pain.
The patient was escorted to the waiting room post vaccine injection. He reported feeling light-headed. At 1220 while the NP was by his side, he became clammy, lost color, and became unresponsive with eyes rolled.  He maintained his breathing and became conscious at 1225 with color returning and alert and oriented x 3. Pulse 65 BPM, O2 Sat 97-98% RA. He was escorted to the exam room table with the NP and PCT and placed in the supine position. He reports feeling light-headed and nauseous but alert and oriented x 3; BP 102/65, P 65 BPM, RR 16, O2 sat 97-98%. Notified at 1238. The patient was observed by the NP and remained with continuous pulse ox monitoring. At 1309, HOB raised to 30 degrees and patient given sips of water; BP 104/60, P 61 BPM, RR 16, O2 sat 97% RA. At 1323, HOB raised to 45 degrees. Patient c/o dizziness and nausea but tolerating sips of water;  BP 110/75, P 63 BPM, RR 16, O2 sat 100% RA. At 1330, HOB raised to 90 degrees. Patient c/o dizziness and nausea, tolerating sips of water,  BP 110/75, P 60 BPM, RR 16, O2 sat 98%. Patient escorted to waiting room chair at 1330 with NP and PCT. He c/o dizziness and nausea with position change, BP 110/75, P 60 BPM, RR 16, O2 sat 98% RA. He remains in the waiting room chair with PCT observation. At 1335, he begins with vomiting x 1 episode. He reports that he feels better and denies dizziness at this time. At 1353 he reports that he is feeling better. Denies dizziness or nausea; BP 104/60, P 65 BPM, RR 18, O2 sat 100% RA. He was discharged at 1410 with his boss from work. He is alert and oriented x 3, denies SOB, dizziness, lightheadedness, or N/V.
This initial spontaneous case, was received from other non-health professional on 02-Oct-2017, concerning a 41-year-old, adult, female pregnant patient. The last menstrual period of the patient was 10-Jul-2017, it was reported that, the patient had no significant personal (relevant to pregnancy) or paternal medical history (hereditary disease). On 01-Oct-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: Intramuscular, batch number: 195236 (as reported), expiry date: May-2018, anatomical location: right deltoid). It was reported that, this was the first pregnancy of the patient and she received FLUCELVAX QUADRIVALENT when she was 12 weeks pregnant. The estimated date of delivery was reported as 16-Apr-2018. The reporter assessed the event as non-serious. Follow up report received on 20-Oct-2017: The LMP of the patient was added, it was reported that, the patient had no significant personal (relevant to pregnancy) or paternal medical history (hereditary disease). The anatomical location (right deltoid) was added. The batch number was updated from 195235 to 195236. The EDD of the patient was added. The narrative was amended accordingly.
Shot didn't help. Still get them, but not as bad./Suspected Vaccination failure; Shot didn't help. Still get them, but not as bad.; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient received Shingles vaccine and had shingles. The patient stated that he/she feel your pain as shot did not help and still, he/she get them, but not as bad and also stated 10 years of these devils. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting. The follow-up would not possible as no contact details were available.
I still had right arm pit pain. It was short lived but it lasted for about 3 days. I had a minor headache. The headache lasted less than 24 hours. Its wasn't right after the shot, it was mostly the next day. I took some Tylenol. A rash appeared on my leg on 4/15. I ended up with insane red and itchy skin on both of my legs. I tried to take a bath and it made it sting. It was really uncomfortable. I was using cortisone for a while. I reached out to my doctor and he prescribed a topical cream. I also had flu like symptoms with the rash. I haven't had the flu in years. I had an a headache, fatigue, chills and fever for 48 hours. So far, I've had this rash for 10 days. All other symptoms have subsided.