chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Jan2021 at 16:30 as dose 1, single (Batch/Lot number: unknown), in left arm, on 30Jan2021 at 16:00 as dose 2, single (Batch/Lot number: unknown), in left leg and on 15Aug2021 at 15:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 54 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 24Jan2022 at 13:15 as dose 4 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "asthma" (unspecified if ongoing); "LBP" (unspecified if ongoing), notes: LBP; "Interchange of Vaccine" (unspecified if ongoing). Concomitant medication(s) included: ADVAIR, start date: Jan2016; SINGULAIR, start date: Jan2016; GABAPENTIN, start date: Jan2020. Past drug history included: Keflex and vicryl sutures, reaction(s): "Allergy", notes: known allergies: Keflex and Vicryl sutures. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2022) Negative; (May2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course included: COVID-19 was treated with Pfizer drug (lot number:  FY5656) from 2MAy2022 to 6May2022. Day 1-4 post Paxlovid treatment She tested negative on home antigen test. Day 5 woke up with symptoms (headache, sore throat, dry cough, chest tightness, arthralgias). Tested positive on home antigen test. Rebound.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information provided in the narrative, a causal association between the suspect drug and the events cannot be completely excluded.
was very sleepy; pain in his arm; end of the gums at around the wisdom tooth area on the bottom part of the jaw, he noticed white spots that were like pimples. They were infection spots and were painful; This is a spontaneous report from a contactable consumer or other non Healthcare Professional. (Patient, reported for self).  A male patient of (age: 44; unit: unknown) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number and Expiration date: Not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient mentioned that he received the 1st dose of the vaccine and experienced side effects. During the 1st day, he was okay. but was very sleepy the day after with a little pain in his arm. About 3-4 days after, he mentioned that at the end of the gums at around the wisdom tooth area on the bottom part of the jaw, he noticed white spots that were like pimples. They were infection spots and were painful. He already consulted his dentist and he cannot determine if this was related to the vaccine. He is due for a follow up in 2 weeks to see if there is improvement. He mentioned that his friends  whose parents also experienced these effects after getting the 2nd dose. He is concerned because he is due for his 2nd dose next week and doesn't want to have any more problems. The clinical outcome of the adverse events were unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained
five employees in a nursing home have gotten the first dose of the vaccine, and then tested positive for COVID; five employees in a nursing home have gotten the first dose of the vaccine, and then tested positive for COVID; This is a spontaneous report from a contactable nurse. This nurse reported similar events for five patients. This is the fourth of five reports. A patient of unspecified age and gender received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiry date not reported) via an unspecified route of administration, on an unspecified date, single dose for COVID-19 immunization. Relevant medical history and concomitant medications were not reported. It was reported that five employees in a nursing home have gotten the first dose of the vaccine, and then tested positive for COVID on an unspecified date. They would like to know if they still get the second dose. Outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: The information currently provided is too limited to make a meaningful medical assessment hence, the events are conservatively assessed as related to the suspect drug BNT162B2 until further information becomes available.,Linked Report(s) : US-PFIZER INC-2021021881 Same reporter/ drug/ event  for different patients
No adverse event, we were instructed to report to VAERS because vaccine was given to a pt under 18 yrs old.
foggy; dizzy; hurt; got a bump near where she had the vaccine that itched like crazy; got a bump near where she had the vaccine that itched like crazy; hive; This is a spontaneous report from a contactable consumer reported for herself. A 73-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EN6205, Expiration date: unknown), via an unspecified route of administration, administered in Arm Left on 01Mar2021 (age at vaccination was 73 years) as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were unknown. On an unspecified date the patient experienced foggy, dizzy, hurt, got a bump near where she had the vaccine that itched like crazy and hive. Patient had the usual symptoms and was foggy, dizzy, she hurt, and was out of it. Patient said that Saturday night she got a bump near where she had the vaccine that itched like crazy. Patient took 2 Benadryl to treat it, the next day she took a Benadryl and the day after that she took a Benadryl and it went away. Patient said that it was like a itchy bumpy hive. Patient was told to come back on 29Mar2021 but she found one to where she could get it on 23Mar2021. Patient was able to get a second Pfizer dose scheduled for Tuesday 24Mar2021. Therapeutic measures were taken as a result of got a bump near where she had the vaccine that itched like crazy and hive. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions and concomitant medications was reported. On 10-MAR-2016, the patient was vaccinated with a dose of PROQUAD (Merck) subcutaneously (dose, lot #, expiry date and anatomical location were not specified). Other suspect therapies included VARIVAX (Merck) (dose, lot #, expiry date, route of administration and anatomical location were not reported) administered on the same day. This was outside of the labeled recommendations in both the PROQUAD and VARIVAX (Merck) prescribing information. No adverse effect was reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
COVID-19 treatment; COVID-19 treatment; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 67-year-old male patient received BNT162b2 (BNT162B2), on 03Feb2021 as dose 1, single (Lot number: EL9262), on 25Feb2021 as dose 2, single (Lot number: EM9809) and on 27Sep2021 as dose 3 (booster), single (Lot number: 30135BA) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "BPH" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing); "Type 2 diabetes" (unspecified if ongoing). Concomitant medication(s) included: ATENOLOL; ATORVASTATIN; FIBERCON; CANAGLIFLOZIN; FAMOTIDINE; FINASTERIDE; GABAPENTIN; GLIPIZIDE; LEVOTHYROXINE; MELOXICAM; QUINAPRIL; SPIRONOLACTONE; TAMSULOSIN. Patient had no known allergies. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "COVID-19 treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19.; Sender's Comments: Based on the information available and close temporal association, a possible contributory role of the suspect Product cannot be excluded for the reported events . The case will be reassessed once new information is available.
Information has been received from a nurse practitioner concerning her 16 year old "healthy" daughter with no pertinent medical history who on 05-AUG-2009 was vaccinated intramuscularly with the first 0.5 ml dose of GARDASIL in the morning. The nurse practitioner reported that on 05-AUG-2009 by the afternoon, the patient developed tongue ulcers, trembles and body aches. The patient sought unspecified medical attention. Additional information was received from an operations IT manager and a physician, who is the patient's father. It was reported that the patient received GARDASIL (Lot # 662724/0313Y) and did not receive any concomitant vaccinations. The patient also developed flu-like symptoms. Therapy with human papillomavirus vaccine was discontinued. On an unspecified date, the patient recovered from tongue ulcers, trembles, body aches and flu-like symptoms. Additional information has been requested.
Initial information received on 04-Oct-2018 regarding an unsolicited valid non-serious case received from a other health professional by phone. This case involves a 15 months old patient who was vaccinated with an 0.5 ml expired dose of ACT-HIB (lot number: UI807AAA and expiry date: 01-Oct-2018) via intramuscular route in the right thigh on 03-Oct-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PREVENAR 13 for Immunisation; and FLULAVAL for Immunisation. It was a case of actual medication error due to expired vaccine used. No adverse symptoms have been reported at this time. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's 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. Documents held by sender: none.
This spontaneous report has been received from a medical assistant concerning an 11 year old patient of unknown gender. The patient's medical history, drug allergies, concurrent conditions and concomitant therapies were not reported. On 21-SEP-2017, the patient was vaccinated with improperly stored GARDASIL 9 with lot number N004798 and expiration date on 31-OCT-2019 (dose, dose number, route of administration and anatomical location were not provided) administered for prophylaxis. It was reported that on an unspecified date, the vaccine was exposed to a temperature between 32 Fahrenheit degrees and 35 Fahrenheit degrees for 72 hours. There was no previous temperature excursion. The call was placed because of a Digital Data logger report. No product quality complained was involved. No adverse effects were reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1710USA016179: US-009507513-1710USA001257:
No feeling in feet; Legs are weak; Cannot walk without assistance; Feet are 100% numb/Numbness traveling higher up the leg, into thighs and hips; This spontaneous case was reported by a consumer and describes the occurrence of SENSORY LOSS (No feeling in feet), MUSCULAR WEAKNESS (Legs are weak), GAIT DISTURBANCE (Cannot walk without assistance) and HYPOAESTHESIA (Feet are 100% numb/Numbness traveling higher up the leg, into thighs and hips) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043B21 and 019B21A) for COVID-19 vaccination.     Concurrent medical conditions included Panic attacks and Menopause (She takes hormone replacement therapy twice a week for Menopause). Concomitant products included ALPRAZOLAM (XANAX) for Panic attacks.   On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Apr-2021, the patient experienced SENSORY LOSS (No feeling in feet), MUSCULAR WEAKNESS (Legs are weak), GAIT DISTURBANCE (Cannot walk without assistance) and HYPOAESTHESIA (Feet are 100% numb/Numbness traveling higher up the leg, into thighs and hips). The patient was treated with GABAPENTIN at an unspecified dose and frequency; DULOXETINE at an unspecified dose and frequency and METFORMIN for Diabetes, at an unspecified dose and frequency. At the time of the report, SENSORY LOSS (No feeling in feet), MUSCULAR WEAKNESS (Legs are weak), GAIT DISTURBANCE (Cannot walk without assistance) and HYPOAESTHESIA (Feet are 100% numb/Numbness traveling higher up the leg, into thighs and hips) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Apr-2021, Blood glucose: 103 (normal) sugar was 103.         Patient was taking Hormone replacement therapy for menopause  Patient reported that she needed back surgery   This case was linked to MOD-2021-224955 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 19-Jul-2021: Follow up received: Outcome of the events was updated to resolved.
Pt had some initial pain from inj for a few days then resolved - but less than 1 wk later she experienced deltoid and left arm pain with arm movement. Pain to elbow. Relatively comfortable with arm at rest. Area in question non tender, no erythema, no visible swelling.
hives all over body; This case was reported by a consumer via other and described the occurrence of generalized urticaria in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced generalized urticaria. On an unknown date, the outcome of the generalized urticaria was unknown.   It was unknown if the reporter considered the generalized urticaria to be related to Shingrix.     Additional Information: GSK Receipt Date: 09-MAY-2022. Reporter's Comments: The reporter stated that she had second dose of Shingrix and had hives all over.
My scale aches and joint pain; My scale aches and joint pain; This is a spontaneous report from a contactable nurse (patient). A 41-year-old female patient received BNT162B2 (Lot/batch number and expiry date unknown), via an unspecified route of administration on 05Jan202115:00 at single dose in the left arm for COVID-19 immunization. There were no concomitant medications. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. The patient reported that her scale aches and experienced joint pain, both on 05Jan2021 18:00. The patient did not receive any treatment for the events. The patient underwent lab tests and procedures which included nasal swab: pending result on 06Jan2021. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination and did not receive other medications in two weeks. The outcome of the events was not recovered.  The following information on the batch number has been requested.
While in observation @ 4:25p, a pt stated she felt weak, and that her defibrillator went off. She has a hx of heart issues and that her defibrillator goes off several times a year when her HR goes above 118 for a certain sustained amount of time. EMT's evaluated the pt, pt was placed on a monitor by emts, refused oxygen, didn't agreed to go to the ER at first but agreed after speaking with EMT's. Brought to  ER, husband who was in the car, was notified by police detail.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old male patient received BNT162b2 (BNT162B2), on 14Dec2021 at 12:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 52 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. No known allergies. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (04Jul2022) Positive, notes: I had rebound tested positive again after 5 day course of plaxovid treatment; (unspecified date) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient received Plaxovid from 24Jun2022 to 29Jun2022 as treatment of COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Her arm where she was injected was a little sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Her arm where she was injected was a little sore) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 091021A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jul-2021, the patient experienced VACCINATION SITE PAIN (Her arm where she was injected was a little sore). On 21-Jul-2021, VACCINATION SITE PAIN (Her arm where she was injected was a little sore) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications was reported. No treatment drug details was reported.   Most recent FOLLOW-UP information incorporated above includes: On 10-Sep-2021: Follow up contains significant information of second dose details
hives, over entire body itching, nausea, loss of memory, double vision, trouble focusing; Deltazone treatment @ ER, Seldane, Lrazepam seperate treatments;
This case was reported by a physician via call center representative and described the occurrence of tiredness in a 63-year-old male patient who received SHINGRIX (batch number 9349T, expiry date 7th March 2021) for prophylaxis. Co-suspect products included SHINGRIX (batch number EH9Z7, expiry date 8th March 2021) for prophylaxis. Concomitant products included SHINGRIX. On 15th October 2018, the patient received the 2nd dose of SHINGRIX. On 17th December 2018, the patient received the 3rd dose of SHINGRIX. On 15th October 2018, unknown after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced drug dose administration interval too short. On 17th December 2018, the patient experienced extra dose administered. On an unknown date, the patient experienced tiredness and pain. On an unknown date, the outcome of the tiredness and pain were not recovered/not resolved and the outcome of the drug dose administration interval too short and extra dose administered were unknown. It was unknown if the reporter considered the tiredness and pain to be related to SHINGRIX. Additional details were provided as follows: On 9th October 2018, the patient received 1st dose of SHINGRIX(batch number 9349T, expiry date 7th March 2021). The patient inadvertently received 3 doses of SHINGRIX, which led to extra dose administered. The patient received 2nd dose of SHINGRIX earlier than recommended interval, which led to shortening of vaccination schedule. The patient now complained of feeling tired and achy since the last dose was administered. The batch number of SHINGRIX was updated from EH927 to EH9Z7, according to sales data sheet. Consent to follow up was given. Doctor reports that the patient's physical exam was normal. The reporter listed all 3 doses of SHINGRIX for chronology and because of the concern that the cumulative effect might be impacting the patient's symptoms. Lab Comments: On an unknown date, the patient's physical examination was normal.
patient stated he had a "tickle" in his throat.   After observing for an additional 10 mins, he stated he was having a little difficulty in swallowing.   Gave him 50 mg of Benadryl gel caps
Medication pulled from freezer, dated with 70 day expiration date instead of 30 day.  Patient received medication that was expired by two days
Headache, vomiting, somnolence, Bodyaches, Sweating, and runny nose.
Enlarged lymph nodes, armpit, Left arm (arm that received injection).  Sore, like a bruise, in armpit and lower left collarbone.  Swelling under armpit.  Alternated ibuprofen and acetaminophen x3 days.  Applied gel warm pack 2x/day x 3 days.  Began two days after booster.   5 days after booster still tender but swelling reduced.  This side effect not present during first two vaccinations.
Information has been received from a registered nurse referring to an unspecified number of patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored doses of (Merck) VARIVAX (lot # K006138, expiration date 29-APR-2016, dose and route were unknown). No adverse effects reported. This is one of the two reports received from the same source. Additional information has been requested.
Chest tightness, a little SOB than normal, using inhaler more often than usual, pruritus at site of injection that became more generalized. Swelling at site of injection. Improving but not resolved yet. On prednisone 50 mg x 3D.
Shaking; Freezing to death; Hair wet, all his clothes wet and sheets were wet from sweat.; Very tired; 101 fever; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Shaking), FEELING COLD (Freezing to death), HYPERHIDROSIS (Hair wet, all his clothes wet and sheets were wet from sweat.), FATIGUE (Very tired) and PYREXIA (101 fever) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042BZ1A and 021BZ1A) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Apr-2021, the patient experienced TREMOR (Shaking) and HYPERHIDROSIS (Hair wet, all his clothes wet and sheets were wet from sweat.). 28-Apr-2021, the patient experienced FEELING COLD (Freezing to death), FATIGUE (Very tired) and PYREXIA (101 fever). At the time of the report, TREMOR (Shaking), FEELING COLD (Freezing to death), HYPERHIDROSIS (Hair wet, all his clothes wet and sheets were wet from sweat.), FATIGUE (Very tired) and PYREXIA (101 fever) outcome was unknown. Not Provided          Concomitant medication list was not provided. Treatment information was not provided.    This case was linked to MOD-2021-101654 (Patient Link).