chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "known allergies: penicillin" (unspecified if ongoing), notes: known allergies: penicillin. Concomitant medication(s) included: ESTRADIOL. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken 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.
He said with his first Pfizer BioNTech COVID-19 Vaccine shot, he felt where the vaccine needle had gone into his (left) arm, and was still having the same feeling in his (left) arm.; left shoulder pain; left elbow pain; left wrist pain; Injection site pain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 16Feb2021 (Lot number: EL9261) at the age of 73 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: PARAESTHESIA (non-serious) with onset 16Feb2021, outcome "unknown", described as "He said with his first Pfizer BioNTech COVID-19 Vaccine shot, he felt where the vaccine needle had gone into his (left) arm, and was still having the same feeling in his (left) arm."; ARTHRALGIA (non-serious) with onset 16Feb2021, outcome "recovered" (2021), described as "left shoulder pain"; ARTHRALGIA (non-serious) with onset 16Feb2021, outcome "recovered" (2021), described as "left elbow pain"; ARTHRALGIA (non-serious) with onset 16Feb2021, outcome "recovered" (2021), described as "left wrist pain "; VACCINATION SITE PAIN (non-serious) with onset 16Feb2021, outcome "not recovered", described as "Injection site pain". Additional Information: clinical course was reported as Adverse Event (AE) Details: He stated he had both Pfizer BioNTech COVID-19 Vaccine shots. He said with his first Pfizer BioNTech COVID-19 Vaccine shot, he felt where the vaccine needle had gone into his (left) arm and was still having the same feeling in his (left) arm. He said he got his second Pfizer BioNTech COVID-19 Vaccine shot on 09Mar2021, and he had pain in his (left) arm. He said he was having pain in 3 places; his (left) shoulder, (left) elbow, and (left) wrist. He said the pain comes and goes. He said last weekend, he had pain in either his (left) shoulder, (left) elbow, or (left) wrist all weekend long. He said the intermittent (left) shoulder, (left) elbow, and (left) wrist pain lasted 3-4 days. He said he would have pain in his (left) shoulder that would go away, and then he might have pain in his (left) elbow, and that pain would go away, and then he would have pain in his (left) wrist that pain would go away. He clarified he rarely had pain in his left shoulder, elbow, and wrist all at the same time. The patient reported that, it was nothing serious, but he continued to have an issue. The patient had not visited emergency room or physician office due to the event and patient had not received any other vaccinations within 4 weeks (Prior Vaccinations). No Relevant Tests was done. Patient had both Pfizer BioNTech COVID-19 Vaccine shots. Patient reported there was no NDC Number or Expiration Date listed on his COVID-19 Vaccination Card for his first or second vaccine dose. Vaccination Facility Type: Hospital. No Vaccine Administered at (Privacy) Facility.   No follow-up attempts are possible. No further information is expected.
pt recv vax & devel pruritus characterized by itchy palms which progressed to a gen body itch, heart burn, & heaviness in chest feeling;pt is recovered;addtl info was recv 29APR96;pt MD attributed sx to triamcinolone inj given prior to vax
following DTP/OPV/HIB vax pt exp a maculopapular rash & an inject site rxn which included swelling, itching & tenderness; seen in office; tx DPH & Calamine lotion; subsequent skin peeling;
Pt reported feeling very cold, UE cold to palpation and observed UE & LE shaking.  AOx3 and able to follow directions and answer questions.  Reports similar allergic reaction to unknown muscle relaxer in the past.  Reports sypmtoms did not occur with 1st Pfizer dose.  Benadryl 50mg PO administered w/ water at 1225.  VSS.  Pt reports feeling "much better" shortly after, intermittent shaking continues.  Requested to use restroom at approx 1240.  Escorted to restroom with family after obtaining stable orthostatic VS and pt reported no dizziness. VS 1220 sitting HR 125, RR 25, BP 145/86, O2 99%RA  1228 sitting HR 71, RR 18, BP 115/66, O2 99%RA  1240 sitting HR 104, RR 18, BP 125/75, O2 98%RA 1242 standing HR 103, RR 18, BP 122/75, O2 98%RA  Released w/ family @ 1250
grunts and groans; grunts and groans; Legs hurting; Having difficulty walking; This is a spontaneous report from a contactable consumer (patient) reported for himself. A 95-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown, Expiry date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on an unknown date (age at vaccination was unknown) at a single dose for Covid-19 immunisation. Medical history included aortic valve replacement. Concomitant medication was not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown, Expiry date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on an unknown date (age at vaccination was unknown) at a single dose for Covid-19 immunisation. The patient was on the line for Celebrex. The patient ran out of medication. He was enrolled before a long time ago. He told her that he did not had any Celebrex since end of Feb2021 or end of Mar2021, and he could hardly walk and legs were hurting. He has had both COVID shots. He said he grunted and groaned a lot nowadays. He was having difficulty walking. Having difficulty walking was reported as worsened. He was not blaming Pfizer for anything if this was cause of his problems. He would like to determine if being out of medication was a cause of his legs hurting. It just dawned on him, that maybe it was why he was hurting so was because he was out of Celebrex. He did not remember the date his legs hurt. This always happened in the past when he took the Generic. The outcome of the events grunts and groans and legs hurting was unknown. The outcome of the event having difficulty walking was not recovered.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
p/vax pt exp a total of two episodes of arthus phenomenon;tics were on for a a short period of time (1-4 hours) producing the phenomenon;pt exp long lasting local rxn of up to more than 1month & also exp erythema migrans;pt outcome unk;
This case was reported by a physician via sales rep and described the occurrence of shingles in a 81-year-old female patient who received SHINGRIX for prophylaxis. On 31st July 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 11th August 2018, 11 days after receiving SHINGRIX, the patient experienced shingles and pain. On an unknown date, the patient experienced post herpetic neuralgia. The patient was treated with LYRICA and antivirals for systemic use. On an unknown date, the outcome of the shingles, pain and post herpetic neuralgia were not recovered/not resolved. The reporter considered the shingles, pain and post herpetic neuralgia to be related to SHINGRIX. Additional details reported as follows: The physician reported to the sales representative that the patient experienced left thoracic shingles on her T-11 area. The patient went to the emergency room, was prescribed an antiviral, and was discharged home. Also, the patient was prescribed LYRICA by her physician.
Information has been received from a registered nurse regarding her 18 year old son. The patient's medical history, drug reactions or allergies were not provided. On 10-JAN-2014, the patient was vaccinated with an intramuscular dose of ZOSTAVAX, (dose and lot number were not provided) instead of GARDASIL as prescribed. No adverse effects were reported. Additional information has been requested.
First dose of Shingrix on 09/272019 / Second dose of Shingrix on 06/28/2021; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 76-year-old male patient who received Herpes zoster (Shingrix) (batch number 393C7, expiry date 25th October 2022) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 27th September 2019, Batch number- 227FL and expiration date- 26th September 2020).   On 28th June 2021, the patient received the 2nd dose of Shingrix (intramuscular). On 28th June 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: The patient received the 2nd dose of Shingrix in right arm, later than the recommended interval, which led to lengthening of vaccination schedule. The reporter did not consent to follow up.
Information has been received from a health professional concerning a 16 year old female with a history of smoking one pack of cigarettes per day and drinks coffee, who on 23-OCT-2007 was vaccinated with her first dose of Gardasil vaccine (Lot# 654510/0962F). On 23-OCT-2007, the patient fainted and vomited while she was still in the office. Subsequently, the patient recovered from fainting and vomiting while she was in the office. Additional information has been requested.
moderate soreness at injection site; swelling and soreness of infraclavicular lymph node; swelling and soreness of infraclavicular lymph node; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old female patient received BNT162b2 (BNT162B2), on 21Aug2021 as dose 3 (booster), single (Lot number: FC3181) at the age of 70 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose: 1, Date: 28Jan2021, Type/Mfr: Pfizer Covid-19 mRNA, Lot Number: EL9262), administration date: 28Jan2021, when the patient was 69-year-old, for COVID-19 immunization, reaction(s): "moderate soreness at injection site", "swelling and soreness of infraclavicular lymph node", "swelling and soreness of infraclavicular lymph node"; BNT162b2 (Dose: 2, Date: 17Feb2021, Type/Mfr: Pfizer Covid-19 mRNA, Lot Number: EN6200), administration date: 17Feb2021, when the patient was 70-year-old, for COVID-19 immunization, reaction(s): "moderate soreness at injection site", "swelling and soreness of infraclavicular lymph node", "swelling and soreness of infraclavicular lymph node". The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "moderate soreness at injection site"; LYMPHADENOPATHY (non-serious), LYMPH NODE PAIN (non-serious), outcome "unknown" and all described as "swelling and soreness of infraclavicular lymph node".  Additional Information: Prior Vaccinations: None. Family Medical History Relevant to Adverse Events (AES): No one in family has had adverse reaction to vaccines of any kind. Relevant Tests and Specific Relevant Test for Thromboembolic Events with Thrombocytopenia: None. The Product did not work as expected. Contracted positive COVID 3 weeks past vaccine Checked. The patient experienced adverse event(s) due to the lack of effect of the product. The patient taken 6 COVID vaccine. All previous were Pfizer except 5 which was Merck. Moderate soreness at injection site. Swelling and soreness of infraclavicular lymph node lymph node experienced with each of the 6 COVID injections.
DIFFICULTY IN BENDING; WEAKNESS IN LOWER BODY; PAIN ON LOWER BACK; HURTING NECK; MUSCLE WEAKNESS; JOINT PAIN IN LOWER EXTREMITIES/KNEE PAIN/HIP PAIN; LEG PAIN; This spontaneous report received from a patient concerned a 52 year old male. The patient's weight was 215 pounds, and height was 71 inches. The patient's concurrent conditions included hypothyroidism, alcohol use, non-smoker, and autoimmune disease/vitiligo/skin disease, and other pre-existing medical conditions included the patient had no known allergies. the patient had no history of drug abuse or illicit drug use.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A expiry: 07-AUG-2021) dose was not reported, administered on 13-MAY-2021 for prophylactic vaccination. Concomitant medications included levothyroxine for hypothyroidism. On JUN-2021, the subject experienced pain on lower back. On JUN-2021, the subject experienced hurting neck. On JUN-2021, the subject experienced muscle weakness. On JUN-2021, the subject experienced joint pain in lower extremities/knee pain/hip pain. On JUN-2021, the subject experienced leg pain. On 22-JUN-2021, Laboratory data included: Blood test (NR: not provided) Negative. On an unspecified date, the subject experienced difficulty in bending, and weakness in lower body. Treatment medications (dates unspecified) included: prednisone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from muscle weakness, joint pain in lower extremities/knee pain/hip pain, hurting neck, pain on lower back, and leg pain, and the outcome of difficulty in bending and weakness in lower body was not reported. This report was non-serious.
Injection site red after 1st dose; Injection site swollen after 1st dose; Injection site hot to the touch after 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Injection site red after 1st dose), VACCINATION SITE WARMTH (Injection site hot to the touch after 1st dose) and VACCINATION SITE SWELLING (Injection site swollen after 1st dose) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046b21a) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (Injection site red after 1st dose), VACCINATION SITE WARMTH (Injection site hot to the touch after 1st dose) and VACCINATION SITE SWELLING (Injection site swollen after 1st dose). At the time of the report, VACCINATION SITE ERYTHEMA (Injection site red after 1st dose), VACCINATION SITE WARMTH (Injection site hot to the touch after 1st dose) and VACCINATION SITE SWELLING (Injection site swollen after 1st dose) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
9-10 minutes after the injection the mucous membraines in my mouth (including tongue and lips) went totally dry and tonue and lips started tingling/buzzing and went numb. No productin of saliva was happening making swallowing difficult. Additionally eyes felt dry/itchy. Tongue and lips also felt swollen but didn't appear swollen. I was able to work up a slight amount of saliva after few minutes and swallow with moderate difficulty. Purchased a bottle of water and had no difficulty swallowing that. Did not seek assistance as my heart rate was normal, no difficulty breathing, no outbreak of hives or swolllen face/extremeities. Departed store at 25 min. as symptoms get worse.  Symptoms gradually abated by 12 hour mark.
pt fussiness w/no feeding w/in 1hr p/vax;24hr to ER c/o being limp, eyes rolled up & ? sz x 45sec;
Rash on right upper arm. Initially has pustules that became blisters overnight. No fevers. Monitor for now. May consider starting antibiotics if it continues to spread.
fever 103 x 24hr;then fever of 100 x 24hr;achiness all over;severe soreness of arm inj administered;whelps on arm (4-5 days) where inj given;pt self administered pain med & APAP;did not see MD;
Developed temp 5:30 "felt cold" joints achy at first then few hours later achy all over actually took temp later that evening and temp was 101. Treated self wtih OTC ASA or Tylenol but continued to have temp until 04/13/2005.
unprovoked seizure; does not remember the incident at all; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (unprovoked seizure) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021B21A and 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma and Penicillin allergy.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SEIZURE (unprovoked seizure) (seriousness criteria hospitalization and medically significant) and MEMORY IMPAIRMENT (does not remember the incident at all). At the time of the report, SEIZURE (unprovoked seizure) and MEMORY IMPAIRMENT (does not remember the incident at all) outcome was unknown.            Concomitant medication was not reported. Treatment information was not reported.  Company Comment: This case concerns a 61-year-old, female patient with no relevant medical history, who experienced the unexpected serious AESI event of Seizure and the unexpected event of Memory impairment. The events occurred on an unknown date after the second dose of mRNA-1273 Vaccine. which resulted in hospitalization At the time of the report the outcome of the events was unknown. The rechallenge is not applicable since no further dosing is expected. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This case concerns a 61-year-old, female patient with no relevant medical history, who experienced the unexpected serious AESI event of Seizure and the unexpected event of Memory impairment. The events occurred on an unknown date after the second dose of mRNA-1273 Vaccine. which resulted in hospitalization At the time of the report the outcome of the events was unknown. The rechallenge is not applicable since no further dosing is expected. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Felt terrible; Very little sleep; Dizziness; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Felt terrible), SLEEP DEFICIT (Very little sleep) and DIZZINESS (Dizziness) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (Felt terrible), SLEEP DEFICIT (Very little sleep) and DIZZINESS (Dizziness). At the time of the report, FEELING ABNORMAL (Felt terrible), SLEEP DEFICIT (Very little sleep) and DIZZINESS (Dizziness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.
slight dizziness on 07/31/21 and 08/01/2021.  Unable to walk or drive 08/02/2021 and that continued until today 08/07/2021 which I am still completely spinning when I move any at all.  I am not able to drive.  I am taking Meclizine to help with the nausea from the dizzziness.
Tested positive for covid-19 after receiving 1st dose of the vaccine.; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (Tested positive for covid-19 after receiving 1st dose of the vaccine.) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jul-2021, the patient experienced COVID-19 (Tested positive for covid-19 after receiving 1st dose of the vaccine.). At the time of the report, COVID-19 (Tested positive for covid-19 after receiving 1st dose of the vaccine.) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Jul-2021, SARS-CoV-2 test: tested positive for covid (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were mentioned. No treatment details were reported.
Pt came in today for 2nd shot of series and complained his arm still hurt from first shot in May
Information has been received from a consumer concerning her 19 year old daughter with no medical history and no drug reactions/allergies who on 30-DEC-2010 was vaccinated intramuscularly with the first 0.5 ml dose of GARDASIL (lot number not reported). There was no concomitant medication. On 02-JAN-2011 the patient was complaining of fever, chills, dizziness and fatigue. The patient did not seek medical attention. The patient's fever and chills and dizziness and fatigue persisted. Additional information has been requested.
This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient. A 32-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Lot number: EH9899), in left arm, as dose 2, single (Lot number: EL0140), in left arm and on 21Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 31 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Bipolar" (unspecified if ongoing); "MDD" (unspecified if ongoing); "almonds" (unspecified if ongoing). Concomitant medication(s) included: WELLBUTRIN XL, start date: 01Jan2017, stop date: 25Jul2022; LAMICTAL, start date: 01Jan2017, stop date: 25Jul2022; FEXOFENADINE, start date: 01Jan2017, stop date: 25Jul2022; ADDERALL, start date: 01Jan2017, stop date: 25Jul2022; KETAMINE, start date: 01Jan2018, stop date: 25Jul2022; ABILIFY, start date: 01Jan2017, stop date: 25Jul2022; DEXTROMETHORPHAN, start date: 09Jun2022, stop date: 19Jul2022; ACETAMINOPHEN, start date: 15Jul2022, stop date: 18Jul2022, these were also other medication in 2 weeks. Past drug history included: Allegra, reaction(s): "allergies (daily Allegra use)", notes: allergies (daily Allegra use). The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Pharmacist on duty did not dilute an un-opened vial of the COVID-19 Pfizer vaccine. The patient received 0.3 mls of the undiluted vaccine. No adverse reactions were reported from the patient.