chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Learn about severe allergic reactions; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (Learn about severe allergic reactions) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPERSENSITIVITY (Learn about severe allergic reactions). At the time of the report, HYPERSENSITIVITY (Learn about severe allergic reactions) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medications were reported. No treatment medications were reported.
Patient experienced shortness of breath and itching after receiving first dose of Pfizer vaccine. Was administered Benadryl 25 mg, P.O.  Onsite provider recommended EMS transport for eval, but patient refused.
As mentioned in the chicken pox vaccine information sheet we received, he had swelling around the area where the shot was given.  This persisted and got worse for more than three weeks, growing to the size of a quarter with the appearance of a spider bite.  The swelling is now gone, but a bruise/mark on the location still remains as of 5/11/13.
heavy bleeding; Changes on  menstruation; This is a spontaneous report from a contactable consumer. A 35-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: Unknown) via an unspecified route of administration in the arm left on 21Apr2021 at 23:00 (at the age of 35-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history and concomitant medications. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: Unknown) via an unspecified route of administration in the  left arm on 31Mar2021 at 11:00 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 COVID-19 vaccination. On 23Apr2021 at 09:00, the patient experienced heavy bleeding and change on menstruation(irregular menstruation). The clinical outcome of the event heavy bleeding and change on  menstruation were recovering at the time of this report.    No follow-up attempts are needed; information about lot/batch number cannot be obtained.
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 50-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Mar2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 50 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), 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: MOTRIN [IBUPROFEN], start date: 31May2022, stop date: 26Jun2022.  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: Indication: COVID 19 Treatment. 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.
An expired vaccine of meningococcal was given to a patient which was expired 4 days/No AE; Initial information was received on 08-Jun-2020 regarding an unsolicited valid non-serious case from the other health care professional.  This case involves a patient with unknown demographics who received an expired dose of MENINGOCOCCAL VACCINE [MENINGOCOCCAL VACCINE].  Medical history, medical treatment, vaccination and family history were not provided. List of concomitant medication not reported.  On an unknown date, the patient received a dose of suspect MENINGOCOCCAL VACCINE (produced by unknown manufacturer) [batch number and expiry date not reported] via an unknown route and administration site for prophylactic vaccination.  It was a case of actual medication error due to expired vaccine used. It was reported that vaccine was expired 4 days.   At the time of report, no adverse event was reported.  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.  There will be no information available on the batch number for this case.
Rash; Nausea; Low grade temperatures, 99 to about 101; Had vivid dreams were hard to awake even when I was awaken from it was hard to get out of the dream; Cold sores; Night sweat; red throat; Sweat; brain fog/strange feeling I don't know whether I am going to pass out although it feels different than normal that I have experienced in the past; when I stand up now my head becomes very heavy and I have to sit down because it's such a strange feeling I don't know whether I am going to pass out although it feels different than normal that I have experienced in the past; Right sinus and temple pain when I stand up head becomes very heavy and I have to sit down because it's a strange feeling whether I am going to pass out although it feels different than normal; Body aches and pains; cheeks have gotten red; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19  VACCINE, Solution for injection; lot number and expiration date: not reported), via an unspecified route of administration, on 27Feb2021 (at the age of 76-year-old) as DOSE 2,SINGLE for covid-19 immunization. Medical history included blood pressure fluctuation. Concomitant medications included valsartan taken for blood pressure fluctuation and esomeprazole sodium (NEXIUM) taken for an unspecified indication. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19  VACCINE, Solution for injection; lot number: EL9261 and expiration date: not reported), via an unspecified route of administration, in left arm, on 30Jan2021 (at the age of 76-year-old) as DOSE 1,SINGLE for covid-19 immunization and experienced Headache, nausea, Feeling unwell, Muscle pain and Joint pain. On 27Feb2021, the patient experienced a rash and had taken Tylenol and Benadryl, patient had nausea, low grade temperatures, 99 to about a 101. The patient had vivid dreams that were hard to awake, even when patient was awaken from it was hard to get out of the dream. Cold sores, red throat, right sinus and temple pain standing when she stand up her head becomes very heavy and have to sit down because it's such a strange feeling that she, don't know whether she was going to pass out although it feels different than normal that patient  had experienced in the past. Body aches and pains, sweat, night sweat, brain fog. And also cheeks have gotten red and nausea. Therapeutic measures were taken as a result of events  included Tylenol, Benadryl and included liquid IV. The outcome of all the events was unknown at time of report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt recd vax 11OCT91; 12OCT91 exp malaise, nausea, fever, lt foot swollen; 13OCT91 "choking", difficulty swallowing; 14OCT91 rash, lips & nose swollen, red streaks from lt toe to lt ankle; Saw MD on Pred & DPH; 15OCT91 boil drained lt foot;
5 days after first COVID vaccine (8-30-21), severe intermittent pain in right groin, unlike any pain ever experienced before, lasting 3 days.  Pain then migrated to left groin by 9 days after first COVID vaccine on 9-3-21, resulting in 6 days of severe pain, limping, and to the point of inability to bear weight by 9-6-21.  On 9-6-21 went to ER and fracture and dislocation was ruled out; mystery as to cause of these symptoms. Used walker for 2 days. From 10-21 to 12-29, have had 8 significant incidents of severe pain, weakness, and inability to use affected joint/muscles usually lasting 4-6 days.  These symptoms migrate from each side of the groin, ankles, hands, wrists, fingers, and sometimes shoulders. Disabling pain requiring occasional hydrocodone, use of a walker, and inability to perform activities of daily living.  Palindromic Rheumatism diagnosed on 12-13-21.
Irregular menstrual cycle - much earlier than normal period start date, (early by at least two weeks) compared to regular menstrual cycle start dates.
Information was received on 14-MAR-2017 from a health care worker concerning and unknown number of unspecified patients. No medical history, concomitant medications or patient demographics were reported. The unspecified patients were administered improperly stored vaccines on unknown dates, starting after 01-JUN-2015. There were several different sets of excursion conditions with different vaccine involved. The nurse confirmed that while many of the vaccines lots are now expired, all improperly stored doses were not expired at the time of administration. No adverse effects were reported. The lots of PNEUMOVAX 23 involved in the temperature excursion were lot K015368, exp. 04-MAY-2016; lot L018503, expired 16-MAR-2017; lot K020215, expired 15-MAY-2016; and lot K021577, expired 16-MAR-2017. Other vaccines involved in the temperature excursion were RECOMBIVAX HB (MARRS# 1703USA014564), GARDASIL 9 (MARRS #1703USA014565), PEDVAXHIB (MARRS#1703USA014567), VARIVAX (MARRS# 1703USA014566) and GARDASIL (MARRS# 1703USA007376). Follow-up information was received on 20-MAR-2017 from the reporter. Vaccine PNEUMOVAX 23 Lot K015368, expired 04-MAY-2016, a dose was administered on 10-SEP-2015 (dose not reported) (temperature out of range 24 hours). Lot K020215, expired 15-MAY-2016, doses were administered on 09-JUN-2015, 25-JUN-2015, 09-JUL-2015, 20-JAN-2016, 20-JAN-2016, 22-JAN-2016, 02-FEB-2016 and 02-FEB-2016 (temperature out of range 308 hours, 30 minutes). Lot K021577, expired 22-MAR-2017 (also reported as 16-MAR-2017) doses were administered on 21-JUL-2015, 22-JUL-2015, 11-AUG-2015, 18-AUG-2015, 22-SEP-2015, 22-SEP-2015, 22-SEP-2015 and 20-JAN-2016 (temperature out of range 302 hours 30 minutes). Lot L018503, expired 16-MAR-2017, doses were administered on 22-OCT-2015, 04-NOV-2015, 12-NOV-2015, 19-NOV-2015, 25-NOV-2015, 25-NOV-2015, 11-DEC-2015, 15-DEC-2015, 22-JAN-2016 and 22-JAN-2016 (temperature out of range 265 hours, 30 minutes). Dose and administration sites not reported. No patient identifiers were provided. Additional information has been requested. This is one of several reports by the same reporter.
Chills, low grade fever, nausea: -> pt visited ER and got treated with fluids, aspirin and nausea medication on 10/02/2014 per pt.
A report was received from a health care professional on 11/10/03, concerning a vaccinee who was less than 4 years of age and of unknown gender, that inadvertently received Fluvirin on an unknown date. The reporter did not have information on whether an adverse event had occurred. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
Arthritis in both right and left wrists; This is a spontaneous report from a contactable consumer, the patient. An 84-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm right on 29Jan2021 at 12:00 (at the age of 84-years-old) and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 20Feb2021 (at the age of 84-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included acetylsalicylic acid (BABY ASPIRIN), atorvastatin (MANUFACTURER UNKNOWN), tamsulosin hydrochloride (FLOWMAX) and metoprolol (MANUFACTURER UNKNOWN), all taken for an unspecified indication from an unknown date and unknown if ongoing. On 29Jan2021, the patient experienced arthritis in both right and left wrists. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of the event and included treatment with naproxen sodium (ALEVE). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event arthritis in both right and left wrists was not recovered at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
felt faint; This is a spontaneous report from a contactable consumer (patient) via Pfizer-sponsored program.  A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single  dose for COVID-19 immunization.  The patient medical history and concomitant medications were not reported. The patient felt faint for less than a minute after receiving the shot, on an unspecified date. Final outcome of the event was unknown. Information on the lot/batch number has been requested.
having a fever; Pain at injection site; developed redness at the injection site; heat at the injection site; hardness at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st August 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 1st August 2020, immediately after receiving Shingrix, the patient experienced injection site pain, injection site erythema, injection site warmth and injection site induration. On 2nd August 2020, the patient experienced fever. The patient was treated with benadryl (nos) (Benadryl). On 4th August 2020, the outcome of the injection site pain, injection site erythema, injection site warmth, injection site induration and fever were recovered/resolved.   It was unknown if the reporter considered the injection site pain, injection site erythema, injection site warmth, injection site induration and fever to be related to Shingrix.  Additional details were reported as follows: The patient received 1st dose of Shingrix and immediately after vaccination had a pain at the injection site. Later that evening, the patient developed redness, heat and hardness at the injection site. The next day after vaccination, patient reportes fever. The patient took a Benedryl for symptoms and they cleared up within 2 and half days. The patient asked about receiving the 2nd vaccine. The reporter did not consent to follow up.
Grandparent called 10/30/09 to report slight rash on chest-otherwise fine
It is now on her shoulder; the rash is hot; fever, around 99.5 ° F; rash under her breasts; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (the rash is hot), PYREXIA (fever, around 99.5 ° F), RASH (rash under her breasts) and RASH (It is now on her shoulder) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.     Concomitant products included Liptore for an unknown indication.    On 23-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced FEELING HOT (the rash is hot), PYREXIA (fever, around 99.5 ° F) and RASH (rash under her breasts). On 25-Mar-2021, the patient experienced RASH (It is now on her shoulder). At the time of the report, FEELING HOT (the rash is hot), PYREXIA (fever, around 99.5 ° F), RASH (rash under her breasts) and RASH (It is now on her shoulder) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included liptore. Treatment information not provided.
after receiving both covid and flu vaccination; not feeling well; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PRODUCT USE ISSUE (non-serious), outcome "unknown", described as "after receiving both covid and flu vaccination"; MALAISE (non-serious), outcome "unknown", described as "not feeling well". Additional information: the patient experienced general not feeling well after receiving both COVID and flu vaccination The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This case was reported by a physician and described the occurrence of high fever in a 9-month-old male subject who was vaccinated with PEDIARIX (GlaxoSmithKline). Concurrent medical conditions included environmental allergy (not to medications). On an unspecified date in January 2010 the subject received 3rd dose of PEDIARIX (.5 ml, unknown route, left thigh). On an unspecified date in January 2010, 6 to 10 hours after vaccination with PEDIARIX, the subject experienced high fever of 102 degrees Fahrenheit. The subject was treated with TYLENOL. At the time of reporting the event was resolved after 48 hours. The physician considered the event was possibly related to vaccination with PEDIARIX.
I am actually like in Vertigo phase like somebody in drunk phase; I feel like I am going to vomit while I walk; I am actually like in Vertigo phase like somebody in drunk phase; I feel like I am going to vomit while I walk; I haven't been able to get off from my bed because I am so imbalance; If I walk and I am not holding on to something/ I still like I am going to the right side.; I started to have pain a lot at night couldn't able to work; I started to have pain a lot at night couldn't able to work; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 39-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: ER8737), via an unspecified route of administration, administered in Arm Left on 27Apr2021 (at the time of vaccination 39-years-old), as DOSE 1, SINGLE for COVID-19 immunization. The patient's medical history was not reported. The patient's concomitant medications included vitamins. On 27Apr2021 15:00, the patient experienced she haven't been able to get off from her bed because she so imbalance; she actually like in vertigo phase like somebody in drunk phase; she feel like she going to vomit while she walk; and on an unspecified date Apr2021, she started to have pain a lot at night couldn't be able to work and If she walk and she not holding on to something/ she still like she going to the right side. The reporter stated that reporting adverse effect she not sure this is one of them she put the Covid shot and she haven't been able to get off from my bed because she so imbalance If she walk and she not holding on to something she actually like in Vertigo phase like somebody in drunk phase she feel like she going to vomit while she walk and this is while she having on to walk If she still like she going to the right side. Patient was hospitalized due to events. On 28Apr2021, the patient underwent lab tests and procedures which included blood test: unknown. Second shot scheduled date on 17May2021. The outcome of all the events was unknown.  Information on Lot/Batch number was available. Additional information has been requested.
Pt recvd vax, awoke next morning @ 630AM & began high pitched, screaming 4 hrs; fed sporadically during this time; peak temp 101; no convuls activity; was fine p/initial screaming spell; APAP & cool compress given;
Painful, red, warm swelling to injection site. Tx: Cephalexin 500mg.
I noticed pain on my colar bone and discovered amy superclavicular lymph node swollen and painful. It is currently like a small marble size.