chrisvoncsefalvay/vaers-outcomes huggingface dataset:
received only the diluent part of PENTACEL and not the powder with no reported adverse event; Initial information was received  on 17-May-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 4 years old male patient who reported received only the diluent part of Pentacel and not the powder with no reported adverse event after receiving diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine [Pentacel (VERO)].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included measles vaccine, MUMPS VACCINE, rubella vaccine (MMR) for Immunisation; and VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for Immunisation.  On 11-May-2023, the patient received 0.5 ml, total (once) dose of suspect diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine Suspension for injection (lot:UJ786AA, expiration date:12-Oct-2023, strength: standard) via intramuscular route in the left thigh for Immunization.  On 11-May-2023 the patient had received only the diluent part of Pentacel and not the powder with no reported adverse event (Single component of a two-component product administered) same day following the administration of diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event administration of the pentacel components separately with no reported adverse event.  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 the guidelines. 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.
Facial swelling; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (Facial swelling) 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 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 SWELLING FACE (Facial swelling). At the time of the report, SWELLING FACE (Facial swelling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.
This spontaneous report was received from a registered nurse regarding a patient of unknown demographics. There was no information about concurrent condition and historical medication. On 30-JUL-2015 the patient was vaccinated with expired dose of M-M-R II, Lot # J006955, expiration date- 07-JUN-2015. No concomitant medication was reported. No adverse event was reported. The outcome of the event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Pt's father called and said child had Hep-B shot  on 2/22/02 and on 2/23/02, he had a red rash all over his body. It was raised and red with white centers and itchy. It's the first time this has happened. Father denies any previous allergic reactions. MD was notified and states this could be an allergic rash to IZ. States should not get. Father called family doctor and he ordered Benadryl.
Immune system reaction; Felt poorly; was chilled; fever; fatigued; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNE SYSTEM DISORDER (Immune system reaction), FEELING ABNORMAL (Felt poorly), CHILLS (was chilled), PYREXIA (fever) and FATIGUE (fatigued) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jan-2021, the patient experienced IMMUNE SYSTEM DISORDER (Immune system reaction), FEELING ABNORMAL (Felt poorly), CHILLS (was chilled), PYREXIA (fever) and FATIGUE (fatigued). The patient was treated with IBUPROFEN at a dose of 800 mg. On 26-Jan-2021, IMMUNE SYSTEM DISORDER (Immune system reaction), FEELING ABNORMAL (Felt poorly), CHILLS (was chilled), PYREXIA (fever) and FATIGUE (fatigued) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Jan-2021, Body temperature: 101.5 degree (plane angle) 101.5 At 10:00AM, 102.4 degree (plane angle) 102.4 At 2:00PM and 103.4 degree (plane angle) (High) 103.4  At 4:00PM and at 5:00PM fever came down..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided.
This spontaneous report as received from a healthcare worker refers to a patient of unknown age. On 15-JAN-2014, the patient was vaccinated with improperly stored PROQUAD (Merck). No adverse event reported with the administration. Causality assessment was not provided. This case linked to the MARRS# 1401USA011451 (same reporter link). Additional information is not expected.
left neck moderate to severe pain; pain started radiating down her left arm and down left leg; weakening her joints on those extremities/ shoulder pain; This is a spontaneous report from a contactable other healthcare professional reporting for herself. A 60-year-old female patient received the first dose of bnt162b2 (BNT162B2, lot number: EK5730, expiry date: unknown), via an unspecified route of administration, on 16Dec220, at a single dose on arm right for COVID-19 immunization. Medical history included diabetes mellitus 2, hypertension (HTN), migraines, back pains, hypothyroidism, and allergies to latex and kiwi. The patient received the vaccine at a military base. She did not receive other vaccines in four weeks. The patient was not pregnant at the time of vaccination. She had no COVID prior vaccination and was not tested for COVID post vaccination. Concomitant medications included unspecified medications; she received other medications in two weeks. The patient previously took gabapentin and topiramate (TOPAMAX), in which she experienced allergies. On the second day after receiving the vaccine, 18Dec2020 04:00 AM, the patient started feeling left neck moderate to severe pain, and the pain started radiating down her left arm and down left leg, weakening her joints on those extremities. This continued severely for 3 days. At this time, she continued to feel mild left neck, shoulder and arm pain intermittently. She could not report this immediately due to not having her vaccine documents which she forgot at her workplace as she proceeded to vacation. She had paused in getting the second dose that was due on 07Jan2021, waiting to hear from Pfizer. The patient received NSAIDS and Muscle relaxant medications as treatment for the reported adverse events. Outcome of the events was recovering.
Chills; Muscle pain; Feel like real tired; Headache; headache, it's like migraine; This is a spontaneous report from a contactable consumer (patient). A 50-Year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 05Jan2021 at single dose for covid-19 immunisation. The relevant medical history and concomitant medications were not reported. The patient had the vaccine at her work and like in the night, in the morning, she started experiencing side effects. She was having like chills and muscle pain and she called her doctor and they told her that she had to report the side effects. She felt like real tired and she was having a headache. The patient took some Excedrin for headache, it's like migraine. She took two in the morning at 8:30. The outcome of the events was not recovered.  Information on the lot/batch number has been requested.
Route of Administration: "Intramuscular."; No adverse effects reported; This spontaneous report was received from a medical assistant on behalf of the physician concerning a currently 4 years old child of unknown gender and race. The patient's pertinent medical history, concurrent conditions, drug allergies or reactions, historical and concomitant drugs were not reported.  On unknown date, the patient was vaccinated with one dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) recombinant human albumin (rHA), intramuscular (incorrect route of product administration), lot number R020815 with expiration date on 16-JAN-2020. It was reported that the patient missed the following, future doses. No adverse effects reported.   The outcome of incorrect route of product administration was unknown.
Pt(PREGNANT) recv vax on 3/16/99; on 3/19/99 pt confirmed pregnancy w/ positive test; tx=OB/GYN counsel
Pt. c/o no chills all night, less than AM. (2) nausea. still this am-unable to eat. (3) body aches-all night. (4) Fever-still this AM and all last night. (5) Headache more last night.
After imm administered pt developed a high fever and experienced possible seizure activity - taken to local ER and transferred to another hospital by parents.  04/30/2008 MR received for DOS 2/19-21/2008 with D/C DX: Rigors related to high fevers. Pt presented to ER after 2 episodes of extremity shaking and eyes gazing upward associated with fever 1 day s/p vaccines. First episode ~1 minute, 2nd ~5 min. Temp 39.5'C. PE WNL otherwise. No further episodes.
SICK; OFF LABEL DOSING FREQUENCY; This spontaneous report received from a patient via a company representative via social media concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient previously received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin was not reported, batch number: Unknown, expiry: Unknown) dose was not reported, 1 total, administered on an unspecified date for covid-19 prophylaxis.  The patient got sick following vaccination with covid-19 vaccine ad26.cov2.s (Dose number in series 1). The patient previously received covid-19 vaccine ad26.cov2.s (unspecified manufacturer) (Dose number in series 2) (suspension for injection, route of admin was not reported, batch number: Unknown, expiry: Unknown) dose was not reported, 1 total, administered on an unspecified date for covid-19 prophylaxis.  The patient got sick following vaccination with covid-19 vaccine ad26.cov2.s (Dose number in series 2). The patient received covid-19 vaccine ad26.cov2.s (unspecified manufacturer) (Dose number in series 3) (suspension for injection, route of admin was not reported, batch number: Unknown, expiry: Unknown) dose was not reported, 1 total, administered on an unspecified date for covid-19 prophylaxis which was associated with off label dosing frequency (Dose number in series 3). The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date the patient got sick (Dose number in series 3).  The reporter stated that " Johnson and Johnson I got the. Johnson one shot, then I got the booster, then I got a 2nd booster! Everyone made me sicker than a dog".  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the off label dosing frequency and sick was not reported. This report was non-serious. This case is linked with 20221232989 and 20221233290 as a same patient.
Initial report received from a health care provider on 27/Mar/2006. A five-year-old patient (gender not reported) had received an intramuscular, right arm injection of Daptacel, lot number number C2405AA, on 22/Mar/2006. Two days later, the patient experienced "redness and swelling of the entire arm after vaccination". The patient had received four previous doses. At the time of this report the patient had recovered from the event. The reporter in this case is the same as for 2006-00694, 2006-00695, 2006-00693, 2006-00696, 2006-00698, 2006-00699, and 2006-00700.
This spontaneous report as received from a physician via a company representative refers to a 14 year old male patient. In 2001 (date unspecified, reported also when the patient was one year old) the patient was vaccinated with (Merck) VARIVAX (subcutaneously, dose, units, anatomical location, lot number were not reported). In 2014 (date unspecified, reported as thirteen years after vaccination) the patient experienced herpes zoster. The reporter stated that the patient never received his second injection of (Merck) VARIVAX at the age of one year old. The patient sought medical attention via visiting the physician. The outcome of event was reported as not recovered. The relatedness between event and VARIVAX was not reported. Additional information has been requested.
Info has been received from a health professional concerning a 45 month old Filipino male who on 1/28/03 was vaccinated, SC, in the left arm with a 1st dose of MMRII (lot 642182/0774M). The pt presented on 11/9/05 after having had a fever and swelling of the left side of the face since 09:99, on 11/8/05, No additional info was provided. Additional info has been requested.
Received shot in right arm on Saturday .  On Sunday night I noticed a baseball sized lump under right arm below arm pit.  Feels tender to touch but not excrutiating pain
I developed persistent dry cough the night of the vaccination, which led to an asthma flareup.  Since then, I have had intermittent shortness of breath and and minor wheezing, which has been mitigated with my rescue inhaler.
When I first had it I didn't want to eat at all; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 80 year-old female patient received bnt162b2 (BNT162B2), administration date 17Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DECREASED APPETITE (non-serious) with onset 2021, outcome "unknown", described as "When I first had it I didn't want to eat at all". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: Reporter stated that patient first had it she didn't want to eat at all now , why she lost too much weight so she tried to eat and gain back the weight but 20 pounds is a lot she had only 5 ft 3 and a half; she has seen someone who had this only had one shot.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Around 6pm I started having normal mild reactions to the covid vaccine. Around 10pm I lost feeling in both arms and my lower legs, but otherwise was still able to move without pain. At about 10:30, the loss of feeling turned into partial paralysis and extreme pain where feeling had been previously lost. My hands refused to stay in any position except for a clenched fist or fingers completely extended. Moving my arms and lower legs was only able to be done with great difficulty. I was worried that it would spread to my chest, so I got up from where I'd been sitting at a desk and began forcing myself to walk up and down my apartment hallway. I was able to do this though my gait was stuttery and uneven, and my pain was about an 8 out of 10. I was alone in my apartment at the time and my hands weren't working well enough to handle my phone. After about 10 or 15 minutes the nerve pain and paralysis subsided and hasn't come back since, but my leg muscles felt incredibly weak the rest of the night and my partner had to help me to make sure I didn't fall over a couple of times. I didn't end up going to the doctor or seeking treatment because it didn't come back.
under the age of 65 were administered FLUZONE HD QIV instead of the FLUZONE QIV with no adverse event; under the age of 65 were administered FLUZONE HD QIV instead of the FLUZONE QIV with no adverse event; Initial information received on 26-Oct-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-health care professional.  This case is linked to cases 2022SA447057(CLUSTER) and 2022SA446385(CLUSTER).  This case involves a 35 years old male patient who was under the age of 65 were administered influenza quadrival A-B high dose HV vaccine [fluzone high-dose quadrivalent] instead of the fluzone QIV with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.   On 04-Oct-2022, the patient received suspect influenza quadrival A-B high dose HV vaccine at a dose of 0.7 ml (lot UT7729CA, expiry date: 30-Jun-2023) via intramuscular route in the left deltoid for immunisation.  On 04-Oct-2022, the patient who was under the age of 65 were administered fluzone hd qiv instead of the fluzone qiv with no adverse event (wrong product administered, product administered to patient of inappropriate age, latency: same day).  Action taken: Not applicable.  Outcome: Unknown for both the events.   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 the 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.
Fever 102.3, Terrible headache, head congestion, sore arm, Body aches, FATIGUE
After receiving the flu shot, her arm was abnormally painful, sore, and had experienced shock-like painful sensations down her left arm.
Fever, chills alternating with being very hot, body aches, swollen area at injection site, no energy, loss of appetite
After receiving HPV vaccine patient became pale diaphoretic and was lowered to the floor. Hypotensive. After 15 mins. he left office with mom.
sick; Reaction to preservatives; This case was reported by a consumer via call center representative and described the occurrence of sickness in a adult female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced sickness and reaction to preservatives. On an unknown date, the outcome of the sickness and reaction to preservatives were recovered/resolved.   It was unknown if the reporter considered the sickness and reaction to preservatives to be related to Influenza vaccine Quadrivalent unspecified season.  Additional case details were reported as follows: The age at vaccination was not reported The reporter stated the first 5 to 7 years, the patient got the flu vaccine, and she got sick. She stated it was not until later on that she realized it was probably due to the preservatives in the vaccine. The reporter wasn't able to provide specific time or product manufacturer. The reporter consulted employee health nurse when receiving the vaccine several years ago at which time the nurse recommended to obtain only preservative free form of annual mandatory vaccines. The reporter was uncertain which year this conversation occurred. This case has been linked with case US2020029088, reported by the same reporter; Sender's Comments:  US-GLAXOSMITHKLINE-US2020029088:same patient
female patient received an intramuscular injection of Priorix on 07Jul2023; This non-serious case was reported by a nurse via call center representative and described the occurrence of subcutaneous injection formulation administered by other route in a 19-year-old female patient who received MMR (Priorix) (batch number 75S93, expiry date 11-MAY-2024) for prophylaxis.   On 07-JUL-2023, the patient received Priorix (intramuscular). On 07-JUL-2023, an unknown time after receiving Priorix, the patient experienced subcutaneous injection formulation administered by other route (Verbatim: female patient received an intramuscular injection of Priorix on 07Jul2023). The outcome of the subcutaneous injection formulation administered by other route was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 07-JUL-2023 No symptoms were reported. The reporter consented to follow up via email. The reporter reported that a patient received an intramuscular injection of Priorix, which led to subcutaneous injection formulation administered by other route.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), on 15Oct2022 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. Concomitant medication(s) included: LEVOTHYROXINE, start date: 01Jan2019. The patient had no known allergy.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 including Paxlovid from 25Aug2023 to 31Aug2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
At approximately 10:35am client had completed his 15mins observation and was ready to go home when he briefly felt his throat closing. He then called 911 and went back inside to EMT station and notified EMTs. He was then assessed and denied history of Anaphylaxis or allergies to food or meds. Assessment revealed no hives, rashes, skin flare ups, itchiness or shortness of breath. Client denied chest pain, difficulty breathing or pain throughout the body. Initial  Vital signs were taken and taken every 5mins after that. He was asked to stay for 30mins. Client told 911 operator he felt safe to hang up and stay with EMT at vaccination site. Client's initial vital signs were a pulse of 112, Blood pressure of 164/92, O2 sat of 99% on room air and respirations of 24 with no signs of accessory muscle use. Due to client's vitals improving with his calmer demeanor, no additional interventions were felt to be necessary at this time. Client stated he felt better and was encouraged to follow up with his Primary Care Provider and emergency precautions were given.  Vital Signs:   1035 - 164/92 (BP), 112 (HR), 99 (O2) 1040 - 160/90, 96, 99 1045 - 142/88, 94, 99 1050 - 138/88, 94, 99 1055 - 132/88, 94, 99   No medications were administered.
patient had initial achy arm, felt tactile fever, felt firmness and painful then got less painful but about day 4 more red and presented to clinic day 6 with continued worsening redness. treated for cellulitis given getting worse and day 6.