chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Within a few minutes right hand and forearm (shot arm) was numb then tingling and neck got hot.  On the drive home developed a headache.  No fever.   Day 2 migraine like headache most of the day and numb right hand when woke up, shot sight sore Day 3 better slight headache, shot site sore Day 4/5 woke both mornings by migraine like headache that went to neck  (neck and shoulder pain) Day 6 okay so far
Information has been received from a physician concerning a patient who was vaccinated with the third dose of Rotateq. The physician reported that the patient subsequently experienced a fever of 104 degrees. Unspecified medical attention was sought. The patient's fever subsequently resolved. Additional information has been requested. 06/01/2007 Information has been received from a physician concerning a 6-month-old female with no medical history who on 08-JAN-2007, at 1100, was vaccinated PO with the third dose of ROTATEQ (Lot #655174/0848P). Concomitant vaccinations adminstered on that same day and time included the third IM dose in the right thigh of PREVNAR (Lot #B08653H), the third dose in the left thigh of TRIPEDIA (Lot #U1813BA) and the first IM dose in the left thigh of FLUZONE (Lot #U2174DA). There was no illness at the time of vaccination. The physician reported that on 15-JAN-2007, the patient vomited x 1 and experienced a fever of 102-104 degrees. No other symptoms were reported. Unspecified medical attention was sought. No laboratory/diagnosic tests were performed. On 18-JAN-2007, the patient recovered. Additional information has been requested.
Swollen lymph nodes; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received second dose of BNT162B2 (solution for injection) via an unspecified route of administration, administered in right arm on 11Feb2021 (Batch/Lot Number: EL3302) at single dose for COVID-19 vaccination. The patient medical history was not reported. There were no concomitant medications. The patient previously took BNT162B2 on 20Jan2021 for covid-19 immunisation. Two days ago with her lymph nodes very swollen, mostly around arm pit, she couldn't tell pain in her arm and breast until pressed on side of arm. It was swollen, she has been doing massage and two days ago it started. She says yesterday it was a bit more, and last night it woke her up. She says this morning her arm when it touches side of breast has discomfort, not big pain, discomfort and was swollen around breast and armpit under arm on 11Feb2021. The outcome of the event was unknown.
pt recvd vax 19JAN96 & 20JAN96 w/lt arm swollen around the inj site up to lt shoulder which was very painful;pt stated felt weakness in arm, took all energy to lift it above head, very painful;swelling had dec;felt had nerve damage
Day after vaccine pain and limited range of motion occurred.  This progressively got worse to the point of immobility and excruciating pain.  After 2nd dose, top of right shoulder developed pus filled circular area and pain
chills; fever; This is a spontaneous report received from a contactable consumer (Patient wife) via Medical Information Team.  A male patient of unspecified age had received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: unknown) via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunization. The patient medical history and concomitant were not reported. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: unknown) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. On an unspecified date, the patient had experienced fever and chills. The clinical outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
At the time of injection, my armpit swelled up and got hard in my lymph nodes.  I reported those symptoms through a follow up website at that time. The event I'm reporting now is a stroke that I suffered on June 1 2022.  I'm unsure if the stroke was connected to the vaccine,  but at 47 years old with no significant medical history prior to the vaccine,  I wonder.  I don't drink alcohol, don't smoke, don't do drugs... eat healthy and exercise regularly.  I'm still in recovery from the stroke.
first day: fever 100.7, fatigue, extreme thirsty second day: fever 100.8, very disoriented, extreme fatigue, I passed out and was unconscious for atleast 2-3 minutes  911 was called.
p/vax exp same symptoms as had p/1st dose of lymerix: chills; achiness; fever; fatigue & inj site tenderness; tx: tylenol ES & symptoms resolved;
little fever; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 68 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 31Mar2021 (Lot number: EP7534) at the age of 67 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "DCIS", start date: Feb2020 (ongoing). Concomitant medication(s) included: ANASTROZOLE taken for intraductal proliferative breast lesion. Vaccination history included: Bnt162b2 (Dose 1, single, Lot: EN6198, Anatomical location: Left arm), administration date: 08Mar2021, when the patient was 67 years old, for COVID-19 immunization.  The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "little fever".  No follow-up attempts are possible. No further information is expected.
M is not certain if this child was given MMR or HIB on 4/17/07.  On paper the nurse documented that she was giving HIB & in the computer she documented giving MMR.
About 30 minutes after I received the second shot in my right arm, I started feeling different.  I thought it was normal side effects, but it wasn't like the first Covid shot.  After a couple days I was in pain around my right side of my neck, my right jaw, right ear, and right eye socket.  Also pain on the right side of my head. After a week I decided to go to Urgent Care, where I was told it was an allergy, or maybe I had a bad tooth.  I was told it was not from the Covid shot.  So I took Claridin for a couple days with no relief of pain.  Since the pain was not getting better and was keeping me awake I decided to go the the ER.  The doctor there said it was shingles since I had a couple bllisters on my right jaw.  I was told again it was not from the Covid shot.  I didn't believe any of this.  Just wanted to document this.
Patient was receiving her 2nd dose of pfizer covid vaccine. Upon administering dose, there seemed to be some malfunction with syringe as partial amount of 0.3 ml dosage, leaked from syringe and dripped down patient's arm. Due to this, patient did not receive adequate dose. Upon verifying with Pfizer medical team as to plan of action, their literature states that if patient did not receive more than half of full dose (0.15 ml) or dose received cannot be determined, to administer immediately in opposite arm or wait 48 hours. If patient did receive at least half of full dose, no re-administration is required. Because of the nature of incident and upon consulting with patient, the action determined is to re-adminster full dosage.
3 1/2 x 3 1/2 redness & soreness. Mild warmth occurred day after flu vaccine.
Submanibular/parotid gland swelling, moderate onset 10 days after ProQuad, without fever or other known cause. Papular rash on chest, neck.
Injection was given in the tricep area of the arm.  Unknown if given subcutaneous or intramuscular. When questioning the Pharmacist, he stated ?I read somewhere it?s less painful in the tricep area so that?s why I did it there?. Our concern is CDC and monderna states deltoid is most recommend place to give vaccine. Pharmacist was unable to show confidence if he gave it intramuscular or subcutaneous. He lied to us and changed his story when confronted about our concerns. Pt developed redness and pain for 4 days. More over, there are serious concerns if vaccine was given wrong and will result in being ineffective.
Super tired; Maternal exposure during pregnancy; Sore arm; Fever; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy), PAIN IN EXTREMITY (Sore arm), PYREXIA (Fever) and FATIGUE (Super tired) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Liver disorder. Concomitant products included PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE] for an unknown indication.    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 07-Jul-2020 and the estimated date of delivery was 04-Apr-2021. On 04-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy), PAIN IN EXTREMITY (Sore arm) and PYREXIA (Fever). On 05-Jan-2021, the patient experienced FATIGUE (Super tired). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-fifth week of the pregnancy.  On 04-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved. On 05-Jan-2021, PAIN IN EXTREMITY (Sore arm), PYREXIA (Fever) and FATIGUE (Super tired) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99.5 (High) High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included prenatal multivitamin.   Company Comment: This is a case of product exposure during pregnancy with associated AEs for this 34-year-old female. Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded; Sender's Comments: This is a case of product exposure during pregnancy with associated AEs for this 34-year-old female. Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Patient was inadvertently administered a Pfizer covid-19 dose that was beyond 6 hours from first puncture of vial.
Condition aggravated; This spontaneous case was reported by a consumer and describes the occurrence of CONDITION AGGRAVATED (Condition aggravated) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for an unknown indication.    No Medical History information was reported.   On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced CONDITION AGGRAVATED (Condition aggravated). At the time of the report, CONDITION AGGRAVATED (Condition aggravated) had not resolved.            No concomitant medications were reported. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in  No treatment information was reported.      Reporter did not allow further contact
Right arm became very sore by 8 hrs post injection. Then had whole body shakes and chills and severe body aches for the next 4-5 hrs and was unable to sleep. I used TYLENOL and KLONOPIN to address the response, which seemed to help after a few hours.
Patient's left arm where injections were given developed a lump approximately 1 1/2 inches and her arm started turning red and blotchy. Dr was notified and she saw the patient and ordered 9ml of BENADRYL. Patient's heart rate and respirations were monitored for 30 mins after onset of reaction. Signs didn't progress/worsen over the 30 minutes.
3 minutes p/recvd Td passed out, (fell to knees & fell backward-hitting back of head on floor about 18") unconscious for 45 sec; pulse 76-80; BP 90/60-108/50; pt taken to hosp by ambulance;
Left side of face swollen/neck also. Coughing. Nose stopped up. Eyes felt like film. 7:30 pm symptoms started vaccinated at 4:15 pm.
the vaccine only left me with arm pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), on 19Mar2021 at 10:30 as dose 1, single (Lot number: ER2613) intramuscular, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Type 2 Diabetes", start date: 2005 (ongoing), notes: Only take medication. The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "the vaccine only left me with arm pain". Relevant laboratory tests and procedures are available in the appropriate section.
This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 29-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 28 years, in left arm for Covid-19 immunisation; CoviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for Covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of Covid-19. Clinical Course: Anti viral details product: COVID-19 Treatment, treatment start date:16May2022, indication: Treatment of COVID-19. Adverse event: Vomiting, nausea, bad taste in mouth. Adverse event start date: 16May2022. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
a pregnant 35-year-old patient inadvertently received a dose of Arexvy; a pregnant 35-year-old patient inadvertently received a dose of Arexvy. The patient was around 35-36 weeks gestation; This non-serious prospective pregnancy case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 35-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 20-OCT-2023, the patient received Arexvy. On 20-OCT-2023, an unknown time after receiving Arexvy, the patient experienced inappropriate age at vaccine administration (Verbatim: a pregnant 35-year-old patient inadvertently received a dose of Arexvy. The patient was around 35-36 weeks gestation). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: a pregnant 35-year-old patient inadvertently received a dose of Arexvy). The outcome of the inappropriate age at vaccine administration and vaccine exposure during pregnancy were unknown.   Pregnancy exposure: Pregnancy Exposure (Arexvy): To mother in third trimester Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK receipt date 30-OCT-2023 The pharmacist called to inform that, a pregnant patient inadvertently received a dose of Arexvy.  The patient was around 35-36 weeks gestation according to the reporter. The vaccine administration facility was the same as primary reporter The 35 year old patient received Arexvy, which led to inappropriate age at vaccine administration The reporter consented to follow up.
other than maybe a lump on the arm; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received pneumococcal 13-val conj vac (dipht crm197 protein) (trade name unknown) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for immunization. Medical history included 5 brain tumors, tumors on the adrenals, and a mass on the larynx. The patient's concomitant medications were not reported. After receiving pneumonia vaccine, the patient never had any problems other than maybe a lump on the arm. The outcome of event was unknown.  Pfizer is a marketing authorization holder of pneumococcal 13-val conj vac (dipht crm197 protein) in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of pneumococcal 13-val conj vac (dipht crm197 protein) has submitted the same report to the regulatory authorities.  No follow-up attempts are possible, information about batch number cannot be obtained.
On Tuesday afternoon half of my face became flushed which lasted until Wednesday.  On Tuesday evening is when my arm became  sore,   swollen and red from the top of my deltoid down to midway down my forearm.  As of today the redness and be swollen is still there.  It has gotten a little better but not much.  Wednesday through Thursday I had fever, chills, nausea , vomiting and tiredness.  These symptoms when away by Friday morning.
tingling in arms and legs; has been getting worse ever since 1st dose; Patient has been having extreme fatigue that started after receiving 1st dose; nausea; headache; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (tingling in arms and legs), CONDITION AGGRAVATED (has been getting worse ever since 1st dose), FATIGUE (Patient has been having extreme fatigue that started after receiving 1st dose), NAUSEA (nausea) and HEADACHE (headache) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history information was reported.  Concomitant products included LEVOTHYROXINE for an unknown indication.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 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 PARAESTHESIA (tingling in arms and legs), CONDITION AGGRAVATED (has been getting worse ever since 1st dose), FATIGUE (Patient has been having extreme fatigue that started after receiving 1st dose), NAUSEA (nausea) and HEADACHE (headache). The patient was treated with LORAZEPAM (ATIVAN) at an unspecified dose and frequency. At the time of the report, PARAESTHESIA (tingling in arms and legs), CONDITION AGGRAVATED (has been getting worse ever since 1st dose), FATIGUE (Patient has been having extreme fatigue that started after receiving 1st dose), NAUSEA (nausea) and HEADACHE (headache) outcome was unknown.            Treatment also include steroids. Upon internal review on 4-Aug-21, the age was corrected to 35 years
0915 Injections administered - Pt. became light headed and nauseous. RN recommended for pt. to lay down. Pt. declined recommendation. 0920 pt. became unresponsive for approx. 30 seconds. RN laid pt down on exam table. Initial BP 108/64 Dr. expressed pt. within normal limits. 0925 BP 114/68 Pulse: 49 SpO2 99 room air. 0935 BP 116/62 Pulse: 52 SpO2 98 room air.
Myalgia chills, fatigue Narrative:  Date of vaccination: 1/12/2021 Cold chills/ body aches/ tiredness
EXTREME MUSCLE PAIN FROM 9/20/2019 TO PRESENT TIME. UNABLE TO LEFT ARM OVER HEAD WITHOUT MUSCLE PAIN
Temp 102 on 11/21 and rash on head, body, arms plus multiple lesions.
Diarrhea, sore muscle at injection site, body aches (upper body), headache, fatigue
Pt recv vax on 11/19/98; on 2/12/99 pt exp erythematous papules-blistered then scabbed
On 6-11-10 at 6:00am childs right thigh was red, swollen, and hard.  Next day thigh developed a rash, tea cup saucer size on injection site. Thigh was swollen, bruised, felt hot, also rash spread to the inside of child's thigh according to mother. Child was limping for few days. Mother called to report incident 5 days after vaccine was given, mother called on June 15, 2010 to report vaccine reaction. Mother stated on June 15, 2010 that child was back to normal and was feeling fine and the reason she called was to make sure we chart the reaction in child's chart.
nurse was administering the fluzone hd vaccine and didn't screw a needle on tight enough, so some of the vaccine came out the side and went in the patient's eye with no reported adverse event; nurse did not attach the syringe needle properly with no reported adverse event; Initial information received on 10-Oct-2023 regarding an unsolicited valid non-serious case received via pharmacist.  This case involves an unknown age and unknown gender patient and reporter reported nurse was administering the fluzone hd vaccine and didn't screw a needle on tight enough, so some of the vaccine came out the side and went in the patient's eye with no reported adverse event and nurse did not attach the syringe needle properly with no reported adverse event after receiving influenza quadrival A-B high dose HV vaccine [Fluzone High-Dose Quadrivalent].  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.   On 10-Oct-2023, the patient received an unknown dose of suspect influenza quadrival A-B high dose HV vaccine (strength, form, lot number, expiry date: unknown) not reported via unknown route in unknown administration site for prophylactic vaccination (immunization) and nurse was administering the fluzone hd vaccine and didn't screw a needle on tight enough, so some of the vaccine came out the side and went in the patient's eye with no reported adverse event (accidental exposure to product) and nurse did not attach the syringe needle properly with no reported adverse event (wrong technique in device usage process) (latency: same day)  Action taken with quadrivalent influenza vaccine (Fluzone High-Dose Quadrivalent) was not applicable.  Outcome: Unknown  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.
This spontaneous report as received from a nurse via a company representative refers to three patients of unknown age and gender. The patients pertinent medical history and concurrent conditions were not reported. No previous drug reactions or allergies were reported. On an unknown date the patients were vaccinated with PNEUMOVAX 23 (strength, dose and lot # were not reported) 1 shot in the arm. No concomitant medications were reported. On an unknown date the patients experienced a cellulitis reaction in the arm at the injection site while using PNEUMOVAX 23. The outcome of the event was not reported. The reporter did not provide the causality between the event and the suspect therapy. There was not product quality complaint. Additional information has been requested.