chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial information received on 22-Jan-2019 regarding an unsolicited valid non-serious case received from a nurse by phone. This case involves a 3 years old female patient who was vaccinated with 0.5 ml dose of QUADRACEL (lot C5497AA, expiry date: 17-Jul-2020, route of administration was not reported) in left deltoid instead of IPOL, DAPTACEL on 28-Dec-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included HEPATITIS B VACCINE for Immunisation. It was a case of actual medication error due to wrong vaccine administered as physician ordered DAPTACEL and IPOL, but QUADRACEL was given in error by a medical assistant who was new to the office and inappropriate age at vaccine administration as QUADRACEL was administered at less than 4 years of age. It was reported that QUADRACEL vaccine was given in the left deltoid for the second polio vaccine and the third DTaP vaccine in the patient. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by the sender: none.
Generalized Itching; Hives; Shortness of breath/Difficulty breathing; Swollen eyelids; This case was reported by a other health professional via call center representative and described the occurrence of generalized pruritus in a 34-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 525NP, expiry date 4th September 2021) for prophylaxis.   On 26th July 2019, the patient received Boostrix. On 26th July 2019, 30 min after receiving Boostrix, the patient experienced generalized pruritus (serious criteria clinically significant/intervention required), hives (serious criteria clinically significant/intervention required), shortness of breath (serious criteria clinically significant/intervention required) and swelling of eyelid (serious criteria clinically significant/intervention required). The patient was treated with diphenhydramine hydrochloride (Children'S Benadryl (Diphenhydramine Hcl)) and epinephrine. On an unknown date, the outcome of the generalized pruritus, hives, shortness of breath and swelling of eyelid were unknown.   It was unknown if the reporter considered the generalized pruritus, hives, shortness of breath and swelling of eyelid to be related to Boostrix.  Additional details were provided as follows: The Certified Medical Assistant (CMA) reported these adverse events on behalf of physician (MD). At about 30 minutes later, the patient started to experience generalized itching and hives and children's Benadryl was administered to her.  About 45 minutes later, the patient started experiencing swollen eyelids and difficulty breathing and the EMS (emergency medical service) was called.  The patient then started to experience worsening shortness of breath and 0.4 mg of Epinephrine was administered to her.  The patient was taken to the ER (emergency room) for further evaluation. The reporter consented to follow up.
Sore arm; chills; body fatigue; This is a spontaneous report from a contactable consumer (patient). A 55-years-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: En6203), via an unspecified route of administration, administered in right arm on 05Mar2021 03:00 PM (age at vaccination was 55 years) as 1st dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient was no known allergies. No other vaccine was received by patient in four weeks and no other medications was received by patient in two weeks. The patient was not had covid prior vaccination and not tested for covid post vaccination. On 05Mar2021 10:00 PM, the patient experienced sore arm, chills and body fatigue. No treatment received for adverse events. Outcome of the events was recovered on an unknown date.  No follow-up attempts are possible. No further information is expected.
Red dots all over lips and nose, face red (same as sunburn); Numb right arm; Left arm only numb at injection site; Very hot head and neck; Dizziness; Anxiety; Nasal congestion; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the left arm on 06Apr2021 at 08:30 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. Medical history included generalized anxiety disorder. The patient was not allergic to food, medications, or other products. Concomitant medications included nicotinic acid (NIACIN), garlic extract and cayenne pepper. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient had not been diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 06Apr2021 at 13:30, the patient experienced red dots all over lips and tip of nose, numb right arm, left arm only numb at injection site, very hot head and neck, red face which was same as sunburn, dizziness, anxiety and nasal congestion. The patient did not receive any treatment for the event. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events red dots all over lips and tip of nose, numb right arm, left arm only numb at injection site, very hot head and neck, red face which was same as sunburn, dizziness, anxiety and nasal congestion were resolved on 06Apr2021.  No follow-up attempts are needed. No further information is expected.
Pediatric dose was given to adults mistakenly; Product temperature excursion; Poor quality product administered; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Poor quality product administered) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR5186C) for COVID-19 prophylaxis.     No Medical History information was reported.    In September 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Poor quality product administered) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Poor quality product administered) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Poor quality product administered).    No Concomitant medication was provided by reporter.   It was reported there was a temperature excursion between 26 May 2022 to 30 Sep 2022 and lot AR5186C was administrated between 08 Sep 2022 to 09 Sep 2022.AR5186C was previously reported. Pediatric dose was given to adults mistakenly and were reported and each patient that received the error dose, with instructions to re-vaccinate 2 months from the initial error dose. 051B22A was kept in the freezer upon receipt of shipment on 08-Jan-2022 and individual vials were put in the refrigerator on the day of use.   No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-669791 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-669791:MOD-2022-669791
been unpleasant; the last one I was miserable; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A 33-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1st, My arm was a little sore after the first shot.), for Covid-19 immunization, reaction(s): "My arm was a little sore after the first shot"; Bnt162b2 (Dose: 2nd, My second [Pfizer] Covid vaccines experience was not as good as the first. I did experience pain in my upper arm , I felt sick had a miserable headache.), for Covid-19 immunization, reaction(s): "miserable headache", "felt sick", "pain in my upper arm"; Bnt162b2 (Dose: 3rd, The two [Pfizer] boosters I have received have been unpleasant (I wish I could find (name-withheld) again) post injection side effects have been stronger the last one I was miserable.), for Covid-19 immunization, reaction(s): "been unpleasant". The following information was reported: MOOD ALTERED (non-serious), outcome "unknown", described as "been unpleasant"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "the last one I was miserable".  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Vacation In state. Awoke at 2:30 am on 04/20/2021 with vomiting and diarrhea. Passed out hitting my head on tile floor. Went to Hospital on 04/22/2021.CTSCAN should lesions on my liver and Portal Vein Thrombosis. After laparoscopic surgery doctor discovered there was still blood supply to colon so colostomy wasn't necessary.  Was treated with 2 different antibiotics and Heparin.  Remained in hospital until 04/25/2021, Released with antibiotics and aspirin regiment.  Upon returning home, contacting Dr., had MRI which should no PVT and benign lesions on liver. Prescribed Eloquis
Patient is fully vaccinated.  COVID positive at ED visit on 3/12/2022. 88-year-old female presents to the ED complaining of cough, general malaise, lightheadedness for the last 4 to 5 days. No chest pain or shortness of breath.  No abdominal pain nausea vomiting or diarrhea.Vitals reviewed and found to be within acceptable limits.  She was given an IV fluid bolus.Normal troponin.  Chest x-ray unremarkable.  EKG nonischemic. No hypoxia. Discharged home.
pt devel fever; 21MAR93 assoc w/persistent crying through 17MAR93;
I was dealing with positional dizziness when I would sit up and when I am standing it get worse and I am still dealing with it today.  It was much worse in the beginning and I cannot do all the physical things I used to.
vertigo (counter-clockwise) developed several hours after vaccination. Difficulty with smooth pursuit eye movements present 24 hours afterwards. No nystagmus, normal range of motion.  None of these symptoms occurred after previous 3 Pfizer vaccinations, including first booster (vaccination 3) on Aug. 16, 2021.
ovulated after second vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A female patient received bnt162b2 (BNT162B2), administration date 02Sep2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "seizures" (unspecified if ongoing). Family history included: "little swelling of her arm" (unspecified if ongoing), notes: Mother fine for second vaccine, just a little swelling of her arm. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, single), administration date: 2021, for COVID-19 Immunization, reaction(s): "inflammation", "Facial swelling". The following information was reported: OVULATION DISORDER (non-serious) with onset Sep2021, outcome "unknown", described as "ovulated after second vaccine".  Additional information: The reporter stated that her daughter (patient) took second vaccination around 02Sep2021, she takes birth control because of seizures around ovulation. She ovulated after second vaccine, causing her birth control to not work properly.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Received DTaP/RT 8/12/03. Redness, swelling noted when he woke up at 9 AM 8/13/03-limping and favoring right leg and knee. Lowered ROM. Entire thigh was swollen.
pt recv vax 22OCT97 & pt stated next day large erythematous area @ the inj site;presents 24OCT97 w/erythema 5x6cm @ the inj site;no streaking;cool packs advised;
Reporting administration error as per Agency.  We contacted Pfizer for expiration dates, Pfizer vaccine specialist advised expiration dates and deemed vaccine viable at the time of vaccine administration. Pfizer vaccine vials only include manufactuarer dates on the box and vials. Therefore, we contacted Pfizer to attain expiration dates directly from them.  No adverse reaction reported from the patietn at the time of the vaccination and no adverse reaction reported since given vaccine.
Patient blanked out, tensed up, and rolled her eyes upward for a few seconds (about 3 seconds) and came out of it saying "what just happened?"  Her breathing became more labored and we had to support her to keep her sitting upright while telling  to keep taking slow, deep breath.  After about 5 mins, patient still did not recover and the ambulance was called.  She has a full physical check up, but nothing was administered.  After that, her mother chose to have her taken to the hospital via the ambulance.;
BRAIN FOG; D-DIMER OF 32; STRONG HEADACHE; This spontaneous report received from a consumer concerned a 51 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced elevated d-dimer, brain fog, and strong headache. Laboratory data (dates unspecified) included: Blood test (NR: not provided) Not Reported, and Fibrin D dimer high (NR: not provided) 32. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the strong headache, brain fog and elevated d-dimer was not reported. This report was non-serious.
Miscarriage occurred during 1st pregnancy since the vaccine. LMP April 6, 2021, diagnosis of blighted ovum on June 17, 2021. D&C on June 22, 2021.
Patient experienced syncope episode after receiving vaccinations listed. Patient was sitting on exam table and stated he felt nauseated and fainted. Patient was placed in lateral recumbent position and exacerbated tonoclonic spasms to all extremities for approximatley 30 seconds. He was responive to verbal stimulus immediately thereafter. He appeared pale, skin cool/dry, drowsy, weak and disoriented for several minutes. Patient  complained of stomach hurting, arms weak, head ache and nausea. Vitals signs obtained and normal. Doctor was notified, arrived and provided details of events. Patient evaluated and monitored for 1 hour after onset and released to father by attending provider.
Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Headache-Mild, Additional Details: Patient reports sudden onset of headache, chest tightness and labored breathing. Pt declined benadryl and epi pen on site to treat with benadryl at home. follow up in progress.
Body aches; Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Body aches), PYREXIA (Fever) and CHILLS (Chills) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008B21A and 025A21A) for COVID-19 vaccination.     Medical history was not provided.  Concomitant products included CITALOPRAM for an unknown indication.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Mar-2021, the patient experienced MYALGIA (Body aches) and PYREXIA (Fever). 30-Mar-2021, the patient experienced CHILLS (Chills). At the time of the report, MYALGIA (Body aches) had not resolved and PYREXIA (Fever) and CHILLS (Chills) had resolved.            Concomitant medications included unspecified contraceptive. Treatment details were not reported.
Localized pain, swelling, warmth and redness, about 5 cm by 8 cm at vaccine location.
4 hours after receiving PNEUMOVAX vaccine in right upper arm patient developed right upper arm swelling, pain and tenderness with diarrhea. Evaluated in the office 11/12/15, (+) fever.
I started developing pain around the vaccination site on February 10th. ( 11 days after vaccination).  The pain moved up into my left shoulder with shooting pains generally in the arm and shoulder up to the base of the skull).  On Saturday, Feb 13 a rash appeared.  On February 14th I was diagnosed at clinic with shingles.
Lt arm 3 in x 3 in area of erythema and edema. Hard to touch, warm and uncomfortable. Treated with Augmentin Rx.
The pt experienced a red arm which was warm to the touch, hard sore knots under the arm. The symptoms spread from in the deltoid region down to the elbow and into fingers. The arm was also swollen and range of motion is limited.
Headache, Vomiting, Abdominal Pain, Dizziness.  Was seen at ER and given IV fluids and antinausea medication.
-Soreness in the arm (Day 1) -Fatigue: the evening of day 1-day 3 -headache: day 2-3 -Muscle aches: day 2 -Chills: day 2 -Lymph node pain/swelling in armpit on same side vaccine given: day 7-present
PATIENT REFERS NAUSEA, HEADACHE, ANXIOUS, TREMBLING. PATIENT DEVELOPED ARRYTHMIA, HIPERVENTILATION, SPASTIC EXTREMETIES LIKE EXTRAPYRAMIDAL ADVERSE REACTIONS. WAS TREATED WITH BENADRYL AND OTHER MEDICATIONS LIKE SOLUMEDROL.
central retinal artery occlusion of the left eye; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of an unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or around 17-OCT-2017, the patient was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) (exact dose, dose number, route and site of administration, lot# and expiration date were not reported), for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date, shortly after receiving the zoster vaccine live (ZOSTAVAX), the patient suffered an acute onset of left eye vision loss. The patient was admitted to the hospital and she was ultimately diagnosed with central retinal artery occlusion of the left eye and was completely blind in her left eye, at the reporting time. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) use, the patient's symptoms had resulted in physical limitations not present prior to vaccination. The patient also experienced mental and emotional distress due to resulting physical limitation and seriousness of her condition. As a result of the zoster vaccine live (ZOSTAVAX) use, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) use, the patient suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the event was reported as not recovered. The relatedness between the event and zoster vaccine live (ZOSTAVAX) was reported as related.  Upon internal review, the event of central retinal artery occlusion of the left eye was considered to be medically significant.  The event of central retinal artery occlusion of the left eye was considered to be disabling.
Warm & redness at injection site of MMR (2-3 cm in diameter with slight bruising).
Breakthrough case admisison after 4 vaccines Pfizer 3/15/21 Lot# EP7534;  Pfizer 4/5/21 Lot# EW053;  Pfizer 10/19/21 Lot# FF2590;  PFizer 4/11/22 Lot# FK9894
Vasovagal syncope after getting up to urinate, hit head with loss of consciousness for 10-15 minutes, sustained concussion, admitted overnight for testing and observation.
little blurred vision after the first dose; This is a spontaneous report from a contactable patient. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization.  The patient medical history and concomitant medications were not reported.  The patient experienced little blurred vision after the first dose.  The outcome was not recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
felt pressure on their feet; couldn't walk; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 53-year-old female patient received BNT162b2 (COMIRNATY), on 19Aug2021 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: GAIT DISTURBANCE (non-serious) with onset 2021, outcome "not recovered", described as "couldn't walk"; DISCOMFORT (non-serious) with onset 2021, outcome "not recovered", described as "felt pressure on their feet".  Additional information: Reporter and her husband (male 61 years old) received their first dose on 19Aug2021, they felt pressure on their feet. She stated "like someone hit us with a baseball bat", they couldn't walk. After that they received their second dose on September, her husband 9Sep2021 and caller 10Sep2021; she stated that now we are on May but since the month of March they are still with the same symptoms. They got the injection on their left shoulder and they have lost mobility, they can't lift the arm over their head. She said "it's horrible to say but I can't shave our arm pits." They can not scratch their backs, she stated they have lost mobility and flexibility of their arm totally. At work she has dropped boxes and her husband has dropped tools. And they even feel pain when they sneeze.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received. Sender's Comments: Linked Report(s) : US-PFIZER INC-202200744593 same reporter/product/event different patient
coughing shortly after injection, lasted a few minutes but went away. Benadryl given