chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Injection was administered too high and in back of arm instead of deltoid muscle. During administration, arm tingled and spasmed. Roughly 2 hours after administration, arm was completely immobile due to shooting/stabbing pain meds injection site. Vomiting occurred on 4 separate occasions within the first 14 hours of administration due to uncontrollable pain. 800mg of Ibuprofen and 1000mg of Tylenol were administered with no relief. A steroid shot was administered by a physician roughly 21 hours after the Bexsero shot to control inflammation and pain. Little relief was found. 96 hours later, range of motion in the shoulder is still limited. Daily tasks such as getting dressed are impossible without stabbing pain. Heat/ice and ibuprofen have been used throughout with no relief.
TIREDNESS; SEVERE BODY SHAKES WITH TEETH CHATTERING; CHILLS; HEADACHE; FEVER; This spontaneous report received from a patient concerned a male. The patient's height, and weight were not reported. The patient's past medical history included covid-19, and concurrent conditions included alcohol use, and cigarette smoker, and other pre-existing medical conditions included patient had no known allergies the patient had no history of drug abuse or illicit drug use.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown, and batch number: 1805022 expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 17:00, in left arm, for prophylactic vaccination. No concomitant medications were reported. On 10-JAN-2021, Laboratory data included: Blood test (NR: not provided) Normal. On 10-MAR-2021, the subject experienced severe body shakes with teeth chattering. On 10-MAR-2021, the subject experienced chills. On 10-MAR-2021, the subject experienced headache. On 10-MAR-2021, the subject experienced fever. On 11-MAR-2021, the subject experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe body shakes with teeth chattering on 11-MAR-2021, was recovering from chills, and headache, and had not recovered from fever, and tiredness. This report was non-serious.; Sender's Comments: V1: Medical assessment comments not required as per the standard procedure as the case is assessed as non serious.
Hep A and Varicella given R arm. Woke that evening screaming, R arm swollen.  Parents noted pauses in breathing.  Brought by ambulance to Hospital ER for exam
no further information is available; patient received improperly stored vaccine on 24-AUG-2021; This spontaneous report was received from a medical assistant and refers to a 4-years-old female patient. Information regarding the patient's concomitant therapies, concurrent conditions, medical history and historical drugs was not provided.  On 24-AUG-2021, the patient was vaccinated with one dose improperly stored Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (dosage regimen was not reported, product storage error), lot # U009262 (rHA) and expiration date 19-AUG-2022 administered as prophylaxis.  The improperly stored dose of the suspect vaccine experienced a temperature excursion of -3.3 degree celsius for 4 hours 52 minutes; no previous temperature excursions were reported.
Hives all over body. Lasted 36 hours. Started at 14:00 on 2/05/2021 until 0800 on 2/07/2021
This case was reported by a nurse via call center representative and described the occurrence of erythema of extremities in a 59-year-old female patient who received FLULAVAL QUADRIVALENT 2018-2019 season (batch number 59TS2, expiry date 31st May 2019) for prophylaxis. Previously administered products included INFLUENZA VACCINE (received on an unknown date, without any issues). On 25th February 2019, the patient received FLULAVAL QUADRIVALENT 2018-2019 season (intramuscular). In February 2019, less than a week after receiving FLULAVAL QUADRIVALENT 2018-2019 season, the patient experienced erythema of extremities, skin blotches, induration, swelling arm and injection site discoloration. On an unknown date, the outcome of the erythema of extremities, skin blotches, induration, swelling arm and injection site discoloration were recovered/resolved. It was unknown if the reporter considered the erythema of extremities, skin blotches, induration, swelling arm and injection site discoloration to be related to FLULAVAL QUADRIVALENT 2018-2019 season. Additional details were provided as follows: The patient received FLULAVAL QUADRIVALENT 2018-2019 season on left arm. The registered nurse reported that her clinic administered the FLUARIX QUADRIVALENT and the patient experienced a red and blotchy area from her left shoulder to her elbow that was hard and swollen. The injection site was white, elevated and hard on her left upper arm. She went to her physician on the day after her injection for allergy injections for seasonal and environmental allergies and her physician noticed the red area. The patient has had no issues with the flu vaccine in the past and she regularly gets the flu vaccine, however, she didn't get the vaccine last year. The symptoms are mostly resolved. Consented to follow up was provided.
Patient stated he was lightheaded and vision was blurry. Advised patient to sit with head between knees and take deep breaths. Also gave patient a glass of water and an ice pack to put on his neck. Called a family member to pick up patient. Continued to monitor patient until he was picked up. His vision came back to normal but he was still slightly lightheaded. Advised him to continue to monitor symptoms at home and if he experienced any shortness of breath or developed a rash to seek medical attention.
Ache up into shoulder for several weeks. Was extremely bothersome especially when using left arm for other activities - in snow shoveling/carrying groceries, etc. Pain/discomfort.
Measured in inches 2 and 1/2 in inches all around red and a bit swollen.
Approximately 3 hours after injection it was noted to be swollen and tender below injection site. On 11/5/14 there was an area of redness with swelling noted upon waking (06:00 AM) that was approximately 3 inches in diameter. By 4:15 PM on 11/5/14 the area of swelling and redness was measured at 4 inches from proximal to distal edges on left upper arm. This area is hot to touch and begins at about an inch below the injection site. On 11/4/14 the patient took ibuprofen that seemed to help decrease the tenderness.
Per mother, in the morning on 8/15/17 child was awaken by mother and mother did not notice anything unusual when helping child get dressed. Says child felt warm/feverish but was in a rush and didn't take temperature. Child was given TYLENOL, crackers and water. They went about their day and child never complained and performed normal activities. Around 7 or 8 PM on 8/15/17, mother gave child a bath and that's when she noticed the very large red and swollen area over right deltoid muscle and was warm to touch. Received a call from the mother at 10 AM on 8/16/17 letting me know about the reaction. Mother took the child's temperature and it was low grade of 99.
Bloody urine/gross hematuria, 6 months pregnant due Jan 2022, 1st pfeizer vaccine dose administered 7:00 pm on 10/12/21, symptoms started following morning at 5;30 am.
Left deltoid: 5 x 3 cm nodule with erythema warmth tenderness. Cellulitis treated with Keflex TID x 7 days and warm compresses.
Patients left arm was red around injection site. Patient also complain of pruritis at site of injection.
Patient got her Flu shot on Monday, October 25th, evening. She states waking up the next day with pain and inflammation under her left arm and in the chest/neck/ clavicle area as well. She says today, Thursday October 28th, the pain and inflammation is worse and her doctor's office did not direct her or want to see her. She was directed to go see a doctor if the pain is worsening.
Experienced mild flu like symptoms. Fatigue and body aches. The symptoms were not severe and only lasted for about a day and a half.
Patient did not report any issues or concerns, however the hepatitis A/B vaccine was given with the hepatitis B vaccine.
Patient presented to the ED and was subsequently hospitalized within 6 weeks of receiving COVID vaccination. Diagnosis was gastrointestinal bleeding.
Within 10 minutes of receiving the Pfizer COVID vaccine, she complained of chest tightness, feeling flushed, mild headache, and paresthesias in her hands and mouth.  Symptoms lasted approximately 10 minutes and resolved spontaneously.  No treatment was administered. The patient was observed and discharged to home with no additional treatment.
ACUTE RESPIRATORY FAILURE ACUTE ON CHRONIC HYPERCAPNIC RESPIRATORY FAILURE 1/20/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Agency completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose:12/29/2020pfizer,Lot#EL0142 2nd dose:01/19/21 Pfizer,Lot# EL3247 Diagnosed covid positive:04/20/21 Exposure:unknown Symptoms:Asymptomatic
Patient stated that he could faint from shots. Administer shot, had patient wait 5 minutes. No visible ill effects and patient said fine. Patient fainted at customer service desk, attended by nursing student and pharmacist, call 911 - patient signed and refused treatment or transport.
145PM 7DEC98 pt recv vax & c/o pressure in head, itchy lips;VS 174/98, 110;call to MD 215PM give DPH;235PM 150/100, AR98, c/o pressure in head, lips itchy, flushed;240PM 158/100, R 100;taken to MD;
Varivax 11 days ago. Spots on head and trunk this morning with treatment.
they look like a beehive stung them; reaction is becoming systemic, because the patient now has a terrible itching everywhere, and they look like a beehive stung them; COVID arm; looks like bleeding under the skin; big area that was red and as big as the front part of her arm with a wider irregular shape, about a half inch crescent, dark subcutaneous reaction; as a severe allergic reaction; A spontaneous report was received from a consumer concerning a 79-year-old female who received the second dose of Moderna's COVID-19 (mRNA-1273) vaccine and experienced the following:  covid arm (Vaccination site reaction), looks like bleeding under the skin (Vaccination site bruising), big area that was red and as big as the front part of her arm (Vaccination site erythema), the patient now has a terrible itching everywhere (Generalised pruritus), and they look like a beehive stung them (Generalized urticaria), and the reaction is becoming systemic, a severe allergic reaction (Allergy to vaccine).  The patient's medical history was not provided. Concomitant product use included high blood pressure medication (not specified),  curcumin, and acetylsalicyclic acid.  On 07 JAN 2021, the patient received their first of two planned doses of mRNA-1273 (Batch number not provided).    On 04 FEB 2021, approximately five days prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 (Batch number: 032L20A) intramuscularly in the left deltoid for the prophylaxis of COVID-19 infection.    On 08 Feb 2021, the patient experienced the events covid arm; mother of all covid arms; looked like hell, really bad; looked like bleeding under the skin; big area that was red and as big as the front part of arm with a wider irregular shape, about a half inch crescent, dark subcutaneous reaction; looked like bleeding under the skin; very tremendous reaction, but it does not hurt.   On 11-Feb-2011, the red subcutaneous reaction deepened and started to migrate almost immediately, and slowly migrated 5-6 inches to the bottom of the arm near the elbow. The reporter stated the reaction seemed to be getting better; it was not getting any worse, but was worried it may turn into cellulitis or gangrene. On an unknown date, the patient consulted with a dermatologist for the "Covid arm" and the reporter stated that the reaction was becoming systemic because the patient now had terrible itching everywhere, and they looked like a beehive stung them.  The reporter described it as a severe allergic reaction to the second vaccine dose with onset of this reaction 4-5 days after the second dose. Treatment for the events included some cream with steroids to treat the pruritus, as well as diphenhydramine.  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable.  The outcome of the events was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Initial report received from a health care professional (nurse) on 18 Mar 2011: This patient with an unknown medical history was vaccinated with MENVEO (batch number: M10030) 0.5 ml dose intramuscularly on 17 Mar 2011. The patient received only the Men CWY liquid conjugate without reconstituting with Men A component. No adverse events were noted following this medication error. Follow up report received on 01 Apr 2011. This patient received 0.5 ml of varicella vaccine (batch number 1470Z) on left arm on 17 Mar 2011. The batch numbers for Men A Lyophilized conjugate component of Men CYW-135 liquid conjugate were reported as A10030 and X10030 respectively. The patient received Men CYW-135 liquid conjugate component only. The patient did not experience any adverse reaction.
This spontaneous case, initially received from other non-health professional on 26-Oct-2018, concerns a female patient of an unspecified age. It was reported that whenever flu vaccine was drawn up, it leaked out from the rubber stopper. One of the nurses noticed when they popped the secured lock off the vial the rubber stopper was dented in and off a little. The nurses advised when they removed the hard cap and stuck the needle in the middle, there was a corner on the top where the rubber stopper was dented in causing a hole where the medication would leak. About 5 doses were drawn out of 10 doses in the vial. The vials leaked and only 4 vials were leaking so far. On 02-Oct-2018, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 252234 and expiry date: 30-Jun-2019] from the leaking vial. No adverse events were reported after administration of the vaccine. This case 201804827 is linked to the original case 201804823 due to the same reporter. This case was associated with product quality complaint, hence quality assurance investigation (QAI) had been requested and the corresponding PTC reference number was 1034101. Based on the QA investigation report, it was concluded that FLUCELVAX Batch 252234 was manufactured in compliance with the approved internal procedures and in accordance with the quality requirements. No internal root cause was identified in the manufacturing process. A known trend was identified for the FLUCELVAX batches from the 2018/2019 FLUCELVAX commercial season for vials leaking at the stopper during dosing. A review revealed that the complainant was adding air to the vial prior to extracting doses and was inverting the vial when withdrawing the needle from the stopper. It was known that the addition of air to the vial can over pressurize the vial and cause leaking. In addition, inverting the vial while trying to extract a dosage can increase the potential for the vial to leak. The root cause for this investigation was found to be user-improper handling. The reporter assessed this case as non-serious. Follow-up report received from QA department on 19-Nov-2018: The QA investigation report stated that, the root cause for the leaking FLUCELVAX MDV of Batch 252234 was due to user or improper handling. Added new event (wrong technique in product usage process) in the event tab. The narrative was amended accordingly.
The patient experience a vasovagal reaction approximately 8 minutes after his injection.  He reported he felt fine, then started feeling dizzy, then fell out of his chair in the waiting room after passing out.  He came to quickly.  He looked pale and had lost control of his bladder.  After a few minutes his color returned and he was able to sit up.  His blood pressure, taken about 4-5 minutes after his incident, was 141/78.  He returned to a chair where he waited an additional 10 minutes before leaving.
severe and frequent malodorous flatulence; change in bowel habits; bloating; cramping after eating; soft stools; Booster; This is a spontaneous report received from a contactable reporter(s) (Other healthcare professional). The reporter is the patient.  A 63 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 03Dec2021 (Batch/Lot number: unknown) at the age of 63 years as DOSE 3 (BOOSTER), SINGLE for covid-19 immunization. The patient had no relevant medical history. The patient had no allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient took concomitant medications. Vaccination history included: Bnt162b2 (DOSE 2, lot number unknown, Anatomical Location: Arm Left), administration date: 25Feb2021, when the patient was 63 years old, for COVID-19 IMMUNIZATION; Bnt162b2 (DOSE 1, lot number unknown, Anatomical Location: Arm Left), administration date: Feb2021, when the patient was 63 years old, for COVID-19 IMMUNIZATION. The following information was reported: IMMUNISATION (non-serious) with onset 03Dec2021, outcome "unknown", described as "Booster"; FLATULENCE (non-serious) with onset 05Dec2021, outcome "not recovered", described as "severe and frequent malodorous flatulence"; CHANGE OF BOWEL HABIT (non-serious) with onset 05Dec2021, outcome "not recovered", described as "change in bowel habits"; ABDOMINAL DISTENSION (non-serious) with onset 05Dec2021, outcome "not recovered", described as "bloating"; ABDOMINAL PAIN (non-serious) with onset 05Dec2021, outcome "not recovered", described as "cramping after eating"; FAECES SOFT (non-serious) with onset 05Dec2021, outcome "not recovered", described as "soft stools". Therapeutic measures were not taken as a result of flatulence, change of bowel habit, abdominal distension, abdominal pain, faeces soft.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Left Deltoid raised, reddened, approx 4 1/4 in x 3 1/2 in area painful and warm to touch. Left arm Posterior subqutaneous area has reddened area approx 1 1/2 in x 1 1/2 in. Tylenol 325mg and ice applied.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 38-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27Feb2021 as dose 1, single (Lot number: EN6205), in left arm, on 20Mar2021 as dose 2, single (Lot number: EN6204), in left arm, on 02Nov2021 as dose 3 (booster), single (Lot number: FG3527), in left arm and on 03Jul2022 as dose 4 (booster), single (Lot number: FP4554) at the age of 37 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Congenital Heart disease (shone's complex), 2 mechanical valves" (unspecified if ongoing), notes: Congenital Heart disease (shone's complex), 2 mechanical valves. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 17Aug2022, outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (12Aug2022) Negative, notes: After two negative tests on 12Aug and 14Aug I tested positive again on 17Aug; (14Aug2022) Negative, notes: After two negative tests on 12Aug and 14Aug I tested positive again on 17Aug; (17Aug2022) Positive, notes: After two negative tests on 12Aug and 14Aug I tested positive again on 17Aug. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: There were no other medication in 2 weeks. Patient took Antiviral Product Paxlovid as covid 19 treatment starting on date 25Jul2022 and stopped on 30Jul2022. Adverse Event reported as After two negative tests on 12Aug and 14Aug tested positive again on 17Aug. Patient tested three times to make sure there was no mistake. Positive all three times. Mild symptoms returned, including scratchy sore throat and some chest congestion. No other symptoms so far.
I got constipation on both time; This is a spontaneous report received from a contactable consumer (Patient). A 60-year-old patient of an unspecified gender received two doses of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation, dose 1 (Lot Number: EV6955) in left arm, dose 2 (Lot Number: ER8735). The patient medical history was none. Concomitant medications included levothyroxine. When the patient got both shots, the patient got constipation on both time on an unspecified date. No treatment was given for event. The outcome of event was recovered.               Patient History: No  Investigation Assessment: No   Email Address: Consumer stated, "I don't even read my email, so I will not give you."  LOT#: Consumer stated, "For first shot it's EV6955."      When probed for if consumer still experiencing issue, consumer stated, "No, it's went away."  Treatment: Consumer stated, "No."  QR Comment:  Reason of delay: Daily spike of incoming calls due to COVID19 vaccine.  No follow-up attempts are needed. No further information is expected. This is a spontaneous report from a contactable consumer or other non hcp.
expired Moderna vaccine administered to patient; Vaccine expired on 1 Apr 2022, Vial was initially stored in the refrigerator on 05 Apr 2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired Moderna vaccine administered to patient) and PRODUCT STORAGE ERROR (Vaccine expired on 1 Apr 2022, Vial was initially stored in the refrigerator on 05 Apr 2022) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) 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) .25 milliliter. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired Moderna vaccine administered to patient) and PRODUCT STORAGE ERROR (Vaccine expired on 1 Apr 2022, Vial was initially stored in the refrigerator on 05 Apr 2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired Moderna vaccine administered to patient) and PRODUCT STORAGE ERROR (Vaccine expired on 1 Apr 2022, Vial was initially stored in the refrigerator on 05 Apr 2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  Reporter reported that the administration of vaccine occurred from 6 Apr 2022 to 9 Apr 2022. Patient had no adverse reaction after the vaccination. The manufacturing date of the vial was 1 Dec 2021. Vial was initially placed in refrigerator on 5 Apr 2022. The product did not undergo any temperature excursion issue.  No treatment medication was reported.   This case was linked to MOD-2022-537580, MOD-2022-538614, MOD-2022-538672, MOD-2022-538673, MOD-2022-538675, MOD-2022-538676, MOD-2022-538677, MOD-2022-538678, MOD-2022-538681, MOD-2022-538682, MOD-2022-538688, MOD-2022-538691, MOD-2022-538692, MOD-2022-538693, MOD-2022-538696, MOD-2022-538697, MOD-2022-538698, MOD-2022-538701, MOD-2022-538702, MOD-2022-538688, MOD-2022-538614, MOD-2022-538698, MOD-2022-538676 (Patient Link).
The night of 5/11/01, the pt began screaming and it continued through 5/12/01.