chrisvoncsefalvay/vaers-outcomes huggingface dataset:
10/18/14 warm sensation to right foot. 10/19/14 pins and needles and numbness both feet. 10/20 progression of paresthesia. 10/21 progression upwards involving legs, thighs, abdomen, arms, hands. 10/23 perioral and facial numbness.
Extreme tiredness started 30 minutes after vaccination into the day after. Chills, pain at the injection site, headache, tiredness day after vaccination. Took Motrin 600 mg which relieve headache.
Initial information received on 22-Aug-2018 regarding an unsolicited valid non-serious case received from a other health professional, Nurse. This case involves a 6 months old patient who received vaccines PENTACEL and ACT-HIB at same time. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication not reported. On 22-Aug-2018 at 02 PM, the patient received a 0.5 ml dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot C5458AA. On 22-Aug-2018 at 02 PM, the patient received 0.5 ml dose of suspect HIB (PRP/T) VACCINE lot UI817AA. It was a case of actual medication error due to extra dose administered. It was unknown whether patient experienced any 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 Directive 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.
Information has been received from a registered nurse concerning her 7 year old child, a male with Wolff-Parkinson-White Syndrome, asthma, bicuspid aortic valve, hypersensitivity to Miralax and non steroidal anti-inflammatory drugs, who on 12-APR-2007, in the AM, was vaccinated subcutaneously with a booster dose of varicella virus vaccine live (Oka/Merck) and hepatitis A virus vaccine inactivated (manufacturer not specified). There was no illness at the time of vaccination. Other concomitant therapy included Singulair, an unspecified allergy eye drops, Flovent and flecainide acetate. On 18-JUN-2007, in the PM, the patient developed an itchy rash with red bumps on the chest and back, approximately 40. The patient was seen for "more bumps" on legs and arms. At this time the physician diagnosed the rash as "most likely chicken-pox". A family member, who is a dermatologist, also thought the rash resembled chicken-pox. The patient recovered on 25 JUN 2007. The nurse reported that the physician stated "it was not due to the vaccine". No product quality complaint was involved. Additional information is not expected.
Pfizer BioNTech: Complains of  left foot numbness and tingling that progressed to left leg and then to left hand and left arm.  Benedryl PO 25mg  given at 12:05pm. No changes after Benadryl given.
Patient came in to the pharmacy. Injection site is red and swollen. Patient states it is painful itchy and burning and warm. The redness and swelling appears to be radiating almost down to the elbow from the deltoid muscle. Patient states it has been a week and the area feels worse than before. Patient is instructed by pharmacist to go to the ER or primary care as soon as possible. Patient refused ambulance for ER.
Pt was given Fluzone for second time, nurse did not check patient chart.  No adverse reaction, Pt was informed about the error and verbalized understanding.
2 days after Rotateq, patient began vomiting 11/29/06 ultrasound on 12/1/06 showed signs of obstruction and . Abdomen-surgery on 12/1/06 revealed intussusception with gangrenous ascending and transverse colon-after, colectomy of involved segment  Andre-anastomosis.  Patient is doing well.
slight dizziness; fatigue; Arm soreness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62 year-old patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 18Feb2021 11:00 (Lot number: EN6201) at the age of 62 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "seizure disorder" (ongoing), notes: Patient medical history : Seizure disorder; "Asymmetrical cortical thinning of Right aypocampus lobe" (ongoing). Concomitant medication(s) included: DILANTIN [PHENYTOIN] taken for seizure, cortical dysplasia, start date: 02Jan2000 (ongoing). Vaccination history included: Bnt162b2 (Dose: 1st; Date: 27Jan2021; Time: 10:00 AM; Anatomical Site of injection: Left arm; Route of administration: Intramuscular; Batch/Lot number: EN5318), administration date: 27Jan2021, when the patient was 62 years old, for Covid-19 immunization, reaction(s): "minimal soreness in arm", "I had slight light headed". The following information was reported: DIZZINESS (non-serious) with onset 18Feb2021 11:10, outcome "recovered" (2021), described as "slight dizziness"; FATIGUE (non-serious) with onset 18Feb2021 11:10, outcome "recovered" (2021), described as "fatigue"; PAIN IN EXTREMITY (non-serious) with onset 18Feb2021 11:10, outcome "recovered" (2021), described as "Arm soreness".Therapeutic measures were not taken as a result of dizziness, fatigue, pain in extremity.  Additional information: The reported issue occurred after the use of Pfizer product. No Admission to hospital due to event (Does not include emergency room visit without further admission). The patient did not  received any treatment. Still experienced fine now. No any additional event information and not visited emergency room. Not any surgical treatment needed for the event. Reason to took Covid vaccine for stay alive. Name of product (Both commercial generic of Known): (bnt162b2) BNT162B2 covid vaccine. No other product(s) that were taken together with those indicated above. Shot 1 had slight light feeling about 20 min and a little arm soreness the next day for 2days. Not severe. About 5 on 10 scale. About 25 of pain he had from Shingrex. Shot 2: Slight dizziness and fatigue. No fever, chills etc. resolved in short time. Arm soreness a bit less 2nd time around. Felt fine. No any other vaccination within four weeks prior to the first administration date of the suspect vaccine. Autopsy information: No autopsy done, yet as still alive.  The information which are relevant to this case added in narrative. Other information already captured/added in cross referenced case:2021133667.  No follow-up attempts are possible. No further information is expected.
Upper arm swollen, red and feverish, heart palpitations, dizziness, pallor and SOB. Dr prescribed Benadryl and suggested warm and cool pack, alternating, and topical Benadryl to arm.
itches very bad; circular rash; pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (itches very bad), VACCINATION SITE PAIN (pain at injection site) and VACCINATION SITE RASH (circular rash) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced VACCINATION SITE PAIN (pain at injection site). On 11-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (itches very bad) and VACCINATION SITE RASH (circular rash). At the time of the report, VACCINATION SITE PRURITUS (itches very bad), VACCINATION SITE PAIN (pain at injection site) and VACCINATION SITE RASH (circular rash) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication use was provided  No treatment of events was reported.
Itchy hives at the site of injection; Red hives at the site of injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE URTICARIA (Itchy hives at the site of injection) and VACCINATION SITE ERYTHEMA (Red hives at the site of injection) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 17-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced VACCINATION SITE URTICARIA (Itchy hives at the site of injection) and VACCINATION SITE ERYTHEMA (Red hives at the site of injection). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency and TRIAMCINOLONE for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE URTICARIA (Itchy hives at the site of injection) and VACCINATION SITE ERYTHEMA (Red hives at the site of injection) had not resolved. Not Provided          No concomitant medications were provided by the reporter.
Client has received a Pfizer COVID vaccine on 10/27/2023 and then received a Moderna COVID vaccine on 11/17/2023. Client had no adverse reactions to vaccination after administration.
Pt experienced some redness, swelling and warmth accompanied by tenderness to the left anterior thigh with mild cellulitis.
S&S swelling in throat, rash from top of head to the waist (like hives), rash burns-nausea;
Erythematous maculopapular rash, followed by the appearance of clear vesicles that subsequently crusted over. Localized over injection area (right deltoid) in a dermatomal distribution consistend with cervical nerve root involvement.
Pt was sitting upright on the exam table after receiving GARDASIL #3 and Hep A #1. She was waiting the 15 minute period for GARDASIL, when she fainted. I was a few feet away at my work station and heard her fall. I ran into the exam room - pt was post-syncopal, lying on her left side, and appeared to have fallen onto her left chin/lip area. I made sure her C-spine was protected, airway was open, and kept pt on her side until she awoke a few seconds later. Her left lower lip was swollen with superficial abrasion, not requiring sutures. Pt's front left upper tooth and the tooth next to it bled around the gumline. The teeth were not loose. She did have pain when teeth were palpated. Ice was immediately applied to teeth and lip. I did a neurological exam and she remained dizzy. There were no other neurological deficits. Pt indicated that she did not have pain anywhere else on her body except her mouth/chin/lip area. She denied neck or extremity pain. I stayed with the patient first lying on the ground for 5 minutes, then sitting upright on the ground for another 5 minutes, then sitting in a chair for 5 minutes. Pt was then moved back to the exam table to lie down for 10 more minutes due to mild dizziness. I had her mother call her dentist for an emergency visit this afternoon. Pt indicated that her dizziness resolved and she was able to walk without dizziness. Mother was in a hurry to get pt to the dentist. I called mom later in the evening to check on the pt, see separate entry into EMR. Adverse reaction form for GARDASIL completed. Incident report form completed. Office manager notified to counsel nurse regarding the need to lie patients down for 15 minutes after receiving GARDASIL. Mom also told me later that patient fainted after she received GARDASIL #2 and had lab work done at her last office visit with her previous doctor. Dr. spoke with pt's mother to check on pt. Saw the dentist, no fx. Has recheck with dentist next week to make sure all is okay. Her lip is getting more swollen. No emesis. She kept down a smoothie this evening. Mom says that she is resting and sleeping now. Recommended to mom that she do neuro checks (explained this to mom) every 2 hours tonight. To ER if any emesis, neurological abnormalities, etc. Informed mom that we are filling out an adverse reaction form for the GARDASIL.
First, burning in chest, coughing like wheezing, then felt like I had a lump in my throat, tired, eyes felt swollen and like a film on them--blurry, severe back and body aches, chills overall felt sick. Felt better on Sunday, but hoarseness on Monday.
she couldn't breathe, shortness of breath; sugar went up to 400-something; This spontaneous case was reported by a patient and describes the occurrence of DYSPNOEA (she couldn't breathe, shortness of breath) and BLOOD GLUCOSE INCREASED (sugar went up to 400-something) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In October 2022, the patient experienced DYSPNOEA (she couldn't breathe, shortness of breath) and BLOOD GLUCOSE INCREASED (sugar went up to 400-something). At the time of the report, DYSPNOEA (she couldn't breathe, shortness of breath) had not resolved and BLOOD GLUCOSE INCREASED (sugar went up to 400-something) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In October 2022, Blood glucose: up to 400 something.         Concomitant medication was not reported.  Patient had a spell. Patient thought it was probably due to the shot. She hadn't been feeling good since vaccination day. She was still having shortness of breath. She doesn't felt well. She felt tired. She asked how long this will last.  Treatment drug was not reported.
Patient received vaccine on 31 Mar 2022 which was expired on 27-Mar-2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received vaccine on 31 Mar 2022 which was expired on 27-Mar-2022) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received vaccine on 31 Mar 2022 which was expired on 27-Mar-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received vaccine on 31 Mar 2022 which was expired on 27-Mar-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported.  The reporter mentioned that there was incident because of miscommunication that the expirations date had been extended. The patient received expired dose and it was patient's second booster dose of Moderna COVID-19 Vaccine.  No treatment information was provided.
Information has been received from a nurse practitioner concerning a female child who was vaccinated subcutaneously with a 0.5ml dose of Varivax. One day later, the child experienced an initial varicella-like injection site reaction from which she recovered. No laboratory or diagnostic studies were performed. Unspecified medical attention was sought. There is no additional information to report. There was no product quality complaint involved. Additional information has been requested.
HIGH FEVER, TALKING OUT OF HEAD, ARM SWOLLEN, RASH, CHEST PAIN, SHORTNESS OF BREATH.
Rash on neck and face, swelling and dry skin of face that began around 24 hours after vaccine.
VARIVAX given L arm on 4/9/09, Pt returns on 4/11 with Lt arm about 50 cents size red area with some bruising on upper aspect at injection site, to f/u if worsens - TYLENOL, cold compresses.
At 2am the following day of my second dose vaccine, felt really bad nausea, chills, body aches and I went to the ER to have my symptoms checked out.  I can say today I have no symptoms.
achy; threwup twice; This is a spontaneous report from a contactable health care professional (patient).  A 22-year-old female patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), via an unspecified route of administration on 07Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that she received the second dose of the vaccine and has been really achy since then. She also mentioned that in the past 2 hours, she threw up twice. She wanted to know if this was normal. The outcome of the events was unknown.   Information on the Lot/batch number has been requested.
Patients received the Bivalent vaccination after a temperature excursion; Patients received the Bivalent vaccination after a temperature excursion; No Adverse Event; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the Bivalent vaccination after a temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Patients received the Bivalent vaccination after a temperature excursion) and NO ADVERSE EVENT (No Adverse Event) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 049D22A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the Bivalent vaccination after a temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Patients received the Bivalent vaccination after a temperature excursion) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the Bivalent vaccination after a temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Patients received the Bivalent vaccination after a temperature excursion) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the Bivalent vaccination after a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patients received the Bivalent vaccination after a temperature excursion).    No concomitant medications were reported.   The facility had a temperature excursion in the freezer. They had an inspection and saw that their DDL was not recording the temperatures. At the time of the excursion, the vaccine was in frozen storage. The vaccines were in unbroken cartons with vial size of 2.5 ml and 5.5 ml. Because only manual recording was done twice a day, the maximum and minimum temperatures reached by the vials were unknown. The excursion duration was unknown. The vaccine was returned to the freezer.  The visual inspection showed the vaccine state as still frozen. The vial underwent temperature excursion for the first time.  The patient had received the booster dose of Moderna COVID-19 vaccine, Bivalent.  No treatment information was provided by the reporter.
Fever and crying started around 20:00 and mom and grandmother states that pt was very hot to the touch. Had no thermometer to check temperature. Has vomited his formula X 3. Has been giving him Tylenol. Referred to pt's pediatrician. Not recovered at the present time.
t104 R; mom reports pt was shaking; also had vomiting; taken to hosp ER;
I had a SVT episode on 11/4 morning and 11/5 I checked into the ER due to dizziness.
Initial symptoms were shortness of breath, exhaustion. Starting approx. 3 weeks after second dose, unable to climb one flight of stairs or walk more than a few hundred feet without needing to stop and rest. A chronic cough developed as well during this time period.
Memory impaired; This spontaneous case was reported by a consumer and describes the occurrence of MEMORY IMPAIRMENT (Memory impaired) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Feb-2021, the patient experienced MEMORY IMPAIRMENT (Memory impaired). At the time of the report, MEMORY IMPAIRMENT (Memory impaired) outcome was unknown.            Concomitant medication use was not reported. No Treatment information was provided. Action taken with mRNA-1273 in response to the drug was not applicable.
Pt recvd 3 doses of Recomb vax 1 to 2 yrs prior to report & did not seroconvert (WAES #91090418); pt given new series of vax starting MAY91 & devel serum sickness,nausea, fatigue, malaise & arthralgia; Given 2nd dose JUN91 & sx worsened;
This spontaneous case was reported by a consumer and describes the occurrence of EYE PAIN (hurts to look at things), CHEST PAIN (onstant burning continuously in her chest,chest pains), HYPERHIDROSIS (perspiration), DYSPEPSIA (horrendous heartburn) and EAR PAIN (could feel pain in ears) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047a21a and 001c21) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was provided by the reporter.  Concomitant products included PARACETAMOL (TYLENOL), ACETYLSALICYLIC ACID, CAFFEINE (BC [ACETYLSALICYLIC ACID;CAFFEINE]), DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]), FAMOTIDINE (PEPCID [FAMOTIDINE]), CLARITHROMYCIN (MACROBID [CLARITHROMYCIN]) and CALCIUM CARBONATE (TUMS [CALCIUM CARBONATE]) for an unknown indication. On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Apr-2021, the patient experienced EYE PAIN (hurts to look at things), HYPERHIDROSIS (perspiration), CHILLS (chills), MYALGIA (arm was sore,pain in her calves) and HEADACHE (intense headache,feels headache in her face,massive sudden headaches that are worse through out the night). On 29-Apr-2021, the patient experienced CHEST PAIN (onstant burning continuously in her chest,chest pains), DYSPEPSIA (horrendous heartburn), EAR PAIN (could feel pain in ears), NECK PAIN (could feel pain in neck), GASTRITIS (gastritis,stomach lining was extremely inflamed), ABDOMINAL PAIN UPPER (could feel pain in stomach) and BLOOD DISORDER (factor in the bloodwork made the doctor concerned about a blood clot.). On an unknown date, the patient experienced NAUSEA (nauseous). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at an unspecified dose and frequency. On 29-Apr-2021, HYPERHIDROSIS (perspiration) and CHILLS (chills) had resolved. At the time of the report, EYE PAIN (hurts to look at things), CHEST PAIN (onstant burning continuously in her chest,chest pains), DYSPEPSIA (horrendous heartburn), EAR PAIN (could feel pain in ears), NECK PAIN (could feel pain in neck), GASTRITIS (gastritis,stomach lining was extremely inflamed), ABDOMINAL PAIN UPPER (could feel pain in stomach), BLOOD DISORDER (factor in the bloodwork made the doctor concerned about a blood clot.), NAUSEA (nauseous), MYALGIA (arm was sore,pain in her calves) and HEADACHE (intense headache,feels headache in her face,massive sudden headaches that are worse through out the night) outcome was unknown. Action taken with mRNA-1273 in response to the events was not applicable. This case was linked to MOD-2021-106919.