chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fluzone Quad that was taken out of the fridge to be given to a patient but sat out for 45 mins at room temperature / no AE; Initial information received on 24-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves unknown demographic patient who received a 0.5 mL dose of vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] lot UT6656KA (Expiry date 30-Jun-2020) via unknown route in unknown administration site on an unknown date.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was actual medication error case due to incorrect product storage.  It was reported that Fluzone Quad that was taken out of the fridge to be given to a patient but sat out for 45 minutes at room temperature.  At a time of reporting no adverse event reported.  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 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.
Pt told father on 2/12 that he had hives which started on trunk, back, feet, legs, hand, neck, face and then explosively all over. Pt saw PA 2/20 and treated with antihistamines. Pt saw MD and treated with steroids. Had respiratory problems. Pt is tapering steroids. Pt missed 2 wks of school.
VACCINE VIAL FROZEN TOO LONG. VACCINE MAY HAVE BEEN COMPROMISED.
Initial report was retrieved via a search of scientific literature on 14 May 2014. This case contains information for 1 of 5 patients whose clinical data were provided. Information regarding the other 4 patients were captured in case numbers 2014SA063511, 2014SA063512, 2014SA063513 and 2014SA063514. Verbatim from the abstract: "Background: Fever, leukocytosis, and large local reactions following the PS23 have been described only in isolated case reported in the adult literature. Such atypical reactions can pose difficulty to providers when determining management. Patients experiencing this noninfectious reaction may receive unnecessary treatment if the diagnosis of robust inflammatory response to the PS23 vaccine is not considered. Observations: This is a clinical case series of 5 adult patients who received the influenza and PS23 vaccines and experienced a cellulitis-like reaction, fever, and leukocytosis in the days following vaccination. Four of the five patients received the influenza and PS23 vaccines in the same arm. The patient who received the vaccines in opposite arm had the local findings in the arm that received the PS23 vaccine. All 5 patients sought care and 4 were admitted to the hospital for observation or treatment with intravenous antibiotics. Conclusions: This case series highlights potential side effects of the PS23 vaccine that are not well described in the adult literature. Antibiotics were not helpful in treating these patients' local and systemic symptoms. Patients with histories consistent with that highlighted in this case series may avoid antibiotics and hospitalization if their providers recognize these symptoms as a noninfectious reaction to the PS23 vaccine. Regarding this case which involves a 28 year old male patient with a history of asplenia had received on an unspecified date the following vaccines: an arm injection of Influenza vaccine (manufacturer, lot number, route and anatomical side of administration not reported) and an in the same arm an injection of 23-valent pneumococcal polysaccharide vaccine (manufacturer, lot number, route and anatomical side of administration not reported) and within one day of vaccination developed a fever of 104.5 degrees Fahrenheit and vomiting. The patient also developed local erythema, edema and warmth at the site of injection. The patient had significant leukocytosis with a white blood cell (WBC) of 29.7 K/uL. C-reactive protein and erythrocyte sedimentation rate (ESR) was not checked. The patient was admitted to hospital and treated with antibiotics in hospital and post discharge. Within 5 to 7 days the patient experienced improvement in the skin findings and resolution of the systemic symptoms. The patient had received PS23 pneumococcal vaccine (manufacturer unknown) prior to this reaction for the indication of asplenia. The date of prior vaccination was not available as it occurred prior to the patient's enrollment in the employers healthcare system. The patient had not received any subsequent pneumococcal vaccines. Outcome was recovered for systemic symptoms and unknown for local reaction. Documents held by sender: none.
Multiple vesicular lesions, some scabbed some fluid filled. Also erythematous papules on trunk, legs and arms.
COVID-19; COVID-19; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer (patient). A female patient of an unspecified age received the 1st dose of bnt162b2 (BNT162B2), via an unspecified route of administration, on 13Feb2021, at single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced COVID-19 (medically significant) in 2021 with outcome of unknown. The patient underwent lab tests and procedures which included COVID-19 virus test: positive in 2021.  The information on the lot/batch number has been requested.
Information has been received from an RN concerning her 38 year old husband with no known drug allergies and a history of chicken pox as a child who was not on any medications. On 5/30/01, 1 of the couple's sons was vaccinated with varicella virus vaccine live. The pt was subsequently exposed to the vaccine and on 7/1/01, the pt developed 5 burn-like blisters that were approx. 1" in diameter (4 on his hand and 1 on his left thigh). Unspecified medical attention was sought. All of the blisters subsequently, completely resolved. Additional information has been requested.
Pt had sweating and weakness 10 minutes after injection. Also nausea within 24 hours.
I started getting severe hives from Feb 8-9th and when I consulted doctor they said its from vaccine stimulation. Its still continuing and I get hives which seems to come and go during different time of the day. Doctor called it as dermatographic urticaria. For the last few days  I am also having dizzy/vertigo feeling and its affecting my normal./work life which I am worried about.
Information has been received from a Registered Nurse (R.N.) concerning a patient of unknown age and gender. On 30-AUG-2012, the patient was vaccinated subcutaneously with an expired dose of 0.65 ml of ZOSTAVAX (lot #:670820/0660AA; Expiration date: 04-AUG-2012). There were no adverse events reported. Additional information has been requested.
Pt recvd 3 doses of Engerix-B & was not immune; pt recvd 3 addtl doses & still did not sero-convert;
After verifying which vaccine the patient was to receive and after administration, the patient's wife informed me that the patient already received the Moderna bivalent booster last week. Patient has received a total of 2 bivalent boosters.
Information has been received from a registered nurse concerning a 16 month old Caucasian male patient with seizure disorder and a history of anoxic encephalopathy and who was on a ketogenic diet since 04/15/00 who on 09/11/00 was vaccinated with a 1st dose of MMR live SC in the right thigh. The following day, the patient experienced seizures (considered to be disabling) and the patient's laboratory values included "moderate ketones" (usually in the "large range"). It was noted that the patient's dietician stated that "1 mg of sugar compound is enough to throw ketosis out of kilter." As of 09/14/00, the patient was "doing okay". The patient also developed a raised redness at the injection site "2 1/4 inch in diameter." Unspecified medical attention was sought. Follow-up information from registered nurse indicated that the patient's "ketones went from large to low to moderate to almost small. Hence, seizures began". Subsequently, the patient recovered.
Fever; Sweating profusely; So hot; Kept switching back and forth between chills and sweating; Really bad chills; Muscle pain; Joint pain; Headache; Nausea; Soreness at injection site; Extreme fatigue; Flu like symptoms; weakness; Symptoms are much worse than the first shot; Back pain; This spontaneous case was reported by a consumer and describes the occurrence of CONDITION AGGRAVATED (Symptoms are much worse than the first shot), BACK PAIN (Back pain), HYPERHIDROSIS (Sweating profusely), FEELING HOT (So hot) and DISCOMFORT (Kept switching back and forth between chills and sweating) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A and 002B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Thalassemia minor (Beta) and Anaemia (Iron deficiency). Concomitant products included FOLIC ACID for Thalassemia, IRON, MULTIVITAMINS [VITAMINS NOS] and CALCIUM for an unknown indication.   On 30-Mar-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, the patient experienced CONDITION AGGRAVATED (Symptoms are much worse than the first shot), BACK PAIN (Back pain), INFLUENZA LIKE ILLNESS (Flu like symptoms), ASTHENIA (weakness), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain), HEADACHE (Headache), NAUSEA (Nausea), VACCINATION SITE PAIN (Soreness at injection site) and FATIGUE (Extreme fatigue). On 31-Mar-2021, the patient experienced HYPERHIDROSIS (Sweating profusely), FEELING HOT (So hot), DISCOMFORT (Kept switching back and forth between chills and sweating) and CHILLS (Really bad chills). On an unknown date, the patient experienced PYREXIA (Fever). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, CONDITION AGGRAVATED (Symptoms are much worse than the first shot), BACK PAIN (Back pain), HYPERHIDROSIS (Sweating profusely), FEELING HOT (So hot), DISCOMFORT (Kept switching back and forth between chills and sweating), INFLUENZA LIKE ILLNESS (Flu like symptoms), ASTHENIA (weakness), CHILLS (Really bad chills), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain), HEADACHE (Headache), NAUSEA (Nausea), VACCINATION SITE PAIN (Soreness at injection site), FATIGUE (Extreme fatigue) and PYREXIA (Fever) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient received both scheduled doses of mRNA-1273 prior to the events therefore, action taken with the drug in response to the events was not applicable.   This case was linked to MOD-2021-131959 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 14-May-2021: Added patient demographics (height, weight, medical history), concomitant medications, additional events and updated the outcome of the events from unknown to recovered.; Sender's Comments:  MOD-2021-131959:1st dose case
On 07/29/2022 I was in an airport in crowds of people for an extended period of time. A a few days later on 08/01/2022 I began to get a headache in the evening. I was in the mountains, and I was delirious but my adult daughters, who were with me, attributed it to altitude sickness. I was delirious for the majority of 08/01 and 08/02 and only had flashes of awareness. On the morning of 08/03, my daughters became concerned that I may have COVID-19 because I was still completely delirious, had a high fever of 102 and I had a sore throat. My daughters had a doctor come out to where we were staying who brought an oxygen monitor and PAXLOVID. My oxygen level got down to 81. He put me on a nebulizer, gave me an I.V. of liquid, and gave me a shot, as well as the PAXLOVID. From there, my headache went away but I was still delirious for another few days. I stayed on a concentrator for a few weeks after that even having a portable one on the plane home. I was still in bad shape for close to a month after returning home. I was taking ZOFRAN and azithromycin along with the PAXLOVID and other medications. Due to the lack physicality in my job currently, I was able to take work phone calls a bit starting on 08/02. I didn't really start back at work fully until 08/11, about 12 days after I contracted COVID-19.
Shortness of breath 3 week with cough with excessive mucous product, sore throat with fever 101 for 2 days after the vaccines. twitching of eyes and tightness of jaw. pain of back, after 3 weeks of vaccine. 02/09/07-records received and reviewed for DOS 10/31-11/02/06 DC DX: Weakness Progressive ascending weakness for 5 days, weakness began in his feet and ankles with a pins and needles sensation and tightness in his tendons. Progressed up his legs to mid thigh. Requires assistance to walk. Some facial weakness/paralysis.  One week prior had a URI which progressed to bronchitis with yellow mucus production. For past 2 1/2 months experienced lung tightness chill throat closing after vaccine.  Claims hypersensativity to foods since vaccine. Eating only organic foods has lost 22 pounds. Received high dose vitamin C Ragweed allergy. Takes albuterol nebulizer treatments.   Parents refused neuropsychology consult.  Seen my neuromusclar department which revealed no acute neurmuscular findings. No objective signs of a neuropathy except for the reported sensory changes. NCV study shows no apparent sensory nerve conduction loss. he could have GBS but no way to diagnosis now, if he does it is old and has good prognosis. PMH:Asthma
Product administered outside of prescribing information; No adverse effect; This spontaneous report was received from a consumer (office manager) regarding to a 28 year old male patient. The patients relevant medical history, current condition and concomitant medication were not reported. On an unknown date, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) rHA (recombinant human albumin) (lot # R014354/expiration date: 18-NOV-2019) (unit, frequency, anatomical location: unknown) 1 dosage form via subcutaneous route for prophylaxis (product administered to patient of inappropriate age). The reporter informed that there was no adverse effects.
Patient was scheduled to receive 2nd dose Moderna COVID vaccine and was inadvertently given Pfizer by mistake.  Incident was discovered shortly after patient left the mass vaccination site and after an uneventful observation period.  Patient was contacted by site manager immediately and was informed of CDC guidance regarding administration error.  Incident report was submitted immediately to health and hospital systems.
Arm Hurts; Sore Arm; Stiff Left Arm; Very Sleepy; Fever 100.1 (on forehead); Very Tired; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 07-Mar-2021 and was forwarded to Moderna on 07-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (Arm Hurts), PAIN IN EXTREMITY (Sore Arm), JOINT STIFFNESS (Stiff Left Arm), SOMNOLENCE (Very Sleepy) and PYREXIA (Fever 100.1 (on forehead)) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 06-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced LIMB DISCOMFORT (Arm Hurts), PAIN IN EXTREMITY (Sore Arm), JOINT STIFFNESS (Stiff Left Arm), SOMNOLENCE (Very Sleepy), PYREXIA (Fever 100.1 (on forehead)) and FATIGUE (Very Tired). On 07-Mar-2021, JOINT STIFFNESS (Stiff Left Arm), SOMNOLENCE (Very Sleepy), PYREXIA (Fever 100.1 (on forehead)) and FATIGUE (Very Tired) had resolved. At the time of the report, LIMB DISCOMFORT (Arm Hurts) and PAIN IN EXTREMITY (Sore Arm) outcome was unknown.
At site of Dtap 12cm warmth and redness, 7cm induration, mild tenderness.
Pt developed erythematous maculopapular rashes mostly con fluent all over the body except face 10/14/2001, 4 days after 9 month old immunizations were given.
Burning eyes; blurry vision; headache; This spontaneous case was reported by a consumer and describes the occurrence of EYE IRRITATION (Burning eyes), VISION BLURRED (blurry vision) and HEADACHE (headache) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced EYE IRRITATION (Burning eyes), VISION BLURRED (blurry vision) and HEADACHE (headache). At the time of the report, EYE IRRITATION (Burning eyes), VISION BLURRED (blurry vision) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  Treatment information was unknown.   This case was linked to MOD-2021-265369 (Patient Link).
He started to not sleep well. He would wake 30 minutes to an hour in. Started showing worsened symptoms of reflux. Constantly wanting to nurse again. Sounding really throaty, congested and coughing. Terrible time sleeping at night. Wakes up every hour crying and wanting to nurse and sometimes goes to sleep instantly sometimes have to rock him.
COULD NOT GET UP IN THE MORNING/UNABLE TO GET OUT OF BED; FELT VERY TIRED /TIRED FAST AFTER PHYSICAL WORK; NOT ENERGIZED; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980L, expiry: 20-JUN-2021) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced could not get up in the morning/unable to get out of bed. On 08-APR-2021, the subject experienced felt very tired /tired fast after physical work. On 08-APR-2021, the subject experienced not energized. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from could not get up in the morning/unable to get out of bed on 09-APR-2021, and was recovering from felt very tired /tired fast after physical work, and not energized. This report was non-serious.
This spontaneous report was received from a pharmacist regarding an unknown age patient of unknown gender. The patient's medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not reported. On 18-APR-2018, the patient received an improperly stored dose of VAQTA 50/1.0 U/mL, lot# N020503 and 04-SEP-2018 expiration date for prophylaxis (frequency and route of administration were not reported). The temperature excursion was reported as 47.6 °F for a time frame of 7 hours. Previous temperature excursion was reported as 47.6 °F for a time frame of 6 hours. No symptoms were reported. Data logger was reported. No product quality complain was reported.
10/05/2022, I began having problems the day of the vaccine. I progressively got worse and my doctor told me not to have any more. It makes my asthma and allergic reactions to things worse. I have an overactive immune system. The right side started with weakness in my arm and leg. I was very tired. This went on for a couple of days. I started itching. I broke out in hives from top of my head down, red splotchy itchy hives.
Myalgia, Fever, ErythemaMultiorm, NauseaVomiting, FEVER CHILLS NAUSEA CRAMPING STOMACHK LOOSE STOOLS FATIGUE REDNESS SWELLING INJECTION SITE. Narrative:
Redness and swelling injection site from shoulder to elbow (R) arm. Treated with  antibiotics.
Felt a little weak; Experienced headache; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Felt a little weak) and HEADACHE (Experienced headache) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-May-2021, the patient experienced ASTHENIA (Felt a little weak) and HEADACHE (Experienced headache). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 14-May-2021, ASTHENIA (Felt a little weak) and HEADACHE (Experienced headache) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant products were reported.   This case was linked to MOD-2021-221016 (Patient Link).
No wheal formed on 1st dose; 2nd dose given and wheal formed on 2nd attempt
Shingles caused by the Shingrix vaccine; Felt pain under her arm; Felt pain / on her breast; Rash that appeared on her chest and back; This case was reported by a consumer and described the occurrence of axillary pain in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th November 2020, the patient received the 1st dose of Shingrix (intramuscular). On 20th November 2020, 1 days after receiving Shingrix, the patient experienced axillary pain, breast pain, rash and shingles. On an unknown date, the outcome of the axillary pain, breast pain and rash were recovered/resolved and the outcome of the shingles was unknown.   It was unknown if the reporter considered the axillary pain, breast pain and rash to be related to Shingrix. The reporter considered the shingles to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported but it could be 69 years or 70 years. The patient reported that, she felt pain under her arm and on her breast.  The Pain developed into a Rash that appeared on her chest and back.  She stated that it disappeared after five weeks.  The patient stated that she had shingles caused by the Shingrix vaccine. Consented to follow up.
vaccine 7/6/08night time sore throat, fatigue, malaise, fever. today fever 101. achey. throat red. rapid strept negative. cbc, cmp, blood and throat culture taken. ceftin prescribed as may have bacterial throat infection.
Redness and swelling. Diphenhydramine recommended to pt OTC and take as directed on packaging, per Dr.