chrisvoncsefalvay/vaers-outcomes huggingface dataset:
hives; chills; ache; fatigue; sore arm; itching on left arm; welt on right eyebrow; itchy on right eyebrow; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (welt on right eyebrow), PRURITUS (itchy on right eyebrow), CHILLS (chills), PAIN (ache) and FATIGUE (fatigue) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (The patient's medical history was not provided.).   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Feb-2021, the patient experienced URTICARIA (welt on right eyebrow) and PRURITUS (itchy on right eyebrow). On an unknown date, the patient experienced CHILLS (chills), PAIN (ache), FATIGUE (fatigue), INJECTION SITE PAIN (sore arm), PRURITUS (itching on left arm) and URTICARIA (hives). At the time of the report, URTICARIA (welt on right eyebrow), PRURITUS (itchy on right eyebrow), CHILLS (chills), PAIN (ache), FATIGUE (fatigue), INJECTION SITE PAIN (sore arm), PRURITUS (itching on left arm) and URTICARIA (hives) outcome was unknown.            Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: No specific follow-up information recorded.
Pt had influenza injection in Left deltoid on 11/21/2017 and several hours later started having a lot of pain. The next morning, patient awoke with redness, swelling and itching at the injection site. Pt was seen in our office on 11/22/2017 and was advised to Ice the area and to take OTC ibuprofen. Pt required an ER visit on the evening of 11/22/2017 and started on BENADRYL, dexamethasone dose at the ER along with a prednisone taper to take at home. Pt's mother called to report that all symptoms had resolved on 11/27/2017.
21 month old recently received vaccinations 21 Aug 08, 5 days later developed blistering rash over left wrist, now resolving.  Then right wrist which is now crusting and smaller rash above right eyebrow.
pt recvd vax; devel severe local rxn of redness at inject site; also exp fevers & aches;
Information has been received from a physician concerning a female who was vaccinated with GARDASIL, date therapy started was unspecified by reporter. Subsequently the patient experienced lupus like reactions and was identified as requiring hospitalization. The patient was hospitalized locally and then transferred to another hospital for treatment and was reported to have been in the intensive care unit (ICU). The patient present status was recovering. Lupus-like reactions was considered to be life-threatening. This is one of several reports from the same source. Additional information has been requested.
migraines; I have not been able to work; 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 female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MIGRAINE (non-serious), outcome "not recovered", described as "migraines"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious), outcome "not recovered", described as "I have not been able to work". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The reporter stated that she received both doses of Comirnaty but did not specify a timeframe and was having migraines every day for the past 7 weeks, she had not been able to work because of them. All her tests and labs came back negative and was tested for Covid six times, she don't have Covid.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Post vax, the pt developed local redness, warmth, and tenderness to left upper extremity. Complained of increased temperature, chills and sweats. Treated with Benadryl and Kenalog.
arm more sore than with 1st vaccine dose; extreme headaches that don't respond to medication,; stiff neck and shoulder muscles; swollen legs, ankles, feet (even if wearing support stockings); dizzy/light-headed; very tires; light-headed/dizzy; inability to focus,/ complete tasks; sore throat/drainage;  times of heavy breathing to expel air in order to get oxygen into my system
Patient states he developed painful muscle contractions/spasms, stiffness, fatigue/decreased energy the morning after vaccine admin. Also reported productive cough, shortness of breath. Most symptoms resolved after 3 to 7 days. Slight cough continued.
Information has been received from a registered nurse concerning an approximately 93 year old female with cardiac failure congestive, drug hypersensitivity to narcotics, codeine and shellfish allergy who on 07-DEC-2007 (reported as 6 days ago), was vaccinated with a dose of Zostavax (Oka/Merck) subcutaneously.  Concomitant therapy included alendronate sodium (MSD) and aspirin.  Subsequently the patient developed a 2 inch wide erythema at the injection site.  The patient saw a physician on 05-DEC-2007.  The outcome was reported as not recovered.  There was no product quality complaint.  Further Information has been received from the physician concerning this retired 93 year old female with allergy to DEMEROL.  The physician reported that the patient developed an expanding erythema for one week following injection.  The patients Lyme titer was negative.  The physician reported that the patient recovered on 21-DEC-2007.  Additional information is not expected.
In 13 days it has been a myriad of symptoms some. None are all the time. Many I?ve experienced several times. Within 48 hours, sore arm, diarrhea and rash on face and stomach. Symptoms since vaccine have included numb lips, fingers and tounge, headache, achy body, tightness in chest, dripping nose, sore throat.
This is a literature case, initially received on 19-Feb-2019, concerning a 42-year-old, adult, female patient. The study describes the reports of anaphylaxis after vaccination reported to the Vaccine Adverse Event Reporting System (VAERS) during 1990-2016. A descriptive analysis, including history of hypersensitivity (anaphylaxis, respiratory allergies, and drug allergies) and vaccines given were performed. The patient's historical conditions included hepatitis C infection. The patient's current conditions included: asthma, hereditary onychoosteodysplasia and was allergic to penicillin, quinolones and naproxen. On an unspecified date, the patient was administered INN Flu Vaccine Seasonal              (anatomical location, dose, route of administration, batch number, manufacturer, trade name and expiry date: not reported) for an unknown indication. On the same day, the patient was administered non-company suspect drug ceftriaxone (route of administration: intramuscular, anatomical location, dose, batch number, manufacturer, trade name and expiry date: not reported) for an unknown indication. On the same day, 2 minutes after vaccination, the patient experienced respiratory failure and died. The autopsy was performed and the laboratory tests revealed an increased serum tryptase level. The documented cause of death was reported as anaphylactic reaction (causality: related). The reporter assessed the case as serious (death).; Reporter's Comments: A 42-year-old, female patient with medical history/concurrent condition (asthma, hereditary onychoosteodysplasia and was allergic to penicillin, quinolones and naproxen) experienced fatal respiratory failure, 2 minutes after administration of INN Flu Vaccine. The reported cause of death was anaphylactic reaction. The case meets level 2 of Brighton Collaboration criteria of diagnostic certainty for anaphylactic reaction. Considering the plausible temporal relationship between vaccination and reported fatal events (anaphylactic reaction and respiratory failure) and lack of alternative more plausible causes, the company conservatively assessed the events as possibly related to suspect vaccine. However, multiple drug allergies especially and co-administered ceftriaxone (non company suspect) confound this case. The company assessed the events respiratory failure and anaphylactic reaction as serious (medically significant).; Reported Cause(s) of Death: Anaphylactic reaction.
Email reported to compliance / med safety about a potential side effect / adverse reaction to the vaccine (by provider for pediatric patient): Mom wanted to make sure her kiddo?s new symptoms were reported.   Name:    Symptoms: transient motor tic disorder, onset 1/15/22 Dates of PFIZER COVID vaccine: 1st dose = 12/13/21 2nd dose = 01/03/22  Nursing Notes:  MA 01/18/22 1353 Signed Patient is here with Mom and older brother for uncontrollable twitching of his head. Patient states its happening a lot since Saturday at his Dad's house.   Pt presents today with his mother:  Patient is here with Mom and older brother for uncontrollable twitching of his head. Patient states its happening a lot since Saturday at his Dad's house.  She states that he has been making weird head movements for the last three days.  Mom denies any head injury or any other changes. No new medications. The pt states that she wishes he could make his head stop moving Mom denies any recent illness/fevers.  Mom states that he doesn't do it when he is sleeping. No OTC medications given for symptoms No headache, vomiting or changes in LOC Started involuntary head shaking, which is more often.  Did these movements a bit on the EEG.   Once he sits down, calms down and relaxes, they slow down. Onset January 15th.   Got in trouble - started that day. Happens more when stimulated more. No other types of movements noted. No vocal tics noted. Suppressing it hurts. No pain or urge. Visit Diagnosis   Patient is a(n) 7 y.o. male with the following problems addressed during today's visit: 1. Transient motor tic  2. Abnormal EEG    New onset motor tic.  Does not meet criteria yet for Tourette's syndrome; did discuss with mom today that he is at the age where Tourette's syndrome can begin.  Did discuss that first approach is counseling, and considering underlying trigger (ADHD, anxiety, OCD, etc)   Did review that abnormal EEG may place him at increased risk of seizures, but no described seizure activity at the moment, and his head movements are non epileptic.  Mom aware to inform us if seizure concerns arise; or if she has questions regarding tics.   Will report new onset tic disorder to COVID VAERS. Follow upp PRN
This spontaneous report as received from a pharmacy technician refers to a 1-year-old patient of unknown gender. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant medications were not reported. On 08-FEB-2018 the patient was vaccinated with improperly stored dose of VARIVAX (lot # N022979, expiry date: 23-AUG-2019) (dose, frequency and route were not reported) for prophylaxis. No adverse effect was reported. The VARIVAX temperature excursion occurred on 14-DEC-2017 and 30-DEC-2017. On 14-DEC-2017, the vaccine was exposed to the temperature of 16.9 degree Fahrenheit (F) for 30 minutes. On 30-DEC-2017, the vaccine was exposed to the temperature of 6 degree Fahrenheit (F) to 14 degree F for 30 minutes. It was reported that the event was because of data logger. No product quality complaint was involved. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1802USA001558:
Bleeding, large bruise at injection site followed several hours later by headache.  2 days later, diarrhea, headache, dizziness, fever, chills,
Information has been received from a nurse practitioner concerning an 18 year old female with allergy to VICODIN who on 08-JAN-2008 was vaccinated with the third 0.5 mL dose of GARDASIL vaccine. It was unknown when she received the first and second 0.5 mL doses of GARDASIL vaccine. There was no concomitant medication. The patient began to experience back pain after receiving the second dose. At the time of this report, the patient's back pain persisted. The patient sought unspecified medical attention at the practice. Additional information has been requested.
Eight days after the vaccine I woke up and had huge bruises on my legs and chest, had problems walking and talking. I went to the doctor three months later and Got a brain MRI and they found brain lesions. They performed a brain ultrasound, spine MRI, lumbar puncture and they stated that it looks like its autoimmune.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with the improperly stored (-14 degrees Celsius for 15 hours) doses of VARIVAX (lot # M008173, expiration date 16-FEB-2018; dose and route of administration were not reported) for prophylaxis. No previous excursion and no adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1612USA015104:
I picked up the covid  Pfizer vaccine rather than the PPD skin test; which is what I was to give. It was given SQ like the PPD skin test,  wheal noted. Later that day client's arm became red with an area of cellulitis @ site, she then had flu like symptoms. Client went to her Dr. and was treated with Keflex for the cellulitis to the L arm. that lasted 2 days and caused her to miss work for 2 days. Site has much improved and continues a course of  Keflex.
" For the past three days I have woken up with no voice, it does get better as the morning wears on, and worse if I am speaking at work for long bouts without drinking fluids. I am experiencing no other symptoms, which is why I?m pretty puzzled with what?s going on."
After receiving the vaccine, I get the chills and I just don't feel well for about 36 hours. My husband tested positive before I did. I tested positive for COVID-19 on 10/27/2022. I was cold, all my joints hurt, cough and upset stomach. I contacted my doctor and got a prescription for PAXLOVID. Each day, I started feeling better within 5 days. I picked up a bad cold that lasted a couple of weeks. My doctor prescribed an inhaler, aspirin, a cough pearl for the cough. As of today, I feel very weak.
Rash to upper chest, no hives or swelling of ears or lips, no difficulty breathing.
Site: Itching at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Itch Generalized-Medium, Systemic: Allergic: Rash Generalized-Medium, Additional Details: Patient came to the pharmacy on 11/16 to report the reaction she experienced after the Pfizer bivanlent vaccine. The pharmacist on duty, Gave her benadryl cream to calm the rashes and itchiness. Will follow up with patient in a couple of days!
[Pfizer Covid Vaccine] use for COVID-19 under Emergency Use Authorization (EUA): Patient presented with covid 19 pneumonia after receiving vaccine on 1/22/2021 and 2/12/2021 signifying therapy failure. 62-year-old female with history of CLL pulmonary carcinoid tumor (s/p LLL lobectomy 2015), hypothyroidism, asthma, IDA presenting to the ED today with 5 days of fever, nausea, diarrhea, abdominal pain, malaise, sore throat. COVID +1/17; symptom onset 1/12. Meets sepsis criteria. Imaging shows left lung pneumonia.
EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. 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: 10808609, and expiry: 07-SEP-2021) dose was not reported, administered on 04-DEC-2021 for prophylactic vaccination. No concomitant medications were reported. On 04-DEC-2021, the patient experienced expired vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine administered was not reported. This report was non-serious.
Pain at Injection Site; Product Complaint; Product stopper coring; This case was reported by a pharmacist and described the occurrence of injection site pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis. This case was associated with a product complaint.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site pain, pharmaceutical product complaint and product stopper coring. On an unknown date, the outcome of the injection site pain, pharmaceutical product complaint and product stopper coring were unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.   Rerun  Additional details were provided as follows: The age at vaccination was not applicable for this report. The age group of the patient was not reported, but selected as an adult as per vaccine indication. The pharmacist reported difficulty inserting needle through rubber stopper of several Shingrix antigen vials. It was reported that, adjuvant vial was somewhat difficult to insert needle through rubber stopper; however, the antigen vial was significantly more difficult to puncture. The caller reported this difficulty to insert needle through stopper was a big difference from previous Shingrix vaccines.  The caller reported ordering a new box of syringes assuming the syringe was the issue; however, same difficulty occurred.  The caller reported that, there was no difficulty, while giving other vaccines using newly ordered box of syringes. The caller mentioned that, changing syringes(needle) in between mixing, and reported the antigen rubber stopper still causes needle to become dull and therefore difficult to puncture the skin upon administration. The caller reported that, there was something inside the middle of circle in rubber stopper of antigen, which stopping needle from piercing through the vial.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The age group of the patient was not reported, but selected as an adult as per vaccine indication. The pharmacist reported difficulty inserting needle through rubber stopper of several Shingrix antigen vials. It was reported that, adjuvant vial was somewhat difficult to insert needle through rubber stopper; however, the antigen vial was significantly more difficult to puncture. The caller reported this difficulty to insert needle through stopper was a big difference from previous Shingrix vaccines.  The caller reported ordering a new box of syringes assuming the syringe was the issue; however, same difficulty occurred.  The caller reported that, there was no difficulty, while giving other vaccines using newly ordered box of syringes. The caller mentioned that, changing syringes(needle) in between mixing, and reported the antigen rubber stopper still causes needle to become dull and therefore difficult to puncture the skin upon administration. The caller reported that, there was something inside the middle of circle in rubber stopper of antigen, which stopping needle from piercing through the vial.
Site: Pain at Injection Site-Severe, Additional Details: Pt claims he has constant pain radiating from his left deltoid all the way to his biceps and triceps.
Have a cough; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Have a cough) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COUGH (Have a cough). At the time of the report, COUGH (Have a cough) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No Treatment information  was reported..
These sensitivities started after receiving the third vaccine (booster( on 8.30.2021 . Since about a month my eyes are dryer than normal, my scalp is sensitive and my stomach is more upset than in general. It reminds me a little of the feelings I had when I got chemotherapy 25 years ago.
It was 28MAR2023 and I was out eating with a friend but my friend asked if I was ok due to my left side of my face was not moving and water would drool out of my mouth on my left side arm and leg was drawing up and paramedics were called and I was taken to the hospital by then I was paralyzed on my left side and I was given blood thinner in the hospital and I was rushed to intravascular brain surgery and the clot was removed,  by eight PM that night I was transferred to ICU and was actually able to walk and had full mobility. I was in ICU unit two nights and discharged on 31MAR2023. Five CT scans and an MRI . No cognition or paralysis exist and I wear a monitor now for five years no heart issues or high cholesterol was noted. A single aspirin regiment is daily now and cholesterol medication.  A cardiologist and neurologist appointment will occur every six months now.  Causation of stroke is unknown.
product was administered to patient post excursion, with no reported adverse event; product storage error temperature too low, with no reported adverse event; Initial information received on 16-Feb-2023 regarding an unsolicited valid non-serious case received from a healthcare professional.  This case involves an adult patient (gender: unknown) to whom  INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV] product was administered to patient post excursion and product storage error temperature too low, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE Suspension for injection  (strength: unknown, lot number: UT7683NA; UT7683NA; expiry date: 30-Jun-2023) via unknown route in unknown administration site for prophylactic vaccination and on the same day product was administered to patient post excursion, with no reported adverse event (poor quality product administered) and product storage error temperature too low, with no reported adverse event (product storage error).  It is unknown if the patient experienced any additional symptoms/events. It is unknown if the patient had any medical history, concomitant disease or risk factor. It is unknown if there were lab data/results available. This situation is reported as a medication error due to temperature excursion that exceeded the stability data documented in the local labelling and additional supporting stability data.   Action taken with QUADRIVALENT INFLUENZA VACCINE (FLUZONE QIV) was not applicable.  At time of reporting, the outcome was Unknown for both events.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments:  US-SA-2023SA069591:01495347 US-SA-2023SA069712:01495415