chrisvoncsefalvay/vaers-outcomes huggingface dataset:
did not receive the full dose for dose two of Shingrix/ some of the medication leaked out.; Soreness; This case was reported by a pharmacist via call center representative and described the occurrence of pain in a female patient who received Herpes zoster (Shingrix) (batch number K2CJ4, expiry date 11th November 2022) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 20th June 2021, the patient received the 2nd dose of Shingrix (intramuscular). In April 2021, the patient received the 1st dose of Shingrix. In April 2021, not applicable after receiving Shingrix and less than 3 months after receiving Shingrix, the patient experienced pain. In June 2021, the patient experienced accidental underdose. On an unknown date, the outcome of the pain and accidental underdose were unknown.   It was unknown if the reporter considered the pain to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received 1st dose of shingrix in April 2021, exact date was not provided. No lot or expiration date provided and the patient experienced soreness after the administration. The patient did not receive the full dose for 2nd dose of Shingrix because some of the medication leaked out. which led to accidental underdose. The Healthcare professional noted she had a faulty needle because the product leaked out between the needle and the hub. HCP (healthcare professional ) was uncertain how much of the product leaked out and how much of the product was administered. PQC (product quality complaint )ruled out. HCP (healthcare professional ) declined to provide full patient details because she did not have the patients permission. The reporter consented to follow up.
From initial information received on 4/13/05 from a healthcare professional regarding an adverse event, it was reported that a 24 year old female patient received her first dose of JE-VAX, lot number EJN214A, administered in the left deltoid on 4/6/05. The route and administration was not reported. She also received a first dose of TYPHOID ORAL on 4/11/05. On 4/11/05 at 10:00 PM, the patient developed tingling of her lips. The following day, on 4/12/05, she also developed of tingling left arm, leg, face and back with numbness described as novocaine sensation. The patient was seen by a neurologist in the emergency room on 4/12/05. She still has residual numbness of her left side. At the time of this report, the patient had not recovered from these events. (OMIC)
Onset of progressive tingling in hands and feet progressing to weakness and paralysis. Hospitalized on 05 March, intubated on 07 March. Diagnosed with Guillain-Barre syndrome.
Arm Pain; Headache; Fever; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 51-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In October 2020, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, 1 day after receiving Shingrix, the patient experienced pain in arm, headache and fever. On an unknown date, the outcome of the pain in arm, headache and fever were recovered/resolved.   It was unknown if the reporter considered the pain in arm, headache and fever to be related to Shingrix.  Additional details were provided as follows: The consumer was the caller.  The patient reported that he had the 1st Shingrix vaccine in October, 2020.  That night or the next night, the patient experienced Fever, Headache, and arm pain for four to five hours. For tolerance in 2nd dose refer case US2021AMR008140. The reporter consent to follow up. This is 1 of 4 case reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021007474:Wife's 2nd dose US-GLAXOSMITHKLINE-US2021AMR008109:Wife's 1st dose US-GLAXOSMITHKLINE-US2021AMR008140:same patient, 1st dose
A spontaneous report was received from a Consumer concerning a 77-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events severe abdominal pain, worsen by walking and relieved by sitting..  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 12 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly for prophylaxis of COVID-19 infection.  On 12 Feb 2021, the patient experienced the events severe abdominal pain. worsen by walking and relieved by sitting..  Treatment details included Tylenol  Action taken with mRNA-1273 in response to the events was not reported.  On 15 Feb 2021 the outcome of events severe abdominal pain was resolved.On 15 Feb 2021 the outcome of events worsen by walking and relieved by sitting. was resolved. .
Information has been received from a published literature article. In the literature article it was reported that modern advances in medicine involving the application of intravenous immunoglobulin G (IVIG) had restored host immune defense mechanisms and improved quality of life in patients with primary immunodeficiency. Hypersensitivity reactions could occur with intravenous immunoglobulin G (IVIG). A 2 year old female with a complex medical history including premature birth at 27 weeks, hypogammaglobulinemia and recurrent infections underwent a desensitization protocol for intravenous immunoglobulin G (IVIG). Palivizumab and PCV (manufacturer unknown) resulted in anaphylactoid reaction. The patient was referred to allergy and immunology. Immunoglobulins were significant for a decreased IgG level of 364 mg/dL and an IgA level of 19 mg/dL. Intravenous immunoglobulin G (IVIG) replacement therapy was initiated. Patient developed respiratory distress during her first infusion. An hour after this infusion, hives occurred. Despite clinical improvement, she continued to experience instability in her vital signs during infusions. Therapy was stopped due to intolerance. Desensitization was attempted to ultimately reduce morbidity from recurrent infections. She was initiated on dilutions of intravenous immunoglobulin G (IVIG) in an intensive care setting. Desensitization was tolerated with close monitoring. The outcome of the event was unknown. The reporter considered that the event was related to PCV (manufacturer unknown). Additional information has been requested.
Site: Itching at Injection Site-Mild, Site: Redness at Injection Site-Mild, Systemic: Allergic: Itch Generalized-Medium, Additional Details: pt had itching all over the body but not at the site of injection . few hours after adminstration .
Information regarding PREVNAR was received from a healthcare professional regarding a 2-month-old female patient who vomited blood. The patient received the first dose on 15-JAN-2009. The patient also received a dose of PEDIARIX (GlaxoSmithKline) and Haemophilus B Conjugate Vaccine (Tetanus) on 15-JAN-2009. On 15-JAN-2009, the patient was administered the PREVNAR vaccine. The patient vomited blood two to three times within 24 hours. The patient then recovered (Jan-2009). No additional information was available at the time of this report. See related case(s): US-WYE-H09237509 for the same event that happened after the second dose of PREVNAR.
This spontaneous report as received from a certified medical assistant (C.M.A.) refers to a 40 year old patient of unknown gender. The patient's medical history and drug reactions or allergies were not provided. On 24-AUG--2015 (reported as today), the patient was vaccinated with a second dose of expired (Oka/Merck) VARIVAX (0.5 ml, subcutaneous in the left arm, lot# reported as J006357, expiration date 23-MAY-2015). The first dose of (Oka/Merck) VARIVAX was administered on 20-APR-2015. No adverse events were reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
ablation, was hospitalized; ablation, was hospitalized; This case was reported by a physician via sales rep and described the occurrence of hospitalization in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced hospitalization (serious criteria hospitalization) and surgical procedure. On an unknown date, the outcome of the hospitalization and surgical procedure were unknown.   It was unknown if the reporter considered the hospitalization and surgical procedure to be related to Shingrix.     Additional Information: GSK receipt date: 08-Apr-2022 Reporter's comment: Field representative called on behalf of physician. The patient had an ablation after receiving a dose of Shingrix. The patient was hospitalized and duration of hospitalization was unknown. The patient had not yet received 2nd dose of Shingrix. The reporter was not able to provide any additional information.  The adverse event was filed with very limited information. The reporter requested that safety follow-up with physician regarding the event. The reporter consented to follow-up.
This case was reported by a physician to a sales representative and described the occurrence of an injection site reaction in a child who received diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix). The physician reported that several pt's experienced an injection site reaction following the admin of Infanrix, however, pt identifiers were not provided. On an unspecified date, the pt received a dose of Infanrix (dose number not specified). At an unspecified time following the admin of Infanrix, the pt experienced an injection site characterized by a rash and golf ball size knots. The outcome of the events is unk.
Patient's parents stated "around 9:00pm the baby started breaking out in big whelps. We took him to the ER. Also stated "the doctor said that if he (baby) wasn't on Decadron that it could have been worse."
Three days after injection, there was a sudden onset of hives over much of my body, accompanied by an intense feeling of heat. Affected areas were face, neck, arms, hands, and knees. I took one Benadryl and went to bed. The next morning, most visible signs of the rash are gone, with a slight itchiness remaining.
Patient presented to the ED for diverticulitis and lactic acidosis within 6 weeks of receiving COVID vaccination.
muscle spasms in my chest, back, left calf and neck for over 24 hours; pain was not constant and was sporadic / chest and leg spasms were so painful; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 57 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 27Mar2021 (Lot number: ER2613) at the age of 57 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing). Concomitant medication(s) included: TELMISARTAN. Past drug history included: Lisinopril, reaction(s): "allergy", notes: Allergies to medications, food, or other products: Lisinopril. Vaccination history included: Bnt162b2 (Dose 1; Lot number: EN6202; , administration time: 09:00 AM,, vaccine_location: Left arm.), administration date: 06Mar2021, when the patient was 57 years old, for Covid-19 Immunization, reaction(s): "lightheaded and dizzy". The following information was reported: MUSCLE SPASMS (non-serious) with onset 28Mar2021 02:00, outcome "recovering", described as "muscle spasms in my chest, back, left calf and neck for over 24 hours"; PAIN (non-serious) with onset 28Mar2021, outcome "recovering", described as "pain was not constant and was sporadic / chest and leg spasms were so painful". Therapeutic measures were not taken as a result of muscle spasms, pain. Additional information: After the second shot, the patient experienced muscle spasms in her chest, back, left calf and neck for over 24 hours. The pain was not constant and was sporadic. The chest and leg spasms were so painful the evening of the 27th and the patient was awakened out of her sleep. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
A report has been received from a Health Professional concerning a 4 year old, male subject, who had been receiving unknown FLUMIST Quadrivalent. FLUMIST Quadrivalent started on an unknown date. The nurse reported that they inadvertently administered expired FLUMIST Quadrivalent to a patient. The outcome of the event of inadvertently administered expired FLUMIST Quadrivalent to a patient is unknown. The report was considered to be non-serious.
W/in 24-48 hrs post vax experienced arthralgias of the elbows & knees & swelling of the rt ankle. In addition, developed erythema nodosum approx 1 wk p/immunization.
Pt recvd 2 doses of Engerix-B & 12DEC91 following dose 1 exp numbness, tingling of upper lt arm, face, nose & eye; 3FEB92 following dose 2 again exp numbness, tingling;
Chills; unwell; This is a spontaneous report from a non-contactable consumer, the patient. A 56-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the left arm on 12Apr2021 at 14:45 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. Other medical history of the patient was not reported.  Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not received any other medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 13Apr2021 at 12:00,  the patient experienced chills and unwell. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events of chills and unwell was recovered on an unknown date in Apr2021.  No follow-up attempts are possible. No further information is expected.
Initial report received from a health care professional on 02 January 2008. A five-year-old male patient with a medical history of sulfa allergy, as well as a cough at the time of vaccination, received a dose of Fluzone SV 2007-2008, lot number U2531AA, in the deltoid with a 3/8 inch needle on 27 December 2007. One day later, on 28 December 2007, the patient developed redness and swelling at the injection site that spread to his chest area. He was treated with Keflex and Motrin. He developed a fever of 101 degrees Fahrenheit and became "progressively worse" throughout the evening. He was admitted to the hospital (date not reported). It is unknown whether any laboratory testing was completed. The patient was reported to have spent two to three days in the hospital and may have been discharged on 31 December 2007. The patient recovered from the events.
Runny nose, fever, and headache all appeared while sleeping causing great discomfort at night. Also lost of appetite.
This spontaneous report has been received from a Certified Medical Assistant concerning an unspecified number of patients of unknown age and gender. The patients' concurrent conditions and pertinent medical history were not reported. The primary reporter stated that as of 13-OCT-2015, when temperature excursion was recorded, an unspecified number of patients were administered on unspecified dates, improperly stored doses of GARDASIL 9 (lot # L014198, exp. date on 05-SEP-2017), (strength, route of administration and dose were not provided). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
April 10th I received the first dose of Shingrix vaccine. By April 21st I had a full on outbreak of shingles including severe derm pain on head and forehead.Nowhere in labeling is this reported as a side effect of this vaccine
My HR increased to 160, I became dizzy and my left arm felt numb. I was monitored for 30 minutes my HR improved however my BP was low throughout lunch time.
Case number PHEH2014US022857 is a combined initial and follow up spontaneous report received from the health care professional (also the patient) on 13 Nov 2014 and on 18 Nov 2014. This report refers to a 55-year-old female patient. She was allergic to many things, including sulfites, tannins and nitrates. She was vaccinated with FLUVIRIN (batch number: not reported) via subcutaneous route on 12 Nov 2014 around 01:00 pm. On the same date, within an hour her nose started draining and this continued all day and evening and was still running. At 09:00 pm, she had itching on her underarms and upon examination, the area was red. By 11 pm, the redness and itching had expanded from the underarm to the chest, to the groin area and wrists, which were also itching and it expanded to her neck and to her waist. She put cortisone cream on all the red skin and took 3 ADVIL, Albuterol and also CLARITIN 24 hour. All the red areas were very hot. By 01:00 am, most of her torso was red, swollen and itchy and it spread to her back anywhere, there was restrictive clothing and her necklace. She stayed awake because she was very concerned because of the itchiness and burning. She forgot to add the patches for itching, and redness also showed up on the bends of her elbows and the top of her ankles. By 03:00 am, all the red spot had increased to a very deep red and very hot. Her torso was very hot. She applied even more cortisone cream to all the red areas and even to unaffected skin because it kept spreading. She used an entire one ounce tube of cortisone cream. Some of the heat had gone away so she went to sleep. Then she woke up at 06:00 am, the redness, heat and swelling on the torso and neck had disappeared but there were red skin and bumps on her upper thighs, button and back of thighs. On 13 Nov 2014, she took Albuterol inhaler because she was so congested. The rash resolved on the same date, but she experienced another episode of rash after dinner. It was even worse than the day before with hives all over her body. She did not experience any respiratory symptoms either time. She had not seen a doctor and was planning to make an appointment with an allergist. The outcome of the events hives and pruritic rash were not reported. The outcome of the other events reported as improving. The events reported as non-serious. The causality of the events was not reported. Seriousness assessment of the event (hives all over the body) was upgraded based on the available information in the source document.
Hives breakout all over body, particularly both forearms, eyelids, groin and waist area. Severe itchiness in both arms started around 3-5 hours after vaccine shot. Proliferation of hives in waist and groin area overnight, extremely itchy eyelids on both eyes, redness around eyes. Smaller effect in legs. After 36 hours, hives have continued. Treated with colloidal oat creams and topical steroids. Topical steroids (clobetasol) did not work, only found some relief with colloidal oat cream (Gladskin).
2/24/21 patient was admitted after a cath lab procedure; reason for admission: chest pain per the EUA, hospitalizations are to be reported irrespective of attribution to vaccine This hospitalization does not appear to be related to the vaccine
52 y.o. female patient of DO with history of asthma, obesity, vocal cord paralysis following intubation s/p tracheostomy, prior tobacco use, marijuana use. Presented with worsening dyspnea and found to have acute on chronic hypoxic respiratory failure secondary to COVID-19. Improved with treatment. Medically cleared for discharge.    Acute on chronic hypoxic respiratory failure with hypoxemia, improved In setting COVID-19, asthma exacerbation Baseline trach mask, 2.5-3L/m Improvement w/trach exchange 11/25  Pulmonology consulted   COVID-19 infection 11/20/22 + S/p Remdesivir 11/21, 24, 25 Plan for 10-day Decadron  Pulmonology consulted   Asthma exacerbation  Pt of Pulmonary  Continued Symbicort, Singulair, scheduled Duonebs, steroids  Tussi-Organidin, Tessalon perles for cough  Pulmonology consulted   Vocal cord paresis  S/p tracheostomy 5/2022  Pt of Dr. ; upcoming appt Dr.   S/p trach mask exchange 11/25 w/further improvement, due to inability to pass inner cannula    DM2 11/16/22 A1c 6.5% Requiring insulin inpatient, likely 2/2 steroid treatment Discharged home with home metformin 1g BID Advised to monitor BG & call office if > 300; can consider short term treatment in setting continued steroid-induced hyperglycemia during course    HTN Continued with home hydrochlorothiazide, lasix, losartan    Anxiety Continued home Buspar, Cymbalta, Nortriptyline nightly
Due to  pandemic, 2nd dose given after 6 months; This non-serious case was reported by a physician via sales rep and described the occurrence of social problem in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in early 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced social problem (Verbatim: Due to  pandemic, 2nd dose given after 6 months). The outcome of the social problem was unknown.   Additional Information: GSK receipt date: 04-APR-2023 A GlaxoSmithKline Field Representative reported that a physician stated a patient received their first Shingrix dose in early 2020.  Due to the pandemic, the second dose was given more than 6 months later. Nothing else was reported. The Vaccine Administration Facility was the same as primary reporter. Limited information was given to Field Representative. The dates, patient identifiers, and lot/expiry would be available on follow up with physician. The reporter consented to follow up. The present case US2023049682 was found to be duplicate of the case US2023049689. All the future information corresponding to the US2023049689 (case of deletion) to be submitted in the case of the record (US2023049682).
5/22/02- Pt stated she felt "dizzy" all afternoon after vaccination. That evening around 9:00 pm, she "passed out". Mother states that she witnessed "posturing" or curving of the fingers for approximately 2 minutes. "Lethargic" for approximately 45 minutes. History of hypoglycemia with similar in past. 5/23/02 -  Pt c/o "cramping in fingers," dizziness and hard to breathe ,like a brick on her chest. Advised to seek medical help 5/24/02-still experiencing dizziness. Treatment recommended by physician.
Dime sized Purple/Silver Blister developed below base of thumbnail of my left thumb. Went to Dr. on 1/18/21. She diagnosed as possible staph/strep infection so prescribed Doxcycline Monohydrate 100mg twice a day for 7 days. Scabbed over 1/31/21 then resolved within a week.