chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case reported by a consumer, describes the occurrence of pharyngeal hypoesthesia (numb throat) and alopecia areata (hair loss/now has a bald spot on her head/they said she has alopecia areata) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 039B21A) for COVID-19 immunization. Concurrent medical conditions included alopecia areata. Concomitant products included low-dose Aspirin (acetylsalicylic acid) for an unknown indication. On Apr 21, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Apr 21, 2021, patient experienced pharyngeal hypoesthesia (numb throat). On May 18, 2021, patient experienced alopecia areata (hair loss). On an unknown date, patient experienced alopecia areata (now has a bald spot on her head/they said she has alopecia areata). On Apr 22, 2021, pharyngeal hypoesthesia (numb throat) outcome: unknown. At the time of the report, alopecia areata (hair loss/now has a bald spot on her head/they said she has alopecia areata) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. Treatment medication not reported. Patient reported visiting a dermatologist and was concerned if the condition (alopecia areata) is related to vaccination.
Shingrix- second dose after 8 months; This case was reported by a consumer via interactive digital media and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 2-MAY-2022 Reporter's Comment: This case was reported by a consumer via interactive digital media. The patient received Shingrix second dose after 8 months. Additional Supportive Information: The patient received Shingrix 2nd dose later than the recommended interval, which led to lengthening of vaccination schedule. The follow-up would not possible as no contact details were available.
felt tired for about one day after his second vaccination.; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (felt tired for about one day after his second vaccination.) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047B21A and 008B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Apr-2021, the patient experienced FATIGUE (felt tired for about one day after his second vaccination.). In April 2021, FATIGUE (felt tired for about one day after his second vaccination.) had resolved.            Concomitant medication was unknown Treatment information was unknown   This case was linked to MOD-2021-372062 (Patient Link).
This case was reported by a physician via sales rep and described the occurrence of urine discoloration in a 19-year-old female patient who received BEXSERO. Concomitant products included BEXSERO. On 2nd January 2018, the patient received BEXSERO. On 23rd January 2018, 21 days after receiving BEXSERO, the patient experienced urine discoloration. On an unknown date, the outcome of the urine discoloration was recovering/resolving. The reporter considered the urine discoloration to be unrelated to BEXSERO. Additional details were reported as follows: The date of the first dose was not known. On an unknown date, 3 weeks after receiving the 2nd dose of BEXSERO, the patient developed dark colored urine.
Patient had fever to 104.9 with complex febrile seizure (2 episodes in 24 hours).
Pt seen in ER that night to rule out seizure but all tests for seizure were negative.
This spontaneous report as received from a pharmacist refers to a patient of unknown age (gender was unknown). On 16-AUG-2013 the patient was vaccinated with a dose of expired M-M-R II (lot 3 671320/1121AA, exp. date: 12-JUL-2013) (dose and route not reported) as vaccination. No adverse event reported. It was unknown if the patient sought medical attention or not. Additional information is not expected.
I received my first Pfizer booster for COVID-19 on 11/3/2021. On 5/5/2022, I had a cough, body aches, and a severe headache. On 5/6/2022, a coworker informed me that she had tested positive for COVID-19. On 5/7/2022, I took a home test and got a positive result. I then isolated. My symptoms continued, plus I developed chest congestion, fatigue, mental confusion, and a loss of taste and smell. At the time of this writing, I still have coughing, chest congestion, and brain fog. I still have difficulty tasting food, because food usually doesn't taste right. I think I also probably still have trouble with my sense of smell, but it's not as noticeable as the issue I'm having with my sense of taste. I had a telehealth visit with my doctor on 5/12/2022. He did not prescribe me Paxlovid, because he said that it was too late, since more than 5 days had already passed since the onset of symptoms. I treated myself with hot tea, Robitussin, Tylenol for body aches, and ibuprofen. I began to finally feel better around a month and a half after the onset of the symptoms.  However, I did return to work around 5/23/2022. With regard to the symptoms I still have, I try to treat them with Robitussin, Tylenol, ibuprofen, and hot tea. They help me feel better temporarily, but the symptoms always return.
Fever of 103.9 for 3+ hours; took 2 doses of Tylenol and 1 dose of Motrin to bring down below 101. Large, red, raised, warm rash at sign of injection which I am now on day 3 of. The rash continues to get larger by the day.
2 months later i am experiencing vertigo .. came out of the blue. almost every day of the week.
A couple hrs after vaccines started with a rash that spread face to toes. Rash urticarial. No fever. Mild nasal congestion.
Redness, swelling, itching going down the arm that began the day following administration. Patient taking daily antihistamines to treat symptoms.
Systemic: Fainting / Unresponsive- Mild, Additional Details: Pt fainted a few minutes after injection, but quickly came to and was responsive. Spouse stated pt had history of fainting after giving blood.
Shortness of breath, chest pan, stomach pains/nausea started around 1 pm with a fever of 103.. around 5 pm, only nausea and fever of 101 remained. Overnight, nausea was the main symptom and it caused my daughter to throw up around 3 am. Around 5 pm, she feels much better but still has some queasiness.
This case was reported in a literature article and described the occurrence of anaphylaxis in a 15-year-old female subject who received Tdap vaccine. This case refers to patient 4 in the literature article. Co-suspect products included HPV Quadrivalent vaccine. Concurrent medical conditions included asthma and allergy to vaccine (DTaP). On an unknown date, 2 hrs after receiving Tdap vaccine, the subject developed anaphylaxis. Serious criteria included GSK medically significant and life threatening. Additional event(s) included angioedema with serious criteria of GSK medically significant, generalized urticaria, erythema, pruritus, shortness of breath and abdominal pain. The subject was treated with antihistamine and Bronchodilator. The outcome of anaphylaxis was recovered/resolved. The outcome(s) of the additional event(s) included angioedema (recovered/resolved), generalized urticaria (recovered/resolved), erythema (recovered/resolved), pruritus (recovered/resolved), shortness of breath (recovered/resolved) and abdominal pain (recovered/resolved). The investigator considered that there was a reasonable possibility that the anaphylaxis, angioedema, generalized urticaria, erythema, pruritus, shortness of breath and abdominal pain may have been caused by Tdap vaccine and HPV 4 vaccine. Additional information was provided: This case was reported in a literature article and it described the occurrence of a vaccine-triggered anaphylaxis in a 15-year-old female patient who had received an unspecified Tdap vaccine (manufacturer unknown) and an unspecified quadrivalent HPV vaccine (manufacturer unknown). The patient was a female. The subject's medical history included atopic disease with asthma and other allergy (DTaP vaccine). No further information on the patient's concurrent medical conditions, medical or family history, or concomitant medication was provided. On an unspecified date, between the 1st of January of 2009 and the 31st of December of 2011, the patient received an unspecified dose of an unspecified Tdap vaccine and an unspecified quadrivalent HPV vaccine (dosages unknown; administration routes and sites unspecified; batch numbers not provided). On an unspecified date, 2 hours after the vaccination, the patient developed angioedema, generalized urticaria, erythema and pruritus, shortness of breath and abdominal pain. This was classified as anaphylaxis by the paediatrician. According to the authors the case was considered as Brighton level 2 and setting of initial evaluation was clinic. The patient was treated by oral antihistamine and bronchodilators. At the time of reporting the outcome of the events was recovered. This event was classified as vaccine related according to the authors. The authors concluded that "Anaphylaxis after vaccination is rare in all age groups. Despite its rarity, anaphylaxis is a potentially life-threatening medical emergency that vaccine providers need to be prepared to treat. This case is 1 of the 28 valid cases reported in the same literature article.
I noticed that I got a rash and I told my wife and that it was getting to be hurting; it was very painful. They told me I had shingles. They gave me medications. Went to urgent care and got the prescription. It has healed now.
Tachycardia, resident was sent out to the hospital  for evaluation on 12/30/2020 and came back to the facility on 12/31/2020.
pain, itching, shingles rash valacyclovir 500 mg 3 x day 7 days recovered
Moderna COVID-19 Vaccine EUA  Fever, chills, Nausea
Approx 1400 administered Tdap and Menactra vaccine. Pt looked out of room and immediately fell to floor and hit head on floor. Eyes were open, extremities rigid, Sl shaking, unresponsive for approx 15-20 sec. rash developed on upper chest and arms, perspiring. BP 90/48. Rash disappeared after 15 min and then came back and disappeared. Sent home with mother in stable condition.
This spontaneous report as received from a pharmacist refers to a 62 year old female patient. The patient had no drug reactions/allergies. On 22-OCT-2014 the patient was vaccinated with a dose of ZOSTAVAX (lot# K0091998, expiration date 27-SEP-2015, dose 0.65 ml, subcutaneously in the right upper arm). Concomitant medications were not provided(reported as "Nothing immunosuppressive"). The pharmacist reported that the patient was reporting she had what appeared to be e vesicular rash on her "flank and chest" on 23-OCT-2014. The patient reported to the pharmacist that a nurse, who worked at the facility where the patient worked, observed the rash and told the patient that the rash "looks like shingles." The patient sought medical attention by calling the pharmacy and asking a pharmacist what she should do about her rash. The pharmacist did not observe the rash, nor did the patient described any other symptoms to the pharmacist. At the time of this report, the pharmacist did not think that the patient had notified her healthcare provider. No treatment was given for the event. No lab diagnostics studies were performed. Outcome of the event was reported as not recovered. Additional information has been requested.
Pt had paresthesias and weakness of lower extremities about 1 month (05/18/2021) after the vaccine. These were attributed to possible lower back disc injury with nerve compression when seen by his Internist. He was given outpatient PT with no improvement. On the morning of July 13, 2021 he awakened with difficulty speaking. EMS was called and he was taken to Hospital. He was admitted to their Neurological stepdown ICU. CT scans and MRIs were done and Dx of demyelinating disease was most likely Dx. By the time he arrived in the ICU he could not walk. Shortly thereafter he was totally paralyzed on the Right including both upper and lower extremities and facial 5th nerve paralysis. cont: Left side of body with weakness of both upper and lower extremities. Abdominal  musculature was extremely weak. Speech essentially lost. He was started on IV Solumedrol 500mg BID and transfer to Clinic was arranged. However, due to bed shortage at clinic, he did not arrive at Clinic until 3AM 07/15/2021. He was under the care of neurologist. Attributed his demyelinating disease and acute crisis to his Covid-19 Vaccine. He had further MRIs , PET scan with CT, Lumbar puncture, ultrasound of kidney/bladder. Numerous serological studies on blood and CSF. He was put on Solumedrol 1000mg IV once daily for 5 days. He was given 5 plasmapherisis treatments - 7/16, 7/19, 7/20, 7/22, and 7/23. He  was given OT, PT, Speech Rx and oral feeding evaluation. He was transferred to another Hospital inpatieent Neurological Rehabilitation Center on 07/24/2021 for needed PT/OT and Speech Rx. He was discharged to home on 08/21/2021. He is presently in outpatient Neurological PT/OT.  He has recovered most of his speech and has resolved most of his facial nerve paralysis. He has regained strength in his L extremities and most of the strength in his Right lower ewxtremity. R upper extremity is a work in progress with minimal function to date but progressing in a positive direction. He continues with some paresthesias of his lower extremities and Left hand and scalp/neck area. He is successfully learning to walk. He has never had any intellectual loss. I have listed the onset as the aggressive events of July 13,2021. However, in retrospect, the symptoms of paresthesia and weakness of the lower extremities in later May 2021 were probably the start of the reaction. It is thought to be an Autoimmune reaction started by or exacerbated by the Covid-19 Vaccine.
Previously in outside hospital with acute peritonitis secondary to infected peritoneal catheter; was dc'd to SNF on prolonged antibiotics; c/o diarrhea x 4 wks - presents to hospital; COVID test positive; placed on O2 supplementation; poor appetite; treated with steroids; NRB with adequate O2 sats; pt experienced increase in SOB; treated with Bumex and antibiotics; hypoxic; requiring BiPAP; pt's condition declined; DNR/DNI; decrease in respiratory status; pt was made comfort measures and died in the hospital
a dose of Fluzone quadrivalent was administered to a 5 month old/ no AE; Initial information was received on 28-Jan-2020 regarding an unsolicited valid non-serious case from a nurse.  This case involves a five month old male patient who was received a dose of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  Medical history, medical treatment, vaccination and family history were not provided.   On 24-Dec-2019, the patient received first 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number U6712AB, expiry date- 30-Jun-2020) via intramuscular route in the left thigh for prophylactic vaccination.  It was an actual medication error due to inappropriate age at vaccine administration  The nurse reported that a 0.5 ml dose of Fluzone quadrivalent was administered to a five months old patient.  At the time of report, no adverse event was 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.
10/17/2021 - States she also has nausea, feels like this is from COVID booster she received yesterday 10/27/2021 -07:28 - Patient complains of headache since Sunday that has caused vomiting and dizziness. 10/27/2021 - 20:42 - MRI shows evidence of a subarachnoid hemorrhage. The patient will be admitted to the intensive care unit and will get an intervention tomorrow. 10/27/2021 - 21:18 - Patient presents with NIH stroke scale of 0. she has a modified Rankin score of 1. Her headache started 4 days ago and she had had intermittent problems with vision she denies any other symptoms. She will be admitted to the intensive care unit we will should get every hour neuro checks.
After receiving the second dose of the COVID vaccine the patient went home but returned to the ED the following day complaining of shortness of breath that feels like prior asthma attacks. She presented to the ED at 0833 short of breath with a dry cough and hoarse voice. She was given albuterol then monitored and re-evaluated at 0921. At that time the patient stated that she felt a little better, and declined any further evaluation since she reported that she felt the same as she always does while having an asthma attack. She states that she would not have come to the ER if she had not been at work and been required to. She was discharged with prednisone at 0923.
numbness of tongue after the vaccine shot,code rapid response and employee went to ER and was given  benadryl and IV solumedrol
Vomiting, fever, chills, diarrhea, body aches, cough, shortness of breath, fatigue,
A report has been received from a Health Professional concerning a female patient, who had been receiving FLUMIST quadrivalent (intranasal) 0.2mL, once/single administration, 0.1 mL in each nostril. FLUMIST quadrivalent started on an unknown date. HCP reported first half dose of FLUMIST did not take well as some vaccine was reported to had run out of nose. Second half dose administered with no issue. FLUMIST quadrivalent was continued. The outcome of the event of first half dose of FLUMIST was reported to have run out of the nose was unknown. The report was considered to be non-serious by company physician.
Information has been received from a nurse practitioner concerning unspecified number of patients of unknown age and gender. Patients' medical history and concurrent conditions were not reported. Between 06-APR-2015 and 30-APR-2015, unspecified number of patients were vaccinated with a dose of improperly stored VARIVAX (Merck) (dose, lot# and route were not reported). No adverse effects were reported. Follow up information has been received from a receptionist during a phone call on 02-JUN-2015. The reporter could not supply patient identifiers, lot numbers or dates of vaccination. Follow up information was received on 15-JUN-2015 from a nurse practitioner. The reporter provided the names, dates and lot numbers with expiration dates of the patients who received VARIVAX (Merck) which was incorrectly stored. A total of 22 patients received the improperly stored vaccine between the dates of 06-APR-2015 and 30-APR-2015. On 09-APR-2015, a male patient of unknown age received VARIVAX (Merck) (lot number K021936, expiration date 10-NOV-2016). The vaccine was reported as improperly stored. No adverse event was reported. Follow up information was received on 16-JUN-2015 from a nurse practitioner. Multiple patients received the VARIVAX (Merck) vaccine which was exposed to higher than normal temperature. All vaccines were completed before the date required by the manufacturer. As of 16-JUN-2015, no vaccines were left from the event. Additional information has been requested.
Within an hour, pt had a headache, lasting at least 8 hours. Within a few hours, pt had a low-grade fever, paleness and dizziness and had soreness within minutes, lasting several days where shots were given.
Failed to menstruate for two months following my first injection.  My second dose was on 4/8/21 (Lot EP6955).  At the time I thought I might be pre-menopausal so I didn't think anything of it.  I did start to menstruate again on 5/23/21 and it was the heaviest and longest period of my life, until August.  I had several large clots (nickle to quarter size).  My cycle lasted approximately 10 days, whereas my cycle pre-vaccination was closer to 5 days and never heavy.  I then failed to menstruate again until 8/5/21 and that period lasted until 8/16/21, was longer and definitely heavier.  I was regularly soaking through pads in 1 hour.  I had clots regularly but all were nickle size or smaller.   This menstruation only started to slow on 8/13/21.  Since then I have had regular menstruation.
Child presented with mild varicella on 10/16/2000. No fever or irritability. Symptomatic care. Treatment as needed.
Mother identified child as being 5 years old. Vaccine administered 17 days prior to child turning 5.
Adacel was inadvertently administered to a 2-year old patient with no reported adverse event; physician ordered a hepatitis A vaccine for the patient, but the medical assistant grabbed the wrong vaccine (ADACEL) and administered it to the patient with no reported adverse event; Initial information received on 23-Jun-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves  2 years old male patient and Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine [Adacel] was inadvertently administered to patient and physician ordered a hepatitis a vaccine for the patient, but the medical assistant grabbed the wrong vaccine (adacel) and administered it to the patient with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 23-Jun-2023, the patient received 0.5 ml Total (1X) dose of suspect Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine Suspension for injection (Strength: Standard; Frequency-once) (with an unknown expiry date, lot number) via intramuscular route in the thigh not otherwise specified (NOS) for immunization. Information on the batch number was requested  On 23-Jun-2023, the patient developed events of Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine was inadvertently administered to a 2-year old patient and physician ordered a hepatitis a vaccine for the patient, but the medical assistant grabbed the wrong vaccine (adacel) and administered it to the patient with no reported adverse event (wrong product administered) (product administered to patient of inappropriate age) (Latency: same day).  It was reported, This situation is reported as a medication error due to ADACEL was inadvertently administered to a 2-year old. This is reported as a medication error due to a 2-year old male patient was inadvertently given ADACEL; the office manager reports that the physician ordered a hepatitis A vaccine for the patient, but the medical assistant grabbed the wrong vaccine (ADACEL) and administered it to the patient.  Action taken: not applicable.  Outcome: Unknown  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.