chrisvoncsefalvay/vaers-outcomes huggingface dataset:
left side face swollen and numb; numbness in foot and hand/left side face swollen and numb; face is getting a little worse and now his lip; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 57-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EN6201), via an unspecified route of administration (at the age of 57-years), administered in arm left on 01Mar2021 at 08:45 as dose 1, single for COVID-19 immunization. Medical history included rheumatoid arthritis from 2011 to an unknown date verbatim: rheumatoid disease and diabetes mellitus from an unknown date and unknown if ongoing verbatim: pancreatic diabetes diagnosed about 2007-2008. The patient concomitant medications were not reported. The patient did not take any other products. The vaccination facility type was reported as pop up clinic, drive. On 01Mar2021, the patient experienced left side face swollen and numb, numbness in foot and hand/left side face swollen and numb and face is getting a little worse and now his lip. Caller stated that he got his first dose of the Pfizer Covid vaccine, states the left side of face is swollen and numb along with his left hand and foot. Administered on 01Mar2021 in the morning, stated he noticed the numbness around noon the same day, states his face is getting a little worse and now his lip is involved and the numbness in his hand and foot is just persisting. Caller asked what he should do. The adverse event does not result in emergency room and physician office visit. The clinical outcome for all the events was reported as not recovered.  No follow-up attempts are possible. No further information is expected.
This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 69-year-old female patient who received SHINGRIX (batch number ZG47A, expiry date 12th February 2021) for prophylaxis. On 20th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 22nd July 2018, 93 days after receiving SHINGRIX, the patient experienced shingles and erythromacular rash. On an unknown date, the patient experienced disease prodromal stage. On an unknown date, the outcome of the shingles, erythromacular rash and disease prodromal stage were unknown. It was unknown if the reporter considered the shingles, erythromacular rash and disease prodromal stage to be related to SHINGRIX. Additional details were provided as follows: On 22nd July 2018, prior to the second dose, the patient noticed 2 dots on her upper leg that looked like a bug bite, but at the time of reporting the patient thought that it was shingles. The shingles had not been officially diagnosed at the time of reporting. On 23rd July 2018, the patient received the 2nd dose of SHINGRIX. The patient had prodromal signs a couple days before the spots showed up and followed linear progression.
At 4 PM  Pt. came back to pharmacy said she was experiencing redness of eyes, burning sensation in nose, coughing, and hot feeling in face.
Extreme fatigue, headaches, tingling and numbness in whole body. Couldn't walk. Now walks very very slowly, poor memory. Has had to cut back hours at work. Doctor has advised that shouldn't work. Need to work to keep health insurance.  Has seen several doctors and has done physical therapy.
Myocarditis.  1d after vaccine with fever, tachycardia, chest pain.  Abnormal ekg, elevated troponin.  Admitted
This case was reported by a healthcare professional (distributor) and described the occurrence of injection site tenderness in a subject of unspecified age and gender who was vaccinated with FLULAVAL (GlaxoSmithKline) for prophylaxis. On an unspecified date the subject received unspecified dose of Flulaval (unknown). At an unspecified time after vaccination with Flulaval, the subject experienced injection site tenderness. At the time of reporting the outcome of the event was unspecified. The reporter did not know if the patient had previously received any influenza vaccinations. It was also unknown if the subject had any adverse events following previous vaccinations.
2 weeks after booster, I started breaking out in hives.  It has continued every day, randomly.  PCP put me on Prednisone for 6 days and Hydroxyzine HCl prn.  Benedryl has been only thing effective to keep hives bearable.  My sister (age 41) got same booster same day and has the same exact response- delayed urticaria.
Sore throat; coughing; nausea; This is a spontaneous report from a non-contactable consumer, the patient. A 20-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 06May2021 at 14:45 (at the age of 20-year-old), as a single dose for COVID-19 immunisation. Medical history included asthma. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive other vaccines within 4 weeks prior to the COVID vaccine. The patient received unspecified concomitant medications. On 07May2021, the patient experienced sore throat, coughing and nausea. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events sore throat, coughing and nausea was resolving at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
On 01/06/2023, I went for a routine check-up with my retina specialist. I went back to the office one week later because I started experiencing broken/shattered vision. I was referred to a neurological ophthalmologist. When I went to see them, he sent me for blood test to see if it was temporal arthritis, but that result was negative. I've had to start wearing a patch on my right eye so I can walk. If I do not wear the patch I am not able to walk without bumping into things or falling.
Fever, malaise, pain at injection site, vomiting, rash on face. Loss of urinary continence.
Patient received Pfizer COVID vaccine on 1/23/21 and 2/18/21. On 9/6/21, patient presented to our facility due to having 3 falls in the adult facility and did hit her head. COVID status positive upon admission without any symptoms. Patient admitted for falls related to acute cystitis. As of 9/9/21, patient is still admitted in the med/surg setting.
About 45 min after getting the second dose of the covid-19 vaccine I began to feel tingling and numbness in my fingers, hand, and arm. Then shortly after that I developed a migraine headache.
Lip angioedema; This case was reported by a other health professional and described the occurrence of lip angioedema in a 29-year-old female patient who received Flu unspecified (Influenza vaccine) for prophylaxis.   The patient's past medical history included dermal filler injection (had in the lips (unknown how long prior to the vaccination)).   On an unknown date, the patient received Influenza vaccine. On an unknown date, unknown after receiving Influenza vaccine, the patient experienced lip angioedema (serious criteria GSK medically significant). On an unknown date, the outcome of the lip angioedema was unknown.   It was unknown if the reporter considered the lip angioedema to be related to Influenza vaccine.  Additional details were reported as follows: This case was identified in FDA Briefing Document with respect to the Moderna COVID-19 vaccine. The age at vaccination was not reported. The patient experienced lip angioedema after receiving an Influenza vaccine. The patient also had lip angioedema 2 days after vaccination with Moderna COVID-19 vaccine.
a 63 years-old patient inadvertently received Fluzone High-Dose Quadrivalent instead of Fluzone Quadrivalent/ no AE; a 63 years-old patient inadvertently received Fluzone High-Dose Quadrivalent/ no AE; a 63 years-old patient inadvertently received Fluzone High-Dose Quadrivalent/ no AE; Initial information was received on 17-Sep-2020 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 63 years-old male patient who was inadvertently vaccinated with 0.5 mL (once) dose of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (prefilled syringe; batch number UJ469AB and expiry date 30-Jun-2021) via intramuscular route in unknown administration site on 15-Sep-2020 for prophylactic vaccination instead of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (batch number and expiry date not applicable)(Wrong product administered), (Product administered to patient of inappropriate age) and (Overdose).  Medical history, medical treatments, past vaccinations and family history were not provided.  Patient did not receive any other concomitant vaccines.  This was a case of actual medication error due to inappropriate age at vaccine administration, wrong vaccine administered and it was also a case of overdose (latency was on same day).  At the time of report, 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 holders 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.
Red face 05:20, sore arm 05:20, headache 05:25, fatigue 05:20
06/24/2022 that afternoon, I had what felt like a bad cold. I had a sore throat, sneezing, coughing, headache, a low grade fever and loss of appetite. I tested for COVID twice on 6/24/2022 and the next day that came back negative. 0n 06/26/2022 I tested positive for COVID. I continued to have the symptoms. I had a telehealth with my doctor on 6/27/2022. I started feeling better around 6/28/2022 or 6/29/2022 and am still having symptoms. I continue to have a cough, feel a little foggy and am having some burning and itching in my eyes.
Short-term memory is really bad; Hard time breathing; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of MEMORY IMPAIRMENT (Short-term memory is really bad) and DYSPNOEA (Hard time breathing) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, 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 experienced MEMORY IMPAIRMENT (Short-term memory is really bad) and DYSPNOEA (Hard time breathing). At the time of the report, MEMORY IMPAIRMENT (Short-term memory is really bad) and DYSPNOEA (Hard time breathing) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications was not provided.  Treatment medications was not provided.   Reporter did not allow further contact
This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 78-year-old female patient who received SHINGRIX. Concurrent medical conditions included drug allergy (The patient had IMURAN and TYLENOL allergy, where IMURAN caused temperature increase to 103). On 18th April 2018 14:00, the patient received the 1st dose of SHINGRIX (intramuscular). On 19th April 2018, 1 days after receiving SHINGRIX, the patient experienced injection site swelling, injection site erythema, injection site discoloration and injection site warmth. The patient was treated with antibiotics nos. On an unknown date, the outcome of the injection site swelling and injection site erythema were not recovered/not resolved and the outcome of the injection site discoloration and injection site warmth were unknown. The reporter considered the injection site swelling and injection site erythema to be probably related to SHINGRIX. It was unknown if the reporter considered the injection site discoloration and injection site warmth to be related to SHINGRIX. Additional information was reported as follows: The patient took other unknown medications as concomitant medication. The patient after vaccination with SHINGRIX developed a pink, swollen, hot area at the injection site that was red at the time of reporting and swollen. The area was black and blue at the center that looks like a bug bite. The patient had been prescribed with antibiotics and an ointment, but they do not appear to be helping.
This case was reported by a consumer via call center representative and described the occurrence of respiratory infection in a 69-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles (3 cases). Previously administered products included ZOSTAVAX vaccine. Concurrent medical conditions included blood sugar increased. On 15th September 2018, the patient received the 1st dose of SHINGRIX. On 15th September 2018, less than a day after receiving SHINGRIX, the patient experienced influenza-like symptoms, injection site erythema, injection site lump, blood sugar increased and condition aggravated. In January 2019, the patient experienced respiratory infection (serious criteria hospitalization and GSK medically significant), wheezing (serious criteria hospitalization), herpes zoster infection neurological (serious criteria hospitalization and GSK medically significant) and pain (serious criteria hospitalization). On an unknown date, the outcome of the respiratory infection, wheezing, herpes zoster infection neurological, pain, influenza-like symptoms, injection site erythema, injection site lump, blood sugar increased and condition aggravated were recovered/resolved. It was unknown if the reporter considered the respiratory infection, wheezing, herpes zoster infection neurological, pain, influenza-like symptoms, injection site erythema, injection site lump, blood sugar increased and condition aggravated to be related to SHINGRIX. Additional details were received as follows: On the same day of vaccination, the patient's whole body felt like having the flu. The patient had redness at the injection site, lump the size of a hardball at the injection site. The patient also had high blood sugar levels (in the 300's), despite taking her medications to control it. All the symptoms lasted 3 weeks. In January 2019, the patient had a respiratory infection with wheezing. She also started to have shingles again, despite having the first dose of shingles. She has had cases of shingles where it involved one nerve branch involved however, this time she had 3 nerve branches involved. She had a total of five weeks of pain from the shingles. The patient said that she ended up going to the emergency room (ER) and the hospital to get assistance. The reporter consented to follow up.
From initial information received on 12/28/04 from a registered nurse regarding an adverse event occurring in the USA, it was reported that a 26 year old female patient received a 0.5cc dose of TD ADS ADULT, lot number U1185AA, administered ID in the left forearm in error instead of a 0.1cc dose of TUBERCULIN PPD on 8/16/04 at 10:10 AM. Later that same day, the patient developed redness, swelling and itching at the site of injection. On 8/19/04, she also developed vomiting and diarrhea. It was reported that the patient recovered from the events. The reporter of this case is the same reporter of cases 200402848, 200402849, 200402850, 200404037, 200404038, 200404039, 200404041, 200404042 and 200404043.
This case was reported by a nurse and described the occurrence of incorrect storage of drug in a patient who received HAVRIX. Co-suspect products included PEDIARIX and ENGERIX. On an unknown date, the patient received HAVRIX at an unknown dose, PEDIARIX at an unknown dose and ENGERIX B at an unknown dose. On an unknown date, an unknown time after receiving HAVRIX, PEDIARIX and ENGERIX B, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown. Additional information received: Up to 45 patients may have been vaccinated with vaccine stored outside data limits.
Patient developed severe symptomatic hypocalcemia requiring ER evaluation and treatment about 2 weeks after the second COVID-19 vaccine from Pfizer.  He had no prior self, nor family history of calcium metabolism dysfunction.  He is still on high doses of oral calcium, calcitriol, magnesium, and hydrochlorothiazide to raise his serum calcium which has been very difficult for him and still his calcium is not at goal of at least 8.8 mg/dL.   He now needs parathyroid hormone, Natpara which is very difficult to get coverage from his health insurance and very expensive.
Employee is hospitalized with a pulmonary embolism 2 days after receiving J&J Covid vaccine.
sore arm after; This is a spontaneous report from a contactable consumer (patient's mother) who reported for her son via Pfizer sponsored program. A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number was not reported) via an unspecified route of administration on 17Jun2021 as a single dose for covid-19 immunization. Medical history included that the patient was autistic with catatonia and had combination of Lyme disease and Epstein Barr virus. He also had some hives from sand that they bought from store to make a sandbox, wherein he had head-to-toe dots and blotches everywhere, and the only cause his mother could see was silica. He was also gluten intolerant. The patient visited to doctor on 04Jun2021, and he said okay for vaccination. Concomitant medication included lorazepam (LORAZEPAM) taken for an unspecified indication, start and stop date were not reported. The medication was not working lately, and they had to increase the dose. The insurance company didn't allow the same manufacturer, so they also changed manufacturer on the pharmacy. He was perfectly fine before but had severe allergic reaction with different manufacturer. The patient experienced sore arm on an unspecified date in Jun2021. His mother wanted to know if the vaccine contained gluten, silica or if the ingredients of the vaccine might be used in some other medications that may be hidden and trigger an allergic reaction. She said that she always carries Benadryl that had to go with his Prednisone. The outcome of the event was unknown.  The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.
Child developed fever up to 102 degrees ax. left side of face was swollen. Left pupil more dilated than right pupil saw MD who stated this was not a vaccine related event.
This spontaneous report was received from a nurse and refers to a 9 week old patient of unknown gender. The patient's relevant medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 25-SEP-2017, the patient was vaccinated with improperly stored vaccines, RECOMBIVAX HB (dosing details not reported) (lot # N006321, expiry date: 08-NOV-2019) and ROTATEQ (dosing details not reported) (lot # M042170, expiry date: 22-JUN-2018, orally) for prophylaxis. No adverse effects were reported. The administered vaccines underwent a temperature excursion from 0 degree Celsius (C) to 1 degree C (0.8 degree C) for 52 minutes. The previous temperature excursion was reported as 9 degree C to 25 degree C (10.9 degree C) for 3 hours 17 minutes. The call was because of a data logger. No product quality complaint was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA007011.
Rash (red bumps) on cheeks and nose.  Got worse as week went on.  Still there as of today....3/29/2016 and not getting better yet.
Described body ache that nite after receiving flu shot. Experienced fever the next day of 102 (10/12/2016) along with body ache. Had symptoms for about 8 days-went into MD/clinic at that time. Was found to have pneumonia. Antibiotics were prescribed.
Vaccines administered at 2:30 pm approximately.Mother called to report swelling of eyes and constant snezzing. after leaving our office. Call came in 3:45 pm. Advised parent to give Benadryl- 1 tsp and come back to office around 4:00 pm. Oraped 2 tsps given 4:10 pm. No wheezing-No SOB-puffy eyes-alert and afebrile.
Patient received vaccine that was stored improperly. Vaccine was moved from ultra-cold freezer to freezer on 06/17/2021. According to guidance from  Pfizer, vaccine stored in the freezer after day 17 is considered improperly stored, and the patient will need to be re-vaccinated.
Narrative: The patient's first Moderna Covid-19 vaccine was on 3/3/21, and the second dose was on 3/31/21. The 74 year old patient was admitted to the hospital on 4/24/21 secondary to significant weakness causing the patient inability to walk or stand on his own. He had been seen 2 days prior to the hospital admission in the ER for right-sided weakness. At that time, a stroke workup was done, and the patient was discharged. Since then the patient had progressive worsening of the weakness with lower motor neuron symptoms, and became unable to swallow and non-verbal. A spinal fluid analysis showed elevated protein, and expected to have Guillian-Barre (Miller Fisher variant). The patient completed 5 days of Privigen with immediate and significant improvement in symptoms. The patient had an NGT placed and was intubated from 4/26-4/29 secondary to respiratory distress; on a ventilator. During the course of the hospital stay, the patient experienced BPH with urinary retention, a swollen left upper extremity (no DVT on ultrasound), labile blood pressure (started on lisinopril 2.5mg daily but dc'd due to hypotension, also hypotension with hydralazine), lung infiltrates, and DVT prophylaxis (Lovenox, subq heparin.) Once stabilized, the patient was transferred to Inpatient Rehab, where he remained for over 2 weeks.
cramps; nauseous; rash; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (cramps), NAUSEA (nauseous) and VACCINATION SITE RASH (rash) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse reaction.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jan-2021, the patient experienced MUSCLE SPASMS (cramps), NAUSEA (nauseous) and VACCINATION SITE RASH (rash). At the time of the report, MUSCLE SPASMS (cramps), NAUSEA (nauseous) and VACCINATION SITE RASH (rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication details were not reported by the reporter. Treatment details not reported by the reporter.
at approximately 4:30 am she woke up  and could not move her entire body. She stated that her husband called the paramedics approximately 6:30 am ( event lasted from 4:30am -8:30 am). She stated that she was evaluated by the paramedics and decided to stay home because she began to regain feeling in her arms and hands. However, she reported that  her legs and feet were weak.  She was advised to report her reactions  and follow instructions, if s/s returns to call the hospital or dial 911 for immediate care.