chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Weird feeling in the left side of my mouth, felt like i just left the dentist's; Sore arm; 2 day fever; Muscle soreness; Fatigue; Sore throat; Upset stomach; Diarrhea; Sick for 4 days; This is a spontaneous report from a non-contactable consumer, the patient. A 47-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the left arm on 07Apr2021 at 10:00 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. Medical history included  gestational thrombocytopenia. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medications in two weeks of vaccination. On 07Apr2021 at 00:00, the patient experienced weird feeling in the left side of her mouth, felt like she just left the dentist's. The patient had gestational thrombocytopenia with 3 pregnancies so she was concerned, especially since the center did not give her a side effects sheet. Other than that sore arm, 2 days fever, muscle soreness, fatigue, sore throat, upset stomach, diarrhea, and was sick for 4 days, probiotics helped. The patient would take second dose but was very apprehensive, figured she would chime in as her past issues with the thrombocytopenia. 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 events weird feeling in the left side of her mouth, felt like she just left the dentist's, sore arm, 2 days fever, muscle soreness, fatigue, and sore throat. Therapeutic measures were taken as a result of events upset stomach, diarrhea, and was sick for 4 days, which included treatment with probiotics which helped. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events weird feeling in the left side of her mouth, felt like she just left the dentist's, sore arm, muscle soreness, fatigue, sore throat, upset stomach, and diarrhea were recovered on an unknown date in Apr2021. The clinical outcome of the events 2 days fever was recovered on 09Apr2021 and sick for 4 days was recovered on 11Apr2021.  No follow-up attempts are possible. No further information is expected.
Initial and follow up information has been received from a 65 yr old white female registered nurse with asthma, hypertension, sulfonamide allergy, atropine and epinephrine drug hypersensitivity, who on 12Dec05 (previously reported as 22Dec05) was vaccinated (route unk) in her right upper arm with a first dose of pneumococcal 23v polysaccharide vaccine (lot unk). Concomitant therapy included Lisinopril (manf unk), hydrochlorothiazide (manf unk), fluticasone propionate (+) salmeterol xinafoate (Advair), albuterol and albuterol sulfate. Follow up information from the pt, a nurse, confirmed that at 10:30AM on 13Dec05, within 24 hrs of vaccination, her right upper arm stung at the site of injection and at times there is still discomfort in the site area. She also experienced a heaviness and a general ache of the entire upper arm. She indicated that it would come and go and lasted almost two months. No lump was noted previously; however, the pt reported in follow up that the site still feels somewhat lumpy, when manual pressure is applied. The nurse also indicated that many years ago, she had a flu shot with a gun in her left arm and experienced swelling from the shoulder down to the elbow. She indicated that she has never taken another flu shot and that she is sensitive to many recommended dose amounts. She also felt croupy in the past few weeks. No product quality complaint was involved. Additional information is not expected.
AFTER THE PATIENT TOOK THE FIRST DOSE OF THE VACCINE,  APROXIMATLY 5 HOURS LATER,  PATIENT HAD A SEVERE MIGRAINE HEADACHE WHICH CAUSED THE PATIENT TO HAVE A SEIZURE .
2 weeks post vax, the pt experienced a fever, joint pain, effusions, arthralgias, elevated LFT's and elevated Sed rate. The pt has improved, but still with symptoms.
13 hours after receiving the Shingles/Recombiant Zoster vaccine, I developed chills, fever, headache and a temperature of 100.8 degrees. I telephoned a 24 hour pharmacy at 3:25 a.m. on 7/14, to ask if I could take an NSAID so I could get some relief of my headache. After speaking with two pharmacists, I elected to take one (1) Advil pill. My headache, chills and fever disappeared by 6:30 a.m. I continue to have a < slight > headache and took one (1) Advil at 1:00 p.m.
This case was reported by a healthcare professional and described the occurrence of red bump at injection site in an adult female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). On an unspecified date the subject received a dose of BOOSTRIX (unknown). At an unspecified time after vaccination with BOOSTRIX, the subject experienced local reaction of red itchy bumps at injection site. The reporter had very limited information, no other details were provided. At the time of reporting the outcome of the red itchy bumps at injection site was unspecified. This is one of two reports made by the reporter, for the other case please see A1056649A. Follow up to the initial report received by GSK on 9 January 2013 and by the Quality Assurance Department on 14 February 2014. This complaint was associated with a product quality complaint. The lot number and expiry of BOOSTRIX was also provided. Follow up was received from the Quality Assurance Department on 14 February 2014. Based on results of the investigation by GSK Quality Assurance, the product complaint was assessed to be unsubstantiated.
Client reported that he consumed a marijuana edible prior to coming to the vaccination site. Client received the vaccine and then stated he felt like he was going to faint, he appeared to be post-ictal and was unconscious for approx 30 seconds. Client regained consciousness and was given Gatorade. Client stated he has a history of seizures and marijuana use.
Pt reports only soreness the day after receiving the Covid 19 vaccine, however reports on day 11 after receiving the vaccine redness to injection site with an area size of her palm, itching, and a rash at the injection site. Pt reports that her PCP gave her a steroid injection today.
pt recv vax & approx 1yr later presented w/"lupus-like'' sx.
Information has been received on 16-AUG-2017 regarding a case in litigation from a lawyer and a female patient of unknown age and the patient's spouse. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unknown date the patient was vaccinated with ZOSTAVAX (lot number and expiration not reported), subcutaneous for its intended purpose of the prevention of shingles. Weeks later (date not reported), the patient began to experience prickling in her legs and feet, stabbing pains in her abdomen, and muscle stiffness. On an unknown date, the patient was eventually diagnosed with postherpetic neuralgia as a result of the ZOSTAVAX vaccine. The patient continues to experience chronic prickling and tingling, some stabbing pains, and burning feelings in different spots on her body. As a direct and proximate result of the ZOSTAVAX vaccine, the patient's symptoms have resulted in physical limitations not present prior to using ZOSTAVAX. The patient also experiences mental and emotional distress due to resulting physical limitations from, and seriousness of, her condition. As a result of ZOSTAVAX, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The patient has incurred and will continue to incur medical expenses and other economic harm as a direct result of use of ZOSTAVAX. Postherpetic neuralgia, stabbing pains in her abdomen, and muscle stiffness were considered to be disabling. Additional information has been requested.
Patient received a dose of IPOL too early and ahead of schedule with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from other healthcare professional via Medical Information (MI) (Reference number- 00634966) and transmitted to Sanofi on 09-Jun-2021.  This case involves a 3 years old female patient who received a 0.5 mL dose of suspect IPV (VERO) [IPOL] (lot T1D48 and expiry date: 25-Jul-2022) via intramuscular route in the right arm for prophylactic vaccination too early and ahead of schedule (inappropriate schedule of product administration) on 08-Jun-2021.  The patient's medical history, past medical treatments, past vaccinations, and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP) for Immunisation.  The reporter seeking guidance and is wanting to know is there any harm in the early dose and wanting to know is the dose a valid dose.  It was an actual medication error case due to inappropriate schedule of vaccine administered (latency: same day).  At the time of reporting, the patient experienced no adverse event.  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.
PT RECEIVED HER FIRST COVID VACCINE ON 03/10/2021 AND EXPERIENCED A FLARE UP WHILE OFF XELJANZ; This is a spontaneous report from a contactable Pharmacy report from a contactable other hcp. A 61-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 10Mar2021 (at the age of 61-years-old) as single dose for COVID-19 immunisation and was taking tofacitinib citrate (XELJANZ, Batch/Lot number was not reported), via an unspecified route of administration from an unspecified date to Mar2021 and restarted on Apr2021, at 5 mg, 2x/day for an unspecified indication. The patient medical history and concomitant medications were not reported. Patient reported that she was off of xeljanz for a week for each covid vaccine. Patient received her first covid vaccine on 10Mar2021 and experienced a flare up while off xeljanz for that week. Patient stated she received her second dose of covid vaccine BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on 24Mar2021 (at the age of 61-years-old) as single dose for COVID-19 immunisation and had no issues. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Staff member shared that we had an uneven amount of Shingrix vials vs Shingrix diluent. Our clinic's Practice Manager had our EMR pull a report to see which patients received the Shingrix vaccine over the past few months and performed chart reviews to determine which patient's did not have a diluent documented or the wrong diluent documented. Upon our investigation, of the 9 doses administered from the vaccine lot in question, this patient did not have a diluent documented and thus it was assumed they did not receive the correct diluent.
Stroke, confusion, cognitive deficits.  Went to ER on March 1, 2021. Diagnostics with stroke.
Information has been received from a medical assistant concerning a patient who was vaccinated with a dose of PNEUMOVAX (lot # 659148/1382U).  The medical assistant reported that the patient complained of cellulitis like injection site reaction with the vaccination.  The lot check has been requested by the medical assistant.  A standard lot check investigation was performed.  All in-process quality checks for the lot number in question were satisfactory.  The lot met the requirements of the agency and was released.  This in one of two reports received from the same source.  Additional information is not expected.
This spontaneous report was received from a medical assistant referring to an unspecified number of patient of unspecified gender and age. Since 05-FEB-2017, the unspecified number of improperly stored doses of the RECOMBIVAX HB (lot number L042846, expiration date 15-SEP-2017, lot number M028322, expiration date 31-MAY-2018, lot number M018645, expiration date 31-MAY-2018, lot number L040458, expiration date 04-FEB-2018, lot number L048849, expiration date 04-FEB-2018) (formulation, dose, frequency, route of administration and indication were not reported) were administered to the patients. From 05-FEB-2017 to 01-MAR-2017, the doses were stored 10 times in temperature colder than 32F (28.3F) for an unspecified period of time. It was also reported that the first excursion colder than 32F occurred on 15-FEB-2017. Data logger was involved. There was no previous excursion reported. No adverse effects have been reported. Additional information has been requested. Sender's Comments: US-009507513-1703USA007375: US-009507513-1703USA007373: US-009507513-1703USA007374: US-009507513-1703USA001520: US-009507513-1703USA007372.
Over the course of an hour after the first shot, the ringing in my ears tripled in volume and has stayed that way since. I never had any signs of tinnitus or hearing damage until 2 weeks after my first shot.
11/24/21 presents to ED for "worsening symptoms after recently being diagnosed with COVID" "cough, SOB, and fatigue". PMHx "obesity, hypertension, and OSA"
Severe vertigo/dizziness/motion sickness leading to nausea and vomiting.  Vertigo has lasted 5 days . Nausea and vomiting lasted 2 days. All symptoms started 6 days after dose 1.
2 Days: Severe fatigue, chills, and muscle aches. 100 degree plus fever and mild nausea. 3rd Day: Same symptoms - less severe
Red, raised patches noted on upper arm and complains of joint pain in shoulder and upper arm, neck. Denies itching or respiratory difficulties. First noticed symptoms Friday July 15,2005. Symptoms have not resolved or worsened since. Has not sought out any medical help or taken any medicines. Reports he has previously reacted to penicillin with a red rash on his chest.
Within 10 minutes of taking shot, I had an allergy attack - my nose became stuffy and was hard to breathe. Medic came to my car to assist. Told me to keep window down and take deep slow breathes. This worked, but maybe to minutes later it happened again. My blood pressure and oxygen level was taken. I was given a banana to eat. I ended up calling my husband to pick me up. On  the evening of Sunday 3/14, I noticed a red patch on my chest. Monday, 3/15 when I woke up, red patches were on my arms, hands , neck and face. Tuesday, 3/16 the red patches had spread up my arm and my eyes were puffy. I went back to the vaccination site and reported it to a medic. I was told to take Benadryl. Wednesday, 3/17 my right eye was swollen more and puffiness under my eye.  My left eye was swollen but not as much. I went to clinic and was given Benadryl and prednisone, and told  to go to the emergency room if it gets worse. Today 3/18 blotches still on arms, hands, neck and chest. Swelling on right eye lid has gone down some.
On 4/6/2022, I received my second Moderna booster for COVID-19. On 5/28/2022, I received a call from a contact tracer, who informed me that I had been exposed to COVID-19. On 6/1/2022, I took an at-home test, and the result was positive. During my experience with COVID-19, I was asymptomatic. Even though I was asymptomatic, though, my doctor saw fit to prescribe me a 5-day course of Paxlovid.
Patient felt dizzy, slightly sweaty - similar to previous episode of first dose. Patient observed for 30 minutes and feeling much better.
COLD; COUGH; FEVERISH; FEELING LIKE KNEES BENDING WHEN STANDS UP; CAN NOT SIT TOO LONG IN TOILET AND CHAIR; SEVERE PAIN IN LEGS BEHIND THE KNEES; This spontaneous report received from a patient concerned a 43 year old male. 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: 202A21A, and expiry: UNKNOWN) dose was not reported, administered on 16-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On JUN-2021, the subject experienced feeling like knees bending when stands up. On JUN-2021, the subject experienced can not sit too long in toilet and chair. On JUN-2021, the subject experienced severe pain in legs behind the knees. Treatment medications included: paracetamol. On 16-JUN-2021, the subject experienced feverish. On 17-JUN-2021, the subject experienced cough. On 18-JUN-2021, the subject experienced cold. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from cold, and feverish on JUN-2021, had not recovered from cough, feeling like knees bending when stands up, and severe pain in legs behind the knees, and the outcome of can not sit too long in toilet and chair was not reported. This report was non-serious.
On and off fever up to 102 .  Continuing not that 48 hours post vaccine. General body aches soreness. Tired ness - at some point barely able to get out of bed.
Report of (R) anterior shoulder pain 2 days 4-14-17 after receiving Hepatitis B vaccine 4-12-17 - evaluated 4-18-17 and 4-19-17. Cool pack, gentle pendulum exercises and follow up appointment scheduled 4-26-17.
This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. Information about concomitant medication, pertinent medical history and drug reactions/allergies was not provided. On 19-NOV-2018, the patient was vaccinated with improperly stored ROTATEQ (lot # R015432, expiration date 15-APR-2020) for prophylaxis (strength, dose detail, anatomical location and route of administration were not reported). No adverse effect was reported. The vaccine was exposed to temperature excursion between 0 degree Celsius (C) and 1 degree C for a time frame of 19 minutes and between 9 degree C and 25 degree C for 1 hour without previous temperature excursion. Data logger was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1901USA001125.
Redness, tenderness, localized swelling, and itch  at the Left upper arm site of booster injection. This has recurred since the booster dose in February.  It originally felt like there was a b-b in there, but over time it is getting bigger and bigger, and fluctuating in size and tenderness.  It has grown again just over the past few days.
Information has been received from an RN concerning her 1 year old granddaughter who on 7/6/01 was vaccinated in her thigh with a dose of varicella virus vaccine live. Concomitant vaccination the same day included MMR vaccine, Hib conj-Hep-B vaccine and Prevnar. On approx. 7/8/01, 2-3 days post vax, the pt developed a "knot" at the injection site on 1 of her thighs and a generalized body warmth; a fever. It was reported that the specific sites of injection for each vaccine (right or left thigh) was not known. The fever and the injection site knot on her thigh had resolved on the following day. It was noted that the child had been teething prior to her vaccination. On approx. 7/17/01, the pt developed fine red rash, little dots, on her chest which had resolved within a day. It was also reported by the RN that her father who had asbestosis. emphysema, long term steroid therapy (inhaled and oral) for treatment of his emphysema and a history of being "susceptible to pneumonia", chicken pox and shingles around his chest "several years ago" also had experienced symptoms. On 7/16/01, the child's grandfather had developed blistering around the corner of his eye and forehead, which was initially dx'd as conjunctivitis. The blistering continued to worsen and the pt returned to his physician who dx'd shingles. The pt was treated for shingles with an unspecified medication. It was reported that the pt had scabbed lesions around the corner of his eye, forehead and scalp. On follow-up, it was reported by the nurse that he was "feeling better" today. This episode was reported in (WAES010724661 as secondary transmission of herpes zoster). In follow-up, the RN was interested in information on secondary transmission. The VZV ID Program was discussed with her. The reporting nurse stated that the pt had a number of scabs and there were several in the pt's scalp area, which could be uproofed without risk of scarring. She stated that she would speak with her father to see if he would like to participate in the VZV ID Program. Additional information has been requested.
Based on immunization history Pentacel was indicated. Pediarix was administered. Pt received Hep B dose early. After medication error identified, parent notification made to patient's mother. Per parent, at time of notification 11/8/2023 @ 1844, child was not exhibiting and adverse reactions. Follow up by parent with clinic.
Headache, Myalgia, low grade temp 100.1, malaise Narrative:
Redness around site of injection around 1 inch diameter. Pustule at site of needle entry aprrox. 3/8 inches in diameter.
Patient exhibits rash on inside of R arm after receiving 1st dose Pfizer vaccine in R deltoid. Patient also notes "dry throat". At 0953, RN administered 25mg oral liquid benadryl. 2nd dose 25mg benadryl liquid oral administered at 1015am. Patient rash diminished. Patient states "feeling great" and ready to go home after benadryl administration. Patient instructed to stay hydrated.
fatigue (started about 6 hours after shot, lasted for about 2-3 days), dizziness (started about 6 hours after shot, lasted for about 3 days), heart palpitations (experienced it for 2 nights starting on second night after shot, lasting for a few minutes), sore arm (started about 4 hours after shot, lasted 4 days)
chills; headache; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills) and HEADACHE (headache) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history was provided).    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced CHILLS (chills) and HEADACHE (headache). On 20-Jan-2021, CHILLS (chills) and HEADACHE (headache) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jan-2021: No specific follow-up information recorded.