chrisvoncsefalvay/vaers-outcomes huggingface dataset:
HIB and Prevnar injection to right thigh 12/27/02. Low grade temperature, warm, red 3-4cm area on thigh. Also with red/confluent papular/urticarial rash all over red hands/feet; a bit puffy. Irritable child.
Body ache; Redness; Swelling; hard time breathing/shortness of breath/Difficulty breathing; This is a spontaneous report from a Pfizer Sponsored Program. A contactable consumer reported that a female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date unspecified), via an unspecified route of administration on 22Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that her mother took the first dose of vaccine last Friday 22Jan2021, and was now experiencing side effects, she was having a hard time breathing, body aches, swelling and redness in Jan2021. Reporter also mentioned that the patient was having shortness of breath and she was having difficulty breathing. The consumer wanted to know how long the side effects were expected to last and if they can worsen as the days go on. Because the patient had it on Friday, and it's already been almost 48 hours. Reporter stated that she needs to get off the phone because she need to call her mother's doctor's office and have to call the EMS for her. Outcome of events was unknown.  Information on the lot/batch number has been requested.
Pt began developing numbness in feet, problem progressed to increased weakness, decreased sensation lower half of body; eventual paralysis; diagnosed w/GBS on 21NOV93;
This spontaneous report as received from a 54 year old female consumer with acetaminophen allergy and no pertinent medical history reporting on herself who on 07-NOV-2014 was vaccinated with a second dose of RECOMBIVAX HB (dose, lot #, expiration date and route were not reported). There was no concomitant medication. On 08-NOV-2014, reported as the very next morning after receiving the vaccine she woke up and lost her balance. Her legs "gave out" but she did not fall. These events lasted for about a month on approximately December 2014. Also the patient said that the symptoms started changing and she had aches and pains, stiffness in the back, cramps in the stomach, a "welt" or "hive" located on the inside of her thigh. She also mentioned difficulty moving when she would be siting for a while and attempts to get up she would experience a "challenge" at doing so. She also stated that "one part of her stomach is numb" and there was pain right beneath her breast and above her stomach, almost as if was swollen and mentioned that the pain got worse after she ate and drunk. She also experienced "tingles" in her legs and her legs went "numb" as well. No treatment was given for the adverse events. No laboratories diagnostic tests were performed. The patient sought medical attention saw a doctor. The outcome of lost her balance, welt or hive was located on the inside of her thigh, cramps in the stomach, stiffness in the back, she had aches and pains and her legs "gave out" was reported as recovered/resolved. The outcome of difficulty moving when she would be sitting for a while and attempts to get up  she would experience a "challenge", legs go numb and she experienced tingles in her legs was unknown. The outcome of one of stomach is numb and pain right beneath her breast and above her stomach almost as if something is swollen was reported as not recovered/not resolved. Additional information has been requested.
Patient presented to pharmacy with hives and red spots located on left forearm of recently administered vaccination. Patient reports red spots and itching began at approximately noon the day after vaccination. Recommendation of BENADRYL for hives and itching. Given instructions to contact pharmacy if hives spread further out.
This spontaneous report as received from a pharmacist refers to a male patient of unknown age. Patient's pertinent medical history and drug reactions/allergies were reported as none. His concomitant medications were reported as unspecified medications. On 27-JUL-2016, the patient was vaccinated with PNEUMOVAX 23 (dose 0.5 ml/one dose, route intramuscular in the left deltoid, lot #L040181 and expiry date 18-AUG-2017) for the indication of "on protocol". On the same day evening (also reported as Wednesday), the patient's arm became swollen, itchy, red and warm to touch so the patient applied hydrocortisone cream on the affected area (the area affected was unspecified). On Thursday, the patient's symptoms did not subside so he iced the area and applied Aloe Vera. On 29-JUL-2016 (also reported as today), the patient developed a mild fever and called the pharmacist. The pharmacist stated "the injection site looked fine but the elbow was still swollen". Pharmacist recommended the patient to take TYLENOL to treat his fever. No lab diagnostic tests were performed. The outcome of the events were reported as not recovered. Causality assessment was not provided. No product quality complaint was involved. Additional information has been requested.
fever (briefly) headache (several hours) very sore arm (left, all day, increasingly painful over time)
After 30 minutes of administration of injection my symptoms were headache, light headness, sore arm and throat felt very scratchy and felt like my throat was closing up. The symptoms lasted for two days.  5 days after injection I woke up with shooting pain, numbness, tingling  from waist down down to my toes. I continue to have these symptoms that I cannot rest even at night. Lastly, I have had occurrences of scratchy throat as I have to clear my throat as if my throat is closing up.
bilateral pruritic highly erythematous papular rash primarily on dorsum of hands with smaller areas on arms and neck.  no breathing difficulty or lip swelling.  Given topical triamcinolone along with claritin/benadryl.
it makes me sick; Initial information received on 19-Oct-2023 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-healthcare professional.  This case involves an unknown age and unknown gender patient who reported it makes me sick for  influenza vaccine.  It is unknown if the patient had any medical history, concomitant disease or risk factor. The patient's past medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received influenza vaccine produced by unknown manufacturer via unknown route in unknown administration site for prophylactic vaccination (strength, formulation, dose, batch number and expiry date: unknown). Information on the batch number was requested  On an unknown date the patient reported it makes me sick (illness) (unknown latency).  It is unknown if there were lab data/results available  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event   At time of reporting, the outcome was Unknown for the event
This spontaneous report was received from a physician referring to an unknown number of patients of unknown gender and age. Pertinent medical history or concurrent conditions were not reported. Since 30-MAY-2017 (also reported as since 10-APR-2017), the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB which had the lot # reported as N00236, expiration date 24-OCT-2019, lot # N000235, expiration date 26-OCT-2019, lot # N003536, expiration date 02-NOV-2019, for prophylaxis (dosage information and route were not informed). Information regarding concomitant medication was not provided. Additionally, it was reported that the lowest temperature was 32° degrees Fahrenheit and the highest was 54° degrees Fahrenheit  or 49 hours. Data logger was not involved. No adverse effects were reported. There was no product quality complaint involved. This is one case from several cases from the same reporter. Follow-up information has been received from a physician on 16-OCT-2017 to an unknown number of patients of unknown gender and age. The patients' concomitant medications, pertinent medical history, drug reactions or allergies were not reported. Since 29-APR-2017 (also reported as since 10-APR-2017), the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB (lot # M046140, expiration date 27-SEP-2019, dosage information and route were not provided) for prophylaxis. Additionally, it was reported that the lowest temperature was 47° degrees Fahrenheit and the highest was 49° degrees Fahrenheit for 16 hours. Data logger was not involved. No adverse effects were reported. There was no product quality complaint involved. Follow up information was received from the physician on 27-OCT-2017. This report refers to 3 month old patient. On 19-JUN-2017, the patient was vaccinated with vaccinated with improperly stored doses of LIQUID PEDVAXHIB lot# N000235 with expiration date: 24-OCT-2019. This is one case from several cases from the same reporter.; Sender's Comments: US-009507513-1709USA012770: US-009507513-1709USA012767: US-009507513-1709USA012768: US-009507513-1709USA012769: US-009507513-1709USA012765:  US-009507513-1709USA012764: US-009507513-1709USA007325: US-009507513-1709USA012766:
Pt. received an injection of Tetanus Toxoid Adsorbed, Ultrafined on 08/16/1999 and subsequently developed a headache and a slight fever.  These resolved.  Pt then developed a lump at the injection site. On 09/14/1999 pt developed an oval lump at the injection site.  Approximately 7 mL of purulent fluid was drained from the lump on 10/27/1999. Culture of the drainage was positive for Staphylococcal species and normal skin flora.  A diagnosis was made and the pt was treated with Augmentin. As of 12/18/1999 a small lump (smaller than 3 cm) still remained at the injection site.
No additional AE reported; vaccine was improperly stored and administered; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.  On 20-JAN-2021, the patient was vaccinated with improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) 0.5 ml, lot # T011167, expiration date 27-MAY-2022 (dose number, vaccination site and route of administration were not provided) for prophylaxis.  Administered dose of vaccine was exposed to the temperature excursions of 35.7 degrees Fahrenheit for 1 hour and 30 minutes on 27-OCT-2020 and 30.2 degrees Fahrenheit for 1 hour and 30 minutes on 28-OCT-2020. There was a previous temperature excursion, 64.36 degrees Fahrenheit for 3 hours on 14-OCT-2020. Digital Data Logger was involved. No additional adverse events were reported.
Administered Prevnar and HIB on 9/7/01. Pt was restless with a low-grade temperature that evening and a high-grade temperature in the morning at 11:30 on 9/8/01. Pt had difficulty breathing and went to ER. Was treated with IM steroid and mist treatment.
This is a spontaneous report from a non-contactable pharmacist. A 38-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via intramuscular route of administration in the right arm on 12Apr2021 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19.  The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On an unknown date  in 2021, the patient experienced headache. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department, or urgent care. Therapeutic measures were taken as a result of the event and included treatment with paracetamol (TYLENOL) 2 times. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The clinical outcome of the event headache was resolved on an unknown date in 2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. NO further information is expected.
GAVE TYLENOL AT HOME 4:00PM.  THIS AM STIFF, DECREASE HEAD MOBILITY, INCREASE SCREAMING, TEMP 104
11/30/01 telephone call from pt saying that she began to get a rash the evening of 11/27/01 the day she got her flu and pneumonia shots. The rash is now all over her body and is itchy. She also reports erythema at the injection site. Has had several flu shots in past without problems. Advised to contact private physician re anti pruritic.
Nodules in arm pit of left arm; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old male 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 05Apr2021 at 15:00 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. The patient medical history was reported as none. The patient allergies to medications, food, or other products were reported as none known. The patient did not receive any other medications within 2 weeks of vaccination. 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 COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. On 09Apr2021, the patient experienced nodules in arm pit of left arm. Therapeutic measures were not taken as a result of the event. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the event nodules in arm pit of left arm was recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Seen 11/8 for 6 mo WCC, rec'd immunes. On 11/8 at 12n at her visit cranky fever 103. Decreased with TYLENOL to 101, slept most of day. Seen in our office 11/9 Dx ROM on antibiotics injection sites clear.
Patient presented to ER with c/o nausea and vomiting, diagnosed with Covid 19. GI symptoms related to Covid-19. Given IVF and antiemetics.
Patient given Covid 19 Pfizer-BioNTech and it was over diluted.  Risk Management notified immediately, Physician notified immediately, facility notified, Pharmacy notified, Family notified and physician educated the patient that after speaking to staff that it was recommended that the patient be revaccinated.
Information has been received from a health professional concerning a 73 year old white female, who on 10/23/00 was vaccinated in the left arm with a dose of Pneumococcal vaccine 23 polyvalent. It was noted that the pt had received the influenza virus vaccine "many times in the past". On 10/26/00, the pt experienced left arm pain, elbow warmth and swelling, headache and fever. It was indicated that the pt possibly developed cellulitis. The pt was prescribed 500mg TID of Keflex. The pt subsequently recovered. The reporter indicated that the pt's experiences were considered to be  "Important Medial Events". Two additional pts had a similar experience following exposure to pneumococcal vaccine 23 polyvalent lot 1531J. No further information is available.
Received vaccine on 2/9/12, and presented to clinic on 2/20/12 with c/o noting a "feeling" in right arm & shoulder beginning 2/18/12, shoulder droop noted 2/19/12. Returned to orthopedic & treated with steroids & NSAIDS.
The evening after vaccination was given my daugter had flu like symptoms. Muscle pain fatigue and headache she missed several days of school. She still to this day has muscle pain, joint pain, dizziness, severe migraines, fatigue, insomnia, acid reflux, night sweats, itchy all over and stomach pain. She has been to the dr several times and has missed a lot of school.
After vaccines given in office pt later developed SubJ fevers that subsided 10/28 AM responded well to tylenol. Sx' resolved
We're now at 49 days after receiving 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (We're now at 49 days after receiving 1st dose) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     The patient's past medical history included Knee replacement. Concomitant products included IBUPROFEN for Knee replacement.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jan-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (We're now at 49 days after receiving 1st dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (We're now at 49 days after receiving 1st dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Treatment information for the event was provided. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 08-Mar-2021 and was forwarded to Moderna on 09-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (We're now at 49 days after receiving 1st dose) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     The patient's past medical history included Knee replacement. Concomitant products included IBUPROFEN for Knee replacement.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jan-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (We're now at 49 days after receiving 1st dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (We're now at 49 days after receiving 1st dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Treatment information for the event was provided.
Full body rash/hives, high fever, lethargic, no appetite, weak, chills, lasting for 2 weeks.
Patient returned for there second dose and when stated that when he arrived home from his 1st vaccine he had 2 seizures that his wife witnessed and 1 while he was alone. Patient did not report the reaction to anyone at the office or the via the VSafe app. The provider was consulted and 2nd dose was not given. Patient is to follow up with his PCP as he does not have a history of seizures.
Patient felt unwell on 09/07/2021; chills, cough, mild flu, illness was persistent and he sought medical treatment on 09/09/2021 and was diagnosed with COVID and referred for monoclonal antibody treatment on 09/12/2021.
TINGLING OF LIPS WITHIN 24 HOURS AND THEN SWOLLEN UPPER AND BOTTOM LIPS.
I started develop symptoms on 8/5/2021, with scratchy throat & other symptoms & I went to take a Covid test. I went on a bike ride a couple days after I thought I felt fine & then as I was riding, I ended up falling a cliff. Once I couldn't even make it because my body was so sore. I went to bed & woke up in a pool of sweat & had 103 degree fever. I ended losing 10 pounds in about 2 weeks. I was never in any danger & did not need to go to the hospital. Right after that I had caught shingles, but it was mild.
On 21 Mar 11 red swollen area around injection site. Redness spread to torso (front). Painful at injection site.
This spontaneous case, initially received on 26-Oct-2018, reported by other healthcare professional (nurse) concerns 6-year-old, child female patient. The patient had no relevant medical history. The patient was not taking any concomitant medication at the time of vaccination. On 26-Oct-2018, the patient was administered expired vaccine FLUCELVAX QIVc [dose: 0.5 ml, route of administration: intramuscular, anatomical location: left thigh, batch number: 195245 and expiry date: 18-Jun-2018]. At the time of this report, no adverse event was reported after the vaccine administration. The reporter assessed this case as non-serious.
Swollen has and red arm from just above right shoulder to just below elbow for one week.
t 1510 client received Moderna Covid-19 vaccination. At 1512 client reports syncope. Client is clammy to touch, pale, and reports blurred/loss of vision. Adverse reaction protocol initiated. EMS called at1513 and arrives on site at 1521. Vital taken prior to EMS arrival are as follows: 1. 1514 BP 120/70, R 16, P 68. 2. 1519 BP 110/68 R 16 P 72. Client reports not eating prior to vaccination. Client given drink and consumes entire beverage within about 5 minutes. Client also consumes a pack of cheese crackers and two bottles of water. Client refused epinephrine, benadryl, and EMS transport to hospital. Client reports feeling better and being very nervous about needles. Client reports feeling fine.
Severe dizziness, could noy sit had to lie down. Followed by severe abdominal pain in few min 7-10 mis. Then paramedics came, was very nauseated too.
Urticaria onset Day 4 generalized upper extremities and face; Pfizer COVID vaccine (01Oct2022 11:00) administered with Influenza vaccine (01Oct2022); Pfizer COVID vaccine (01Oct2022 11:00) administered with Influenza vaccine (01Oct2022); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01Oct2022 at 11:00 as dose 5 (booster), single (Lot number: GH9693) at the age of 61 years, in left arm for covid-19 immunisation; influenza vaccine (INFLUENZA), on 01Oct2022 as single dose (Batch/Lot number: unknown), in right arm for immunisation. The patient's relevant medical history included: "Known Allergies: Penicillin" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Primary series of immunization completed, Manufacturer Unknown), for Covid-19 Immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE), for Covid-19 Immunization; Covid-19 vaccine (DOSE 4 (BOOSTER), SINGLE), for Covid-19 Immunization. The following information was reported: OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 01Oct2022, outcome "unknown" and all described as "Pfizer COVID vaccine (01Oct2022 11:00) administered with Influenza vaccine (01Oct2022)"; URTICARIA (non-serious) with onset 05Oct2022 at 18:00, outcome "recovered" (Oct2022), described as "Urticaria onset Day 4 generalized upper extremities and face". Therapeutic measures were taken as a result of urticaria. Additional information: Treatment for urticaria included unspecified antihistamines. The patient has no covid prior to vaccination. The patient was not covid tested post vaccination.  No follow-up attempts are possible. No further information is expected.
Information has been received from a medical assistant referring to unspecified number of patients of unknown age and gender. On unspecified dates, the patients were administered improperly stored M-M-R II lot # L043704 with expiration date of 04-NOV-2017; strength, dosage, frequency and route unspecified for prophylaxis which was reconstituted with sterile diluent. Sterile diluent was not involved in the temperature excursion. No adverse effects were reported. Temperature was from 9 to 25 degree C (11.3 degree C) for 2 hours (refrigerated vaccine). On 14-APR-2017, there was a previous excursion with temperature from 9 to 25 degree (9.7 degree C) for 30 minutes. This is one of 4 cases received from the same reporter. Sender's Comments: US-009507513-1709USA001898: US-009507513-1709USA001897: US-009507513-1708USA003787.
Pt given FLUVIRIN vaccination on 11/05/2008. Started with symptoms of anaphylaxis immediately (within 5 mins.): swelling at site, hives, confusion, dizziness. Did not have reactive airway symptoms. Epil: 1000 1mL injections SQ x1 in clinic, 911 initiated Pt transferred to ER where tx was continued.