chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Received flu shot on 10/22/15 became diaphoretic and dizzy. B/P 130/42 AP 60 at 3:46 pm. Then 118/82 AP 60 at 4:10 pm. Sent home via taxi. Called that eve, had vomited. Called again that eve and next AM - back to work no problems.
This spontaneous case reported by a consumer, describes the occurrence of pyrexia (temperature of about 101ºF) and inappropriate schedule of product administration (2nd dose sooner than 26 days) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 045A2A and 038B21A) for COVID-19 immunization. No medical history reported. On Mar 19, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient had pyrexia (temperature of about 101ºF) and inappropriate schedule of product administration (2nd dose sooner than 26 days). At the time of the report, pyrexia (temperature of about 101ºF) and inappropriate schedule of product administration (2nd dose sooner than 26 days) outcome: unknown/not provided. Diagnostic results: On an unknown date, high body temperature: of about 101ºF after the 2nd dose. Action taken with mRNA-1273 in response to the events: not applicable. Concomitant product use and treatment information not provided.
ON 01/28/00 this pt received on dose of vax. On 02/13, she experienced a diffuse varicella-like rash with 8-10 lesions on her arms, neck and back. The pt sought unspecified medical treatment. After 5 days she recovered.
Hospital admission dx: cultured Staph Peritonsillar abscess positive monospot, highest temp 101.8;
Exposed 05Oct. Symptomatic 07Oct. Headache/body ache/mild fever/ low energy/cold symptoms. Positive home test 08Oct.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 03Oct2023 as dose 1, single (Lot number: HG4680) at the age of 66 years, in right arm for covid-19 immunisation; for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: COVID-19 (non-serious) with onset 07Oct2023, outcome "unknown", described as "Exposed 05Oct. Symptomatic 07Oct. Headache/body ache/mild fever/ low energy/cold symptoms. Positive home test 08Oct.". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of covid-19. Additional information: Exposed 05Oct. Symptomatic 07Oct. Headache/body ache/mild fever/ low energy/cold symptoms.Positive home test 08Oct.   The information on the batch/lot number for bnt162b2 omi xbb.1.5  has been requested and will be submitted if and when received.
4 yo male developed fluid-filled blister (0.2-1.0mm) at vaccination site (LA) on day 3. Blisters evolved to crater-like, scabbed lesions on day 5 and healed within 10 days. Otherwise well
Hidradenitis Suppurativa that has been stable/large flare up on R. buttock and 1 smaller on R. thigh; Hidradenitis Suppurativa that has been stable/large flare up on R. buttock and 1 smaller on R. thigh; This is a spontaneous report from a contactable nurse (patient).  A 55-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number: not provided), via an unspecified route of administration on the left arm on 26Dec2020 03:00 at SINGLE DOSE for COVID-19 immunization.  Medical history included ongoing Hidradenitis Suppurativa has been stable, gastrooesophageal reflux disease (GERD),  and morbid obesity. The patient also had penicillin (PCN) allergy. Concomitant medications included omeprazole (OMEPRAZOLE), losartan (LOSARTAN), and cetirizine hydrochloride (ZYRTEC). The patient reported that she was diagnosed with hidradenitis suppurativa that has been stable then on 03Jan2021 09:00 (approximately 1 week after receiving the vaccine), she had a large flare up on right buttock and 1 smaller on right thigh. The events required doctor or other healthcare professional office/clinic visit and was treated with Doxycycline 100mg BID. Outcome of the event was not recovered.   Information on the lot/batch number has been requested.
Second dose of COVID 19 vaccine Pfizer 301458A allergic reaction. Injection site hot to the touch, itchy, inflammation and red. Felt weak for a couple of days. I been having chest pain for a couple of months now after the injection and was referred to cardiologist. I had no issue before the vaccine with my heart. I have three abnormal EKGs, X-ray showing slightly enlarged heart, blood work with elevated levels. I am scheduled to do an ECO exam and stress test.
severe nausea, chills, fever, muscle aches - lasting 2 1/2 days
day of fever; felt tired; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced fever and tiredness. On an unknown date, the outcome of the fever and tiredness were recovered/resolved.   It was unknown if the reporter considered the fever and tiredness to be related to Shingles vaccine.    Additional Information: GSK Receipt Date: 08-OCT-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient had a day of fever and felt tired after the shingles vaccine.  The patient stated that, minor compared to the agony described. Additional Supportive Information: The follow up would not possible as no contact details were available.
Cellulitis at injection site. Gotten worse. 1/11/21 measured site. 70x80mm. Itching around site.
Rash lasted three days.  Less than 50 pox. No fever. No complicationis. No meds given.
LITTLE BRUISES TO LEFT HAND AND ARM UNDER THE SKIN; TINGLING UP LEG TO THE KNEE LIKE PINS AND NEEDLES/TINGLING ALL UP AND DOWN LEFT LEG; HURTS AFTER A MINUTE OR TWO OF WALKING OR STANDING/IT ONLY HURT WHEN PUT PRESSURE ON LEG; HARD TO SLEEP AT NIGHT; PAIN IS BELOW KNEE ABOUT 3/4 OF WAY DOWN TO THE ANKLE, NOT QUITE ABLE TO PINPOINT EXACT LOCATION; PAIN IN LEFT THIGH; LOWER LEFT LEG PAIN; NERVE PAIN IN LEG ALL ON LEFT SIDE; LEFT HIP BECAME SORE; CYST IN LEFT ARMPIT; This spontaneous report received from a patient concerned a 64 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no related medical history. patient feels normal, super good and fine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, and batch number: 201A21A expiry: 07-AUG-2021) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 10-APR-2021, the subject experienced cyst in left armpit. On MAY-2021, the subject experienced left hip became sore. On 25-MAY-2021, the subject experienced nerve pain in leg all on left side. On 25-MAY-2021, the subject experienced lower left leg pain. On an unspecified date, the subject experienced little bruises to left hand and arm under the skin, tingling up leg to the knee like pins and needles/tingling all up and down left leg, hurts after a minute or two of walking or standing/it only hurt when put pressure on leg, hard to sleep at night, pain is below knee about 3/4 of way down to the ankle, not quite able to pinpoint exact location, and pain in left thigh. Treatment medications (dates unspecified) included: acetylsalicylic acid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from cyst in left armpit on 14-APR-2021, and little bruises to left hand and arm under the skin, pain in left thigh, and left hip became sore, had not recovered from nerve pain in leg all on left side, and lower left leg pain, and the outcome of hard to sleep at night, tingling up leg to the knee like pins and needles/tingling all up and down left leg, hurts after a minute or two of walking or standing/it only hurt when put pressure on leg and pain is below knee about 3/4 of way down to the ankle, not quite able to pinpoint exact location was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comments not required as per standard procedure as the case is considered non serious.
Immediately after receiving DTaP, IPV,and Varicella at 10:45am, patient stiffened up, her arms flexed and her eyes rolled back and became glazed. Layed her down and took vitals BP 120/70, AP 84, R 16.  Patient very scared and cried a little. When asked if she had eaten anything yet, mom replied that she had not. Gave patient juice to drink. Patient stood up after about 10 minutes and walked out with her mother. Called and spoke with parent at 4:30pm. Patient has been fine at home today. Running and playing as usual.
Information has been received from a nurse practitioner concerning an 18 year old female patient who on unknown dates was vaccinated with the three doses GARDASIL (route and lot numbers not provided). It was reported that the patient received GARDASIL series at another physician's office. The patient did not know where she received the vaccinations. On 19-APR-2010 the patient experienced "vulvar carcinoma in situ" after getting all three doses of GARDASIL. The patient's vulvar carcinoma was confirmed upon biopsy. The patient was diagnosed positive for HPV "high risk genotype cervical". The patient was scheduled for a Pap test. The patient was referred to a Cancer Center. The patient's outcome was unknown at the time of reporting. The patient sought unspecified medical attention. Upon internal review, vulvar carcinoma in situ was considered to be an other important medical event. Additional information has been requested.
After 30 minutes observation patient left clinic at 2pm.   Patient return to clinic at 2:20pm  complaining of numbness, tingling in the mouth, and slurred speech.  Patient called PcP.  Per PcP if it does not resolve to got to Emergency Room.  Vitals BP: 122/62,  O2 sat: 99.  Benadryl 25mg p.o was given at 2:30pm.  Patient stated she felt better within 5 minutes.  Patient remain at clinic for approximately an 1 hour and half, patient stated she still felt the numbness/tingling and its not getting worst.    Suggest patient to go to Emergency Room, patient refused and stated she'll contact her PcP again and if it gets worst she'll go to urgent care.
Pruritus and hives, persisting for >24 hours following vaccine administration. Resolves with Benadryl. No anaphylaxis.
This spontaneous report was received from a consumer (patient's mother) reporting on her 12 month old son. The patient's pertinent medical history, drug allergies and concomitant medications were not reported. On 19-JAN-2016, the patient was vaccinated with VARIVAX (Merck) in the right leg. On the same day the physician accidentally administered PROQUAD (Merck) in the left leg. The reporter stated that "because the physician administered a high dosage of varicella, her son had a severe adverse reaction". On 25-JAN-2016, the patient started to develop a high fever. On 30-JAN-2016, the reporter took her son to the physician's office. Once they were at the physician's office, the patient's fever became worse and then he was rushed to hospital. The patient had a fever of 107 degrees and had developed chicken pox as well. She stated that he was "highly contagious". The patient was on the antibiotic (CEFDINIR), for two weeks. The patient came home from the hospital on 03-FEB-2016. He has recovered from the fever, but he still has "bumps on his legs" from the chicken pox (recovering). The reporter did not provide the relatedness of the events with VARIVAX (Merck) and PROQUAD (Merck). Additional information has been requested
For two weeks-Low grade fever, vomiting, nausea, headache, body aches, chills. 04/19/21 -Flu test, Strep Test, Covid Test, Prescribed Ala-Hist  04/21/21 Health Clinic-Covid test, bloodwork 04/21/21 Hospital Emergency Department - IV Fluids, Zofran, Tylenol and Ibuprofen , discharged with zofran rx
L arm pain with intermittent numbness and tingling for at least 1 week after inj. Ibuprofen 600mg TID with food x 2 weeks, ice.
very weak; generally unwell; her arm finally quit hurting today from her injection; nausea; dehydrated; throwing up; sick; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 71 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 05Mar2021 12:15 (Lot number: EN6198) at the age of 71 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "heart condition" (unspecified if ongoing); "Blood pressure high", start date: 2000 (unspecified if ongoing), notes: She says that the high blood pressure was diagnosed 15-20 years ago, let's say in 2000,. The patient took concomitant medications. The following information was reported: VOMITING (non-serious) with onset 05Mar2021, outcome "unknown", described as "throwing up"; ILLNESS (non-serious) with onset 05Mar2021, outcome "unknown", described as "sick"; ASTHENIA (non-serious), outcome "unknown", described as "very weak"; MALAISE (non-serious), outcome "unknown", described as "generally unwell"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "her arm finally quit hurting today from her injection"; NAUSEA (non-serious), outcome "unknown", described as "nausea"; DEHYDRATION (non-serious), outcome "unknown", described as "dehydrated". Therapeutic measures were not taken as a result of vomiting, malaise, nausea.  Additional information: She says she had her first shot at noon on Friday, and it is now Wednesday and she has been sick and throwing up and was very weak. She says she has been generally unwell since it all happened. She says the first vaccine is in her system and it is almost time to get her second dose which is scheduled for the 27Mar2021. She says that her arm finally quit hurting today from her injection. She says that her feeling sick and throwing up started the day she got her injection, two hours after. She says she did no treatment for throwing up, she just threw up one time that day, then a couple days she had nausea and then she threw up again yesterday twice. She says that she had thought it would have gone away by yesterday. Patient have not had any other recent vaccinations or started any new medications. She says she has been on some medications for years but has started nothing new. No further information provided about her medications. She cannot take unspecified steroids, and that she has a heart condition, high blood pressure. Caller says she doesn't want to take the vaccine again if this might happen again or is just the tip of the iceberg, as was beginning to get dehydrated, and she wonder if this immunization was going to work at all without her second shot, but everyone she asks, no one knows anything. Reporter seriousness for sickness, throwing up, weakness and arm was hurting were unspecified.   No follow-up attempts are possible. No further information is expected.
Information has been received from a nurse concerning an unspecified number of unspecified patients of unknown age and gender. No current or historical conditions were reported. On unspecified dates, the patients were vaccinated with improperly stored doses of VAQTA (route, dose, Lot# and expiration date were not reported). No adverse effects were experiences. This is one of several reports received from the same reporter. Additional information is not expected as the reporter was not allowed to be contacted.
Immediate erythema surrounding varicella injection site (appropriately 4" in diameter). (+) painful, swollen area marked-BENEDRYL given and iced region with some improvement in office. Child observed for 30 mins. Mom called about 2 hours later with concern of facial swelling, no resp sx's and swelling self resolved.
COVID 19 Treatment; COVID 19 Treatment; vaccine brand other=Moderna; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Feb2021 at 16:00 as dose 1, single (Batch/Lot number: unknown), in left arm, on 09Mar2021 at 11:00 as dose 2, single (Batch/Lot number: unknown), in left arm and on 30Sep2021 at 10:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 63 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 09Apr2022 at 10:00 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm and on 23Sep2022 at 11:00 as dose 5 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Obesity" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE, start date: Jul2015. Past drug history included: Amoxicillin, reaction(s): "Known allergies: amoxicillin", notes: Known allergies: amoxicillin. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 09Apr2022 at 10:00, outcome "not recovered", described as "vaccine brand other=Moderna"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19; Negative, notes: after receiving a negative  home test on Day 10. Therapeutic measures were taken as a result of vaccination failure, covid-19, interchange of vaccine products.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This case was reported by a pharmacist via sales rep and described the occurrence of welts in a patient who received SHINGRIX. In March 2018, the patient received the 1st dose of SHINGRIX. In March 2018, immediately after receiving SHINGRIX, the patient experienced welts. The patient was treated with ibuprofen. On an unknown date, the outcome of the welts was unknown. It was unknown if the reporter considered the welts to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX dose about 2 days ago before the time of reporting and developed a whelp on the arm almost immediately after the dose of the vaccine. The patient was treated with ice and ibuprofen. This case has been linked with case US2018GSK047411, reported by the same reporter.
This spontaneous report as received from a pharmacist refers to several women, all over 60 years old female patients. On an unknown date, the patients was vaccinated with PNEUMOVAX23 (lot # J004196, Expiration Date: 06-DEC-2014) injection intramuscular. Concomitant medication was unspecified by the reporter. It was reported that the patients experienced same type of reaction to the PNEUMOVAX23 injection. The reported that on an unknown date each patients suffered the following reaction: entire arm from elbow to injection site was red and they felt absolutely terrible on an unspecified date. No treatment was given. Patient sought medical attention and one/ more patients went to pharmacy. No Product quality complaint. It was unclear if any of the patients
Injection site became a red swollen knot that was warm to the touch for 5-6 days.  Days 2-3 were also characterized by fatigue/flu-like symptoms.  After 5-6 days the red knot transitioned to a red rash that covered majority of the upper arm.  The rash was warm to the touch and extremely itchy.
Headache, Myalgia, Fever, arm soreness, chills Narrative:  Pt experienced arm soreness, chills, fever, headache, mayalgia on day after covid vaccine admin. Pt self treated with acetaminophen 650mg oral.
Pt is 27 yo female who is 7 months pregnant as of 7/23. She is s/p full Pfizer COVID-19 vaccination: first dose 4/16, second dose 5/7. On 7/22 reports sore throat and congestion/runny nose. Voluntary COVID-19 testing results back positive on 7/22.
Vaccine given at approximately 1300. At 1330 pt reported itchiness at injection site, 1335 itchy hair going down back, arm rash and chest tightness. 1338 Epi given in left thigh. 1345 Relief of chest tightness verbalized. O2 saturations: 95% and and pulse 85. Recommended pt. to go to ED via ambulance. Pt declined due to large copay for ambulance ride. RN, called report ED who later stated pt. arrived.
Information has been received from a pharmacist concerning a greater than 70 year old female who on 11-JUN-2008, "last summer", was vaccinated with the first dose of ZOSTER vaccine live (Merck) (lot # 658844/0204X).  On approximately 10-APR=2009, "within the last 10 days", the patient developed shingles.  No details about the shingles were known except the rash was still present.  The patient had not recovered at this time.  The patient saw the physician and sought unspecified medical attention.  Additional information has been requested.
Client was unaware of pregnancy at time of vaccination. Client was ~7 weeks gestation according to EDD.
This case was reported by a other health professional via sales rep and described the occurrence of redness in a 4-year-old female patient who received KINRIX (batch number A73C4, expiry date 29th March 2019). Concomitant products included PROQUAD. On 19th April 2017, the patient received the 1st dose of KINRIX (intramuscular) .5 ml. In April 2017, less than a week after receiving KINRIX, the patient experienced swelling arm, injection site vesicles and skin breakdown. On 20th April 2017, the patient experienced redness. On an unknown date, the outcome of the redness, swelling arm, injection site vesicles and skin breakdown were not recovered/not resolved. It was unknown if the reporter considered the redness, swelling arm, injection site vesicles and skin breakdown to be related to KINRIX. Additional details were provided as follows: It was reported that the patient's birth weight was 3.820g. At 14:05 hours, the patient received a dose of KINRIX in left deltoid. On 19th April 2017, the patient received a dose of PROQUAD (batch number: M032497, expiry date: 2nd January 2018) on left arm. The healthcare provider reported to the sales representative that the patient developed redness in the left arm 1 day after the vaccine was administered. It was also reported that the patient had redness and swelling of the whole arm most around injection side. Multiple vesicles developed around injection site and skin breakdown occurred about a dime size.