chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Swelling at injection site; felt like skin on fire; tired; dizzy; muscle pain from shoulder to wrist; brain fog; no appetite; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14May2022 at 11:15 as dose 4 (booster), single (Lot number: FM9992) at the age of 70 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Fibromyalgia" (unspecified if ongoing); "High Blood Pressure" (unspecified if ongoing). Concomitant medication(s) included: METOPROLOL; TARTRATE DE PENTOLONIUM; ESTRADIOL. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: EN6208, Location of injection: Arm Left), administration date: 16Mar2021, when the patient was 69-year-old, for Covid-19 immunization; BNT162b2 (Dose Number: 2, Batch/Lot No: EW0151, Location of injection: Arm Left), administration date: 06Apr2021, when the patient was 69-year-old, for Covid-19 immunization; BNT162b2 (Dose Number: 3, Batch/Lot No: FH8028, Location of injection: Arm Left), administration date: 15Nov2021, when the patient was 69-year-old, for Covid-19 immunization. The following information was reported: INJECTION SITE SWELLING (non-serious) with onset 15May2022 at 07:00, outcome "recovering", described as "Swelling at injection site"; FEELING ABNORMAL (non-serious) with onset 15May2022 at 07:00, outcome "recovering", described as "brain fog"; DIZZINESS (non-serious) with onset 15May2022 at 07:00, outcome "recovering", described as "dizzy"; SKIN WARM (non-serious) with onset 15May2022 at 07:00, outcome "recovering", described as "felt like skin on fire"; MYALGIA (non-serious) with onset 15May2022 at 07:00, outcome "recovering", described as "muscle pain from shoulder to wrist"; DECREASED APPETITE (non-serious) with onset 15May2022 at 07:00, outcome "recovering", described as "no appetite"; FATIGUE (non-serious) with onset 15May2022 at 07:00, outcome "recovering", described as "tired". Therapeutic measures were not taken as a result of injection site swelling, skin warm, fatigue, dizziness, myalgia, feeling abnormal, decreased appetite.  Additional information: Age group: Adult (18-64 Years). Facility type vaccine: Pharmacy or Drug Store. No other vaccine in four weeks. Other vaccine in two weeks were metoprolol, tartrate, estradiol. Adverse event: Swelling at injection site, about 3" in diameter, bright red in color, hot to touch pain in all joints, felt like skin on fire, tired, dizzy, brain fog, muscle pain from shoulder to wrist, no appetite. No covid prior vaccination. Covid was not tested post vaccination. No known allergies.
Pt had swelling at the injection site that progressed up and down the extremity and into the shoulder. It also swelled the axillae and the lymph nodes in the axillae. Pt complained of pain. Stated that by the time I saw it, the swelling had gone down a little, but it was still visible.
Headache, Myalgia, Arthralgia, Diarrhea, NauseaVomiting, The employee reports experiencing fatigue, body aches, and nausea 24 hours after the vaccine. Next day headache and SOB. Following 3 days diarrhea, worsening fatigue, emesis for 2 days, and no appetite. After one week she is back to work and feels better Narrative:
When i arrived home my stomach start being upset then vomiting began.  I emptied my stomach and then just dry heaves continued for 4 hours.  I was feel rough until around 3:00 am before I actually was able to sleep.
I believe I had Covid 19 in January 2020 and I tested positive in July 2020. After I got this vaccine on 01/20/21, I had got almost all of the symptoms of Covid again that I had:  chills, 100-101 fever,  bad body aches, nausea, vomiting, very tired for 3 days, severe migraine headaches, and very sore left arm.  I had all these symptoms in January and July too. The only thing that I didn?t have was a deep cough and trouble breathing that I also had in January and July.
Patient's caregiver states that he experienced fever to 100.4F ~30 hours after the first vaccination. She reports it was also associated with decreased BP, some increase in confusion, and 1x episode of diarrhea. She provided him fluids and administered acetaminophen with resolution of all sx in about 6x hours.
Painful hands--couldn't make fist, cut vegetables, open jars. Used a ball to exercise hands. Kept getting worse. Difficulty moving--getting out of bed, getting up and down from sitting position, getting dressed, bathing. Steroids helped but couldn't be on too long.
Rebound Covid symptoms; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Rebound Covid symptoms) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Niaspan). Concomitant products included PREDNISONE, SALBUTAMOL (VENTOLIN [SALBUTAMOL]), BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT) and IPRATROPIUM BROMIDE, SALBUTAMOL SULFATE (COMBIVENT RESPIMAT) for an unknown indication.    On 16-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-May-2022, the patient experienced COVID-19 (Rebound Covid symptoms). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 05-May-2022 to 09-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (Rebound Covid symptoms) was resolving.            It was reported that the patient was taking any other medications/products within 2 weeks of starting COVID-19 treatment.   The device Date reported as 17-May-2022.  Company Comment: This spontaneous case concerns a 41-year-old male patient, with concomitant medications Symbicort and Combivent, who experienced the unexpected AESI of COVID-19. The event occurred approximately 5 months after receiving the third dose of mRNA-1273 Vaccine. The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19, however the patient had Rebound COVID-19 symptoms 7 days after Paxlovid treatment. The outcome of the event was reported as resolving. The patient's treatment with Paxlovid and concomitant medications Symbicort and Combivent, remain as confounders for the occurrence of the event. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 41-year-old male patient, with concomitant medications Symbicort and Combivent, who experienced the unexpected AESI of COVID-19. The event occurred approximately 5 months after receiving the third dose of mRNA-1273 Vaccine. The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19, however the patient had Rebound COVID-19 symptoms 7 days after Paxlovid treatment. The outcome of the event was reported as resolving. The patient's treatment with Paxlovid and concomitant medications Symbicort and Combivent, remain as confounders for the occurrence of the event. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Chills; Moderate fever; Headache; Body(joint) pain; Body(joint) pain; This is a spontaneous report from a contactable consumer, the parent. A 16-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 14Apr2021 at 15:15 (at the age of 16-years-old) as a single dose for COVID-19 immunisation. Other medical history was reported as none. 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 medications within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 24Mar2021 at 15:30 (at the age of 16-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 15Apr2021 at 06:00, the patient experienced chills, moderate fever, headache and body(joint) pain. The events 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 events which included treatment with Tylenol. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events chills, moderate fever, headache and body(joint) pain was recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
pt recvd vax & 8 hrs later exp h/a, weakness, sore arm, backaches, anorexia, redness of eyes;
pt recv vax;recv 2nd dose;2 days later, devel erythematous, raised, migratory rash on back & torso; was seen by MD by 2mar94;had recovered;
Information has been received from a 37 year old female with asthma, hypertension, high cholesterol, allergies to ofloxacin (Floxin), trimethoprim sulfamethoxazole (Septra) and statin meds, generalized allergies, and history of antihistamines being too dry and montelukast sodium (MSD) causing backaches (WAES0502USA02083), who on Oct 29 2004 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. Concomitant therapy included colesevelam hydrochloride (Welchol), benazepril HCL (Lotensin), ranitidine HCL (Zantac), ibuprofen (Advil), budesonide (Rhinocort), fluticasone propionate (Flovent), albuterol, acetaminophen (Tylenol), guaifenesin, and olopatadine hydrochloride (Patanol). Starting 3 days after vaccination, the patient developed a fever, swollen glands, headache, and joint pain. She went to see her physician who prescribed cephalexin (Keflex), and she felt better. After she finished the antibiotic regime, she was feeling those same reactions including headache, swollen gland on the same side as the injection site, stiff neck, joint pain, and a bit feverish. Follow up information from the physician indicated that on Oct 30 2004, the next day after vaccination, the patients left arm was swollen, hot and mottled. Subsequently the patient developed increased lymp nodes in the left axilla and pain in the left axilla. On Nov 01 2005 the patients complete blood cell count was within normal limits. Within last 24 hours, on approximately Nov 02 2004, the patients nodes in her antecubital area and neck area were hurting. During a physical exam on Nov 03 2004 the patient was described as upset and frustrated. The physical exam also showed that she was tender in her left pericervical area  but had no pericervical nodes, that her left antecubical was tender, 1.5 cm of her left axilla area was tender, and her left deltoid area was tender with out redness, fluctuation or heat. On approximately Nov 06 2004 the patient developed a ulcer in her left posterior pharynx and a fever. It was reported that there was no rash or cough and the patients asthma was ok. The patients experience was assesses as reaction to pneumococcal 23v polysaccharide vaccine vs. secondary infection after injection. Treatment included cephalexin (Keflex) 500 tid 7d and diclofenac sodium (Voltaren) 75 bid 20. The patient was to return to the office if not responding. At the time of the report the patients status was unknown. Additional information is not expected.
Caller got first vaccine dec 28th, tested positive jan 4th; Caller got first vaccine dec 28th, tested positive jan 4th; 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, Solution for injection, lot number and expiration date not provided), via an unspecified route of administration on 28Dec2020 at Single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  The patient got first vaccine on 28Dec2020, tested positive 04Jan2021. The patient wanted to know if she needed to wait to get second dose or if she should wait. The outcome of the event was unknown.  Information on lot/batch number has been requested.
MIGRAINE; ACHY FEELING; CHILLS; This spontaneous report received from a patient concerned a 49 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included migraines. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, and expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 10:20 on right arm for prophylactic vaccination. No concomitant medications were reported. On 01-APR-2021, the subject experienced achy feeling. On 01-APR-2021, the subject experienced chills. On 01-APR-2021 12:30, the subject experienced migraine.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from migraine, chills, and achy feeling. This report was non-serious.
pt very irritable during noc @ 2AM 4SEP t103R even w/APAP;mom noted ?twitch across shoulder blades off & on x 1hr when holding pt;mom gave lukewarm tub bath, temp still 103 R & occ twitch;no unresponsiveness;took bottle well;seen by MD;
Triggered a Behcet's outbreak with a flare of mucosal membrane ulcers.
Redness below the site area and soreness with slight swelling. The patient was taken to the ER and referred back to us as we are who administered the immunizations. Mom stated the evening of the shots the patient complained of a headache and the left arm was a little sore. Mom took the patient to the ER for evaluation because there was some redness and soreness noted. She was referred back to us due to us administering the immunizations. Mom let the patient go back to school on 2/8/2019 and when she picked him up he was presenting with redness and mild edema on the left arm below the site area. It was warm to touch. The ER had treated the patient with cool compress and MOTRIN. Due to the area being warm to touch and the edema she was advised to take him to doctor for evaluation.
Information has been received from a physician concerning an approximately 63 year old female who on 28-SEP-2010 was vaccinated with PNEUMOVAX 23 (Lot # not provided, route and injection site not reported). After administered of the vaccine, the patient experienced redness, pain and swelling at the injection site. The patient also experienced swelling of the arm. Outcome of the events were not reported. Follow-up information has been received from a medical assistant concerning the patient who had injection site reactions after vaccination with the same lot number (Lot # 667274/0883Z) of PNEUMOVAX 23. The patient had "severe" reactions consisting of red, hot, painful and swollen arms with the reaction extending from the injection site to elbow. Outcome of the events were not reported. This is one of several reports received from a same source. Additional information has been requested.
patient had a seizure; This is a spontaneous report from a contactable consumer. An unspecified patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number and expiration date were unknown), via an unspecified route of administration, on an unspecified date, as single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient's historical vaccine included the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number and expiration date were unknown), via an unspecified route of administration, on an unspecified date, as single dose, for COVID-19 immunization. On an unknown date, patient had a seizure. Outcome of the event was unknown.   The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Two days after Menactra was given. Pt developed itchy red raised papules, vesicular rash with possible exposure to Iris plant. Doubt this is from Menactra. Claritin 10 daily.
Injection site itchy; Injection site red; Injection site started being swollen again; Injection site a little swollen; Injection site sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Injection site itchy), VACCINATION SITE SWELLING (Injection site a little swollen), VACCINATION SITE PAIN (Injection site sore), VACCINATION SITE ERYTHEMA (Injection site red) and VACCINATION SITE SWELLING (Injection site started being swollen again) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE for an unknown indication.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced VACCINATION SITE SWELLING (Injection site a little swollen) and VACCINATION SITE PAIN (Injection site sore). On 14-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (Injection site itchy), VACCINATION SITE ERYTHEMA (Injection site red) and VACCINATION SITE SWELLING (Injection site started being swollen again). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. On 06-Mar-2021, VACCINATION SITE SWELLING (Injection site a little swollen) and VACCINATION SITE PAIN (Injection site sore) had resolved. At the time of the report, VACCINATION SITE PRURITUS (Injection site itchy), VACCINATION SITE ERYTHEMA (Injection site red) and VACCINATION SITE SWELLING (Injection site started being swollen again) outcome was unknown.            Concomitant medication provided also include hormone replacement patch.  Treatment provided include anti itch-cream.   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Follow up received on 10-May-2021, the details about, De challenge and re challenge results updated
Initial information received on 29-Oct-2018 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. This case involves a female patient of unknown age who was feeling ill, after she received vaccine INFLUENZA VACCINE. The patient's past medical history, medical treatment(s), vaccination(s), family history and concomitant therapy were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (also reported as Fluzone) produced by unknown manufacturer lot number not reported via unknown route in unknown administration site. On an unknown date, the patient was feeling ill within 2 hours following the administration of INFLUENZA VACCINE. Patient was ill for two days and had to stay home. No lab test was reported. Final diagnosis was feeling ill. It was not reported if the patient received a corrective treatment. The patient outcome is reported as recovering for feeling ill.
Received  second Pfizer  shot 5/3/21 in left arm.  Woke up next morning 5/4/21 around 6am with bad case of chills and fever. Temp was 101.7 continued to take IBU's and Tylenol to keep fever down but still didn't feel well.  On 5/5/21 I was still weak and slept a lot but better then the two previous days. Today 5/6/21 I am about 95% better.
Site: Pain at Injection Site-Medium, Systemic: shooting type pain in the arm-Medium, Additional Details: Patient has pain in the arm possible nerve pain
Chills; sweats; aches and pain; Reports she was up all night opening the window and tuning on the heating blanket during the night; This is a spontaneous report from a contactable consumer (patient).  A 67-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number "CJ1685 and 228255" pending clarify), via an unspecified route of administration on 22Dec2020 08:30 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that she got the covid-19 vaccine yesterday (22Dec2020) at 08:30 A.M. Reported that all night long (22Dec2020) she had chills, sweats, aches and pains. She was told that she should be fine by Christmas. She was up all night opening the window and tuning on the heating blanket during the night. She was wrapped in blankets. Patient was advised to contact healthcare professional for treatment recommendations. Patient declined any treatment to the events. Patient also mentioned that her doctor did not want her to get the vaccine. She works as a certified nurse assistant (CNA) in the hospital. For the lot number, NDC number, and expiration date, she provided details from the card she was given for the vaccine. She read first dose COVID-19: "CJ1685 and 228255". She put her glasses on to read the card. The patient she wanted to lay down. The outcome of the event chills, aches and pains was not recovered, for event sweats was recovering, for the rest of event was unknown.
new born received Havrix; received Havrix instead of Engerix; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a neonate patient who received HAV (Havrix) (batch number 95EG7, expiry date 6th February 2023) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 18th March 2022, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 18th March 2022, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details reported were as follows: The age at vaccination was not reported. Medical assistant reported that a new born patient came to the office and received Havrix instead of Engerix B, which led to inappropriate age at vaccine administration and wrong vaccine administered. The patient demographics were asked but the healthcare professional did not provide them.  The consent to follow up was given.
Shingles; severe pain in back; severe pain in leg; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old male patient received first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA Vaccine; Lot number: UNKNOWN), via an unspecified route of administration in left arm on 05Mar2021, 16:00 (at the age of 47-year-old) as a single dose for COVID-19 immunisation. The patient medical history was not reported. The patient had not received any other medications within 2 weeks of vaccination. The patient did not report any allergies to food or other medicinal products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 21Mar2021, the patient experienced shingles, severe pain in back and leg. Therapeutic measures were taken as result of events reported and included treatment with anti-viral and pain medication (unspecified). The events resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events shingles, severe pain in back and leg were resolving at the time of this report.   No follow up attempts are needed; information about lot/batch number cannot be obtained.