chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Severe headache, muscle pain in whole body, fatigue, fever, inability to do any daily work due to sx
6/30/04: 2 hours after the shot, patient becomes feverish and the following day left arm was swollen. Pt went to ER at hospital and was prescribed Keflex.
Gray dot on thigh; This case was reported by a nurse and described the occurrence of skin discoloration in a infant patient who received DTPa-HBV-IPV (Pediarix) (batch number X9HS4, expiry date unknown) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis and Hib (Hiberix) (batch number 335N9, expiry date unknown) for prophylaxis.   Previously administered products included pediarix with an associated reaction of skin discolouration (received 1st dose on 20th June 2022, refer link case US2022AMR171169) and hiberix with an associated reaction of skin discolouration (received 1st dose on 20th June 2022, refer link case US2022AMR171169).   On 19th August 2022, the patient received the 2nd dose of Pediarix, Pediarix Pre-Filled Syringe Device and the 2nd dose of Hiberix. On an unknown date, less than 3 months after receiving Pediarix, Pediarix Pre-Filled Syringe Device and Hiberix, the patient experienced skin discoloration. On an unknown date, the outcome of the skin discoloration was unknown.   It was unknown if the reporter considered the skin discoloration to be related to Pediarix, Pediarix Pre-Filled Syringe Device and Hiberix.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Linked case(s) involving the same patient:  US2022AMR171169   Additional Information: GSK Receipt Date: 16-NOV-2022 Reporter's Comments:  The patient experienced gray dots noted on legs (right thigh) after receiving Pediarix, Hiberix The reporter was consented to follow up. Additional supportive information: This was 1 of several linked cases, reported by same reporter.; Sender's Comments:  US-GSK-US2022AMR171025:Same reporter US-GSK-US2022AMR171007:Same reporter US-GSK-US2022AMR171034:Same reporter US-GSK-US2022AMR171044:Same reporter US-GSK-US2022AMR171042:Same reporter US-GSK-US2022AMR171039:Same reporter US-GSK-US2022AMR171028:Same reporter US-GSK-US2022AMR149561:Same reporter US-GSK-US2022AMR149560:Same reporter US-GSK-US2022AMR149551:Same reporter US-GSK-US2022AMR148962:Same reporter US-GSK-US2022AMR148961:Same reporter US-GSK-US2022AMR148919:Same reporter US-GSK-US2022AMR171056:Same reporter US-GSK-US2022AMR171052:Same reporter US-GSK-US2022AMR171062:Same reporter US-GSK-US2022AMR171050:Same reporter US-GSK-US2022AMR171048:Same reporter US-GSK-US2022AMR171083:Same reporter US-GSK-US2022AMR171088:Same reporter US-GSK-US2022AMR171095:Same reporter US-GSK-US2022AMR171047:Same reporter US-GSK-US2022AMR171154:Same reporter US-GSK-US2022AMR171088:Same reporter US-GSK-US2022AMR171095:Same reporter US-GSK-US2022AMR171083:Same reporter US-GSK-US2022AMR171154:Same reporter US-GSK-US2022AMR171169:Same reporter US-GSK-US2022AMR171047:Same reporter US-GSK-US2022AMR171095:Same reporter US-GSK-US2022AMR171083:Same reporter US-GSK-US2022AMR171088:Same reporter US-GSK-US2022AMR171154:Same reporter US-GSK-US2022AMR171197:Same reporter US-GSK-US2022AMR171230:Same reporter US-GSK-US2022AMR171264:Same reporter US-GSK-US2022AMR148961: US-GSK-US2022AMR149560: US-GSK-US2022AMR149561:
Lymph node in my left arm pit has been swollen and tender ever since my second dose. It has now been 17 months - March 2021 through August 2022.
This is what the patient reported in our hospital reporting record.  I received the flu shot on Monday, 11-21-22, at clinic. I had waited until late November because I had been diagnosed with myopericarditis in August and I was waiting (on the advice of my cardiologist) until I had a decrease in frequency in my chest discomfort (and therefore hopefully an increase in healing) before taking a vaccine which could potentially aggravate the condition. After the vaccine, I had some soreness in my upper arm at the administration site within 24 hours, which was expected. However, 24 hours after the vaccine, I began to experience severe ankle pain in both ankles unrelated to any other activity, which lasted through Sunday (11-27-22) and finally began to improve Monday (11-28-22). I experienced an increase in chest discomfort (squeezing, pain) frequency compared to before the vaccine, and it is ongoing (and more frequent than before). I informed my cardiologist, clinic, and one of my supervisors.
stomach ache and diarrhea about 7-9 hours after shot that lasted about 24 hours leg cramps about 18 hours after shot while sleeping (only an issue the first night) general malaise for 72 hours after shot massive headache that started 48 hours after shot and lasted ~24 hours before turning into a milder but continuous headache for about 4 days.  Around the time the headache turned milder I developed a case of tinnitus which has still not gone away. Tinnitus is ever present in both ears
Positive redness and swelling within 1-2 minutes after injection. Redness, swelling, erythema, increased warmth, and induration lasted for 3 days.
Redness, swelling deltoid, cellulitis, treated with antibiotics. Keflex 250mg/5 x 10 days.
pt w/ irregular menstrual cycles recv vax may96 & 22apr97; pt learned that she was 5 wk pregnant; varicella titer 12may97 revealed pt was seronegative; pt exp spontaneous abortion; hx of live birth
pt recv vax 12AUG96 & 13AUG96 was lethargic & tired;14AUG96 pt had a fever of 104 & was taken to clinic;clinic felt this was unrelated to vax;APAP given for 2 days;fever broke 16AUG96;even w/APAP temp was not below 101;
Facial swelling , mom giving Diphenhydramine 50 mg q 6 hours x 3 days.
Systemic: Fainting / Unresponsive-Medium, Additional Details: Patient passed out shortly after receiveing the vaccine. Patient has a history of passing out when blood is taken but this is the first time after receiveing a vaccination. Ambulance was called, he was responsive shortly before the EMS arrived. They checked him out ans he was ok. Patient refused to go to the ER. I called him about 2-3 hours later and his wife said he was doing well.
I initially had chills, myalgias, headache, and nausea (starting later that evening), which I recognized as normal immune reactions. It lasted until about 24 hours after the vaccine. Over the last week, I?ve had horrible insomnia, waking up multiple times throughout the night with difficulty falling back asleep. I didn?t think much of it other than it?s very unlike me until a handful of other coworkers vaccinated around the same have also been experiencing this.
FEVER; HEADACHE; TIRED; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's past medical history included hypothermia, and concurrent conditions included penicillin allergy. The patient experienced drug allergy when treated with azithromycin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 041A21A expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced fever. On APR-2021, the subject experienced headache. On APR-2021, the subject experienced tired. Laboratory data included: Body temperature (NR: not provided) 102 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, and headache, and the outcome of tired was not reported. This report was non-serious.
Hives/rash on neck, chest, arms, upper back, low back. Lasted from 24 hours after vaccination- 48 hours after vaccination. Rash/hives decreased after taking benedryl, but had residual itchy feeling on skin for several days after vaccination.
Pt had TDAP vaccine on 10/29/08, exhibited expected s/sx after injection "knot at side, pain, fever, headache". Two weeks later had lymph node on clavicle. Having periodic pain (burning) to arm, top of shoulder and clavicle area - having ODS to remove lymph node.
Swelling of face and body, stinging and burning sensation of skin, diffuse erythema, peeling of lips, no resp. issues.
Costochondritis: Symptoms started 3 days after vaccine. Dull achy pain in left rib area. EKG ruled out any heart issues.
Information has been received from a registered nurse referring to an unspecified adult patient of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On an unknown date, the patient was inadvertently administered only one dose of 5 microgram (mcg) of RECOMBIVAX HB (lot#, expiration date, and route were unknown) for prophylaxis, instead of two doses to make the combined total dose of 10 mcg.  No adverse effects reported. Additional information has been requested.
Immediate fever, followed by chills. Pt took aspirin. Went to bed and started having night sweats. Took more aspirin fever went down. Pt came back a week later to be seen.
Recipient experienced a Vasovagal response. He described feeling "lighted headed, nauseous and hot". He presented with pallor, diaphoesis and a pulse rate of 60-70 bpm. Recipient provided an ice pack and juice. He declined lying down and pretzels. After juice and ice, he recovered within 20 minutes.
patient was diagnosed with COVID-19; patient was diagnosed with COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician) from product quality group. The reporter is the patient.  A 67 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 15Jan2021 (Lot number: EL3248) at the age of 66 years as dose 2, single and administered in arm left, administration date 24Dec2020 (Lot number: EK9231) as dose 1, single for covid-19 immunisation. Relevant medical history included: "hyperlipidemia" (unspecified if ongoing); "osteoporosis" (unspecified if ongoing). The patient had no known allergies. Concomitant medication(s) included: ATORVASTATIN. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2021, outcome "unknown" and all described as "patient was diagnosed with COVID-19". The patient underwent the following laboratory tests and procedures: sars-cov-2 test (nasal swab): (03Jan2022) pending result.; Sender's Comments: Event "COVID-19" is assessed as related to BNT162B2 in the setting of lack of drug effect. Case will be reassessed upon receipt of additional information.
I26.99 ACUTE PULMONARY EMBOLISM 12/27/2022 HTN (HYPERTENSION) I82.403 ACUTE DVT OF BILAT LEGS, UNSPECIFIED VEINS 12/27/2022 HTN (HYPERTENSION) I95.9 HYPOTENSION 12/27/2022 HTN (HYPERTENSION)
Rapid response called 8 minutes into 30 min obsrvation.  Client known to have a vague history of a reaction to an unknown medication from many years ago.  Client states 'feeling off'; HR regular BP slightly elevated.  Symptoms increasing with dizziness and cough.  EMS called and client transported to ED via ambulance, RN
Initial and follow up information has been received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. The medical history, drug reactions and allergies of the patients were not reported. On unknown dates, the unspecified patients received improperly stored doses of ROTATEQ by oral route, lot # K015816, expiration date 29-MAY-2016 (dose and frequency were not reported). No concomitant medications were reported. No adverse effect was reported. No product quality complaint was involved. This is one of several reports from the same source. Additional information has been requested.
Information has been received from a healthcare worker referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concomitant medication were not provided.  On an unknown date after 07-OCT-2016, the patient was vaccinated with improperly stored VARIVAX (lot # L020001, expiration date 02-JUN-2017, 0.5 ml, subcutaneous) for prophylaxis. No adverse effects were reported. The excursion temperature included higher than 5 Fahrenheit degree but lower than 14 Fahrenheit degree for 8 hours and 30 minutes and higher than 14 Fahrenheit degree but lower than 46 Fahrenheit degree for 30 minutes. There was no previous excursion. Data logger was involved. No product quality complaint was involved. This is one of several reports received from the same reporter.  Additional information has been requested.; Sender's Comments:  US-009507513-1701USA003754:
This spontaneous report has been received from a nurse practitioner, via company representative, concerning a a patient of unknown age and gender. On 13-MAR-2019, the nurse reported that on an unspecified date, a patient missed a dose of GARDASIL 9 injection, intramuscularly, lot number N035957 and expiration date of 10-OCT-2020 for prophylaxis. Because particulate matter in the dose that was to be administered (reported as "foreign matter on the insider of unknown number of vaccines) (product impurity). No adverse effects were reported. At the reporting time, the outcome for product impurity was unknown. The causal relationship regarding product impurity between GARDASIL 9 was not reported. This is a non-valid case due to the lack of a patient identifier.
Swelling, redness, pain, R ice, Duricef 500 mg if redness develops Tylenol #3 Q 4 hours PRN.
lt shoulder pain-redness abscess draining-pus-no temp;abscess drain & clear;
No additional adverse effects reported.; patients have been administered improperly stored vaccines; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information about the patient's pertinent medical history, concomitant therapies or drug reactions and allergies provided. The case concerns 1 patient and 1 combination product. On 05-JUN-2020, the patient was vaccinated with improperly stored hepatitis a vaccine, inactivated (VAQTA) prefilled syringe injection, lot # S026003, expiration date 17-OCT-2020 (exact dose and injection site were not reported) for prophylaxis.  Administered dose of vaccine experienced the temperature excursion of below 36 degrees Fahrenheit (29.5 degrees Fahrenheit) for 10 minutes. The digital data logger was involved in recording the temperature excursion details. No previous temperature excursion had occurred. No additional adverse effects were reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; manufactureraddress:; manufacturercity:; manufacturerstate:; manufacturercountry:; devicelotnumber: S026003; expirationdate: 17-OCT-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2007USA001137: US-009507513-2007USA001781: US-009507513-2007USA001782: US-009507513-2007USA001783: US-009507513-2007USA001777: US-009507513-2007USA001778: US-009507513-2007USA001779:
This non-valid, spontaneous report was received from a registered nurse, referring to an unspecified number of patients of unknown age and gender. No information was provided regarding the patients' medical history, previous drug reactions, allergies, concurrent medical conditions or concomitant medications. On unknown dates, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB lot number N034005 (expiration date 31-JAN-2020) and lot number reported as "N021920" (expiration date 07-FEB-2020) for prophylaxis (doses, routes and anatomical locations of administration were not reported). Additionally, the patients were vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) by oral route, lot number N005078 (expiration dates 22-NOV-2018 and 04-OCT-2018) for prophylaxis (doses were unknown), GARDASIL 9 lot number N020352 (expiration date 10-APR-2020) for prophylaxis (doses, routes and anatomical locations of administration were not provided) and M-M-R II for prophylaxis (dose numbers, routes and anatomical locations of administration were not provided; lot numbers N010496 [expiration date 31-MAR-2019], N014485 [expiration date 10-MAY-2019], and N023149 [expiration date 24-AUG-2019]). The vaccines were reconstituted with sterile diluent which was reported to be properly stored. The doses of all vaccines were exposed to a temperature excursion below 32 degrees Fahrenheit (F) (also reported as 31F) during a time frame of 15 days, which was detected by the Digital Data Logger. There was no prior temperature excursion and no adverse effects were reported. Follow-up information was received from the nurse on 17-DEC-2018. The reporter provided patients' demographics which made the case valid. This report refers to a 14-year-old patient of unknown gender. On 26-JUN-2018, the patient was vaccinated with an improperly stored dose of GARDASIL 9 lot number N023828 (expiration date 25-JUN-2020). This is one of multiple reports received from the same reporter.; Sender's Comments:  US-009507513-1807USA011661:
left arm has been aching ever since the shot/ pain in the left arm; This is a spontaneous report received from a contactable reporter (consumer or other non HCP).  A female patient received BNT162b2 (BNT162B2), in 2020 as dose 1, single (Batch/Lot number: unknown), in right arm for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (medically significant), outcome "not recovered", described as "left arm has been aching ever since the shot/ pain in the left arm". The event "left arm has been aching ever since the shot/ pain in the left arm" required physician office visit. The patient underwent the following laboratory tests and procedures: X-ray: there is no problem there. Therapeutic measures were taken as a result of pain in extremity. Clinical course: The patient's husband reported that two years ago, they had the Pfizer shot for the COVID 19 and they were happier and had the shot in the right arm. Now, the left arm has been aching ever since the shot, they never had anything in the left arm, and they have pain now in the left arm. They had a reverse shoulder in the left arm (as reported) number one, and they had no trouble with the reverse shoulder. It has been fine, they had X-rays and everything else and there was no problem there. They have had pain in the left arm, and they believed it was the result of the Pfizer vaccine shot. They are wondering if there is anything they can take that Pfizer would recommend because none of their doctors know what to do with it. They had the booster shot also.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201050862 same reporter, product, and event; different patient;
Sore arm the next day. A slight cough developed 1 week in. 8 days in I developed a fever of 100-101, throbbing lymph nodes, very sore eyes, aching joints and body, very short of breath and more persistent cough. 9 days in I developed a full body rash which is currently worsening.
guillian barre syndrome; symptoms of lower extremity weakness began about 12 hours after getting the second vaccine. lower extremity weakness progressed to bladder incontinence, which prompted her to come to the hospital. areflexic in the lower extremities upon arrrival.
Hardness at injection; swelling at injection; Itching at injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (Hardness at injection), VACCINATION SITE SWELLING (swelling at injection) and VACCINATION SITE PRURITUS (Itching at injection) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On an unknown date, the patient experienced VACCINATION SITE INDURATION (Hardness at injection), VACCINATION SITE SWELLING (swelling at injection) and VACCINATION SITE PRURITUS (Itching at injection).   At the time of the report, VACCINATION SITE INDURATION (Hardness at injection), VACCINATION SITE SWELLING (swelling at injection) and VACCINATION SITE PRURITUS (Itching at injection) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant product use was not provided by the reporter. No treatment information was provided.
After vaccine administration (10-15 mins later) patient complained about mucus in her throat and started coughing and getting nervous.
ACHY; tired; headache; UPSET STOMACH; tenderness at the injection site; This case was reported by a consumer via call center representative and described the occurrence of pain in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included ulcerative colitis.   On 3rd December 2020, the patient received the 2nd dose of Shingrix. On 3rd December 2020, less than a day after receiving Shingrix, the patient experienced pain, tiredness, headache, upset stomach and injection site tenderness. On an unknown date, the outcome of the pain was recovered/resolved and the outcome of the tiredness, headache, upset stomach and injection site tenderness were recovering/resolving.   It was unknown if the reporter considered the pain, tiredness, headache, upset stomach and injection site tenderness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. It was reported that on 3rd December 2020 patient received 2nd dose of Shingrix in left arm and on same day patient felt achy, tired with a headache and an upset stomach and tenderness at the injection site. The achy feeling has resolved and the other symptoms were resolving. The reporter consented to follow up.
Attempted to administer MMR in RA & Patient pulled arm away from mother and only received partial dose of vaccine.  Approximately 15 min later two raised areas were observed @ site where partial MMR dose was administered, which looked like hives.  No hives were observed on any other areas of patient's body and no redness or itching noted.  Child was administered 0.2 ml of Benadryl 50mg/ml IM Left arm per standing orders.  Patient was assesed 15 min after receipt of Benadryl and possible hives had resolved.  Patient was A/O and in stable condition prior to leaving facility.
2 episodes of Vertigo in 2 days.  First last led for about 1 min.  The second lasted for 10 mins.  Blurred vision persisted for days.
Progressively got worse. Fever. Headache. Chest congestion. Diarrhea. Got shot Tuesday felt better Saturday.
When patient received a shot, blood gushed out.  Later patient reported some swelling, bruising and pain in the arm.  It got better over the next few days.  She was advised to apply heat and take Tylenol if needed and it helped.
I felt sick on Jan 20th with chills and got covid test.  Results came back on 25th showing positive.  I quarantined at home.  I called my Dr.  who made an appt for me to get the anti-bodies which I received.
6 days after my second vaccination dose, I began to have itchy hives on my arms and legs in the early afternoon. By 5 p.m. I began to feel fatigued and by 6 p.m. I had a mild fever of 99. Soon after I had very strong chills and aches with my fever increasing to 102 by 8 or 9 p.m. The fever reduced after I took some ibuprofen but returned by 11p.m. when I went to bed. I slept soundly through the night with no recurrence of high fever or chills and felt very fatigued the next day or two.