chrisvoncsefalvay/vaers-outcomes huggingface dataset:
woke up feeling like I had a temperature (which I did)/ fever; Headache; This case was reported by a consumer and described the occurrence of fever in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On 20th October 2017, the patient received the 2nd dose of Shingrix. On 20th November 2020, 1127 days after receiving Shingrix, the patient experienced headache. On 20th November 2020 03:30, the patient experienced fever. On 20th November 2020 18:00, the outcome of the fever was recovered/resolved. On an unknown date, the outcome of the headache was recovered/resolved.   The reporter considered the fever and headache to be related to Shingrix.  Additional details were provided as follows: The patient reported case for herself. The patient received second shingles shot and the next morning about 3:30 a.m., woke up feeling like patient had a temperature (which she did).  The fever lasted until about 6 p.m., and then patient was fine.  The patient commented if the two shot vaccine keeps her from suffering from shingles, it would be worth it. This case has been linked with US2020AMR233691, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR233691:same reporter
Arm ache, chills, fever (100.3), fatigue, slight headache. Took Tylenol extra about every 6 hrs through night and next morning. Fever broke next morning. Other symptoms subsided, by afternoon gone except headache, described as sinus headache. Took Tylenol sinus and headache. by evening headache gone.
Headache, Fever & NauseaVomiting Narrative:  Received vaccine in morning. By evening experiencing flu-like symptoms. Missed the next two days of work. Did not seek medical treatment. Managed low fever with tylenol.
About 15 minutes after receiving flu shot.  I began to feel tightness of my throat and chest and head and difficulty breathing. About 2 hours later I began to feel urgency to cough and my throat more tight about 6 hours after the shot I began having body aches, muscle pain and fever of 100. Resolving throat and head tightness and congestion.
Information has been received from a Nurse Practitioner concerning a 15 year old female patient who was vaccinated with her first dose of Gardasil. Subsequently, the patient experienced prolonged dizziness. Medical attention was required. The patient recovered. The nurse practitioner reported that she was unsure if the 2nd dose of Gardasil should be administered. Additional information has been requested.
She on 07/26 suddenly became agitated, began moaning and crying, then quick repetitive movements involving twisting right to left without stopping, she held onto objects with the left hand without dropping them. She would not focus with verbal, tactile, or photo stimuli. She quit cruising, could crawl, did not play in bathtub, she was not making her usual baby babble or verbal response, she appeared not to be focusing or tracking with her eyes. That night/early morning she only slept 10 hours then 20 hours. She continued to do this until 07/28 with gradually less severe symptoms. She slept only 2 hours the night of 07/27. Also she was having tongue thrusting and lip smacking repetitively. She finally on 07/28 afternoon fairly well had returned to her baseline. She slept her usual 8 hours that night. Appetite was definitely off and fed poorly. Pupils were midpoint and poorly reactive through this time. No fever was found.
Wearing off effect; Wearing off effect; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4336281-00.  A 65-year-old female patient received BNT162b2 (BNT162B2), on 05Jul2021 as dose 1, single (Batch/Lot number: unknown) and on 16Dec2021 as dose 2, single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation; risankizumab (SKYRIZI [RISANKIZUMAB]), (Batch/Lot number: unknown), subcutaneous for psoriasis. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), THERAPEUTIC RESPONSE SHORTENED (medically significant) all with onset 2021, outcome "recovered" (2021) and all described as "Wearing off effect". The patient underwent the following laboratory tests and procedures: Body temperature: 104. The action taken for risankizumab was unknown.  The reporter's assessment of the causal relationship of "wearing off effect" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the available information and the known product safety profile, a causal relationship between the reported events, Drug Ineffective, therapeutic response shortened and BNT162B2 is considered possible
Patient experiencing needle like shooting pain which had disrupted her life since she got the shot. Pain scale 6-8 and extremely uncomfortable with any chore at home.
My arm was sore. And then it started being hot and red. In a small circle the size of silver dollar. Over time it grew to be a diameter of softball - about 4 inches across. Right at the injection site. There was some itchiness. As it was growing, I did get on an antibiotic (approximately on the 20th) - it may have been Keflex. It was treated as if it were cellulitis and in three days it was gone.
11:23 Post vaccination c/o dizziness w/no additional or associated symptoms Medical monitoring x 30 min, rest, snack provided; symptoms resolve Released from facility w/self
her joints hurt; muscles hurt; This is a spontaneous report from a contactable consumer (reporting on behalf of his daughter). A 50-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. The patient medical history was not reported and concomitant medications was none.  After the first shot, patient experienced her joints and muscles hurt on an unspecified date. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Complaint of chills, sore/scratchy throat, headache, runny nose/congestion, loss of taste/smell, and myalgia
My arm became swollen at the i he ruin site and is quite painful.  I also had a fever and chills for 2 days following the vaccination, as well as mild nausea.
Patient was administered with a PENTACEL vaccine which was not reconstitute with the liquid portion with no AE; Initial information regarding an unsolicited valid non-serious case was received from a consumer/non-health care professional via Medical Information (Reference number- 00797394) and transmitted to Sanofi on 04-Oct-2021.  This case involves a patient (unknown demographics) who was administered with a DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] which was not reconstituted with the liquid portion (product preparation issue).  Medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (batch number and expiry not reported) via unknown route in unknown administration site for prophylactic vaccination.  It was a case of an actual medication error due to inappropriate reconstitution technique (latency same day).   It was reported "Vaccine specialist states her customer reported a misuse of PENTACEL, states that the customer did not reconstitute the vaccine and only the liquid portion of PENTACEL was administered to the patient. Vaccine specialist states customer had tried calling last week and was told that they would receive a call back to discuss recommendations following misuse of PENTACL, but they have not received call back. Vaccine specialist asks if this agent can call her customer."  No other adverse event was reported.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number for this case.
I began having serious muscle aches that persisted for 2+ weeks.  I also had on-going headaches, and light-headedness. On November 17 I collapsed at work with severe lightheadedness, and began vomiting and my BP was 200/100.  I am an RN and I was at work and I was taken to the ER.  The diagnosis I was given was vertigo, however I had no "room spinning" or nystagmus, but my BP remained elevated.  Three days later I went to my PCP and my BP was still around 200/100.  A physical in October with my GYN doctor had a BP of 128/74 listed.  From the time I had the Seasonal vaccine-lot # U3203AA, and the H1N1 vaccine-lot # UP005AA, I had not felt well and my BP certainly explains the symptoms.  I was started on Atenolol (advanced to 75 mg/day over a couple weeks) and HCTZ. Those made me feel tired, dehydrated, and nauseated, so I was switched to Lisinopril 10 mg.  Over several weeks, my BP has dropped to the 120s-140s and the dose of lisinopril has not had to be increased. I believe there is a direct link between the H1N1 and my BP because I have taken the seasonal vaccine the last few years without any side effects.  I also had a doubling of both my SGOT and SGPT during those weeks after the vaccines.  I know this because I had routine lab work done on 10/26/09 right before getting the vaccines.  I continue under doctor's care for the HTN.
Left arm (deltoid) red, swollen, inflamed of injection site 2 days after injection.
MOderna vaccine induced  thrombocytopenia  (worsening of  thrombocytopenia)
Initial report received from another manufacturer on 12 September 2008 who received the report from a physician.  A child (gender and age not reported) developed autism after receiving TDaP (trade name, manufacturer, lot number, date of administration, route/site of administration not reported).  The reporting physician had no information concerning the patient's physician, symptoms, or treatment.  It was indicated that no additional information was available.
never came back for the second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 83-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 12th September 2021).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: never came back for the second dose).  The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 31-AUG-2023 The pharmacist called to inquire that should the patient start the Shingrix series over? or get the second dose? The Registered Pharmacist (RPH) reported that a patient never came back for the second dose and asked how to proceed? The health care professional (HCP) declined follow-up from safety.     Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Received phone call from mother on 3/15/13 at 4:30 pm. States she noticed patient had a small red welt approximately 2 in. away from injection site on (R) deltoid on 3/12/13. Noted that lower right arm swollen without redness, warmth or pain. Mother stated swelling noted just by looking at arm. Using ice to decrease swelling.
DTAP was 6 days expired when administered. EXP 11/26/2021. No adverse reaction reported. Child's mother notified of situation.
Patient was vaccinated on 12/30/20 and 1/19/21, so was fully vaccinated when testing positive for COVID-19 on 10/4/21.
rigors, t max 103.9, severe bone pain, nausea and vomiting, severe fatigue - symptoms lasted > 72 hours
Information has been received from a certified medical assistant concerning a 9 year old male with no known drug allergies, ADH and bipolar disorder who on 03 Feb 1998 was vaccinated with a dose of Varivax. Concomitant therapy included Risperdal and "others" (therapy unspecified). On 05 Mar 2006 the patient developed lesion on his body and in his mouth. No lab or diagnostic studies were done. The patient was treated with comfort measures (not futher specified). Subsequently, the patient recovered. There was no product quality complaint involved. Additional information has been requested.
1 of 3 pts vaxed from the same vial who devel a fever of 103-104 & was irritable w/persistent crying w/in 24hr following vax;pt recvd vax 13MAR95;required MD visit;treated w/APAP;
shingles; This case was reported by a consumer and described the occurrence of shingles in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingles Vaccine  (about 15 years ago).   On 20th November 2022, the patient received the 1st dose of Shingrix. In November 2022, less than a week after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.     Additional Information: GSK Receipt date: 6th December 2022. Reporter's Comment:The patient got a Shingles Vaccine about 15 years ago. The got the first of the 2 Shingrix Shots. The reporter stated that he/she found it very unusually coincidental that by the end of the week, had shingles.  The reporter asked if there was any data on people who have contracted shingles from the vaccine.  The reporter know it was not the norm but stuff happens. The reporter could be contacted at this email address. Additional supportive information: The case has been linked with case US2022AMR183219 reported by same reporter.; Sender's Comments:  US-GSK-US2022AMR183219:same reporter
Periodic low grade fever. Received Vaccine 1/22/21  1/25/21 had low grade fever (100.2) took ibuprofen.  1/31/21 had low grade fever (100.2) took ibuprofen 2/2/21 had low grade fever (101.4) took ibuprofen. Concern is the low grad fever coming and going.
A week after getting my first dose of the moderna Covid vaccine, I developed a sore arm near the injection site as well as a red rash (2 inch diameter). There is some minor itching. I was 11 weeks pregnant at the time of the vaccination and gave experienced a healthy pregnancy so far. At 10 weeks my obgyn did see a pretty small subchorionic hematoma and has had me on pelvic rest as it heals. My due date is Nov. 30th 2021.
Patient reported that within 7-10 days he could barely move arms and legs, severe pains, extreme chest pain and stomach pain
High fever chills jerking motion headache weakness had fever just for a few hours felt weak for two and a half days.
Patient passed out after receiving vaccine. Patient was watched for a period of time and reexamined by provider.
Patient was 17 at the time of vaccination. This error was not discovered until after second vaccination on 4/19/2021, lot# 037A21B
Pt rec'd DTP/HIB/OPV became lethargic, pale w/circumoral cyanosis; 02 administered x 15min; Pt then alert & responsive w/color improved;
On 12/28, start getting a really bad headache. Within two hours, I started developing aches all over my body. Developed chills for a few hours. Chills were gone by morning, but headache and some of the aches remained by noon.
A consumer report has been received. The report concerns, female consumer, who had been receiving FLUMIST (Intranasal). FLUMIST (Intranasal) started on an unknown date. It was reported that a child who was vaccinated with IIV and two weeks later against her mother's wishes was vaccinated wit FLUIMST in a school-located vaccination program. The child developed a fever post FMQ administration. The outcome of the event of fever and vaccinated with IIV and two weeks later against her mother's wished was vaccinated with FLUMIST and child received FLUMIST vaccine twice by mistake is unknown. The report was considered to be non-serious.
Pt complaining of right shoulder pain, chest discomfort, substernal chest pain, racing heart, shortness of breath. Later complaining of pain and swelling at injection site.
Called clinic 11/2 hr after receiving vaccine complaint of allergic reaction -felt like her lips and tongue swelling, generally not feeling well. Sent to local ER. Stable in ER. VSS. No swelling noted anywhere, no hives or rash, no SOB, no nausea or vomiting, no lightheadedness. Treated for subjective symptoms with IV BENADRYL, PEPCID, SOLU MEDROL and observe for 11/2 hr. Complete resolution of symptoms and discharged with prednisone for three days. No further symptoms.
Jul 29, 2021  Felt weak & fainted twice at night, had to call an ambulance.   Jul 29, 2021  Went into the emergency room at Hospital feeling weak and dizzy.   Jul 29- October 1, 2021  Constant dizziness   October 1, 2021  Loss of consciousness & memory.   October 1-7, 2021  Hostpital, multiple tests run was. Discharged from the hospital without a diagnosis.
KEPT HIM UP AT NIGHT WITH LACK OF SLEEP; VOMITING; JOINT PAIN MOSTLY IN KNEES AND ANKLES; CHILLS; PERSISTENT MYALGIA WITH 10/10 PAIN; HEADACHE; NAUSEA; This spontaneous report received from a physician concerned a 25 year old male. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, expiry: 09-JUN-2021) dose was not reported, administered on 20-MAR-2021 at left arm for prophylactic vaccination. No concomitant medications were reported. On 20-MAR-2021, the subject experienced kept him up at night with lack of sleep. On 20-MAR-2021, the subject experienced vomiting. On 20-MAR-2021, the subject experienced joint pain mostly in knees and ankles. On 20-MAR-2021, the subject experienced chills. On 20-MAR-2021, the subject experienced persistent myalgia with 10/10 pain. On 20-MAR-2021, the subject experienced headache. On 20-MAR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills on 23-MAR-2021, was recovering from headache, and had not recovered from persistent myalgia with 10/10 pain, joint pain mostly in knees and ankles, vomiting, nausea, and kept him up at night with lack of sleep. This report was non-serious.
Client fainted immediately post vaccine administration and regained consciousness within moments. Her last meal was breakfast & vaccine administration occured in the mid PM. Mother called me today (12/29/08)reporting the client ate upon returning home the day of vaccine administration, slept the rest of the day, and had no further problems. Mother verbalizes the client had never experienced this problem post vaccine administration in the past.
He completed two Moderna vaccines in Feb 2021. He was initially diagnosed with COVID on 12/12/21. He received Regeneron, but he started having shortness of breath on 12/16/21. He was sent to hospital ER, and he was admitted on the same day. On hospital day 2, he is afebrile, on 3L oxygen. He is started on dexamethasone, Remdesivir, and Ceftriaxone.
This spontaneous report was received from a physician, via company representatives and from a support services director, concerning to a patient of unknown age and gender. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On 10-MAR-2015 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 10 single Ds 0.5 ml VIs 10 SDV (lot number and expiration date: K007262 and 25-NOV-2015 respectively; route of administration was not provided). The vaccine had an excursion of 32 degrees Fahrenheit (0 degrees Celsius) (lowest recorded temperature) for 304 hours (sum of hours in excursion). The vaccine status was reported as "in excursion". The vaccine storage criteria and type were reported as "refrigerator (R)". No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Began developing redness and pruritis around the area of injection, which then developed into blisters appearing like previous Shingles infection.  Blisters also stung and were painful like a previous shingles infection.
Within 5 to 10 minutes I had tingling in left hand (my husband had his 5 minutes after mine and had that too), but I had red fingers tips that were hot and toes. Later that night we both had electrical shocks/bites here and there in head and body. 14 days later WE BOTH felt like we were run over by a truck for a day and with horrific headaches. I got tested for covid, in case, and it was negative. 2 days later those symptoms were gone....but FOR ME...I began having a buzzing/strong vibration in my left chest. It's like a cell phone is on vibrate strongly on my chest. It happens every 2 to 10 minutes and has been constant since. Still have it. I am supposed to have the 2nd shot in 5 days, not sure if I should. Need to know if anyone else has reported these symptoms.
Fatigue to staying in bed for 2 days, followed by six days of diarreha for the first injection.  The second injection resulted in very severe stomach pains on  second day which lasted overnight.
10-13-21- tested for covid due to exposure- 10-15-21 positive result. Low grade fever 99.4
Feels bad; This spontaneous report received from a patient concerned a 62 year old male. The patient's height, and weight were not reported. The patient's past medical history included covid-19, and concurrent conditions included rectal surgery. The patient received covid-19 vaccine (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the subject experienced feels bad. The action taken with covid-19 vaccine  was not applicable. The patient recovered from feels bad. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case assessed as non serious.
Subsequent to receiving one dose of varicella virus vaccine live the pt experienced profound fatigue, one vesicle on his face with a few on his back, flu-like symptoms, aches, generalized muscle and joint pain, a mild persistent headache, listlessness and a low grade fever. He ended up with 28 generalized lesions on his upper arms chest and back.
Fever, significant Chills , Joint Pain in shoulders (both) elbows and neck. Injection site pain,  Injection site minimal swelling, Muscle pain in  arms and ribs.
S.T.E.M.I. In the right coronary artery due to multiple blood clots. Clots cleared via balloon angiogram, no stent required because artery was healthy. Pt will most likely recover fully however will need to remain on medication for extended time frame and likely to effect his career. Symptoms included, sudden onset chest pain accompanied by bi lateral arm numbness over the duration of 45 min prior to arrival of EMS. CP & arm numbness did not subside until after PT was cleared of the blockage.
Post first dose of vax, the pt subsequently experienced an increae of fevers. The pt sought medical treatment.