chrisvoncsefalvay/vaers-outcomes huggingface dataset:
i have fever today; This case was reported by a other health professional via other manufacturer and described the occurrence of fever in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date). Concurrent medical conditions included gastrointestinal symptom nos and rheumatoid arthritis. Concomitant products included tofacitinib citrate (Xeljanz).   On 19th November 2020, the patient received the 2nd dose of Shingrix. On 20th November 2020, 1 days after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was unknown.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional details were reported as follows: The age group was not reported, but was selected adult as per vaccine indication. The age at vaccination was not reported. The patient reported that he/she had gastrointestinal symptoms before starting Xeljanz and was unchanged since previous contact (10th August 2020). The patient received 2nd dose of Shingrix and next day experienced fever. Physician awareness was not stated.
LOCAL REACTION TO L UPPER ARM--SWELLING (FIRM INDURATION) AND WARMTH OF L UPPER ARM FROM SHOULDER TO JUST ABOVE ELBOW NOTED STARTING THE EVENING OF 6/30/2009 BY MOM.
fever for 5 days, frontal h/a; had ache in finger only when fever; no swelling; pt was also tired;
Elevating fever, extreme fatigue, body aches- 9th day bleeding while urinating: 10th day- BLOOD CLOT while urinating 2nd vaccine - milder fever, less fatigue, fewer body aches. 5th day, blood in urine. End of side effects.
This spontaneous report was received from a pharmacist refers to a 90 year old female patient. Drug reactions/allergies were reported as none. On 28-MAY-2014, the patient was vaccinated with a dose of ZOSTAVAX (lot#J013138, expiration 17-JAN-2015), 0.65 ml, subcutaneously in the left posterior triceps arm. The patient, who received ZOSTAVAX, experienced a reddened area at the injection site "within a few minutes" that was approximately a quarter to a half-dollar sized in diameter. The patient informed the pharmacist on 30-MAY-2014, that the reddened area was itchy and had expanded to 3 inches by 1 inch in size. Today, 02-JUN-2014, the patient informed the pharmacist that her area of redness at her injection site was 8 inches by 3 inches in size, slightly pink, and the original area of redness that was observed on 28-MAY-2014 was now dark-reddish purple in color. The pharmacist did not believe that the area was hard or warm, and he stated that the patient had not reported a fever or malaise. The patient informed him that when the area itches, she applied hydrocortisone cream to the area. The patient had not consulted her healthcare provider regarding the experience. No medical attention was sought. The pharmacist accepted the offer of the VZVIP packet, and VZVIP faxed to the pharmacist. The patient had not recovered from the events. Causality was not reported. This is one of several reports received from the same reporter. Additional information has been requested.
severe swelling of arm 3 inches in diameter, covid arm, migraine for 9 days, vomiting, chills, cold sweats, shortness of breath, diarrhea, dizziness, confusion,
Low grade fever three days; aches; headache;malaise for three days hives on day four
Sore at injection site for about 3 days, then began to resolve. Woke up on 1/20/21 with pain at site rated at 6. Redness and swelling at site approximately 3 inches x 2 inches, warm to touch. Writer advised vaccine recipient to be evaluated by PCP ASAP. She reports being evaluated on 1/21/21 and was prescribed an oral antibiotic, and given a steroid injection. She describes symptoms as improving today.
HEART DAMAGE; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (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 was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced heart damage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of heart damage was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non-serious
Hot, swollen, pain down to elbow, up to shoulder - shot given 10/24/11 - symptoms started 10/25/11 - came to practice 10/27/11 - tx'd with Abx today (10/27/11) & filed report.
First dose, 11/22/2021: Pain/swelling to injection site and upper arm, Headache for four days, fatigue/myalgia for two days, nose bleed one time- Tylenol, Ibuprofen, rest, and hydration. Second dose, 12/14/2021: Pain, swelling, and itching to injection arm from shoulder to fingertips, Headache and myalgia has not subsided as of day 3, chills for 2 days, Nausea for 2 days with no emesis- Tylenol, Ibuprofen, Benadryl, rest, and hydration
Itchiness, puffy lips, puffy face, rash, itchy tounge tongue lips. Given benadryl took more on the way home and taken steroid to help lessen rash and swelling
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old male patient received BNT162b2 (BNT162B2), on 12Apr2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 60 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Migraines" (unspecified if ongoing); "seasonal asthma" (unspecified if ongoing); "borderline diabetic" (unspecified if ongoing); "Overweight" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Known allergies: iodine intravenously, reaction(s): "Known allergies: Iodine intravenously"; Known allergies: immetrix, reaction(s): "Known allergies: Immetrix"; Known allergies: morphine, reaction(s): "Known allergies: Morphine". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: Report about covid treatment: Yes, If vaccine received: Yes with Paxlovid (Treatment start date: 09Jan2023 and Treatment stop date: 14Jan2023).  The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received.
Pt has had on/off fevers since the date of vaccination on 6/19/21.  These have responded to acetaminophen use.  However, today she reports that beginning yesterday 6/27/21 she has started to see more redness around the injection site.  She states her range of motion is ok, but in addition to the redness she as a little bit of itchiness and a little bit of numbness in that arm.
Dry mouth  and itching on the back 20 minutes after receipt of vaccine.  Throat feeling blocked.  Headache.  Diphenhydramine 50 mg  PO x1 given.  Symptoms started to subside approximately 20 to 30 minutes after administration of diphenhydramine.  Blood pressure initially elevated at 178/84 but decreased to 142/82 approximately 15 minutes following administration of diphenhydramine.  Patient a little drowsy from the diphenhydramine.   Ears ringing and itching began 1 hour 15 minutes following administration of vaccine (and approximately 45 minutes following administration of diphenhydramine).    Famotidine 20 mg  PO x1 administered.
Patient reports felt fatigue right away, has been sleeping about 12-18 hours per night, has slightly raised red swelling 3 inches at widest, and no appetite.
This case was reported by a physician via sales rep and described the occurrence of injection site necrosis in a 57-year-old female patient who received SHINGRIX for prophylaxis. On 4th June 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site necrosis (serious criteria GSK medically significant) and injection site indentation. On an unknown date, the outcome of the injection site necrosis and injection site indentation were not recovered/not resolved. It was unknown if the reporter considered the injection site necrosis and injection site indentation to be related to SHINGRIX. Additional information was reported as follows: At the time of reporting, the patient was 57 years old. The age at vaccination could be 56 or 57 years. The physician reported to the sales representative that the patient experienced permanent damage from the indentation and necrosis.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 09-SEP-2015, the patient was vaccinated with 3rd dose of improperly stored GARDASIL with lot number: K010215, expiry date: 05-MAY-2017 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Information has been received from a nurse practitioner concerning a 9 week old female with no allergies and a history of easily choke who on 03-JUN-2011 was vaccinated with a dose of ROTATEQ (lot # 669071/1269Z, expiration date 15-AUG-2012). Concomitant therapy included PENTACEL and PREVNAR at the same office visit. On 03-JUN-2011 the patient choked and might have aspirated a dose of ROTATEQ and had trouble catching her breath during administration. The patient was kept of the office for 1 hour after the choking incident and then went home recovered. The patient did not require any treatment for the choking incident. Additional information has been requested.
Became nauseated has itchy throat and chest tightness with in 5 mins of receiving the vaccine
Patient fainted.  She felt like she was going to faint so she went to her knees.  She stated that she had fainted in the past so she know what it felt like.
post vax pt skin clammy & blanched;pt stiffened & became non-responsive to voice command;ammonia capsule used w/o response;tremors & jerking of limbs w/stiffening legs;circumoral pallor, urine incontinent, eyes fixed;pulse accelerated rhyth
Within 5 minutes, my daughter felt faint and her throat started to close up and her chest got real tight. She was put on oxygen & monitored blood pressure for 20 minutes. Later that evening around 10:30 - all the symptoms started again. Couldn't breathe, chest tight and throat started to close up. I took her to E.R. and she was given BENADRYL to offset the allergic reaction. After her blood pressure was stable we were sent home. We also had to use BENADRYL the next day as well when her chest started to feel tight again. This was very scary for us and we will not be getting the other two doses.
cellulitis on vax site, seen on 5SEP97: treatment w/keflex, pt did not come back for f/u;
Vasovagal Syncope. Patient lost consciousness briefly and fell off chair but recovered instantly.
Patient reported arm was inflamed, warm to touch and the size of a golf ball.  Patient also had fever.  She was seen by her physician and given medication.
ADVERSE SIDE EFFECTS; This spontaneous report received from a patient concerned a female of unspecified age. 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: Unknown) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced adverse side effects. Laboratory data included: CT scan (NR: not provided) Unknown, Chest X-ray (NR: not provided) Unknown, and EKG (NR: not provided) Unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of adverse side effects was not reported. This report was non-serious.; Sender's Comments: V0 Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. During 2011, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) administered by a physician, as recommended for routine adult health maintenance and for the prevention of shingles. ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. During 2016 the patient was treated by a physician for a blistering vesicular outbreak which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expense, and pain and suffering, and other damages. Additional information has been requested.
pt recvd vax & exp elevated liver enzymes,flu-like sx,h/a,aching,joint aching,& fever;addl exp tingling in arm & hands;
Booster; I am also experiencing headache pretty bad headache; It seems to be sustaining or worsening; I have got a really large swollen area like a big lump under my arm pit and it''s really painful; I have got a really large swollen area like a big lump under my arm pit and it''s really painful; I have got a really large swollen area like a big lump under my arm pit and it''s really painful; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 27 year-old female patient received bnt162b2 (BNT162B2), administered in arm left (Lot number: FD7218) at the age of 27 years as dose number unknown (booster), single for covid-19 immunisation. Relevant medical history included: "Depression" (unspecified if ongoing); "sleeping" (unspecified if ongoing), notes: I have a sleeping medication Zolpidem. Concomitant medication(s) included: VENLAFAXINE taken for depression; ARIPIPRAZOLE taken for depression; ZOLPIDEM taken for sleep disorder. Vaccination history included: Covid-19 vaccine (DOSE NUMBER UNKNOWN; , MANUFACTUERER UNKNOWN), for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "Booster"; SWELLING (non-serious), AXILLARY MASS (non-serious), PAIN (non-serious) all with onset 07Dec2021, outcome "not recovered" and all described as "I have got a really large swollen area like a big lump under my arm pit and it''s really painful"; HEADACHE (non-serious), outcome "unknown", described as "I am also experiencing headache pretty bad headache"; CONDITION AGGRAVATED (non-serious), outcome "unknown", described as "It seems to be sustaining or worsening". Therapeutic measures were taken as a result of swelling, axillary mass, pain, headache.  Additional information: The patient received a Pfizer booster dose (Unspecified Shot) a few days ago and had a large swollen area like a big lump under her arm pit and which was painful. Patient guessed, she started at the night of 7th and really on the 8th of this month Dec. Patient received a shot around 48 hours ago and so may be 12 hours after she received the booster shot, she woke up and she was having lot of she was experiencing a lot of pain in her underarm that was continued she did not notice, when she went to shower, she noticed. The patient did take some Tylenol, so it didn't helped too much yesterday, she was also experiencing headache pretty bad headache but she was not sure if that was related, since the lump was right under the injection site so it was probably from that, she was also experiencing headache so all she was taking was Tylenol. It seemed to be sustaining or worsening. The patient's top of arm felt better like she would be able to, but the thing under her arm was very painful but otherwise the injection site felt like it got better.  No follow-up attempts are possible. No further information is expected.
48 hours after second COVID vaccine Patient started to have epistaxis lasting 8 hours on the first day, and persisting intermittently since then.  It was treated with Afrin three times in 24 hours, pressure, and ice.  The next day she went to an ENT who cauterized her nose.  She went back to an urgent care subsequently where her hct dropped from 39 on June 7, 2021 to  34.9 on June 12, 2021.  WBC briefly was 2.3 on 6-7-2021  but rebounded to 4.7 on 6/12/2021. Patient is otherwise well with no PH epistaxis, no meds, no allergies.
Migraine headache, brain fog, confusion, photosensitivity, sound sensitivity. Confusion started within two hours. Fever started within 12 hours. Left side migraine headache with photosensitivity from 12 hours and thru the following 5-6 days.
This case was reported by a physician via sales representative and described the occurrence of muscle pain in a 12-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). On 25 March 2010 the subject received 1st dose of CERVARIX (.5 ml ,unknown, unknown arm). On 27 March 2010, 2 days after vaccination with CERVARIX, the subject experienced severe muscle pain, joint pain, vomiting, diarrhea, facial flushing, fever, nausea, blurred vision, lethargy, headache and blood in urine. On 10 April 2010, the muscle pain, joint pain, vomiting diarrhea, facial flushing, fever, nausea, blurred vision, lethargy, headache and blood in urine were resolved. Follow-up information received from healthcare professional (the subject's mother) on 13 May 2010: CERVARIX was administered intramuscularly. The events resolved on 11 April 2010 (previously reported as 10 April 2010). The immunisation series with CERVARIX was discontinued.
Pt had 2nd dose of 0.25ml preservative free Fluzone at 5:50 pm and began wheezing with respiratory distress 45 minutes later. Pt received neb x2 and Prelone with adequate relief. Pt was wheeze free next day.  MR received revealing a healthy 9 month old in for well visit with only c/o mild chest congestion beginning that am. 1st Flu given at that time with no problem.  Infant began wheezing ~45 minutes after 2nd vax. Seen by MD and PE showed mild respiratory distress, a RR of 70, audible wheezing and decreased aeration. Given Xopenex nebs and Orapred with improvement noted.  F/U next day with resolution of wheezing, and lungs CTA.  Nebs were continued for 48 hrs.
The next day after getting the vaccine, it went up to 189/85/74, I took her to the hospital emergency room and it went up to 207, I had already gave her losartan 100mg at 10:00 pm and Lopressor at 11:00 pm, all these days she has been with pressures of 164/76/66, 179/80/72, mostly a range of 150 to 164 systolic, before administering the vaccine she had been 8 months more or less with stable pressure of 126/58/76 .
02/04/2021 I began to get an itchy arm and I developed a rash. my arm was sore. the rash covered my upper arm down to my elbow. today 02/08/2021 the rash is mostly gone but still noticeable and very itchy but much improved. I was very miserable and I am unsure if I should get the second.
Headaches, paresthesia, weakness, dizziness, twitches, body aches, brain fog, temperature intolerence, fainting. Treatment was ferritin infusion, medication, consuming lots of salat and water, iron supplement, vitamin D regimen. Outcomes are autonomic dysfunction and anemia.
Sudden on/off joint pain in hips and shoulders. Shoulder pain went away after 3  months. Hip pain continues and comes and goes in severity throughout the day, from zero pain to noticeably altering how I walk.
Called on-call pediatric nurse at 8/22/11 6:55pm 1 yr old with fever x 1 day which has resolved. Developed red, raised tiny rash to face, chest, and legs. Mom states rash looks like heat bumps. No discomfort to child. Norm behavior. Eating and drinking well. Family has convinced mom rash is the measles. MMR vaccine given 8/11/2011. Denies new detergent or medication. Was introduced to baked beans yesterday. Afebrile. No cough, vomiting, diarrhea, rash inside mouth, or redness to eyes. Seen on 8/23/11 at 10am at Clinic. Pt awake, afebrile, generalized red papular rash, no other symptoms. Discharged from visit with orders to monitor rash, RTC if it worsens. No meds rx.
when patient got the vaccine she had instant drop of blood pressure, felt so dizzy but not had any breathing issue. no treatment  was given to the patient. After few minutes patient was about to talk and felt fine. Her blood pressure come up to 106/69 and was able to go home.
According to patient - I was given the second COVID-19 Moderna vaccine and had a very bad reaction. My arm became extremely swollen, bright red, and hot. The injection site was the size of a golf ball.
05/31/2019: Per reporter, patient was later seen by PCP and assessed as Rocky Mountain Spotted Fever (RMSF). PCP information not available.   Pt received vaccine 4/8 and had no issues until 4/13, she stated in the evening on 4/13, she started to get fever/chills. Pt stated that the fever and chills continued and she had a full body rash on 4/18. She called dr office and the covering physician told her to take ZYRTEC 10mg otc. She has taken that with no change. When I spoke with her on 4/25, I urged her to contact her physician again as something more may be going on.
Approximately 2 months after the booster shot, I developed tinnitus in my left ear.  My hearing has been checked and it is normal.    I am not around loud noise or any other environment that would cause tinnitus.  I believe my tinnitus is a result of the booster shot.
Body aches that evening, next day body aches, chills, swimming head feeling, sore throat and nausea. Today sore throat, spins and nausea. Left early from work yesterday and took today off.
Patient received the 5-11 year old dose and was 12 at time of second Pfizer vaccination.
This is a spontaneous report from a non-contactable consumer (mother) via a project director for a market research study being conducted on behalf of the PREVNAR 13 pediatric brand team. A 12-month-old male patient received a dose of PREVENAR 13 on 16May2011. The patient went to his well visit and received 5 immunization shots, 3 in right leg and 2 in left leg on 16May2011. The mother does not know which vaccines they were, or if one of them was a Pfizer vaccine. The mother reports one was a "pneumococcal vaccine". Relevant medical history, concomitant medications and past product history were not reported. On 16May2011, within hours after vaccination, the child developed painful "bulges" and "tight lumps" on both injection sites. The mother applied warm moist compresses and administered liquid aspirin to relieve mild fever that had developed, following instructions that the doctor had provided. The child was monitored for 2 days while symptoms subsided. The patient is healthy today with no apparent permanent effects. The outcome was recovered.
Fatigue, fever, muscle aches, swollen lymph nodes in neck and right armpit, pain in arm at Injection site, itchy right armpit, congestion and cough. Last about 40 hours. Lymph node swelling and itchy armpit still ongoing