chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pain; 2019 after her first dose of Shingrix in July/second dose of Shingrix as January 2020 /shingles that began in the 3rd week of August, 2020; shingles that began in the 3rd week of August, 2020; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (experienced shingles outbreak (average per 2 year)). Previously administered products included Zostavax (received Zostavax vaccine several years ago).   In July 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In January 2020, the patient received the 2nd dose of Shingrix. On 23rd August 2020, between 1 and 2 years after receiving Shingrix and between 6 and 8 months after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the patient experienced pain. The patient was treated with acyclovir and gabapentin. On an unknown date, the outcome of the vaccination failure and pain were unknown and the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingrix and Shingrix.  Additional details were provided as follows:  The age at vaccination was not reported. The patient 2 doses of shingrix and experienced shingles. The patient had history of chronic shingles (average per 2 days). The patient had received Zostavax several years ago and did not diminish number of shingles outbreak. After 1st shingrix vaccination, patient experienced atleast one outbreak in 2019. The reporter mentioned that, patient had recently recovered from case of shingles that experienced in 3rd week of August. At the day of reporting, patient started to experience shingles. The patient was treated with acyclovir and during outbreaks and gabapectin for pain. This case was considered as suspected vaccination failure as details regarding laboratory confirmation was unknown at the time of reporting. The reporter did not consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020190572:1st dose
pt recvd vax & devel a mild fever & a rash; No further details were provided;
pt recvd vax 12PM; between 5-6PM began screaming unconstrolably lasting x 3 hrs; t102-104 APAP was given q 4 hrs; woke 25NOV w/temp still 104 lasting until 2PM that day was fussy & irritable that day-but no temp;
PT. INITIALLY HAD SEVERE SORENESS ON DAY 2, AND THEN PROCEEDED TO HAVE AREA GROW VERY ERYTHEMATOUS AND PRURITIC.  THE AREA IS WORSENING.  THE AREA IS HARD, SWOLLEN, AND SORE.  THE CONCERN IS THAT AREA IS WORSENING.  ICE PACK HAS BEEN APPLIED.  PER INTERNET RESEARCH, NSAIDS HAVE NOT BEEN EFFECTIVE, SO WE HAVE NOT PURSUED THIS.
PFizer-BioNTech Covid-19 Vaccine EUA Muscle soreness at the injection site lasting for 24 hours.
Headache in exactly the same spot on the side where the vaccine was given.  Does not respond well to NSAIDS rizatriptan refilled to counter headaches.  Will be getting an MRI for more info in the future.
7/29/21: Patient arrived at the ER due to being found unresponsive with low blood sugar. Patient tested positive for COVID on 7/29/2021.  Diagnosed with COVID-19 pneumonia Note: patient previously vaccinated with Pfizer COVID-19 vaccine (2nd dose in Feb 2021) 8/8/21: patient transferred to ICU 8/12/21: patient still admitted at the time of this report submission. Please note: Patient received First dose of Pfizer COVID-19 vaccine on 1/14/2021, followed by the second dose on 2/3/2021 (confirmed through database)
p/vax pt c/o dizziness, BP taken BP 92/60 AR 80 reg, RR20;radial pulse 77 reg;911 called pt refused to got for f/u;
The Medical Assistant went to give the vaccine and the child kicked  and only half the vaccine was given.  The MA states she cleaned the needle with an alcohol wipe and cleansed the child's skin with a fresh alcohol wipe and injected the rest of the vaccine.
Tingling/pin prick sensations on right side of face. Including forehead, around eye, right temple, around ear, cheek, mouth and chin; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 67 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 26Feb2021 12:30 (Lot number: EN6202) at the age of 67 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Low thyroid" (unspecified if ongoing); "Allergy" (unspecified if ongoing), notes: Sulfa base. Concomitant medication(s) included: LEVOTHYROXINE SODIUM; VITAMIN D [VITAMIN D NOS]. The following information was reported: PARAESTHESIA (non-serious) with onset 09Mar2021, outcome "recovering", described as "Tingling/pin prick sensations on right side of face. Including forehead, around eye, right temple, around ear, cheek, mouth and chin". The event "tingling/pin prick sensations on right side of face. including forehead, around eye, right temple, around ear, cheek, mouth and chin" was evaluated at the physician office visit. Therapeutic measures were not taken as a result of paraesthesia.  Additional information: Facility where the most recent COVID-19 vaccine was administered was Pharmacy or Drug Store. The patient did not recieve any other vaccines within 4 weeks prior to the COVID vaccine. Other medications the patient received within 2 weeks of vaccination included Levothyroxine, multivitamin, vitamin D. The adverse event resulted in visit to Doctor or other healthcare professional office or clinic visit. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.   No follow-up attempts are possible. No further information is expected.
Full body aches; Fatigue; This is a spontaneous report from a contactable nurse via Pfizer sales representative. This nurse reported similar events for two patients. This is first of two reports.   A 16-year-old patient of an unspecified gender received meningococcal group b rlp2086 (TRUMENBA) on an unspecified date, at single dose, for immunization. Relevant medical history and concomitant medications were unknown. On an unspecified date, 24 hours after the vaccination, the patient experienced full body aches and fatigue. Clinical outcome of the adverse events was unknown at time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020322824 Same reporter, product, AE and different patient
Rash developed at injection site. Patient noticed adverse effect within 24 hours of injection. Rash is red, warm, and feels hard at injection site. No fever is reported. Immunizer advised patient to report to MD if rash worsens or does not subside.
After taking the vaccine when she got home she was very tired.  About 3 days later she had a fever. She started to feel dizziness and weakness and taking to the hospital. Her blood pressure went up and her heartbeat became very fast. After a few days in the hospital she was dx with COVID.
13 hours later i began to shake uncontrollably for about 15-20 minutes. Shivering, very cold, seemed like a fever. 7 hours after that my whole body aches, but no shivering.
Approx 2-3 hrs p/vax given pt devel fever 101-103 (lasting 3 days), nausea, weakness, upper respiratory congestion, sore throat;
Hives on arms, hands, redness on face appeared 2 days after vaccine. Nothing at injection site. Pt unsure of these s/s were related to the vaccine or not.
Rapid Heart beat....Went to the ER 11:00AM and got treated for Afib.
Severe burning in both armpits with red lumps; Severe burning in both armpits with red lumps; Fever of 100.0; headache; sore injection site; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 39-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL9264 and expiry date: unknown), dose 1 via an unspecified route of administration, administered in Arm Left on 28Feb2021 at 12:15 as DOSE 1, SINGLE for covid-19 immunisation (age at vaccination: 39-years-old). Medical history included hypothyroidism. The patient had no known allergies. Concomitant medication included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), levothyroxine sodium (LEVOTHYROXINE SODIUM), liothyronine sodium (CYTOMEL). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced severe burning in both armpits with red lumps, fever of 100.0, headache and sore injection site on 28Feb2021 at 22:00. The patient underwent lab tests and procedures which included body temperature: 100 on 28Feb2021 (100 degree). No treatment was received for the events. Outcome of all the events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
After receiving all those immunization shots I noticed on the leg that recieved the shots he could barely walk on that leg and was walking on his tip toes. For almost a week after my son had that limp and tip toe walking. Eventually the limp went away but the tip toe walking never went away and now he tip toe walks with both legs. I have had my son with me every day of his life I don?t work so I literally mean every single day he never walked like that prior
Hypotension; nauseous; dizzy/feeling extremely faint; This is a spontaneous report from a contactable other healthcare professional (patient). A 24-year-old female patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number unknown), via an unspecified route of administration in left arm on 16Jan2021 03:30 at a single dose for COVID-19 immunization. There were no medical history and concomitant medications. The patient have no known allergies to medications, food, or other products. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. On 16Jan2021 03:30, the patient experienced hypotension, nauseous, dizzy/feeling extremely faint. The patient underwent lab tests and procedures which included monitoring and check of vitals with unknown results. Outcome of the events was recovered on Jan2021.  Information on batch/lot number was requested.
Very bad headache; soreness in neck; This is a spontaneous report from a contactable consumer (patient).   A 65-year-old patient of an unspecified gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in arm right on 10Feb2021 at 18:30 (Batch/Lot Number: EL9269) as single dose for covid-19 immunisation.  Medical history included 3 joint arthroplasty and methylenetetrahydrofolate reductase deficiency (MTHFR). The patient's concomitant medications were not reported. On 11Feb2021 06:30, patient experienced very bad headache with outcome of not recovered, soreness in neck with outcome of not recovered.    Follow-up (11May2021): Follow-up attempts completed. No further information expected.
Woke the night following the vaccine with a fever of 100.4, body aches, a headache, and sharp pain at the injection site that made me unable to move my arm. I was unable to sleep or move around without fatigue. These symptoms continued throughout the following day and ibuprofen had little effect. My fever broke after a Tylenol PM and  on the second day following the injection the other symptoms started to alleviate.
Semi paralyzed/immovable neck, low back; pain; blurry vision; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 29Sep2022 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "HAE-type 1" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Unknown manufacturer), for COVID-19 immunization; Bnt162b2 (Dose 2), for COVID-19 immunization, reaction(s): "like being crushed underneath a train car for 4 days". The following information was reported: PARALYSIS (medically significant) with onset 2022, outcome "unknown", described as "Semi paralyzed/immovable neck, low back"; VISION BLURRED (non-serious) with onset 2022, outcome "recovering", described as "blurry vision"; PAIN (non-serious) with onset 2022, outcome "recovering". Clinical course: Semi paralyzed from the most recent booster. Received on 29Sep2022. Pain 3 hours after escalating all week to immovable neck, low back and blurry vision. Today a 20% improvement, so promising! Patient had HAE-type 1 and have had all vaccines and boosters. Patient second vaccine reaction was like being crushed underneath a train car for 4 days. Patient was afraid to get another booster. Patient stated that didn't have knowledge to know if could become a fatality.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Woke up on 10/22 around 6 am with pain, edema and erythema at sight of injection on left arm. Was told to monitor site; have rechecked on 10/24 if still hurts.
Patient was given booster dose of 12+ pfizer vaccine after fda pulled approval for monovalent booster.
Patient developed numbness of left side of face within 1-2 hours after the covid vaccine administration which lasted for 24 hours, resolved completely the next day without any medications.  She also had extreme weakness of extremities, couldn't get out of bed.  Denies chest pain, SOB, palpitation, fever, headache, hives/rash.  Has history of allergic reaction to flu vaccine in 2007.  She developed dyspnea, SOB, dysphagia after flu vaccine. She was not evaluated at ED at that time.
Pt received COVID-19 vaccine @ 1422 and reported feeling lightheaded, dizzy and tingling at approximately 1430 in 15 minute waiting parking lot B/P 80/40 HR 66 O2 stats 97% appeared pale -encouraged to lie his seat back and rest for a few minutes. B/P received approx. 20 later and was high to 112/62 lying and 118/64 sitting --Major assessed pt and encouraged him to seek medical attention --encouraged him not to drive himself-- pt called friends to come pick him up -- he seems to have had a near  episode encouraged to have had 2nd dose at a medical clinic or hospital -- monitored for approx. 5 minutes (1430-1518./m,n1
After 11 days after the shot the red spot getting bigger and etching. Also the  spot around the shot is still firm.
arm swelling Strong arm and shoulder pain severe fatigue severe muscle ache severe joint aches  fever up to 102 at 24 hours after vaccine
DIZZINESS; SLEEPY ALL DAY; 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 not reported, batch number: Unknown) dose was not reported, administered on 19-JUN-2021 18:50 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 20-JUN-2021, the subject experienced dizziness. On 20-JUN-2021, the subject experienced sleepy all day. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sleepy all day on 20-JUN-2021, and had not recovered from dizziness. This report was non-serious.
Sudden onset of high fever (104.4), chills, hands, arms and chest, cool and clammy to touch. Difficulty Breathing, behavior changes -> lethargy and small raised hives around injection site. Symptoms started approx 8 hours after vaccination.
Chills, body aches, fever (up to 102.9), and extreme tiredness for about 24 hours
Rash all over her body and discomfort in hands and feet since 07/29/17. On exam: Bilateral arms and thighs w/scattered erythematous raised urticaria lesions that are symmetric in their distribution. Swelling of joints. (R) and (L) arms, thighs, hands and feet. ROM none. Possible reaction to GARDASIL 9 vaccine. Patient's symptoms improved with use of CLARITIN and topical lotion.
Headache, 5 dime sized bumps on Right Butt cheek, menstrual period started up again 7 days after injection, diarrhea , itchy throat, sneezing, runny nose
Approximately 7-10 days after the VAX, my wife noticed a small bald spot on the back of  my head about 1 inch in diameter.  It slowly grew larger and is now 3.5 inches in diameter.
Red spots on chest. Red hot hard welt about 1.5 inches on right thigh.  Bruising left and right thigh.
tested Covid positive/extreme tiredness, and was sleeping a lot, with terrible body aches and pains; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 08Mar2021 as 1st dose, single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient stated that she wanted to reschedule her 2nd vaccine shot. The first dose was on 08Mar2021 and her next dose was supposed to be on 29Mar2021. The reason for her rescheduling was that she contracted COVID infection after having the first dose. She tested COVID positive last 10Mar2021. The advice to reschedule came from her doctor. The patient experienced extreme tiredness, and was sleeping a lot, with terrible body aches and pains. These have now subsided, but she was still not feeling 100% better. The patient underwent lab tests and procedures which included COVID test result positive on 10Mar2021. The outcome of the event was unknown.  Medical Information: Were any unaddressed medical questions referred or forwarded to Medical Information No  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Information has been received from a Licensed Vocation Nurse referring to two unspecified six month old patients of unknown gender. On 12-JUN-2015, the patient were inadvertently vaccinated with a dose of VAQTA (lot number, dose and route were unknown) (Drug administered to patient of inappropriate age). No adverse effects were reported. Additional information is not expected because the reporter did not want to be contacted.
COMPLAINS OF NUMBNESS TO TIP OF LIP WITHIN MINUTES OF ADMINISTRATION. DENIES HISTORY OF ANAPHYLAXSIS. TRANSFERRED IMMEDIATELY TO HOSPITAL ED
4 hours after vaccine patient complained to mom of dizziness and shortness of breath. Mom states patient had fever, but did not take temperature. Mom listened to patient and she was not wheezing.
The area vaccinated turned red and raised the day given. The redness increased each day and the redness spread down her arm about 8inches a week later. It was warm to touch and raised.
Headache, Sedation, Myalgia, Arthralgia, chills and fatigue. pain at injection site. Narrative:
Face flushed. Skin on arms got blotchy. Burning sensation going up neck and back of head and around mouth and forearms. Sensation kept moving. Would last a couple of seconds and move. Lasted for about an hour and a half after getting shot. Took Benadryl as suggested by nursing staff.
The patient got the shot which is Pfizer, after 5 minutes the patient complained feeling of  nauseous. The nurse offered a emesis bag, assessed and monitored her vital signs every 10 minutes. Initial vital signs is BP: 90/63 PR: 102. Encouraged to increased fluid intake and to stay calm and rest. A provider came to checked the patient. After 1 hour of treatment, vital signs are stable within the same range  for the past hour. Patient verbalized feeling of relief and no more complains. Education was imparted to stay hydrated, eat and rest.
Information has been received from a consumer concerning her 15 month old daughter with a history of hives who on 22-JAN-2010 was vaccinated with the first dose of MMR II (lot# not reported). There was no concomitant medication. It was reported that her daughter was pre-medicated with BENADRYL prior to administering MMR II. She was given ZYRTEC after receiving MMR II. On 22-JAN-2010, within seconds of receiving MMR II, the patient develop a hive on her leg less than an inch below injection site. The hive cleared quicker this time. This is one of several reports from the same source. No further information is available. This is an amended report. The registration number is changed from V210 to V205C. This report was previously sent to V210 from previously submitted report.
In the ~3 days after my booster, I had the same symptoms I?d had with my first two shots (fever, pretty significant chills, fatigue), but didn?t find these unusual or alarming. On the morning of 11/3, I woke up and within about 30 minutes developed what I thought were hives across my trunk and limbs. It felt (itchiness) like the anaphylactic reactions I?d had as a kid, but the rash didn?t look like the wheals I?d had in those events. It looked like a really severe version of dermatographia (e.g. large red, raised, itchy patches where clothes touched skin, even lightly); I?ve had dermatographia my entire life, but nowhere bear this severe. I started seeing red blotches on my neck and promptly had my partner take me to the ED, since my anaphylaxis events as a kid involved my airway, and I didn?t want to be wrong and not be seen for this reaction in case I did have an airway threat. I took a Benadryl on the way, and ended up staying in the ED for a few hours for observation; I didn?t need any epinephrine. I was advised to continue Benadryl as needed and add an H2-blocker (famotidine) and an H1-blocker like cetirizine as well. I took these consistently but did not find relief and was seen at an urgent care clinic on 12/6 for a dose of dexamethasone, which helped to a degree for several days. I continued taking cetirizine (eventually switched to fexodenadine) regularly and Benadryl as needed and used ice packs and cool showers to allay symptoms. These symptoms have reduced over time but are still intermittently present.
I was not feeling well and I thought I had a sinus infection. My sinus hurt, I had a lot of phlegm and a high fever. I ended up doing a COIVD-19 Home Test and it was positive. I did reach out to my health care provider, and it was too late to get on a medication. I did end up feeling better after COVID but I had a sinus infection as well following it and I had to go in for an antibiotic as well.
A few minutes after receiving her 4th dose of the Moderna Covid Vaccine the patient started complaining of a "lumpy/scratchy" feeling in the back of her throat that was very noticeable upon swallowing. She complained the sensation was getting worse and she was concerned for airway occlusion. Epi Auto-injector given to patient and EMS notified. EMS arrived within 6 min and transferred patient to nearby ER. Patient was alert and oriented upon EMS arrival and was verbalizing that the sensation had gotten better since receiving the EPI.
Lightheaded & dizzy. Checked blood pressure, patient stated it was lower than normal. Had patient sit w/ feet elevated. Blood pressure returned to normal after approx 20 min.