chrisvoncsefalvay/vaers-outcomes huggingface dataset:
feeling like something moves down with intermittent tingling; falling down feeling on left side of face and cheek bone / like skin is pulling down towards ear; This case was reported by a physician via call center representative and described the occurrence of tingling in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16th March 2021, the patient received the 1st dose of Shingrix. On 16th March 2021, less than a day after receiving Shingrix, the patient experienced tingling and feeling abnormal. On 8th June 2021, the outcome of the tingling and feeling abnormal were recovered/resolved.   It was unknown if the reporter considered the tingling and feeling abnormal to be related to Shingrix.  Additional details were provided are as follows: The age at vaccination was not reported. The patient received 1st dose of Shingrix and on same day experienced falling down feeling on left side of face and cheek bone and feeling like skin is pulling down towards ear or feeling like something moves down with intermittent tingling. No further information were provided. The reporter consented to follow up.
SORE ARM; 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: 202A21A, expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sore arm. This report was non-serious.
Vial of vaccine was not diluted prior to administration.  Patient had no adverse affects from dose
Resting heart rate in the 140s, normally in the 80s with heavy pressure on chest started 1 day after shot and lasted for 2 days followed by asthma symptoms.
After 8 hr pt got injection, pt had an reaction of swelling. Pharmacist told pt that she needs to try BENADRYL and cortizone cream. On next day, pt came to ER and prescribed prednisone 20mg.
This spontaneous report has been received from a licensed practical nurse referring to a 14 year old patient of unknown gender. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications were not reported. In April 2018, the patient was vaccinated with improperly stored vaccines of GARDASIL 9 lot # N025428 with expiration date of 19-JUN-2020 (strength, dose, route, and anatomical location were not provided), RECOMBIVAX HB, VARIVAX and M-M-R II (strength, dose, route, anatomical location and lot/batch# were not provided) for prophylaxis. The vaccines were exposed to a temperature excursion below 32 degree Fahrenheit (31.1 degree F) for 8 hours and 27 minutes, also between 32 degree F to 35 degree F (32.5 degree F) for 4 hours and 33 minutes, which were called by a data logger. No adverse events were reported. Product quality control issue was not involved. This is one of the 46 reports from the reporter.
First dose: She felt like she could hardly move; she felt like a new person; First dose: She felt like she got hit by mac truck, she was that tired; First dose: She felt like she got hit by mac truck, she was that tired; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 22Mar2021 15:40 (Lot number: EH6204) at the age of 63 years as dose1,single for covid-19 immunisation. Relevant medical history included: "Allergic to cats, dogs, and everything outside" (unspecified if ongoing); "Neuropathy" (ongoing); "Blood pressure" (ongoing). Concomitant medication(s) included: CLONAZEPAM taken for neuropathy peripheral; CAPTOPRIL taken for blood pressure management.  The following information was reported: FEELING ABNORMAL (non-serious), FATIGUE (non-serious) all with onset 23Mar2021, outcome "recovered" (25Mar2021) and all described as "First dose: She felt like she got hit by mac truck, she was that tired"; MOVEMENT DISORDER (non-serious), outcome "unknown", described as "First dose: She felt like she could hardly move"; PERSONALITY CHANGE (non-serious) with onset 25Mar2021, outcome "unknown", described as "she felt like a new person".  Additional information: It was reported that, patient had other concomitant Products Allergy shot: She goes to a clinic weekly to receive. Unknown name. She has been taking for over a year as patient was allergic to cats, dogs, and everything outside. Allergy shot: On the weeks that she received the first and second dose of her covid vaccine, she skipped getting her allergy shot that week. She normally gets her allergy shots every week. She gets vitamin B12 injections once a month, but she knows those were not vaccines. She received the first dose of the covid vaccine on 22Mar2021. She did have a reaction to the first dose. She just felt like she got hit by mac truck, she was that tired. She did not check for a fever. She did not have a headache. On 25Mar2021, she felt like a new person. She was out of work for two days. Clarifies that she was only out of work for one day. She went to work on the second day, and felt like she could hardly move.   No follow-up attempts are possible. No further information is expected.
1 week after injection the site became inflamed, hot to the touch and itchy and was about 13 cm diameter. Have not treated yet, but will take Benadryl this evening. Appears to be an allergic reaction at this time.
patient received the vaccination. asked him to wait for 15 min. during his waiting period fell and hit his head. he said he feel light headed . we called EMS and took him for evaluation
Pt developed epididymitis one day post receiving vaccines. Pt treated with Septra suspension (oral antibiotics) given x 10 days - given on 8/21/19 after visiting Hospital ER. Pt given Rocephin (IM antibiotics) while in ER. Pt given Ibuprofen on 8/21/19 while in ER. being seen for epididymitis. Pt given Kinrix and Proquad vaccines on 8/19/19. Pt seen in Hospital ER on 8/21/19 with right testicular pain and swelling. Pt seen at Pediatrics on 8/27/19 for a follow up visit from being diagnosed with epididymitis and is feeling better. Pt has no more teste swelling on 8/27/19 office visit.
Given PEDIARIX L thigh 6-9-08 afternoon, began w/ purple red that pm.  Seen 6/10 at clinic with 35mm x 18mm irreg red/purple non-blanching patch at injection site, no color, no pain. Afebrile.  F/U 6-12-08 - much better - 30 x 3mm..
This spontaneous report as received from a pharmacist refers to her currently 4 month old son with milk allergy. In February 2014, reported as "at 2 months", the patient was vaccinated at pediatrician's office with first dose of ROTATEQ (oral, dose and Lot # not reported). After the first dose in 2014 the reporter noticed a problem with baby's feeding, it was not good. On 05-MAY-2014, the patient was vaccinated with second dose of ROTATEQ (oral, dose and Lot# number not reported). On 12-MAY-2014, the baby received another set of vaccines like pneumococcal vaccine (manufacturer unknown). Concomitant therapies included MYLICON drops. The pharmacist stated that after the second dose, in May 2014 the same signs occurred (the baby's feeding was not good). In addition, his stomach was painful, he cried in sleep and appeared to be in constant discomfort. There was no vomiting or diarrhoea. On an unknown date the patient experienced a sensitive tummy. The pharmacist used Elementum for a sensitive tummy. The pharmacist contacted the pediatrician who stated that baby might have been getting used to live virus. On 06-MAY-2014, the baby developed fever and was given TYLENOL for and the fever went away (unspecified date in May 2014). No lab diagnostics studies were performed. The patient's outcome was reported as not recovered from problem with baby's feeding, painful stomach, crying in sleep, constant discomfort, sensitive tummy and fever. Causality assessment was not -provided. Additional information has been requested.
Frequent migraines , 2-3 per week, severe neck pain and debilitating head pain. Sudden onset?s no aura.
Patient reported ER visit 2 days following 2nd dose of covid 19 pfizer vacccine.  He stated that he had severe flu-like illnesses & became severely dehydrated.  He was given 4 bags of IV fluids in ER.
1 vial of undiluted Pfizer-BioNTech Covid-19 Vaccine was administered to the patient. 30 minutes after, patient denies allergic reaction. a follow up call was made to inform the patient about 1 undiluted vial administered, patient  denies reaction but feeling Ok. Patient was told to go to the Hospital if not feeling well. Another follow up call x2 patient denies allergic reaction, Another call 4/7/21,  AM and PM patient express no allergic reaction.
Patient given expired vaccine.  Vaccine expired on 3/1/2021.  No symptoms when checked on patient on 3/12 and 3/16
feels somewhat nauseous; has not been feeling well; feeling feverish- does not have a fever; glands/lymph nodes are swollen; feels ungodly tired; Chills; has not been feeling well/glands/lymph nodes are swollen/feels ungodly tired; This is a spontaneous report from a contactable consumer (patient).   A 79-years-old female patient received BNT162B2(PFIZER-BIONTECH COVID-19 MRNA VACCINE, Batch/Lot Number: EM9810; Expiration Date: 30Jun2021), via an unspecified route of administration, administered in Deltoid Left on 22Feb2021 15:30 (at the age of 79-years-old) as dose 2, single for covid-19 immunization.  Medical history included ongoing Systemic Lupus ,it was pretty bad and she had it for quite a few years; caller clarified she has had this for about thirty years. The patient's concomitant medications were not reported.  Patient historical vaccine included BNT162B2(PFIZER-BIONTECH COVID-19 MRNA VACCINE, Batch/Lot Number: EN5318; Expiration Date: 31May2021), via an unspecified route of administration, administered in Left shoulder on 28Jan2021 (at the age of 79-years-old) as dose 1, single for covid-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19, did not receive any other vaccines within 4 weeks and no other medications within 2 weeks. Since the vaccination, has the patient has not been tested for COVID-19. Patient was feeling unwell about a week and a half ago around 8Mar2021. She started feeling nauseous about three days ago, around 17Mar2021, and it is about the same. It was reported on 7Mar2021 or 8Mar2021, patient started feeling feverish but with no fever, her glands and lymph nodes were swollen; she started feeling ungodly tired; chills; and feeling unwell and like crap. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
was not able to get out of bed or have lights on; Knot, Swollen and heat at the injection site; Knot, Swollen and heat at the injection site; Knot, Swollen and heat at the injection site; Unbearable Headache; Continues eye twitching; Extremely tired; had a hard time walk due to the body aches; had a hard time walk due to the body aches; This is a spontaneous report from a non-contactable nurse (patient).  A female patient of an unspecified age received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) , via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization.  The patient medical history and concomitant medications were not reported.  The patient experienced Knot, Swollen and heat at the injection site, unbearable Headache that pain relievers would not help, Continues eye twitching, Extremely tired, and was not able to get out of bed or have lights on. She had a hard time walk due to the body aches. Outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Mobility decreased cannot be excluded.  The case will be reassessed if additional information becomes available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
,headache, left arm pain, body aches, chest pain, nausea, vomiting, diarrhea and fatigue X 2 days Itching X 6 days Benadryl 7 days Methylprednisolone for 6 days
Extreme soreness in upper left arm at the site of the injection; extreme fatigue (starting about 4 hours after the injection); headache (particularly behind the eyes); aching in joints all over the body.
11 year old child experienced a sudden, severe abnormal onset of her menstrual cycle 2 days post vaccine. She has had light regular cycles before but this one came 2 weeks early. This period has been abnormally heavy in that she is soaking a pad every hour, has severe menstrual cramps, nausea, and difficulty eating. She is also experiencing light headedness and headache. She has been unable to attend school due to the symptoms.
Patient hospitalized 10/16-10/21 with CHF exacerbation and increased weakness. Assessment by HH 10/23/12 and vaccine given. Patient developed nausea later in the day. Called EMS morning of 10/24 and patient taken to E.R.
Presented to office on 7/10/07 c/o facial stiffness, pain in ears, sl cough sniffles. Pain along bilateral parotids, bilat facial weakness. DTR's 2+, symmetric all 4 ext. 8/23/07-records received for DOS 7/10-7/13/07 DC DX: Bilateral facial palsy. Presumed Guillain Barre Syndrome. . IVIG treatment. Presented with C/O blurred vision and facial weakness/pain. Pain behind ear, mouth weakness and difficulty closing eyes. No fever no chills. Decreased reflexes on exam.
Mom contacted the clinic on 9/20/2013 stating pt has red and swelling on (R) arm pt came to clinic for visual pt applying ice pack. Large area on (R) arm no other symptoms.
This spontaneous report as received from a other health professional refers to a patient of unknown age. On 04-AUG-2017 the patient was vaccinated with LIQUID PEDVAXHIB lot # N000237, intramuscular in the left arm for prophylaxis. On 04-AUG-2017, 1 day after onset of therapy the patient experienced wrong drug administered. On an unknown date the patient experienced no adverse event. The outcome of wrong drug administered and no adverse event is unknown.
First vaccine received 11/20/21 with no symptoms. Second vaccine received 12/11/21 with irregular and fast heart beat. Saw his cardiologist on 12/20/21 EKG preformed and normal. Heart monitor given to record heart rhythm for 24hrs and blood work taken.  Results not in yet
5 days following vaccine - fever/chills/complete loss of strength... 30 days following vaccine COMPLETE LOSS OF STRENGTH.. patient fell twice - no strength to get himself up ... sent to hospital ... then to rehab facility
Bad reaction; Cough; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Bad reaction) and COUGH (Cough) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Bad reaction) and COUGH (Cough). At the time of the report, VACCINATION COMPLICATION (Bad reaction) and COUGH (Cough) outcome was unknown.            No concomitant medication was reported.  No treatment medication use was reported.   This case was linked to MOD-2021-363638 (Patient Link).   Reporter did not allow further contact
Broke out with shingles on September 17, 2020. Sensitivity, pain, and blisters
About an hour after receiving the vaccine I felt weakness in my arm and it was sore. Next day the injection site was swollen and I had mobility problems. I had a fever but it didn?t linger and a cough that lasted for 2 days. On Thursday 02/04/2021, I felt pain in my armpits and neck. The next day it was completely swollen. I went to the ER on 02/06/2021 and the gave me Motrin and an IV to help with the inflammation. Today is 02/08/2021 and my lymph nodes on my neck and armpit on my left side are still swollen and painful to the touch and I?m having problems moving my neck.
03/24/2023 I tested positive for Covid-19. I had trouble breathing with hip and joint pain. I was also fainted during the duration of Covid-19. I reached out to my doctor and symptoms are on going.
My entire body experienced extremely severe body pain; I couldn't walk; rash; Very weak and tired; Very weak and tired; This is a spontaneous report from a contactable consumer (reporting for herself). This 70-year-old female patient received first doe of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN5318) via an unspecified route of administration on left arm at a single dose on 04Feb2021 09:45 AM, for Covid-19 immunization. She Received second dose BNT162B2 (Pfizer Covid 19 vaccination, lot number EN6200) via an unspecified route of administration, on left arm at an single dose on 25Mar2021 for Covid-19 immunization. She was not pregnant at the time of vaccination. She had not received any other vaccine in four weeks. Medical history included type II diabetes, high blood pressure and pneumoconiosis. She was allergic to Chlorol Hydrate and Thimerasol. Concomitant medications included Metformin, Losartan HCTZ, Amlodipine, Zyrtec. On 09Mar2021 07:00 AM, the patient experienced a rash above her right knee, up my thigh, and knee pit, felt very weak and tired, her entire body experienced extremely severe body pain from upper neck down to feet. It got so bad that she could not walk, only took baby steps. It was stated that she would cry with hand on the wall with each baby step. On 12Mar2021, the patient went to the hospital emergency room and the patient was tested for Covid-19, blood test came out to be negative, results of SARS CoV-2, diagnostic radiologic EC EKG were unknown. She was treated with intravenous and pain medication. The outcome of the events of rash, felt very weak and tired, extremely severe body pain and could not walk was recovering.  No follow-up attempts are needed. No further information is expected.
Reported reaction much later than dose. Per Patient arem was initially sore- but not like the whole deltoid she says just "one little spot". Area initianlly red a flakey then darker pigment. Now light pink scar of 14mm x 17mm. She does not describe it in a manner consistent with cellulitis or allergic reaction. Told her to get preservative free next year.
Heartbeat 120 on April 27 and May 18 at night after both shots went away the next day. Dizziness and Nausea right after 1st shot. Sore arm 1st shot.
Patient received 2nd Pfizer COVID vaccine today; completed 15 min RN observation; however, described to nursing staff she was starting for feel dizziness, tingling of hands, feet and " sudden odd, metallic taste" in mouth.     A/O x 4 VS stable; reports dizziness, tingling to hand and feet bilaterally.  Patient was assisted w/transfer from chair to wheelchair and transported to UC department accompanied safely by RN. RN/COM advised of incident.
Initial misuse report received from a healthcare professional on 09 July 2013. A 4-year-old patient received the DTAP/IPV component of PENTACEL vaccine instead of DTAP/IPV combination or separate DTAP and IPV vaccines. The patient already had 4 doses of Hib vaccines previously. No adverse event was reported. List of documents held by sender: none.
Swelling of arm at DTAP injection site, resolved on its own after 48 hrs. No s/s of infection per mom.
Chest pain and rapid heart beat.  Fever, headache, nausea, muscle pain, tired.
This spontaneous report as received from a Register Nurse refers to a 11 year old patient, of unknown gender. Medical history and concurrent conditions were not reported. On 30-SEP-2014, the patient was vaccinated with RECOMBIVAX HB lot # J009051, expiration date 26-MAR-2016 (dose, strength, route and frequency were not reported). The patient was vaccinated with improperly stored RECOMBIVAX HB. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
onset day 3-4 myalgias, weakness;migratory (proximal to distal flexors to extensors); dx polymyositis-lab CPK 800's; days 10-11 facial rashes; tx steroids day 13; time course 3 wks;
Day 4 after second vaccine I noticed itching in injection arm - no redness. Day 5: rash began- itching painful. Day 6: rash grew at fast rate. Covered right side of left arm from shoulder to about 1 inch above elbow. Itching, painful, bumps with overall redness. Day 7: continues to grow  now has gone toward left side of arm  also down to forearm now. Continue to covers to chest but not yet beyond. Can be felt toward armpit. Itchy, bumpy with overall redness, pain. Treating with: ice, 1% hydrocortisone, tylenol ? Benadryl. I do not currently have a PCP so I have not consulted with physician.
Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Additional Details: Patient complains of rash on face, was told to take benadryl and see if resolves. For patient to call us back or doctor if worsening.
awoke 1030AM on 13AUG98 w/red flat rash on chest, stomach, back, head, & neck;no fever; c/o itching;
patient called on 4-7-21  and stated she had redness and arm pain on 4-5-21 and lasted one day, and wanted to make sure it was ok, or if normal that this occurred
Patient under age 18 was vaccinated with Moderna, which is a vaccine error.  (If the person may receive a second dose, it will be per policy off-label use for a 17-year old). Troubleshooting: Scribe and vaccinator did not validate age;  screeners at the beginning of the process did not ask or turn away. Parent validated age as 18. Unreported as error, found in data mining.
Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Mild
Large rash at the injection site that was itchy and painful.  Underarm muscle soreness and pain in the same arm at the same time the rash developed.
The student complained of feeling dizzy after receiving the four vaccines. She looked pale and sweating . She is awake and responds to verbal stimuli. Denied any shortness of breath, chest discomfort  or nausea and vomiting. Student placed on flat position with feet elevated. Vital signs: 2:33pm ( Laying down)BP 82/43, HR 58, RR 20, pale, sweating  and dizzy, no n/v, no SOB 2:35pm ( Laying down)BP 84/50, HR 69, RR 20, pink color, sweating, no SOB and no dizziness 2:38pm ( Laying down)BP 89/53, HR 68, RR 20, pink , no sweating, no SOB and no dizziness  2:46pm  ( Laying down)BP 84/48,HR 65, RR 20, pink, no sweating, no SOB and no dizziness 2:51pm  ( Sitting)BP 98/65, HR 66, RR 20, pink, no sweating, no SOB and no dizziness 2:57pm  ( Sitting)BP 89/58, HR 64, RR 16, pink, no sweating, no SOB and no dizziness 3:01pm  ( Sitting)BP 90/69, HR 67, RR 16, pink, no sweating, no SOB and no dizziness 3:06pm  ( Standing)BP 94/61, HR99 , RR 16, pink, no sweating, no SOB and no dizziness 3:14pm  ( Standing)BP 92/70,  HR99 , RR 16, pink, no sweating, no SOB and no dizziness 3:30pm  ( Sitting)BP 92/65, HR75, RR 16, pink, no sweating, no SOB and no dizziness Mother took student home in stable condition. Advised to call EMS in case of shortness of breath or chest discomfort.