chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Stung by 200 bees; Slight swelling at injection site; This spontaneous case was reported by a consumer and describes the occurrence of ARTHROPOD STING (Stung by 200 bees) in a 92-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Feb-2021, the patient experienced ARTHROPOD STING (Stung by 200 bees) (seriousness criterion hospitalization). On an unknown date, the patient experienced VACCINATION SITE SWELLING (Slight swelling at injection site). The patient was hospitalized on 20-Feb-2021 due to ARTHROPOD STING. The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (intravenous) at an unspecified dose and frequency. At the time of the report, ARTHROPOD STING (Stung by 200 bees) and VACCINATION SITE SWELLING (Slight swelling at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Additional treatment for the event included IV steroids.  Company Comment : Based on provided information of patient being stung by bees, the event Arthropod sting is assessed as unlikely related to mRNA-1273. Based on the current available information and temporal association between the use of the product and the start date of the event of vaccination site swelling, a causal relationship cannot be excluded.; Sender's Comments: Based on provided information of patient being stung by bees, the event Arthropod sting is assessed as unlikely related to mRNA-1273. Based on the current available information and temporal association between the use of the product and the start date of the event of vaccination site swelling, a causal relationship cannot be excluded.
Diarrhea, abdominal cramps, malodorous gas, general unwell feeling; Started on 03/02/21 around 8 Am.. Still ongoing at time of this report.
Left thigh itchy rash 2 x 3 cm developed 10 days after the 1 yr old received MMR and PCV 13 in left thigh. (She also received varicella, HEP A, HIB in right thigh). No treatment required but will recheck. Cautioned avoid direct contact with rash from vaccinated individuals.
left shoulder got frozen; muscle spasm; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administered in deltoid left, administration date Jan2022 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Vaccination history included: Bnt162b2 (1st dose), administration date: Dec2021, for COVID-19 immunization, reaction(s): "taking antidepressants and antipsychotics, but after receiving the vaccine, her medications had stopped working.", "she has gained 10 pounds". The following information was reported: MUSCULOSKELETAL STIFFNESS (medically significant), outcome "unknown", described as "left shoulder got frozen"; MUSCLE SPASMS (medically significant), outcome "unknown", described as "muscle spasm". The events "left shoulder got frozen" and "muscle spasm" were evaluated at the physician office visit.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events and the use of suspect product BNT162B2 cannot be fully excluded. 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.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 10-AUG-2018, the patient was vaccinated with an improperly stored PROQUAD recombinant human albumin (rHA) (Strength, dose, route and anatomical location were not reported) of lot # N016993 with an expiry date of 29-NOV-2018 for prophylaxis. The concomitant therapy included sterile diluent. The PROQUAD underwent a temperature excursion from - 14 degree Celsius to - 10 degree Celsius for a timeframe of 16 minutes. The previous temperature excursion was from - 14 degree Celsius to - 10 degree Celsius for 14 minutes. Digital data logger was involved. No adverse effects were reported. Product quality complaint was not involved.
runny nose; sneezing; don't feel right; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program. An 82-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, unknown lot number and expiration), via an unspecified route of administration on 14Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  The patient experienced side effects after receiving the COVID-19 vaccine on 14Jan2021. The patient experienced runny nose, sneezing and he don't feel right in Jan2021. He is also concerned about his wife if there is a possibility of infecting her since she doesn't have received the COVID-19 vaccine yet. Outcome of the events was unknown.   Information on the lot/batch number has been requested.
After mass vaccination event on Friday March 12, while entering data, I noted that client had received his boost vaccine one week early. Client notified of error. Denies any current side effects. Given info that there is no recommendation to acquire a 3rd dose at this time. Also spoke with mother who stated client was having fever today (Mar 14). Information restated for mother.
Very bad swelling around their neck/very severe/swelling came down a little but it is still swollen; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Very bad swelling around their neck/very severe/swelling came down a little but it is still swollen) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, the patient experienced SWELLING (Very bad swelling around their neck/very severe/swelling came down a little but it is still swollen). At the time of the report, SWELLING (Very bad swelling around their neck/very severe/swelling came down a little but it is still swollen) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.
Information has been received from a registered nurse (R.N.) concerning a, 43-year-old female housewife with no pre-existing allergies, birth defects or medical conditions who on 05-JUL-2007 was inadvertently vaccinated with a subcutaneous dose of Zostavax (Oka/Merck) instead of Varivax (Oka/Merck).  There were no illnesses at the time of vaccination.  It is reported that this error was not due to product confusion but due to human error.  It is unspecified if medical attention was sought.  No adverse experience was related to this event.  No further information is available.  No product quality complaint was involved.  Follow-up information received on 30-Jul-2007 via a telephone call from the registered nurse indicated that there has been no further contact from the female patient and there is no information about adverse experiences.  The patient's name was unknown, the physician involved was unavailable and the box of Zostavax (Oka/Merck) has since been emptied so the lot number could not be obtained.  The nurse reported that the event happened because the nurse administering the vaccination thought she was grabbing a vile of generic varicella.  The boxes were stored one in front of the other.  No more information is expected.
Information has been received from a physician concerning a 76 year old male with heart disease, elevated cholesterol, atrial fibrillation, enlarged prostate and allergy to epinephrine and a history of stroke who on 04-NOV-2008 was vaccinated with PNEUMOVAX vaccine, 0.5 mL, intramuscularly in arm. It was reported that on 04-NOV-2008, the patient developed local redness and swelling at injection site of PNEUMOVAX vaccine. This developed the evening of the injection. At the time of the report, the patient had not recovered. Additional information has been requested.
Rash began on Thur am around injection site on leg going to mid thigh.  By Friday pm still same.  By Saturday am all over body of arms, legs, face and bottom bright red, hot to the touch and itchy.  Patient miserable from listing above.  Treated with Benadryl, 3 ml every 6 hours.  Did for 3 days.
Severe body aches and muscle spasms.  Shoulders, arms, back and hip area.   Shoulders and upper arms are the worst though.  I?ve drank a lot water, Gatorade, took Ibuprofen and ate a banana for potassium but still experiencing the muscle pain and tightness.  It has only been 2 days though but I was advised to report it.
Patient reports possible reaction to first vaccination.  She reported having a rash on her forearms.  She had not reaction to the 2nd or 3rd dose at all.  Pt states she is allergic to many medications and foods.  She stated she may not be able to attribute it to the vaccine at all.
Begin itching on arms/legs/torso. Bumps like/size of chickenpox with small blister heads appeared. Severe itching so took BENADRYL and used cortisone cream. Bumps spread over torso, back of arms, armpits, tools of legs, behind knees. Bumps still itchy and very visible as of 9/17/2016. No fever. No malaise. No headache or other symptoms.  Bumps do not scab over nor do blisters break and spread. Largest bump about width of frozen green pea.
Excessive swelling redness and pain at the injection site. Benadryl by mouth and cold compress at site. Reaction was about 3 inches across.
Got the vaccine, got home and was fine.  She waited for the same reactions that she had with the first one, felt perfectly fine.  She went to sleep at around 11:00 AM, and got up around 7:00 and as soon as she woke up she could feel the lump under her arm.  It was a little smaller than a baseball, soft, cystic like.  I couldn't put her arm down, had to keep her hand on the hip due to this.  The following day the left breast started to feel funny and hurting, but cannot feel a lump but it feels swollen and went up into the shoulder and neck.  She cannot turn her neck as if she has a crick in it.  She had a headache for a couple of days on and off, and then it goes away.  She has taken the arthritis Tylenol.  She has called her doctor and told her to take the Tylenol as needed.
Narrative:  Pt is a 45 y/o male with PMH significant for T2DM, panic attach, cognitive disorder, PTSD, psychosis, anxiety disorder, HTN, obesity, fibromyalgia, and low back pain. Pt received first Covid-19 vaccine dose on 3/10/2021. At the time, pt reported to physician 18 minutes after receiving vaccine feeling increased HR. Patient denied chest pain, dyspnea, weakness, flushing, abdominal pain, rash, or N/V/D. Vitals were checked which resulted: BP 153/103 HR 75 O2 Sat 98 % on RA. Pt endorsed that elevated BP and HR is normal when in an anxious state, pt also states he is worried about vaccine side effects. Repeat BPs were taken: BP 4:35 157/109 mmHg HR 75, 4:42 150/103 mmHg. Pt was observed for 40 minutes since reporting sxs and remained stable with no c/o. Pt was reexamined and cardiac/pulmonary examination remained normal. Pt received his second Covid-19 vaccine dose on 3/31/2021. Per chart review, no noted s/sx related to COVID-19 post 2nd administered dose.
Upon awakening: 5:15AM-soreness in R arm, nausea, vomiting and headache which continue through 10:30AM (time of report). Ate usual bkft-inc. water/coffee and is now leaving work early.
Information has been received from a physician via a registered nurse concerning his sister who was vaccinated with a dose of pneumococcal vaccine 23 polyvalent. Subsequently, the patient found that her injected arm became swollen, warm, and painful. The nurse also provided information regarding other patient's experiences. The patient sought unspecified medical attention. Additional information has been requested.
During the third injection of Engerix B the pt experienced severe pain at the injection site. She cried. Reportedly the appearance of Engerix B was normal. On follow-up the reporter stated that the symptoms resolved within one week without further complications. the most recent information received reports the outcome of the event as resolved.
patient states she has vaccines in late March/April 2021 This is a 63y.o. female with hx of COPD, HTN who presents to the hospital with a chief complaint of chest pain since 10/19 4pm. Pt states that the pain is in the middle of the chest and feels like she go punched in the chest. Her chest pain radiates to the right side. Pt  Was Covid vaccinated with Pfizer in march/april. Pt states that she has been coughing since 10/16 on which she went to a kids football game and she was sitting outside, so she attributed it to getting a small cold. Right knee replaced 2021. Pt states she has drop foot of the left foot which she sees a orthopedic doctor with providence after clubfoot repair. Pt states that she smokes 1/2 PPD but quit recently and relapsed. Pt states that she does not drink.  Pt states that daughter can make medical decisions for her if she becomes incapacitated. Pt states that she had surgery in the past to fuse vertebrae of the neck and lower back with recurrent nerve damage after the procedure and associated neuropathy.
On Wednesday night July 27 2022 I ran a slight fever and my nose was running on the 28th I was achy with a runny nose still during the daytime of the 29th I had a sore throat and high temperature and had a positive COVID-19 test. I called my doctor this same day and was prescribed PAXLOVID I took the medication for the seven day regimen and remained at home. On the fourteenth of August I saw my kidney doctor and my function was slightly lower but within range. I was also fatigued for about three weeks as well.
pt recv vax & devel severe swelling in rt thigh 24hr p/vax;developed significant pain, limping;tx for cellulitis w/keflex in ER;swelling resolved in 2-3 days;
This spontaneous report was received from a nurse refers to an unspecified number of patients of unknown age. On an unknown date, the patients were vaccinated with improperly stored GARDASIL 9, lot # M013636, 15-FEB-2018, lot # M009378, 23-APR-2018, lot # M014927 expiration 18-FEB-2019 for prophylaxis. No adverse effects reported. Temperature excursion 10-AUG-2016 50.5 F for 1hour and 12mins, 18-AUG-2016 49.6F for 29mins, 29-AUG-2016 47.1 F for 21mins, 06-SEP-2016 48.2F for 12mins, 15-SEP-2016 47.4F for 25mins, 23-SEP-2016 34.1F for 1hour 13mins, 24-SEP-2016 34.7 F for 33mins, 25-SEP-2016 35F for 18mins, 26-SEP-2016 53.2 for 1hour 15mins. High temperatures 53.2 F 262 minutes, Low temperatures 34.1F 124 mins. Follow-up information has been received on 30-NOV-2016. All telephone attemps to obtain follow-up information have been unsuccessful. This is one of the two reports received from the same reporter. Additional information has been requested. Sender's Comments: MERCK 1610USA008045: Mfr number.
10/21/2021 Awake feeing Nauseous and Vomiting. Did telehealth appointment and was prescribed anti-nausea medicine. 10/25/2021 put on Metoclopramide 5 mg twice a day morning and evening 11/08/2021. Day after the stomach issue because care for on medication and upcoming doctor/advised against dose two since stomach issue is ongoing. Medicine to help stomach contract and still on medication and able to work but still having issue with stomach.
Within an hour of the vaccine I had a headache but after 6 hours I noticed pulsatile tinnitus in my right ear only. It has been 7 months and it has not gone away at all.
No adverse reactions. After administering and screening, the patient admitted to getting Pfizer on May 29, 2021.  Pt. only had one dose of Pfizer.
Pfizer Dose 1 5/13/21 (ER8736) COVID Positive 1/1/22  1/1/22: Patient is a 84-year-old male history of chronic COPD not on home oxygen presents to ER with chief complaint of shortness of breath that is associated with cough and diarrhea for the past 1 week.  Patient denies any fevers or chills, reports to poor p.o. intake and generalized weakness.  Denies any recent travels,  reports to possible exposure to individuals with COVID-19.  In the emergency room patient was treated with supplemental oxygen, imaging study noted for bilateral pneumonia, blood cultures and stool studies were obtained, patient was treated with empiric Rocephin and azithromycin alongside with IV Solu-Medrol, unfortunately Facility currently does not have any rapid COVID-19 test available, therefore a COVID-19 PCR test was ordered for this patient.  Per ER provider report patient was vaccinated for COVID-19, however has not received his booster yet.  1/29/22: Patient is a 84-year-old male history of chronic COPD not on home oxygen presents to ER with chief complaint of shortness of breath. Patient admitted for acute hypoxic respiratory failure secondary to COVID-19 pneumonia.  Patient has been weaned to 3 L with rest. Hospital course complicated by acute left MCA CVA.  Patient was also does have a right ICA stenosis.  He will need further management outpatient.  Patient will be transferred to rehab.
Pt reported swelling at injection site that began on 4/11/19. She said was size of an egg but had gone down some by 4/12/19. Pharmacist answering the phone advised using an ice pack and ibuprofen for any discomfort.
Diarrhea; Achy; Very tired; Dizzy; Sore Arm; This spontaneous case was reported by a patient family member or friend and describes the occurrence of DIZZINESS (Dizzy), DIARRHOEA (Diarrhea), FATIGUE (Very tired), MYALGIA (Achy) and VACCINATION SITE PAIN (Sore Arm) in a 19-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022B21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-May-2021, the patient experienced VACCINATION SITE PAIN (Sore Arm). On 19-May-2021, the patient experienced DIZZINESS (Dizzy) and FATIGUE (Very tired). On 25-May-2021, the patient experienced DIARRHOEA (Diarrhea) and MYALGIA (Achy). The patient was treated with IBUPROFEN on 25-May-2021 at an unspecified dose and frequency. On 25-May-2021, DIZZINESS (Dizzy) had resolved. At the time of the report, DIARRHOEA (Diarrhea), FATIGUE (Very tired), MYALGIA (Achy) and VACCINATION SITE PAIN (Sore Arm) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications provided   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Follow up received on 25th may 2021 contains no new information
Husband and wife came in for Pfizer booster. Wife needed flu shot in addition to booster. Pharmacist was distracted and administered both Pfizer boosters to wife/patient.
Initial report received from Consumer on 14 October 2013. An 87-year-old female patient whose medical history and concomitant medication were not reported, had received a dose  of FLUZONE HD (lot number, route and anatomical site of administration were not reported) on an unspecified date on last Wednesday. On an unspecified date Sunday, the patient had begun to perspiring and feeling "woozy". The patient sat down for a few minutes. When the patient went home felt weakness, headache, sore throat, hoarseness and rash on chest. Laboratory investigations and corrective medications were not reported. On an unspecified date, the patient had recovered from events. Documents held by sender: none
2nd dose after 1 month (instead of 2); This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 8th November 2021, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.  Additional details were provided as follows: The patient received the first dose of Shingrix on 6th October 2021 The pharmacist reported that the patient received the second dose of Shingrix after 1 month (instead of 2) from first dose which led to shortening of vaccination schedule. The Health Care Professional didn't had patients demographic information. The reporter Consented to follow up
Pt was given vaccines (DTap-IPV-HBV (PEDIARIX), HIB, PCV13, ROTARIX) that was meant for another patient. No treatment Dr did address the incident with the parent. Not expecting any symptoms.
I had reported before that I have started having fasciculations in both calves. I now sometimes have muscle spasms above the calves usually on right side right butt cheek.  I also reported hot, burning sensation in my feet, mainly left and sometimes a wet sensation that lasted for about 30 seconds. I recently had a skin biopsy, and it indicates I now have small fiber neuropathy! See email for Neurologist below.
Severe pain at injection area , it is not constant but generally every day since 06/05 2021 especially at night. Also there is a lump on my shoulder.
THIS VACCINE IS ONLY FOR 18 YEARS OR OLDER. HOWEVER, THIS PATIENT IS ONLY 16 AND GOT THIS SHOT ON 04/05
Patient was brought to the ED with shortness of breath.  Patient was admitted with Covid and treated with remdesivir.
Booster; Dry mouth; my tongue is stuck to the roof of my mouth; I feel like it did something to me/ I am really afraid/ terrible; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 10Dec2021 (Lot number: FJ8757) at the age of 54 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ESTRADIOL. Vaccination history included: Flu vaccine, administration date: 05Oct2021; Bnt162b2 (Dose 1, Lot number: ER8730, anatomical location: Left arm), administration date: Mar2021, for COVID-19 Immunization; Bnt162b2 (Dose 2, Lot number: EW0153.", anatomical location: Left arm), administration date: Apr2021, for COVID-19 Immunization, reaction(s): "Dry mouth". The following information was reported: IMMUNISATION (non-serious) with onset 10Dec2021, outcome "unknown", described as "Booster"; DRY MOUTH (non-serious) with onset Dec2021, outcome "not recovered", described as "Dry mouth"; TONGUE DISCOMFORT (non-serious) with onset Dec2021, outcome "unknown", described as "my tongue is stuck to the roof of my mouth"; FEELING ABNORMAL (non-serious) with onset Dec2021, outcome "unknown", described as "I feel like it did something to me/ I am really afraid/ terrible". The events "dry mouth", "my tongue is stuck to the roof of my mouth" and "i feel like it did something to me/ i am really afraid/ terrible" were evaluated at the physician office visit.   Follow-up attempts are completed. No further information is expected.