chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Chills; Light headed; Sweating; Itchy; Bumps all over body/bumps on neck/bumps on stomach/bumps on arms and legs/cluster of bumps; Hives; Rash; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Light headed), HYPERHIDROSIS (Sweating), PRURITUS (Itchy), SWELLING (Bumps all over body/bumps on neck/bumps on stomach/bumps on arms and legs/cluster of bumps) and URTICARIA (Hives) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032B21A and 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.  Concomitant products included IBUPROFEN for Menstrual disorder NOS, IRON for an unknown indication.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021 at 9:40 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 10-Apr-2021, the patient experienced DIZZINESS (Light headed), HYPERHIDROSIS (Sweating), PRURITUS (Itchy), SWELLING (Bumps all over body/bumps on neck/bumps on stomach/bumps on arms and legs/cluster of bumps), URTICARIA (Hives) and RASH (Rash). On 10-Apr-2021 at 8:00 PM, the patient experienced CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) for Symptomatic treatment, at a dose of 1 dosage form. At the time of the report, DIZZINESS (Light headed), HYPERHIDROSIS (Sweating), PRURITUS (Itchy), SWELLING (Bumps all over body/bumps on neck/bumps on stomach/bumps on arms and legs/cluster of bumps), URTICARIA (Hives), RASH (Rash) and CHILLS (Chills) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable.
presents at this time does not only feel like he is infected but just very short of breath Patient also had underlying hypertension and atrial fibrillation he was evaluated by cardiology medications has been adjusted, patient atrial fibrillation rate was well controlled during this admission. His shortness of breath persisted and managed for COPD exacerbation supplemental steroids. He tolerated this management well his oxygen requirement significantly decreased however the patient still remains on 2 L of oxygen via nasal cannula. He has been evaluated and seen by physical therapy and felt to be an appropriate candidate for skilled nursing facility. Follow-up with his primary care physician. ED visit to hospital admission wihtin 6 weeks of receiving the COVID vaccine.
After giving vaccination, about 2 mL came out from the arm. was not re-vaccinated per guidelines.
I take omeprazole (40mg) every morning, plus dietary supplements *multivitamin *1000mg fish oil capsule *1 tab calcium-magnesium-zinc-D3. I got my 2nd Pfizer vaccination on 030521, at about 2:30pm. I believe it was between 1:00am to 2:00am on 030621 I woke up with a bad headache and felt feverish. I think I took 1 acetaminophen 500mg tablet at that time and went back to bed. Throughout the morning and day of 030621 I experienced *bad headache *low-grade fever *body discomfort (some aching) *lethargy *extreme tiredness *extreme fatigue *weak and shaky when trying to get up and walk *nausea *dry heaves *fever and chills on-and-off. I took 1 tablet of acetaminophen 500mg 2 to 3 more times throughout the day, including at bedtime on 030621; to deal with the headache and other issues. The headache, extreme fatigue, extreme tiredness and low energy continued through 030721 Although I started "recovering" late 030721, I continued feeling "under the weather" through 030821 and 030921, then got stronger. I called the Hospital Vaccination Clinic to report my reaction, but they told me they don't take the report, just to report to my doctor at my next visit. I have not had an appointment with my doctor, but I will report this information the next time I see my doctor.
Information has been received from a licensed practical nurse concerning a 76 year old male with no medical history or known drug allergies who on 01-FEB-2007 was vaccinated at 12:30 intramuscularly into the left deltoid with a dose of Pneumovax (Lot # 655152/0889F). Concomitant therapy included PRILOSEC, ROZEREM and diltiazem hydrochloride. On 02-FEB-2007 at 14:00, the patient developed swelling and tenderness in the arm that was vaccinated. The patient also experienced pain at the injection site and pain of the upper part of the arm. the patient was told to place hot packs on his arm and was being treated with cephalexin. The patient was diagnosed with cellulitis at the injection site. it was noted that the patient had allergy testing two days prior to vaccination. At the time of this report, the patient had recovered. No product quality complaint was involved. Additional information is not expected.
Menstrual Issues (Continued bleeding); This is a spontaneous report received from a contactable healthcare professional (patient). This 43-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 08Feb2021 (Batch/Lot Number: EL9264) as 2nd dose, single for COVID-19 immunization. Patient received the first dose on 13Jan2021 (Batch/lot number: EL1283). The patient's medical history and concomitant medications were not reported. Patient is not pregnant at time of vaccination. The patient previously took a cortisone shot at the end of Dec2020. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient has not been tested for COVID-19 since the vaccination. Patient experienced menstrual issues: continued bleeding on 08Feb2021 with outcome of not recovered. Treatment was received. Event resulted in doctor or other healthcare professional office/clinic visit.; Sender's Comments: Based on chronological connection to the vaccine a causal relationship between event "menstrual issues: continued bleeding" and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be completely 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.
Patient has been unable to get in for second dose; This spontaneous report as received from a nurse refers to a 21-year-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.      On 09-MAR-2020, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection as first dose, 0.5 ml for prophylaxis (strength, frequency, route of administration, lot # and expiration date were not reported).  On an unknow date in 2020, the patient was unable to get in for second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9).
Fatigue, headache, dizziness, stomach ache, diarreah, fever (temp of 101), nausea, aching at injection site.
initially a very short sz-typ event, followed by tingling & numbness in all four extremities & diff swallowing on 3 separate occassions;cont sense of vibration in both legs & feet (1 .5 yr p/vax) cont;myriad blood & urine tests done;
pt reports water like blisters on left wrist. they were itchy and swollen red. Provider dignosed her for shingles.
5 days after receiving the vaccine,  member had a red, inflamed, raised rash at the injection site.
she had fever; her arm was bothering her a lot; fatigue/she is tired today; diarrhea; She had chills; nausea; loss of appetite; dizzy; This is a spontaneous report from a contactable consumer. This consumer (patients Husband) reported for a female patient (Wife):  A 70-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Lot Number: EL9262; Expiration Date: 31May2021), via an unspecified route of administration on 23Jan2021, 0.3mL single, via an unspecified route of administration. On 13Feb2021 at 10:15 (Batch/Lot Number: EL9266; Expiration Date: 31May2021) as 2nd dose 0.3mL single for covid-19 immunization. Patients medical and concomitant medications history were not reported. It was reported that, patient experienced tremendous side effects, her arm was bothering her a lot, she had fever until Monday up to 103 and diarrhea. She had chills, nausea, fatigue. The fever stopped today she no longer has fever, but she is still experiencing dizziness and fatigue. She woke up dizzy this morning, she is tired today, she had diarrhea twice again today, but the dizziness is bothering her the most. She also has loss of appetite; she does not want to eat. She wants to know why she is dizzy all these days later. Patient received her second dose 13Feb2021 at 10:15 in the morning. Dizziness started this morning patient was very dizzy. It went away for a while she ate lunch, she forced lunch down, but she is still dizzy now. She was drinking water because her husband thought she was dehydrating herself. She ate a piece of chocolate and sat down incase her sugar was dropping. She had diarrhea starting Saturday and she had the feeling yesterday, but she didn't go then today she went twice. Patient had chills were Saturday, Sunday, and now she is done with the chills and the fever. That went away yesterday. Now she just has the tiredness and the dizziness. The tiredness she can handle but she cant stand buy herself she gets dizzy when she is walking. Outcome of event was recovered for fever and chills, not recovered for dizziness and rest of the events was unknown.   No follow up attempts are needed. No further information is expected.
54 year old received Bexsero; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 54-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 21st August 2022, the patient received the 1st dose of Bexsero and Bexsero Pre-Filled Syringe Device. On 21st August 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 15-Sept-2022 Reporter's comment: The pharmacist stated that the patient received dose one of Bexsero and as of this call dose two has not been administered. The first dose was given at another location. No further details were available or provided at the time of call. The reporter consented to follow-up. Additional supportive information: The patient received 1st dose of Bexsero at inappropriate age, which led to inappropriate age at vaccine administration.
Sharp shooting pains in the back of head & ear - numb & tingling feeling on left side of face. Experienced cold chills last night.
Patient's arm was very swollen and hot.  Patient reported it was aching and even hurt in his back.  We recommended Benadryl and Aleve.  It appears he had a pneumonia vaccine also on 11/7/06.
Running on and off fever of 102+ for 5+ days with flu like symptoms; RUNNING ON AND OFF FEVER OF102+ FOR 5+ DAYS; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the left arm on 08Apr2021 at 11:00 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. Medical history included fibromyalgia, pneumothorax spontaneous, bronchitis chronic, chronic sinusitis and allergy to raw fruit and vegetables. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included buspirone hydrochloride (MANUFACTURER UNKNOWN) 30 mg, methocarbamol (ROBAXIN) 750 mg and clonazepam (CLONOPIN); all for an unknown indication and unknown start date and unknown if ongoing. The patient previously took cefaclor (CECLOR) and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206) via an unspecified route of administration in the left arm on 18Mar2021 at 13:30 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. On 09Apr2021 at 03:00, the patient had running on and off fever of 102+ for 5+ days with flu like symptoms. On 09Apr2021, patient body temperature was measured and the result was 102+ (unspecified units). The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event running on and off fever of 102+ for 5+ days with flu like symptoms was recovered with sequelae at the time of this report.   No follow-up attempts are needed. No further information is expected.
Red bumps around injection site. Large red, raised patches from shoulder to elbow on the affected side. Pain and tenderness to touch of the upper arm.
CDC reports: 5 mo infant developed fever to 105 following immunization x 2 days. Reported 1 1/2 mo p/occurence. The MD did not see the pt but recommended pediatric DT.
(R) arm red and painful. Pain decreased over 24 hours. Swell with red indurated area covering 1/2 upper arm (viewed 5/1/14).
Runny nose, body ache, severe headache, sore throat, coughing lasting for 3 days, treated with Tylenol and rest
Advised by Vsafe/CDC to fill out VAERS Form. Received booster from work 10/1/2021. On 1/7/22, felt strange or off. Checked temperature multiple times. No fever was detected until late afternoon. Fever became high at 103.5f+. Took Tylenol to curb fever. Fever became lower on 1/8/22 to 101f+. Took COVID test(was positive). Sore throat, congestion, headache, body aches started afternoon of 1/8/22. Fever did not stop being 101f+ until 1/12/22 even with 24hr use of Tylenol. Rest of symptoms stopped on 1/13/22.
patient who meets age requirement for FLUZONE HIGH DOSE QUADRIVALENT was given the FLUZONE QUADRIVALENT with no reported adverse event; Initial information received on 05-Nov-2020 regarding an unsolicited valid non-serious case received from a physician via call center.  This case involves a 76-year-old female patient who met age requirement for fluzone high dose quadrivalent was given the influenza quadrival A-B vaccine (Fluzone Quadrivalent), 450 - FLZ QIV NP (wrong product administered) (batch number: UJ506AB and expiration date: 30-Jun-2021) at an unknown dose and frequency via unknown route and site for prophylactic vaccination.  Medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  This was an actual medication error case due to the event wrong product administered (latency: unknown).  Disclaimer: this suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in directive 2001/83/ec and module VI of the good Pharmacovigilance practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
This spontaneous report as received from an office manager refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' pertinent medical history, concomitant medications and drug reactions or allergies was provided. On unknown dates starting on or after 11-JAN-2017, the patients were vaccinated with improperly stored doses of ROTATEQ lot number M017558, expiration date: 27-FEB-2018 or lot number M040271, expiration date: 30-APR-2018, orally, (dose and dose number were not provided) for prophylaxis. The reporter also stated that in February 2017, the patients were administered improperly stored doses of ROTATEQ lot number M032636, expiration date: 06-APR-2018 and in March 2017, the unspecified patients received improperly stored doses of ROTATEQ lot number M038846, expiration date: 26-APR-2018, orally, (dose and dose number were not provided) for prophylaxis. According to the reporting office manager, the first two vaccines underwent a temperature excursion of 47 degrees Fahrenheit to 77 degrees Fahrenheit for 839 hours, while the third vaccine was exposed to the excursion conditions of 52.3 degrees Fahrenheit for 168 hours (from 20-JAN-2017 to 26-JAN-2017), 46.9 degrees Fahrenheit for 336 hours (from 07-FEB-2017 to 21-FEB-2017) and 46.4 degrees Fahrenheit for 8 hours (from 27-FEB-2017 to 28-FEB-2017). The last vaccine with lot number M038846 was exposed to the excursion conditions of 49.5 degrees Fahrenheit for 144 hours (from 16-FEB-2017 to 21-FEB-2017), 46.4 degrees Fahrenheit for 8 hours (from 27-FEB-2017 to 28-FEB-2017), 46.6 degrees Fahrenheit for 120 hours (from 10-MAR-2017 to 12-MAR-2017), 53.4 degrees Fahrenheit for 48 hours (from 14-MAR-2017 to 15-MAR-2017) and 53.4 degrees Fahrenheit for 48 hours (from 20-MAR-2017 to 21-MAR-2017). There was no previous temperature excursion reported. No adverse events were reported. No digital data logger was involved. Follow up information has been received from the reporting office manager via telephone call on 18-MAY-2017. The reporter stated that she would run a report and fax the patient identifiers and dates of vaccination. This is one of several reports received from the same reporter (linked with MARRS# 1704USA005744, 1706USA007377 and 1706USA007379). Additional information has been requested.; Sender's Comments:  US-009507513-1706USA007379: US-009507513-1706USA007377: US-009507513-1704USA005744:
pt recv vax & exp pain @ the inj site;the next morning the inj site pain had subsided, but pt awoke w/blurred vision;pt vision did not clear when put on glasses;
Pt became weak and dizzy while walking outside to car.  Pt had syncopal episode and fell on sidewalk outside clinic.  Her sister reports seeing her strike her head on their vehicle.  Pt c/o her back hurting. Pt declined exam of back.  No nausea.  No LOC.  Pt A & Ox3.  Pallor.  Diaphoretic.  Pulse 72  BP  80/36  Head:  NT/AC without abrasions or bleeding.  Heart:  RRR.  Lungs:  CTA  Neuro:  CNs II-XII grossly intact.   Cold wash rag applied.  Cold water given for hydration.  Pt transferred to vehicle and legs placed above level of heart.  BP increased to 84/46.  Pt states she began feeling better.
Vaccine administered on 1/14/2023 past the use by date of 1/11/2023.
body aches; fever; diarrhea; Headache; chills; dry heaving first night; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 39 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 26Oct2021 18:15 (Lot number: Fh8028) at the age of 39 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "bradycardia" (unspecified if ongoing). Concomitant medication(s) included: MIDODRINE. Past drug history included: Penicillin, reaction(s): "allergy". Vaccination history included: Bnt162b2 (Dose 1, lot number=Er2613, administration time=12:00 PM, vaccine location=Left arm), administration date: 18Mar2021, for COVID-19 Immunization; Bnt162b2 (Dose 2, lot number=Em9809, administration time=13:00 PM, vaccine location=Left arm), administration date: 08Apr2021, for COVID-19 Immunization. The following information was reported: HEADACHE (non-serious) with onset 26Oct2021 22:00, outcome "recovering", described as "Headache"; CHILLS (non-serious) with onset 26Oct2021 22:00, outcome "recovering", described as "chills"; RETCHING (non-serious) with onset 26Oct2021 22:00, outcome "recovering", described as "dry heaving first night"; PAIN (non-serious) with onset 27Oct2021, outcome "recovering", described as "body aches"; PYREXIA (non-serious) with onset 27Oct2021, outcome "recovering", described as "fever"; DIARRHOEA (non-serious) with onset 27Oct2021, outcome "recovering", described as "diarrhea". Therapeutic measures were not taken as a result of headache, chills, retching, pain, pyrexia, diarrhoea.  Additional information: Did the patient receive any other vaccines within 4 weeks prior to the COVID vaccine: No. Prior to vaccination, was the patient diagnosed with COVID-19?: No. Since the vaccination, has the patient been tested for COVID-19?: No    Follow-up attempts are completed. No further information is expected.
Patient reports 27 hours feeling fatigued after vaccine yesterday but unable to sleep.  Said could not sleep "not a single minute" last night even though tired.  Could not sleep at all today and feeling racy and anxious like he does if he were to go without his clonazepam but insists he has taken it properly.  Note, patient didn't experience any of this with his first dose.  But also came into his second vaccine asking about if this would interact with his lamictal.  Patient seems convinced the vaccine is interacting with his medications.  After discussion he is going to be seen at an urgent care for how to proceed.
Mother said child's left leg had excessive swelling and redness. He was lethargic and his eyes started to roll back. Vomited once. She took him to the ER.
Pain at Injection Site; Low-grade fever; Nausea; Headache; Generalized Aches and Pain; Redness; pain down neck; flu-like symptoms; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st April 2019, 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 pain, low grade fever, nausea, headache, generalized aching, erythema, neck pain and influenza-like symptoms. The patient was treated with paracetamol (Tylenol) and ibuprofen (Advil). On an unknown date, the outcome of the injection site pain, low grade fever, nausea, headache, generalized aching, erythema, neck pain and influenza-like symptoms were recovered/resolved.   It was unknown if the reporter considered the injection site pain, low grade fever, nausea, headache, generalized aching, erythema, neck pain and influenza-like symptoms to be related to Shingrix.  Additional information received were as follows: The patient received 1st and 2nd dose of Shingrix doses in left deltoid over a period of 3 months. After receiving 1st dose, the patient experienced pain at injection site, redness, low grade fever, nausea, headache, generalized aches and pain down neck (flu-like symptoms), which lasted approximately one week until fully resolved. The reporter consented to follow up reports taking Tylenol and Advil intermittently . This was 1 of the 2 cases reported by same reporter.