chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from an administrator refers to unspecified patients of unknown demographics. The patients medical history was not reported. On an unknown date, the patients were vaccinated with improperly stored dose of LIQUID PEDVAX (Strength, dose, frequency, route and anatomical location were not reported) of lot # M014925 with an expiry date of February 2019 for prophylaxis. There were no concomitant therapies reported. The vaccine was exposed to 9 to 25 Celsius degree (C) (8.7 C) for 7 hours and 11 minutes, 9 to 25 Celsius degree (C) (9.2 C) for 11 hours and 43 minutes, 9 to 25 Celsius degree (C) (11.3 C) for 21 hours and 19 minutes, 9 to 25 Celsius degree (C) (9.2 C) for 9 hours and 34 minutes and 9 to 25 Celsius degree (C) (9.5 C) for 4 hours and 44 minutes. Digital data logger was involved. There was no previous temperature excursion involved. There were no adverse symptoms reported. There was no product quality complaint involved. The health care worker stated that no additional information was available at the time of the call. She additionally reported that the office had no means to gather the requested data, including patient identifiers and date of vaccination. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1708USA005276:
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 60 years, in left arm for Covid-19 immunisation. The patient's relevant medical history included: "Mild asthma" (unspecified if ongoing), notes: other medical history: Mild asthma; "hypertension" (unspecified if ongoing); "Allergic to cantaloupe" (unspecified if ongoing), notes: Known allergies: Allergic to cantaloupe; "moderate latex allergy" (unspecified if ongoing), notes: Known allergies: moderate latex allergy. Concomitant medication(s) included: NORVASC; LITHIUM. Past drug history included: Opiates for hives, reaction(s): "Allergy: Opiates", notes: Known allergies: Opiates give me hives and difficulty breathing.; Opiates for difficulty breathing, reaction(s): "Allergy: Opiates", notes: Known allergies: Opiates give me hives and difficulty breathing. Vaccination history included: Covid-19 vaccine (Dose 1, UNKNOWN MANUFACTURER), reaction(s): "Covid-19 Immunization"; Covid-19 vaccine (Dose 2, UNKNOWN MANUFACTURER), for Covid-19 Immunization; Covid-19 vaccine (Dose 3 Booster, UNKNOWN MANUFACTURER), for Covid-19 Immunization. The following information was reported: PRURITUS (non-serious), ECZEMA (non-serious), VACCINATION SITE MASS (non-serious), URTICARIA (non-serious) all with onset 20Apr2022, outcome "not recovered" and all described as "Large deep red raised hard itchy lumps kind of like eczema and kind of like an insect bite but no bite. Started near infection site, have spread to legs, harms, hands, last 5-7 days". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pruritus, eczema, vaccination site mass, urticaria. Additional information: Reported Event: Large deep red raised hard itchy lumps kind of like eczema and kind of like an insect bite but no bite. Started near infection site, have spread to legs, arms, hands, last 5-7 days. Other like hives come and go. Started about 2 weeks after last injection. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19, Prior to vaccination. The patient has been tested for COVID-19, since the vaccination. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
She has pain in her joints and where they gave her the injection; She is very tired/Exhaustion; started feeling like kind of lightheaded like we have a little joint or something; She has pain in her joints and where they gave her the injection/injection site is very painful; This is a spontaneous report from a contactable consumer. This consumer reported information for two different patients. This is the second of two reports. An 83-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number, expiration date was not reported), via an unspecified route of administration, in upper left arm, on 16Mar2021 02:30, at dose 1, single for covid-19 immunization. Medical history included osteoporosis, arthritis, Afib (atrial fibrillation), blood pressure, covid in last August (as reported), thyroid. Concomitant medications included atorvastatin (LIPITOR), she is on blood thinners and blood pressure medications and 4 different medication for thyroid (unspecified). The patient had pain in her joints and where the injection was given, she is very tired/exhaustion, the injection site is very painful, started feeling like kind of lightheaded like; had a little joint or something (as reported) on an unspecified date. The outcome of the events was unknown.    No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021416521 Same reporter/drug and different patient/events
some redness was noted at injection site; Pain at injection site; This is a spontaneous report from a contactable Physician (patient).  A 29-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE;lot number: EL0140), intramuscular in Left arm on  24Dec2020 at 11:45 am at single dose for COVID-19 immunisation .  Medical history was none.No known allergies to medications, food, or other products. There were no concomitant medications. On 24Dec2020 at 10:00 pm (as reported) the patient experienced pain at injection site and on 25Dec2020 some redness was noted at injection site; events were reported as non-serious and described as follows: pain at injection site, started 10 hours after vaccination (as reported), lasted 24 hours. Also some redness was noted at injection site a day after vaccination,  that self resolved in 2 days. Patient did not need to take any pain medication, no treatment given for the events. Patient recovered from the events in Dec2020.
Large knot at site of DTaP-IPV.  Started fever in afternoon.  Fever to 104 at 6am this morning.
Pt recv vax on 9/8/98; on 9/21/98 pt exp chicken pox rash
4cm X 3cm erythematous, warm to touch, red, swelling to area
Day 2, a little pain at injection site.    Day 4, I found an itchy hard lump was underneath the bandaide at the injection site.  The lump was hot, bright red, and it was the same size as a mosquito bite.  The lump went after 2 days.   I did not do any treatment.  I have been very tired since the injection, and I have to sleep 3-4 hours during the daytime.   I do not normally have to take a nap during the day.   I am still very tired and am sleeping a lot since the injection.   Normally I am very active during the day.
It was reported the patient had a serious allergic reaction from their 4th Moderna shot, it was the first bivalent Moderna shot that caused her to swell up; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (It was reported the patient had a serious allergic reaction from their 4th Moderna shot, it was the first bivalent Moderna shot that caused her to swell up) in a 77-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-Oct-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced SWELLING (It was reported the patient had a serious allergic reaction from their 4th Moderna shot, it was the first bivalent Moderna shot that caused her to swell up). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, SWELLING (It was reported the patient had a serious allergic reaction from their 4th Moderna shot, it was the first bivalent Moderna shot that caused her to swell up) was resolving.            No concomitant drug was reported.  The patient reported she had no problems until dose 4, which was her only bivalent booster. The patient had the Moderna primary series and first booster with no issues, and it was the first bivalent Moderna shot that caused her to swell up. The patient took over the counter Zyrtec, and reported it was able to help.
Daily fever up to 101.4, severe cough, fatigue, no appetite, night sweats, weakness from June 2 through June 9. Visited emergency clinic 6/9 .
I82.412 ACUTE DVT OF LEFT FEMORAL VEIN 7/16/2021 UTI (URINARY TRACT INFECTION) J96.10 CHRONIC RESPIRATORY FAILURE 9/23/2021 UTI (URINARY TRACT INFECTION) I82.412 ACUTE DVT OF LEFT FEMORAL VEIN 7/16/2021 BACTERIURIA J96.10 CHRONIC RESPIRATORY FAILURE 9/23/2021 BACTERIURIA I82.412 ACUTE DVT OF LEFT FEMORAL VEIN 7/16/2021 GROSS HEMATURIA J96.10 CHRONIC RESPIRATORY FAILURE 9/23/2021 GROSS HEMATURIA I82.412 ACUTE DVT OF LEFT FEMORAL VEIN 7/16/2021 DM 2 WO COMPLICATIONS J96.10 CHRONIC RESPIRATORY FAILURE 9/23/2021 DM 2 WO COMPLICATIONS
FEELS LIKE BP IS HIGH, ELEVATED HR, WEAKNESSS. Evaluated by EMS- refusal to transport.
Information has been received from a physician concerning a 26 year old female with no drug reactions or allergies and a history of seborrhoea who on unspecified dates was vaccinated with GARDASIL series.  Concomitantly, the patient used medicated shampoo.  In May 2008, the patient experienced hair loss.  At the time of this reporting, the patient was recovering from hair loss.  Biopsy was performed and the results showed alopecia with mild fibroplasia.  Unspecified medical attention was sought in the office.  Additional information has been requested.
I developed a very large welt approximately 20 cm by 10 cm, around and below the site of the injection. I also developed this with the first injection. So only localized. Aside from a headache and fatigue the next day, I was fine. I prefer this to shingles.
Patient experienced a rash on neck the morning following her flu vaccine.  Patient states it has worsened over the past few days.  Has contacted her PCP for treatment and follow-up
Patient reported swelling and pain in left shoulder muscle. Patient went to doctor for resolution. On November 9th patient reports shoulder muscle feels better.
12/17/2005 1st signs of nerve damage, 12/19/05 Dr visit no diagnosis, 12/21/05 Dr visit referred to neurologist, 12/22/05 Neurologist diagnosed GBS, 12/23/05 EMG Spinal Tap confirmed Guillain Barre Syndrome, 01/24/06 partially recovered. Information from medical records includes paresthesis, decreased reflexes, ataxia. msv
4 inch x 3 inch red, swollen, warm & tender area around injection site (cellulitis).
17JUL91 t103, pain, swelling of LUA: 24JUL91 had convuls x 1, quit breathing taken by ambulance to Med ctr hospitalized x 1 day;  Had 4 teeth pulled on 24JUL91 & was given Demerol;
Arm redness, swelling, nausea, fever, joint pain. Symptoms present after 48 hrs. Tylenol and ice packs, Zofran for nausea.
Urticaria, angioedema trunk & face about 1 hr p/immun; tx Susprine & Pediocare allergy
This spontaneous report was received from a registered nurse, concerning to multiple unspecified patients of unknown age and gender. There were no concurrent conditions, medical history, drug reactions or allergies, or concomitant medications reported. On unspecified dates, the patients were vaccinated with improperly stored doses of PROQUAD (dose, frequency and route were not reported) lot # L046506 with expiration date of 17-MAY-2017, for prophylaxis. The sterile diluents (manufacturer unknown) (lot # and expiration date were not reported) used to reconstitute the PROQUAD were properly stored. The temperature of the PROQUAD was between 6 °F and 14 °F for a time frame of 30 minutes. No previous temperature excursion occurred. No adverse effects were reported. Data logger was involved. This is one of two reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1704USA009837.
Redness, edema, warm to the touch, itching, orange skin at injection site.
Patient reported having a fever and achiness in her right shoulder on the night of receiving vaccine and it lasted until the Sunday after, which was 2 days post vaccine. Spoke to her on 10-11-17 and she said she was feeling better but she has returned to pharmacy on 11-15-17 to report she is still feeling ill and now has joint pain all over. She saw md and all tests to this point are negative and has been referred to Rheumatologist for further testing.
I had a very mild stroke 4 hrs. after shot; This spontaneous case was reported by an other health care professional and describes the occurrence of CEREBROVASCULAR ACCIDENT (I had a very mild stroke 4 hrs. after shot) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 057F22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CEREBROVASCULAR ACCIDENT (I had a very mild stroke 4 hrs. after shot) (seriousness criteria hospitalization and medically significant). At the time of the report, CEREBROVASCULAR ACCIDENT (I had a very mild stroke 4 hrs. after shot) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Patient experienced a very mild stroke 4 hrs. after the shot. He lost the use of his right arm and leg. The use of his right arm returned in about a day but leg took about 5 days to be normal again.  Treatment information was not reported.  Company comment:  This spontaneous case concerns a 71  year  old male patient, with no medical history reported, who received a dose with mRNA  1273 original vaccine (reported as fourth dose of his COVID  19 immunization schedule) and experienced the unexpected, serious (medically significant and hospitalization) AESI of cerebrovascular accident. Latency cannot be properly assessed since exact onset date and vaccination date were not provided. The report mentioned the patient lost the use of his right arm and leg, without facial dropping or speech change. The use of his arm returned in about a day, and the leg took about 5 days to be normal again. The outcome of the event was recovered. No further clinical details were provided for medical reviewing. Patient´s age remains as confounder for the event. The benefit-risk relationship of mRNA  1273 original vaccine is not affected by this report.
While at work on 3 occasions between 4:00pm and 9:00pm I got really warm and felt like I was going to pass out. That same night I went to bed and woke up in a complete sweat, had a headache and low grade fever. The next morning I woke up and my muscles and joints hurt, nausea, low grade fever, dizzy and felt disoriented and not to mention, the left arm was so painful and my armpit was extremely sore!!! I called the clinic and spoke with my Drs nurse and she excused me from work because I was incapable of going! I rested all day Wednesday. I took a lot of Ibuprofen which didn't help the fever or pain for very long. I had absolutely no appetite and did my best at keeping hydrated!Wednesday night I woke up a few times drenched in sweat that I had to wash my pillow and bedding. I couldn't afford to miss another day, so Thursday I went to work. It was completely rough as I work in healthcare. I was in a sweat my entire 8 hours and was dizzy, weak and nauseous as well as leg achiness and feeling of being shocked. I forgot to mention I did call facility back and talked to my Drs nurse and she said I had an allergic reaction to the pneumonia vaccine.
A raised lump the size of a plum,  red, hot rash that extended to my inner arm. Still present but extended to the inner part of my arm 1 week later it is still present,  but the lump is going down.
Rec'd DTaP in office on 8/20/13. S/S began next evening, including erythema, edema, and warmth. Seen 8/22/13 with fever (101.5 Max). Increased fussiness with (L) thigh with purplish discoloration and area approximately 3x6cm of redness, induration and hot to touch. Tx with MOTRIN.
This spontaneous report was received from a pharmacist via field representative, refers to two female patients of unknown age. The patient's medical history, concurrent conditions and concomitant medications were unknown. On an unknown date in 2015 (also reported as in the past month), the patient was vaccinated with ZOSTAVAX, (dose, frequency and route of administration not provided). On an unknown date in 2015 (also reported as in the past month), both patients experienced injection site swelling and redness after receiving ZOSTAVAX. No treatment was given for adverse events. Therapy with ZOSTAVAX was continued. The outcome of events was unknown. Causality assessment was not provided. No product quality complaint (PQC) was filed. Additional information has been requested.
Patient admitted to hospital 1 week after receiving 3rd dose of hepatitis B vaccine. Admitted with  1 week symptoms of fever, headaches, stiff neck, dizziness, syncope, nausea, blurred vision. LP and PCR sent and negative for all pathogens. Cell counts appear to be aseptic meningitis.
A little over 2 months after the shot I have pain in my arm in the area of the injection.  It is also itchy. The area is also red and feels warm.
Immediate reaction of heart flutter, dizziness, near fainting, shortness of breath, rapid heart rate, nausea, neurological response of shaking, tingling and numbness up neck, swollen tongue, headache. Resolved at Urgent Care after 45 minutes of monitoring.  7 hours post even still experiencing dizziness, nausea, tiredness and heart flutters.
28 year old patient received a pediatric dose; 28 year old patient received a pediatric dose; This case was reported by a other health professional via call center representative and described the occurrence of underdose in a 28-year-old female patient who received HBV (Engerix B pediatric) (batch number CM294, expiry date 19th April 2024) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 22nd September 2022, the patient received Engerix B pediatric 10 ug and Engerix B Pre-Filled Syringe Device. On 22nd September 2022, unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were 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: 22-SEP-2022 Reporter's Comments: The reporter reported that the 28 years old patient received a pediatric dose of Engerix B. Additional Supportive Information:  The patient received a pediatric dose of Engerix B, which led to underdose and adult use of a child product.
vaccination site movement impairment; Felt warm; Severe pain above the injection site (left arm), around shoulder; Redness; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (vaccination site movement impairment), VACCINATION SITE WARMTH (Felt warm), VACCINATION SITE PAIN (Severe pain above the injection site (left arm), around shoulder) and VACCINATION SITE ERYTHEMA (Redness) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history.).    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2021, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (vaccination site movement impairment), VACCINATION SITE WARMTH (Felt warm), VACCINATION SITE PAIN (Severe pain above the injection site (left arm), around shoulder) and VACCINATION SITE ERYTHEMA (Redness). In January 2021, VACCINATION SITE ERYTHEMA (Redness) had resolved. At the time of the report, VACCINATION SITE MOVEMENT IMPAIRMENT (vaccination site movement impairment) had not resolved and VACCINATION SITE WARMTH (Felt warm) and VACCINATION SITE PAIN (Severe pain above the injection site (left arm), around shoulder) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment medications included ibuprofen and diclofenac prescribed by her doctor. Patient also had ice for the pain.    Based on the current information and the temporal association between the use of the product and the start date of the events a causal relationship cannot be excluded.   Reporter did not allow further contact; Sender's Comments: Based on the current information and the temporal association between the use of the product and the start date of the events a causal relationship cannot be excluded.
extreme hives, itching, all over the body, including torso, front and back, extremities. Dr. prescribed prednisone 20 mg for 1 week, with a tapering by the 7th day along with liquid certrizine 10 ml twice a day. This dx and treatment was made on Dec 30, 2021 and the patient is still taking 10 ml of certrizine at least once a day.
OK to get another Shangrix, even if we got it 6 years ago; This non-serious case was reported by a consumer and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose 6 years ago).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: OK to get another Shangrix, even if we got it 6 years ago). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 19-APR-2023 The case was reported by patient. The reporter stated that six years ago patient had a shingles vaccination but we did not remember which one or where she got the shingles vaccination.  The reporter stated that it was okay to get another Shingrix, even if it was Shingrix that she received six years ago. The reporter also asked how many years after having Shingrix and the booster she need to get the series again or it would give permanent immunity to shingles. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination. The case had been linked to US2023AMR058073, reported by the same reporter, for a different patient.; Sender's Comments:  US-GSK-US2023AMR058073:Same reporter.
a little fuzzy in the head; This is a spontaneous report from a contactable consumer, the patient. A 71 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: unknown), dose 1 , single dose via an unspecified route of administration on an unknown date for COVID-19 vaccination. She is due to get the next dose on 27Jan2021. Relevant medical history was unknown. On an unknown date, the patient  was "a little fuzzy in the head" no other side effects reported, no injection sight pain. She carries an (epinephrine (EpiPen). The clinical outcome of fuzzy in the head  was unknown.    Information on Lot/Batch has been requested.