chrisvoncsefalvay/vaers-outcomes huggingface dataset:
severe swelling; extremely red rash; This is a spontaneous report from a contactable pharmacist via a Pfizer sales representative. An elderly female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date at 0.5 mL, single dose for immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced severe swelling and an extremely red rash on an unspecified date, after use of product. The outcome of events was unknown.  No follow-up attempts are needed. information about lot/batch number cannot be obtained
Administered vaccine on 4/21/14. Pt reported tenderness, itching and hardened area. On 5/4 pt stated she developed blisters which opened into a 3 cm x 2.4 cm erosion (R) deltoid.
patient presented with a red spot at injection site about 4x4 area. She stated also having rash on back ,legs, and breast that itches. She stated that she has gotten dizzy also. Patient has taken Zyrtec and applied ice to area. Pharmacist suggested benadrylas it is a   better choice for itching and can bring down  swelling of arm and to continue using ice.
I21.4 ACUTE NON ST ELEVATION MI 8/1/2022 ATHEROSCLEROSIS OF AORTA
Pediarix and Rotarix / Below temperature exursion; This case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a 4-month-old male patient who received Rota (Rotarix lyophilized formulation) (batch number 5BC7N, expiry date 11th July 2022) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis, DTPa-HBV-IPV (Pediarix) (batch number T4Y35, expiry date 28th November 2022) for prophylaxis and dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 6th May 2021, the patient received Rotarix lyophilized formulation (oral), Rotarix Oral Applicator Device, Pediarix and Pediarix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Rotarix lyophilized formulation, Rotarix Oral Applicator Device, Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug 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 details were provided as follows: The nurse reported about Pediarix and Rotarix administration to patient after the vaccines suffered a below temperature excursion, which led to incorrect storage of drug. No further events were reported.
Information has been received from a registered nurse concerning a patient of unknown age and gender. Patient's pertinent medical history, drug reactions or allergies were not reported. On 07-JAN-2016, the patient received an improperly stored dose of PROQUAD (Merck) with lot # L032761, expiration date 24-FEB-2017 (dose, route and anatomical location of administration were not reported). The condition storage was 7F for 10 minutes. There was previous temperature excursion with 8F for 40 minutes and 18.2 F for 5 minutes. No concomitant therapy was provided. No adverse effects or reactions to this vaccine were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same source. Additional information has been requested.
Redness and swelling left deltoid for 1 day. Firm, induration, swelling over left deltoid with tenderness. OTC Motrin for pain.
Adverse reaction began with basic sore arm. During the night, developed chills and low grade fever 99<100 degrees taken orally. Next morning, had developed body aches, headache, elevated glucose readings, and extreme fatigue which lasted all day on Friday 05Nov21. Symptoms were gone morning of 06Nov21. only sore arm remained which is normal.
No adverse event noted.  Recent finding of a sustainability window for the lot number of COVID vaccine received.
Received Menactra in left arm and Varivax in right arm 3/26. The following morning, left arm began to swell. By 3/28/08, there was an area of induration 8cm x 5cm around the Menactra injection site. Treated with Benadryl.
There was maybe a little pain around the injection site for the second shot; I was scheduled to get my second shot a few days after my surgery and just didn't think I could do it, so I re-scheduled for 06/21/21; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (There was maybe a little pain around the injection site for the second shot) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (I was scheduled to get my second shot a few days after my surgery and just didn't think I could do it, so I re-scheduled for 06/21/21) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 054C21A and 025C21A) for COVID-19 vaccination.     Concurrent medical conditions included Seasonal allergy (Typical symptoms: running nose, watery eyes, stuffy nose, itching, sneezing, etc.), Food allergy (Peppers causes Diarrhea, abdominal discomfort, gas, pain during digestion), Milk allergy (Symptoms of lactose intolerance.), Food allergy (Ice cream: Symptoms of lactose intolerance.), Obesity and Pain. Concomitant products included PARACETAMOL (TYLENOL) for Pain.   On 09-May-2021 at 11:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jun-2021 at 11:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Jun-2021 at 11:00 AM, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (I was scheduled to get my second shot a few days after my surgery and just didn't think I could do it, so I re-scheduled for 06/21/21). On an unknown date, the patient experienced VACCINATION SITE PAIN (There was maybe a little pain around the injection site for the second shot). On 21-Jun-2021 at 11:00 AM, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (I was scheduled to get my second shot a few days after my surgery and just didn't think I could do it, so I re-scheduled for 06/21/21) had resolved. At the time of the report, VACCINATION SITE PAIN (There was maybe a little pain around the injection site for the second shot) outcome was unknown.            Treatment details were not reported.   This case was linked to MOD-2021-221086 (Patient Link).
Possible AE; Patient was fully vaccinated with the Moderna vaccine during breastfeeding; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (Possible AE) and MATERNAL EXPOSURE DURING BREAST FEEDING (Patient was fully vaccinated with the Moderna vaccine during breastfeeding) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Possible AE) and MATERNAL EXPOSURE DURING BREAST FEEDING (Patient was fully vaccinated with the Moderna vaccine during breastfeeding). At the time of the report, IMMUNISATION REACTION (Possible AE) outcome was unknown and MATERNAL EXPOSURE DURING BREAST FEEDING (Patient was fully vaccinated with the Moderna vaccine during breastfeeding) had resolved.  No concomitant and treatment medications were reported.  Patient was fully vaccinated with the Moderna COVID-19 vaccine and her baby got fully vaccinated as well.  It was reported that patient wanted to know if it was ok to receive the bivalent booster while breastfeeding.   Reporter did not allow further contact
Information has been received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies were not reported. On 29-DEC-2017, the patient was vaccinated with an expired dose of PNEUMOVAX23 (expiry date 30-AUG-2017) for prophylaxis (dose, route of administration and lot number were not reported). No adverse effects were reported.
Patient presented to the ED and was subsequently hospitalized for Closed fracture of right tibial plateau within 6 weeks of receiving COVID vaccination.
At 12pm , 5mins post vaccination, patient reported feeling headache, light headed, she felt her lips were swollen, dizziness, and nausea. Vital signs were taken and all within normal range. Patient was placed in exam room, on exam bed, and reassessed for symptoms after 30mins.  At 12:30, Vital signs taken and all within normal range. Patient reported "feeling much better", patient denied feeling lip were swollen, patient denied feeling light headed, Patient denied feeling dizzy, patient denied feeling nauseated, but had slight headache, Per MD instructions patient is to be reassessed after 30minutes.  1:00pm, Patient denied headache, and felt much better. Patient was discharged home with ER precautions.
Information has been received from a Registered Nurse for VARIVAX (Merck), a Pregnancy Registry product, concerning an approximately 27 year old female patient with allergies (unspecified) and sulfa and aspirin allergies that recently had a baby who on 13-MAR-2008, was vaccinated SQ with a 0.5 ml first dose of VARIVAX (Merck) (Lot# 658967/1521U) (Expiration date: September 2009) because she wanted to get pregnant. Second 0.5 ml dose of VARIVAX (Merck) (Lot# 658518/1527U) (Expiration date: September 2009), SQ was given on 07-MAY-2008. Concomitant therapy included CLARITIN. The nurse mentioned that the patient was told recently by her Obstetrician/Gynecologist that she had to be revaccinated. Nurse was unsure if the Obstetrician/Gynecologist did titers since there was no record in their office of titers done after the two vaccinations. The last titer done at their office was in February 2008 which showed "titers were less than 0.9". The outcome of the patient was not reported. The patient sought medical attention by an office visit. Follow up information has been received from a registered nurse for VARIVAX (Merck), a Pregnancy Registry product, reported that her record had no documentation that the patient received any further (Merck) VARIVAX in their office. She stated there was nothing in the chart that suggested she went elsewhere for further vaccine administration. The received further information regarding (Merck) VARIVAX revaccination with low titers. She stated that if her OB-GYN had wanted her to get further vaccination 'although not recommended by Merck', she more than likely would have received vaccination here. The registered nurse stated they had no information regarding the health of the patient's infant or any dates surrounding her pregnancy, since they are an adult internal medicine office. Additional information is not expected.
On 01/29/2021 I was given the 2nd dose of COVID 19 vaccine at approximately 5:00 pm.  At 1:30 am 01/30/2021, I woke up with headache with lasted until 03/12/2021.  On April 9, 2021 the headache returned and on April 14, 2021 I was diagnosed with Herpes Zoster Opthalmicus right eye.  I have been treated with Valtrex, Zirgrin, Bacitracin, PFATs, gabapentin,Percocet,
Moderna vaccine (NDC 80777-0273-98) lot # 039D21A and GHN 00380777273983 was administered after the beyond date of 10/23/2021.  Contacted Manufacturer Moderna = no need to repeat the dose
Caller mentioned she got the first dose of the Pfizer COVID-19 vaccine on February 4 2021. Her husband got tested positive for COVID last Saturday.; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 04Feb2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Caller mentioned she got the first dose of the Pfizer COVID-19 vaccine on 4Feb2021. Her husband got tested positive for COVID last Saturday. Caller wants to know what's was the efficacy after dose one. Caller wanted to know if she test positive could she receive the vaccine. If she get the vaccine while being positive would that be terminal to her health. Caller asked should she get tested for COVID before receiving the vaccine. Outcome of the event was unknown.  Information on lot/ batch has been requested. Follow-up attempts are completed. No further information is expected. .
Patient received dose around 9 AM on 3/16/2021 and felt fine the rest of the day.  On 3/17/2021, patient was so weak he fell at home and could not get himself back up.  A friend was called who was able to help the patient up off the ground and got him a walker to use.  Patient was able to get around using the walker, but then fell again around 20:00 on 3/17/21.   He called 911 because he could not get himself up off the ground and EMS brought him to the hospital.   Patient denied other symptoms other than new onset BLE weakness.  Patient worked with PT/OT next morning and was able to walk 400 feet on level terrain and safely ascend/descend 4 steps with rails.
Patient had received 2 diluents instead of the diluent and powder and reported side effects of fever, arm pain and fatigue.
rt leg swollen & red;advised to put ice on the leg;pt cont crying started 12PM till 12AM;t103;advised to give APAP;
10cm erythema left deltoid with discomfort. No fever. Per annual report-The vaccine was administered at a local health unit.  Lot numbers are not available to them.
Noted Itchy nodule on back later in the night. Next day noted multiple sensitive, itchy, burning pain type nodules on left chest and left back. Next day nodules with pearly white heads were noted along the left armpit edge and inner left arm. Went to Urgent care in Friday the 28th and they diagnosed Shingles. Started Valacyclovir 1000 mg 3 times per day for a week treatment. Developed port herpetic neuralgia. Completed treatment. Post herpetic neuralgia increased following treatment and has stayed at the same level.  I had taken pictures and sent to my primary doctor. I also saw a dermatologist and they confirmed Shingles and PHN.
DX:  COVID, + test on 8/24 and denies feeling better.  ED visit on 9/14 and Reports cough, congestion, and difficulty sleeping, migraines and body aches. SOB, dry cough, fevers and chills. Fatigue, chest tightness, myalgia, weakness, headaches and rhinorrhea. Treatment:Given dose of steroids here. Will follow up as directed. Will return to the ER if symptoms worsen. Continue home pulse oximetry.
Received doses from an expire vial; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received doses from an expire vial) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 054C21A and 054C21A) for COVID-19 vaccination.     Concurrent medical conditions included Hyperlipidemia since 02-Apr-2019. Concomitant products included PRAVASTATIN for Blood cholesterol abnormal.   On 27-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received doses from an expire vial). On 24-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Received doses from an expire vial) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medication provided.
VASOVAGAL: The patient stated he wasn't "feeling good," he felt very dizzy and his vision was blurry, he was sweating as well. I immediately grabbed another chair and raised his feet above his heart level. He immediately stated that he was "feeling better" and his vision was improving. I then offered him a cold bottle of water. He appeared very stable within a few minutes. We did call 911 as a precaution, they arrived a while later and deemed the patient was stable and their additional services were declined by the patient. I insisted the patient stay and finish the bottle of water. All together I believe the event was about 30 - 35 minutes before leaving. I encouraged the patient to drink plenty of fluids and electrolytes and to take it easy for the rest of the day.
vasovagal episode that begin immediately following the injection with vaccine. Patient was alert, oriented. He was evaluated, blood pressure and vital signs checks were performed. Mental status was maintained. following a period of rest he recovered and was discharged
Diluent not added to pediatric Pfizer. Patient reported fatigue at this time. No other adverse side effects.
Information has been received from a registered nurse concerning a 29 year old female with no known medical history or allergies who "two years ago," in 2004, "after giving birth" was vaccinated with a dose of MERUVAX II. A "recent" antibody test was negative, in approximately January 2006. The nurse reported that the patient was not pregnant at the time of the vaccination, but "is now." Unspecified medical attention was sought. There was no product quality complaint involved. Additional information has been requested.
Sitting down after 5 minutes she started not feeling well; feeling different; felt little nervous; Headache; Heartrate rapid; Blood pressure 169/90; Shortness of breath; Felt hot blood through her body like hot oil through her body, for 1 minute; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (Felt hot blood through her body like hot oil through her body, for 1 minute), MALAISE (Sitting down after 5 minutes she started not feeling well), FEELING ABNORMAL (feeling different) and NERVOUSNESS (felt little nervous) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     The patient's past medical history included Rhythm nodal and Arthritis rheumatoid. Concurrent medical conditions included Arrhythmia and Hypertension. Concomitant products included CARVEDILOL, VALSARTAN, FLECAINIDE, METHOTREXATE, ADALIMUMAB (HUMIRA), ESCITALOPRAM OXALATE (LEXAPRO), BUSPIRONE and AMLODIPINE for an unknown indication.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced FEELING HOT (Felt hot blood through her body like hot oil through her body, for 1 minute), FEELING ABNORMAL (feeling different) and NERVOUSNESS (felt little nervous). On an unknown date, the patient experienced MALAISE (Sitting down after 5 minutes she started not feeling well). The patient was treated with IBUPROFEN at a dose of 1 dosage form and PARACETAMOL (TYLENOL) at a dose of 1 dosage form. On 07-Jan-2021, FEELING HOT (Felt hot blood through her body like hot oil through her body, for 1 minute) had resolved. At the time of the report, MALAISE (Sitting down after 5 minutes she started not feeling well), FEELING ABNORMAL (feeling different) and NERVOUSNESS (felt little nervous) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Jan-2021, Blood pressure measurement: 169/90 (High) 169/90. On 07-Jan-2021, Heart rate: rapid (abnormal) abnormal.     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.   Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded, however medical arrhythmia and hypertension was assessed as potential trigger for blood pressure increased as well as for heart rate increased.   Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: Significant Follow-up Contains Patient demographic details,new concomitant medications added & new events also added; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded, however medical arrhythmia and hypertension was assessed as potential trigger for blood pressure increased as well as for heart rate increased.
January 2022: Neuropathy in right foot.  April 2022: had to use a cane. June 2022 began testing.  October 2022 diagnosed with MDA5 autoimmune disease, which caused dermatomyositis in my leg with muscle inflammation. It has progressed to my entire leg and I am have to get a wheelchair. I have had 2 infusions of IVHGH and I infusion if Ruxton. No signs of re-leaf. November 2022 had a heart attach. A blood clot in an artery that could not be stinted and heart attacks do not run in my family
Temp of 100.5 morning of 10/9/18, loose/diarrhea type stools started as well. For 3 days having multiple per day. Pt had decreased appetite. Pinpoint rash to trunk started on 10/12/18 and spread to whole body on 10/13/18. Pt began improving on 10/14/18 and continued to. Pt's appetite returned 10/15/18. Here today with parents with concerns of continued loose stools, irritability, and decreased appetite. Started with 100.5 temp on Tuesday after getting flu shot on Monday. Loose stools x 3 days. Multiple per day. Today stools are more formed, but still not eating well. He did eat watermelon for lunch. No blood to stool. No vomiting. He is much more irritable and fussy than normal. He is less energetic than normal. Pinpoint rash just noticed to trunk this afternoon. No cough or runny nose.
Elevated heart rate that is almost like in her throat; Low grade fever; weakness that comes and goes/Very weak; This is a spontaneous report from a contactable consumer (patient). A 30-year-old female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine; lot number: EH9899), via an unspecified route of administration on 20Jan2021 at a single dose for covid-19 immunization. The patient has no medical history and concomitant medications. On 20Jan2021, the patient experienced weakness that comes and goes/very weak. The patient reported that it started an hour and a half after the COVID-19 Vaccine. Comes in waves. At the time of the report, the patient stated that it was starting to subside, but after a while it will come back again. The patient added that she trying to fight through the weakness, but it was stopping her from doing things. The patient also experienced low grade fever on 20Jan2021 that was fluctuating. In the evening of 21Jan2021, the patient experienced elevated heart rate that was almost like in her throat. Heart rate was normally between 75-80, but it continues to jump over 100. The outcome of the events was not recovered.
Facial swelling (particularly eyelids), facial itchiness.  Treated with liquid benadryl immediately and every 6 hrs after.
First strong fever, like "hit by a bus" for about 30 hours, followed about 40 hrs after injection by strong pain in the throat on swallowing and adding to that strong swelling of glands (below ears and chin) about 48 hrs after injection and still lasting as of now, 68 hrs since injection. Visible face deformation. Unable to chew, eat. Drinking tea.