chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: Patient went to the Urgent Care/ER and they said the swelling, soreness and redness (on about 6 inches of her left upper arm) was a local reaction to Shringrix. They said could could get her 2nd dose when it is due, but to have benadryl and ibuprofen on hand after next dose.
Information has been received from a physician concerning a male (age not reported) who in October 2007, "2 to 3 weeks ago" was vaccinated with a first dose of pneumococcal 23v polysaccharide vaccine. In October 2007, the patient experienced erythema, warmth, and swelling localized to his arm. The patient sought medical attention. The patient was treated with cephalexin (KEFLEX). After a week, the patient recovered. No additional information is available.
infant developed fussiness, apparent abdominal pain, passed bright red bloody stool, taken to hospital via ambulance. US consistent with intussusception. Baby transferred to higher level of care, s/p air enema. Admitted x 2 days. seen in follow up clinic on 10/27 and patient doing well.
little level one pain at the left arm; Swelling at the left arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (little level one pain at the left arm) and VACCINATION SITE SWELLING (Swelling at the left arm) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced VACCINATION SITE PAIN (little level one pain at the left arm) and VACCINATION SITE SWELLING (Swelling at the left arm). On 03-Apr-2021, VACCINATION SITE PAIN (little level one pain at the left arm) and VACCINATION SITE SWELLING (Swelling at the left arm) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported. Treatment information not provided.
Migraine type headache, nausea, stomach upset, numbness/tingling in my feet and hands, low-grade fever (99.9) and extreme fatigue **I had the similar reaction to the first dose received on 3/17/2021, with the exception of no numbness/tingling or fever.
Onset of fever and chills - 6 p.m., 6 hrs. after vaccine Initial temp. taken at 7:30 p.m.: 100.7 Progressed to 103.1 at 10 p.m.  1000 mg Tylenol given at that time (10 p.m.) Temp increased to 103.6 by 10:30 p.m. Temp decreased to 103.2 at 11 p.m. 5 a.m. temp recorded at 101.6  1000 mg Tylenol given 9 a.m. temp recoded at 99.7 1000 mg Tylenol given 10:30 a.m. temp at 98.1 Still feeling weak and somewhat nauseated; headache, clammy.
H. Pylori; chills; nausea; headache.; fever; This spontaneous case was reported by a consumer and describes the occurrence of HELICOBACTER GASTRITIS (H. Pylori) in a 65-year-old female patient who received mRNA-1273 for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Helicobacter pylori infection.    On 11-Apr-2021, the patient received second dose of mRNA-1273 (Intramuscular) 2 dosage form. On 11-Apr-2021, the patient experienced PYREXIA (fever). On an unknown date, the patient experienced HELICOBACTER GASTRITIS (H. Pylori) (seriousness criterion medically significant), CHILLS (chills), NAUSEA (nausea) and HEADACHE (headache.). At the time of the report, HELICOBACTER GASTRITIS (H. Pylori), PYREXIA (fever), CHILLS (chills), NAUSEA (nausea) and HEADACHE (headache.) outcome was unknown.            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   Reporter did not allow further contact; 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
No additional AE reported.; Patient was administered expired VAQTA; This spontaneous report was received from Pharmacist and refers to an unknown patient of an unknown age or gender.  The patient's medical history, concurrent conditions, concomitant therapies and previous drugs reactions or allergies were not reported.  On 21-FEB-2023, the patient was vaccinated with an expired vaccine of hepatitis a vaccine, inactivated (VAQTA) lot #U021561, expiration date: 14-JAN-2023, administered for prophylaxis (strength, and route of administration were not provided) (Expired vaccine used), it was stated that No Temperature Excursion reported for Affected Product prior the administration of the vaccine. No additional adverse event was reported.  This case was considered as non-valid due to lack of patient identifiers.  Follow-up information has been received from the pharmacist on 11-SEP-2023. The patient's demographic information was updated. The case was regarding a 87-years-old male patient. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not reported. The previously reported expired dose of Hepatitis A Vaccine, Inactivated (VAQTA) was administered intramuscularly. It was reported the patient and primary physician were informed of the incident and that the patient had no side effect or adverse reactions from the expired dose administered.
Two weeks after the first Pfizer COVID vaccine shot, developed severe neutropenia (ANC = 0.62 and WBC = 3.24). Follow up with hematologist four weeks after first shot and neutropenia were worsened (ANC = 0.49 and WBC = 2.65). No treatment was admitted and follow fever protocol and visit the hematologist after 6 more weeks. Hematologist also called off second Pfizer shot.
The patient stated that she felt sick after receiving a flu vaccine. The patient complained of feeling tired and feeling like she was catching a cold.
The pt started 2/7/01 with 20 pox lesions, then on 2/12/01 had full blown case of varicella.
Headache; Fever of 101.4F; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), PYREXIA (Fever of 101.4F) and PAIN IN EXTREMITY (Sore arm) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, the patient experienced HEADACHE (Headache), PYREXIA (Fever of 101.4F) and PAIN IN EXTREMITY (Sore arm). At the time of the report, HEADACHE (Headache), PYREXIA (Fever of 101.4F) and PAIN IN EXTREMITY (Sore arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Treatment medication - Advil consent for follow-up given   Reporter did not allow further contact
After I received my second dose of the Pfizer vaccine, I developed tinnitus three weeks later.
Had fatigue and soreness in arm with second shot now has abnormal CBC. lymphocytes  0.9 (low) 1/28/2022 CD3 total Tcells- 624 (low-done 01/28/2022 CD4 345 (low) CD8-266 CD4/CD8 ratio 1.30
I have not been able to do average things with my right arm, like writing with a pen. I went to take my shower and there is a two inch thick 3 inch wide abscess on my deltoid. It hurts tremendously and I do not know what to do besides hot water and pressure. My first vaccine area on the left arm still hurts whenever touched. So I am unsure what is going on because the first one had no abscess but hurt badly , but I?m in terrible pain with this huge abscess on my shoulder area.
Injection given too high in the arm. Now have reduced/limited movement of the arm due to pain, shoulder joint hurts, deltoid muscle aches.
Congestion; Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of NASAL CONGESTION (Congestion) and DIARRHOEA (Diarrhea) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 12-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced NASAL CONGESTION (Congestion) and DIARRHOEA (Diarrhea). At the time of the report, NASAL CONGESTION (Congestion) and DIARRHOEA (Diarrhea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided. Treatment medication was Honey and cough medicine.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. The patient experienced congestion after the first dose, was mowing to the lawn and had allergies.  Second dose was scheduled on 06 JUN 2021.   Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: Follow-up received and contains no new information
Sudden onset of warmth, diaphoresis, darkening of vision, and inability to hear. Reported while sitting and remaining in his chair.   No fall or injury. Return of consciousness quickly on the vaccination floor. Full recovery after 27 minutes of observation.   Initial BP was 71/57 sitting and alert, he was placed supine. Next BP was 98/63, and remained in the normal range thereafter.    Pulse -88-103.  O2 sat 97%. No orthostasis after recovery.  Standing BP - 114/83.  Very typical and self resolving vasovagal reaction.
APPROX 1 WEEK AFTER - HEADACHES, STOMACH ACHE.
Patient was given a pfizer vaccine for COVID instead of the influenza vaccine he had wanted/ expected. Patient had previously completed a two dose series of the Moderna vaccine for COVID.
Very sore RT Deltoid beginning 5 hours after injection and lasting for 3 days.  Fever of 102.7 beginning 20 hours after injection and lasting for 24 hours.
This spontaneous report as received from a physician refers to a 67 years old male patient with diabetes, hypertension, hyperlipidemia, vitamin B12 deficiency, depression and no drug reactions/allergies. On 04-JAN-2013, the patient was vaccinated IM with a booster dose of PNEUMOVAX23 (lot # H013399, Exp. Date: 07-MAR-2014). No other co-suspects were reported. Concomitant medications included metformin XR, hydrochlorothiazide (+) lisinopril. JANUVIA, LIPITOR, glipizide, vitamin B12, PROTONIX and amitriptyline hydrochloride. On 04-JAN-2013, the patient became flushed and warm 5-10 minutes after receiving "a booster dose" of PNEUMOVAX23,. The physician stated that patient was visibly red in the face, arms, hands and chest and the patient reported he felt hot and had a headache. The physician mentioned these symptoms subsided within 20 minutes and mentioned the patient had fasted for 14 hours prior to receiving PNEUMOVAX23 for unspecified blood work testing and was diabetic. The physician also mentioned the patient received a first dose of PNEUMOVAX23 on an unspecified date in October 1998. The patient was given water for the events. No lab diagnostics studies were performed. At the time of the report, the patient was recovering from the evens. Additional information has been requested.
Information has been received from a consumer concerning a 7 year old male who on 28-FEB-2000 was vaccinated with a dose of Varivax. On 13-JUL-2006 the patient developed a chickenpox rash. The patient was triaged by the office. Subsequently, the patient recovered. No further information was available. The patient's siblings (WAES # 0608USA04849 and 0608USA04854) also had adverse experiences after vaccination. Additional information is not expected.
redness developed from around site to within an inch or two of elbow, pain and swelling followed  The redness faded over a week but the soreness remains to the extent of limiting normal use of the arm to this date
throwing up; stomach cramps; dry heaving; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection), via an unspecified route of administration on 23Mar2021 11:30 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that she got her first shot of the vaccine yesterday i.e. 23Mar2021 at 11:30 EST.  About 1:45 EST this morning i.e. 24Mar2021, she started throwing up and have been throwing up ever since. She had constant stomach cramps and dry heaving. She don't even know if get the second shot. She can't keep anything down. Even throwing up water. The outcome of event was unknown.  Information about batch/lot number has been requested.
Muscle soreness in the upper left arm; Lethargy the next day.; This is a spontaneous report from a contactable consumer (patient). A 33-year-old non-pregnant female patient received bnt162b2 first dose of (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL3247), via an unspecified route of administration, administered Left arm on 05Feb2021 at 02:00 PM (at the age of 33-year-old) as dose 1 and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration, administered Left arm on 26Feb2021 02:00 PM (at the age of 33-year-old) as dose 2, single for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient's medical history included Allergic to morphine, sulpha drugs. The patient's other medications within 2 weeks of vaccination included etonogestrel (NEXPLANON). 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. Since the vaccination, the patient was not tested for Covid-19. New information (04Mar2021): included this is a follow up-spontaneous report from a contactable consumer. This consumer reported in response to consumer letter sent via e-mail which included that she provided a response to the first email, she received this morning. she was aware of the adverse event on 26Feb2021, as stated in her report. On 27Feb2021, they received a report from patient that you experienced some adverse events after the 2nd dose COVID-19 vaccine. In the report it stated the event onset date was on 26Feb2021 Muscle soreness in the upper left arm and Lethargy the next day. The patient did not receive any treatment for the events. The oucome of events was recovering.  No follow-up attempts are needed. No further information is expected.
1. Repeat episodes of extreme pain in upper left arm and left shoulder which lasted for ca. 30 minutes for a period of a week. 2. Tremor in left hand while using a mobile phone for photos. 3. Inability to raise left arm beyond waist level. 4. Multiple Post-event Physical Therapy Sessions
Pt first noticed a red raised non-itching rash on the entire trunck of her body on Thursday night while changing clothes.
pt recv vax 10AM TC from son states pt has had few vax a/, almost blacked out & have diff w/equilibrium;having nausea & some diarrhea;
Syringe Connection Issue; Vaccine underdose; This spontaneous case was reported by a nurse and describes the occurrence of DEVICE CONNECTION ISSUE (Syringe Connection Issue) and UNDERDOSE (Vaccine underdose) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced DEVICE CONNECTION ISSUE (Syringe Connection Issue) and UNDERDOSE (Vaccine underdose). At the time of the report, DEVICE CONNECTION ISSUE (Syringe Connection Issue) and UNDERDOSE (Vaccine underdose) had resolved.        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.   Exactly which syringe/needle unit was being used was not recorded. A second dose was not administered per current CDC guidelines at the time. Patient was informed that he will be notified if an additional dose will need to be administered.  No concomitant medications were reported. No treatment information was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2021: Non-significant Follow-up
Ice cold hands and feet since being vaccinated.; This is a spontaneous report from a contactable consumer (patient) via COVID-19 Adverse Event Self-Reporting Solution (COVAES). A 40-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection) via an unspecified route, administered in left Arm on Mar2021 at 10:00 (Lot Number: ER8732; at the age of 40-year-old) as a dose 2, single via an unspecified route, administered in left Arm on Mar2021 at 10:00 (Lot Number: ER8732; at the age of 40-year-old) as dose 1, single, both doses for COVID-19 immunization. The patient's medical history included heart arrhythmia and Hashimoto's. No past drug was reported. The patient's concomitant medications included levothyroxine sodium within 2 weeks of vaccination. Facility where the most recent COVID-19 vaccine was administered was Pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. On 16Apr2021 at 20:00, the patient experienced ice cold hands and feet since being vaccinated. Since the vaccination, the patient had not been tested for COVID-19. The adverse event resulted in doctor or other healthcare professional office/clinic visit. The patient had not received any treatment medication for the reported event. The outcome of the event was not recovered.  Follow-up attempts are completed. No further information was expected.
Developed hives 3 days after #1 covax; This is a spontaneous report from a Pfizer sponsored program Pfizer First Connect. A contactable female consumer (patient) reported that a 71-year-old female patient received the first dose of bnt162b2 (BNT162B2, Pfizer-BIONTECH covid-19 vaccine, Formulation: Solution for injection, Lot number and expiration date was not provided) via an unspecified route of administration on Jan2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient received the first dose of Pfizer's COVID vaccine 1 month ago and developed hives 3 days after receiving the vaccine of COVAX on Jan2021. She had a hunch biopsy done with her dermatologist which confirmed hives and she continued to have hives for the month following the vaccine. Her dermatologist recommended her to get the second vaccine with Claritin on board when she receives it and before receiving the vaccine, to take Benadryl and continue to be watched for 4 hours after the vaccine. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
My father suffered an Ischemic stroke on March 2nd and died on March 9th. He was was healthy and fit up to this point and walked several times a day.
1 day p/vax pt exp myalgia;As of 11NOV the myalgia cont & pt was unable to work;this is 1 of 5 pt from this facility to have an adverse exp p/vax w/lot# 4978216;
Patient received Moderna COVID vaccine on 3/2/2021.    She developed a swollen gland on the R neck and R ear pain in early March 2021.   She saw a physician and diagnosed with a viral illness.    Over few weeks glands decreased in size and resolved.  She received another dose of the Moderna vaccine on 3/30/2021.    Since that time patient had tenderness over the anterior neck with a sense of fullness when swallowing.    A primary care provider diagnosed the patient with thyromegaly.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A 40-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 38 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Sulfa-containing antibiotics" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient was given treatment of Paxlovid from 06Aug2023 to 10Aug2023.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Blood at injection site; Moderna covid vaccine/left side of the body severe lymphatic reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE HAEMORRHAGE (Blood at injection site) and LYMPHATIC DISORDER (Moderna covid vaccine/left side of the body severe lymphatic reaction) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Hidradenitis suppurativa and Rheumatoid arthritis.    No Medical History information was reported.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In September 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced VACCINATION SITE HAEMORRHAGE (Blood at injection site) and LYMPHATIC DISORDER (Moderna covid vaccine/left side of the body severe lymphatic reaction). At the time of the report, VACCINATION SITE HAEMORRHAGE (Blood at injection site) and LYMPHATIC DISORDER (Moderna covid vaccine/left side of the body severe lymphatic reaction) outcome was unknown.            Issue with the pen where Humira medication did not come out of the pen and the needle did not prick skin.  No concomitant medications were reported. No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.