chrisvoncsefalvay/vaers-outcomes huggingface dataset:
sore throat & itching in ear Narrative:  At 1622, patient stated to this RN monitor that she was experiencing itchiness in her right ear and soreness on the right side of her throat. She described  the sensation in the right side of her throat as "like I've been yelling at a concert".  She stated that she was experiencing neither symptom prior to receiving the vaccine nor was this something she typically experiences. VS were taken at 1623.  Reassessed the patient at 1638. She stated she was still feeling some itchiness in her right ear but not as much as before. She stated she was still feeling mild soreness on the right side of her throat but no worse than before. Patient stated that she was not SOB, she stated she felt no swelling in her tongue/lips/face. RN  did not visualize swelling in her tongue, lips, face. Patient had no other signs and  symptoms. Advised patient that should she feel SOB or welling in her tongue,  throat, face, lips that she should immediately call emergency services. Patient epxressed understanding and was released from the clinic. 1623 VS: BP 120/82, HR 63, SaO2 96% 1638 VS: BP 125/79, HR 64, SaO2 98%  RN Signed: 04/16/2021 16:55
On 07/04/2022 my mother flew and she tested positive for COVID-19 on 07/07/2022. She lives with me and I was caring for her. On 07/10 I began having symptoms such as headache, sore throat, body aches, fever, vomiting, diarrhea, chills, coughing, sinus congestion, and ear pressure. I tested positive for COVID-19 on 07/11/2022. On 07/13/2022 I received a Monoclonal antibody infusion. By 07/14 my symptoms were starting to improve and I no longer had a fever. I tested negative with an at home test on 07/19.
extremely sore on and around the left arm towards the elbow; pain when raised up. lost sleep all night; painful cramp in left calf. Feeling chill all day, requiring extra heat from a portable heater. As of today, 1/23/2023, I still have the soreness on my arm with injection site and nit feeling free to raise it to my head.
Received Moderna covid vaccine on Wednesday December 30. On the morning of Thursday January 7, noticed intense pruritis and redness of left shoulder surrounding the injection site of previous covid vaccine. The redness initially measured 7.5 cm by 4.5 cm and had several small wheals. Took 180 mg Allegra and 600 mg ibuprofen which relieved the itchiness and wheals, slightly decreased the intensity of the redness. By the next morning, rash expanded to 9.5 cm by 6.0 cm but was without pruritis or wheals. Denies additional areas of urticaria or associated symptoms. Denies previous history of allergies to vaccines.
Belching, severe diarrhea for about 10 hours and then subsided, began again 24 hours later.
(1) Abdominal pain. Started the next day and lasted about 3 weeks, lessening over time.  My stomach hasn't been the same since. (2) Lost sensation in lower legs (below the knees, mostly the calves), along with some hair loss/thinning.  I dont recall noticing this until at least a week after the shot.  Maybe a couple weeks.  This weird sensation lasted several months.
arm around the injection site was swollen, red, warm, and itchy; arm around the injection site was swollen, red, warm, and itchy; arm around the injection site was swollen, red, warm, and itchy; arm around the injection site was swollen, red, warm, and itchy; little lightheadedness; little bit of pain in her arm; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (little lightheadedness), PAIN IN EXTREMITY (little bit of pain in her arm), VACCINATION SITE WARMTH (arm around the injection site was swollen, red, warm, and itchy), VACCINATION SITE PRURITUS (arm around the injection site was swollen, red, warm, and itchy) and VACCINATION SITE ERYTHEMA (arm around the injection site was swollen, red, warm, and itchy) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced PAIN IN EXTREMITY (little bit of pain in her arm). On 09-Feb-2021, the patient experienced DIZZINESS (little lightheadedness), VACCINATION SITE WARMTH (arm around the injection site was swollen, red, warm, and itchy), VACCINATION SITE PRURITUS (arm around the injection site was swollen, red, warm, and itchy), VACCINATION SITE ERYTHEMA (arm around the injection site was swollen, red, warm, and itchy) and VACCINATION SITE SWELLING (arm around the injection site was swollen, red, warm, and itchy). At the time of the report, DIZZINESS (little lightheadedness), PAIN IN EXTREMITY (little bit of pain in her arm), VACCINATION SITE WARMTH (arm around the injection site was swollen, red, warm, and itchy), VACCINATION SITE PRURITUS (arm around the injection site was swollen, red, warm, and itchy), VACCINATION SITE ERYTHEMA (arm around the injection site was swollen, red, warm, and itchy) and VACCINATION SITE SWELLING (arm around the injection site was swollen, red, warm, and itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.    No treatment information was provided
Red, measle like rash over trunk and extremities.  Sseemed resolved on day 14, but worse on day 16 to include entire trunk, face and all extremities with irritability.
Patient received the second dose of Prevnar-13 on July 28, 2020. He received this in the Right Vastus Lateralis.  The patient experienced significant redness and  swelling of the right thigh the  following day on July 29, 2020. The patient did not have a fever or experience any breathing difficulties.
Urticaria NOS. A physician reported that an infant received the 1st dose of Prevnar along with DTaP/Hib combination and immediately developed hives.
Patient noticed rash at injection site of shingrix morning of 10/4/19. Told patient she could take benadryl to help speed up the healing process or it would resolve on its on. Rash was about one inch by one inch.
High fever, nausea, loss of appetite, no strength, terrible headache, muscle ache, and fatigue
COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer). The reporter is the patient. A 65-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Sep2022 as dose 5 (booster), single (Lot number: GJ2524) at the age of 64 years, in right arm for COVID-19 immunization; BNT162b2 (BNT162B2), on 08Apr2022 as dose 4 (booster), single (Lot number: FK9893), in left arm for COVID-19 immunization; BNT162b2 (BNT162B2), on 24Dec2020 as dose 1, single (Lot number: EK9231), on 14Jan2021 as dose 2, single (Lot number: EK4176), in left arm and on 02Oct2021 as dose 3 (booster), single (Lot number: FF8841), in left arm for COVID-19 immunization. The patient's relevant medical history included: "T1DM" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2023) Positive. Therapeutic measures were taken as a result of vaccination failure and COVID-19. Clinical information: It was reported that the patient had no known allergies. In 2023, the patient had COVID-19 (positive results) and started treatment with PAXLOVID from 27Feb2023 until 03Mar2023.
Pt was 2 months pregnant at the time of vaccination. Pt has been experiencing morning sickness and throwing up. No further information is available.
Information has been received from a women from a pediatric office concerning an 11 year old female who on 02-JUN-2008 was vaccinated subcutaneously in the "right" with a second dose of VARIVAX (Oka/Merck) (Lot #660279/1895U). "24 hours post injection:, on 03-JUN-2008 the patient experienced injection site pain, tenderness, redness, swelling and warm to touch. The diameter of the area was 5-6 cm. The patient also experienced fever and cellulitis. The patient's body temperature was up to 101. the patient was treated with TYLENOL, MOTRIN and possible antibiotics for cellulitis. At the time of the report, it was unknown if the patient had recovered from the events. Additional information is not expected.
received a Shingrix injection almost 3 years ago, but did not get dose 2 yet.; This case was reported by a pharmacist via call center representative 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 (1st dose received almost 3 years before the reporting date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The initials and date of birth of patient were unknown.  The patient did not receive the 2nd dose till the time of reporting which led to incomplete course of vaccination. The reporter did not consent to follow-up.
Larette Fitts came into immunization mobile "CareVan" van to receive Hep A/B (Twinrix®) vaccine.  ½ hour after being immunized patient c/o redness, heat at site, vomiting, and blurred vision.  Nurse at facility where patient is housed (Caritas Intake, 140 N. Ashland Avenue, Chicago)  stated she administered 50mg benadryl to patient. Twenty minutes after patient received benadryl patient stated that she felt much better.
redness, swelling , pain at injection site. injection site hot to the touch.  Itching at injection site. redness extending out from injection site 2-4 inches. Redness continues to extend from injection site 3 days post injection.
This case was reported by a pharmacist and described the occurrence of adverse reaction in a male patient who received BOOSTRIX (batch number 75354, expiry date unknown). On an unknown date, the patient received BOOSTRIX. On an unknown date, an unknown time after receiving BOOSTRIX, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown. It was unknown if the reporter considered the adverse reaction to be related to BOOSTRIX.
Information has been received from a nurse concerning a 24 year old female with seasonal allergy who on 09-OCT-2008 was vaccinated IM with the first 0.5ML dose of GARDASIL (lot # 661044/0548X).  Concomitant therapy included montelukast sodium (MSD).  On 09-OCT-2008, about 6 hours after vaccination the patient experienced tingling of outside of ears and ears became painful to touch which became worse when talking.  No treatment required.  The patient sought medical attention by phone.  Additional information has been requested.
Employee started feeling very anxious and light headed. She was evaluated by EMT. She was tachycardic and hypertensive but was severely anxious as she has a lot going on in life right now and has been anxious all day. EMT offered to drive her to the hospital but she refused and thinks it is due to anxiety. Employee was told if she still feels heart rate and blood pressure are high later today she should call primary care doctor or go to hospital. She left after about 45 mins of being evaluated feeling better but still anxious. Heart rate 119 and blood pressure 150/90.
Whelp appeared on left arm below the injection site of the MMR. Diluent used was Merck R032354 EXP 6-11-2021 Whelp was .5 cm in size. redness noted around whelp. Advised to apply ice and give antihistamine.
pt recv flu vax 29SEP96 & on 1OCT96 reported that this AM large red warm area noted @ inj site;states knew was allergic to Thimerosal in eye solution-made eye burn;no tx other than APAP given;
33 hours after second shot: tired, dizzy. Continuing through today (10.5 days later); 33 hours after second shot: tired, dizzy. Continuing through today (10.5 days later); This is a spontaneous report from a contactable consumer (Patient). A 82-years-old male patient received second dose of bnt162b2 (BNT162B2, solution for injection; Batch/Lot number was not reported), dose 2 via an unspecified route of administration, administered in Arm Left on 11Feb2021 07:00 as dose 2, single (At the age of 82-years) for covid-19 immunisation. Historical vaccine included received first dose of BNT162B2 (COMIRNATY, solution for injection, Batch/Lot Number: was not reported), via an unspecified route of administration, on an unspecified date as dose 1, single for COVID-19 immunization. Medical history included leukaemia and allergic to penicillium, anti-inflamatories. from an unknown date and unknown if ongoing. No other vaccine given in four weeks. Prior to vaccination, patient was not diagnosed with covid-19. Concomitant medication(s) included levothyroxine sodium (LEVOTHYROXINE SODIUM), amlodipine (AMLODIPINE), lisinopril (LISINOPRIL), sulfamethoxazole, trimethoprim (BACTRIM) and glucose (GLUCOS) all taken for an unspecified indication, start and stop date were not reported. On 12Feb2021 at 14:00 the patient experienced 33 hours after second shot: tired, dizzy. continuing through today (10.5 days later). Since the vaccination, patient has not been tested for covid-19. Patient did not receive any treatment for the events. The outcome of the event was not recovered.  Follow-up attempts completed. No further information expected.
Vaccine H1N1 shot given 10/20/09. Reported lip swelling and numbness 10/21/09 AM.
Nausea followed by chills, fever, vomiting, severe diarrhea, headache.
summer cold or flu; Flu; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (summer cold or flu) and INFLUENZA (Flu) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-May-2021, the patient experienced NASOPHARYNGITIS (summer cold or flu) and INFLUENZA (Flu). At the time of the report, NASOPHARYNGITIS (summer cold or flu) and INFLUENZA (Flu) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no concomitant medications are provided. treatment to the events not provided.
This spontaneous report as received from a Registered Nurse concerning to an approximately 13 years old patient who was vaccinated with an expired 0.5 ml VARIVAX (merck), SQ, right arm, (Lot # 1003Z, Exp 28-JUL-2012) on 15-OCT-2012. No other co-suspects were reported. No concomitant medications were reported. No adverse effects were reported. Additional information has been requested.
Patient to potentially receive the second dose of the vaccine more than 36 days from the first dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient to potentially receive the second dose of the vaccine more than 36 days from the first dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient to potentially receive the second dose of the vaccine more than 36 days from the first dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient to potentially receive the second dose of the vaccine more than 36 days from the first dose) 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.   Concomitant medication use was unknown
On January 6th the patient started noticing itching, redness and warm to the touch at the injection site. On the 7th the patient noticed a large knot and swelling at the injection site. Swelling was gone after approximately 24 hours.
pains everywhere; ear pain; back pain; rib pain; joint pain; body pain; fever of 100 to 101 degrees Farenheight.; headaches; feels like we have the Covid-19 virus again; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (pains everywhere), EAR PAIN (ear pain), BACK PAIN (back pain), MUSCULOSKELETAL CHEST PAIN (rib pain) and ARTHRALGIA (joint pain) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in September 2021.    On 09-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Nov-2021, the patient experienced PAIN (pains everywhere), EAR PAIN (ear pain), BACK PAIN (back pain), MUSCULOSKELETAL CHEST PAIN (rib pain), ARTHRALGIA (joint pain), MYALGIA (body pain), PYREXIA (fever of 100 to 101 degrees Farenheight.), HEADACHE (headaches) and SUSPECTED COVID-19 (feels like we have the Covid-19 virus again). At the time of the report, PAIN (pains everywhere), EAR PAIN (ear pain), BACK PAIN (back pain), MUSCULOSKELETAL CHEST PAIN (rib pain), ARTHRALGIA (joint pain), MYALGIA (body pain), PYREXIA (fever of 100 to 101 degrees Farenheight.), HEADACHE (headaches) and SUSPECTED COVID-19 (feels like we have the Covid-19 virus again) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Nov-2021, Body temperature: 100-101 (High) 100 to 101 degrees Fahrenheit.     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.   No Concomitant medications were reported. No treatment medications were reported.  This is a spontaneous case concerning a 73-year-old male patient with no relevant medical history, who experienced non serious, AESI, unexpected event of Suspected COVID-19. The event occurred 2 days after the first dose of mRNA-1273 vaccine. The rechallenge was not applicable since only information about the first dose was disclosed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 73-year-old male patient with no relevant medical history, who experienced non serious, AESI, unexpected event of Suspected COVID-19. The event occurred 2 days after the first dose of mRNA-1273 vaccine. The rechallenge was not applicable since only information about the first dose was disclosed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
PT HAD NO ADVERSE REACTION BUT WAS NOT SUPPOSED TO GET A THIRD DOSE. ORIGINAL SERIES COMPLETED BACK IN 2019. 1ST DOSE 5/30/2019 AND 2ND DOSE 8/20/19
Patient reports shortness of breath, headache and dizziness 15 minutes after received COVID-19 vaccination. Patient stayed in observation area for 1 hour. Patient reports "brain fog" for 4 days after vaccine and 1 week after vaccine experienced tinnitus.
Headache injection site, itching, swelling and pain, abdominal cramping, lethargy, back pain (side of injection) Narrative:
Pt recvd a booster dose of Engerix-B 19AUG92 & 19AUG92 pt exp peristent insomnia w/multiple nightly awakenings; pt indicated was exhausted from lack of sleep; Restoril & valium are of no help;
Pt had no adverse reaction in the office.  Follow up call to mom on 4/25/2022, patient was still doing fine, no adverse reaction.  Denies any fever, vomiting, diarrhea or headache.
Extreme tiredness/fatigue; Sleeping double; Painful neck; Felt like cold coming on; Rash on right arm; Headache/Painful back of head; Sore arm; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ep6955) via an unspecified route of administration in the arm right on 27Mar2021 at 14:00 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included daily vitamin (MANUFACTURER UNKNOWN),  airborne gummies and vitamin D3 (MANUFACTURER UNKNOWN) for an unknown indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 27Mar2021, patient was shot in right arm and experienced sore arm. On 28Mar2021, the patient experienced rash (in past few days) a weird rash was appearing in random areas for a day, rash on right arm/rash on lower back, arms, legs, torso, chest, feet and headache/painful back of head. On 29Mar2021 at 12:00, the patient felt like cold coming on. On 30Mar2021, the patient experienced painful neck, experienced sleeping double what she usually sleeps (16 hours instead of 8 hours) and extreme tiredness/fatigue. The event resulted in emergency room/department or urgent care. On 05Apr2021, the patient went to urgent care, they even thought she had caught COVID at the same time as getting the vaccine and checked with nasal swab test but the test came back negative. Therapeutic measures were taken as a result of neck pain which included treatment with ketorolac (MANUFACTURER UNKNOWN). The clinical outcome of the event sore arm, rash on right arm/rash on lower back, arms, legs, torso, chest, feet, felt like cold coming on, headache/painful back of head, painful neck, sleeping double and extreme tiredness/fatigue was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
This spontaneous report was received from a physician via company representative refers to a female patient of unknown age. The patient had splenectomy done in the past. On an unknown date in 2013, the patient was vaccinated with a dose 3 of PNEUMOVAX 23, (lot number reported as 51 YOWF or 5LYOWF, expiration date and route was not reported). Concomitant medications were not reported. On an unknown date in 2013, the patient became febrile after she received PNEUMOVAX 23. The patient experienced red, swollen arm. The patient had received a dose of PNEUMOVAX 23 in 2008 at the physicians office as well as possibly one prior to 2008 from another unspecified healthcare provider. The outcome of reported events were unknown. The patient sought medical attention. Additional information has been requested.