chrisvoncsefalvay/vaers-outcomes huggingface dataset:
warm to the touch around the injection site - right arm; itchy near injection site - right arm; little hard near injection site - right arm; red patch near injection site - bout 3 by 4 inches - right arm; rash around the injection site - right arm; headache; sore arm - right arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (warm to the touch around the injection site - right arm), PAIN IN EXTREMITY (sore arm - right arm), VACCINATION SITE PRURITUS (itchy near injection site - right arm), VACCINATION SITE INDURATION (little hard near injection site - right arm) and HEADACHE (headache) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]) for an unknown indication.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, the patient experienced PAIN IN EXTREMITY (sore arm - right arm) and HEADACHE (headache). On 06-Feb-2021, the patient experienced VACCINATION SITE WARMTH (warm to the touch around the injection site - right arm), VACCINATION SITE PRURITUS (itchy near injection site - right arm), VACCINATION SITE INDURATION (little hard near injection site - right arm), VACCINATION SITE ERYTHEMA (red patch near injection site - bout 3 by 4 inches - right arm) and VACCINATION SITE RASH (rash around the injection site - right arm). At the time of the report, VACCINATION SITE WARMTH (warm to the touch around the injection site - right arm), VACCINATION SITE PRURITUS (itchy near injection site - right arm), VACCINATION SITE INDURATION (little hard near injection site - right arm), VACCINATION SITE ERYTHEMA (red patch near injection site - bout 3 by 4 inches - right arm) and VACCINATION SITE RASH (rash around the injection site - right arm) had not resolved and PAIN IN EXTREMITY (sore arm - right arm) and HEADACHE (headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment included cool packs.
Chills, felt hot, then cold - did break a sweat felt "run down", weak no fever detected (had no thermometer available) by hand on forhead 12/14/07-12/15/07 (Lasted approx. 30 hours)
Patient arrived on 4/1/2021 to receive his second dose of the COVID vaccine.  Patient reported he developed hives 3 days after the first dose of vaccine and that the hives are still present.  Called by nurse and I advised to not give 2nd dose.
Flu-like symptoms, muscular and joint pain, headache, low grade fever, chills, jaw and tooth pain on left side, pain in left arm and shoulder.
Localized site reaction with swelling and redness, improved over time but still has a nodule present at 4 month well child (2 months later)
Redness at the injection site; Swelling at the injection site; A spontaneous report was received from a Consumer concerning a 75-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced redness at the injection site and swelling at the injection site.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 20 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot batch: 042L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 20 Jan 2021, the patient experienced the events redness at the injection site and swelling at the injection site.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   the outcome of events redness at the injection site and swelling at the injection site was resolved on 23 Jan 2021. .
This spontaneous report as received from a nurse practitioner refers to a 60 years old patient. The patient was vaccinated with (Merck) VARIVAX inadvertently instead of intended ZOSTAVAX on 24-SEP-2012. Lot# and route were unspecified. NO adverse effects reported. Additional information has been requested.
It started seeing things. I also slept for 3 days straight. These symptoms went on for months. I happen to be on a heart monitor due to a car accident. That happen to pick up a Techy cardiac. My heart rate was 168. For about 2 months I had really bad hot flashes. I had really bad acid reflux that I could not eat or drink anything. I had 2 months of fatigue. I went to the ER. They said I was dehydrated.
Flu like symptoms for 36-48 hours after vaccination. Joint pain starting about 48 hours after injection.  Pain seems to come and go and show up in various parts of my body (shoulders-both, right knee, hips-both, lower back  and arms.
FEVER, VOMITING, ABDOMINAL PAIN, HEADACHE, SORE THROAT, MILD SWELLING AT INJECTION SITE.
Localized rash over the injection site (Left arm deltoid area). Began with erythematous papules that coalesced into a wheal. Itchy, red, warm to touch. Resolved in about 3 days. Took Claritin 10mg daily.
3/14/03 1 p.m. Left side of mouth tingly 3/14/03 10 p.m. Left side of mouth drawn and Left eye muscles twitching  Prednisone 60 mg 3 tablets on day 1, 2 tablets on day 2 and 1 tablet on day 3
Narrative:  65 year old male with a past medical history of HTN, COPD on room air, hx of PE on Xarelto, hx of subarachnoid hemorrhage, hypothyrodism, T2DM insulin depedent, HLD presented to the ED from his independent living facility due to worsening shortness of breath. Pt received both Pfizer vaccines in the community. The patient was admitted to the COVID unit on 4/23/21 on room air. Dex, remdesivir, and convalescent plasma was not started on admission or in the ED. 1L NS was given to the patient in the ED due to dehydration from diarrhea. The patient was observed overnight and did not require any oxygen supplementations except at night when he refused to use CPAP machine for OSA and was on room air otherwise. His diarrhea decreased, he was able to tolerate PO intake without concern. The patient was discharged to his independent living facility with isolation precautions for 10 days post discharge.
UTI/hurts to pee/went to bathroom 20 times; Dizziness; body shakes and shivers; Body ache/pain/pressure/soreness; Headache; body shakes and shivers; body is Tired; This spontaneous case was reported by a consumer and describes the occurrence of URINARY TRACT INFECTION (UTI/hurts to pee/went to bathroom 20 times), DIZZINESS (Dizziness), TREMOR (body shakes and shivers), MYALGIA (Body ache/pain/pressure/soreness) and HEADACHE (Headache) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 642B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history reported). Concomitant products included FOLIC ACID, METHOTREXATE and DICLOFENAC for an unknown indication, VITAMIN D NOS, ASCORBIC ACID (VITAMIN C ACID) and PREDNISONE.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, the patient experienced DIZZINESS (Dizziness), TREMOR (body shakes and shivers), MYALGIA (Body ache/pain/pressure/soreness), HEADACHE (Headache), CHILLS (body shakes and shivers) and FATIGUE (body is Tired). On 08-Apr-2021, the patient experienced URINARY TRACT INFECTION (UTI/hurts to pee/went to bathroom 20 times). At the time of the report, URINARY TRACT INFECTION (UTI/hurts to pee/went to bathroom 20 times), DIZZINESS (Dizziness), TREMOR (body shakes and shivers), MYALGIA (Body ache/pain/pressure/soreness), HEADACHE (Headache), CHILLS (body shakes and shivers) and FATIGUE (body is Tired) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.
approx 4yrs p/vax exp chickenpox w/85 lesions all over body
Sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27Sep2022 at 14:00 as dose 5 (booster), single (Lot number: GF400) at the age of 70 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose Number: 4, Batch/Lot No: FK9893, Location of injection: Arm Left, Vaccine Administration Time: 04:00 PM), administration date: 27Apr2022, when the patient was 70-year-old, for COVID-19 Immunization; Covid-19 vaccine (Dose number :3, Unknown manufacturer), for COVID-19 Immunization; Covid-19 vaccine (Dose number :2, Unknown manufacturer), for COVID-19 Immunization; Covid-19 vaccine (Dose number :1, Unknown manufacturer), for COVID-19 Immunization.  The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 27Sep2022, outcome "recovered", described as "Sore arm". Therapeutic measures were not taken as a result of pain in extremity.  Additional information: Patient had no known allergies. Patient did not receive other medication in 2 weeks. Sender's Comments: Linked Report(s) : PFIZER INC-202300018678 Same patient, different vaccine dose/event.
Expired dose of Engerix-B administered to a female patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 20-year-old female patient who received HBV (Engerix B) (batch number LP724, expiry date 18-MAY-2023) for prophylaxis.   On 01-JUN-2023, the patient received Engerix B. On 01-JUN-2023, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: Expired dose of Engerix-B administered to a female patient). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt date: 01-JUN-2023 A reporter reported about a patient who received expired dose of Engerix-B which led to expired vaccine used. The reporter consented to follow up.
Received injection at approx 10:45am, became pale, clammy skin, and c/o weakness. Blood pressure low, patient stated he had not eaten today. EMS here at 11:08, blood pressure normotensive. Patient states he feels better, significant other called and arrived. Patient reports he has had vasovagal/fainting episodes with vaccines/injections in the past. Patient stable, A&0x4, in good spirits, EMS deemed patient stable and able to return home with significant other.
Patient received vaccines on 10/16- the next morning of the 17th- pt reports feeling hot/cold with chills, muscle weakness and tired. Symptoms lasted about 24hrs and then resolved. No current medical concerns.
moderately painful herpes simplex virus blister on my lower lip; moderately painful herpes simplex virus blister on my lower lip; felt mildly unwell; slight headache/mild shooting pains into my left ear and on the left side of my head; mild shooting pains into my left ear and on the left side of my head for a couple of days; mild shooting pains into my left ear; This is a spontaneous report from a contactable nurse (patient). This non-pregnant 66-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EM-9809) via an unspecified route of administration in the left arm on 11Feb2021 at 14:30 (at the age of 66-years-old) as a single dose for COVID-19 immunisation. Medical history included osteoporosis, Hashimoto, nodular thyroid disease, and fever blister with the same shooting pain from unknown dates and unknown if ongoing. Prior to vaccination the patient was not diagnosed with COVID-19. The patient had no allergies to medications, food or other products. Concomitant medications included metoprolol succinate and biotin from unknown dates for unknown indications. On 16Feb2021 at 08:00 the patient developed a moderately painful herpes simplex virus blister on her lower lip 5-6 days after the vaccine injection. She also felt mildly unwell with a slight headache and mild shooting pains into her left ear and on the left side of her head for a couple of days. The pains were reported as peripheral, not deep seated. She reported she had this fever blister before with the same shooting pains, but not after a vaccine. The events were reported as non-serious and did not require hospitalization. The patient was treated with valacyclovir (VALTREX) 2 grams every 12 hours for 2 doses on days 1 and 4. The clinical outcome of the moderately painful herpes simplex virus blister on her lower lip, felt mildly unwell, slight headache, and mild shooting pains into her left ear and on the left side of her head were reported as recovering. It was also reported that since vaccination the patient had not been tested for COVID-19.
Initial information received on 07-Nov-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to cases 2018SA324602, 2018SA324603, 2018SA324604, 2018SA324606, 2018SA324607, 2018SA324608, 2018SA324605, 2018SA324609 (same reporter). This case involves a male patient of unknown age who received vaccines FLUZONE QUADRIVALENT and FLUZONE HIGH DOSE after vaccines were exposed to the temperature excursion. The patient's past medical history and concomitant medication were not provided. On an unknown date, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot number not reported via unknown route in unknown administration site. On an unknown date, the patient received a 0.5 ml dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ048AB (expiry date: 31-May-2019) via intramuscular route in the left deltoid. It was a case of actual medication error due to incorrect product storage. It was reported that the refrigerator temperature dropped overnight to 29.1 degrees Fahrenheit and was out of range for 11 hours. It was also reported that eight patients were administered a dose from the box that was exposed to the temperature excursion. It was unknown if patient experienced adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
hair has been falling out; COVID arm [after second and booster doses]; shaking; hot; itching; bumps; red; she got fever between 100-101; chills; This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (hair has been falling out), VACCINATION SITE REACTION (COVID arm [after second and booster doses]), TREMOR (shaking), VACCINATION SITE WARMTH (hot) and VACCINATION SITE PRURITUS (itching) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058F21A, 038A21A and 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy, Drug allergy, Sulfonamide allergy, Drug allergy, Hypertension (started 20 years ago) and Osteoarthritis (15 years ago; age-related).   On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced ALOPECIA (hair has been falling out), VACCINATION SITE REACTION (COVID arm [after second and booster doses]), TREMOR (shaking), VACCINATION SITE WARMTH (hot), VACCINATION SITE PRURITUS (itching), VACCINATION SITE SWELLING (bumps), VACCINATION SITE ERYTHEMA (red), PYREXIA (she got fever between 100-101) and CHILLS (chills). In November 2021, VACCINATION SITE REACTION (COVID arm [after second and booster doses]), TREMOR (shaking), VACCINATION SITE WARMTH (hot), VACCINATION SITE PRURITUS (itching), VACCINATION SITE SWELLING (bumps), VACCINATION SITE ERYTHEMA (red), PYREXIA (she got fever between 100-101) and CHILLS (chills) had resolved. At the time of the report, ALOPECIA (hair has been falling out) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2021, Body temperature: 100-101 got fever between 100-101.  Concomitant medication was not provided. Patient received flu shot in September 2021 was given within 1 month prior to Moderna COVID-19. It was reported that, patient was standing ankle deep in her shower cleaning hair out of her drain. She would call it shedding lots and lots of shedding. The patient also added that after taking booster dose, had the COVID arm - red, hot, itching, bumps, not blisters. That lasted between 5-6 days. Within 24 hours, she got fever between 100-101. That lasted about 24 hours. Treatment information was not provided.   This case was linked to MOD-2022-481363 (Patient Link).
This spontaneous report as received from a registered nurse refers to 2 patients of unknown demographics. On 16-NOV-2013, M-M-R II of batch H018950, lot 1483AA and expiration date 18-NOV-2014 went through an unsupported temperature excursion. On 19-NOV-2013 the 2 patients were vaccinated with this lot of M-M-R II. No adverse effects reported. Additional information has been requested.
Approximately 8pm my right shoulder at the site of the shot started itching. Circular area approximately 4 inch diameter became raised and red w numerous small bumps - like hives -  Incredibly itchy. I took Benadryl.  By the following morning the site was only slightly raised and only slightly red and bumpy.
pt recvd vax adm to hosp 6JUN93 w/t105; all appropriate test which were neg; poss react to DTP; to give DT next visit;
On 8/1/18, patient presented to pharmacy with redness, slight swelling, and pain at the site of injection. The redness was in the shape of a square about 2inches x 2inches. Patient stated there was a bit of pain and no itching. He has not taken any medication since onset of reaction. Advised patient to take ibuprofen for pain and BENADRYL to counteract the reaction and we will follow-up with him in a few days. On 8/4/18, I followed up with a phone call to the patient. He said he took ibuprofen (no diphenhydramine) after he came on 8/1/18. The area of injection was sore for one extra day and then the rash and pain resolved.
Rash x 2D local site reaction left deltoid. Generalized Macular paular rash.
Headache , fever 100.8, chills, Fatigue,  body ache  . Nausea
I arose at 7, took a shower and felt fine.  Then while making the bed with my wife I suddenly felt vey week, needed to sit on the side of the bed.  My wife said my face was white.  I had some mild intestinal cramping so went to the toilet.  I was doubled over sitting on the toilet and in a cold sweat with diarrhea.  There was no nausea.   I felt weak afterwards and napped most of the morning with one more episode of diarrhea, very mild this time, at 10:45.  I did not seek medical help, was able to eat lunch and dinner with no problem, but was very low on energy for the remainder of the day.  I went to bed early with 2 Acetaminophen and slept 11 hours.  Felt better the next day.
lower back pain; sore; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (lower back pain) and MYALGIA (sore) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A17A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On an unknown date, the patient experienced BACK PAIN (lower back pain) and MYALGIA (sore). At the time of the report, BACK PAIN (lower back pain) outcome was unknown and MYALGIA (sore) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.
Symptoms of rash growing in size at my left ear, quickly spreading and thickening with yellow liquid oozing, crusting over, breaking and oozing. Spreading down my neck to my collar bone area and taking over my whole ear front and back. Spreading further to my jawline and upward and behind the eat into the hairline as I was misdiagnosed and on three different antibiotics and a probiotic for two weeks prior to being sent to the ER for a IV of heavier antibiotics. The ER doctor declined the IV and immediately identified shingles, prescribing Valacyclovir which cleared it over another week and a half. The cost after insurance for just the ER visit was 860.00, plus an office visit for 65.00 together, and the RX prescribed. I was also in bed without energy, missing work due to the illness affect for a week.
No adverse reaction. Vaccine had been given 5 days past expiration date. Merck & Co. contacted vaccine was still viable upon injection. Patient has had no signs or symptoms of adverse reaction.
Swollen Lymph Nodes Near the Injection Site; Fatigue; Chills; Fever - Temperature of 101.0F; Tingling Sensation Under Skin; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Tingling Sensation Under Skin), VACCINATION SITE LYMPHADENOPATHY (Swollen Lymph Nodes Near the Injection Site), FATIGUE (Fatigue), CHILLS (Chills) and PYREXIA (Fever - Temperature of 101.0F) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Feb-2021, the patient experienced PARAESTHESIA (Tingling Sensation Under Skin), FATIGUE (Fatigue), CHILLS (Chills) and PYREXIA (Fever - Temperature of 101.0F). On 02-Mar-2021, the patient experienced VACCINATION SITE LYMPHADENOPATHY (Swollen Lymph Nodes Near the Injection Site). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 05-Mar-2021, PARAESTHESIA (Tingling Sensation Under Skin), VACCINATION SITE LYMPHADENOPATHY (Swollen Lymph Nodes Near the Injection Site), FATIGUE (Fatigue), CHILLS (Chills) and PYREXIA (Fever - Temperature of 101.0F) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Feb-2021, Body temperature: 101 (High) 101 degrees Fahrenheit.         No concomitant medications were reported.
Muscle aches; This case was reported by a consumer via interactive digital media and described the occurrence of muscle pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 12 hrs after receiving Shingrix, the patient experienced muscle pain. On an unknown date, the outcome of the muscle pain was unknown.   It was unknown if the reporter considered the muscle pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as per the vaccine indication. The patient experienced muscle aches 12hours after 2nd dose of Shingrix. The patient asked, if this was a Shingrix side effect or something else like flu or Covid.