chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Developed body aches and fatigue the day of the vaccine.  Developed fever of 100 and high bp and p 12/22 (day after vaccine).  BP 151/108, p 116.  Referred to clinic for f/u.
Initial and follow up information has been received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, drug reactions and allergies were not reported. On 16-SEP-2015, the patient received an improperly stored dose of GARDASIL, lot # K005881, expiration date 14-JAN-2017 (dose, frequency and route were not reported). No concomitant medications were reported. No adverse effect was reported. No product quality complaint was involved. This is one of several reports from the same source. Additional information has been requested.
Injection site is swollen; Lymph nodes tender on the same arm; Injection site is red; Fever; Body aches; vomiting; diarrhea; pain; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (vomiting), DIARRHOEA (diarrhea), MYALGIA (pain), INJECTION SITE SWELLING (Injection site is swollen) and VACCINATION SITE LYMPHADENOPATHY (Lymph nodes tender on the same arm) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 3000493) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Fibromyalgia since 1980. Concomitant products included GABAPENTIN, AMITRIPTYLINE HYDROCHLORIDE (LAROXYL), PAROXETINE, CETIRIZINE and FENOFIBRATE for an unknown indication.    On 09-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, the patient experienced VOMITING (vomiting), DIARRHOEA (diarrhea) and MYALGIA (pain). On 11-Feb-2021, the patient experienced INJECTION SITE SWELLING (Injection site is swollen), VACCINATION SITE LYMPHADENOPATHY (Lymph nodes tender on the same arm), INJECTION SITE ERYTHEMA (Injection site is red), PYREXIA (Fever) and MYALGIA (Body aches). The patient was treated with PARACETAMOL (DOLIPRANE) for Adverse event, at an unspecified dose and frequency. At the time of the report, VOMITING (vomiting), DIARRHOEA (diarrhea), MYALGIA (pain), INJECTION SITE SWELLING (Injection site is swollen), VACCINATION SITE LYMPHADENOPATHY (Lymph nodes tender on the same arm), INJECTION SITE ERYTHEMA (Injection site is red), PYREXIA (Fever) and MYALGIA (Body aches) outcome was unknown.            Antispasmodics were reported as treatment medication.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: Follow up information received on 14-JUL-2021 and contains significant information- date of vaccination, concomitant products updated and events are updated. On 14-Jul-2021: Translation received on 23 Jul 2021 contain  concomitants, treatment medication and events, medical history were added.; Reporter'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.
sore arm after the first shot; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm after the first shot) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     Concurrent medical conditions included COPD, Emphysema, Artificial cardiac pacemaker user (pacemaker) and Heart attack.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm after the first shot). On 19-Feb-2021, PAIN IN EXTREMITY (sore arm after the first shot) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-054934 (E2B Linked Report).; Sender's Comments:  MOD-2021-054934:2nd dose of Vaccine
pt recv vax 16JAN96 & c/o rash under both axilla bilateral gluteus,& rt flank;itching & tenderness denied;reported it was noticed 17JAN96 AM;rash worsened 22JAN96 reported by computer mail;recv ATB from pvt MD;reported had vague flu-like sx
pt recvd vax & 1 hr & 15 mins p/inject had lightheadedness & white, papuar rash; pt sx resolved;
Patient states she believes her vaccine was given too low as she has chronic upper arm and shoulder pain.  She thinks a nerve was hit and now she can't raise her arm more than 90 degrees.  She said the vaccine hurt during administration and from then on.  She can't sleep on her arm as it hurts if she presses on a spot below her deltoid and if she raises her arm.  Her doctor stated it is from her flu shot most likely given too low.
No additional AE; it was given subcutaneously as opposed to intramuscularly; injection site is "7 inches too low"; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. Information regarding the patient's concurrent conditions, medical history, historical drugs and concomitant therapies was not provided.  On 29-JUN-2022, the patient was administered her second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5 milliliter, administered for prophylaxis (strength, lot #,and expiry date were not provided). The mother of the patient is a nurse and stated that the recent injection site was "7 inches too low" on the deltoid (product administered at inappropriate site) and believed it was given subcutaneously as opposed to intramuscularly (incorrect route of product administration). No additional information was provided. No additional adverse event/product quality complaint (PQC) was reported.
This spontaneous report as received from a pharmacist refers to an unspecified number of patients of unknown age. In 2017, the patients were vaccinated with improperly stored doses of ZOSTAVAX lot # N014018 for prophylaxis. Concomitant therapies included sterile diluent. No adverse event. Sender's Comments: US-009507513-1709USA002093: Original Case: 1709USA002093.
Within 15 minutes of getting the Pfizer vaccine my upper lip felt numb, also my chin/neck, along my face mask, felt puffy but was not visibly puffy. I could swallow and breath. At 25 minutes I went to a RN and had my neck checked to make sure I would be fine to leave. I did not mention the numb upper lip because at 25 minutes it had gone away. At 12:30 AM on 4/20/21 I woke up not feeling well. My upper lip was again numb, and it had spread to my face (it felt puffy but was not visibly puffy), and the numbness had spread to both sides of my face to my ears, up to my eyes, and down to my chin/neck. I went to the ER. When I arrived at the ER, the numbness was not as bad as when I woke up. Since it was not getting worse. and my vitals were good, they released me. My face is still numb. The numbness always includes my upper lip plus other parts of my face. Also, the numbness spread to inside my mouth and to the back of my throat. The degree of numbness varies. Sometimes I think it's getting better, and then it gets worse. I am also still feeling sick, nausea, feeling of unwellness, and I get exhausted doing things that would previously not made me tired. On 4/27/21, around bedtime, inside my body started feeling hot & icy at the same time, that continued all day on 4/28/21, and still feels this way on 4/29/21.
There was serve pain in my legs. The pain moved from my legs to my chest. I am also experiencing extreme fatigue. I had to have assistance with walking around and help with  my self care.
Her neck is swollen; difficulty moving her arm; This is a spontaneous report from contactable consumer (Patient) via Medical Information Team. A 58-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on 28Apr2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE for COVID-19 immunisation. The patient stated that she got Pfizer 2nd vaccine yesterday. Injection was done a bit higher toward the shoulder joint. Her neck was swollen and have difficulty moving her arm (on an unspecified date). She questioned Anything else than taking Tylenol and putting ice that she could do. Outcome of events was unknown  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Phlegm; allergies in the fall; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCTIVE COUGH (Phlegm) and HYPERSENSITIVITY (allergies in the fall) 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 PRODUCTIVE COUGH (Phlegm) and HYPERSENSITIVITY (allergies in the fall). At the time of the report, PRODUCTIVE COUGH (Phlegm) and HYPERSENSITIVITY (allergies in the fall) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
pt w/onset swelling, erythema rt arm below inject site-resolving w/cool compress;
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information about the patient pertinent medical history, concurrent medications and drug reactions or allergies was provided. On an unknown date, the patient was vaccinated with improperly stored dose of VAQTA (dose, dose number, route of administration, lot# and expiration date were not provided). On 20-JAN-2018, the the patient was re-vaccinated with a dose of VAQTA dose, dose number, route of administration, lot# and expiration date were not provided). No adverse event was reported. This is one of a several reports received from the same reporter.; Sender's Comments: US-009507513-1806USA001552: US-009507513-1806USA001551: US-009507513-1806USA001553: US-009507513-1806USA001554: US-009507513-1806USA001555: US-009507513-1806USA001556: US-009507513-1806USA001557: US-009507513-1806USA001558: US-009507513-1806USA001559: US-009507513-1806USA001560: US-009507513-1710USA003103: US-009507513-1806USA001547: US-009507513-1806USA001549: US-009507513-1806USA001550: US-009507513-1806USA001561:
Today I started to have a bad stomach ache and thought I was having indigestion.  Thean I had loose bowels.  This continued and got worse.  This started around 11 a.m.  Around 3 p.m. I felt dizzy and faint and nearly passed out.  I was very weak.  I had to lie down.  I still feel weak and dizzy and it is now 4 pm but I feel a little better.  My stomach is still gurgling
Client states that 24 hours post vaccination he began experiencing  nausea, vomitting, chills, lack of sleep, body aches. He states the felt like "he had the flu but it was on steroids and much more severe". He contacted his PCP and he instructed him to not take the second dose.
Patient was given the Moderna Vaccine and should have received the Pfizer vaccine due to his age.  No reactions reported from giving the vaccine.  Parent was notified of error on the vaccine and also spoke to representative who advised to proceed with Moderna again for his 2nd dose to complete the series
This is a spontaneous report from a non clinical study program for a contactable consumer who reported for her daughter. A female patient of an unspecified age and ethnicity received the first dose of TRUMENBA, via an unspecified route of administration on 03MAR2015 at single dose. The patient medical history and concomitant medications were not reported. In MAR2015, 1-2 weeks after vaccination, the patient experienced had a lot of pain in her tongue. On an unspecified date the patient developed a pea sized swelling at the injection site. The outcome of the events was unknown. Follow up (06APR2015): New information from a contactable consumer included: new event, vaccination date.
Five minutes after receiving my 1st shot, I experienced a warming sensation more up my chest into the throat and the had a metallic taste.  I felt the need to clear my throat several times.  This lasted about 20 minutes.  No other problems throughout the day until I went to bed that evening.  After laying down I experienced the metallic taste again.
Severe lower back pain at site of herniated disk, fever, diarrhea, weakness.
Panic/anxiety - immediately. Heart rate increase - blood pressure increase. Burning sensation in hands and eyes. Irrational thoughts - labored speech. I've had 3 MRI's and an MRA; blood tests; vestibular tests, EKG etc - heart tests etc.
Varicella and MMR given and immediately red area observed approximately 6 cm circle on (R) thigh. Red area warm to touch. Given oral diphenhydramine and ibuprofen. Redness decreased within 30 min.
I went into the Rheumatologist for my routine appt 01/14/2022 and my BP was  193/107. I felt hyper and face was flushed.  I had a recheck on the opposite arm (left arm) and it was diastolic 106 to a reading of 131-even while rested it was going up. They sent me to the ER same day around noon a couple of blocks away. They checked my BP again and it was Initially 214/125 and pulse 77 respirations 18 O2 sat 99%. I was prescribed Clonidine 0.01mg  1 time dose. I was kept in the ER and rested about and checked again 149/102. I had a slight headache the whole time but that continued and felt very fatigued. I was discharged and told to f/u with PCP. I did f/u with my PCP and have checked my BP and most are normal, headache went away on the 16th, and just some BP readings high. My PCP is continuing to monitor my BP for the next few weeks. Before this happened my BP was actually running a little low so they did not want to increase my BP medication. I also have been taking Benadryl 50mg at night because my BP runs higher at night and to help me sleep.
On 4/5/2018, I administered the SHINGRIX vaccination IM using a SQ needle (25 G x 5/8'').
Shaking fever sweats chills bad headache. 26 weeks pregnant due date 11/12/21
Rec'd ZOSTAVAX on 6/26/12 - following day 6/27/12 woke up with red swollen area above (L) eye - no itching - followed up with primary physician.
On 12/11/00, at 14:00, pain started in shoulder of arm and went down to wrist. As of 1/10/00, pain continues. Saw MD X 2, orthopedist X 1 and received cortisone shot on 1/10/01, with good relief.
vaccine exposure during pregnancy; Fatigue; Arm soreness; This spontaneous prospective pregnancy case was reported by a health care professional and describes the occurrence of PAIN IN EXTREMITY (Arm soreness), EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy) and FATIGUE (Fatigue) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to antibiotic (Allergy to Flagyl).    On 09-Jan-2021 at 9:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 06-Nov-2020 and the estimated date of delivery was 30-Aug-2021. On 09-Jan-2021, the patient experienced PAIN IN EXTREMITY (Arm soreness). 09-Jan-2021, the patient experienced FATIGUE (Fatigue). On 09-Jan-2021 at 9:30 AM, the patient experienced EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  ninth week of the pregnancy.  On 09-Jan-2021 at 9:30 AM, EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy) had resolved. On 11-Jan-2021, PAIN IN EXTREMITY (Arm soreness) and FATIGUE (Fatigue) 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.   No concomitant medications provided. No treatment information provided.
Developed a "funny" tongue sensation followed by a scratchy throat.  No shortness of breath, chest tightness, rash, nausea.  Symptoms resolved in about 17 minutes with no treatment.
Redness at the site of injection; Swelling at the site of injection; Pain in triceps; Swollen armpit; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th February 2022, the patient received the 2nd dose of Shingrix. On 19th February 2022, 1 days after receiving Shingrix, the patient experienced injection site erythema, injection site swelling, muscle pain and local swelling. On an unknown date, the outcome of the injection site erythema and injection site swelling were recovered/resolved and the outcome of the muscle pain and local swelling were not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema, injection site swelling, muscle pain and local swelling to be related to Shingrix.  Additional details were provided as follows: The patient self reported this case. The age at vaccination was not reported The patient received 2nd dose of Shingrix vaccine and day after the dose, experienced redness and swelling at the site of injection.  The patient also experienced pain in his triceps and swollen armpit.  Redness and swelling at the site of injection had resolved but pain in triceps and swollen armpit had not. The reporter did not consent to follow-up. This case has been linked with case US2022046179, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022046179:same reporter
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 69-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), on 09Mar2021 at 12:00 as dose 1, single (Lot number: EN6199), in left arm, on 30Mar2021 at 12:00 as dose 2, single (Lot number: ER8732), on 06Oct2021 at 12:00 as dose 3 (booster), single (Lot number: FE3590) and on 04Apr2022 at 12:00 as dose 4 (booster), single (Lot number: FK9895) at the age of 68 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 08Sep2022 at 12:00 as dose 5 (booster), single (Lot number: AS7144B), in left arm and on 15Jun2023 at 12:00 as dose 6 (booster), single (Lot number: AS7184B), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Supp. O2" (unspecified if ongoing); "Chronic Heart Failure" (unspecified if ongoing); "Hypertrophic Obstructive Cardiomyopathy" (unspecified if ongoing); "Pulmonary Hypertension" (unspecified if ongoing); "A-fib" (unspecified if ongoing); "other abnormal heart rhythms" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "Hypercholesterolemia" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing); "Fibromyalgia" (unspecified if ongoing); "Osteoarthritis" (unspecified if ongoing); "Peripheral Polyneuropathy" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Piroxicam, reaction(s): "Known allergies: Piroxicam"; Benazepril, reaction(s): "Known allergies: Benazepril"; Meloxicam, reaction(s): "Known allergies: Meloxicam". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2023, outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 with paxlovid from 25Sep2023-30Sep2023.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300321886 Same patient, different product, different event;
After vaccination, patient felt light headed, cold sweat, blurry vision, and upset stomach leading to soft stool. After 45 minute observation, patient felt well enough to drive home. At home she felt shaky and weak. Patient stated she did not eat very much during the day before the vaccine.
Incorrect vaccine administered to a pediatric patient of 11 y/o.  Patient received a Pfizer vaccine for adult and an adult dose of 0.3 ml. Patient developed headache which resolved spontaneously.  Mother was notified of mistake and upon follow up by phone was oriented to receive the proper pediatric vaccine dose in  21 days.
The shot produces a large painful lump under the skin. The lump is smaller but the skin is discolored and it's 3 months later. It looks/feels like a scar or bruise.
not feel well; headache; nauseous; fever-elevated temperature; fatigue; body aches; her arm was sore after receiving the vaccine; daughter also felt very anxious; Felt like she had the flu; she experienced flu like symptoms; This is a spontaneous report from a contactable consumer or other non hcp.    A 37-years-old female patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection (Batch/Lot Number: EN6200), dose 1 via an unspecified route of administration on 23Feb2021 as 1st dose, single for covid-19 immunisation. Medical history included ongoing tobacco user, covid-19 from an COVID-19 symptoms started on 08Dec2020, she tested positive for COVID on 10Dec2020. Concomitant medication(s) included ascorbic acid (VIT-C); ergocalciferol (VIT D). The patient previously took Lexapro for anxiety. It was reported that, The patient experienced she experienced flu like symptoms on 23Feb2021 with outcome of unknown, nauseous on 24Feb2021 with outcome of recovered , body aches on 23Feb2021 with outcome of recovered , fever-elevated temperature on 24Feb2021 with outcome of recovered , fatigue on 24Feb2021 with outcome of unknown , not feel well on an unspecified date with outcome of unknown , headache on 24Feb2021 with outcome of recovered , her arm was sore after receiving the vaccine on 23Feb2021 with outcome of unknown , daughter also felt very anxious on 23Feb2021 with outcome of unknown , felt like she had the flu on 23Feb2021 with outcome of recovered.  The patient underwent lab tests and procedures which included covid-19: positive on 10Dec2020.   No follow-up attempts are needed. No further information is expected.
Huge red rash that appeared about 8 hours after I got my second vaccination. It is painful to touch and itchy, and often feels like the skin is burning. The rash feel feverish. It started out smaller, but increased in size over the next few days. I received my second vaccination on 3/3/21 and I still have the rash today on 3/6/21. I have also had a very light fever that has come and gone, along with extreme fatigue and severe body aches.
Abdominal pain; Headaches; This is a spontaneous report from a contactable consumer (patient). A 28-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in left arm on 08Apr2021 08:15 (Batch/Lot number was not reported) at the age of 28 years old, as single dose for COVID-19 immunisation. Medical history included acid reflux, asthma, allergy to peanut butter, allergy to dogs, and COVID-19 (COVID-19 prior to vaccination: Yes). The patient was not pregnant at the time of vaccination. The patient took unspecified other medications in two weeks. No other vaccines received in four weeks. On unspecified date the patient experienced abdominal pain (hospitalization) and headaches (hospitalization). No treatment was given for the events. The events resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care visit. The patient has not recovered from the events. The patient has not been tested for COVID-19 post vaccination.   Information on about lot/batch number has been requested.