chrisvoncsefalvay/vaers-outcomes huggingface dataset:
headache; In the 12 -20 hours post injection I needed to urinate about every 45 minutes an amount inconsistently large to the amount of fluid I had taken in; 12 hours after I experienced severe chills; Body aches; Fever of 101; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER 8727) via an unspecified route of administration in the right arm on 14Apr2021 at 10:15 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. Medical history included ulcerative colitis and allergy to adhesive tape. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included fexofenadine hydrochloride (ALLEGRA), ascorbic acid, tocopheryl acetate, zinc, xantofyl, zeaxanthin (AREDS) and B-3; all for unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took ciprofloxacin (CIPRO), morphine (MANUFACTURER UNKNOWN) and mesalazine (ASACOL) and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN 6208) via an unspecified route of administration in the right arm on 24Mar2021 at 10:30 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. On 14Apr2021 at 22:30, after 12 hours of vaccination, the patient experienced severe chills, body aches, fever of 101 and nausea. On the same day the patient underwent body temperature test and the result was 101( units unspecified). In the 12 -20 hours post injection, the patient needed to urinate about every 45 minutes an amount inconsistently large to the amount of fluid had taken in. On 15Apr2021 at 05:30, about 19 hours after vaccination, she experienced a headache. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events severe chills, body aches, fever of 101, nausea and headache was recovered on 16Apr2021; while that of the event needed to urinate about every 45 minutes an amount inconsistently large to the amount of fluid was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
I received the Moderna vaccine on Saturday February 13th, 2021.  I had no adverse event on that day.  The next day when I woke up around 6:00 am I felt muscular pain in my upper left arm (arm of vaccine) when I moved my arm, and I could not raise my arm.  Later that day I took an Ibuprofen and went out to eat Indian food at night.  The pain went away.  The following day the pain was almost all gone, and after that it went away completely.
low grade fever; coughing; congestion; Sore left arm; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PYREXIA (low grade fever), COUGH (coughing), NASAL CONGESTION (congestion) and PAIN IN EXTREMITY (Sore left arm) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for an unknown indication.     The patient's past medical history included No adverse event (No reported medical history). Concomitant products included APIXABAN (ELIQUIS), SOTALOL HYDROCHLORIDE, ATORVASTATIN, LISINOPRIL, EMPAGLIFLOZIN (JARDIANCE), INSULIN LISPRO (HUMALOG), INSULIN GLARGINE (LANTUS), DULAGLUTIDE (TRULICITY), METFORMIN and LAMOTRIGINE for an unknown indication.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore left arm). On 27-Mar-2021, the patient experienced COUGH (coughing) and NASAL CONGESTION (congestion). On 29-Mar-2021, the patient experienced PYREXIA (low grade fever). On 22-Mar-2021, PAIN IN EXTREMITY (Sore left arm) had resolved. On 30-Mar-2021, PYREXIA (low grade fever) had resolved. At the time of the report, COUGH (coughing) and NASAL CONGESTION (congestion) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Reporter called to enquire if it was normal to experience these events. Treatment information was not provided.
Patient had a very sore, red, and swollen arm, much more than when she has gotten previous vaccines.  It started the night of getting the shot.  It has been getting better over the past few days, but the redness has moved to the front of her arm.  She also stated she was diagnosed with cellulitis and was put on an antibiotic.  She also had a fever, chills, and felt overall awful the night of and day after getting the shot.  She does feel better now, 3 days later,  but still has visible redness and says it still hurts, but is getting better each day.
Information has been received from an office manager concerning a male who on unspecified dates was vaccinated with three doses of RECOMBIVAX HB (lot numbers: 654745/0608F and 655149/0006U (unspecified for which doses).  The office manager reported that the patient have not seroconverted after 3 doses of RECOMBIVAX HB were given.  The reporter also indicated that the patient was feeling "sick".  No further information was available.  This is one of several reports received from the same source.  A standard lot check investigation was performed.  All in-process quality checks for the lot number (654745/0608F) in question were satisfactory.  In addition, an expanded lot check investigation was performed.  The testing performed on the batch prior to release met all release specifications.  The lot met the requirements of the Centers for Biologics Evaluation and Research and was released.  Supplemental lot information of 03-FEB-2009 reported that a standard lot check investigation was performed.  All in-process quality checks for the lot number (655149/0006U) in question were satisfactory.  In addition, an expanded lot check investigation was performed.  The testing performed on the batch prior to release met all release specifications.  The lot met the requirements of the Center for Biologics Evaluation and Research and was released.  Additional information has been requested.
This spontaneous case reported by a consumer, describes the occurrence of vaccination site pain (sore arm at the injection site, but not as sore as the with the 1st dose) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On Feb 4, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Mar 3, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Mar 3, 2021, patient experienced vaccination site pain (sore arm at the injection site, but not as sore as the with the 1st dose). At the time of the report, vaccination site pain (sore arm at the injection site, but not as sore as the with the 1st dose) outcome: unknown. No concomitant medications or treatment information provided. This case linked to MOD-2021-304896 (patient link).
Pt received vaccine at 1645. Pt sitting in observation for 15 min post vaccination. After 13 minutes patient reports dizziness, fatigue, eye lids are getting heavy with pressure, throat with burning sensation, difficulty breathing and clearing throat. At 1700 patient given Benadryl 25mg PO and obs for 1 hr. Symptoms resolved.
At about 6 pm I began to have pain in my legs. Felt like a million pins and a vice grip on them. Pain grew stronger & in following days (week) moved up my body. Could not get into or out of bed by myself. When husband got me upright I could scoot my feet on floor and could walk a little with help. This lasted about a week. Was so filled with pain could not do anything for myself. Went to see Orthopedic Surgeon who had done a knee scope about a month earlier. Saw Dr. 10/23/2012. Dr. thought I had spinal stenosis. He referred me to Spine Specialist. Saw Dr. on 11/10/2012. He could not determine exact cause of pain. Thought it could be pinched nerve in neck and lower back.  He referred me to Neurologist for a "needle" test. Shoulders, back, arms, wrists, hands became so painful to move. For the past month I have had no decrease in pain. I have been going to physical therapy twice each week. I take 300mg gabapentin three time daily for the pain.
Extreme chilling, fever, fatigue, nausea. Was bed ridden from Sunday, 10-7-18 with chills and fever. Those symptoms ran through the night both Sunday and through Monday into Tuesday, 10-9-18. Light nausea subsided on Tuesday and I was able to eat soup at that point. Dealt with slight dehydration due to extreme symptoms. Symptoms subsided later on Tuesday but slight fever returned at night for two more nights. Returned to normal activity on Saturday morning 10-13/18.
This spontaneous report as received from licensed practice nurse (also reported as medical assistant) refers to a 12 year old and unknown gender patient with hepatitis b vaccine. Patient's medical history was not reported. On an unspecified date patient was administered RECOMBIVAX HB 10 microgram/milliliter (MCG/ML). On an unspecified date hepatitis B titer was low. 09-JAN-2014 the patient was vaccinated with second dose of RECOMBIVAX HB which had expired on 16-DEC-2013 (lot number, dose and units were unknown). Medical assistant stated that she has only worked at the practice for one year. No adverse events were reported. The outcome of the result of hepatitis titer on an unspecified date was low, no adverse event and hepatitis B series was repeated with a second dose of RECOMBIVAX HB on 09-JAN-2014 which had expired in 16-DEC-2013 is unknown. No further information was provided. Additional information has been requested.
My arm was not sure it just felt like something kind of pinched me; I was sweating in the face. My cloth masked was full of sweat inside out. The back of my neck and forehead was also wet in sweat.; soreness in her arm; She said she prepare them overnight and keeps them in the fridge.; She said she prepare them overnight and keeps them in the fridge. /lady just came out of the back with the syringe prefilled already; This is a spontaneous report received from Pfizer sponsored program from  a contactable consumer (patient) reported for herself. This is the 2nd of 2 reports, for the 2nd dose.  A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) at single dose for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. The patient previously received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) at single dose for covid-19 immunisation, and had a sore arm with the first dose which lasted a day and the next day everything was fine. Reported that I received my second shot of the Pfizer vaccine. My arm was not sure it just felt like something kind of pinched me. I was sweating in the face. My cloth masked was full of sweat inside out. The back of my neck and forehead was also wet in sweat, a good deal of sweating. She has experienced some soreness in her arm the next date after she had her second shot, She took a couple of aspirins for her soreness. Stated doesn't feel sick though. Also reported that "When I received the first dose the syringe contained a cloudy solution whereas the second dose was clear. The girl didn't even prepare the second shot in front of me. She said she prepare them overnight and keeps them in the fridge. The guy who gave me the first dose prepared it in front of me. I don't know what the young lady gave me. They could've  administered anything. Pharmacy should really set a protocol to draw the vaccine from the vial in front of patients." For her second shot, the lady just came out of the back with the syringe prefilled already. Said she doesn't trust, or know what she got, since the lady is going back and forth to a back room. Outcome for events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021395376 same report/patient, different dose/AE.
Patient is 17 years old and received her second dose of MODERNA COVID-19 vaccine. Patient is under the appropriate age to receive this particular COVID vaccine. A previous incident report was made after the first dose was given.
Swollen, hot, hard and itchy at site. Swollen upper arm. Sore and stiff neck and arm muscles same side of the body as injection site. Slight swelling right side of the jaw. Overall itchiness.
Pt. developed rash on scalp, neck, torso, arms, about 2 weeks after receiving ZOSTAVAX. Also had fever, body aches and cough; reval 11/18/13 resolved.
After receive the shot I had a bump in the injection site. She told me to make sure I didn?t bother it. It?s been 2 weeks now and it?s still there. Is there any type of cream I can put on it to go away. Not much information was passed along.
Patient presented to ED 1 day after administration of COVID-19 vaccine. She had rigors and chills the day before and day of ED presentation. Denies having a fever prior to ED presentation but did note general body aches and nausea. Patient also had 1 episode of vomiting on 12/22. Patient's vital signs were BP 145/109, HR 75, RR 20,  O2 sat 96, temp 98.7F. Receive IV bolus of NaCL 0.9% 1,000 mL in ED in addition to ketorolac 15 mg, and ondansetron 4 mg. Patient was discharged home from the ED.
Post vax the patient had a red raised area at the site of injection and red-swelling lesion on her arm.
Site: Bruising at Injection Site-Mild, Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Itch Generalized-Severe, Systemic: Allergic: Rash Generalized-Medium, Systemic: Abdominal Pain-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Headache-Mild, Systemic: Nausea-Mild
MOTHER REPORTED THAT PATIENT WOKE WITH "WELTS" ON LEGS MORNING OF 04/07/2008. WAS ADVISED TO GIVE BENADRYL AT THAT TIME. PATIENT WAS SEEN IN OFFICE 04/08/2008 COMPLAINING THAT RASH WAS SPREADING. EXAM SHOWED VESICULAR LESIONS ON LEGS, CHEST, BACK AND ARMS. ALSO COMPLAINED RASH WAS ITCHY.
Patient said next day his arm was swollen, tender and painful and he went to his physician and examined him, he is in so much pain, patient is receiving pain relievers, also he reported fever.
REACTION: FEVER, CHILLS, HEADACHE, BODY ACHES  EXPERIENCED APPROXIMATELY 13 HOURS AFTER VACCINE WAS ADMINISTERED. SYMPTOMS EASED IN APPROXIMATELY 12 HOURS AND COMPLETELY GONE IN 48 HOURS
So sometime In march after dose 2 swollen and pain joints in fingers. As time went on it has began to move on to other joints as well. Still ongoing as of today. Inflammatory arthritis, seeing an Rheumatologist now.
My arm that got the injection was hurting too bad to lift up to shoulder height. This started two hours after the injection. Then shortly after the arm pain, it felt like there was a weight on my chest, which caused difficulty breathing. At that same time, I started feeling dizzy and confused.  About 5 hours after injection, I was shivering and cold feeling, but my skin was hot to the touch.
No adverse event; they accidentally administered 1 dose of Moderna COVID-19 Vaccine to a patient on 16MAR2023 but vial expired on 12MAR2023; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (they accidentally administered 1 dose of Moderna COVID-19 Vaccine to a patient on 16MAR2023 but vial expired on 12MAR2023) and NO ADVERSE EVENT (No adverse event) in a 13-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 071B22A) for COVID-19 prophylaxis.     no known allergy or relevant medical historical conditions, concomitant diseases and risk factor.   On 16-Mar-2023, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 16-Mar-2023,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (they accidentally administered 1 dose of Moderna COVID-19 Vaccine to a patient on 16MAR2023 but vial expired on 12MAR2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (they accidentally administered 1 dose of Moderna COVID-19 Vaccine to a patient on 16MAR2023 but vial expired on 12MAR2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (they accidentally administered 1 dose of Moderna COVID-19 Vaccine to a patient on 16MAR2023 but vial expired on 12MAR2023).    The patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  No concomitant medications were reported.  No adverse events were reported.  No treatment medications were reported.
Swelling and redness at site x 2 weeks with rash. Now rash and scabbing at site/discoloration approx 3.5cm.
3 hours after vaccine patient developed drooling, was swollen in face, lethargic and seen in ER.
Received immunization 07/16/2003.  At 21:30, same day temperature 103.4F, very fussy and crying, diarrhea x 2.  Fever continued seen by MD 07/17/2003 @ 11:00.  Fever and fussiness responsive to Tylenol and Motrin.
Patient developed muscle aches in arms, shoulders and left leg. Hands were sore to write with. On 6/5/01, patient got a fungus in the mouth and became very tired. She developed a strange illness at school and then slept 2 days. After 5 weeks, she was still very tired and receiving treatment for oral fungus.
Information has been received from the authors in a published literature article, concerning a healthy 14-year-old female who five days after receiving the first injection of GARDASIL vaccine, experienced numbness and tingling in the toes. Over the following 2 weeks, the numbness and tingling increased to involve the lower extremities and pelvis. Other symptoms, such as fatigue, headache, nausea, diarrhea, weight loss and tachycardia ensued. Nuclear magnetic resonance imaging (MRI) of the brain and cervical spine were unremarkable, and laboratory testing showed positive antinuclear antibodies (ANA) with titers I: 160 with speckled pattern. Rheumatological evaluation was unrevealing raising a possibility of fibromyalgia. A tilt table test demon striated a supine heart rate of 72 bpm which increased to a maximum of 123 bpm within 10 min of tilt without evidence of orthostatic hypotension. Heart rate responses to the Valsalva maneuver and deep breathing test were unremarkable, and sweat output in the leg with the quantitative sudomotor test was borderline reduced. The results of the autonomic testing indicated Postural orthostatic tachycardia (POTS) and possible small fiber neuropathy, and the patient was started on metoprolol tartrate to control the tachycardia. Over the following 2 years, her symptoms had improved with the use of metoprolol tartrate for Postural orthostatic tachycardia syndrome (POTS) and amitriptyline. The reporter stated that neurocardiogenic syncope (NCS) was diagnosed during the tilt table test. The reporter stated nevertheless, none of the patients experienced complete resolution of symptoms, and all patients continued to experience some residual symptoms. Possible pathogenesis of the new onset POTS after vaccination may include the mechanism of molecular mimicry, whereas HPV vaccine epitopes may induce formation of cross-reacting antibodies against potential tarts of the autonomic ganglia, neurons, cardiac proteins or 231/2-adrenergic and M2/3 muscarinic receptors. Additionally, induction of bystander lymphocyte lymphocyte activation and a broad spectrum of cytokine responses elicited by the HPV vaccine may also be involved. The reporter stated that the temporal association between vaccination with GARDASIL and the onset of symptoms of POTS in healthy young women is significant and deserves further investigation for assessment of a possible casual relationship. Additional information has been requested.
Emergency Room/Hospitalization for 18 hours due to extreme pain in esophagus.  Chest pain but Heart issues ruled out. Possible new diagnosis of GERD
Patient was gasping for air, pulse was weak and thready. Took patients vitals and they were 60/30 @ 1330 Took again it was 100/60 @ 1335. Patient used her own inhaler 4 times. Epinephrine was given at 13:47.  Right after the Epinephrine was given the ambulance arrived.
random  pricks on her body; arms started tingling, both her left and right arm; throat scratchy, very itchy and like it could be a little swollen; throat scratchy, very itchy and like it could be a little swollen; pins and needles on her arm  that went from there to her whole body; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (arms started tingling, both her left and right arm), THROAT IRRITATION (throat scratchy, very itchy and like it could be a little swollen), PHARYNGEAL SWELLING (throat scratchy, very itchy and like it could be a little swollen), PARAESTHESIA (pins and needles on her arm  that went from there to her whole body) and PARAESTHESIA (random  pricks on her body) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse reaction (no adverse reaction reported).    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jan-2021, the patient experienced PARAESTHESIA (arms started tingling, both her left and right arm), THROAT IRRITATION (throat scratchy, very itchy and like it could be a little swollen), PHARYNGEAL SWELLING (throat scratchy, very itchy and like it could be a little swollen) and PARAESTHESIA (pins and needles on her arm  that went from there to her whole body). On 17-Jan-2021, the patient experienced PARAESTHESIA (random  pricks on her body). On 14-Jan-2021, PARAESTHESIA (arms started tingling, both her left and right arm), THROAT IRRITATION (throat scratchy, very itchy and like it could be a little swollen) and PHARYNGEAL SWELLING (throat scratchy, very itchy and like it could be a little swollen) outcome was unknown. On 17-Jan-2021, PARAESTHESIA (pins and needles on her arm  that went from there to her whole body) outcome was unknown. At the time of the report, PARAESTHESIA (random  pricks on her body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medications reported. No treatment information provided.