chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a doctor of pharmacy concerning an adult patient who on unknown date, was vaccinated with a dose of PNEUMOVAX 23. The pharmacist stated that a patient at a long term facility may had received PNEUMOVAX 23 intradermally. Also, the pharmacist said that "he did not know who the patient was or who the physician was" and" the nursing staff may have mistakenly thought they were giving the patient a Purified Protein Derivate (PPD)". No adverse effect reported. At the time of the report, the patient's outcome was unknown. Additional information has been requested. Additional information has been requested.
Soreness in my arm; Feeling like when the needle went in when I touch my arm; Hurting; This is a spontaneous report from a contactable consumer ((patient herself). A 72-years-old female patient received first dose of BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, MODERUN number: 013L20A), via an unspecified route of administration on 23Jan2021 at 11:00 as 1st dose, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 23Jan2021, unspecified date the patient experienced soreness in her arm, feeling like when the needle went in when her touch my arm; hurting. Patient had the COVID shot done on the Saturday at 11'o clock and she was wondering why my arm was sore. she was felt it. she just told you she had the COVID shot done on the Saturday and she can still feel the shot she means the soreness in my arm. When probed if consumer took the Pfizer COVID Vaccine, consumer stated, "Yes, she took the COVID Vaccine on Saturday" (Not appropriately clarified, hence unchecked as Pfizer product). All the number she had on card is one she did give you and 12321. DPCLEESBILE that was with the health clinic. She go back to get my second shot the 20Feb2021. The events were assessed as non-serious. The consumer stated that she received the treatment and rubbed it with some alcohol and took some Tylenol then put hot compress on it as a result of feeling like when the needle went in when her touch my arm, hurting. The outcome of the events was reported as not recovered on an unspecified date.  Information on the lot/batch number has been requested.  Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Patient refuses to move left upper arm or shoulder on arrival in emergency room, no clavicle tenderness, elbow, forearm or wrist pain or tenderness.  Left radial pulse intact.  Patient with pinpoint area of erythema three finger breadths below acromion where vaccine was given, no surrounding erythema, edema or warmth.  No discharge noted.  Has  arm pain, myalgias, rhinorrhea.  Rx with oral NSAIDS and warm compress.  After treatment left arm pain with full ROM after medications, no numbness, tingling or signs of infection
- In bed since the event and unable to operate car or go to work  - Brain fog unable to process surroundings and/or make decisions  - unable to get deep sleep, and constant sleep inertia (vivid dreaming)  - feels semi conscious  and/or sedated   - almost immediately felt lethargic and foggy, pharmacy kept for 30 minutes  - Called pharmacy the next day and told they are normal side effects  - after a few more days called doctors office and made appointment for check-up however unable to get in until 8/23/2021. Visited urgent care clinic on Friday 8/20/2021 after no improvement for vital check and inner ear evaluation.
Resident found unresponsive and without vital signs the morning on April 17, 2021 at 6:35am. The nurse started CPR, called a code, 911 called, AED applied. Local EMS responded, took over the code.  EMS had contact with the local hospital ER, code called at the facility. Resident expired.
Started feeling "off" almost right away. Tinitus and feeling like my ears were clogged began within 30 min, but subsided in a few hours.  About 6 hours later I felt like I was getting sick, and by 12 hours I had a fever, chills, headache, body aches. It felt like I had the flu.  Fever spiked to 100.5 but tended to stay around 99.5-100. Worst of symptoms lasted 36 hours before beginning to subside.  Most symptoms subsided in two days, with some lingering fatigue for another day or two.
REVACCINATION WITH DIFFERENT COVID-19 VACCINE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via another pharmaceutical company (Pfizer Inc.) concerned a 35 year old. The patient's height, and weight were not reported. The patient's past medical history included: stroke (Stroke at 25 years old), and concurrent conditions included: unspecified drug allergy. The patient received first dose of covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin, batch number and expiry date were not reported) dose was not reported, 1 total administered on unspecified date for covid-19 prophylaxis. The batch number was not reported and has been requested. Concomitant medications included valaciclovir for unknown indication. It was unknown whether patient had any adverse events following covid-19 vaccine ad26.cov2.s (Dose number in series 1).  The patient also received second dose of non-company suspect vaccine Moderna covid-19 vaccine (elasomeran) (Dose number in series 2) (form of admin, route of admin, batch number and expiry date were not reported) dose was not reported, administered on unspecified date for covid-19 prophylaxis. It was unknown whether patient had any adverse events following Moderna covid-19 vaccine (elasomeran) (Dose number in series 2).  The patient also received third dose of non-company suspect vaccine Moderna covid-19 vaccine (elasomeran) (Dose number in series 3) (form of admin, route of admin, batch number and expiry date were not reported) dose was not reported, administered on unspecified date to right arm for covid-19 prophylaxis which was associated with revaccination with different covid-19 vaccine (Dose number in series 3). On an unspecified date in 2023, patient experienced suspected covid-19 infection (Dose number in series 3). The patient started taking treatment with non-company suspect drug Paxlovid, nirmatrelvir/ritonavir (form of admin and route of admin were not reported, batch number: GE3016 expiry: unknown) dose and frequency were not reported from 02-MAY-2023 to 06-MAY-2023 for treatment of covid-19. On 10-MAY-2023, four days after non company suspect drug paxlovid treatment, the patient experienced minor head cold. On 11-MAY-2023, the patient experienced more severe head cold (congestion, sneezing), minor aches, tightness in lungs and oxygen levels were 93-95%. Laboratory data included: Oxygen saturation (93-95%). On 12-MAY-2023, six days after non company suspect drug paxlovid patient felt tightness in lungs and Laboratory data included: Oxygen saturation (94%).  The action taken with covid-19 vaccine ad26.cov2.s, elasomeran (Dose number in series 2), and elasomeran (Dose number in series 3) was not applicable; and action taken with nirmatrelvir/ritonavir was not reported. The patient had not recovered from suspected covid-19 infection, and the outcome of revaccination with different covid-19 vaccine was not reported. This report was non-serious.
Arm was in pain; Achy; Muscle pain; Chills; Fever; Nausea; Vomiting; Shortness of breath; This spontaneous case was reported by an other health care professional and describes the occurrence of DYSPNOEA (Shortness of breath), PAIN IN EXTREMITY (Arm was in pain), PAIN (Achy), MYALGIA (Muscle pain) and CHILLS (Chills) in a 39-year-old male 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 03-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Jan-2021, the patient experienced DYSPNOEA (Shortness of breath). On 04-Jan-2021, the patient experienced PAIN IN EXTREMITY (Arm was in pain), PAIN (Achy), MYALGIA (Muscle pain), CHILLS (Chills), PYREXIA (Fever), NAUSEA (Nausea) and VOMITING (Vomiting). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, DYSPNOEA (Shortness of breath), PAIN IN EXTREMITY (Arm was in pain), PAIN (Achy), MYALGIA (Muscle pain), CHILLS (Chills), PYREXIA (Fever), NAUSEA (Nausea) and VOMITING (Vomiting) outcome was unknown.        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 provided Treatment For the symptoms: Tylenol.
Rashes on arms, neck, hypotension, taken to ED, epinephrine inj, Benadryl tab and prednisone tab for 2 days.
Covid Arm  On Sunday my arm was very red, swelled up, puffy, hot to the touch, and itchy
Patient thought she had shingles, no visible outside rash, had pain all over her body. Contacted MD for pain medicine.
I have extreme limited movement in my left arm with severe pain in my left shoulder all the time.  I can't raise my arm up very high or even to do things like put on a necklace, wash my hair, fix my hair, etc. without lots of pain (& some not at all).  I also now have severe pain in my right elbow  all the time and loss of strength all the way through my right hand.  I have a hard time shaking hands or turning the steering wheel in my vehicle and definitely opening things, like lids.  Lastly, my left knee keeps catching and I can't walk or put any pressure on it.  I will be in the middle of walking and it just immediately stiffens up where I can't move.  I can't find a way to move my leg to get it out of the catch and just have to work on it and wait.  All of these started happening 3 days after my shot and the first one was my left shoulder (where my shot was).  I have NEVER had any joint pain or trouble with any of these areas before my shot and then all 3 things started happening.  I've done therapy and had shots in all 3 areas to relieve the pain and it does not help at all.  I can't get any relief and this has affected me for the rest of my life.
Patient called on 10/13/2021 and stated during the evening on 10/6/2021 hives appeared on left shoulder to arm, fever, chills, and a red lump that was warm to the touch. Symptoms resolved within 48 hours. Patient did not seek medical attention. Patient did not take any medication to relieve symptoms.
Received second shot of Moderna on 3/10/21.  Two months later I went blind in my right eye.
1. Mildly elevated liver enzymes (ALT and AST). Temporary after vaccination. Additional blood test showed a return to normal levels a few weeks later.  2. Moderate hearing loss in right ear. Source of damage unknown. Treatment of Flonase ineffective. Examination shows no blockages or anything unusual within ear. MRI pending.
After the first shot I had extreme soreness in my arm/shoulder. The pain began the 2nd day and was only sore at first, by the end of that day I could not lift my arm higher than my shoulder. This lasted another day and then by the 4th day after the shot I could move my arm normally but it was still sore until the 6th day after the shot.  After the second shot I began experiencing a lot of join pain in my hands and fingers and my feet and toes. The pain was mild, maybe a 4 out of 10 and lasted for about 3 days. Earlier this year I had similar issue's with joint pain that lasted a while but it had been gone for almost two months before returning immediately after the second shot.
Localized erythema with well demarcated area of induration and warmth at injection site.
No adverse event; Dose administered after 30-day Use By Date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) and NO ADVERSE EVENT (No adverse event) in a 70-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 045H22A) for COVID-19 prophylaxis.     Concurrent medical conditions included Drug allergy.    On 21-Mar-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 21-Mar-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date).    Concomitant medication details not reported by the reporter. Treatment details was not reported by the reporter.
Swelling, redness and pain around injection site extending from shoulder to elbow and is also very difficulty to lift arm.  Patient also has a headache that may or may not be from this immunization.  Over night pain & swelling increased.  Counseled patient to take BENADRYL and use hydrocortisone cream and if it hadn't subsided to visit her MD for further treatment.  Called patient on 10/13/09.  She said she's getting better without taking any medication.
This case was reported by a healthcare professional and described the occurrence of anaphylactic reaction to vaccine in a 38-year-old female subject who was vaccinated with influenza vaccine (manufacturer unspecified). Concurrent medical conditions included allergy to eggs. On an unspecified date in 2005 the subject received unspecified dose of influenza vaccine (unknown). At an unspecified time in 2005, after vaccination with influenza vaccine, the subject experienced anaphylactic reaction to vaccine. The subject had an anaphylactic reaction in approximately 2005 following flu shot. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the anaphylaxis was unspecified. The healthcare professional refused to provide complete contact information. The subject had an adverse event with FLUARIX 2011-2012 vaccine, please see A1005612A.
currently having symptoms of Covid-19; currently having symptoms of Covid-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID.  A male patient received BNT162b2 (BNT162B2), in 2021 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "currently having symptoms of Covid-19".  Clinical course: The caller contacted us regarding the Covid-19 vaccine, he mentioned that he received the vaccines last year and is currently having symptoms of Covid-19. The caller only speaks another language and attempts to transfer to the consumer line, advising they will have to get a translator, and the caller hangs up.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Severe diaper rash from diarrhea; Diarrhea; Fever; Generalized sleeping difficulty; Chicken pox rash (5 pox lesions); Crankiness; Information has been downloaded from Agency (US-CHIRONMA-PHHY2015US001687).  This spontaneous report was received from an other health professional referring to an one year old male infant. The patient's concurrent conditions, medical history and concomitant therapies were not reported.  On 31-OCT-2014, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX), influenza virus, and pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine (CRM197) (PREVNAR), all at 1 dosage form (strength, route, lot # and expiration date for all vaccines were not reported) for immunization.  On 09-NOV-2014, the patient experienced chicken pox rash (5 pox lesions), crankiness, diarrhea, fever and generalized sleeping difficulty. On 10-NOV-2014, she experienced severe diaper rash from diarrhea. The outcome of the events was not resolved.  The causality between varicella post vaccine and influenza virus was suspected, and the causality between other events and influenza virus was not provided. The causality between all the events and varicella virus vaccine live (Oka/Merck) (VARIVAX) and pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine (CRM197) (PREVNAR) was not provided.  All the events were reported to be medically significant.
Localized reaction: 5cm x 6cm no edema, erythema in circumscribed area.
Severe shoulder pain and upper arm pain for 36 hours. Moderated pain continued for 4 more  days. Range of motion of shoulder and arm were limited for 5 days.
I was given 3 step Hep B vaccine in 1990: 5/10/90 - 6/11/90 - 11/15/90. In 1995, perioperative of a total hysterectomy, I was diagnosed with ITP. Prior to the surgery, multiple other treatments were attempted for my menorrhagia including hormone therapy and D & C. Since then I was placed on prednisone, IVIG and eventually had a splenectomy. I have had multiple life threatening sequelae. I was treated for the ITP by a hematologist. The large extended doses of prednisone caused morbid weight gain and osteoporosis. The ITP is a likely cause for the menorrhagia. I had the hysterectomy in July 1995. I had the splenectomy in Nov. 1996. I had Roux-N-Y (gastric bypass) Sept. 2002 (or '03). I was admitted with pneumococcal meningitis in April 2008 - hospitalized for 30 days with complications of bilateral pulmonary emboli and GI bleed following IV heparin with emergency surgery. Pathological compression fractures of two lumbar vertebrae Jan 2009. Daily injections of FORTEO for two years for osteoporosis. I was just made aware that ITP is a adverse reaction to Hep. B vaccine.
Moderna COVID-19 Vaccine  Moderate to severe chills, fatigue, myalgias, and headache. Moderate to severe tension like pulling in posterior neck and posterior head.  NyQuil and Advil therapy.
Patient states  at approximately 9pm on the evening of receiving her Pfizer Covid booster that she begin having blurry vision that lasted approximately 15 minutes. Patient also states that she began having left arm and leg numbness on the same evening. Patient states that the blurry vision resolved, but patient still have some numbness and tingling in the left arm and leg after 3 days.  Patient advised to contact PCP today about these issues as well.
Breakthrough case admission after 3 vaccines Pfizer 3/30/21 lot# ER8730;  Pfizer 4/20/21 lot# EW0162;  Pfizer 11/18/21 lot# FH8027
After first dose, experienced sore arm, feeling foggy, headaches but better the next day.; After first dose, experienced sore arm, feeling foggy, headaches but better the next day.; After first dose, experienced sore arm, feeling foggy, headaches but better the next day.; This is a spontaneous report from a non-contactable consumer.  A patient of unspecified age and gender received the first dose of bnt162b2 (BNT162B2) vaccine , via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation .  The patient medical history and medications were not reported. The patient  experienced sore arm, feeling foggy, headaches but better the next day on an unspecified date with outcome of recovering.  No follow-up attempts are possible ; information about lot/Batch number cannot be obtained.
Off-Label Use; received the Comirnaty booster; Product use for unapproved combination; was very sick with flu like symptoms for 2 days; was very sick with flu like symptoms for 2 days; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 80 year-old female patient received bnt162b2 (COMIRNATY), administration date 2021 (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), administration date 2021 (Batch/Lot number: unknown) as dose number unknown, single for immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine ("DOSE X; MANUFACTUERER UNKNOWN" (where X=1, 2, or number unknown)), for COVID-19 immunization. The following information was reported: OFF LABEL USE (non-serious), outcome "unknown", described as "Off-Label Use"; IMMUNISATION (non-serious), outcome "unknown", described as "received the Comirnaty booster"; PRODUCT USE ISSUE (non-serious), outcome "unknown", described as "Product use for unapproved combination"; ILLNESS (non-serious), INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown" and all described as "was very sick with flu like symptoms for 2 days". The lot number for bnt162b2 was not provided and will be requested during follow up.
Pfizer-BioNTech COVID-19 Vaccine EUA  Extreme tiredness, mild nausea, moderate feelings of being "unwell". Noticed about 1:30pm after getting the vaccine at 9:30am. Laid down for a nap and woke up about 3 hours later feeling mostly better, but with a moderate stomach ache.
About 7 hours after I started to get migraine/sinus pain Dizzy Exhausted Arm pain at injection site Fever and chills that rolled in and out  The above symptoms lasted for three days.  The extreme exhaustion lasted for 9 days.  I was sleeping the whole night and taking 2-3 naps throughout the day for 2-3 hours.
.  She received the second covid pfizer vaccine 1/29/21.  Within minutes post vaccine she had bilateral hand arm tingling.   She stayed longer for observation and the provider did a brief exam which was normal.  The paresthesias have persisted but now only in bilateral 4th to 5th digits.  Severe, 8-10 HA began 7-8 hours later and has persisted in severity of 8/10 at worst and 6/10 this morning as she slept better through the night.  It is located in the left orbit, left frontal area, throbbing, persistent, causing nausea and vomited 4 times since onset.  Her vision is intermittently, "fuzzy" like she as if she does not have her glasses on only in the left eye.  This comes and goes and seems to be present as the HA worsens.  She has a hx of menstrual triggered headaches that resolve with meneses and just with OTC treatment.  No photophobia.  She has taken IBU 400mg q 8 hours, APAP 1g last night, melatonin 10 mg last night to sleep.  Did not work her night shift last night due to the vision and HA she did not think she would be able to perform functions of her job.   She also has flu  Like symptoms of body aches, tired, no fever.     Admits her anxiety is making the symptoms worse.
Pt received vaccine and then came to us on 7-16-07 and was 10 wks preg, said had vaccine on 6/5/07
next day after shot started having fever, chest pains, and pounding in the head, blurry eyes, was in bed for 15 days