chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Arm hurt slightly after receiving the second dose of the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm hurt slightly after receiving the second dose of the vaccine) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21A and 007M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm hurt slightly after receiving the second dose of the vaccine). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of 1 dosage form. At the time of the report, PAIN IN EXTREMITY (Arm hurt slightly after receiving the second dose of the vaccine) outcome was unknown.            No concomitant medication details was reported.   This case was linked to MOD-2021-361743 (Patient Link).
Patient received partial dose of vaccine due to needle would not retract.  Vaccine left in syringe.
Pt called afternoon of 5th concerned about swelling in right leg tight size of baseball and red brought pt in the am pt leg still swollen and a little warm dr told parent to use ice and come back if condition worsened.
11/14/2018- Per parent, patient developed a non-itchy rash on face. 11/16/2018 - Per CRNP, at an urgent care facility, rash spread to entire body.
Patient just turned 12 years old but nurse administering vaccine thought he was still 11 (cerebral math error), so she administered a 0.2mL dose of Pfizer (5-11) to the patient. Patient had no adverse reaction to the vaccine. Parent was counseled to bring patient back in 21 days to receive age-appropriate dose to complete primary series.
ANOREXIA; GENERALIZED PAIN; FOGGY FEELING; FEVER; FATIGUE; This spontaneous report received from a health care professional concerned a 35 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included attention-deficit/hyperactivity disorder, and other pre-existing medical conditions included the patient does not have any allergies to medication, food, or other products, no other illnesses at the time of vaccination and up to one month prior, and no adverse event following any previous vaccine. The patient received covid-19 vaccine  (suspension for injection, intramuscular, batch number: 203A21A, expiry: UNKNOWN) dose was not reported, administered on 08-MAY-2021 16:45:00 for prophylactic vaccination. Concomitant medications included amfetamine aspartate/amfetamine sulfate/dexamfetamine saccharate/dexamfetamine sulfate, ergocalciferol, magnesium, and rhodiola rosea.  On MAY-2021, treatment medications included: paracetamol. On 09-MAY-2021 06:00:00, the subject experienced anorexia. On 09-MAY-2021 06:00:00, the subject experienced generalized pain. On 09-MAY-2021 06:00:00, the subject experienced foggy feeling. On 09-MAY-2021 06:00:00, the subject experienced fever. On 09-MAY-2021 06:00:00, the subject experienced fatigue. The action taken with covid-19 vaccine was not applicable. The patient was recovering from fatigue, fever, foggy feeling, generalized pain, and anorexia. This report was non-serious.
Getting an elevated temperature as a side effect from it [vaccination]; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) via medical information team. The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), 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: BODY TEMPERATURE INCREASED (non-serious), outcome "unknown", described as "Getting an elevated temperature as a side effect from it [vaccination]". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Call was transferred from DSU: (withheld) ID: withheld, Reportum number: withheld). Caller stated he got his second booster dose of the Pfizer-BioNTech Covid-19 vaccine yesterday evening [19Apr2022] at a (facility name, city, state withheld). This was his second booster. All of his vaccinations have been Pfizer. He forget what his experience was in the past, but he remembered getting an elevated temperature as a side effect from it [vaccination] and now, but he was experiencing a 101 degree F fever." Caller asked: was this normal or not. According to agent, caller declined to provide last name and address. Question: Caller asked: What database does (facility name withheld) puts the Pfizer-BioNTech Covid-19 vaccine in (withheld).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200604609 Same reporter/ patient, different dose number/ event
Red, warm, painful area at injection site. Duration four days. Resolved self. 2nd injection 7/10/00 lot #128A2. Rtn to Dr. 7/26/00 with constant back pain and swelling and pain in hands/knuckle, shoulders. X-rays-referred to rheumatologist. 3rd injection 6/8/01 lot #128A2-joint conditions worsening. 12-2000 diagnosed with rheumatoid arthritis. A 60-day follow up report received 8/4/2003 adds: Rheumatoid arthritis-joint swelling, redness, pain specifically in hands, wrists, feet, knees, elbows, neck and shoulders, hips. Presently working with rheumatologist to try to find a medication, or combination of medicines, to control the above symptoms. Presently on Humira, Methotrexate and Prednisone. The medical record states confirmation of diagnosis of arthritis and elevated rheumatoid factor.
Pt. received HPV #1, approximately 30 min after vaccine pt. developed HA & fever up to 101.1. Mother gave ibuprofen/Acetaminophen.
Pain at injection site, fever, fatigue (slept for two days), nausea, terrible headache.
Site of vaccination swollen, red and hot size 2 inches x 1 inch, pain in right shoulder right neck and face with muscle in right cheek involuntarily contracting, next day site swelling doubled, face swelling, some choking.
she experienced Diarrhea; she had muscle weakness in both legs and back; legs felt weak; This is a spontaneous report from a contactable consumer (patient). A 80-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Right on 05Feb2021 13:40 (Batch/Lot Number: EM9810) as single dose for covid-19 immunisation. Medical history included Diabetes from Mar1964, she does some exercise after the shower for the hip surgery done prior to the vaccine. Concomitant medication included insulin lispro (HUMALOG) uses with a pump taken for diabetes mellitus. Caller stated she received her first dose of the Pfizer covid vaccine on Friday, and yesterday morning 09Feb2021 she experienced Diarrhea and then later on she had muscle weakness in both legs and back. She does some exercise after the shower for the hip surgery done prior to the vaccine and uses a cane to walk. She said she is a little better today and wanted to know if that was due to the vaccine. Outcome of the event she had muscle weakness in both legs and back was unknown. Outcome of the other events was recovered on 10Feb2021.
Right leg redness and swelling, warm to the touch. Size of area 14 x 11 cm on (R) thigh. Meds = KEFLEX 250mg tid x 10 days.
I got Covid; I got Covid; This is a spontaneous report from a non-contactable consumer (patient). This consumer reported similar events for two patient. This is the first of two reports.   A female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot and expiration date unknown), via an unspecified route of administration on 25Feb2021 as a single dose for covid-19 immunization. The patient's medical history included an auto immune deficiency, do not have a spleen, and anaemic all from an unknown date. The patient's concomitant medications were not reported. The patient was supposed to get the second dose to be somewhere between the 18Mar2021 and 21Mar2021. But she got Covid. The patient got the first dose and was supposed to go back and get it another week to take the second dose. But somehow at work like she was not in the office. Other ladies had it before she got it. But she have an auto immune deficiency, do not have a spleen and was anaemic. So her doctor said get the vaccine 'unless' she get COVID. Patient would like to know if she can still get her second dose after this. The outcome of the 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-2021280057 same reporter/drug/event, different patient
Her arm was painful and started to swell 2 hours after receiving vaccine, then next day she had swelling from elbow to shoulder reaching part of torso. She called her PCP. He said to go to an urgent care clinic. The urgent care clinic said to wait and see if goes in forearm, ice and elevate. Second day she was still worried. PCP called her and told her to call pharmacy to make us aware of issue and for her to take Zyrtec.
Almost immediately after I got my second vaccination, I had a knot at the injection site, which was on my right arm. The knot was present for about a month before it finally disappeared. I also felt more fatigued and achy starting on 1/21/2021 (the day after the vaccine). That lasted for about three or four days.
pt recv vax 1OCT96 PM, 630PM started crying inconsolable-crying was high pitched & different sounding than usual cry;MD was consulted @ 8PM-parents instructed to give a dose of Ibuprofen susp;pt was consolable by 830PM;no inc temp was noted
4/1/2021   Pt was observed post Covid-19 immunization for 30 minutes based on pre-vaccination screening .  During the observation period, he experienced an adverse reaction with the following symptoms:  dizziness.   Assessment : Time of assessment 1100 Alert and oriented.   Actions taken: Observation increased to 30 minutes, VS taken, BP- 100?52, P- 68, water offered and accepted, VS 11:10 BP- 120/80 , P- 80.          Medications administered: No medication administered.   Disposition: Reports no further symptoms of adverse reaction after observation for 30 minutes. Discharged home.     Immunizations Administered    Name Date Dose VIS Date Route   Pfizer COVID-19 Vaccine 4/1/2021 10:52 AM 0.3 mL 12/11/2020 Intramuscular   Manufacturer: Pfizer, Inc   Lot: EP7533   NDC: 59267-1000-2
booster; anxiety and panic attacks; anxiety and panic attacks; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP) from medical information team. The reporter is the patient.  A 67-year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 30Nov2021 (Batch/Lot number: unknown, Expiration Date: 28Feb2022) at the age of 67 years as dose 3 (booster), 0.3 ml single for covid-19 immunisation. Relevant medical history included: "She has had anxiety all her life." (ongoing), notes: She has had anxiety all her life.; "Migraine" (unspecified if ongoing), notes: Took it that night after her vaccine for Migraine. Concomitant medication(s) included: AJOVY [FREMANEZUMAB] taken for migraine (ongoing). Vaccination history included: Bnt162b2 (Dose no:1, First dose 12Mar2021, Lot: EN6199, Expiration: Unknown, She already had her 2 doses of the vaccine without experiencing any side-effects), administration date: 12Mar2021, when the patient was 66 years old, for COVID-19 Immunization; Bnt162b2 (Dose no:2, Second dose 02Apr2021, Lot: EP6955, Expiration: Unknown, She already had her 2 doses of the vaccine without experiencing any side-effects), administration date: 02Apr2021, when the patient was 66 years old, for COVID-19 Immunization. The following information was reported: ANXIETY (non-serious), PANIC ATTACK (non-serious) all with onset 30Nov2021, outcome "recovered" (01Dec2021) and all described as "anxiety and panic attacks"; IMMUNISATION (non-serious) with onset 30Nov2021, outcome "unknown", described as "booster". Therapeutic measures were taken as a result of anxiety, panic attack, immunisation. Additional information: Reporter had severe anxiety and panic attacks (probably the worst panic attack she has ever had) 3 hours after with booster dose, administered on 30Nov2021. She has had anxiety all her life. Patient was on medications. It was reported that patient took clonazepam in the morning to make sure she was ok and felt a lot better. Reporter added as if she had a hard time reading the booster dose lot number as said it could be FJ8757.  The lot number for bnt162b2 was not provided and will be requested during follow up.
received expired FLUZONE QIV NP with no reported adverse event; Initial information received on 15-Oct-2021 regarding an unsolicited valid non-serious case received from an other health professional via Agency (under the reference 00814563).  This case is linked to cases 2021SA344343, 2021SA344107, 2021SA345249, 2021SA345624, 2021SA345587, 2021SA344898, 2021SA345067, 2021SA345099, 2021SA345086, 2021SA345823 and 2021SA345419 (same reporter).  This case involves a 48 years old female patient who received expired INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV] (expired product administered).  The patient's past medical history, medical treatment(s), concomitant medication(s) and family history were not provided.  Patient had no other vaccines.  On 14-Oct-2021, the patient received a dose of suspect FLUZONE QIV (0.5 ml, total, once, lot UT7108MA and expiration date: 30-Jun-2021) via intramuscular route in the left deltoid for prophylactic vaccination.  It was an actual medication error due to expired product administered (same day latency).  No adverse event was reported.  It was reported "Nurse practitioner states that 12 patients have received FLUZONE QIV NP vaccines in her practice from 14OCT2021 to 15OCT2021 that expired on 30JUN2021. Caller asked how to proceed in this situation. Caller asked if there were any differences between the 2020 FLUZONE QIV NP vaccine and the 2021 FLUZONE QIV NP vaccine."  At time of reporting, the outcome was unknown for the reported 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 the 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.
Shortness of breath; Body aches; Fatigue; Minor headache; Arm  soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm  soreness), DYSPNOEA (Shortness of breath), MYALGIA (Body aches), FATIGUE (Fatigue) and HEADACHE (Minor headache) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 16-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced PAIN IN EXTREMITY (Arm  soreness). On 22-Jan-2021, the patient experienced DYSPNOEA (Shortness of breath), MYALGIA (Body aches), FATIGUE (Fatigue) and HEADACHE (Minor headache). On 18-Jan-2021, PAIN IN EXTREMITY (Arm  soreness) had resolved. At the time of the report, DYSPNOEA (Shortness of breath), MYALGIA (Body aches), FATIGUE (Fatigue) and HEADACHE (Minor headache) outcome was unknown.            No Concomitant medication were provided Treatment included Tylenol for soreness
Caller had a reaction from the pneumonia vaccine 15 yrs ago/ left arm swelling; Caller had a reaction from the pneumonia vaccine 15 yrs ago/ like edema; Caller had a reaction from the pneumonia vaccine 15 yrs ago/ rash; Information has been received from a 63 years old female patient via other company, referring on herself. The patient's medical history and concomitant therapies were not reported. As concurrent conditions was reported an allergies to phenoxyethonal (something that they put in lotions and perfumes). The patient's historical vaccines included shingles and flu vaccines without trouble. On an unspecified date in 2006, the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (strength, anatomical location, administration route, lot number and expiration date were not reported) as prophylaxis. On an unknown date, the patient had a reaction from the vaccine, she experienced her left arm swelled, like edema and rash. The outcome of arm swelled, like edema and rash was unknown and the casuality assessment between the vaccination with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) and the aforementioned events was reported as related.
SWELLING, REDNESS, ITCHING, PAIN AT INJECTION SITE. BUMP SIZE OF 3INCH X 2 INCH. LASTED FOR ABOUT 1 WEEK.
Patient received a different manufacturer for her second COVID-19 vaccine that her first. She experienced no adverse reaction or illness. The doses were administered 29 pages apart.
1 month of malaise, sore throat, dry cough, and shortness of breath. The patient initially attributed her symptoms to seasonal allergies and felt that they got worse after she received her pfizer covid vaccination on 3/20 and 4/11.
Rash on her arm (COVID arm); Red rash; Itchy rash; Warm rash; When she went touch it felt like bee sting; This spontaneous case was reported by a consumer and describes the occurrence of DERMATITIS ALLERGIC (Rash on her arm (COVID arm)), RASH ERYTHEMATOUS (Red rash), RASH PRURITIC (Itchy rash), RASH (Warm rash) and RASH (When she went touch it felt like bee sting) in a 46-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 02-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, the patient experienced DERMATITIS ALLERGIC (Rash on her arm (COVID arm)), RASH ERYTHEMATOUS (Red rash), RASH PRURITIC (Itchy rash), RASH (Warm rash) and RASH (When she went touch it felt like bee sting). The patient was treated with DIPHENHYDRAMINE at an unspecified dose and frequency. On 07-Mar-2021, DERMATITIS ALLERGIC (Rash on her arm (COVID arm)), RASH ERYTHEMATOUS (Red rash), RASH PRURITIC (Itchy rash), RASH (Warm rash) and RASH (When she went touch it felt like bee sting) had resolved. Not Provided          Concomitant product use was not provided by the reporter.  Action taken with mRNA-1273 in response to the events was not applicable.
Information has been received from a registered nurse (R.N.) concerning a 41-year-old female with no pertinent medical history or allergies, who in the 1990's was vaccinated with two doses of Varivax. On 30-NOV-2006 the patient had a titer done that came back negative. Unspecified medical attention was sought. Subsequently, the patient experienced no symptoms. No product quality complaint was involved. Additional information has been requested.
still experiencing intermittent ear pressure/congestion following 3rd dose. Experienced the rash and dry skin as with the first 3 doses. About the 6th of May I started to have intense jaw pain and travelling dental pain that would travel up my face to ears and eye on left side, it wasn't all focused on one spot, just all over the left side. Headaches. My skin felt tight and yet loose on my whole face. Tingling and numbness around my mouth, both sides. Sensation of tingling and numbness on the left side. Week of 5/18/22 I definitely felt like my skin on my left side was droopy and my eye felt droopy and I could see the sagginess on the left side. I felt as if I might wake up and not be able to close my eye. I scheduled an appt to see my Dr. ASAP. Saw Dr on the 20th. Ive also had tingling on my legs and arms ascending to my head, which is still going on. Did assessment for neurological issues. Didnt see any dental infections. Saw my reactions to the first 3 doses and ruled out stroke symptoms. He advised it would probably clear up, but to follow up with dentist to make sure there werent any impacts to facial nerves from teeth. Dentist found nothing. Since the booster, i've had these nerve issues, some digestive issues, and a sense of malaise. Just a general feeling of being unwell and fatigue. They've come and gone. This week it seems like they are abating and that im having longer periods of times without the symptoms. However last night with all the symptoms and it feels like some shortness of breath, chest tightness, tingling all over. This last week my blood pressure has been really low, about 80/55.
Information has been received from a physician concerning a 15 year old female with seasonal allergic rhinitis who on 19-OCT-2007 was vaccinated in the right deltoid with the first dose of GARDASIL. Concomitant therapy included ALLEGRA, ADACEL, MENACTRA and hepatitis A vaccine (unspecified). On 19-OCT_2007 the patient experienced near syncopal episodes (likely vasovagal) that lasted 5 minutes and mild hypotension with spontaneous recovery. Subsequently, the patient recovered from near syncopal episodes and mild hypotension. No further information is available.
Mother reports that on 8-11-97 in the a.m. child complained left arm felt "funny".  On the a.m. of 8-12-07, left arm had edema and erythema, not hot to the touch.  Mother gave child Tylenol and applied ice pack to left arm with relief.  Mother called and reported to HD on 8/13/07.
11AUG97 @ bedtime, arm felt warm @ inj site, redness around inj site & hard nodule palpation;12AUG97 arm swollen @ inj site, erythema 3 1/2 to 4" in diameter around inj site;pain all along;13AUG97 took clariten swelling & redness dec;
larger red and swollen itching injection spot; patient had larger red and swollen itching injection spot; patient had larger red and swollen itching injection spot; tired; sore arm; nausea tired; Earache; headache; This is a spontaneous report from a contactable consumer (Patient) reported for himself. A 44-years-old female (Non-Pregnant) patient received first dose of bnt162b2(PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: EN6203, Expiration date: unknown), via an unspecified route of administration in left arm on 24Feb2021 at 11:30 AM (at age of 44years) at single dose for COVID-19 immunization. Patient medical history included which was acid reflux. Patient had Known allergies to gluten, food sensitivity to dairy and tomatoes. Patient concomitant medications included esomeprazole (20mg) two times in daily, vitamin B12 (5000mcg). Patient did not receive any vaccine in four weeks. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. On 24Feb2021 at 12:00 the patient experienced headache, nausea, earache and on 25Feb2021 second day patient had sore arm headache and tired, on 26Feb2021 (day 3) the patient had red, swollen, and itching at vaccination site also, tired, nausea. and on 27Feb2021 (day 4) the patient had larger red and swollen itching at vaccination spot nausea tired. Patient didn't take treatment for the events. The outcome of the events was recovering.  No follow up attempts are possible. No further information is expected.
Local erythema - 4 cm. Arm became itchy 3/17 PM - Erythema noted 3/18/08 AM. Rx - observation. Erythema faded within 2 days.