chrisvoncsefalvay/vaers-outcomes huggingface dataset:
100.8°F fever; Back pain; Having no strength/ couldn't lift off the chair; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Back pain), ASTHENIA (Having no strength/ couldn't lift off the chair) and PYREXIA (100.8°F fever) in an 88-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028l20a and 027c21a) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Sep-2021, the patient experienced BACK PAIN (Back pain) and ASTHENIA (Having no strength/ couldn't lift off the chair). On 16-Sep-2021, the patient experienced PYREXIA (100.8°F fever). On 15-Sep-2021, BACK PAIN (Back pain) and ASTHENIA (Having no strength/ couldn't lift off the chair) had resolved. At the time of the report, PYREXIA (100.8°F fever) outcome was unknown.            He used to take number of medications as concomitant for unknown indication. Treatment information was not reported.
Severe rash that also itches at injection site, on arm and face and right side swelling; Severe rash that also itches at injection site, on arm and face and right side swelling; Severe rash that also itches at injection site, on arm and face and right side swelling; Right side swelling; This is a spontaneous report from a contactable consumer, the patient. A 23-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EE3592) via an unspecified route of administration in the right arm on 14Sep2021 at 17:15 (at the age of 23-years-old) as a single dose for COVID-19 immunisation. Medical history included Charcot-Marie-Tooth disease (CMT), Sjogren's, Multiple Sclerosis (MS), irritable bowel syndrome (IBS), allergy to latex and allergy to adhesive (Contact dermatitis). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks of vaccination. The patient did not receive any concomitant medications. The patient previously took atomoxetine hydrochloride (STRATTERA), paracetamol (TYLENOL), lamotrigine (LAMICTAL), risperidone (RISPERDAL); all for an unknown indication on an unknown date and experienced drug allergy. On 14Sep2021 at 18:00, the patient experienced severe rash that also itched at injection site, on arm and face and right-side swelling. 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 rash that also itched at injection site, on arm and face and right-side swelling were not resolved at the time of this report.
Eight hours after Fluzone, was having a disagreement with husband, out of the ordinary, throwing things, banging hands on table, driving away without shoes, some events she did not remember doing.
Pt received 2nd Shingrix vaccination, reports SOB following. Visited ED with respirophasic c/p. Negative w/u with nl CBC,CMP, CXR, CTchestPE, BNP, Troponin. DX non-specific immunologic reaction vs musculoskeletal c/p. No sequelae
Patient was given an expired pneumovax-23 shot on 10/11/23.  No adverse reactions was reported or noted from patient.   Patient was contact and a new pneumovax-23 shot was administered for patient on 10/12/2023.
On 28-FEB-2021, at approximately 2000, I developed left facial numbness felt on top of the left forehead, left eyebrow, left nasal bridge, inside of left nose (nares), top and bottom of left lip, left side of the cheek, and left side of the tongue.  Left eye blin is weak and unable to fully close left eye.  Left ear was aggravated and irritated when scratched.  Hearing is distorted, felt as if I had been submerged in water for a prolonged amount of time.  There is ringing at times on left ear as well.  Symptoms were progressive.  Today (05-MAR-2021), also developed vertiginous sensation and light-headedness.
Shortness of breath and tightness of chest 30 minutes after vaccine, rapid heart rate, pain and swelling at injection site, heavy feeling in entire arm and up to neck, swollen lymph nodes in back of n; Shortness of breath and tightness of chest 30 minutes after vaccine, rapid heart rate, pain and swelling at injection site, heavy feeling in entire arm and up to neck, swollen lymph nodes in back of n; Shortness of breath and tightness of chest 30 minutes after vaccine, rapid heart rate, pain and swelling at injection site, heavy feeling in entire arm and up to neck, swollen lymph nodes in back of n; Shortness of breath and tightness of chest 30 minutes after vaccine, rapid heart rate, pain and swelling at injection site, heavy feeling in entire arm and up to neck, swollen lymph nodes in back of n; Shortness of breath and tightness of chest 30 minutes after vaccine, rapid heart rate, pain and swelling at injection site, heavy feeling in entire arm and up to neck, swollen lymph nodes in back of n; Shortness of breath and tightness of chest 30 minutes after vaccine, rapid heart rate, pain and swelling at injection site, heavy feeling in entire arm and up to neck, swollen lymph nodes in back of n; Shortness of breath and tightness of chest 30 minutes after vaccine, rapid heart rate, pain and swelling at injection site, heavy feeling in entire arm and up to neck, swollen lymph nodes in back of n; This is a spontaneous report from a contactable other HCP. This 36-year-old female other HCP reported for herself that that she received the first dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Intramuscular at right arm at single dose for COVID-19 immunisation on 22Dec202008:00 AM.  Relevant history included Endometriosis and allergies with Keflex, Levsin. Concomitant drug included bupropion SR which received within 2 weeks of vaccination. The patient experienced shortness of breath and tightness of chest 30 minutes after vaccine, rapid heart rate, pain and swelling at injection site, heavy feeling in entire arm and up to neck, swollen lymph nodes in back of neck 4 days after vaccine. Tightness on chest was gradually improving but comes and goes daily for the past week. The events was considered as non-serious. No treatment was received. The outcome of events was reported as recovered with lasting effects. The patient did not receive any other vaccines within 4 weeks prior to the COVID. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient been tested for COVID-19 with negative result per Nasal Swab on 23Dec2020.  Information on the lot/batch number has been requested.
Pain on right side of her chest between ribcage; Difficulty breathing; Didn't had enough sleep on that night due to the pain.; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL CHEST PAIN (Pain on right side of her chest between ribcage), DYSPNOEA (Difficulty breathing) and INSOMNIA (Didn't had enough sleep on that night due to the pain.) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017B21A and 03M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021 at 2:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Mar-2021, the patient experienced MUSCULOSKELETAL CHEST PAIN (Pain on right side of her chest between ribcage), DYSPNOEA (Difficulty breathing) and INSOMNIA (Didn't had enough sleep on that night due to the pain.). The patient was treated with CODEINE PHOSPHATE, PARACETAMOL (TYLENOL WITH CODEINE) for Chest wall pain, at an unspecified dose and frequency. At the time of the report, MUSCULOSKELETAL CHEST PAIN (Pain on right side of her chest between ribcage), DYSPNOEA (Difficulty breathing) and INSOMNIA (Didn't had enough sleep on that night due to the pain.) outcome was unknown. Not applicable          Concomitant product use was not provided.   Action taken with mRNA-1273 in response to the events was  not applicable.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Two weeks to the day of my second shot I woke up with extreme chills, vomiting, diarrhea, and a 103 fever at 7:30 in the morning.  My family member took me to the ER where I was treated.  I was released that day, but continued being feverish for a few days more and broke out with an extreme case of shingles/herpes under my right eye.  Since then I have twice been admitted to the ER with tachycardia.
Patient received 2-dose series of Moderna 4/1/21 and 4/28/21. Patient came to the pharmacy today to receive booster vaccine and influenza vaccine. Patient falls under the booster dose guidelines due to immunocomporomised. However, patient received Pfizer instead of Moderna which was not corrected prior to administration.
BRUISING ON LEGS AND ARMS; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced bruising on legs and arms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of bruising on legs and arms was not reported. This report was non-serious.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5, (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3, (booster), single (Batch/Lot number: unknown) and as dose 4, (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High cholesterol" (unspecified if ongoing); "Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Codeine, reaction(s): "Known allergies: Codeine"; Erythromycin, reaction(s): "Known allergies: Erythromycin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical information: Anti-viral details: COVID 19 Treatment, brand Pfizer, treatment start date 27Jan2023, treatment stop date 31Jan2023, lot number GF9369, indication Treatment of COVID-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
12 days p/vax pt devel an inj site rxn characterised by a 5x6mm nodule, redness & warm;
Knee arthroplasty; Skin fissures / skin cracking when it was humid; Vaccination site pain / pain right arm; Tendon rupture / torn tendons in left hand/pinky/ring finger; This is a solicited report from a contactable consumer and physician based on information received by Pfizer (Mfr. Control No. #: 21K-163-4140628-00).  A 60-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in right arm on an unspecified date (Batch/Lot number was not reported) as single dose for Covid-19 immunisation; upadacitinib (RINVOQ), oral from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at unspecified dose for moderate to severe rheumatoid arthritis. Medical history included patient had surgery due to tore tendons in left hand two weeks before covid shot. The patient's concomitant medications were not reported. The patient experienced knee arthroplasty, skin fissures/skin cracking when it was humid, vaccination site pain/pain right arm, tendon rupture/torn tendons in left hand/pinky/ring finger, all on an unspecified date after the first dose. The events were reported as medically significant. The patient recovered from vaccination site pain, and recovering from tendon rupture. Outcome of the other events was not recovered.    Causality for RINVOQ (UPADACITINIB): The reporter's causality for the event(s) of left knee replacement, torn tendons in left hand/pinky/ring finger, skin cracking and pain right arm after first covid vaccination with RINVOQ(UPADACITINIB) was no reasonable possibility.  The reporter's assessment of the causal relationship of the events with the suspect product (BNT162B2) was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events Joint injury, Skin fissure, vaccination site pain, Tendon rupture  and BNT162B2.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
pt fainted after getting the shot. pt was dizzy and pale after the shot. pt blood pressure was normal then dropped quickly to 80/40 per nurse and then came back to normal. pt rested and was given water and candy afterwards.  pt walked around store after wards and felt fine and went home with parent.
This spontaneous report as received from a physician via a company representative concerned to a female patient (Age not reported) with a negative papanicolaou (PAP) test. On an unknown date the patient was vaccinated with a dose of GARDASIL (dose and site not reported). On an unknown date the patient had a positive PAP after the receipt of GARDASIL. Patient's outcome on smear cervix abnormal was not reported. Relationship between smear cervix abnormal and vaccination with GARDASIL was not reported. Additional information has been requested.
Previously well child woke up at 10pm screaming, pale, activity with somnolence, eyes rolled back" per parents - no tonic clonic activity.? Night tremors or seizure activity - was taken to ER but not seen - she was fine per parents on arrival.
Pfizer Bivalent (booster) vaccine given as the first dose by error. The child previously did not receive any covid vaccine. No adverse event noted.
I had extreme pain that started on the right side of my abdomen; the pain moved to the middle & lower right side of my back.  The pain lasted about a week; I was nervous to go to Er; This is a spontaneous report from a contactable consumer or other non hcp.     A 49-years-old female patient received bnt162b2 (BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection (Batch/Lot Number: ER 7533)), dose 1 via an unspecified route of administration, administered in Arm Left on 01Apr2021 08:30 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant was not reported. The patient did not receive any other vaccine in four weeks. Prior to vaccination patient diagnosed with COVID. Post vaccination patient did not test for COVID. The patient had not known allergies. It was Reported that, the patient experienced had extreme pain that started on the right side of my abdomen on the pain lasted about a week and also Nervousness on 02Apr2021 with outcome of recovered.  No follow-up attempts are possible. No further information is expected.
COVID-19 INFECTION; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose was not reported, administered on 29-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested.  No concomitant medications were reported.  On 01-JUL-2021, the patient experienced covid-19 infection. Laboratory data included: SARS-CoV-2 test (NR: not provided) positive. On 16-JUL-2021, Laboratory data included: SARS-CoV-2 test (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from covid-19 infection on 16-JUL-2021. This report was non-serious.; Sender's Comments: V0-Medical Assessment comment is not required as per standard procedures, as the case was assessed as non-serious.
No additional adverse events reported.; expired dose; This spontaneous report was received from registered nurse, referring to a 50-year-old patient of unknown gender. Information regarding the patient's pertinent medical history, concurrent condition, drug reactions/allergies and concomitant medication was not provided.  On 25-FEB-2022, the patient was vaccinated with expired pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (0.5 ml, lot # S029542, expiration date 10-JUN-2021, strength and route were not provided) for prophylaxis (expired product administered) in the office. No other information given. No additional adverse events reported.
The patient was given an adult dose of PNEUMOVAX 23. She was supposed to be given PREVNAR 13. She received a 0.5ml injection of the vaccine in her Right thigh. There were no adverse reaction, but she will have to have the immunization repeated.
Pt had vaccine on a Monday. Tuesday started having swelling and redness greater than 1 inch at injection site. Hot to touch. Pt evaled by provider-watching SX for improvement.
2 days after receiving vaccine I noticed that eating was painful. My tongue seemed sore and swollen and eating was difficult because of this. No other symptoms were experienced. The symptoms never worsened, they lasted for about a month following the 2nd dose in the series.
Headache, Fever of 100.5, stiffness, tired, red spot where the was administrated.
1-2 cm area of pink and induration around injection site, 6-8 pink papular/wheal type lesions grouped on lower part of left thigh. Started on triamcinolone acetonide topical ointment 0.1%
A little over 24 hours after first vaccination shot suffered a suspected TIA.  Symptoms: Shortness of breath, extreme weakness, racing heart, visual disturbance, inability to move. Episode lasted approximately 1 hour. Was unable to call for help or pick up phone to dial 911.
Initial information received on 21-Nov-2018 regarding an unsolicited valid serious case received from a nurse. This case involves male patient of an unknown age who experienced left arm cellulitis, 8x9 cm on left deltoid, while he received vaccines TRUMENBA and MENACTRA. The patient's past medical history included Depression in 2016 and Anxiety in 2016. The patient's past medical treatment(s), vaccination(s) and family history were not provided. On 24-SEP-2018, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot U6151AB, expiry date: 16-MAR-2020 via intramuscular route in the right deltoid. On 24-Sep-2018, the patient received a 0.5 mL dose of suspect TRUMENBA not produced by Sanofi Pasteur lot W09937, expiry date: JAN-2020 via intramuscular route in the left deltoid. On 24-Sep-2018, the patient developed a serious left arm cellulitis, 8x9 cm on left deltoid same day following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE and TRUMENBA. Patient had physician office visit. This event was assessed as medically significant. Other relevant tests included no lab data. Final diagnosis was arm left arm cellulitis, 8x9 cm on left deltoid. The patient was treated with PREDNISONE for Product used for unknown indication and KEFLEX for Product used for unknown indication. On 27-Sep-2018, the patient was recovered from left arm cellulitis, 8x9 cm on left deltoid. The reporter assessed the event to be related to TRUMENBA. List of documents held by sender- none. Sender's Comments: This case involves a patient of an unknown age who experienced cellulitis of 8x9 cm same day post vaccination with TRUMENBA and MENACTRA. Time to onset is compatible. To be noted that MENACTRA was administered in right deltoid and cellulitis was observed on left deltoid (TRUMENBA site) and reporter also the event to be related to TRUMENBA. Based upon reported information, role of MENACTRA is considered unlikely.
Flu like symptoms; Swollen lymph nodes left neck; Swollen left arm (Site of Injection); This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), LYMPHADENOPATHY (Swollen lymph nodes left neck) and VACCINATION SITE SWELLING (Swollen left arm (Site of Injection)) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20a) for COVID-19 vaccination.     The patient's past medical history included SARS-CoV-2 infection in April 2019 and Flu like symptoms from 30-Dec-2020 to 07-Jan-2021. Concurrent medical conditions included Hypertension since 2010 and Swollen lymph nodes since 30-Dec-2020. Concomitant products included LOSARTAN for Hypertension, VITAMIN D [VITAMIN D NOS], VITAMIN C [ASCORBIC ACID] and ZINC for Vitamin supplementation.    On 03-Dec-2020 at 2:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Dec-2020, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), LYMPHADENOPATHY (Swollen lymph nodes left neck) and VACCINATION SITE SWELLING (Swollen left arm (Site of Injection)). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms) and VACCINATION SITE SWELLING (Swollen left arm (Site of Injection)) had resolved and LYMPHADENOPATHY (Swollen lymph nodes left neck) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications were reported.  The swollen lymph nodes were reported to be in th left neck and left arm (injection site).   Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2021: Follow up was received on 22-APR-2021. Patient demographics- Date of Birth, age, weight, height and race, medical history information, vaccination dose details, vaccine facility information, concomitant medications and all reported events were added.
pt recv vax & devel a large local rxn the size of a softball that was hot to touch & sore, body aches, & fever a few days later;pt recovered;
3 days after shot arm started to itch and hurt. By next day hard red circle developed, increasing to size of 1/2 dollar.19 days later Persistant pain and sensitivity on skin. redness is just starting to fade.
He had a severe reaction and was running around the house, hitting his head on the walls. Then he showed signs of sensitivity to light, sound, smelling, taste, and touch.
Extreme congestion  and difficulty breathing the next day. Had some dexamethasone at home, took a dose  and felt better. Feels fine now.