chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Narrative:  09/03 COVID vaccine dose #1 of 1 in right deltoid 09/07 Pt developed pain and swelling to right axillary area 09/08 Pt reports area has become more swollen, more painful, and red 09/10 Pt developed fever of 100.5 09/11 Pt seen in ED, axillary described as 7cm x 7cm area of induration, mildly tender, 2cm area of erythema and fluctuance on top, mild-moderate surrounding erythema and calor; CT chest WNL, discharged from ED with rx for keflex and bactrim 09/14 Pt returns to ED c/o increased pain and worsening swelling, sharp axillary pain with movement; incision and drainage in ED with purulent discharge, pt admitted for obs; given clindamycin 900mg iv, continued to clindamycin po; wound culture grew MRSA 09/20 Discharged from hospital with home health for wound care and Bactrim po x 14 days
swelling in the arm on the site of injection; there is a rash, it's itchy, and it's a little bit uncomfortable. It's hot there as well.; there is a rash, it's itchy, and it's a little bit uncomfortable. It's hot there as well.; there is a rash, it's itchy, and it's a little bit uncomfortable. It's hot there as well.; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of INJECTION SITE SWELLING (swelling in the arm on the site of injection), INJECTION SITE RASH (there is a rash, it's itchy, and it's a little bit uncomfortable. It's hot there as well.), INJECTION SITE PRURITUS (there is a rash, it's itchy, and it's a little bit uncomfortable. It's hot there as well.) and INJECTION SITE WARMTH (there is a rash, it's itchy, and it's a little bit uncomfortable. It's hot there as well.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced INJECTION SITE SWELLING (swelling in the arm on the site of injection). 21-Jan-2021, the patient experienced INJECTION SITE RASH (there is a rash, it's itchy, and it's a little bit uncomfortable. It's hot there as well.), INJECTION SITE PRURITUS (there is a rash, it's itchy, and it's a little bit uncomfortable. It's hot there as well.) and INJECTION SITE WARMTH (there is a rash, it's itchy, and it's a little bit uncomfortable. It's hot there as well.). At the time of the report, INJECTION SITE SWELLING (swelling in the arm on the site of injection), INJECTION SITE RASH (there is a rash, it's itchy, and it's a little bit uncomfortable. It's hot there as well.), INJECTION SITE PRURITUS (there is a rash, it's itchy, and it's a little bit uncomfortable. It's hot there as well.) and INJECTION SITE WARMTH (there is a rash, it's itchy, and it's a little bit uncomfortable. It's hot there as well.) 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 medication provided. no treatment given
Cellulitis, pain, erythema, edema, lesions to right anterior thigh, spreading circumfrentially over anterior thigh area.
No adverse event; erroneously vaccinated  clients with expired vaccine; The (BUD) refrigeration date  on 01-Jul-2022 and vaccine was adminstered on 11-Jul-2022; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (erroneously vaccinated  clients with expired vaccine), PRODUCT STORAGE ERROR (The (BUD) refrigeration date  on 01-Jul-2022 and vaccine was adminstered on 11-Jul-2022) and NO ADVERSE EVENT (No adverse event) in a 29-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Jul-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 11-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (erroneously vaccinated  clients with expired vaccine) and PRODUCT STORAGE ERROR (The (BUD) refrigeration date  on 01-Jul-2022 and vaccine was adminstered on 11-Jul-2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (erroneously vaccinated  clients with expired vaccine), PRODUCT STORAGE ERROR (The (BUD) refrigeration date  on 01-Jul-2022 and vaccine was adminstered on 11-Jul-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (erroneously vaccinated  clients with expired vaccine) and PRODUCT STORAGE ERROR (The (BUD) refrigeration date  on 01-Jul-2022 and vaccine was adminstered on 11-Jul-2022).    Concomitant medications details were not reported by the reporter.  It was reported that 10 days past expiry date the patient received the vaccine. Vial was initially stored in refrigerator on 07-JUN-2022. Vial size was reported as 5.5 ml. Vial did not undergo any temperature excursion.  Treatment details were not reported by the reporter.   This case was linked to MOD-2022-681156 (Linked Report).; Sender's Comments:  MOD-2022-681156:Master Case
This case was reported by a healthcare professional and described the occurrence of hepatitis b surface antigen positive in a 34-year-old female subject who was vaccinated with Engerix B for prophylaxis.  The reporter was a friend of the subject.  On 14 April 2007 the subject received unspecified dose of Engerix B (unknown, unknown arm).  On 21 April 2007, the subject donated blood.  A diagnostic test report dated 07 May 2007, less than one month after vaccination with Engerix B, revealed that the subject was positive for hepatitis B surface antigen.  A confirmatory test for hepatitis B surface antigen was also positive.  At the time of reporting the outcome of the event was unspecified.
Sore arm for 6 weeks. Left breast pain. Lower left abdominal pain.  Swollen glands. Chest pain
Pt developed mild local vaccine reaction at the site of injection (R deltoid area): swelling & redness approximately 2 inches. Seen back by us on 9/5/2019. No other systemic condition. Given 1 dose of Benadryl & Ibuprofen
arm was swollen about 5-6 inches; rash around it; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (arm was swollen about 5-6 inches) and VACCINATION SITE RASH (rash around it) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     Concurrent medical conditions included COPD, Osteoporosis and Drug allergy (Allergy to Lyrica(Pregabalin)).    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Feb-2021, the patient experienced VACCINATION SITE SWELLING (arm was swollen about 5-6 inches) and VACCINATION SITE RASH (rash around it). At the time of the report, VACCINATION SITE SWELLING (arm was swollen about 5-6 inches) and VACCINATION SITE RASH (rash around it) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
pt stated that almost a week after she got the vax she could not move,  her body was stiff and her pain level was at a 12.  She was not able to work that day but the pain was still bad but she was able to go to work.  Pt had a virtual appt w/ PCP  where she was told it was a reaction to taking the vax.  She was ordered blood work on 2/22/2021 and told if she does not here from them that means everything should be ok.  She later had an appt w/ her Neurologist which confirmed the symptoms were related to taking the vax.  Pt no longer has this pain.
See attached does; The patient presents with headache. These symptoms began 2 months ago. Other comments Include: seen here for headaches about 6 weeks ago was referred to Dr at that time mother has been unable to get through to the neurology department though (and Dr now on maternity leave); bad headaches twice a day now has been able to continue her job went to ER last month for a headache, there head CT normal. Comments: patient said that she has been getting headaches on and off since June she would like some bloodwork done.
fever; had shaking with fever; This is a spontaneous report from a contactable consumer or other non-HCP.   A 67-year-old male patient received bnt162b2 (Pfizer BioN Tech Covid-19 MRNA vaccine, Formulation: Solution for injection, Batch/Lot number: EL9265) via unspecified route of administration, administered in right arm as Dose 1, Single on 03Feb2021 (age at the time of vaccination was 67-year-old) (at 18:00) for Covid-19 immunisation. The patient medical history included he just finished Chemotherapy on 14Jan2021, ventricular tachycardia from 25Jan2021 (ongoing) and had an ablation on the same date and pancreas cancer which started from 30Jan2020 (ongoing). The patient had no family history. The patient's concomitant medications were not reported. The patient experienced fever and had shaking with fever on 16Feb2021. The patient stated that he had a highest temperature, of 101.7 and was currently at 101.0. The patient was concerned about fever and did not have fever at all while going through chemo for pancreas cancer. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Additional vaccines administered on same date of the Pfizer Suspect was none. Prior Vaccinations (within 4 weeks) If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine was none. Outcome of the events was recovering.  Follow-up attempts are completed. No further information is expected.
Vaccinated in left arm.  Left armpit became red and sensitive and inflamed. Flu vaccination was Sanofi.
Pt reports that the reaction began on 1/25/18, and by 1/26/18, the injection site was "all welted up," hot, painful to touch, and felt like someone punched her really hard in the arm. When she came in to the pharmacy today on 1/29/18 to physically show me her arm, it still had some red blotches, she said it was still a little sore but for the most part was resolving on its own.
Increased heart rate (120 bpm resting); Severe neck pain on same side ofinjection site; fever; This is a spontaneous report from a non-contactable consumer, the patient. A 22-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0169) via an unspecified route of administration in the right arm on 22Apr2021 at 17:30 (at the age of 22-years-old) as a single dose for COVID-19 immunisation. Medical history included postural orthostatic tachycardia syndrome (POTS) and latex allergy. Concomitant medications included propranolol (MANUFACTURER UNKNOWN), baclofen (MANUFACTURER UNKNOWN), ascorbic acid (VITAMIN C), vitamin d (VITAMIN D) and levonorgestrel (KYLEENA) intrauterine device (IUD), all started on unknown dates for unknown indications and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the right arm on 24Mar2021 at 17:30 (at the age of 22-years-old) as a single dose for COVID-19 immunisation. On 23Apr2021, the patient experienced increased heart rate (120 bpm resting), severe neck pain on same side of injection site and fever. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. On 23Apr2021, the patient underwent a heart rate check and the result of the resting heart rate was 120 beats per minute. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events increased heart rate (120 bpm resting), severe neck pain on same side of injection site and fever was recovering at the time of this report.  No follow-up attempts are possible. No further information is expected.
Erythema 6 x 8 cm. Induration 2 x 3 cm. Treatment: KEFLEX 500mg TIX x7 days.
Systemic: patient came back after 5 min stating he had pain all over his body, no other symptoms. we had him sit and relax and called ambulance.  He started felling better-Mild, Additional Details: Patient came back after 5 mins and stated he started to get pains all over his body. We had him take a seat by the pharmacy and called EMS. They arrived after about 5 mins and assessed him.  He did not take ambulance but said he started to feel better
"Pain throughout arm, mostly on top, sometimes a burning sensation, like nerves.  Needed to take tylenol with codeine. Complains wasn't given correctly.
Patient is a 75 y.o. male patient of PRIVATE MD with a history of dementia admitted for COVID-19 pneumonia repeat chest x-ray shows improvement patient clinically stable inflammatory markers have significantly improved remains afebrile oxygen saturation 98% most of the times we do not keep oxygen on.  Plan discharge   Discharge Diagnoses: * Pneumonia due to COVID-19 virus Assessment & Plan Patient clinically has improved   Chest x-ray shows improvement in infiltrates.   Has completed remdesivir   Dyslipidemia Assessment & Plan Continue home medication   Primary hypertension Assessment & Plan Blood pressure stable   Hematuria Assessment & Plan Needs outpatient follow-up with urology   Moderate early onset Alzheimer's dementia (HCC) Assessment & Plan Previous chart reviewed continue home medication   Rheumatoid arthritis involving multiple sites (HCC) Assessment & Plan Patient currently on methotrexate continue the same.
Fever/chills; Fever/chills; Body aches; Arm pain from injection; Loss of smell & taste; Loss of smell & taste; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF2593) via an unspecified route of administration in the left arm on 28Oct2021 at 10:00 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. Medical history included allergies to penicillin. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF8841) via an unspecified route of administration in the left arm on 07Oct2021 at 10:30 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. On 28Oct2021, within 12 hours after second dose, the patient experienced fever/chills, body aches and arm pain from injection. On an unknown date in Oct2021, within 48 hours after second dose, the patient experienced loss of smell and taste. 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 fever/chills, body aches, arm pain from injection and loss of smell and taste was not resolved at the time of this report.
Slight skin rash on belly.  30 minutes later, developed into hives on belly, legs and face.
Pediarix given instead of Infanrix; This case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 15-month-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number 9552X, expiry date 26th October 2024) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 14th February 2023, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. On 14th February 2023, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered. On an unknown date, the outcome of the wrong vaccine administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 16-FEB-2023 Reporter's comment: The nurse reported that a patient accidentally received a dose of Pediarix instead of Infanrix.  The HCP (Health care professional) declined to provide his last name. The vaccine was given at clinic or reporting agency. The reporter consent to follow up. Additional Supportive Information: The patient received Pediarix instead of Infanrix, which led to wrong vaccine administered.
1) First: Blurry vision, tachycardia, anguish, high pressure 168-140. 2):Second. Blurry vision, difficulty breathing, anguish, high pressure 169-140. 3 days after in the night high pressure and pain in the heart and headache, tingle in full body.
PATIENT WAS GIVEN ZOSTAVAX INSTEAD OF VARIVAX.  PATIENT REPORTED MILD PAIN AT THE INJECTION SITE BUT DENIES OTHER SYMPTOMS.
Patient returned to store 2 days after vaccine to show approximate 4 inch round red, hot area at site of injection.  Told patient to take BENADRYL & let me know if any worse.  Never called back.
Fever 102 > 48 hrs, rigors, pan muscle weakness & pain.  I missed 3 days of work.
MD reported that child recv vax when was 2 or 3yr old;child mom reported that p/vax child arms became swollen & numb;pt recovered p/2mo;
Initial report received on 11 March 2009 from a health professional (pharmacist). A 17 year old male patient, with a history of seasonal allergies and acne, received a second subcutaneous injection of JE-VAX (lot number EJN234A) in the left arm on 11 March 2009. The date of the first injection of JE-VAX was not reported. Concomitant medications included Zithromycin and Zyrtec. The patient had no illness at the time of vaccination. On 11 March 2009, five minutes after administration, the patient experienced numbness down his left arm to the pinky finger and he also had a feeling of cold inside his arm, although the arm was warm to touch. The events had just occurred as the pharmacist was reporting them, and by the time the report was ending, the patient stated that the arm numbness was "better, but not gone" and that his arm still felt "a little weird". The patient was planning to see his own health care professional if needed. The patient's recovery status was reported as unknown. Follow-up information received on 13 April 2009 from a health care professional. The patient had the JE-VAX vaccination at 14:00 pm on 11 March 2009, and the adverse events started at 14:05 pm on 11 March 2009. The feeling returned to the arm in approximately 20 minutes with no additional treatment for symptoms. The patient returned for his third dose of JE-VAX with no reported reactions. The patient is considered to be recovered. No further information is expected.
sneezed; This spontaneous case was reported by a consumer and describes the occurrence of SNEEZING (sneezed) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On 23-Apr-2021, the patient experienced SNEEZING (sneezed). At the time of the report, SNEEZING (sneezed) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
PATIENT SUFFERED A CONVULSIVE SYNCOPE EPISODE.  PATIENT PASSED OUT IN CHAIR AND ARMS AND LEGS STARTED FLAILING.  PHARMACIST WAS ABOUT ADMINSTER EPINEPHRINE THEN PATIENT WOKE UP.  HE WAS HELPED TO THE FLOOR  TO LAY AND LEGS WERE ELEVATED UNTIL PARAMEDICS ARRIVED.
booster; swelling of my throat got worse; Runny nose/The running of nose pretty bad the mucus got stuck on my throat; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date Dec2021 (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose:1, Manufacturer unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose:2, Manufacturer unknown), for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset Dec2021, outcome "unknown", described as "booster"; PHARYNGEAL SWELLING (non-serious) with onset Dec2021, outcome "not recovered", described as "swelling of my throat got worse"; RHINORRHOEA (non-serious) with onset Dec2021, outcome "unknown", described as "Runny nose/The running of nose pretty bad the mucus got stuck on my throat".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Loss of hair from head, in patches throughout one month. (Alopecia Areata).
Covid Arm - Tenderness and pain at injection site and arm increased on day 7. Red rash began on day 8 - Rash became more red and circular and grew to the size of a fist surrounding injection site on day 9.
5:30AM (time I got up) Injection site soreness and stiffness, headache and body aches (skin sensitivity). Took Ibprophen and  hot shower; symptoms  subsided in about 30 to 60 minutes.
Information has been received from a 71 year old retired male consumer who on 12-JAN-2006 and 20-OCT-2006 was vaccinated with a first and second (0.5 ml) dose of hepatitis A virus vaccine inactivated respectively. Additional suspect vaccination included a first and second dose of hepatitis B virus vaccine rHBsAg on 20-OCT-2006 and 20-NOV-2006 respectively. Other concomitant vaccination included a dose of influenza virus vaccine (unspecified) on 20-NOV-2006. There was no illness at the time of vaccination. In late November 2009, the patient experienced not feeling well and high liver enzyme levels. Medical attention was sought, two CAT scans and unspecified blood work was performed the only results reported were "high liver enzyme levels." At the time of the report the patient was recovering. Additional information from the physician indicated that on 29-NOV-2006 the patient had persistent transaminitis (elevated SGOT and elevated SGPT) and persistently elevated alkaline phosphatase. It was reported that a CT scan performed showed a normal appearing liver. There was no product quality complaint involved. No further information was provided. Additional information has been requested.