chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Severe pain and lymph node swelling in right arm; Lymph node swelling in right arm; Nerve pain in right arm and left leg; High fever; Chills; Dose received: 3; This is a spontaneous report from a contactable reporter (consumer or other non HCP). The reporter is the patient.  A 34-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in right arm, administration date 22Jan2022 at 10:00 (Lot number: FD7218) at the age of 34 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Proteinuria" (unspecified if ongoing); "Blood pressure high" (unspecified if ongoing), notes: High blood pressure and "Nickel sensitivity" (unspecified if ongoing), notes: Known allergies: Nickel. Concomitant medication included: LISINOPRIL. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot Number: EP6955, Anatomical location: Left arm, Administration time: 15:30), administration date: 31Mar2021, when the patient was 33 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE, Lot Number: ER8736, Anatomical location: Right arm, Administration time: 15:00), administration date: 23Apr2021, when the patient was 33 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 22Jan2022 at 10:00, outcome "unknown", described as "Dose received: 3"; PAIN IN EXTREMITY (non-serious) with onset 22Jan2022 at 13:00, outcome "not recovered", described as "Severe pain and lymph node swelling in right arm"; LYMPHADENOPATHY (non-serious) with onset 22Jan2022 at 13:00, outcome "not recovered", described as "Lymph node swelling in right arm"; NEURALGIA (non-serious) with onset 22Jan2022 at 13:00, outcome "not recovered", described as "Nerve pain in right arm and left leg"; PYREXIA (non-serious) with onset 22Jan2022 at 13:00, outcome "not recovered", described as "High fever"; CHILLS (non-serious) with onset 22Jan2022 at 13:00, outcome "not recovered", described as "Chills". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pain in extremity, lymphadenopathy, neuralgia, pyrexia and chills.  Additional Information: The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.
On 11/27/2018, patient came to pharmacy to report adverse reactions on left arm such as redness, swelling, painful area of 11 x 11 cm. Patient went to urgent care and according to her urgent care MD, it possible cellulitis, given prescription for Doxycycline for 5 days. We did inform Patient Primary Care provider about the incident. Urgent Care facility and PCP are same facility, so they have al the information about incident. According to patient after starting antibiotic treatment, the condition is improving, swelling has been reduced.
BAD BODY ODOR; This spontaneous report received from a patient concerned a 36 year old female. 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: Unk) 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 subject experienced bad body odor. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from bad body odor. This report was non-serious. This case, from the same reporter is linked to 20210660241.
Started with hard lump appearing, then a couple days later site is hot and red. Red patch is growing in size. Not painful but uncomfortable to touch.
Ischemic left occipital stroke - The patient was seen by Neurology team and recommendation was to monitor on telemetry. The patient was discharged on 30-day Holter monitor. ED visit and hospital admission within 6 weeks of receiving the COVID vaccine.
OBSTRUCTIVE SLEEP APNEA 5/5/2022  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
fever; stiffness in my arm for a week; Initial information received on 07-Nov-2020 regarding an unsolicited valid non-serious social media case received from a consumer (patient).  This case involves a patient (with unknown demographics) who experienced fever (pyrexia) and stiffness in his/her arm for a week (musculoskeletal stiffness), after he/she received INFLUENZA VACCINE.  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number and expiry date not reported via an unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed fever (pyrexia) and stiffness in his/her arm for a week (musculoskeletal stiffness) (unknown latency) following the administration of INFLUENZA VACCINE.  Other relevant tests not reported.  It was not reported if the patient received a corrective treatment.  At the time of reporting, outcome for events was unknown.  There will be no information on the batch number for this case.
Fever, chills, body ache, nausea increased over course 24 hours.  Nausea and Fatigue next 24 hours.  Tylenol for fever Emetrol for nausea.
Minor injection site pain; A spontaneous report was received from a consumer concerning a 72-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events minor injection site pain.  The patient's medical history was provided as Sinus infection as current condition. Relevant concomitant medications were not reported.  On 16 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 031L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 16 Feb 2021, the patient experienced the event minor injection site pain.  Treatment information was provided as antibiotic.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event's, minor injection site pain,  was unknown.
Arm  pain has not subsided. Feeling very nauseous and dizzy with a headache to the point I am unable to get out of bed.
Timeline of Events  1017 Vaccine Administered, Left Deltoid (30 observation period)  1042 Symptoms Onset  1042 HR taken - 92bpm  1043 BP taken - 130/90  1045 Received 20mL of Benadryl   1046 Pt reports continued strange taste, scratchy throat, tingling in upper lip; Temp taken - 98.1 *F  1057 Ambulance was called; BP retaken - 128/84; HR retaken - 112bpm  1100 HR retaken - 92bpm  1102 Ambulance arrived  1115 Pt assessed by EMT and was cleared/released to return home with improvement of symptoms
My left arm was itchy. I did not notice it at first because I thought my arm was healing from the vaccine. My arm was really red. I contacted the doctor they prescribed a steroid cream and an antihistamine. I also had a lump under my armpit for 6 months.
This case was reported by a pharmacist and described the occurrence of arm numbness in a 42-year-old male subject who was vaccinated with ENGERIX B (GlaxoSmithKline).  Concurrent vaccination included MMRII (Merck) and TB vaccine (Sanofi) both given on 30 May 2008.  There were no concurrent medications.  On 30 May 2008 at 08:00 the subject received 1st dose of ENGERIX B at 0.5 ml left arm.  This was considered to be an inappropriate dose of drug administered as this adult subject received a pediatric dose of ENGERIX B.  On 30 May 2008, during vaccination with ENGERIX B, the nurse hit a nerve and the subject's arm jerked.  Immediately after vaccination with ENGERIX B, the subject experienced arm numbness and tingling and three red steaks were noted near the site of injection.  The subject also experienced loss of grip strength (losing his grip) and dropped the phone when he went to pick it up after injection.  At the time of reporting, the events were unresolved and tingling and loss of grip outcomes were unknown. Follow-up information was received on 26 June 2009, via pharmacist. Prior to receiving Engerix B, the subject's titers were negative for antibodies. The subject's "previous series of hepatitis b was completed three times in past, but current titers for antibodies were negative"; dates and manufacturers were not provided. It was reported that the subject received an adult booster of Engerix B at 1 ml in the left upper arm on 30 May 2008. A full adult does was given. Hepatitis B titer drawn 6-8 weeks after this injection, resulting in a positive titer for antibodies (surface antibody) on 08 August 2008, so no further hepatitis b injections were necessary. The events resolved on 30 May 2008 and were not related to Engerix B. The pharmacist associated the events with erroneous administration and probably nerve involvement.
Starting 11/27/2022 in the afternoon, I had symptoms. I tested myself at home on 11/28/2022 and was positive. I went to urgent care that day where they confirmed with a COVID-19 test that I was positive. I remained positive on at-home tests until 12/08/2022. I had fever, headache, chills, body aches, diarrhea and difficulty concentrating for long periods of time. Also, I had a cough, congestion and wheezing. The symptoms lasted until about 12/05/2022 and I was slowly recovering that last week.
Patient in area of observation had left arm cold, excessive sleepiness, right side neck red. P 75 Sat 99% BP 125/80 Dxt 109 was in observation for 1hr.
DTap given on 01/08/2002. Mother brought pt back noted large area on left leg with redness, swelling and warmth. Advised to apply cool towels and see PMD as needed.
2 days later started coughing, congestion on chest, a lot of mucus. Was in terrible shape, affected immune system for at least 2 weeks. Called the doctor but no medicine given; took natural cough syrup; it helped a little but it was hard to sleep because of the cough. Arm sore for a couple of days as well. Today no more congestion, cough is gone, has more energy, no more mucus. Patient is very upset that doctor did not provide vaccine specifics as it relates to the ingredients before the vaccination.
No adverse event; This spontaneous case was reported by a consumer and describes the occurrence of NO ADVERSE EVENT (No adverse event) in a patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: MODERNA COVID-19 VACCINE and SPIKEVAX. Past adverse reactions to the above products included No adverse event with MODERNA COVID-19 VACCINE and SPIKEVAX.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) Additional Booster. On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related.    No concomitant medication information was reported. No treatment medication information was reported.  The patient stated I had Moderna Covid-19 2 regular shots and 3 boosters and denies being immunocompromised.
hardness; pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (hardness) and VACCINATION SITE PAIN (pain) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M207) for COVID-19 vaccination.     Concomitant products included AMLODIPINE, FAMOTIDINE and VITAMIN D [VITAMIN D NOS] for an unknown indication.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced VACCINATION SITE INDURATION (hardness) and VACCINATION SITE PAIN (pain). At the time of the report, VACCINATION SITE INDURATION (hardness) and VACCINATION SITE PAIN (pain) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
No side effects.  The HIB was mixed with sterile diluent instead of the diluent for Haemophilus 'b' conjugate.
Pt recvd vax 16OCT92 & devel fever of 102, blotchy rash & cranky behavior; given APAP & DPH;
Bone Marrow Transplant; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of bone marrow transplant in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. In SEP-2022, an unknown time after receiving Shingrix, the patient experienced bone marrow transplant (Verbatim: Bone Marrow Transplant). The outcome of the bone marrow transplant was unknown.   It was unknown if the reporter considered the bone marrow transplant to be related to Shingrix.     It was unknown if the company considered the bone marrow transplant to be related to Shingrix.   Additional Information: GSK Receipt Date: 10-MAY-2023 The pharmacist reported that patient received Shingrix series approximately in 2021 and then had a bone marrow transplant September 2022.  Pharmacist does not know the indication for the transplant.  The Shingrix series was not administered at her facility, so the pharmacist did not have any records with the dates of administration or lot number information, she just knew the patient said he had the series about a year before the transplant.  The reporter consented to follow up.
Patient received several vaccines from prefilled syringes and vials on 10/31/16. On 11/02/16, we received call from school nurse at 9am that patient presented with redness and swelling on left arm. Patient was seem in our office same day with irregular shaped erythema over right deltoid, warm but not tender 7x4 cm. Diagnosed with cellulitis and treated with ZITHROMAX Z-pak 250mg, 2 tabs on 1st day, then 1 tab daily for 4 days.
5 days post inject, pt devel a red nodule @ site of inject 10 x 15 cm it resolved p/3 days;
Patient had a known exposure from roommate testing positive for covid and was being closely monitored, on 11/12/21 she developed nausea, vomiting, nasal drainage, and a dry cough.   She tested positive for covid and influenza B.  She is current with seasonal flu vax for this season
Through May I continued to feel lethargic. / I was still feeling lethargic; was still feeling lethargic and off balance; Vitamin D level was checked and is low; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (Through May I continued to feel lethargic. / I was still feeling lethargic), BALANCE DISORDER (was still feeling lethargic and off balance) and VITAMIN D DECREASED (Vitamin D level was checked and is low) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0481321A and 019B21A) for COVID-19 vaccination. No medical history was provided by the reporter.  Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO) and ROSUVASTATIN CALCIUM (CRESTOR) for an unknown indication. On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced LETHARGY (Through May I continued to feel lethargic. I was still feeling lethargic) (seriousness criterion medically significant), BALANCE DISORDER (was still feeling lethargic and off balance) (seriousness criterion medically significant) and VITAMIN D DECREASED (Vitamin D level was checked and is low) (seriousness criterion medically significant). The patient was treated with COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) from 09-Jun-2021 to July 2021 at an unspecified dose and frequency and CYANOCOBALAMIN (VITAMIN B12 [CYANOCOBALAMIN]) from 09-Jun-2021 to July 2021 at an unspecified dose and frequency. At the time of the report, LETHARGY (Through May I continued to feel lethargic. I was still feeling lethargic) had not resolved and BALANCE DISORDER (was still feeling lethargic and off balance) and VITAMIN D DECREASED (Vitamin D level was checked and is low) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2021, Allergy test: not provided not provided. In May 2021, Vitamin D: decreased (Low) Decreased. No treatment medication details was provided. Other lab tests include Vitamin B test on ??-MAY-2021 and results are not provided. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested. This case was linked to MOD-2021-286509 (Patient Link). Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.
pt recvd vax 9OCT95 in lt delotid on 11OCT pt states lt & rt legs started aching severly on 12OCT in the AM started experiencing low mid section backache;saw MD on 13OCT;BP was 130/84; no other problems noted; MD informed pt to contact clic
Case number PHEH2013US010207, is an initial spontaneous report received from the health care professional on 02 May 2013. This report refers to a male patient of unspecified age. He received only the MENVEO (batch number: not reported) intramuscularly without being reconstituted with Men A component on 28 Apr 2013. No adverse event was reported following this administration error. No additional information was available.
Swelling to 3 1/2 inches surrounding injection site with pink erythema warmth and tenderness. No fever, no lymphangitis.
PAIN IN UPPER NECK; PAIN IN SHOULDER; PAIN IN UPPER ARM; PAIN IN INJECTION SITE; This spontaneous report received from a patient concerned a 44 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and batch number: 042A21A expiry: UNKNWON) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced pain in injection site. On 23-APR-2021, the subject experienced pain in upper neck. On 23-APR-2021, the subject experienced pain in shoulder. On 23-APR-2021, the subject experienced pain in upper arm. The patient was recovering from pain in injection site, and had not recovered from pain in upper arm, pain in shoulder, and pain in upper neck. This report was non-serious.
Headache 10 mins after shot.... 2 hours after shot arm became swollen and extremely hot... Along with face becoming red and hot... Became super tired and eyes sunken in... Raised temperature...  After 5 hours all of the above subsided besides fatigue
This spontaneous report was received from a nurse practitioner and refers to a patient of unknown age and gender. On 17-OCT-2011, the patient was vaccinated with improperly stored dose of VARIVAX lot # 669601/0138AA dose 1. On 22-NOV-2011, the patient was vaccinated with second improperly stored dose of VARIVAX, lot#: 669601/0138AA. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
pt recvd vax 22JUN93 & 3 days later felt tired; 27JUN93 exp back, hip & stomach aches & a dry throat; pt went to MD who dx OM; pt was treated w/Eryc twice daily for 10 days;
rash from head to toe; chills; face swelled up; This is a spontaneous report from a contactable consumer (Patient) reported for self. A 67-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Batch/Lot Number: EL9267), dose 1 via an unspecified route of administration on 24Feb2021 (at the age of 67-years-old) as DOSE 1, SINGLE for COVID-19 immunization. Medical history included thyroid disorder (Thyroid) from an unknown date and unknown if ongoing. Concomitant medication included levothyroxine (LEVOTHYROXINE) taken for thyroid disorder, start and stop date were not reported. Investigation assessment reported as no. Patient wanted to report symptoms after the Pfizer vaccine. On 24Feb2021 Patient had rash all over body and swelled up a little hands, face everything and got the chills. Patient was in the last stages hopefully of rash disappearing. Rash all over my body from head to toe. Second dose schedule on 17Mar2021. Patient was asking, will experience the same side effects on the second dose with what experienced in the first dose. If it would be safe to get only one dose of the vaccine? Patient took Benadryl. The outcome of the events were unknown.  No follow-up attempts are possible. No further information is expected.
Developed fever, cough and cold symptoms. On Friday, lost fever last night. Developed a few spots as on chest yesterday, more today - scattered on trunk but a few on neck, leg, arm some papules, some blisters, 2 scabbed, one scratched/bleeding.
Vaccine vial stored longer than the recommended time frame (potentially up to 28 days in the fridge) no adverse reaction
Pt presented with 1 week of progressive fatigue, dry cough, chest pain, nocturnal fevers. Presented to ER on 5/30/2021, hs troponins were 71 twice. Discharged with advice for symptom management with antipyretics.  Symptoms worsened and pt returned to ER, worsening CP and fevers up to 100+F. Repeat troponins 1100 to 1200+, elevated LFTs, diffuse 1mm J point elevation on EKG  Cardiac MRI 6/1/2021:  IMPRESSION: 1. Patchy subepicardial left ventricular delayed enhancement, greatest in the basal inferolateral wall, compatible with myocarditis. Normal left ventricular size and systolic function. LVEF = 52%. 2. Patchy consolidation in the right lower lobe consistent with pneumonia. Small right pleural effusion. 3. Mild splenomegaly.  CT chest RLL consolidation, splenomegaly
pt recv vax 17JAN97 &  devel itchy, red hives on neck;pt recovered from the hives p/3 days;
pt felt very weak upon waking and lost consciousness shortly after arriving to work.  Ambulance was called but patient did went home on her own.  pt did not receive treatment.
Diarrhea; Nausea; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), NAUSEA (Nausea) and VOMITING (Vomiting) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, the patient experienced DIARRHOEA (Diarrhea), NAUSEA (Nausea) and VOMITING (Vomiting). At the time of the report, DIARRHOEA (Diarrhea), NAUSEA (Nausea) and VOMITING (Vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided. Treatment information was not provided.