chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Within two weeks after getting the second dose of the vaccine I started to have cognitive problems. It felt like my brain was lagging. I was having trouble coming up with words. I had brain fog and my reaction time was slow after hearing things. I could not talk normally. I still have some problems after eight months I have some problems doing my job because it is hard to write things. I went to the ER and I had testing because I had Stroke symptoms but tests ruled it out. I did not get a Neuropsychological test because I lived out of town. I tried some Prevagen but it did not seem to help.
Pt experienced vomiting & dizziness post vaccination. BP 119/76; HR 71; RR 21. Pt denies chest pain, swelling, SOB. Hx of vertigo.  No medications given, pt stable & released from vaccination site, recommended f/u w/PCP
pt did not have a reaction to the vaccine, instead patient received a .5ml dose of energix, not compleating the adult series
This spontaneous report as received from a physician via company representative refers to a male patient of unknown age. No information on his medical history and current condition was provided. On 17-NOV-2014, the patient was vaccinated with a dose (unspecified) of GARDASIL (route intramuscular, dose, lot number and expiration date were not reported). No concomitant medications were reported. On 20-NOV-2014, the patient experienced swelling, pain and irritation in the axillary area of his arm, after receiving GARDASIL. The patient sought medical attention and had an office visit with his physician on unspecified day. No information about lab diagnostics and studies performed. It was unspecified which dose of dosing series of GARDASIL the patient received so far and if the patient will receive any subsequent doses. The outcome of the swelling, pain and irritation in the axillary area of patient's arm was not reported. The relatedness between the events and GARDASIL was not provided. No product quality complaint was filled. Additional information has been requested.
This report describes a 44 y.o. male who did not respond to the Hep B vaccine recombinant (Engerix-B) immunization series. The subject's medical history and concurrent conditions included hypertension (onset 2000). Concurrent medications were not specified. The vaccinee was not obese or a smoker. The vaccinee received Engerix-B on 9/15/01 (lot #ENG3382A4), 10/13/01 (lot ENG5178A4) and 4/5/02 (lot ENG5178A4). A Hep B surface antibody titer, measured on 5/25/02, 50 days after the 3rd injection of Engerix-B was "negative."
Patient called on-call provider on 9/24 stating he thought his asthma was flaring or he had a cold. Had rib pain with coughing, congestion, rhinorrhea, post-nasal drip, and sputum (clear to white). Took at home COVID test and it was negative. Denied shortness of breath, wheezing, chest pain. Was advised to use inhaler and treat symptoms but if he developed shortness of breath/chest pain - go to ER. Wife states he was miserable on 9/24, felt better on 9/25, and was found dead on 9/26 in the morning.
Patient claims she experienced hot skin to the touch, rash, chills, aches and fever the next day after shot, Friday 10/21/17 being the worst day in regards to symptom severity.  Patient claimed the rash expanded  to an approx. size of 1 foot x 3 inches on the arm that received the 2 injections. I recommended the patient contact her medical provider as soon as possible for safety reasons.
Fever 104 then after taking over-the-counter meds 103.3.  Chills, nausea, joint pains, headaches, dizziness, brightness sensitivity.  Diarrhea.
Initial information received on 24-Jul-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 14 months old patient who experienced tender, 1 cm sterile abscess and warm red at the injection site, while he/she received vaccine PENTACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 03-Jul-2018, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot C5437AA via intramuscular route in the thigh NOS. The patient developed a non-serious tenderness following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE. The patient developed a non-serious 1 cm sterile abscess following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE. The patient developed a non-serious warm red at the injection site following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE. (Other relevant tests included No lab data). Final diagnosis was warm red at the injection site, 1 cm sterile abscess and tender. An unknown corrective treatment was received. The patient outcome is reported as Unknown for warm red at the injection site, as Unknown for 1 cm sterile abscess and as Unknown for tender.
I have quite a bit of fluid and swelling under my left armpit- uncomfortable.; I have quite a bit of fluid and swelling under my left armpit- uncomfortable.; I have quite a bit of fluid and swelling under my left armpit- uncomfortable.; dose received: 3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 20Dec2021 16:00 (Batch/Lot number: unknown) at the age of 42 years as dose 3 (booster), single for covid-19 immunization. Relevant medical history included: "High Blood Pressure" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EN6207, Location of injection: Arm Left, Vaccine Administration Time: 05:00 PM), administration date: 14Apr2021, when the patient was 42 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6202, Location of injection: Arm Left, Vaccine Administration Time: 05:00 PM), administration date: 23Mar2021, when the patient was 42 years old, for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 20Dec2021 16:00, outcome "unknown", described as "dose received: 3"; HYPERHIDROSIS (non-serious), SWELLING (non-serious), DISCOMFORT (non-serious) all with onset 22Dec2021 01:00, outcome "not recovered" and all described as "I have quite a bit of fluid and swelling under my left armpit- uncomfortable.". Therapeutic measures were not taken as a result of hyperhidrosis, swelling, discomfort.  Additional information: The patient does not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received blood pressure medicine within 2 weeks of vaccination. The patient had quite a bit of fluid and swelling under his left armpit- uncomfortable. The patient does not received treatment for AE. Prior to vaccination, was the patient does not diagnose with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient has no known allergies.  The lot number for bnt162b2 was not provided and will be requested during follow up.
got a big lump; arm is very very red; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non-HCP), Program ID: (159558). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Lot number: unknown), in arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: MASS (non-serious), outcome "unknown", described as "got a big lump"; ERYTHEMA (non-serious), outcome "unknown", described as "arm is very very red".  Additional Information: Description of Event Outcome: Caller said that she got the Pfizer shot on Sunday the 9th and her arm is very very red and she got a big lump and it seems not getting any better. She searched online and it says 2 or 3 days but it's the 5th day now.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
irregular period; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adult female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) 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 immunisation. The following information was reported: MENSTRUATION IRREGULAR (non-serious), outcome "unknown", described as "irregular period".  Additional information: The patient was in her early mid 40s, otherwise healthy female. Experienced irregular period after second COVID vaccine. Event took place after use of product.  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) : 202201313623 same patient/drug, different dose/event;
difficulty breathing; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (difficulty breathing) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced DYSPNOEA (difficulty breathing). At the time of the report, DYSPNOEA (difficulty breathing) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was reported.
Received his first shot of the Pfizer Covid-19 vaccine on 09Mar2021 and his second dose was scheduled for 30Mar2021, but on 23Mar2021 he tested positive for COVID-19; Received his first shot of the Pfizer Covid-19 vaccine on 09Mar2021 and his second dose was scheduled for 30Mar2021, but on 23Mar2021 he tested positive for COVID-19; Started to feel ill; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 67-year-old male patient received first dose of BNT162B2, (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot Number and expiration date were unknown) via an unspecified route of administration in left arm on 09Mar2021 14:45 (age at vaccination 67 years old) at single dose for COVID-19 immunisation at pharmacy. There was no medical history, no relevant family history and concomitant medication. There were no other vaccines in four weeks and no AEs following prior vaccinations. There was no history of previous immunizations with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available). There were no additional vaccines administered on same date of the Pfizer Suspect. The patient stated that he received his first shot of the Pfizer Covid-19 vaccine on 09Mar2021, and his second dose was scheduled for 30Mar2021, but on Tuesday 23Mar2021 he felt ill and had a Covid 19 test on 23Mar2021 17:00 which was positive and was quarantined for 12 to 15 days. He would like to know if he should schedule his second dose. Has been over 3 weeks since first vaccination; hasn't gotten second yet. He took 10-12 days off an away from everyone. He was supposed to have his second vaccine on 30Mar2021, but he was still on quarantine for 2 more days at that time. The patient stated that he was trying to reschedule his second vaccine and wanted to know if that was the right thing to be doing. The patient also stated that since it was beyond the 3 weeks period from his first one, he wants to make sure whether he was doing the right thing by scheduling his second one for tomorrow. The patient stated that he had no issues after the vaccine and states that the illness was not that bad for him. Reporter states that he just needs to confirm his appointment online and he can get his vaccination tomorrow at 14:45. The patient also said since it was beyond the 3 weeks from his first vaccine, he just wants to make sure he was doing the right thing. The patient did not visit emergency room or physician office, states he only spoke on the phone with his doctor after his positive test. The report is not related to a study program. Patient did not have lot number as he was at work and does not have his card. Also states he thought he took a picture of it on his phone but he didn't. The outcome of events was unknown.  Information on the lot/batch number has been requested.
oN 1-8-03 infant received DTAP, Comvax, IPV & Prevnar w/o incident.  Instructed on s/e & use of tylenol.  On 1-9-03 infant believed to have had a seizure and was taken to hospital by ambulance to have a CAT Scan and be seen by neurologist.
DEVELOPED A RED, WARM, PAINFUL SWELLING ON THE LEFT OUTER THIGH - 10 CM X 10 CM APPROX. NO FEVER. C/O PAIN ON WALKING & LIFTING WEIGHTS
Redness and warm to touch noticed the evening of 09/24/2015.  Denies fever. Seen in clinic 09/25/2015 with 10cm x 13cm area of warm, erythema, and mildly tender.  Treated with Keflex 500mg q 12hrs x 10days.
Enlarge lymph node under armpit/ numbness tingling on left side of face and arm and hand where I received the shot // pain spasms all over on left side.// chest pain n tightness
Numbness and tingling on half my face, tongue, ear, head and neck on the same side I got the shot. Numbness lasted about 6 hours.
CTA showed extensive bilateral PE involving R and L-pulmonary arteries with extension into lobar, segmental and subsegmental branches with questionable heart strain.    LE US showed L-DVT in L-femoral vein, popliteal vein, posterior tibial veins, gastrocnemius vein.    He denies any prior COVID diagnosis and reports 2nd dose of Pfizer vaccine on 3/31.   Patient treated with heparin infusion and subsequently discharged on xarelto. No urgent mechanical thrombectomy or catheter thrombolysis was done.
Case number PHEH2015US001208 is an initial spontaneous report from a nurse received on 13 Jan 2015. This report refers to a patient of an unknown age and gender. The patient was vaccinated with only Men CYW-135 liquid component of MENVEO (batch number: M14042) intramuscularly without reconstitution with the lyophilized Men A component on 17 Dec 2014. No adverse event reported following this medication error (inappropriate preparation of medication).
PAITENT WAS GIVEN 2 BIVALENT INJECTIONS . ONE ON 11/2022 AND 04/12/2023
2/27/12 - pt. seen in office. ? Cellulitis ? allergic reaction 9cm x 9cm, erythema with lesions near center at injection site. Warm, swollen. Pt given KEFLEX 250 - 1 tsp. TID x 7D.
Once needle was pulled out of patient's arm, her blood began to shoot out. The blood sprayed for a moment then began to run down her arm. Patient noted there was swelling that occurred within 5 minutes of receiving vaccine and her entire arm was become sore quickly. Patient was given 600 mg ibuprofen and water and was observed for about 20 minutes.
Breakthrough Case  **Lot number for 2nd dose not found on website  *** 1st vaccine dose was administered at Health Management Group -
Fever (Night of 4/27) - fever peaked at 100.4  Nausea (Night of 4/27, day 4/28) Headache (4.28-4.30) Rash (4.28- ongoing/spreading)  - rash on arms/stomach, back, and legs  - itchy  Vivid fever dream
Itch the day before his dose is due since starting Dupixent /starts to itch the day before his dose is due since starting dupixent; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itch the day before his dose is due since starting Dupixent /starts to itch the day before his dose is due since starting dupixent) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunization.    Co-suspect product included non-company product DUPILUMAB (DUPIXENT) for Atopic dermatitis.  No Medical History information was reported.   On 10-Jul-2021, the patient DUPILUMAB (DUPIXENT) (Subcutaneous) dosage was changed to 600 milligram once a day. On 17-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient started DUPILUMAB (DUPIXENT) (Subcutaneous) 300 milligram once a day. On an unknown date, the patient experienced PRURITUS (Itch the day before his dose is due since starting Dupixent /starts to itch the day before his dose is due since starting dupixent). At the time of the report, PRURITUS (Itch the day before his dose is due since starting Dupixent /starts to itch the day before his dose is due since starting dupixent) outcome was unknown.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  On an unknown date the patient developed a start to itch the day before his dose was due since starting dupixent following the first dose intake of DUPILUMAB and COVID-19 VACCINE MRNA (MRNA 1273). It was notices that he starts to itch the day before his dose was due since starting Dupixent. No treatment reported for the itching and after the dose was given it goes away but starts to itch again the day before dose was due. It was also reported that consumer took Moderna vaccine last Tuesday and started to itch on areas that are healing and not scarred yet. The nurse received the information from consumer's wife. At the time of the report, the Dupixent was continued.  No concomitant medication information was provided.  No treatment medication was provided.
Fatigue, diffuse myalgias on day 1 after vaccination, progressing to chest pain on exertion the following day. He continues to have mild chest pain today (day 4)
Patient reports 72 hours after second injection of BioNTech she started having severe headaches every evening. Tries to medicate with OFC acetminophen and motrin with no relief. Needing to go to bed very early to deal with the pain. Reports she has never had headaches like this ever and nothing else in her life has changed since the vaccine that could account for the headaches.  Patient is a provider so she has not visited her provider.
4/20/21 1300 Pt got 1st dose of COVID vaccine today. Reporter went to check on pt and reports some feeling of itching all over her body. Did not appear to have any rash present anywhere on body. No rednesss to injection site or pain.  Reported to reporter and she went to speak to pt about concenrn.  Pt reported to reporter that she feels fine just has sensation of itching. Pt denied any throat swelling, difficulty breathing, or wheezing. Pt was advsied by reporter that we will monitor her for the next few minutes but if develops a rash or symptoms when she leaves the office to go to urgent care. spoke to pt before she left she states that she is doing ok was still with itching sensation but had no symptoms of anaphylactic reaction. Pt again made aware that if she goes home and develops any concerning symptoms to make sure to call office, go to urgent care, or if severe call 911 and get to ER. She understood. 4/30/21 0453 Triage call received from patient.  She states she had the 1st dose of the COVID vaccination yesterday.  She is itchy, has a rash, face is swollen, and difficulty breathing.  Triage advised ER.  Verbal understanding received. 4/30/21 0930Called patient to see how she is feeling, she states that she is still having itching and difficulty breathing. She states "I haven't had a chance to get the epi pen they ordered at the hospital". Advised patient to seek emergency care due to her having difficulty breathing. She stated "Ok, I will figure it out. I have a lot of stuff to do today". Again urged patient to seek emergency care ASAP. "Ok, I will"
Patient came to pharmacy on Friday after receiving Zostavax on Wednesday and showed her arm which was red and warm to touch. I spoke to patient on Saturday and Sunday and redness has subsided but has a lump at injection site. Patient feels fine.
This spontaneous report was received from a medical assistant refers to a female patient of unknown age. No medical history was reported. On an unknown date in April 2010, the patient received her first dose of GARDASIL (lot #, expiry, route, dose not reported) and just received her second dose of GARDASIL (lot #, expiry, route, dose not reported) on an unknown date in May 2013. Additional information has been requested.
Pyrexia, vomiting  This case was reported by a physician and described the occurrence of fever in a 2 month old female subject who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis adsorbed, hepatitis B recombinant and  inactivated poliovirus vaccine combined for prophylaxis. On 02/09/2005 the subject received the 1st dose of Pediarix. On 02/10/2005, 1 day after vaccination with Pediarix, the subject experienced fever and vomiting. The subject was seen in an emergency room. The outcome of the events was not reported.
SWOLLEN L ARM 4 INCH BY 5 INCH AREA ABOUT 2 INCHED BELOW INJECTION SIGHT. AREA IS SORE, PAINFUL TO TOUCH, MODERATELY SWOLLEN LEGS, CRAMPS, HOT FLASHES, COLD CHILLS, FLU LIKE SYSTEMS, COLD SWEATS, ITCHY AND HOT LEGS AT NIGHT, SWOLLEN L UNDERARM, NAUSEA, LEGS BLOTCHY AND DISCOLORED, TINGLING SENSATION THROUGH OUT BODY, NUMBNESS IN L ARM. HEADACHES.
About 30 minutes after the shot, I didn't feel right, my face, my arm and my chest was broken out in hives. The arm that I got the shot in felt numb. I called the medical people over and they wanted to check me right away. They observed me for 20 minutes and I started having a hard time breathing. I used my epi pen and the ambulance was called and I went to the ER. On Monday, I went to see my doctor and was prescribed medication. I had a hard to walking and still have a hard time breathing and have a cough.
Arthritis pain; This is a spontaneous report from a contactable consumer (patient) from a Pfizer-sponsored program. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Lot number and expiration date was not reported) as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced arthritis pain after 10 days of vaccination and for 6 days the HCP put her on methylprednisone. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.