chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Client came in 09/07/2022 to receive a Hepatitis B Peds, DTAP, Polio, Pneumoccoal 13, Hib, MMR; instead he received the Hepatitis B Peds and Varicella. I wrote the clients sibling vaccines on the consent form that we write vaccines on of the above-mentioned vaccines. He did not need a Varicella vaccine he was already up to date. Once I realized that I made this error I called to speak to the parent on 9-8-2022 but his phone number went straight to a recording stating ?this caller phone is not setup to accept voicemail?. I then reached out to the translator that accompanied the family and she answered the phone. She stated that the parents will not answer their phones that is just what they do and that she will be the best contact person. I explained to her that I did give the wrong vaccine and she was familiar with this error because she had an appt slip that had written down what the sibling and this client were to receive. But I was looking at the vaccines that I had written down on the consent form. I asked if she knew if the client had a pediatrician so I could notify their physician of my error and get guidance due to the incorrect vaccine ? Varicella this client received. She stated that this client does not have a pediatrician and that this is the reason the client was brought to the health department. I explained that I do need to get an update on how the child is doing. Also, my error was reported to Nurse Manager on  9-8-2022 and that a VAERS will be done. I explained to her the parent should expect to be contacted by VAERS of this however, I will be entering both the parent phone number and hers on the VAERS, just in case the parent is not reachable. She  said ok.  She called me this morning 9-9-2022 and stated the parents were very upset and I told her I do not blame them and I apologized several times for my error. She stated the client was up and playing around with no issues. Per translator the parents will be taking the client to a physician to be evaluated and go from there. I did ask that the translator call me back with the physician?s name and she said ok.  When I spoke with the translator 9-14-2022 she said that the parents have made an appt with a physician but it is a month out before the child will be seen. I asked that the translator call me back with the md name and date of appt. She said she would but I have not heard back from her as of yet.
Within 2 hours of getting the vaccine my arm started feeling sore. Several hours after that the swelling started. Within 6 hours of the shot the injection site was swollen, red, sore, and itchy. By the time I went to bed, about 11 hours after the shot, I was exhausted, very itchy, had a headache  and chills, and had a very  sore arm. Took 2 Tylenols and that helped the chills and headache. When I awoke this morning I was so tired that I went back to sleep after having coffee. No headache, no chills but my arm is still swollen, red, and very itchy.
Patient said a headache started 40 minutes after first dose, then flushing began 8 to 9 hours after first dose. The headache and flushing lasted four days. (Fatigue also started that afternoon but stopped 24-48 hr later. Sore arm started the same day and lasted three days.)
This initial spontaneous case, was received from other health professional on 13-Nov-2017, concerns a 65-year-old male patient. The patient's medical history included mental retardation, high blood pressure, diabetes type II, congenital blindness and concomitant medications included metoprolol, metformin, lisinopril, atorvastatin. On 02-Nov-2017, the patient was administered with FLUAD (dose: 0.5 ml, route of administration, anatomical location: right deltoid, batch no: 179303 and expiry date: 30-Jun-2018). On 13-Nov-2017, the patient accidentally received second shot of FLUAD (explicitly coded as inappropriate schedule of vaccine administered). It was reported that there was no AE after vaccination (explicitly coded as no adverse event). The reporter assessed this case as non-serious.
itchy hive at injection site; This is a spontaneous report from a contactable female consumer (patient herself) of 65-years-old received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, Batch/Lot number EL9269) via an unspecified route of administration on 05Feb2021 at 04:45pm in right arm as single dose for covid-19 immunisation. Patient's medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. Patient was reported to known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was on Lexipro and Pravistatin within two weeks of vaccination. On 12Feb2021, approximately day 8 patient experienced an itchy hive at injection site. No therapeutic measures were taken. The outcome of the event was not recovered.
(R) shoulder bursitis seen 11/8/12 & 11/12/12 then to orthopedist 11/16/12.
Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium
Initial unsolicited report received from non-healthcare professional (company representative) on 03 Dec 2017 and live follow up was received on 06 Dec 2017. This case involves 27 years old female patient who was vaccinated with a dose of INFLUENZA QUADRIVAL A-B VACCINE (FLU) (batch number: UI886AB, expiry date: 30 Jun 2018, route and site of administration were not reported) on 02 December 2017. The patient's medical history and concomitant medication were not reported. On an unknown date (events reported to company representative on 03 Dec 2017), following the vaccination the patient experienced redness and swelling around the injection site causing some discomfort and pain- the area was marked and overtime, swelling, redness seamed to spread, diarrhea. On an unknown date, the patient was diagnosed with cellulitis. Laboratory investigation was not reported. Patient was on a 10 day regimen of antibiotic as corrective treatment. Outcome of events was not reported. Upon internal review the case was considered as serious due to important medical event: cellulitis. List of documents held by sender: none.; Sender's Comments: This is a poorly documented case in which patient was diagnosed with cellulitis post vaccination with INFLUENZA QUADRIVAL A-B VACCINE. Time to onset (1 day) is compatible with the role of vaccine. Further information on medical history, immune status at the time of vaccination, previous vaccination and tolerance, laboratory investigations excluding alternative etiologies would be needed to fully assess this case. Based on the information available, a role of the vaccine cannot be assessed.
50-year male who received his first dose of the Moderna vaccine today, 05/04/2021 at 10:08am. His observation time ended at 10:23 am. Patient admitted to going thru some trash earlier. Moderna Vaccine, lot #024C21A, Expiration date 05/04/2021. Received in the right deltoid. After one hour, approximately 11:13am, the patient returned to the vaccine site stating he had bilateral lower arm itching with visible rash. The patient reports a history of emphysema, blunt head trauma, and prior history of taking Dilantin. He reports no medication history with last Dilantin dose approximately one year ago. He denies chest pain, shortness of breath, headache, dizziness, difficulty swallowing, cough, facial/mouth swelling, and throat swelling. Vital signs were 108/82, HR 70, SpO2 93%, RR 18. Upper breath sounds diminished. The patient was observed by medical staff for approximately 10 minutes, upon which he wanted to return to his room (#205). The patient received one dose of diphenhydramine 25mg with relief of symptoms. Patient received education on anaphylaxis with strict ER return precautions.
Patient developed multiple large purple "bruise-like" spots (not at injection site) on bilateral shoulders/back four days after receipt of Hepatitis A vaccine per mother's report.
Right sided facial/lip swelling.  Started about 0200 on 12/16/20.  Patient sometimes gets angioedema, so unsure if this is related but wanted to report
Patient developed muscle weakness several weeks following vaccination for covid. after extensive testing and evaluation, she was diagnosed with ALS (amyotrophic lateral sclerosis)
No adverse event; Dose administered after 30-day Use By Date or after manufacturer date of expiry; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry) and NO ADVERSE EVENT (No adverse event) in a 25-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 060B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Mar-2023, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 10-Mar-2023,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry) 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 assessment was provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry).    No concomitant medication details was reported. No treatment medication details was reported.
She woke up soaking wet. She had sweats kind of.; Tested positive for COVID; Tested positive for COVID; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect. A contactable nurse (patient herself) reported that a 64-year-old female patient received her first dose of bnt162b2 (BNT162B2 also reported as PFIZER-BIONTECH COVID-19 VACCINE, lot EK5730, expiry date not reported), via an unspecified route of administration in the upper left arm on 21Dec2020 17:00 at SINGLE DOSE for Covid-19 immunisation. Medical history included ongoing hypertension (blood pressure high). She was a former smoker, a teenage smoker. She has not smoked since the age of 19 years old. Concomitant medication included amlodipine for high blood pressure. The patient informed that she was vaccinated on 21Dec2020. On 05Jan2021, she had a positive COVID Test and she was wondering when she should have the second dose of the COVID Vaccine. She thought initially she just had a cold. She took the COVID test as a precaution. It started out with a stuffy nose. She had a congested cough, upper airway cough, nothing deep in the lungs. She had a low grade fever. It was like 99.9. It was possible it was higher, but she had taken Ibuprofen at night. She woke up soaking wet. She had sweats kind of. Her temperature however never registered a true fever if a fever  was considered 100.4. She was not really having body aches any more unusual than one would have for a 64 year old. She has a very mild sore throat. Her stuffy nose had improved, it's still there slightly, but not like it was the first few days. The outcome of events was unknown.; Sender's Comments: Test positive for covid19 found 14 day following the first dose of COVID-19 vaccination, bnt162b2, no adequate effect of the suspect vaccine thus could be reasonably achieved to protect from the targeted infection/disease due to the very short time lag.
Heart palpitations and chest pain, occurring  4 times total since vaccination, lasting several minutes each episode.
pt recv vax & devel inj site rxn (hip to knee), characterized by warmth, redness & tenderness;sx resolved the following day;
Narrative: Patient with myalgias, chills, fatigue and dyspnea on exertion following vaccine administration. Symptoms persistent 4-5 days after vaccine administration in patient with known CAD so presented for further evaluation as an inpatient.
small red bumps covering her body; headache; nausea; aches and pains; rash on legs; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (small red bumps covering her body), HEADACHE (headache), NAUSEA (nausea), PAIN (aches and pains) and RASH (rash on legs) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH ERYTHEMATOUS (small red bumps covering her body), HEADACHE (headache), NAUSEA (nausea), PAIN (aches and pains) and RASH (rash on legs). At the time of the report, RASH ERYTHEMATOUS (small red bumps covering her body), HEADACHE (headache), NAUSEA (nausea), PAIN (aches and pains) and RASH (rash on legs) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment and concomitant medications were not provided by reporter.
shaking so bad; feeling cold; feeling really warm; took her temperature 100.4°F and later 100.7°F; bad chills; This spontaneous case was reported by a patient and describes the occurrence of TREMOR (shaking so bad), FEELING COLD (feeling cold), FEELING HOT (feeling really warm), PYREXIA (took her temperature 100.4°F and later 100.7°F) and CHILLS (bad chills) in a 71-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 7162b) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure abnormal, Drug allergy (Aspirin) and Penicillin allergy (penicillin antibiotic for a sinus infection). Concomitant products included OLMESARTAN MEDOXOMIL (BENICAR) for Blood pressure abnormal, ROSUVASTATIN CALCIUM (CRESTOR) and LEVETIRACETAM (KEPPRA [LEVETIRACETAM]) for an unknown indication.    On 28-Sep-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced TREMOR (shaking so bad), FEELING COLD (feeling cold), FEELING HOT (feeling really warm), PYREXIA (took her temperature 100.4°F and later 100.7°F) and CHILLS (bad chills). At the time of the report, TREMOR (shaking so bad), FEELING COLD (feeling cold), FEELING HOT (feeling really warm) and PYREXIA (took her temperature 100.4°F and later 100.7°F) had not resolved and CHILLS (bad chills) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100.4 F and 100.7 F.         No other vaccines were given within 1 month prior to Moderna COVID-19 vaccine. Patient reported receiving antibiotic for a sinus infection in the past. Patient was not tested positive for COVID-19. Patient received the following doses of the Moderna COVID-19 vaccine -1st dose on 5Aug 2021 lot #031m20a,  2nd dose on 26Aug2021 lot #026a21a and 3rd dose on 23Nov2021 lot #013f21a. No treatment medications were reported. She consumed hot tea and more water, she also reported she was unable to take Aspirin.   This case was linked to MOD-2022-654032, MOD-2022-654068, MOD-2022-654088.
mom states pt cried for 4 hrs continuously p/vax; pvt MD called & advised no pertussis next shot; mom decided to take to MD but pt fell asleep in car so did not take to MD;
Information has been received from an RN concerning a 13 month old male pt who on 12/13/01 was vaccinated with a dose of varicella virus vaccine live. It was reported (on 12/21/01) that the pt now had about 10 generalized lesions (chest, legs and face) characterized as "red bumps". It was unknown if there was any past medical history or concomitant therapies. Unspecified medical history was sought. Additional information has been requested.
tested positive for Covid; tested positive for Covid; This is a Solicited report based on information received by Pfizer from (Manufacturer Control Number#: 21K-163-4111738-00). A contactable consumer (patient) reported that a 32-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 2 in Mar2021 and dose 1 in Feb2021 (Batch/Lot number was not reported), both via intramuscular as single dose for COVID-19 immunisation; adalimumab (HUMIRA) subcutaneous from an unspecified date at unspecified dose for hidradenitis. The patient medical history and concomitant medications were not reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. In 2021, the patient experienced tested positive for Covid. The action taken in response to the event for adalimumab was unknown. The outcome of event was not recovered. The reporter's causality for the event of tested positive for Covid with adalimumab was not provided. The reporter's causality for the event of tested positive for Covid with bnt162b2 was not provided  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events Drug ineffective and COVID-19 and BNT162B2.
Six days after receiving the Johnson & Johnson/Janssen vaccine, the patient complained about strong pain in the right arm (same as vaccination arm). She went to the ER on the 7th day after receiving the vaccination and after doing EKG, ultrasound, and CT scan, they found multiple blood clots in her right arm where she receive the vaccine.
chills; runny nose; Herpes Simplex 1; Upper respiratory feeling; This is a spontaneous report from a consumer. This 71-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unknown route of administration on 27Jan2021 at dose 1, single for COVID-19 immunisation. Medical history and concomitant medications were not reported. It was reported that her first dose vaccine was given on 27Jan2021 and on an unknown date in 2021, she had chills went into runny nose, Herpes Simplex 1. Upper respiratory feeling. HCP indicated immune response. Put her on antivirals. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Clinician gave my son the adult dose.  I had also questioned the dosage prior to her administering  (she was very short and appeared annoyed) and  told me he should receive a full dose which is 100% incorrect.
Initial and follow up information has been received from a physician via a wholesaler concerning a 39 year old patient who was vaccinated with a  dose of pneumococcal 23v polysaccharide vaccine (lot # 649111/0287P).  Subsequently the patient developed the shakes and swelling around the injection site.  The patient did not undergo a work up or hospitalization.  No other information was available.  In follow up information it was reported that 4 other patients developed the same reaction after vaccination with pneumococcal 23v polysaccharide vaccine (lot # 649111/0287P).  Additional information has been requested.
local redness/swelling at site c blisters . Raised Redness about 5in circle. site itchy
severe yeast infection 24 hours after shot, using Monistat7, 3 days later better but still active
Child had itchy,  hives around his neck, under his arms, and on his chest and his face was flushed. Child kept complaining of how much he was itching and was violently scratching his neck and under his arms. He would also cough periodically. He denies shortness of breath; no labored breathing noted. 0.5 ml of Bendryl was administered IM and  they stayed in the clinic for 30 minutes. Patient no longer complained of itching, his hives weren't as pronounced, and his face was no longer flushed.
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions and allergies were not reported. The patient received a dose of ZOSTAVAX on 18-APR-2011 (subcutaneously; dose, lot#, expiration date and anatomical location were not reported) and on 25-FEB-2015 (subcutaneously; dose, lot#, expiration date and anatomical location were not reported). No adverse effects were known at the time of the report. Additional information has been requested.
Patient winced upon injection, stiffened up for approximately 1 to 2 seconds then passed out.  Woke up immediately. Felt nauseous which passed then developed a headache.  EMS was called.  Vitals good except irregular heartbeat detected.  Went home with family, advised to follow-up with physician.
Vaccine had a BUD of 1/18/2023 as it was delivered unfrozen and immediately placed in the refrigerator unit.
Individual complained of feeling a little tingling in her throat and on her tongue. The assigned PA directed that staff member would need 2- 50 mg Benadryl capsules PO. Yes- we did have an epi pen next to us. VS: BP 137/82, O2 SAT 99%, HR 89 minute. Vitals at 10 minutes post symptoms/Benadryl BP 160/89, P 82/min, O2 SAT 100%, 15 minutes post symptoms/Benadryl BP 139/91, P 81/min, O2 SAT 99% No symptoms per staff member's verbal statement. She returned to work.
Expired vaccine used; Accidental overdose; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and ACCIDENTAL OVERDOSE (Accidental overdose) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 034C21A, 042C21A and 047B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 18-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 01-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .3 milliliter. On 01-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and ACCIDENTAL OVERDOSE (Accidental overdose). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and ACCIDENTAL OVERDOSE (Accidental overdose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) to be not related. No further causality assessment was provided for ACCIDENTAL OVERDOSE (Accidental overdose).    No concomitant medicines were reported No treatment medicines were reported. It was reported that the patient did not experienced any adverse event.
Patient was a 43 yo F who presented to ED on 12/25/2020 with complaints of worsening shortness of breath for past 3-4 days. The patient tested positive for COVID 12/16/2020 and her symptoms worsened three days prior to admission. Patient was diagnosed with COVID infection with acute respiratory failure with hypoxia. She was treated with dexamethasone 6 mg once daily for 3 days, Tussionex 5ml q12h prn for cough for 2 days. Patient was discharged home on 12/30/2020 with improved SpO2 and a discharge medication list of dexamethasone 6mg daily for 7 days, benzonatate 200 mg one capsule by mouth TID prn, guaifenesin ER 600 mg, Tussionex 10-8 mg/5ml, and Vitamin D 2000U.
Lost the vision in my left eye.  Taken to Hospital in on April 10th at 6:00 in the morning and over the next 3 days had a CT scan, MRI,  Heart monitor and Heart Test w/ Bubble. and the veins in my neck tested.   Nothing abnormal was found to have caused an CRAO.  Since then I have had family members tell me of three other people who had a similar situation happen to them after the second shot and within several weeks of receiving the second shot.   I have not regained the sight in my left eye.   I had no symptoms of anything before this happened.