chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a 66 year old male physician with no medical history and with no drug reactions or allergies reporting on himself. On 22-AUG-2014 the patient was vaccinated with a dose of ZOSTAVAX (0.65 ml, intradermally in the outer axillary area of unspecified arm, lot#, expiration date not reported). Concomitant medications were not reported. The physician/patient reported that he received a dose of ZOSTAVAX and he thought it might have been administered intradermally in the outer axillary area of an unspecified arm. He stated that after he received the ZOSTAVAX, a bandaid was applied and he left the bandaid on for a "couple days" and when he took the bandaid off it was "immediately" painful at the injection site (in approximately August 2014, exact date not specified). He reported that prior to taking the bandaid off, it was a "little achy" at the injection since an unspecified date (in approximately August 2014). He also stated that he noted a "linear" ulcer located at the injection site after the bandaid was removed (in approximately August 2014, exact date not specified). He also described the skin at the injection site as looking like a "needle track" which he noted after removal of the bandaid (in approximately August 2014, exact date not specified). He reported that it hurt to have anything touch the injection site since an unspecified date (in approximately August 2014). There were no laboratory tests performed. There was no treatment given for the reported events. The outcome of linear ulcer located at the injection site after the bandaid was removed, the skin at the injection site looking like a needle track and painful at the injection site/a little achy at the injection/it hurts to have anything touch the injection site was reported as not recovered/not resolved. The patient did not seek medical attention. The relatedness between the therapy with ZOSTAVAX and the events of linear ulcer located at the injection site after the bandaid was removed, the skin at the injection site looking like a needle track and painful at the injection site/a little achy at the injection/it hurts to have anything touch the injection site was not reported. Additional information has been requested.
MMR was given on 3/12/09.  She started having an erythemitous papular rash on 3/23/09.  The rash began on her face and spread to her neck, chest, back and arms by her office visit on 3/24/09. She did not have any prodromal symptoms except for some fatigue.  She denied fever, chills, nausea, or vomiting. On exam she also has Koplik's spots on her left buccal mucosa.  She was treated symptomatically.
Patient had severe swelling extending to elbow with hives. Patient received a steroid dose from the urgent care clinic last night and the rash had greatly improved by today. She was also prescribed antibiotics and steroids.
Trouble remembering recent information, pain lower back, pain headache frequently, sleep problems, insomnia, vision, poor tolerance for bright lights, nervousness (anxiety).
Right after I got the shot, my arm was sore. I became nauseous a few hour laster and that lasted for a few hours.   Beginning a few hours after the shot, I started to get very tired and have body aches. This lasted for 36 hours after the shot and then went away.
Doses administered past the published expiry; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided by reporter. No treatment medications were reported.
On July 17, 2021, I fainted and was told my heart went into AFib. And taken to hospital. Echo cardio gram performed and heart was strong and realeased with no medication added.  Wore a heart monitor for 2 weeks, and 6 heartbeats were in question.  Again, no medication added. Within, one week of that doctors visit, I developed a cough that became chronic and I experienced extreme difficulty in breathing.  I was given antibiotics and an inhaler. After 4 days I progressively got worse. They schedule a breathing treatment and prior to administering the treatment they did an ekg and I was in AFib again. I tribute the vaccine to my AFib since I have had no prior problems. It is my feeling that because AFib is common, it is not being considered vaccine related.
swelling/tenderness at upper arm to elbow. Began swelling evening pt received Pneumovax.
Post administration of vaccine patient became pale, diaphoretic and began twitching and slumped in chair with loss of consciousness for approximately 45 seconds. Responded to stimuli 911 called. BP 80/40 70/40. Transported by EMS to ER. Spoke with patient at 11:35 AM, stated he is having diagnostic testing done at this time and feeling much better.
4.5 cm W 5.5 cm H > erythema, mildly warm, no induration. No systemic symptoms.
Combine initial and follow up information report from physician received on 23 Jul 2010 and 26 Jul 2010: This patient was vaccinated with S-OIV FLUVIRIN (batch number. unknown), intramuscular, on an unspecified date. The patient was broke out in hives from an injection of S-OIV FLUVIRIN and previous to that broke out from eating gummy bear on an unspecified date. The outcome of event was not reported.
Pt recvd vax 28SEP92 & on 20OCT92 devel severe diarrhea which was bloody; Stool cult was pos for an unspecified organism;
Patient developed approximately 15 skin lesions on back and left arm described by physician as red vesicles, purulent in appearance, itching, and non painful.  Patient prescribed Benadryl and recommended to follow up as needed with physician.
Developed redness, swelling and itching 8 days later consistent with cellulitis.
Patient complained of pronounced burning on injection of the vaccine. Patient communicated to the vaccination administrator that this was different from what he had experienced with previous vaccinations.
Patient vaccinated x3 (Pfizer: 09/24/2021, 10/22/2021, 04/22/2022)  Patient admitted to medical center and tested COVID+ on 11/02/2022
Pt became light-headed and had a few second period of LOC immediately after the shot. Pt regained consciousness few seconds. Pt was seated and safe the whole time. Pt was monitored and observed for 1/2 hr. Pt was well at that point to walk out to car with mother.
pt devel wheal @ site of MMR inj, 2 1/2mm long x 1 1/2mm wide;ice applied to site;
102.9F fever the next day, swollen glands, nausea and dry heaves no appetite. treated with Tylenol every 6 hours  then the 2nd day - bad nausea, fever 101F then when up in temp on Monday to Tuesday Tues. morning glands going down but top of the left shoulder painful  Wed . swollen glands on the left of neck , below the neck front a swollen lump and below neck left shoulder a 2 inch wide ridge swollen and 1 inch wide and now starting on the right side
DIZZINESS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose was not reported, administered on 28-MAY-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 2021, the subject experienced dizziness. The action taken with covid-19 vaccine ad26.was not applicable. The outcome of dizziness was not reported. This report was non-serious.
Received dose from expired vial; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received dose from expired vial) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination.     No Medical History information was reported.  On 09-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received dose from expired vial). On 09-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Received dose from expired vial) had resolved.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.       No treatment information was provided.  The patients were told to hold on to this vaccine because of the potential extension. Date the vial was initially stored in the refrigerator: 16-Sep-2021. It was stated that the vial did not undergo any temperature excursions, and the box has an expiration date of FEB 2022.
Patient received a flu shot on 10/23 and it's still hard for me to lift up her arm, she feels it all the time, muscle pain.
I was experiencing very severe body aches and pain. I as well ran a high fever over 101 F.
vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine given 6 days post expiry) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 041L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.  Patient did not experience any other adverse reactions.   This case was linked to (Patient Link).
33 year old female received Daptacel and not prescribed Tenivac tetanus vaccine, no AE; 33 year old female received dose of Daptacel, no AE; Initial information received on 28-Jan-2021 regarding an unsolicited valid non-serious case.  This case involves a 33 years old female patient who received DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] instead of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] (wrong product administered and product administered to patient of inappropriate age).  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included INFLUENZA VACCINE (INFLUENZA VACCINE) for Immunisation.  On 26-Jan-2021, the patient received a 0.5 ml dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (lot C5611AA and expiry date: 03-Apr-2021) (frequency once dose) via an intramuscular route in the right arm for prophylactic vaccination.  It was a case of actual medication error due to wrong product administered and product administered to patient of inappropriate age (latency on same day).  It was also reported that a nurse reporting that a 33 year old female received Daptacel and not prescribed Tenivac tetanus vaccine.  Reporter relationship: health care professional (HCP), Product used: used and still using product: no  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
pain in arm at injection site; This is a spontaneous report from a contactable other healthcare professional (hcp). A 61-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EL1284, expiry date not given), intramuscular on 29Dec2020 18:00 at a single dose in the left arm as Covid Vaccine. Medical history included hypothyroid, low adrenal cortex and allergies to sulfa. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of the vaccination. Concomitant medication included fluoxetine. The patient had no vaccine in four weeks. The patient previously took amoxycillin and experienced allergies. On 29Dec2020 (reported as at 5:30 AM and 5:00 AM; pending clarification), the patient experienced pain in arm at injection site. Since the vaccination, the patient has not been tested for COVID-19. The event reported was not serious (did not result in death, not life-threatening, did not cause/prolonged hospitalization, not disabling/incapacitating and not a congenital anomaly/birth defect. The outcome of the event pain in arm at injection site was recovering.
pt recv vax 25JUL95 & 1AUG95 devel maculo-papular, erythematous shaped lesions on face, back & extremities that were purpuric; By the 3rd day lesions were fading; devel a high fever of 105 & was hospitalized; dx w/erythema multiforme;
COVID 19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID 19) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Patient do not have any allergies.    On 17-Feb-2021 at 2:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021 at 3:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Nov-2021 at 2:00 PM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID 19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 19-May-2022 to 24-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID 19) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2022, SARS-CoV-2 test: negative (Negative) Negative/ tested negative for 9 days. On an unknown date, SARS-CoV-2 test: positive (Positive) Positive and positive (Positive) Positive/ symptoms returned tested postive.         Concomitant medications were not reported.  The patient had reported had rebound of COVID-19 after completing 5 day course of Paxlovid. The patient had tested negative for 9 days then symptoms returned after 6 days and after completing course and patient had tested positive again.  Company comment: This spontaneous case concerns a 56-year-old female patient with no relevant medical history who experienced the unexpected non serious AESI of COVID 19 which occurred unknown days after the administration of third dose of mRNA-1273 vaccine in COVID 19 vaccination series. Patient received NIRMATRELVIR, RITONAVIR (Paxlovid) as treatment for COVID 19 from 19-May to 24-May. After the treatment with Paxlovid, patient tested negative for COVID 19 for 9 days. Symptoms returned 6 days later and patient again tested positive. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-581235 (Patient Link).; Sender's Comments: This spontaneous case concerns a 56-year-old female patient with no relevant medical history who experienced the unexpected non serious AESI of COVID 19 which occurred unknown days after the administration of third dose of mRNA-1273 vaccine in COVID 19 vaccination series. Patient received NIRMATRELVIR, RITONAVIR (Paxlovid) as treatment for COVID 19 from 19-May to 24-May. After the treatment with Paxlovid, patient tested negative for COVID 19 for 9 days. Symptoms returned 6 days later and patient again tested positive. The benefit-risk relationship of mRNA-1273 is not affected by this report.
This spontaneous report was received from a medical assistant referring to a currently 76 year old female patient. The patient's medical history, concurrent conditions, and historical drugs were not reported. Concomitant therapies included atenolol. On an unknown date (reported as "recently"),  the patient was vaccinated with PNEUMOVAX 23 (strength, route, dose, frequency, anatomical location, lot # and expiration date were unknown) for prophylaxis. On an unknown date (reported as "a day after receiving PNEUMOVAX 23"), the patient experienced arm swelling, as well as pain and warmth at the injection site after receiving PNEUMOVAX 23 at an unknown pharmacy. The medical assistant stated that the patient reports she had previously received a dose of what was reported to be "plain PNEUMOVAX " not PNEUMOVAX 23 several years ago but the date and details of the prior vaccination were unknown by the reporter. No laboratory diagnostics or studies were performed. The patient sought for medical attention, she called to the pharmacy and saw a physician. At the time of the report, the outcome of injection site swelling, injection site warmth and injection site pain was unknown. The  medical assistant did not mention the causality assessment between the events of injection site swelling, injection site warmth and injection site pain, and PNEUMOVAX 23.
patient initially asked for janssen then desided to get pfizer but he recieved janssen.
localized reaction (rash) at and around the injection site on the upper lateral arm; This spontaneous report has been received from a nurse prescriber and refers to a female patient of unknown age.  The patient's pertinent medical history, other drug reactions or allergies, concurrent conditions and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, at a dose of 0.5 milliliter (ml), administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided).  On an unknown date, the patient experienced localized reaction (rash) at and around the injection site on the upper lateral arm (vaccination site rash).  At the time of reporting, the outcome of the event localized reaction (rash) at and around the injection site on the upper lateral arm was not provided.  The causal relationship between the event and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not provided.
Event occurred after 2nd vaccine.   12/28/2021: 65-year-old female who presented to emergency department complaining of 2 days of worsening weakness, cough, mild shortness of breath patient presented Facility department with fall yesterday
Patient received her second dose of SHINGRIX on Friday 3/8/19 at approximately 1112 am. Patient stated she felt the heat from the injection before she even left the pharmacy. She stated it became painful, red, and warm to the touch later that evening. She stated that was the worse it was. It slowly has been getting better day by day. It is still red and warm to the touch.
The patient's son reports noticing swelling in both of the hands 1 week after the patient recieved their vaccine.
Received message from front desk that patient received shingrix vaccine and is concerned on a possible vaccine reaction.    I walked to lobby and brought patient back into an exam room. Patient states she received shingrix vaccine at 1:46pm and then had labwork completed after. She was sitting in the car when she felt hot, flushed, itchy and slightly short of breath which prompted her to come back into clinic.   She feels slightly short of breath siting in exam chair. She feels itchy and a little lightheaded. She feels her HR is high. She  Patient declines difficulty swallowing or throat tightening. No hives, no rash at injection site. No swelling of mouth, lips, cheeks or elsewhere. Patient states she has had recent reaction to PEG (polyethylene glycol) in Moderna COVID-19. She is also concerned to be allergic to Poly-Sorbate 80, which she describes to be similar  "cousin" to PEG. After she received her shingrix vaccine, the patient looked it up to see it contains PolySorbate 80 and it does. Patient took 25 mg tab of benadryl at around 2:40pm. I took patients vitals at 2:50pm to be HR 93, SpO2% 97%, BP 176/96, Temp is 99.1 and RR is 18. I told patient I was going to discuss with Dr. and return to the exam room.   I spoke to Dr. and explained patient situation and vitals. She asks for patient to stay in exam room for 30 minutes for another reevaluation afterwards to see how she is after receiving benadryl 25 mg.   Re-examined patient at 3:30pm. She states her face isn't flushed. She is no longer short of breath or having much tingling in her face and arms. She states overall she is feeling better Vitals are HR is 83, SpO2% at 98%, BP 160/80 and RR is 16. Patient states she feel strong and safe enough to go home. I relayed that I'll update Dr.
Crohn's flare up; body aches; This spontaneous case was reported by an other health care professional and describes the occurrence of CROHN'S DISEASE (Crohn's flare up) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    No relevant past medical history was provided.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. On an unknown date, the patient experienced CROHN'S DISEASE (Crohn's flare up) (seriousness criterion medically significant) and MYALGIA (body aches). At the time of the report, CROHN'S DISEASE (Crohn's flare up) and MYALGIA (body aches) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   concomitant product information was not provided  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.; 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.
The morning after I received my vaccine I had the following symptoms which have not gone away till today:  - Slight shortness of breath - Inability to complete a full deep breath in - Coughing - Coughing while sleeping
pt recvd vax; exp tingling in arms & legs; Lt hip sciatic pain; Lt arm swelled (entire arm) & flushed;
On the 13th I started to have what I thought was a sore throat, coughing, headache and fatigue and congestion. They got worse for a couple days for a week, about until the 20th. The cough has continued. I did an in home test for strep throat and it was negative. I called and had a virtual visit with UC and they told me to go get tested. I went to a drive through testing site and that night or next morning I got my results and it was positive. I took over the counter cold and flu medication and Tylenol as needed.