chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt complained of soreness the next day. Vax given to left upper arm. Felt lump about the size of a half dollar. After 3 days, has reddened and soreness to area remains and fever.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in an 86-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Feb-2021 at 10:14 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 27-Feb-2021 at 10:14 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 86.11.  Concomitant products were not provided.  On 27-Mar-2021, Excursion time was 09 AM, 11 AM, 12 PM, 01 PM, 02 PM, 03 PM, 04 PM and 05 PM, temperature was 33, 35, 35, 35, 35, 34, 34 and 35 respectively, total doses given for the day was 199, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 24-Feb-2021, vial was moved to clinic on 27-Feb-2021. 20 vials was sent to clinic. Vaccine BUD dates was 26-Mar-2021.  Vial was stored on cooler 1, on 27-Mar-2021, Excursion duration At 9 AM: 33, 10 AM: 36, 11 AM: 35, 12 AM: 35, 1PM: 35, 2 PM : 35, 3 PM: 34, 4 PM: 34 and 5 PM: 35.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a brand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
Given the second dose of hepatitis A vaccine 1 month after first dose. Patient is experiencing nasal congestion past two month with no relief. She also complains of headache on left side, and stomach ache frequently.
This case was reported by a pharmacist and described the occurrence of red rash injection site in a subject of unspecified age and gender who was vaccinated with FLUARIX (GlaxoSmithKline). In October 2008, the subject received a dose of FLUARIX (.5 ml, unknown). In October 2008, at an unspecified time after vaccination with FLUARIX, the subject experienced red rash injection site and pharmaceutical product complaint. The pharmacist received a call from a nurse at a nursing home facility that reported that 80 out of 100 subjects developed a "grapefruit size bright red" rash at the injection site. At the time of reporting the outcome of the events were unspecified. For the other 79 linked subjects please see cases: A0756483A - A0756501A, A0756503A - A0756562A. The CRC provided lot number AFLUA3208A to QA regarding this product complaint, while the report received in CMG Safety stated AFLUA3508A. With a possibility of a coding mistake to batch AFLUA320AA and on the basis that there are 80 cases out of 100, it was decided to ask for a Quality investigation (including cold chain) of all three batches (correct numbers: AFLUA350BA, AFLUA320BA and AFLUA320AA). On 16 January 2009, QA results were received for batches reviewed of (AFLUA320AA and AFLUA320BA): AFLUCA320, AFLUA320A, and AFLUA320B. The report indicated that no deviation that could be linked to the complaint and no cold chain deviation was recorded on the batches AFLUA320AA and AFLUA320BA. On 26 March 2009, QA results were received for batches reviewed (AFLUA350BA): AFLUCA350 and AFLUA350B. The reporter indicated that no deviation that could be linked to the complaint and no cold chain deviation was recorded on the batch AFLUA350BA.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Mar-2021 at 10:09 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 20-Mar-2021 at 10:09 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 59.20 for dose administered on 20-Mar-2021.  No concomitant medications were reported.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F. Temperature recordings were taken using a traceable temperature monitor at every hour. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  On 20-Mar-2021, vials were stored in cooler 1, at following time and temperature respectively, 9 AM: 34, 10 AM: 30, 11 AM: 41, 12 PM: 45, 1PM: 44, 2 PM: 44, 3 PM: 44, 4 PM: 44 and 5 PM: 43.  On 20-Mar-2021, Excursion time was 09 AM and 10 AM, temperature were 34,37 respectively and total doses given for the day was 184, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 09-Mar-2021, vial was moved to clinic on 20-Mar-2021. 19 vials were sent to clinic. Vaccine BUD date was 08-Apr-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  No treatment medications were reported.
became dizzy & nauseous w/in min, dec BP;problems cont x 1wk;
This spontaneous report was received from a registered nurse refers to a female patient of unknown age. The patient's concurrent conditions, medical history, drug reactions, allergies and concomitant medications were not reported. On 29-MAY-2018, the patient was vaccinated with first dose of VARIVAX (dose, units and frequency not reported) (lot# and expiration date not reported) subcutaneously. On 12-JUN-2018, reported as 2 weeks later, the patient was vaccinated with second dose of VARIVAX (0.5 ml and frequency not reported) (lot# and expiration date not reported) subcutaneously. Reporter stated that, the second dose was not administered as per schedule. No adverse reactions experienced. No product quality complaint was involved.
PATIENT DEVELOPED BLISTERS ON THE POINT OF INJECTION AND THE AREA WAS WARM
none to report-followed up in 3 days. Pt. was  notified, doctor, Dept., Health, too. Pt. asked verbally for a Shingles shot. Staff thought she wanted a covid shot, so she got a third covid shot.
Malaise, Body Aches, weakness, tiredness.  Over all flu-like Sx without fever.  Chills feel as if "Hit by a Truck"
Left deltoid red, swollen and warm to touch, "has fever in it" per mom.
A Little Sore Arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (A Little Sore Arm) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced VACCINATION SITE PAIN (A Little Sore Arm). At the time of the report, VACCINATION SITE PAIN (A Little Sore Arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
FEVER; CHILLS; ACHINESS; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (FEVER), CHILLS (CHILLS) and PAIN (ACHINESS) in a 23-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 04-Feb-2021, the patient experienced PYREXIA (FEVER), CHILLS (CHILLS) and PAIN (ACHINESS). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PYREXIA (FEVER), CHILLS (CHILLS) and PAIN (ACHINESS) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Lab details were not provided.
This spontaneous report as received from a Licensed Practical Nurse refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with 0.5 ml VARIVAX (Merck) which was post supported excursion date 24-NOV-2014, lot # J014407, expiry date: 13-NOV-2015, (dose number, route, application site not reported). No adverse effects reported. The outcome of post event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
The administration error was observed during internal vaccine reconciliation. No adverse events were reported by the child's guardian.
Severe headache to  left side of head. Left Eye pain, left ear pain, joint pain in all major joints, fever 100.9, nose bleeds intermittent for following 24 hours, fatigue.  Neck pain. Shakes and chills.
Acute pericarditis; This is a spontaneous report from a contactable Physician reporting for himself   A 37-year-old Male Physician received second dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EZ3248) on 11Jan2020 at single dose, via an unspecified route of administration,  on left arm  for COVID-19 immunization. Relevant medical history included hypothyroidism and hyperlipidemia. The patient received first dose of BNT162B2 on Dec2020 via an unspecified route of administration  on left arm for COVID-19 immunization.  Concomitant medications included atorvastatin and levothyroxine sodium (SYNTHROID). On 21Feb2021 at 17:00, the patient experienced acute pericarditis resulted in doctor office/clinic visit. Treatment received included Ibuprofen, Colchicine and Pantoprazole. At the time of the reporting, the patient was recovering from the event.; Sender's Comments: Based on the limited information currently available, a possible association of the suspect drug administration with the reported event cannot be excluded, due to a plausible temporal relationship. This case will be reassessed when additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Information has been received from a patient who in approximately 2008, "about two years ago", was vaccinated with a dose of ZOSTAVAX (Merck). Subsequently the patient experienced shingles all over the right side of face, ear and hair. It was unknown if the patient sought medical attention. At the time of the report, the outcome of the patient was unknown. It was also mentioned that the patient was vaccinated with ZOSTAVAX (Merck) because the patient's mother had shingles. Additional information is not expected.
Information has been received from a medical assistant via representative for Immunization program referring to unspecified multiple patients of unknown age and gender. On unknown dates in October 2016, the patients were vaccinated with doses of M-M-R II (lot # L037356, expiration date 28-SEP-2017, dose, route not provided). That vaccine had been maintained at proper temperatures except there was missing data from data logger for one week in October 2016 and unspecified doses might have been administered with no adverse effects. This is one of several reports received from the same source. Additional information has been requested.
About an hour after administration, she started feeling like she couldn't catch her breath. She also stated that it felt like her tongue was too big for her mouth. She also stated that it looked like there was a mosquito bite at the site of administration. She took a benadryl (unknown strength) about 1 hour after developing the breathing symptoms, and an hour later, she was starting to feel better. As of 24 hours after, the administration site reaction is not resolved.
The patient was brought to the ED by EMS  on 10/17/23 for evaluation of weakness and after a fall. In the ED he had a fever of 101.4 F. O2 sats were at 87% so patient was placed supplemental O2. A COVID PCR test resulted positive while the patient was in the ED. Ultimately, the patient was admitted 10/17/23 - 10/20/23 with discharge diagnoses including acute hypoxic respiratory failure due to COVID 19 pneumonia and suspected superimposed bacterial pneumonia, among other diagnoses. During admission, the patient was able to be weaned off oxygen.   The patient has received the Pfizer Monovalent COVID vaccine (given 2/19/21; 3/11/21; 12/6/21) and the Pfizer Bivalent COVID vaccine (given 2/4/23).
chest pain; not feeling well; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (chest pain) and MALAISE (not feeling well) in a patient of an unknown age and gender 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHEST PAIN (chest pain) and MALAISE (not feeling well). At the time of the report, CHEST PAIN (chest pain) and MALAISE (not feeling well) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported. Treatment details were not reported.
Anaphylactic reaction 6 days post vaccine 24Dec2020; I had severe chest tightness; SOB; throat soreness; hoarse voice; mouth swelling; This is a spontaneous report from a contactable physician, the patient.  A 34-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL0140), via an unspecified route of administration in the left arm on 18Dec2020 at 15:30 (at the age of 34-years-old) as a single dose for COVID-19 immunization.  Medical history included severe dust mite allergy (based on skin test).  Prior to the vaccination, the patient was not diagnosed with COVID-19.  Concomitant medications included cetirizine hydrochloride (MANUFACTURER UNKNOWN), hydrocodone bitartrate/paracetamol (NORCO), ibuprofen (MANUFACTURER UNKNOWN), and ondansetron (ZOFRAN); all for unspecified indications from unknown dates and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination.  On 24Dec2020 at 10:00, 6 days post vaccination, the patient experienced anaphylactic reaction, severe chest tightness, shortness of breath, throat soreness, hoarse voice, and mouth swelling; all reported as life threatening.  The events led to an emergency room visit and she was given epinephrine (EPI-PEN), methylprednisolone (SOLUMEDROL), and diphenhydramine hydrochloride (BENADRYL) as treatment. The patient stated that she developed the reactions 45 minutes after she took premedications for a dilatation and curettage procedure. The premedications included ibuprofen, hydrocodone bitartrate/paracetamol, ondansetron. She stated she had taken these medications several times before and this was the first time she had this reaction. Since the vaccination, the patient had not been tested for COVID-19.  The clinical outcomes of the anaphylactic reaction, severe chest tightness, shortness of breath, throat soreness, hoarse voice, and mouth swelling were recovered on unknown dates.; Sender's Comments: Anaphylactic reactions presented as chest tightness, shortness of breath,  throat soreness, hoarse voice, and mouth swelling, developed 45 minutes after premedications including included ibuprofen, hydrocodone bitartrate/paracetamol, ondansetron for a dilatation and curettage procedure and 6 days post vaccination with BNT162B2, the event therefore is most likely attributed to these premedications unrelated to the vaccine use.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
positive covid test on 10/12.  fever, body ache, headache, cough, congestion, fatigue, loss of sense of smell
Lot number : 007B21A 2nd Dose of Covid Moderna Vaccine  When I received my second shot I was unable to move my right arm. This year I had a new C Pap machine and I used it 3 times 8 hrs each time and next thing I know i caught covid for 3 months. On April 5th I woke up paralyzed where I couldn't move my body. Cardiologist checked if there was a problem with my heart. My PCP wanted to wait for results. On May I was seeing a Rheumologist and pain doctor. June I saw an orthopedic doctor for my hand. I had a hand disease going on. AFter that I was having leg and arm problem.
temporary numbness of tongue; A spontaneous report was received from a consumer concerning his wife, a female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and who experienced temporary numbness of tongue.  The patient's medical history was not provided nor were concomitant products.   On 08 Jan 2021 approximately two days prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   On 10 Jan 2021, it was reported that the patient experienced temporary tongue numbness after waking from a nap.  It disappeared and returned to normal that same day.   Treatment information was not provided.   Action taken with mRNA-1273 in response to the event was not provided.   The outcome of the event, temporary numbness of tongue, was considered unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
received one dose of Shingrix in 9.2020; This case was reported by a other health professional via interactive digital media and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (received 1st dose in September 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 30-JUN-2022 Reporter's Comments: This case was received from other healthcare professional via interactive digital media. The patient was there to get Shingrix again and the question was that she had to get a second dose after (2-6months) after receiving the dose on the date of reporting.  The follow-up would not possible as no contact details were available. Additional Supportive Information: Till the time of reporting, the patient did not receive second dose of Shingirx which led to incomplete course of vaccination.
TRANSIENT ISCHEMIC ATTACK MORE FREQUENT; POSSIBLE BLOOD CLOT; SHORTNESS OF BREATH; CHEST PAIN; SWELLING IN ONE LEG; PULSATING HEADACHE; This spontaneous report received from a patient via social media concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, 1 in total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, after took vaccine the patient had major health problems which was described as transient ischemic attack which was more frequent and lasted longer, headaches were a pulsating headache, shortness of breath(more than usual),chest pains, swelling in one leg and seems to be blood clots. The patient was enquire about the involvement of people in vaccine study with conditions like hepatitis C, strokes, chronic obstructive pulmonary disease, chronic headaches, liver problems, transient ischemic attack. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the transient ischemic attack more frequent, pulsating headache, shortness of breath, chest pain, swelling in one leg and possible blood clot was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0-20210452291JANSSEN COVID-19 VACCINE Ad26.COV2.S  This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
SYNCOPE AFTER VACCINE ADMINISTRATION, VITALS GOOD, NO TREATMENT NEEDED
Itching on arms and hands that evening after the shot, dizziness the next day whenever sitting up or standing.