chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Potential AE due to doses administered from vials that may have been compromised; Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion; Administered vaccine from vials that may have been compromised; This spontaneous case was reported by a pharmacist and describes the occurrence of IMMUNISATION REACTION (Potential AE due to doses administered from vials that may have been compromised), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine from vials that may have been compromised) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Potential AE due to doses administered from vials that may have been compromised), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine from vials that may have been compromised). At the time of the report, IMMUNISATION REACTION (Potential AE due to doses administered from vials that may have been compromised), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine from vials that may have been compromised) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was reported that, vaccines administered at pharmacies that were stored in an unapproved freezer and thus might have been compromised. At pharmacy, digital data loggers and freezers expired before they were re-calibrated. They were aware in some of the freezers there was a temperature excursion that their data logs showed. The vaccines never reached a temperature that was considered outside of frozen recommended range. The data loggers had laps where they were not considered calibrated, so they had paper logs to monitor those temperatures. That was in several different freezers and the vial temperatures never went out of range when they were using the paper log.  The beyond used date was reported as 01-Dec-2021 to 15-Dec-2021. Moderna date ordered was reported as 01-Nov-2021 and 15-Nov-2021.  No treatment details were reported.
Cerebellitis -  patient presented with ataxic dysarthria , dizziness and an increase in neck and head pain.  Spinal fluid analysis demonstrated 52  white cells, 2  red cells. mild cerebellar enhancement on MRI.  Infectious screen and autoantibody screen negative.  Patient is spontaneously improving  Without therapy.
Ache and fever next day. Chills, 24th ache and cold, arm red and swollen about 2 inch red area, just didn't feel good, feels some better today (24th)
Itches; started to experience swelling; Redness; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itches), SWELLING (started to experience swelling) and ERYTHEMA (Redness) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, the patient experienced PRURITUS (Itches), SWELLING (started to experience swelling) and ERYTHEMA (Redness). At the time of the report, PRURITUS (Itches), SWELLING (started to experience swelling) and ERYTHEMA (Redness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication details were provided. No treatment medication details were provided.
Estimated due date:  04/10/2021 I started to get very flush and warm, dizzy so I had to sit down for a moment (I had to stop the procedure I was doing in order to sit down and drink some water). I kept trying to hydrate and had a headache the rest of the day and it went through the evening and night. I did not take anything and went to bed with the headache and woke up and felt fine.
This patient is an 80-year-old man, followed by Dr.  He was exposed to his wife with COVID.  He was not having any symptoms, but was tested on January 12th and was positive for COVID.  He started developing some COVID symptoms on January 14th.  He is fully vaccinated.  His symptoms have been fever, cough.  He started developing shortness of breath and weakness.  He was actually in the emergency room on January 16th, main complaints were weakness, had some dehydration at that time. He was able to be discharged home.  He started having worsening weakness and shortness of breath.  He was found to have a pulse ox of 84% at home and was brought here for further evaluation.  I asked the patient if he had been started on any treatment for COVID and he admitted to taking doxycycline.  Pharmacy on the med reconciliation though notes that he is taking 4/5 days of Molnupiravir for COVID.   DISCHARGE SUMMARY HAS NOT BEEN COMPLETED AT THIS TIME.
No adverse event; Received 0.5ml Bivalent Booster instead of 2nd primary Monovalent dose; 2nd primary dose was given 6 months after the first primary dose; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (Received 0.5ml Bivalent Booster instead of 2nd primary Monovalent dose), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd primary dose was given 6 months after the first primary dose) and NO ADVERSE EVENT (No adverse event) in a 52-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Sep-2022, the patient received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 26-Sep-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Received 0.5ml Bivalent Booster instead of 2nd primary Monovalent dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd primary dose was given 6 months after the first primary dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Received 0.5ml Bivalent Booster instead of 2nd primary Monovalent dose), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd primary dose was given 6 months after the first primary dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for WRONG PRODUCT ADMINISTERED (Received 0.5ml Bivalent Booster instead of 2nd primary Monovalent dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd primary dose was given 6 months after the first primary dose).    No concomitant medications were reported. On 22-FEB-2022, the Patient received first primary dose of Moderna monovalent vaccine of Batch no 033K21-2A, Expiry date was unknown. Patient had not reported any adverse reactions. No treatment information was provided.
I received my third Moderna vaccine dose for COVID-19 on 12/04/2021. At around midnight on 11/21/2022, I had chills and a fever of about 101. I also developed a headache, which along with the fever, lasted all day that day. On 11/22/2022, I developed a productive cough with thick mucus and a sore throat. I don't remember much about my symptoms otherwise, except my fever lasted until 11/24/2022. During this time, my fever was about 100-102. Then on 11/25/2022 and 11/26/2022, my fever dropped a little and was in the 99-100 range. During this time, I also had profuse night sweats. I took DAYQUIL and NYQUIL to treat my symptoms; they were helpful, because every time I took them, my temperature would drop significantly within a couple of hours of my taking the medicines. I took home antigen tests on 11/21/2022 and 11/22/2022, and they both yielded negative results. When I took another test on 11/23/2022, I got a positive result. I emailed my PCP's practice, and I got a response with information about self-care during my illness and also about the option of taking PAXLOVID. I chose not to get the PAXLOVID and just stuck with the OTC medicines I had been taking. The symptoms gradually improved on a daily basis. I tested myself every day during my illness and always got a positive response until 12/02/2022, which was the day I finally got a negative result for the first time since my illness. At the time of this writing, I'm doing much better, except I still have some fatigue, a little bit of a cough, and minor sinus congestion.
Allergic reaction to serum; Swelling; redness; warmth; This is a spontaneous report from a contactable consumer (patient).   A 70-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Batch/Lot number was not reported),  via an unspecified route of administration, administered in right arm on 28Feb2021 10:30 (at the age of 70-years-old) as dose 1, single for covid-19 immunization.  Medical history included Breast cancer remission. Patient previously took  Penicillin and experienced allergy.  The patient's concomitant medications were not reported. Prior to vaccination, the patient was not pregnant, not diagnosed with COVID-19, did not receive any other vaccines within 4 weeks and no other medications within 2 weeks. The patient experienced allergic reaction to serum, swelling, redness and warmth on 01Mar2021 11:00.  The patient underwent lab tests and procedures which included sars-cov-2 antibody test: negative on 06Jun2020.  The events were treated with doxycycline antibiotic. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Approximately 12 hrs after vaccine I started having chills, severe joint and muscle pain, headache, nausea, and pain in the left arm at the injection sight.  About 24 hrs after the injection I started having a fever which got as high as 103? I still feel unwell, am very tired?52 hrs after the injection..
Left lat arm 8x11 cm erythema with 6x4 cm induration. non tender, increase local temp. on 10/25/06 exam reaction noticed 10/24/06 evening. Flu vaccine given IM left deltoid 10/23/06.
Headache for 4 days following vaccine. On day 5 following vaccine developed hives on arms and chest.
Face redness, very hot, sweating,  huge migraine headache, confusion,  neck veins were  about to pop
At the pharmacy, pt is 12+ years old (specifically 15 years old) and was given 0.25 ml moderna bivalent when it should've been 0.5 ml full dose. pt and parent were fine and we gave the remaining dose.
Server low blood pressure and heart rate readings. Also, dizzy,sweating,weakness, and blance issures.
Dose administered 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 manufacturer date of expiry) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     Previously administered products included for an unreported indication: PFIZER BIONTECH COVID-19 VACCINE (First dose was Pfizer on 05Apr2021) on 05-Apr-2021, PFIZER BIONTECH COVID-19 VACCINE (second dose was Pfizer and on 26Apr2021 at a mass vaccination facility.) on 26-Apr-2021.    On 08-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 ml. On 08-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry). On 08-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant treatment was provided. No treatment medication was provided.
ACHES; DIFFICULTY WALKING; JOINT PAIN; TIRED; This spontaneous report received from a patient concerned a female of unspecified age. The patient's past medical history included several joint replacements, and flu, and concurrent conditions included severe arthritis, and scoliosis. The patient had no known allergies. The patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 15-MAR-2021, the subject experienced aches. On 15-MAR-2021, the subject experienced difficulty walking. On 15-MAR-2021, the subject experienced joint pain. On 15-MAR-2021, the subject experienced tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from aches, joint pain, tired, and difficulty walking. This report was non-serious.
Headache, Myalgia, feverish, weakness, injection site pain Narrative:  Employee reports feeling "feverish" (did not take temperature), had chills, body aches, weakness, injection site pain/discomfort, headache, and fatigue. Took ibuprofen (no dose/frequency reported).
1 day post vax pt exp sore arm;2nd day post vax pt felt achy all over, feet tingled;pt had chills & the low fever (99 1/2), & felt very weak & had a little appetite;3rd day had h/a, still low fever & chills & weakness, chills, & no appetit
stress related hives; stress related hives; Rash in arm,hand ,shoulder and face; Rash on her arm, little itchy and uncomfortable; red shoulder; Sore arm; Red , swollen shoulder; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), SWELLING (Red , swollen shoulder), PRURITUS (Rash on her arm, little itchy and uncomfortable), ERYTHEMA (red shoulder) and STRESS (stress related hives) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included APIXABAN (ELIQUIS), VITAMIN D NOS and VITAMIN C [ASCORBIC ACID] for an unknown indication.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), SWELLING (Red , swollen shoulder) and ERYTHEMA (red shoulder). On 25-Jan-2021, the patient experienced PRURITUS (Rash on her arm, little itchy and uncomfortable) and RASH (Rash in arm,hand ,shoulder and face). On an unknown date, the patient experienced STRESS (stress related hives) and URTICARIA (stress related hives). At the time of the report, PAIN IN EXTREMITY (Sore arm), SWELLING (Red , swollen shoulder) and ERYTHEMA (red shoulder) had not resolved and PRURITUS (Rash on her arm, little itchy and uncomfortable), STRESS (stress related hives), URTICARIA (stress related hives) and RASH (Rash in arm,hand ,shoulder and face) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient was using xyroxen 0.125mg 1/day along with other conmeds. Patient stated that the rash she had was not a reaction to the vaccine but stress related hives, her doctor confirmed it.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 01-Jul-2021: added events and updated case details.
Information has been received from a Certificate Medical Assistant (CMA) and registered nurse (RN) regarding a patient of an unknown age and gender. The RN stated that on 19-JUL-2013, the patient received a dose of PROQUAD (lot number J001052, expiration date 28-JUL-2014) (dose and route were not provided) that had been improperly stored. The R.N. stated that the patient had not experienced adverse effects. No additional details had been provided at that time. This is one of several reports from the same source (other MARRS #s 1308USA013854, 1309USA013044 and 1309USA013045). Additional information is not expected.
Breakthrough case admission after 2 vaccines Moderna 1/28/21 lot# 028L20A;  Moderna 2/25/21 lot# 004M20A
trouble Breathing Swollen legs. Admitted to hospital for two days.  CAT scans & X rays performed. Told i have blood clots in both lungs & legs  Eliquis prescribed
Screamed for 3 days, 2 hrs at time beginning day of shot. She hit her head repeatedly during the 2 hrs. She also bit anyone she could get her mouth on. We could not get her calmed down.
Fatigue; This is a spontaneous report from a contactable consumer. A 14-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EW0217) via intramuscular route of administration in the left arm on 05Jun2021 at 14:45 (at the age of 14-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not receive any other medications in two weeks of vaccine. The patient had no known allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EW0217) via intramuscular route of administration in the left arm on 14May2021 at 13:45 (at the age of 14-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 06Jun2021 at 10:45, the patient experienced fatigue. No therapeutic measures were taken a result of the adverse event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event fatigue was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected
Has not received the second dose; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a adult female patient who received Herpes zoster(Shingrix for prophylaxis.   Previously administered products included Shingrix (1st dose received on September 2020, 0.5ml, intramuscular route in an unknown arm).   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 details were preovided as follows: The reporter was the patient. The age at vaccination was not applicable for this report. The reporter declined to provide demographic information or provide any other information. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter did not consent to follow up.
after few hours of taking the vaccine, headache,low body temperature.next morning, low blood pressure, nausea, body ache, stiffness in right arm, this continued for whole one day. 2nd day, fever, body ache. fever continued for 3rd day.
at site of injection, allergy appeared; hot; burning sensation; red; pain; Fever/Now, I have something mild; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 04-Mar-2021 and was forwarded to Moderna on 04-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (at site of injection, allergy appeared), VACCINATION SITE WARMTH (hot), BURNING SENSATION (burning sensation), VACCINATION SITE ERYTHEMA (red) and VACCINATION SITE PAIN (pain) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma. Concomitant products included GABAPENTIN (NEURONTIN), LEVOTHYROXINE SODIUM (SYNTHROID) and CIRCUPLEX for an unknown indication.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPERSENSITIVITY (at site of injection, allergy appeared), VACCINATION SITE WARMTH (hot), BURNING SENSATION (burning sensation), VACCINATION SITE ERYTHEMA (red), VACCINATION SITE PAIN (pain) and PYREXIA (Fever/Now, I have something mild). At the time of the report, HYPERSENSITIVITY (at site of injection, allergy appeared), VACCINATION SITE WARMTH (hot), BURNING SENSATION (burning sensation), VACCINATION SITE ERYTHEMA (red), VACCINATION SITE PAIN (pain) and PYREXIA (Fever/Now, I have something mild) outcome was unknown.        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.   The patient reported that she received treatment with unspecified pills for allergies along with hydrocortisone cream with aloe. Following treatment, did not have her arm as hot as before and also she did not feel discomfort in her arm.
Patient states awoke during night with trembling, dizziness, vomiting x's 1 approx 5 days after injection#1. Pt with IDDM, BS elevated at that time. Episode lasted approx two hours. Also with similar complaints after Injection #2, will report as separate event. Of note, pt diagnosed with Shingles on 3-5-07.
After the vaccine I started coughing on that day but was mild. I developed a pain in the arm ad radiating from my shoulder to wrist, The next day I was fatigue and the arm pain continued. The cough came and sent over the month. Last week it was getting worst and I am not sure why and I am trying to make a doctors appt. My concern is that when I inhaled there was some irritation in my chest and even when I breathe.
Tingles in shoulder, neck, behind my left ear, across my left side of my face, over my mouth and under my left eye.
Initial report received from a healthcare professional on 01 May 2013. A 33-year-old female patient had received first intramuscular dose of ADACEL (Lot number: U4612AA, anatomical site of vaccination was not reported) on 01 May 2013. The patient was pregnant at the time of vaccination. The last menstrual period date was 15 October 2012 and the expected date of delivery is 22 July 2013. The patient's health during pregnancy and risk factors (e.g.: alcohol, tobacco or recreational drugs) were not reported. As of 01 May 2013, the patient did not experience any adverse event. List of documents held by the sender: None.
Patient received a Janssen Covid shot and 7 minutes after being given the shot became light headed. Pharmacist came out when alerted by the patients mother and helped the patient to the ground. Patient lost consciousness for 10-15 seconds on the way to the ground. 911 was called . Patient was assessed and it was determined he was ok. Patient left on his own accord after about 30 minutes.