chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The vial was initially stored in the refrigerator on 16-Mar-2023; no adverse event; Dose administered after 30-day Use By Date or after manufacturer date of expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 16-Mar-2023) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 066H22A) for COVID-19 prophylaxis.     No Medical History information was reported.  On 20-Apr-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 20-Apr-2023, 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 PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 16-Mar-2023) and 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), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 16-Mar-2023) 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 EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 16-Mar-2023).    No concomitant medications were reported.  It was unknown if the patient receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. The BUD was reported as 15-Apr-2023.  The vial was initially stored in the refrigerator on 16-Mar-2023. The vial did not undergo any temperature excursions.  No treatment medications were reported.  This case contains information for the 3 of 5th adult patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-720516 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-720516:1st patient case (Master case)
Dizziness, rapid heartbeat, difficulty breathing.  Lasted 11/2 hrs.  Took 3 verapamil, & used albuterol inhaler.
Overnight the night after vaccination, patient reports the site of Spikevax (covid-19) vaccination became locally red, swollen, and itchy.  She tried Advil which provided marginal relief.  Over the following two days she reports that the swelling has slowly improved but the red area somewhat spread, on 11/3 appears roughly the diameter of a tennis ball.  Counseled patient to continue to montior and symptomatically treat; that this is not unheard of.
Mild firmness under papule where shot given, 3 days after administration. Treat by monitoring. Mom reported that it was larger mass and blue appearing.
She had a small dot on her back which proceeded to produce many dots in a pattern in one section that moved around her torso towards her belly button. This lasted for a month and all we could do is cover her up so it would not pass on to any other family members. We also went to see her doctor on 3/28/2014 and she was diagnosed by Doctor with Shingles. She never once had chicken pox just the vaccine to prevent it.
Pt has dizziness, felt nauseated, and vomited. We observed her for 15 minutes and felt fine.
Pt not able to lift arm c/o pain radiating into neck and into back. Tx: NSAIDS, ice, rest.
pneumonia vaccine for a 67 year old healthy male patient vaccinated at approximately 3:30 PM on Friday   About three hours after the shot the pain in the arm became excessive. An area about 4 inches by 6 inches in the area of the shot in the upper left arm became very warm and red. Cramping in the left hand near the the thumb and both the middle and ring fingers took place. Cramping also took place behind the left knee and on the outer left ankle. I am a  deliberate water drinker of over 6 glasses of water a day so there was no dehydration. I could not sleep on my left side. I took Tylenol.    The next day any movement of my left arm caused pain. I elected not to carry out any normal activities. The cramps subsided although during the night my entire right leg cramped too.  All of this cramping is not at all normal for me.   This continued until Sunday morning.  After  speaking to a nurse I started cold for 15 minutes 3 times a day and more Tylenol  Monday morning as I am writing this the area is red. It is no longer puffy.  I am returning to normal I think.  I have never had a reaction like this to a vaccine before.  Only minor pain the day of the vaccination.
Severe anaphylactic.  Tongue swollen throat swollen. Facial swelling throat swelling.   First occurred at 10:50. Epi pen given.  Second wave of symptoms at 1.  2nd dose epi given to leg and went to emergency room
Pt. admitted to hospital on 23 Jan 21 with  Abdominal distention; Abdominal pain; Benign prostatic hyperplasia without lower urinary tract symptoms; Bilateral lower extremity edema; Chest pain; Essential hypertension; Generalized abdominal pain; Lower extremity edema; Mesenteric mass; Pain of upper abdomen; Shortness of breath; Weakness Discharged 25 Jan 21
18 y.o. female admitted voluntarily arrives to the facility seeking help for her mental health (chronic depression).   Tested positive for COVID upon admission.
"Approx 45 min after vaccination" felt anxious. "Arms felt twitchy" lasted for 2 hrs. in all, felt he couldn't focus on a task & increased energy - ran in place to relieve feelings. Felt at times he couldn't control his movements. This satisfied his increased anxiety per mother. Difficulty falling asleep. Did attend school as usual 1/10/13. No medical follow up. Called nurse practitioner in AM & was not concerned. Mth stated this helped her to feel better.
horrible pain on left side; general musccle soreness; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain and muscle soreness. On an unknown date, the outcome of the pain and muscle soreness were not recovered/not resolved.   It was unknown if the reporter considered the pain and muscle soreness to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 13-JUN-2022 Reporter's Comment: The patient self-reported this case via interactive digital media. The patient received dose of Shingles vaccine and experienced horrible pain on left side and general muscle soreness all over. The patient stated that still above symptoms had not went away. The patient hate to thought, what the real thing felt like. Additional supportive information: The follow-up would not possible, as no contact, details were available.
had swollen lymph nodes in her throat; This spontaneous case was reported by an other health care professional and describes the occurrence of LYMPHADENOPATHY (had swollen lymph nodes in her throat) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LYMPHADENOPATHY (had swollen lymph nodes in her throat). At the time of the report, LYMPHADENOPATHY (had swollen lymph nodes in her throat) 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 considered LYMPHADENOPATHY (had swollen lymph nodes in her throat) to be related.    Concomitant medication was not reported.  Patient had a reaction 2.5 years ago when she received her first shot and had swollen lymph nodes in her throat and did not need to go to the doctor and was okay the next day.   It was mentioned that patient has received other doses and now has an EpiPen.  Treatment medication was not reported.
Arm pain; aches; tiredness; This is a spontaneous report from a non-contactable consumer (patient). A 49-year old male patient received second dose of bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 17Feb2021 12:30 (Lot Number: EL3247) as single dose (at age of 49-year-old) for covid-19 immunisation. Medical history included asthma. Patient received first dose of bnt162b2 (BNT162B2) on 26Jan2021 at 12:00 PM in Left arm (at age of 49-year-old) for covid-19 immunisation, lot number: EL3247. Concomitant medications in two weeks included ubidecarenone (COQ10), ergocalciferol (VIT D), glucosamine (GLUCOSAMINE). Patient did not receive any other vaccine in four weeks. On 18Feb2021 patient experienced arm pain, aches, tiredness. Patient was able to perform work but at a reduced pace. No treatment was received for the events. Patient did not have COVID prior vaccination and also patient was not tested for COVID post vaccination. Patient had not recovered from the events, at the time of the report.  No follow-up attempts are possible. No further information is expected.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP)  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "Tested positive for COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Dec2022) Positive.  Clinical course: Caller stated that she was around 12 people, which consisted of a cousin who came from # and was not feeling well. Caller stated by the end of the week, 7 of the 12 individuals tested positive for COVID, in which they all had gotten the vaccines.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
no adverse event; HCP (nurse) called to report TE for VARIVAX (lot: W031813 expiration: 10/05/2024) that occurred on 05/11/2023 but she was not made aware by the state until today (06/26/2023).  The product was stored at 10.8F for 8 hours, 23 minutes and 0 seconds with; This spontaneous report was received from a nurse referring to a 12-month-old patient of unknown gender. The patient's medical history, concurrent conditions, historical drugs, and concomitant therapies were not reported.  On 11-MAY-2023, varicella virus vaccine live (oka/merck) (VARIVAX) injection (lot number W031813 was verified to be valid, expiration date reported and confirmed as 05-OCT-2024) suffered a temperature excursion (TE). On 23-JUN-2023, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) injection, 0.5 milliliter (lot number W031813, expiration date 05-OCT-2024), administered as prophylaxis (route of administration and anatomical location were not provided) (Product storage error). The reporter made aware of the TE by the state until 26-JUN-2023 (reported as "today"). The product was stored at 10.8F for 8 hours, 23 minutes and 0 seconds with a supported TE stability evaluation, and there were not any previous excursions and 8 doses total were administered. No adverse outcomes or side effects were reported or observed by the patient who received the administered dose by an experienced HCP.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2306USA012560: US-009507513-2306USA012702:
Was in bed for one and half days; he has received 1 dose of the vaccine and never got the 2nd dose as advised by his HCP; Had slight fever; This spontaneous case was reported by a consumer and describes the occurrence of BEDRIDDEN (Was in bed for one and half days), PRODUCT DOSE OMISSION ISSUE (he has received 1 dose of the vaccine and never got the 2nd dose as advised by his HCP) and PYREXIA (Had slight fever) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BEDRIDDEN (Was in bed for one and half days), PRODUCT DOSE OMISSION ISSUE (he has received 1 dose of the vaccine and never got the 2nd dose as advised by his HCP) and PYREXIA (Had slight fever). At the time of the report, BEDRIDDEN (Was in bed for one and half days), PRODUCT DOSE OMISSION ISSUE (he has received 1 dose of the vaccine and never got the 2nd dose as advised by his HCP) and PYREXIA (Had slight fever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
Twenty minutes after receiving the test I started having sever menstrual bleeding. I had already had my menstrual for the month and have never had two in one month. I also have never had a cold sore in my mouth and after the vaccine I have two that appeared twenty four hours after the first shot.
Had swelling and redness at site ~ 3" x 3" began 8/28/02. Rx Augmentin 400 BID x 10 d.
No Adverse event; Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial(10 mcg) instead of blue cap vial(25 mcg), when blue cap was indicated; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial(10 mcg) instead of blue cap vial(25 mcg), when blue cap was indicated) and NO ADVERSE EVENT (No Adverse event) in a 6-month-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch nos. 216K22A and 214K22A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 04-May-2023, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 10 microgram. On 01-Jun-2023, received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 10 microgram. On 04-May-2023, the patient experienced WRONG PRODUCT ADMINISTERED (Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial(10 mcg) instead of blue cap vial(25 mcg), when blue cap was indicated). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial(10 mcg) instead of blue cap vial(25 mcg), when blue cap was indicated) 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 assessment was provided for WRONG PRODUCT ADMINISTERED (Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial(10 mcg) instead of blue cap vial(25 mcg), when blue cap was indicated).    No concomitant medications were reported. The patient didn't received third dose. No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-730780 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-730780:Master case
Received 1st dose Moderna on 01/12/2021.  Had low grade fever, headache and fatigue for 5 days.  Arm was sore as well for 3 days but no redness at injection site.  On 01/23/2021 noted red marks on fingers and palms., itiching to only 1 finger.  Also noted on left wrist hives with itching.  Also, had 2 red dots on both elbows mirroring each other.  As well as 1 red spot on top of each foot and ankle both Left and Right again mirroring each other.  Went to express clinic and given Cortisone cream 2.5%.    Following day 01/24/2021 noted Right wrist with hives and in same location as Left wrist which was still with hives.  Also noted numerous red dots 8-10 dots on Left hip no itching.  Both days I had headache and fatigue, no fever.
Slight pain on injection. Bump formed quickly. Bump turned to a hot, red swelling area the size about 3 inches in diameter. Bruising and burning at injection site 9/10 through today (9/14).  Patient reports lethergy and diarrhea.
Breakthrough COVID admit to Hospital on 8/21/2021. Patient received Pfizer COVID-19 vaccine, last administration on 3/26/2021.  8/21/21: admitted to Cardiac Medical Med/Tele. Patient tested positive for COVID-19. Diagnosed with COVID19 pneumonia  8/28/21: Patient discharged home.
Pt began to itch, become hot, lips and tongue began to swell, hard to breathe, throat began to swell, pt described "euphoric state". Pt went to ER.
The following day after receiving vaccine, developed L delt redness, swelling, tenderness. Used no remedies to relieve.
Severe reactive arthritis started 3 months after vaccine. I?ve never had any symptoms of arthritis even mildly before this event.  Severe arthritis started in left knee overnight and has progressed to both knees and right elbow. Pain has been consistently present for 7 months with no moments of relief. It was so bad I had to start using a cane. I sought treatment immediately and have been tested for several autoimmune conditions and infections with the only diagnosis currently being that it?s reactive arthritis resulting from some viral or bacterial infection that triggered an autoimmune response. I am currently taking sulfasalasine but it has not remedied the inflammation. Currently only steroid injection gives momentary relief. Still working with rheumatologist on next plan of action.
I started having headaches, fatigue and if I would stand up for long period of time, I would get dizzy. This morning I feel like I had vertigo and also the day of the vaccination. I felt tired and had a lot of chest pain. I also had the flu vaccine the same day I got the dose 3. Also, on 11/09/2021 I had a sleep study for 48 hours and I will get the results in two weeks.
This spontaneous report as received from a healthcare worker refers to an 8 week old patient of unknown gender. On 25-APR-2014 the patient was vaccinated with ROTATEQ lot # H013164, expiry date 01-MAR-2014, dose 1, 2 ml, oral. No adverse events were reported. Additional information has been requested.
Stomach cramps, migraine headache, nausea, decreased appetite, aches and pains, dizziness, ear ache, and joint pains.
5 days after TB test, throbbing pain in left forearm, unable to lift due to increased pain. NO swelling or redness at injection site.  3 inch bruise noted on 11/09, went to provider on 11/10.
Hardness in the arm, stiff arm that was fine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MUSCULOSKELETAL STIFFNESS (non-serious), outcome "recovered", described as "Hardness in the arm, stiff arm that was fine".  Additional information: Patient had been tested since the vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a consumer concerning her 21 year old daughter with no known drug allergies and no medical history who on 10-JAN-2011 was vaccinated with her first dose of GARDASIL which was expired (lot # and expiration date unknown) at a health center. There was no concomitant medication. The patient felt faint after receiving the vaccine and the vaccination was painful. The patient was in observation. Lab diagnostics studies were not performed. The patient had sought unspecified medical attention. At the time of reporting, the outcome was unknown. No further information is available.
13 hours post shot I had fever, chills, body aches, headache-lasted about 14 hours.  2 days later I developed a rash all over my chest, belly and up the sides of my neck.
Client reported on screening form this was first dose, but they had actually received a full series of Sinovac previously. Monovalent vaccine given in error, client is aware and scheduled for a bivalent booster instead.
a patient who just got the Covid-19 Vaccine and has tingling in her fingers.; This is a spontaneous report from a contactable pharmacist.   A patient of unspecified age and gender received an unknown dose BNT162B2 (FIZER-BIONTECH COVID-19 MRNA VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunization. he patient medical and concomitant medications were not reported.  The experienced tingling in her fingers after getting the COVID-19 vaccine. Reporter wanted to know whether it is normal, he does not think so. He told he will fax AE for side effects tingling in fingers. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Outside of the normal reactions (lymph node swelling, arm discomfort), I also felt Heart fluttering, and had blurred vision evening of the booster. I felt mild heart fluttering after first 2 vaccines as well which were Moderna, but it was very mild. It was worse after booster, as I felt some heart fluttering / chest pain the day of the booster and the following day as well.
High fever, intense headache first 4 days   Major hormone disruption: heavy menstrual bleeding 10 days prior to expected period ; impact on energy, mood; swollen breasts/nipples. Bleeding stopped, other symtpoms weakening but not entirely gone. Not due next period yet (assuming it will arrive my normal 29 days from the vaccine-induced bleeding).   Context:  Not pre-menopausal  Regular, light/average bleeding, never early Generally well, fit and healthy
starting that evening, I had fever to 101, headache, heartburn and diarrhea for about 30  hours. on 2/25 I had an echocardiogram that had been scheduled 3 months prior.  It showed a trace pericardial effusion which was unexpected.
Neck pain began 4 or 5 hours after the shot in left arm.  It has persisted daily and contant since then ans limits range of movement in my neck.   I had to previous long term persistent neck pain.  I am currently undergoing physical therapy for my neck which is slowly improving  the condition.   I asked my doctor if I should take the second vaccine.  He was indecisive.