chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I have persistent pain in my left arm at the injection site 5 months after receiving my first vaccination. The nurse provider jabbed my arm with the shot extremely hard (like you would administer an epipen rather than how a shot is normally given).  The pain started while the needle was in my arm and continued to worsen to an excruciating level over the next hour.  Immediately after receiving the vaccine, I could not lift my arm off my side; this continued for 3 days.  I couldn't sleep for several nights due to the severe pain, as the slightest brush of anything against my arm would jolt me awake.  I would categorize my pain level for the first 3 days as a 6 continuously and an 8-9 if touched near the injection site. After the first 3 days, I was finally able to regain a small amount of movement and ability to move my arm away from my side.  A week out from the first shot, the pain level had settled down to a 3-4, where it has remained steady ever since.  My arm hurts every moment, and there is no relief, including from OTC pain medication. I knew something was wrong the moment I got the shot, but thought it was just a bad reaction and would clear up with time.  After 5 months with no improvement, I have concluded that the pain will not resolve on its own. I did receive my second dose on 04/10/2021 in the same facility, and the experience was completely different.  I had no movement restriction, no immediate pain at administration, and mild soreness that resolved within 12-24 hours.  The second, normal experience reinforced for me that what I experienced after the first shot was not normal. I believe that I have a persistent shoulder injury due to improper administration of my first Moderna dose.
Developed chest tightness consistent with how I get when I get bronchitis.  Had to leave work due to symptoms. Woke up a few hours later with headache, dry cough. When to urgent care for my usual bronchitis meds and covid test. Overall took about 2 weeks to get back to normal lung function.
Per RN documentation below:  Patient states "I don't do good with needles"/ C/o dizziness, nausea, placed head down leaning forward. Helped patient down to lie flat, patient diaphoretic, VS 96/69, HR 59, 98% on room air. RR is 15.  Patient sat up, BP 86/62 Patient had cup of water.  Up in gurney HOB , BP 91/67.  Patient able to eat cookies/drinking water.  Denies dizziness while walking outside, picked up by mother.  Total  monitor time 40 min in recovery.
patient received the Covid vaccine below the deltoid muscle, possibly in the subcutaneous tissue.; patient had an injection induration at administration site.; This is a spontaneous report from a contactable pharmacist. A female patient of an unspecified age received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), via an unspecified route of administration on the arm (also reported as below the deltoid muscle), on an unspecified date at single dose for COVID-19 vaccination. The patient's medical history and concomitant medications were not reported. It was reported that the patient received the COVID vaccine below the deltoid muscle, possibly in the subcutaneous tissue. It was asked if there is a need for revaccination. Patient also had an injection induration at administration site. The outcome was unknown.   Information about lot/batch number has been requested.
pt recvd vax & devel area of swelling; redness; tenderness of left arm; tx w/ atb & meds; resolved in 3 days;
Patient received an expired Moderna Vaccine; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received an expired Moderna Vaccine) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received an expired Moderna Vaccine). On 15-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Patient received an expired Moderna Vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. Treatment medications were unknown.    This case was linked to MOD-2021-237427, MOD-2021-237470 (Patient Link).
swelling, burning, itching, redness, hot to the touch, change in skin texture - spreading up:down are from injection site for 10 days and not getting any better. COVID ARM
Patient started experiencing flu like symptoms, body ache, chills, fatigue, etc., about a day after receiving the first dose of his Shingrix vaccine, he does not want to receive the second dose due to feeling so awful after receiving the first dose.
Pt. came into pharmacy 11/19/13 and complained about reaction to ZOSTAVAX vaccine given on 11/14/13. I observed area very swollen, red and skin ruptured around site of injection, she said area had a nodule filled with fluid and burst, Dr. gave pt BACTRIM DS to prevent infection.
Patient reports soreness in his vaccinated arm, which started the next day and lingered for two weeks.
burning sensation over the skin in lower extremities on both sides; pain in extremity; Vaccination site pain; burning sensation over the skin underneath both arms; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (pain in extremity), VACCINATION SITE PAIN (Vaccination site pain), SKIN BURNING SENSATION (burning sensation over the skin underneath both arms) and BURNING SENSATION (burning sensation over the skin in lower extremities on both sides) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 05-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, the patient experienced PAIN IN EXTREMITY (pain in extremity), VACCINATION SITE PAIN (Vaccination site pain) and SKIN BURNING SENSATION (burning sensation over the skin underneath both arms). On an unknown date, the patient experienced BURNING SENSATION (burning sensation over the skin in lower extremities on both sides). On 08-Mar-2021, PAIN IN EXTREMITY (pain in extremity) and VACCINATION SITE PAIN (Vaccination site pain) outcome was unknown. At the time of the report, SKIN BURNING SENSATION (burning sensation over the skin underneath both arms) and BURNING SENSATION (burning sensation over the skin in lower extremities on both sides) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   concomitant  medications  provided  was Atorvastatin,blood pressure medication Treatment information  provided was Tylenol.
a few hr p/vax pt devel a fever & an inj site rxn characterized by redness, soreness & a nodule;pt seen in ER & treated w/ATB & NSAID;pt recovered;
Initial side effects were six hours after the injection. I had severe headache, diffuse myalgia, nausea, photophobia, chills, and fever. About a month after the injection, I have had vague intermittent cheat palpitations for the last 4 months. Most recently, I had acute chest pain and went to the ER. My troponins were elevated but my hearth catheterization was normal. I am have daily palpitations and fluttering. After my heart catheterization  I went  into Atrial fibrillation. I was cardioverted 3x. I am currently following up with a Cardiologist for further evaluation.
Expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A, 027L20A and 015M20A) for COVID-19 vaccination. No Medical History information was reported.  On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 09-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments Facility type is Doctors office. Concomitants and Treatment medications were not provided. Most recent FOLLOW-UP information incorporated above includes: On 12-Nov-2021: follow up received
Mom fed pt approx 530AM; Returned to check on pt 11AM; Pt unresponsive; Called EMS; 24JUL91 DOA 1130-12PM; SIDS?
This spontaneous report was received from a medical assistant via field representative refers to unspecified patients of unknown gender and age. There was no information regarding the patients' medical history, concurrent conditions, drug reactions/allergies and concomitant medications. On unknown dates, the patients were vaccinated with ZOSTAVAX (dosing details were not provided). On unknown dates, the patients complained of shingles. Medical assistant reported that according to a protocol at an unspecified clinic, for patients who experience shingles after receiving ZOSTAVAX were to be administered with a booster dose of the same vaccine. The representative was unaware whether or not the adverse experience of shingles after vaccination has ever been reported, nor does he now how many patients received a booster dose of ZOSTAVAX. He also reported that currently at the time of this report, there were no patients experiencing shingles after the receipt of ZOSTAVAX. Outcome of the event was unknown. Causality assessment was not provided. Additional information has been requested.
This spontaneous report as received from a Registered Nurse refers to a patient of unknown age and gender (patient identifier: 7715627). On an unspecified date the unspecified patient was administered RECOMBIVAX HB (Lot # H010380, expired date: 18-NOV-2014) dose, frequency, route and location unspecified was stored improperly (first exposed to 9C for 30 minutes and then exposed to 8.3C for 1 hour). No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Cancelled second dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Cancelled second dose) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Mar-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 PRODUCT DOSE OMISSION ISSUE (Cancelled second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Cancelled second dose) outcome was unknown. Not Provided      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.
I was breastfeeding at the time and my milk production drastically decreased a day after the injection and has been slowly lessening since.
1) On or about 2/9/2021 I began running a low grade fever daily of approximately 99.5 starting every day at 3:00 PM lasting until after midnight.  The fevers continued daily until approximately 2/26/2021. 2)  On or about 2/19/2021 I began to show a red spotted rash UNDERNEATH my skin.  The rash covered all my torso up to my neck, my arms to my wrist, and my legs to my ankles.  The rash mostly subsided within about two weeks however to this day I still show some mild traces of this rash on my torso.   Please see continuation page below.                Please see continuation page below.3)  On or about 3/4/2021 I began to notice a ringing in both my years, this has continued continuously 24 hours a day, to this date. It seems to inhibit my hearing acuity.  To this day my hearing seems to be diminishing at noticeable daily rate.   4)  On or about 3/7/2021 I began to notice an impairment in my vision.  This impairment is manifested in both eyes equally as a washed out field of vision making it hard to read and discern fine details. At times I also see some small sparkles in my vision and dark impairments (not floaters) that seem to last up to a few minutes and then disappear. These impairments occur at random times during the day for no apparent reason.  To this day my vision seems to be diminishing at a noticeable daily rate. On 2/19/2021 I received an eye exam and at that time, my vision was normal and was diagnosed as such.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old male patient received BNT162b2 (BNT162B2 NOS), on 13Sep2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 52 years for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient received Plaxovid from 11Jan2023 to 16Jan2023 for the treatment of COVID-19. The patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This information has been received from a registered nurse concerning a patient of unknown age and gender. The patient's medical history, drug allergies, concurrent conditions and concomitant therapies were not reported. The nurse stated that on 31-MAY-2017, the patient was inadvertently vaccinated with a dose of GARDASIL 9 with lot number M041213 and expiration date on 22-JUN-2019, administered for prophylaxis by an unspecified route that was supposed to be administered to the patient's sister (dose, dose number and anatomical location were not provided). There was no product quality complaint (PQC) involved. No adverse effects were reported. Additional information has been requested.
Body aches Brain fog Low energy Coughing Shortness of breath Diagnosed with Superimposed pneumonitis & asthmatic bronchitis Treatment: Steroids, Antibiotics, Nebulizers, Inhalers
She got the vaccine, and then she pulled over to wait 15 minutes, a nurse came around and she asked if she was feeling okay, she told her that her left arm and hand were numb.  She told her to more her hand around and then came back within 5 minutes and said to go home and gave her some literature. She had loss of taste as well and a headache/sharp pains.   The area of the injection was hurting, but not badly.  She has extreme tiredness, feels like she is walking through water.  Also upset stomach, started not being able to taste food (metallic taste), and was able to start tasting food yesterday.  She has stayed in the house all week, sometimes feels jittery, she just gets this feeling and surprises her.  She woke up last night during the night and the upper arm were hurting and the hand and arm were numb again.  She keeps exercising the arm which helps some, but it has to go away on it's own and it continues to come and go.  She took Tylenol 2-3 days for the headache.  Two days after the vaccine her normal temp if 97.6, and 2 days after it was almost 100 but that went away and has had no temperature since.  Called her doctor and the vaccine center and they told her to call her doctor and she has an appointment on Monday.
I had done with my 2 dosses of COVID vaccination. It's been almost more than 3 weeks now that i had my 2nd dose of COVID 19 vaccine. There is a little arm pain where i had my vaccine for first couple of days and after that i did started my regular activities including my games (volleyball, etc.). After a week's time, I started to develop intense pain around the injected area and this pain is not regular. The pain starts after i return from my sporting activity or doing a regular home activity that involves arms. This is a routine till date and the pain's intensity might be the same or a level less compared to initial days. Still sees the soreness spot around the injected area even today.  Dose 1 - Apr 7 (Pfizer - ER8729) Dose 2 - Apr 28 (Pfizer - EW0176)
I am allergic to it; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (174934). The reporter is the patient.  A 49-year-old female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HYPERSENSITIVITY (non-serious), outcome "unknown", described as "I am allergic to it".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
About 3 weeks after receiving the bivalent Pfizer vaccine, I started to experience perceived shortness of breath, elevated pulse and an elevated blood pressure that wouldn't resolve. My BP was running 187/104 and that made me go to the ER. At the ER, they did a chest X-Ray, a CT scan with contrast, an EKG, full blood work-up and tested for the enzymes for when someone has a heart attack. I was there for about four hours and they weren't able to find any problems. I was told to follow-up with my PCP. I followed up the following day with my PCP and she did a medication change from lisinopril to metoprolol succinate. The episodes continued, feeling like I couldn't breathe and an elevated pulse. Sometimes it would last for minutes and sometimes it would last for hours. On 11/14, I had the feeling that I couldn't breathe, all night long, and I couldn't sleep. I emailed my doctor and she decided to change the metoprolol to amlodipine besylate. I am still experiencing the feeling of not being able to breathe. On 11/24, the episodes continued from early morning through the entire day. I had the feeling that I couldn't breathe and my pulse was elevated. Today, I am doing good.
24 year female patient administered expired dose of Adacel, no AE; Initial information received on 02-Sep-2020 regarding an unsolicited valid non-serious case received from a other health professional .  This case involves a 24 year old female patient who received 0.5 ml first expired dose of vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (lot U6021AA and expiry date: 27-Jul-2020) via intramuscular route in the right deltoid on 31-Aug-2020.  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.  It was a case of actual medication error due to expired vaccine used.   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 set out in Directive 2001/83/EC and Module VI  of the Good Pharmacovigilance Practices. 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.
Approximately 12 hrs after vaccine, pt developed red, warm area on thigh that progressively got bigger. 2 days after came to office with 6x8 inch area of warmth, redness, tenderness with no induration. Put on antibiotics & steroids.
Moderna COVID-19 Vaccine EUA  Severe Injection Site Pain. A ball formed in my shoulder and pain prevented use of arm. Majority of pain has gone away after five days.
She got her vaccine, had no reaction immediately other than her arm was a little sore the rest of the day.  The next day her arm was a little sore, perhaps a tiny bit of fatigue.  Went to bed and woke up about 2 or 3:00 AM and her ears were screaming, ringing, and had a weird headache, and was frightened because of the way she felt.  She went to the UC and they gave her Ativan and told her that was having anxiety and sent her home.  The ringing in the ears never stopped, and 2 days later the same thing happened in the middle of the night.  This happened 5 times up until the end of January and all that whole time and up until today she has been woken up 2-3 times a night with ringing in her ears.  She had a MRI done which did not show any fluid or growth/tumor in her ears.  It did show some ischemia, but no reason for the ringing in her ears.  She went to an ENT to find out what was going on, and is in the process to have a hearing test to see if there is something wrong.   She has not slept a full night since the getting the vaccine.  She has to turn the TV on in the night and sit up to calm herself down as it is a horrible, horrible thing.   She said that she was fine until the booster shot.    She only had sore arms from the 1st and 2nd ones, light fatigue but nothing like this.
Patient is 17 years and 10 months of age.  Should not have received vaccination.  There have been no immediate adverse effects.  I have spoken both to the patient and her mother.
Nausea, head ache, tiredness, chills, low grade fever for the next 36 hours.
pt recv vax;approx 5 min later,c/o feeling dizzy,became pale thus unconscious;arms flexed as body became rigid while arching 10 sec,was incontinent;regained consciousness;PC from PAR;sore arm but no other problems;was advised to inform MD;
Pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnancy) in a female 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (Pregnancy). At the time of the report, EXPOSURE DURING PREGNANCY (Pregnancy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided. No concomitant medication was provided.  Company Comment: This is a case of product exposure during pregnancy with no associated AEs for this female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.