chrisvoncsefalvay/vaers-outcomes huggingface dataset:
muscle tendon pain on the left side of neck/pain went to right side of neck/pain appeared both sides and still persisting; muscle tendon pain on the left side of neck/pain went to right side of neck/pain appeared both sides and still persisting; pain on the shoulder area; stiff neck; This is a spontaneous report from a contactable consumer, reporting for herself.  A 79-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: EL9263, via an unspecified route of administration on 09Feb2021 at 16:30 (at the age of 79 years old) as a single dose in the left arm for COVID-19 vaccination. Medical history included atrial fibrillation diagnosed about 15 years ago. Concomitant medications were not reported. . The patient did not receive any other vaccines within four weeks prior to the vaccination. On 10Feb2021, the patient experienced muscle pain and tendon pain. It was reported that she experienced a pain on the shoulder area and a "muscle tendon pain" on the left side of the neck the next day. The pain then went to her right side of her neck the day after. The day after that, she mentioned that the pain appeared on both sides of her and is still persisting until now. She mentioned she had a real stiff neck that she could barely turn her head without having great amount of pain. She could only align her ear to her shoulder on that range. She is not 100% sure it's related to the vaccine but she mentioned that this has never happened before. She is asking if this a normal side effect and how long should this last. It was "Reported she got her first COVID-19 Vaccine shot last Tuesday, 09Feb2021. She said on Wednesday, 10Feb2021, she developed a cramp on the left side of her neck (clarified as more of a muscle or tendon pain) She said the area from where her left bra strap sits to her left ear was sore. She said she got her COVID-19 Vaccine administered in her left shoulder. She said she didn't think anything about the left neck pain at first. She said she put cream on her neck and took some Tylenol as needed. She said the following day, Thursday, 11Feb2021, the left side of her neck was fine, but the right side of her neck had the same muscle pain or tendon pain.  She said both the right and left sides of her neck hurt now. She said she can barely turn her head in either direction due to the pain. Caller asked if her neck pain is some kind of reaction to the COVID-19 Vaccine." She had blood work done on Oct2020 with unknown results. As treatment, she has been taking Extra Strength Tylenol ever since she developed neck pain and arnicare cream for muscle  and tendon pain. The clinical outcome of muscle pain and tendon pain was not recovered. The outcome of stiff neck and pain on shoulder area was unknown.
Adverse reactions: 8/23/07 - 10/12/07 headache, redness, rash, itching, soreness and swelling at injection site.  When fatigued, still have muscle ache at injection site muscle area.
Patient fainted after vaccination.  He regained consciousness very quickly, but was pale.  I gave him an ice pack and checked his blood pressure at 12;18PM (104/57 pulse 48).  Patient stated he has not fainted for a vaccination before, but has fainted for bloodwork in the past.   Blood pressure rechecked at 12:40pm (112/69, pulse 53), Patient no longer pale and he said he felt back to normal.  He did not want any additional assistance.
Rash; Arthritis pain after first two injections; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An elderly female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 05Mar2021 (Lot number: EN6205) as dose 2, single and administered in arm left, administration date 11Feb2021 (Lot number: EM9810) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Heart Problems" (unspecified if ongoing), notes: other medical history: Heart Problems; "Known allergies: Contrast Dye" (unspecified if ongoing), notes: Known allergies: Contrast Dye. The patient took concomitant medications. The following information was reported: RASH (non-serious) with onset 2021, outcome "unknown", described as "Rash"; ARTHRALGIA (non-serious) with onset 2021, outcome "unknown", described as "Arthritis pain after first two injections".  Additional information: No other vaccines received in four weeks. The patient received hypertension medication in 2weeks. On 26-Nov-2021, the patient received third dose of Pfizer covid-19 vaccine.  No follow-up attempts are possible. No further information is expected.
ED to Hosp-Admission Discharged 9/6/2021 - 9/9/2021 (3 days) Pneumonia due to COVID-19 virus   DETAILS OF HOSPITAL STAY   Presenting Problem/History of Present Illness/Reason for Admission Shortness of breath [R06.02] Pneumonia due to COVID-19 virus [U07.1, J12.82] COVID-19 [U07.1]     Hospital Course   Pleasant 69-year-old female admitted to the hospital with generalized weakness, shortness of breath, cough, respiratory insufficiency related to COVID-19 pneumonia.  She is nearing 14 days out from initial diagnosis, she reports ongoing symptoms throughout that time.  She was started on Decadron, remdesivir but was not requiring supplemental oxygen.  She did however have oxygen saturations in the low 90s on room air.  With Decadron and remdesivir she slowly improved over the course of 2 days.  By the final day of admission she was averaging sats in the high 90s on room air.  I felt she was appropriate for discharge home.  Inflammatory markers are rather benign.  She will continue a course of prednisone taper at discharge.  She is to follow-up with PCP within 7 to 10 days.  I advised her to continue isolation until the 14th day from initial diagnosis.  The remainder of her stay was unremarkable.
she had Covid last Dec2022; she had Covid last Dec2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A 73-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Oct2022 as dose number unknown (booster), single (Lot number: GJ3277) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose number unknown (booster), single (Lot number: FJ4991) and as dose number unknown (booster), single (Lot number: FF2590) 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), SUSPECTED COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "she had Covid last Dec2022". Clinical course: The patient would be travelling to overseas in October and said that she got the original and the booster shot. She had 3 boosters with lot numbers GJ3277, FF2590, FJ4991 from her vaccination card. She added that she would like to get the newest booster but was not out yet. She wanted to know if she wanted to get the old one or should she wait.
On 10/26, 9:35AM, patient called the pharmacy complaining she has a hard time using her left (L) arm. She can raise her arm up a little, but has to use her other arm to hold it up more. She can?t stretch it out without pain, and is sore to the touch at the injection site. She also mentioned seeing a flu shot commercial (the wolf in sheep?s clothing, Sanofi) about the flu shot, and how you may experience ?muscle weakness?; she went on to say she did not hear the word ?pain? in the commercial, but thought her arm situation might be from getting the shots.  I apologized for what happened to her (I was the one who administered the vaccines Fluad and Shingrix in the L arm.   I contacted  her MD's office and discussed some physical therapy and/or medication therapy recommendations, on 10/26, 11:39AM.
on Jul 1st 2021, an expired Infanrix dose/ exp. 10/23/2020/ was given; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 16-month-old male patient who received DTPa (Infanrix) (batch number CX59C, expiry date 23rd October 2020) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 1st July 2021, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 1st July 2021, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient received dose of Infanrix which was already expired on 23rd October 2020, which led to expired vaccine used. The reporter stated that, this dose was not patient's 1st Dtap dose. The health care professional reported that she would call again to the patient in order to revaccinate. The reporter consent to follow up. Note : Since it was unknown when patient received 1st Dtap dose, it was mentioned only in narrative and was not captured as conmed or historical drug.
Injection site swelling up. Patient was seen at clinic. Patient went home with cold compresses.
Classic rash on left side of abdomen only; Shingles; This case was reported by a physician via sales rep and described the occurrence of rash in a 72-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included apremilast (Otezla) for an unknown indication.   On 13th September 2019, the patient received the 1st dose of Shingrix. On an unknown date, the patient started Otezla at an unknown dose and frequency. On 17th September 2019, 4 days after receiving Shingrix, the patient experienced rash and shingles. The action taken with Otezla was unknown. On an unknown date, the outcome of the rash and shingles were unknown.   It was unknown if the reporter considered the rash and shingles to be related to Shingrix.  Additional case details were reported as follows: The patient seen at office week of 16th September 2019, showing classic rash on left side of abdomen only, patient began experienced symptoms week of September 2019, approximately 4 days after receiving Shingrix vaccine. The patient also using Otezla prescribed by rheumatologist.  The reporter did not think incidence of shingles related to use of Shingrix. The reporter consented to follow up.
sever H/A; muscle pains; joint pains; chest pain; her heart has been acting up; extremely upset; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation.  Medical history included ongoing asthma, systemic lupus erythematosus. The patient states she has a HX of Lupus, and was informed by all her specialist that she should be vaccinated, but since then she is experiencing, sever H/A, muscle pains, joint pains that have been extreme, states her heart has been acting up and has been taking nitroglycerin for chest pain, and with her history of asthma has had to use her nebulizer. The reporter is extremely upset and feels like the vaccine almost killed her and is leery of taking the second dose.   No follow-up attempts are needed; information about lot/batch number cannot be obtained
Information has been received from a certified medical assistant concerning an unspecified number of patients of unknown age and gender. On an unknown date since February 2016, the patients were vaccinated with oral, ROTATEQ lot # K017576, which were improperly stored, the temperature excursion recorded was 47.3 degree Fahrenheit for 71 hours and 50 minutes (time frame/date of excursion: 11-JAN-2016). No adverse effects were reported. No product quality issue involved. Additional information has been requested.
11/11/11 at about 830am. Pt for healthy visit. BP prior to vaccination 124/64. Pt rec'd GARDASIL in (LT) upper arm and then within 1 1/2 mins rec'd flu vaccine in (RT) arm. As soon as second vac completed; pt eyes dilated, had fixed gaze to the left, would not respond to verbal command & then feel to right side with assistance, eyes closed sl. jerking of upper extremities & then 45 secs came around.
Does not monitor freezer temperatures/Possible freezer temperature excursion but unknown; Potential of a subtherapeutic dose due to poor frezer documentation following a freezer changeover/ Potential  subpotent dose; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Does not monitor freezer temperatures/Possible freezer temperature excursion but unknown) and POOR QUALITY PRODUCT ADMINISTERED (Potential of a subtherapeutic dose due to poor frezer documentation following a freezer changeover/ Potential  subpotent dose) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 057M21A) for COVID-19 prophylaxis.     It was unknown if the patient had ever been diagnosed with/ tested positive for COVID-19.     On 17-May-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 17-May-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Potential of a subtherapeutic dose due to poor frezer documentation following a freezer changeover/ Potential  subpotent dose). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Does not monitor freezer temperatures/Possible freezer temperature excursion but unknown). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Does not monitor freezer temperatures/Possible freezer temperature excursion but unknown) and POOR QUALITY PRODUCT ADMINISTERED (Potential of a subtherapeutic dose due to poor frezer documentation following a freezer changeover/ Potential  subpotent dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered POOR QUALITY PRODUCT ADMINISTERED (Potential of a subtherapeutic dose due to poor frezer documentation following a freezer changeover/ Potential  subpotent dose) to be not related. No further causality assessment was provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Does not monitor freezer temperatures/Possible freezer temperature excursion but unknown).    No concomitant medications information was reported.  Reporter stated that a site that administers the Moderna COVID-19 vaccine did not monitor the freezer temperatures where the Moderna vaccine is stored. The site had a data logger, but it was not set up to record. The HCP stated there is no freezer minimum and maximum temperatures to report as the temperatures were not recorded by the site.Therefore, it was unknown if a freezer temperature excursion actually occurred. There were no adverse events. Only the potential of a subtherapeutic dose due to poor freezer documentation following a freezer changeover was reported.  The event did not cause the patient to seek medical care.  No treatment medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2022: Quality complaint number added
Itching & swelling around eyes, lips & congestion of chest & sinuses. Given SOLU MEDROL in ER and recovered. Given epi s.q. & BENADRYL. Symptoms began approximately 10 min after vaccination. In ER 1500.
On 02/02/2021 I had the vaccine and the following day I was feeling the symptoms like I had a cold. On 02/05/2021 I called my physician and he said to treat it as a cold. I was not getting better so on 02/08 I came in to the office and got diagnosed with a sinus infection. On 02/16/2021 I was getting worse and couldn?t breathe so they gave me another antibiotic.
Multiple ER visits, and correspondence with my primary care physician documenting heart inflammation symptoms.  Symptoms included painful pressure deep in left side of chest for days at a time. Onset was confusing at first as was not directly following working out but did occur repeatedly in times when I increased cardiovascular activity overall.  Also experienced period of extreme discomfort in the form of stabbing pains from left shoulder down to the elbow and tingling numbness of left shoulder. Also woken up many nights with heart pounding to an extreme degree.  Ultimately referred to Cardiologist due for need for specialized care. Cardiologist stated it was pericarditis and possible myocarditis. Prescribed 2400mg of Ibuprofen per day (which took the edge off the pain but didn't make it subside entirely, as well as pantoprazole (40mg) 2/day and Colchicine (0.6mg) 2/day. After another major adverse pain event on June 1st, I was put on a decreasing treatment of Prednisone (10mg) with 4/day for 7 days, then 3/day for 7 days, then 2/day for 7 days and finally 1/day for 7 days. My last pain event was June 15th. No inflammation was seen on the MRI with stress test July 6th 2022.
Client was given wrong doses of 0.3 ML, instead of 0.5 ML as recommended dose. Per Moderna hotline, ref. case # MOD21-091103, recommendations are to "not give an additional dose and bring them back for their usual (2nd) dose without further action".  Client was made aware of error and will be informed that no additional dose is needed, RN.
Date of injection, became redness/warmth & swelling at injection site. During sleep developed chills with temp of 102 degrees F (not < 101 x 2 days) & body aches, dizziness. 11/28 pm began developing redness/warmth of hairs, axilla, popliteal anticubital. Present Temp 99.4. Seen by dr 11/29/12 & DX serum sickness with steroids & antihistamines.
transverse sinus thrombosis; This is a spontaneous report from a non-contactable pharmacist. A 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 30Apr2021 (Batch/Lot number was not reported) as unknown, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced transverse sinus thrombosis on 01May2021 which caused hospitalization. Therapeutic measures were taken as a result of transverse sinus thrombosis. The outcome of the event was unknown.  No follow-up attempts are possible, information about lot number cannot be obtained. No further information is expected.
Two days after 3shot. Broke out in rash on arms and legs for roughly two weeks.  I did have the flu vaccine 1 day before the 3rd shot.
Site: Pain at Injection Site-Mild, Systemic: Body Aches Generalized-Medium, Systemic: Patient had leg pain that made her feel like she couldn't walk-Medium
While reviewing with the Department of Health, we determined that the vaccine had a brief excursion outside of the recommended temperature storage conditions prior to vaccination.
left arm was slightly painful; The patient reports that the patient was having difficulty picking items up with the left arm; Since that time each day the pain is getting a little worse.; tenderness at the injection site; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (left arm was slightly painful), LIMB DISCOMFORT (The patient reports that the patient was having difficulty picking items up with the left arm), PAIN (Since that time each day the pain is getting a little worse.) and INJECTION SITE PAIN (tenderness at the injection site) in a 68-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.    Co-suspect product included non-company product DIPHENHYDRAMINE HYDROCHLORIDE, PARACETAMOL (TYLENOL NIGHTTIME) tablet for an unknown indication.    No Medical History information was reported.   On 26-Oct-2023, the patient received fourth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form and DIPHENHYDRAMINE HYDROCHLORIDE, PARACETAMOL (TYLENOL NIGHTTIME) (Oral use) 2 dosage form once a day. In October 2023, the patient experienced PAIN IN EXTREMITY (left arm was slightly painful), LIMB DISCOMFORT (The patient reports that the patient was having difficulty picking items up with the left arm), PAIN (Since that time each day the pain is getting a little worse.) and INJECTION SITE PAIN (tenderness at the injection site). In October 2023, INJECTION SITE PAIN (tenderness at the injection site) had resolved. At the time of the report, PAIN IN EXTREMITY (left arm was slightly painful) had not resolved and LIMB DISCOMFORT (The patient reports that the patient was having difficulty picking items up with the left arm) and PAIN (Since that time each day the pain is getting a little worse.) outcome was unknown.            No concomitant medication was reported. It was reported that the next day the patient was not wiped out. The patient felt a little tenderness at the injection site. The injection site was not red and not inflamed. The tenderness at the injection site lasted for at least 3 days. About a week later the patient noticed that the left arm was slightly painful in raising the arm and putting the clothes on. Since that time each day the pain was getting a little worse. As soon as the patient raise the arm, the patient can feel it and it was painful. The patient reports that the patient was having difficulty picking items up with the left arm. Just raising the hand with nothing in it was painful. Any kind of twisting motion like putting a jacket on hurts. The patient cannot sleep on the left side at night as it was painful. No treatment medication was reported.   This case was linked to MOD-2023-748684, MOD-2023-748682, MOD-2023-748686 (Patient Link).
Warm to touch for all of them; Injection site startedto feel itchy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Warm to touch for all of them) and VACCINATION SITE PRURITUS (Injection site startedto feel itchy) 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 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Warm to touch for all of them) and VACCINATION SITE PRURITUS (Injection site startedto feel itchy). At the time of the report, VACCINATION SITE WARMTH (Warm to touch for all of them) and VACCINATION SITE PRURITUS (Injection site startedto feel itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.   This case was linked to MOD-2021-003892, MOD-2021-004767, MOD-2021-008393 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event,s a causal relationship cannot be excluded.