chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial case was received on 01 November 2010 from a health care professional. A female patient in her forties received on 07 October 2010 an intramuscular injection of influenza vaccine (lot number reported "U3271AA" -not a valid sanofi pasteur lot number). A few days later the patient experienced temporomandibular joint disorder ("TMJ") NOS. The patient "may have seen a dentist" (no report provided). No further information was provided. As of this report the patient had not recovered. Follow-up information received from a nurse on 16 December 2010. The patient had contacted the reporter on 08 November 2010 stating that she did not believe her TMJ symptoms were caused by the flu vaccine that she received on 07 October 2010. The patient's brother told the patient that he misquoted that the flu vaccine can cause lock jaw, he was actually referring to Tdap vaccines. The patient stated she has experienced prior problems with TMJ, however it had not ever been as severe. The patient did not wish to file any further claims for this adverse event following the 07 October 2010 influenza vaccination. The patient sought medical attention from her dentist, who referred her to her primary medical doctor. No treatments was provided and the TMJ eventually resolved on its own approximately 4 weeks after onset. Per the reporter, no further action will be claimed or filed. Follow-up information was received 24 January 2011 from a health care professional. The patient had not been administered a Tdap vaccine; they declined. Per the reporter, the condition was not related to Tdap vaccine. The patient received FLUZONE, lot number U3721AA (previously reported as U3271AA), expiration of 30 June 2011 on 07 October 2010. According to the reporter the reason for TMJ was undetermined. The patient had no illness and she had not been taking any concomitant medications at the time of vaccination. The reporter stated they had no further information to provide. Documents held by sender: None.
I was traveling on 02/11/2023 through 02/19/202. On 02/21/2023 sore throat and postal nasal drip. I tested positive for COVID-19 that day. I called my provider and I had to take a blood test at a local heath care facility. On 02/22/2023 the provider prescribed PAXLOVID and my symptoms were, pain, sore throat (much worst), headache. I completed my 5-day course, but I still had a lingering taste of metal. I isolated for the full 5 days and masked for the following 5 days.
This spontaneous case reported by a consumer, describes the occurrence of erythema (red ring on the arm) and exposure via breast milk (breast feeding) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 027B21A) for COVID-19 immunization. No medical history reported. On Apr 12, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Apr 21, 2021, patient experienced erythema (red ring on the arm). Apr 21, 2021, patient experienced exposure via breast milk (breast feeding). At the time of the report, erythema (red ring on the arm) outcome: unknown/not provided. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown.
Information has been received from a healthcare student referring to a patient of unknown age and gender. Information about medical history and concomitant conditions were unspecified. On an unknown date, the patient was vaccinated with one dose of PNEUMOVAX23 (lot number, dose and route were unknown). On an unknown date, the patient experienced a fully body rash. The patient sought medical attention via visiting a physician. The outcome the event was unknown. The causality between the event and PNEUMOVAX23 was unspecified. Additional information has been requested.
The pt's arm became red and swollen around the site later in the day. On 12/22/2001, arm was red and swollen down to elbow of right arm.
Initial information received on 21-Aug-2018 regarding an unsolicited valid non-serious case received from a non-healthcare professional (office staff). This case involves elderly patient who received FLUZONE HIGH DOSE (lot details, expiry date were not reported). It was a case actual medication error due to Incorrect product storage as Shipment was too long in transit and one dose was given to patient before staff realized the mistake with the shipment. It was unknown if any adverse event occurred. 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. Documents held by sender: none.
I developed left arm pain few hours after the injection, also had fever, chills body ache lasting for about 3 days since then noticed by left elbow is hurting constantly , more so on the medial aspect of my elbow. If I take ibuprofen, pain improves for about 2 to 3 days and then recurs I curbsided a urgent care colleague, most likely tendinitis and try conservative treatment - brace, motrin, ice , They only provide temporary relief.
Pt reports 8/10 pain in left upper arm (deltoid area). Pt is currently swollen in injection area and around.
On 1/07/2021 approximately 11:30 am patient started experiencing weakness; by 1:30 p.m. patient couldn't get out of a chair or walk without assistance of cane and person.  Patient became increasingly weak and by 4 pm could not walk nor understood how to walk without caregiver telling him.  Patient's doctor was called and at 5:30 pm patient was told to go to the hospital.  Doctor thought patient could have had a mini stroke.  Patient arrived at hospital at approximately 6:30 pm and underwent stroke test, COVID test, blood work; chest xrays and brain scans.  All were negative.
Patient reports she started to have RT arm and shoulder pain after the injection, which was expected side effect, so patient did not report to the clinic. However, the pain did not go away over 3 weeks and it started to spread to RT upper back and shoulder and patient also started to feel numb in the area. Patient came to the clinic on 04/22/2021, reporting this is about 1 month and problem persists. Patient is referred out to nuerologist visit, and is prescribed for gabapentin 100mg BID. Will follow up in 2 weeks again.
This case is linked to case number 2013-07182 (same reporter, same vaccine). Initial misuse report received from a healthcare professional on 07 June 2013. It was reported that a child was given only DTaP/IPV from PENTACEL. No adverse event was reported. Documents held by sender: none.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a male patient who received SHINGRIX for prophylaxis. On 11th January 2019, the patient received SHINGRIX. In January 2019, less than a week after receiving SHINGRIX, the patient experienced injection site erythema, injection site pain and injection site warmth. On an unknown date, the outcome of the injection site erythema, injection site pain and injection site warmth were not recovered/not resolved. It was unknown if the reporter considered the injection site erythema, injection site pain and injection site warmth to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The injection site was red, sore and warm to the touch. Pharmacist does not had additional details.
patient's wife called the pharmacy and asked us to report to CDC that her husband had red purple swollen area where he got the shot
Shortness of breath, swellling of vocal chords, numbness in legs, panic attack.
FELT THE STOMACH PAIN AGAIN; VACCINE CAUSED PAIN IN ARM; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (FELT THE STOMACH PAIN AGAIN) and VACCINATION SITE PAIN (VACCINE CAUSED PAIN IN ARM) in an adult male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ulcerative colitis.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free. On an unknown date, the patient experienced ABDOMINAL PAIN UPPER (FELT THE STOMACH PAIN AGAIN) and VACCINATION SITE PAIN (VACCINE CAUSED PAIN IN ARM). At the time of the report, ABDOMINAL PAIN UPPER (FELT THE STOMACH PAIN AGAIN) was resolving and VACCINATION SITE PAIN (VACCINE CAUSED PAIN IN ARM) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       It was unknown if the patient was enrolled in COVID-19 vaccine trials.  No concomitant product reported by reporter.  The reporter's causality for the event of FELT THE STOMACH PAIN AGAIN was a reasonable possibility and for the event of VACCINE CAUSED PAIN IN ARM was no reasonable possibility with HUMIRA(ADALIMUMAB).   No treatment medication reported by reporter.  This case was identified as part of a retrospective clean-up activity where certain emails received in the moderna mailbox were missed to be booked-in.
Pain arm where the shot was administered since March 24. I could not move my arm that evening and took Tylenol the next day due to pain and stiffness. I still have slight stiffness and some pain in my arm.
Within 10-15 minutes after DTAP administration, IM into left deltoid, arm at site was swollen, reddened and tender with a blotchy rash. No dyspnea or other signs or symptoms of anaphylaxis. Given cold compresses and Motrin, 1 tsp in office.
Sone itching at injection site about 3 hours after shot was given,  the next morning there was a large Red, raised area, itchy,  hot to the touch and painful if pressed,, at injection site.  Fatigue.
This spontaneous report was received from an office manager and refers to multiple unspecified patients of unknown age and gender. No information about the patients' medical history, concurrent conditions, drug reactions, allergies and concomitant therapies was provided. On an unknown dates, the patients might have been vaccinated with improperly stored doses of RECOMBIVAX HB injection, lot # L008660, expiration date: 10-NOV-2016 (dose and site of injection were not reported). All doses were administered before labeled expiration dates. The RECOMBIVAX HB was exposed to 34.7 degrees Fahrenheit for 56 minutes. The temperatures were logged with digital data logger and there were no previous temperature excursions. No adverse effects were reported.  Product quality compliant was not involved. This is one of several reports from the same reporter.  Additional information has been requested.; Sender's Comments: US-009507513-1612USA003244:
On evening of 9/9, I developed pain in my left elbow.  Over time it got much worse, and spread down my arm.  Could not fully straighten arm, limited ability to raise hand  to head or should level.  The pain of Movement during sleep would awaken me.  I went to the ER the next day because the pain was very unusual and I know that pain in the left arm can be a signal of a heart attack in women.
A few minutes after receiving the vaccine the patient experienced color change/purple hives on from her neck up through the face and ears. Patient become short of breath and weak and was laid to the floor. Pharmacist was immediately notified and he assisted in positioning her and immediately assessed the situation. He determined that an epi-pen was appropriate and he retrieved and immediately administered one dose. Very quickly the reaction was reversed and patient color was restored and situation stabilized. No second dose administered. EMT arrived and did full vitals workup. She left on her own power per EMT group and went to the local hospital for observation. Pharmacist followed up after 2 hours and patient is doing well.
Left upper arm- mild redness, tenderness at injection site. Pt noticed area 1 day ago.
Headache, Arthralgia, Diarrhea, Weakness, fatigue Narrative:
An intense fever began around 10:30 PM, about nine hours after injection into the upper right arm, with an intense headache accompanying it. OTC flu medication was taken at that time. In the morning the headache persisted (with light sensitivity) and extreme mental cloudiness was experienced. I was also light-headed and irritable. The fever had ceased by the morning but the whole day was characterized by being constantly physically and mentally fatigued. As I write this, (20 May, when the shot was administered 18 May), some mental cloudiness remains and some physical fatigue remains, but the other symptoms have abated.
Received the Moderna vaccine at approximately 2:20 pm on 3/13/21.  Other than soreness at the injection site, I had no adverse reaction.  Then on 3/14/21 at about 4pm,  I began to have abdominal cramping, Sdiarrhea and vomiting.
Patient reported fever, lethargy, nausea, vomiting, diarrhea and dry cough.
3Nov91: Pt called PHN, devel h/a on 26Oct91; 27Oct91 devel aches & pains;29Oct devel URI;took APAP, could not talk due to "prolific s/s";felt better on 5Nov91.Pt's spouse has sxs only worse,did not have flu vax;21Nov91 pt & spouse well.
Allergy to vaccine; This spontaneous case was reported by a consumer and describes the occurrence of ALLERGY TO VACCINE (Allergy to vaccine) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Concurrent medical conditions included Plaque psoriasis.   On 14-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Oral) 1 dosage form. In 2021, the patient experienced ALLERGY TO VACCINE (Allergy to vaccine). At the time of the report, ALLERGY TO VACCINE (Allergy to vaccine) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   The concomitant medication was not reported.  The reporter causality for the events with respect to Skyrizi was provided as not reported.  The treatment medication was not provided.
lethargy; headache; low grade fever; tiredness; booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 26 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administered in arm left, administration date 17Dec2021 17:30 (Batch/Lot number: unknown) at the age of 26 years as dose 3, (booster) single for covid-19 immunisation; influenza vaccine (FLU), administration date 17Dec2021 (Batch/Lot number: unknown) as dose number unknown, single for immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Comirnaty (Dose Number: 2, Location of injection: Arm Left, Vaccine Administration Time: 07:00 PM, Route of Administration: Intramuscular), administration date: 16Jun2021, when the patient was 26 years old, for COVID-19 Immunization; Comirnaty (Dose Number: 1, Location of injection: Arm Left, Vaccine Administration Time: 07:30 AM, Route of Administration: Intramuscular), administration date: 26May2021, when the patient was 26 years old, for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 17Dec2021, outcome "unknown", described as "booster"; LETHARGY (non-serious) with onset 18Dec2021, outcome "recovered" (2021), described as "lethargy"; HEADACHE (non-serious) with onset 18Dec2021, outcome "recovered" (2021), described as "headache"; PYREXIA (non-serious) with onset 18Dec2021, outcome "recovered" (2021), described as "low grade fever"; FATIGUE (non-serious) with onset 18Dec2021, outcome "recovered" (2021), described as "tiredness". Therapeutic measures were not taken as a result of immunisation, lethargy, headache, pyrexia, fatigue. Additional info- It was reported that Since the vaccination,  the patient had not  been tested for COVID-19.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Pt developed rash on left inside of arm in which she received the vaccine. Redness, raised rash on inner arm, no pain or discomfort other symptoms reported by patient.
hypotonic-hyporesponsive episode about 12 hrs p/2nd vax;
Information has been received from a healthcare worker referring to an unspecified number of patient with unknown age and gender. On unknown dates, the patients were vaccinated with doses of improper stored VARIVAX (Merck) (lot # L035129, expiration date 14-SEP-2017)( dose and route were not reported). It was reported that the temperature fluctuated periodically with the worse case scenario 1 month. The vaccine was supported until expiry. There was no previous temperature excursion. This was not a data logger. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has not been requested.
chills; headache; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), HEADACHE (headache) and PAIN IN EXTREMITY (sore arm) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     Concomitant products included LISINOPRIL and ROSUVASTATIN for an unknown indication.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced CHILLS (chills), HEADACHE (headache) and PAIN IN EXTREMITY (sore arm). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, CHILLS (chills), HEADACHE (headache) and PAIN IN EXTREMITY (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Patient vaccinated with PNEUMOVAX and FLUARIX on 8/16, 1 day after vaccination patient felt tired, terrible. 2 days after pt's arm red from shoulder to elbow, and painful. radiating to chest. 8/18 patient went to emergency room with fever 101 to 102--admitted overnight on IV antibiotics--discharged on 8/19 on oral Keflex.
Full-blown case of varicella, 5 days fever and > 200 Lesions < VACCINE FAILURE >
arm became red, swollen and hot to the touch Redness extended down entire arm. Lasted for about 4 days. Resolved today. was sl weak also, strength almost normal
I had typical common side effects for the two days following the second vaccine (fever, chills, body ache and head ache).  Beginning on third day following the second vaccine started severe pain in back of neck, left should blade and arm.  Started on Celebrex and steroid to help with inflammation.  Nothing is cutting the pain.  Muscle relaxers along with prescription pain medication helps slightly.  Pain is severe still almost one month later with only being able to sleep a couple of hours at night because of pain.  Pain seems to be worse at night than during the day.
Dose administered >12 hours post puncture; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered >12 hours post puncture) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017f21a) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered >12 hours post puncture). On 07-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Dose administered >12 hours post puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was provided by the reporter. No treatment medications was provided by the reporter.
- Skin hot to touch hours after the shot and still to this day. Overheating without sweating  - tachycardia. Resting heart rate will occasionally get above 100bpm, compared to the usual 60-70bpm. Became overly noticeable 1.5wks after shot - brain fog. In school and grades have started dropping since the week after the first injection. Struggling to concentrate - muscle weakness. Noticed 2 weeks after the shot
She did not feel good; Eyes were blurry/ she felt pressure in them; Bad head cold; she couldn't bend over; Aches all over; Back pain; Eyes were blurry/ she felt pressure in them; This is a spontaneous report from a contactable consumer from a Pfizer sponsored program. An 80-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EJ1687), via an unspecified route of administration on the left arm, at the age of 80 years, on 29Jan2021 17:00 at a SINGLE DOSE for covid-19 immunisation. Medical history included cataract, arthritis and seasonal allergy from an unknown date and unknown if ongoing. There were no concomitant medications.The patient stated that a couple of times she did not feel good and got very sore and could not bend over to pick things up and her eyes blurred up. After she got the shot, she gradually noticed aches all over and back pain. It was stated it hurt really bad in her back on the right side on the bone and she used the heating pad on it. Then the next day she was stiffer than ever and she couldn't bend over. She added her eyes were blurry, they felt like she had a cold in them, and she felt pressure in them. She added she always has this problem with her eyes but it got a little worse after the shot. All of that has gotten better now. It was stated they are telling her the second dose was worse and she was unsure about getting the second dose. Also mentioned they were saying you can wait a little longer and she was unsure if maybe she should wait. She wanted to ask about getting the second dose. She added she was scheduled to receive the second dose of the vaccine on 19Feb2021. The patient said it was right sided back pain. She said she applied heading pad and took ibuprofen. She also experienced "eye pressure" and "blurry eyes", "how you feel when you have a bad head cold". She said, "I have allergies-seasonal, so this isn't new to me".  Therapeutic measures were taken as a result of back pain (back pain). The outcome of the events did not feel good, eyes were blurry/ she felt pressure in them and  bad head cold was unknown while other events were recovered on 31Jan2021.
Information has been received from a health professional concerning a female patient who on 11/20/00 was vaccinated in the left arm with a dose of pneumococcal vaccine 23 polyvalent. Subsequently, the patient experienced swelling and pain where she was vaccinated. On 9/20/01, the patient reported that she was still experiencing pain and swelling where she was given pneumococcal vaccine 23 polyvalent. She also reported that she had recently been told that she had arthritis in that shoulder. Unspecified medical attention was sought. Follow up information from the registered nurse reported the office records indicate that patient received a dose of the flu vaccine in the left arm, but the patient reports that she received pneumococcal vaccine 23 polyvalent. The RN reported that the influenza vaccine could have been responsible for the reaction. No further information is available.