chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patients received a dose past 30-day use by date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients received a dose past 30-day use by date) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients received a dose past 30-day use by date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patients received a dose past 30-day use by date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medication was reported.   No treatment medications were reported.   This case was linked to MOD-2021-355943, MOD-2021-355908 (Patient Link).
I have a MIRENA IUD (inserted 3 years ago) and my menstrual cycles  have been on the light side when I do get them. I had a menstrual cycle begin December 30, 2020 ending January 5th 2021 and lasting 7 days; another one beginning January 29th 2021 ending February 4th 2021 lasting 7 days. a cycle began March 13th and ended March18th 2021 lasting 6 days and my current cycle beginning April 2nd and continuing through today - and as of right now lasting 11 days. My cycles are typically heavy the first few days then light the rest. This cycle was extremely heavy the first few days, and varying between medium and light the rest of the days.
2-3 red maculo papular lesions with some scattered petechial over lower extremities bilaterally. Rash appeared within 10 minutes vaccine. RX Benadryl 6.25. Twin has same reaction.
Within 5-minutes of vaccination, the patient reported a syncopal event. EMS evaluated the patient on-site. The patient was hypotensive (72/46) with a FSBG of 142mg/dl. EMS administered 4mg Ondansetron and 1L of Normal Saline. EKG demonstrated NSR, rate 73bpm, no ST elevation. EMS transported the patient to Hospital Emergency Department. In the ED, the patient reported nausea and feeling lightheaded prior to EMS treatment. Patient stated history of vasovagal episodes in the past. Patient's hypotension improved to 103/82mmHg. After laboratory work-up, orthostatic BP tests, and EKG, the patient was discharged with diagnosis of Vasovagal syncope status post-COVID vaccine.
Sinus running clear and fast ... slight rash developed on my neck.   on 10/28 I developed pain in my trapezius which is growing in intensity radiating down to my deltoid, up my neck to the base of my skull, and between my shoulder blades on the left side
Information has been received from a woman in a doctor's office concerning a 50 yr old female with a history of pneumonia  who on 02/19/2002 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent, (lot number 641531/1352L). That evening the pt's arm was described as "swollen twice the size of normal from shoulder to elbow," and painful with limited movement in her shoulder. It was also reported that the pt had itching. The pt sought unspecified medical attention. The symptoms, according to the reporter, resolved, but the time frame was unknown. No further information is expected.
One hour post-vaccination: Throat tightening, hive-like rash, difficulty breathing.  Zyrtec 15 mg stat, then 10 mg every day. Follow up on 10/22/2003: "Lot #'s and Manufacturer's must be obtained from post."
Information has been received from a nurse concerning her 15 year old daughter who on unspecified dates was vaccinated with the first and second doses of Gardasil (0.5 ml).  Subsequently, following the second dose, the patient broke out in hives on her legs.  Medical attention was sought and the patient was treated with BENADRYL and the symptoms cleared up.  It was reported that the patient did not have this experience after the first dose.  Additional information has been requested.
01/12/2004: chicken pox : 40 spots : over entire body, itchy, fever (mild)
Urticarial rash in head, truck, prox extremities-most obvious in interdigit regions; 1 cm erythema about HIB inject;
Roughly 21 hours after vaccine was administered: Fever 100.3, Chills, Sweats, Extreme Fatigue Treated with Tylenol 500ml every 6 hours.  Felt better the next day after sleeping most of the day after vaccine administered. As of 4/28 still experiencing extreme fatigue randomly/ previously not experienced Very active, goes to gym every day, eats healthy otherwise.
Swollen hand. I was told by son he was taking her to ER. I am not sure if they actually went or not. Pt failed to tell us that she had gotten pneumo last year.
Bells Palsy diagnosed at Emergency Room Paralysis of right side of my face Pain behind my ear  Woke up at 5am on July 4 and my eye wouldnt close.  Looked in mirror.  Right side of Face was drooping and I couldn't
SORE THOAT; HEADACHE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, expiry: UNKNOWN) dose was not reported, administered on 13-MAR-2021 in left arm (deltoid) for prophylactic vaccination. No concomitant medications were reported.  On 14-MAR-2021, the subject experienced headache. On 15-MAR-2021, the subject experienced sore thoat. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore thoat, and headache. This report was non-serious.
Fever of 103, cold chills, shivering, confusion, fatigue, headaches
The evening I received the 2nd dose of Pfizer vaccine, I began to feel feverish, with chills and body aches. This lasted throughout the night to the degree that I was unable to sleep more than a couple hours. In the morning, I felt pain and heat through my head and spine primarily, but it radiated out through the rest of my body too. I had  one episode of a sudden severe headache when I turned my head, which lasted several minutes then returned to the baseline pain level. I experienced stiffness throughout my body and loss of appetite. Other symptoms included significant low back pain that was unaffected by position or movement. I am an active, fit, healthcare professional that exercises several times per week, and I was so weak that I was unable to get out of bed for nearly the whole day.  I didn't have energy to read, listen to music, or do other passive activities. It was unlike anything I have ever felt before even when I have been sick in the past. By the evening of 8/6, the day after receiving the vaccine, I began to feel improvement. The morning of 8/7, I felt back to normal.
redness and hives on her neck.; redness and hives on her neck.; Caller states they are starting to spread on her neck and the other side and she is starting to see dots all over her body; This is a spontaneous report from a contactable consumer (Patient). A 33-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 01Jun2021 12:00 (Batch/Lot Number: EW0179) as 2ND DOSE, SINGLE for covid-19 immunization. Medical history included allergic to Penicillin. The patient's concomitant medications were not reported. The patient previously took bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 11May2021 (Batch/Lot Number: EWO175 or EW0175) as 1st DOSE, SINGLE for covid-19 immunization. For AE(s) following prior vaccinations, stated none and stated last vaccines were as a child. On 03Jun2021, the second day after her shot, the patient when she woke up, she had developed redness and hives on her neck which started to spread on her neck and the other side, and she was starting to see dots all over her body. She would like to know if this was normal, and what to do next. The outcome of the events was not recovered.  Follow up needed, further information has been requested.
Patient returned within one half hour of receiving vaccine. Patient's face was red, swollen, urticarial rash and increased WOB with retractions. Given Albuterol 25mg x 2, Prednisone 25mg x one, BENADRYL 12.5 mg. 12/11/09 and 12/14/09  Pediatric records received for DOS 11/16/09.  Pt. returned 30 minutes after vaccinations with urticarial rash, swollen face and increased work of breathing with retractions. Treated with Albuterol, prednisone and Benadryl. Pt. discharged.
Patient presented to the emergency room on 9/17/2021 after testing positive for COVID-19 due to worsening of shortness of breath. She declined monoclonal antibodies at that time and was discharged home. She returned to the emergency department on 9/22/2021 due to worsening symptoms and hypoxia and was admitted for further management. She was treated with dexamethasone and supplemental oxygen. She was discharged home on 10/5/2021.
Over two weeks later after 2nd vaccine, the back of my arm hurt significantly and there are several red bumps and swelling at the injection site. I had a fever 9/20 of 100.1. I e had trouble breathing, and I also experienced swelling of my eyes and hives on my face.  It looks like shingles and the injection site. Also itching.
Initial report received from a healthcare professional on 12 August 2013. A 30-year-old female patient had received an intramuscular dose 1 of ADACEL vaccine (batch number: U4646AA, site of administration was not reported) on 09 August 2013. The patient was pregnant at the time of vaccination. The patient's last menstrual period date was 05 December 2012. The estimated date of delivery was 11 September 2013. The patient's health during pregnancy and risk factors was reported as 'N/A'. Concomitant medications, medical history and laboratory investigations were not reported. Treatment for infertility was reported as 'N/A'. At the time of this report, the patient had not experienced any adverse event. Documents held by sender: none.
arm is a little sore; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (received 1st dose of shingles vaccine on an unknown date).   On 1st October 2022, the patient received the 2nd dose of Shingles vaccine. In October 2022, less than a week after receiving Shingles vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 05-OCT-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient stated that, he/she was very fortunate that, his/her insurance paid 100 percent of both shots of shingles and received the second one the day before reporting and arm was a little sore but manageable.  The patient further stated that, he/she highly recommend receiving the vaccine it was better than having the virus. Additional Supportive Information: The follow up would not possible as no contact details were available.; Sender's Comments:  US-GSK-US2022AMR142018:Same reporter
T104 x 1 day then 102 x 1 day then to nl;c/o diarrhea & possible abd cramps;tx children's APAP;
flu-like symptoms; Muscle ache; Lethargy; Chills; This case was reported by a consumer via call center representative and described the occurrence of flu-like symptoms in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th September 2019, the patient received the 2nd dose of Shingrix. In September 2019, less than a week after receiving Shingrix, the patient experienced flu-like symptoms, muscle pain, lethargy and chills. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the flu-like symptoms, muscle pain, lethargy and chills were unknown.   It was unknown if the reporter considered the flu-like symptoms, muscle pain, lethargy and chills to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. On the day before reporting date, the patient received his 2nd Shingrix shot. The patient experienced side effects including flu-like symptoms, muscle ache, lethargy and chills but no fever. The patient was asking for treatment for Shingrix side effects and told he would be going to receive Ibuprofen. He took Tylenol for his flu-like symptoms. The patient did not want to provide his street address or MD contact information. No further information provided.
approx 1hr p/vax started screaming for about 5hrs;area on leg red & swollen, t101, listless rest of day p/crying;OK the next day
Site: Itching at Injection Site-Medium, Systemic: Allergic: Itch Generalized-Medium, Additional Details: Pt is having itching sensation but there are no eruptions on the skin until she actually itches the skin. Pt of any other issues such as trouble breathing. Recommended trying benadryl 25mg today and seeking treatment from urgent care if benadryl does not help.
This spontaneous report was received from a 73 year old male consumer (who is also the patient) refers to himself. The patient was a recovering alcoholic. The patient's medical history included open heart surgery and 4 back operations. Current conditions included shingles. The patient had no drug reactions or allergies. On an unknown date in October 2012, the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiration date and route not reported). Concomitant medications included LUNESTA, SOLARCAINE and chlorothiazide. On an unknown date in October 2012, the patient experienced increased pain. The patient was given ZOSTAVAX by his physician to treat an existing case of shingles in which he had symptoms of pain. After receiving ZOSTAVAX, the patient described the pain which he was experiencing increased to such a degree that he could no longer sleep. The patient also stated that he was not able to use the arm in which the injection was given due to the intense pain. The physician prescribed the patient several painkillers to treat the pain but the patient would not take them as he was a recovering alcoholic. The patient 2 CAT scans done and the results were unknown. The treatment rendered for the event was OXYCONTIN, hydrocodone, gabapentin but the patient would not take them as he was a recovering alcoholic. At the time of this report the patient was not recovered from the events. The patient sought medical attention. Additional information has been requested.
Extreme acute swelling of distal joint on index finger right hand; Extreme acute swelling of distal joint on index finger right hand; Pain in all joints of hands; Pain in all joints of hands; tingling of fingers; aching at prior fracture site; This is a spontaneous report from a contactable physician. A 63-year-old female patient received BNT162B2 (BNT162B2, solution for injection, Batch/Lot Number: EP7533), via intramuscular route of administration, in right arm on 06Apr2021 09:15 (at the age of 63-year-old) 2nd dose single for covid-19 immunisation. The. Patient medical history was not reported. The patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and not tested for COVID-19, since the vaccination. Patient drug history was none. The patient received other medications within 2 weeks of vaccination. Historical vaccine included first dose of BNT162B2 (BNT162B2, solution for injection) via intramuscular route of administration in left arm on 16Mar2021 12:00. On an unknown date, the patient experienced extreme acute swelling of distal joint on index finger right hand, Pain in all joints of hand , tingling of fingers , aching at prior fracture site. This case was serious due to disabling or Incapacitating. No treatment was reported. Outcome of the events were not recovered.  Additional information has been requested.; Sender's Comments: Based on the information available and a close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of joint swelling,finger swelling,Arthralgia,paresthesia,bone pain. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
signif pain 1st 24 hrs followed by edema & erythema shoulder to mid fore arm-resolving by 4th day p/inj
Period change; Spotting continues after regular 7 day period, spotting has been continuing for longer than 7 to 10 days; Having strange pain/heaviness in right arm occasionally; Having strange pain/heaviness in right arm occasionally; This is a spontaneous report from a non-contactable consumer, the patient. A 34-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 17Jul2021 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID -19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medications. On 01Aug2021, the patient had period change. The spotting continued after regular 7 day period and spotting had been continuing for longer than 7 to 10 days. The patient had strange pain/ heaviness in right arm occasionally. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events period change, spotting continues after regular 7 day period, spotting has been continuing for longer than 7 to 10 days and having strange pain/heaviness in right arm occasionally were unknown at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Red raised area to injection site on right arm. Size of 50 cent piece. Area does have itching.
Sensation in teeth. Jaw then dizzyness. Headache. Took tylenol at work..then went home and took benadryl.  Sensitivity to spoons, metal. Today 1/04 itching and lump at injection site.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with a first dose of RECOMBIVAX HB. Then on an unknown date, the patient received late the second dose of RECOMBIVAX HB (dose, route, lot # and expiration date were not provided). No adverse symptoms reported. Additional information has been requested.
patient developed shingles in her left arm several days after vaccine.  shingles were only in her arm.
accidentally administered third dose; This case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th June 2022, the patient received the 3rd dose of Shingrix. On 29th June 2022, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 29-JUN-2022 Reporter's comment: The pharmacy intern reported that the patient was accidentally administered third dose of Shingrix on 29th June 2022, at approximately noon. The reporter did not consent to follow-up. Additional Supportive Information: The patient was accidentally administered with third dose which led to extra dose administered.
Patient received their second dose of the Moderna COVID-19 vaccine 21 days after their first dose. . The first dose was administered on 06/24/2021 and the second dose was administered 07/15/2021. No side effects reported when contacted for  follow up on 07/16/2021.
Fever 103.4, headaches, no appetite, nauseous, shivers, fatigue.
Arm pain; couldn't lift my Shingles shot arm; This case was reported by a consumer and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Shingrix and Influenza vaccine Quadrivalent unspecified season. On an unknown date, less than a day after receiving Shingrix and Influenza vaccine Quadrivalent unspecified season, the patient experienced pain in arm and mobility decreased. On an unknown date, the outcome of the pain in arm and mobility decreased were unknown.   The reporter considered the pain in arm and mobility decreased to be related to Shingrix and Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and flu vaccine and had pain in arm and mobility decreased. The reporter stated it was administered at the same time as the flu vaccine. The patient took shot together with flu vaccine and had pain and latest for about a week. The Shingles arm pain lasted for a week and then suddenly it was better and was so relieved because arm felt normal again. The patient had to get a 2nd booster shot.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR216227:same reporter
11JAN99 c/o pain from inj site & sore arm;stated could not sleep because of arm pain;12JAN99 nauseous/vomiting off & on during day;13JAN99 nauseous/vomited this AM;took motrin;states feels better;arm not as sore today;able to eat something;
Sudden severe soreness of left arm and inability to fully use left arm for 6 weeks. Arm was too sore to lift, move or use at all for 4 weeks. Persistent soreness and limited ability to use arm for next 4 months without pain.
6 hours (4pm) after injection started having body aches and fever.  The got progressively worse and by 8:00 pm I was in horrendous pain all over my body.  This pain lasted 24 hours.  I was also experience extreme tiredness.  Some pain and tiredness was for 3 days.  I was able to get the fever down with tylenol but I had never experienced this much pain in my whole life.  I took a covid test the next day and it was a very faint negative.  I had a phone conference with the NP at my doctor and she called in a rx for paxlovid.  Another covid text later that day was negative.  I tested the next two days and they were also negative so I didn't take the rx.  I should have gone to the er but was so tired I  didn't even think of it.   This was the Moderna updated booster.