chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient has history of cancer and due to multiple chemo treatments she has a suppressed immune system. She informed the pharmacy of this medical history when she requested a third dose of moderna 11/23/21. Instead of receiving an additional dose of 0.5mL for being immune compromised, she received 0.25mL for a booster dose. `Patient received a additional dose of 0.5mL today, 4/26/22, and will now receive a booster dose when necessary in 4 months.
swollen lips; This spontaneous case was reported by a consumer and describes the occurrence of LIP SWELLING (swollen lips) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Jan-2021 at 12:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced LIP SWELLING (swollen lips). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] at an unspecified dose and frequency. At the time of the report, LIP SWELLING (swollen lips) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2021: no new information.
Chills, high fever, nausea, uncontrollable shaking, extreme weak, extreme fatigue, terrible headache, body aches, injection site sore and swollen,
Patient develop symptoms of cough, fatigue, and body aches on 07/26.  She tested positive for COVID on 7/28/21
Patient received FLUZONE HD and states that a month later still suffers from pain in the injection arm. States she felt pain radiate from deltoid all the way down her fingers starting on day of injection.
The vaccine was ordered to be delivered on 8/31/22 and this was done. However, the vaccine administration was done the next day on 9/1/22. This was an errant administration since the FDA required the use of Bivalent COVID-19 vaccines as of 9/1/2022. There were no adverse physical events associated with this administration.
Case number PHEH2013US004809 is an initial spontaneous report received from a consumer on 25 Feb 2013. This case refers to a 42-year-old male patient. He was little overweight but otherwise he was healthy. He was vaccinated with the first dose of post exposure RABAVERT (batch number: 504011C, expiration date: Jan 2016) intramuscularly on 11 Feb 2013, and experienced events (see linked case: PHHY2013US020907). He received the second dose of IMOVAX (other manufacturer, batch number: EO801-H1180, expiration date: 28 Mar 2014) intramuscularly on 13 Feb 2013. After the second dose, he experienced pain below the kidney that radiated into groin, which persisted but was not really bad. This pain went into both sides after he received the third dose with RABAVERT (batch number: not reported) intramuscularly on 18 Feb 2013. On day seven, his blood pressure was elevated to 187/115. It was also reported that he had pressure in his head. The next day he had fever of 101 F and pain in lower back. As of 25 Feb 2013, he still had increased blood pressure, flu-like symptoms, fever and body aches. The patient has no history of high blood pressure. The increase in blood pressure ranged from 150-160s/90-125. He was vaccinated with the fourth dose of rabies vaccine with an unspecified rabies vaccine (manufacturer and batch number: not reported) on 25 Feb 2013. The final outcome of these events was not reported. The seriousness and causality were not reported. No other information was available.
Pt had redness, rash and a raised 5cm X 7cm macular rash medial to injection site. He was placed on oral Keflex for cellulitis.
Fever the next day 100 degrees or more. At 15 days there were hives on the body and they have continued like this for a month and a half to date. I have attended urgent care twice, then with my primary doctor and finally with an Allergist. I have mentioned that I started 15 days after getting the Pfizer vaccine. They only give me allergy medicine so far but they don't help me. Apart from the welts, my eyes and lips are already swollen. I was referred to a Rheumatologist as well.
Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Hyperventilation-Mild, Systemic: Weakness-Mild, Additional Details: Notified by another vaccinated person waiting that pts "eyes were rolling to the back of their head". RPh went over and pt was having difficulty speaking, difficulty breathing. Husband translated that she was saying she could not breathe. RPh instructed staff to call 911, grab epinephrine, grab pulse ox and BP cuff. Epipen was NOT administered although box was open and dose was taken out (EMS can confirm this as well). EMS arrived on scene when pts BP was 130/105, pulse 103, O2 sat 92.
blurred vision in both eyes which lasted for 30 minutes. at 30 minutes the vision was back to 90% and returned to 100% soon after.
Initial report received from nurse on 01 Dec 2009: This patient, who was a child younger than 4 years, received FLUVIRIN lot number 1013261P expiry date Feb 2010, 0.5 ml intramuscular on 25 Nov 2009. No adverse event was reported.
Patient reported signs and symptoms of SOB/right leg pain 1 week after receiving the Moderna vaccine. He stated that he was "breathing fire" and woke up with an extremely painful and swollen leg. Upon coming to the ED, it was found to be bilateral PE and right leg DVT.
Extreme body ache, chills, headache, vomiting, chest pain, difficulty breathing, sore throat.   Tylenol & ibuprofen eased body ache, chills, headache but  did nothing for chest pain, difficulty breathing, sore throat.   So far, symptoms continue approximately 72 hours after receiving vaccine.
I elevated heart rate  to 159, I was hot, flush, sweating, elevated BP 154/94 which is high for me. I stayed 15 more minutes and everything was back to normal. The next morning I had a headache. By noon, I had vomiting. I went for a COVID 19 test.
On 1/8/21 received dose and had nausea <1 hour; Left shoulder pain.  Swelling in pm and pain continued x 4 days, then, local tenderness persisted for additional week.  Onset of HA 1/18/21 through 1/25/21 for 6 of the 7 days, for a few hours duration and relieved with Aleve qd to BID. On 1/22/21 noticed Left shoulder muscle weakness, visible atrophy of muscle and dull pain in shoulder/ arm and neck.  Clicking in the joint with rotation movement. Spoke to Director of Rehab and advised to contact CDC and seek medical care.  Call placed to PCP 1/23/21 with office closed for weekend. Due to non-urgent symptoms, opted to wait for appointment on Monday.  Continued pain and symptoms through the weekend with feeling of instability in the shoulder. Spoke to CDC for Q/A on 1/24/21 and sought medical attention with appointment for care on 1/25/21.
POST VACCINATION ONE HOUR LATER PARENT CALLED AND INDICATED THAT PATIENT HAS REDNESS AND SWELLING AT INJECTION SITE.
1. Feverish on 12/23.  2. Fine rash 12/25 with mild sore throat, put on Medrol Dosepak.  3. Seen again at urgent care clinic 12/26, stable vs dizzy, worse rash, spread from neck & face 12/24 to torso & limbs 12/26.
approx 4hr p/vax pt sleeping, awoke from sleep, eyes rolled up, body shook for approx 1 1/2min;temp @ that time 99 R;went back to sleep p/the episode;unwitnessed episode by medical staff & witnessed by mom;
Information has been received from a 20 year old female patient with no relative medical history, drug reactions or allergies who was vaccinated with third doses of GARDASIL (lot number 661044/0648X), site and route not reported).  Concomitant therapy included OCELLA.  She didn't know the dates of the vaccination, but she finished the series about one month ago, in approx March 2009.  After the second dose, she developed joint pain at the wrists and ankles and this got worse after the third dose.  The pain affected all of her joints and muscles after the third dose.  She was seen on 24-MAR-2009 by the doctor and was prescribed NAPROXEN but it didn't help.  She saw the physician again on 30-MAR-2009 for the condition described above.  The events persisted at this report time.  Follow-up information was received from a registered nurse who reported that the patient was seen by the physician on 08-APR-2009 and still had "aches" and the doctor referred patient to a rheumatologist.  It was confirmed that the patient was not hospitalized.   Additional information has been requested.
Initial report received from a nurse on 16 Sep 2010: This patient received a intramuscular 0.5 ml dose of MenA lyophilized conjugate component of MENVEO (batch number 100022) that was reconstituted with a sterile water instead of MenCYW-135 component on 16 Sep 2010. The patient had not received the MenCYW-135 liquid conjugate component of MENVEO. No adverse events were reported.
Arm at injection site sore at first. Has become difficult to use arm. Can not lift it above about 6 inches.  Sore in neck from arm.  Unable to move arm usual distance.
pt recv vax 130PM;pt was w/mom;grandma shopping & became ill-on way home grandma observed a sz of approx 15sec;taken to ER 5PM t105.2;cooling baths & APAP supp given;t101 on d/c to home;pt dazed, confused, irritable on ER admit
Pt was well at time of physical. 1 1/2 hrs later developed red and blotchy rash all over body. No breathing issue. Rash started to resolve over before getting BENADRYL. Rash gone by next AM, but then got headache and temp to 103. Also a red mark where shot was given that was not there right before.
Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications are provided.  No treatment medications are provided.
My son received these vaccines on 03/09/2022 and on 03/20/2022, 11 days later, he had a febrile seizure. His fever reached 104.6 on this day and it came on very quickly. He has never had a seizure before this. It is now 03/24/2022, and while he has not had another febrile seizure, I am seeing issues in his balance, and his ability to pay attention/awareness of his space. He has moments of what appears to be spacing out for up to 30 seconds.
ON 4/16/2012, GRANDMOTHER REPORTED ALLERGIC REACTION AFTER 12/13/2011 VACCINES. STATES THAT STUDENT HAD SWELLING OF THE LIPS, MOUTH, EYES AND LEFT ARM, ALSO REPORTS HIVES TO THE BODY. FAMILY DID NOT SEEK TREATMENT FOR SYMPTOMS. FAMILY UNABLE TO RECALL HOW LONG SYMPTOMS LASTED.
This spontaneous report was received from a pharmacist and refers to an approximately 83 year old female patient. Patient used ZOSTAVAX in the past and experienced swelling around injection site (1410USA007296). Allergies were reported as none. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 inj, 0.5 milliliter, (also reported as left shoulder) (lot# K010016) (expiry date: 05-AUG-2015) subcutaneously in the left arm. Other suspect therapies administered on the same day included FLUZONE (dose, frequency and route unknown) on the other arm for unkonwn indication. Concomitant therapies were reported as none. On 10-OCT-2014, the patient experienced extreme swelling (disability) after receiving PNEUMOVAX 23, the swelling extended out to chest and back area next to her left shoulder, the swelling was so bad that the patient's shirt sleeve was getting pinched up. The patient also reported to the pharmacist that the swollen area was very painful (disability) and pain and swelling restricted her arm movement for half a day (disability), she could not do anything with her left arm. No treatment specified. The outcome of the events was reported as recovering. The causality assessment was not provided by reporter. Product quality complaint was not reported. The reporter considered events to be serious as the patient had restricted arm movement due to swelling for half a day (disability). This case is linked to 1410USA007296 (same patient). Additional information has been requested.
Breakthrough COVID infection resulting in hospitalization. Symptoms include cough, shortness of breath, congestion, malaise, and fatigue. Onset of symptoms not known. Tested positive on 09/03/2022.
On 19APR2018 the Sponsor identified this case during data reconciliation activities. A 20 year-old female received immunization with ACAM2000 and 11 days later developed encephalitis. Medical history was positive for dizziness/fainting spells, numbness and/or paralysis. Concomitant medications or other vaccines were not reported. On 08Apr2010, the female received ACAM2000. On 19Apr2010 'encephalitis following immunization procedures' was reported. Diagnostics such as lumbar puncture and magnetic resonance imaging of the spinal cord were not performed. No further information was provided. This information was retrieved during surveillance activities; therefore, a causality assessment was not provided.
This case was reported by a physician and described the occurrence of not responding to therapy in a 23-year-old male subject who was vaccinated with Engerix B, Twinrix, and Havrix for prophylaxis. On 19 September 2006, 28 March 2006 and 24 January 2006 the subject received 3rd dose, 2nd dose and 1st dose of Engerix B (1 ml, unknown). On an unspecified date the subject received unspecified dose of Twinrix (unknown). On 19 September 2006, 28 March 2006 and 24 January 2006 the subject received 3rd dose, 2nd dose and 1st dose of Havrix (unknown). At an unspecified time after vaccination with Engerix B, Havrix and Twinrix, the subject experienced not responding to therapy. The physician reported that the surface antibody was negative as well as the core antibody. Relevant test results included  [laboratory results/hospital investigations]. At the time of reporting the outcome of the event was unspecified.
High Fever (102 F)  and shakes followed by swelling Lymph nodes in the back of the neck - under chin - temple and scalp..   Rash breakout similar to a skin burn -- swelling in cheeks - swollen ears and eyes -- forehead and entire face cover ..  - still growing .
Immediately felt severe dizziness, nausea, floating sensation, confusion. She laid down until most dizziness passed. Took about 45 minutes for all symptoms to pass.
10 hours after injection of Hep B #1 developed erythematous rash on chest, arms, leg - took BENADRYL better today.
Constant pain in upper right groin. Pain in lower outside of right hip. Pain in right tibia that comes & goes, not always same area. Pain in right patella tendon.
Sore joints all over for almost 1 year. Unusual heart beat for 3 - 4 months.
Varicella Vaccine Breakthrough. Diagnosed in office by Dr. on 5-1-09. Had 30 lesions. VARIVAX X 2.
After the expiration date; Inappropriate schedule of vaccine administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (After the expiration date) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030B21A and 016B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (After the expiration date) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On 22-Sep-2021, EXPIRED PRODUCT ADMINISTERED (After the expiration date) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment information was not provided.   This case was linked to MOD-2021-413535, MOD-2021-413554 (Patient Link).
Nothing serious, just odd. I am not one to get headaches, but have had recurring  mild headaches, tinnitus, and the strangest event is that whatever I hear, especially music, will repeat in my head for hours. The best way to describe it is a busyness in my mind, which I did not have before. Nonstop, which causes insomnia.
Nausea starting 5 hours after injection  Extreme Fatigue beginning 3 hours after injection  Body Aches beginning 5 hours after injection  Pain in injection area beginning 2 hours after injection.
530PM spitting up, limp, turned gray, lips turned blue, breathing stopped-mouth to mout breathing performed; taken to hosp seen by ER MD;
after the first 2 doses of the COVID-19 vaccine, her friend had a light change in her menstrual cycle; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (159558).  A 41-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, single), for Covid-19 Immunization. The following information was reported: MENSTRUAL DISORDER (non-serious), outcome "unknown", described as "after the first 2 doses of the COVID-19 vaccine, her friend had a light change in her menstrual cycle". The event "after the first 2 doses of the covid-19 vaccine, her friend had a light change in her menstrual cycle" required physician office visit.  Additional Context: She stated after the first 2 doses of the COVID-19 vaccine, her friend had a light change in her menstrual cycle. She stated after her friend's booster dose of the COVID-19 Vaccine almost a year ago, her friend was suffering from horrible long strong cycles. Indication: Caller stated her friend believed the first 2 were preventing COVID but did not and stated her friend felt coerced to receive the booster so that she would be able to fly. Reporter stated her friend did not want the booster. Reporter stated she knows her friend received COVID after the booster dose but she stated her friend might have gotten COVID after the first 2 doses as well.    The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Pain / Ache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain / Ache) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced PAIN (Pain / Ache). At the time of the report, PAIN (Pain / Ache) outcome was unknown.            No concomitant medications were reported  It was unknown if the patient was enrolled in a COVID-19 Vaccine trial. Causality for Moderna: Ache (Causality as per reporter (Drug/Vaccine) reported as Possible.  Causality for Humira: The reporters causality for the event of pain before next Humira injection unknown onset, pain before next Humira injection unknown onset and aches after moderna covid vaccine was not provided.  No treatment medications were reported
bilateral hip and muscle pain starting 1/21/21. Limiting my movement. Pain level 7.  1/28/21 L arm with large red area (size of softball). Red area lasted 3 days. Erythema, inflamed, itching. Hip joint pain lasted 2 weeks, despite taking NSAIDS.
Increased swelling & redness to right upper arm 6x6 cm ~2 hours after 6/25/08.  BACTRIM 3tsp BID.
presents originally for loss of appetite and nausea vomiting times eight  X 1 day after getting her Johnson & Johnson vaccine.  Since she came into the emergency room last night her vomiting has subsided,4L of LR given,  pain has been controlled, however she remain tachycardic after negative infectious work up, negative CT scan
pt recv vax & has been crying since AM;given APAP;used cold compresses, nothing works;
I feinted 2 min after the vaccine. Upon regaining consciousness I felt pain above my knees. I felt better 30 min after but after driving in the car, I started  to feel vertigo, numbness in my legs and arms and it was a bit hard to breath.  I went to the ER. 1h after the vaccine, I started feeling very week and my body was shaking, I threw up. After being treated in the ER room for 3 hrs with three bags of IV, I felt better. The next day I was very weak and all motions made me very dizzy, I was out of breath. Then the pain in my joints started. It lasted for 20 days. I couldn't use my hands well and couldn't stand for a long time. I could not drive the car as I was getting very dizzy. Moving objects made me dizzy for 26 days. I am still out of breath if I lecture for 80 minutes.