chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I received my second Moderna booster for COVID-19 on 9/9/2022. On the evening of 9/12/2022, my right arm was swollen and I had some pain at the injection site. My arm was also itchy the entire day, and I had been scratching a lot. I went to a neighbor's house to pick something up, and she remarked that my arm was really red. At this point, the injection site pain had expanded to the area below the injection site on my right upper arm and above my elbow. The area was swollen, red, itchy, and hot to the touch. It was a very distinctive patch that a definitive border that separated it from the unaffected area. I called the pharmacy where I had received the shot to receive guidance, and I was told that the side effect was not unheard of. They told me that I could take BENADRYL for the itchiness and ADVIL for pain and swelling. I took one dose of BENADRYL, which helped for about a day and kept the swelling down the following day. I also took ADVIL about 2-3 times over the next couple of days, and it helped reduce the pain. I don't really like taking OTC medicines, so I tried to take them only when it was absolutely necessary. The last time I took any medicine was 9/14/2022. After those few days, I just let it be. The redness finally resolved on 9/16/2022 or 9/17/2022. The pain finally resolved as of 9/19/2022. At the time of this writing, I still have some itchiness, though it's not as intense as it was before. It's sporadic and still localized to the area where the red patch was.
Patient admitted with abdominal pain and increase in diarrhea. Pt with hx of ulcerative colitis previously on Entyvio and most recently on Humira. Pt s/p booster dosing of Covid vaccine on 8/15 - found to be COVID+ during routine admission testing. Pt did have GI symptoms c/w COVID gastroenteritis as well as a UC flare found on colonoscopy. Pt without respiratory symptoms during admission.   Unknown if pt would have sought care or recognized infection given ongoing UC flare
Information has been received from a women at a health department concerning an 8-year-old male who on 09-FEB-1999 was vaccinated with a first dose of Varivax (Oka/Merck). It was reported that the patient received his second dose of Varivax (Oka/Merck) on 10-FEB-2006. On 17-FEB-2006 the patient developed a rash. It was noted that the school nurse diagnosed with child but it was unknown if he saw a physician. There was no duration or outcome reported. Additional information received on 12-JUL-2006 indicated that no further information is available. Additional information is not expected.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 67-year-old female patient who received SHINGRIX for prophylaxis. On 18th August 2018, the patient received the 1st dose of SHINGRIX. In August 2018, less than a week after receiving SHINGRIX, the patient experienced injection site swelling and injection site erythema. On 18th August 2018, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain, injection site swelling and injection site erythema were unknown. It was unknown if the reporter considered the injection site pain, injection site swelling and injection site erythema to be related to SHINGRIX. Additional information was received as follows: The patient was received SHINGRIX on the left arm. The patient reported that she was experiencing a painful injection and then had injection site reaction that included pain, swelling to a circumference of about 1 inch to 1 and ¾ inches and some redness. The patient ended the call before pharmacy information could be gathered or permission to contact prescriber or healthcare professional.
Immediately after administration of vaccine, the patient's left arm began to swell, ice was applied and the patient was sent over to local urgent care center for further evaluation
Redness and swelling of injection site with extreme itching and hardness which appeared one week after the injection
Pt. stated she started to feel palpitations 5 minutes after getting vaccinated.  Vital signe were done.  BP 146/80, O2 Sat 100%, HR 92, R 16, EKG done-normal sinus rhythm.  At 3:43 pm she stated she is not feeling palpitations any more, just a little nausea.  At 3:50 pm she stated she was feeling better.  At 3:52pm she went home.
necrosis of organs; cell death; low semen sperm count hard time retention; killing of my heart; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A female patient received bnt162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA 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: NECROSIS (medically significant), outcome "unknown", described as "necrosis of organs"; CELL DEATH (non-serious), outcome "unknown"; SPERM CONCENTRATION DECREASED (non-serious), outcome "unknown", described as "low semen sperm count hard time retention"; CARDIAC DISORDER (non-serious), outcome "unknown", described as "killing of my heart". The patient underwent the following laboratory tests and procedures: Sperm concentration: low, notes: 38 39. Details were as follows:   The information on the batch/lot number for (BNT162B2 OMI XBB.1.5), has been requested and will be submitted if and when received.
lip swelling; A spontaneous report was received from a healthcare professional concerning a 78-year-old, female  patient who experienced lip swelling.  The patient's medical history included rheumatoid arthritis. Concomitant medications reported were Remicade.  On 29 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 0131204) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 3 Feb 2021, the patient experienced lip swelling, especially on the bottom lip.  Treatment details included prednisone 20mg once a day for 5 days.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event, lip swelling was unknown.
Febrile seizure.  Mom noticed child acting fussy while asleep.  Checked forehead and felt warm.  Woke up startled and then had a generalized tonic clonic seizure x 1 minute.  Called 911 and went to ER - had fever documented in the ER.  Acted appropriately after stopped crying.  Sent home without work-up.  H/o febrile seizures in family including brother and father's side.
5 minutes after vaccine,  patient began to feel like her throat was tightening/ closing and that it was difficult to swallow. She also reported feeling like her tongue was swelling mildly. She felt mild itching but denied rash, chest pain, or difficulty breathing. Also denied nausea, vomiting, abdominal pain. She received 50 mg of IM Benadryl and was observed until an ambulance arrived to transfer her to an emergency department. She felt better after the Benadryl. Reports a history of similar reaction to eating berries.
I began feeling  a sore throat around 12/27/21.  I isolated myself.  On 1/7/22  I was feeling fewer symptoms and had a RNA test performed that tested positive for COVID-19.   I was retested using a rapid test on 1/13/22 and tested negative for COVID-19.  The only symptoms were the sore throat and congestion.
metallic taste; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (metallic taste) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0482A1) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DYSGEUSIA (metallic taste). At the time of the report, DYSGEUSIA (metallic taste) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant information use was not reported.  Treatment information was not provided.
On 3/4/99, when pt awoke, she had blurry eyes and could not see details of people's faces. She said eyes were not painful but slightly red. The next day, the school sent her home and parents took her to physician who referred them to opthalmology. There she was dx with severe uveitis. She was treated with prednisone and Isopto-Homatropine. The pt's symptoms were not relieved and she was seeing a physician for this problem at least once a week. Due to the medication she was taking,  the pt also developed cataracts and had to be treated for very high eye pressure.  She currently has methotrexate shots once a week, eye drops twice daily, and she sees a physician twice a week.
Immediately folowing the HPV vaccine patient began feeling sick to her stomach and complaining of bad h/a. These symptoms continued throughout the entire next day and that afternoon she had a seizure. Patient does have hx of seizures, before she had this seizure, but last seizure hadn't been for an entire year.
Patient received vaccine at 0845, reports symptoms of intermittent dizziness directly after receiving vaccine dose.  Patient stayed for observation for 30 minutes.  Patient reported feeling fine and left observation on her own and went home.
I had extreme chills and was subnormal that I woke up in middle of night and had to put a sweater and socks on.  It was like I was placed in a bath tub filled with ice water.  My feet were freezing.  I am lethargic and lack energy
No adverse events.  Expired vaccine administered on 4/14/21.  (Vaccine expired 3/31/21).  Patient instructed to return for repeat dose.
This case was reported by a healthcare professional (subject and nurse) and described the occurrence of lip swelling in a 38-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline). Concurrent medications included lisinopril, chlorothiazide, ZOLOFT and ADDERALL. On 27 September 2013 the subject received a dose of influenza vaccine unspecified (.5 ml, unknown route, right arm). On 30 September 2013, 3 days after vaccination with influenza vaccine unspecified, the subject experienced lip swelling, swelling of eyes, swelling of hands and feet, swelling of face. These symptoms occurred when she woke up on 30 September 2013. The subject sought medical care at an emergency room and was treated with BENADRYL and an unknown intravenous treatment. The subject did not stay in the emergency room overnight. On 10 October 2013, 13 days after vaccination with FLUARIX, the subject had a sudden onset of heart rate high, felt like about to pass out. The subject sought medical attention from the emergency room. "She had a 24 hour Holter monitor; she was monitored and all cardiac testing came back negative." On 12 October 2013, 15 days after vaccination with FLUARIX, the subject "woke up again with the same symptoms as of 10 October 2013 and she had to go again to the emergency room" and also experienced a feeling of doom (described as a "feeling of impending doom"). In 2013, within the same month of vaccination with FLUARIX, the subject also experienced feeling weak and feeling tired. At the time of reporting the outcome of the events of lip swelling, swelling of eyes, swelling of hands and feet, swelling of face, heart rate high, felt like about to pass out, and feeling of doom were resolved. The subject reported still feeling weak and tired at the time of reporting.
1 hour past vaccines patient became hyporesponsive and pale. Mom brought him to clinic. He was saturation 85% room air and was difficult to arouse. His vital were stable and he responded to oxygen. Was transported to the ED where he recovered and was sent home. Normal labs, CXR ? mild RLL infiltrate. The nxt Day he was wheezing and is being treated for an asthma exacerbation. He has asthma. There was no symptoms prior to episode. He was well without any distress.
Information has been received from a healthcare worker referring to unspecified patients of unknown age and gender. Since 27-JAN-2016, the patients were vaccinated with an unknown number of doses of improperly stored M-M-R II (lot # L015279, expiration date 30-APR-2017, strength, dose, frequency, lot# expiration date and route were unknown). No adverse effects were reported. Additional information has been requested.
Severe body pain (level 7 on 1-10 chart), headache, was kinda spaced out due to pain
Systemic: Dizziness / Lightheadness-Medium, Systemic: Headache-Medium, Systemic: Hypertension-Medium, Systemic: Tachycardia-Medium, Additional Details: Patients original BP was 146/97 and HR 102. Second reading 5 minutes later was 142/93 and HR 98. Patient wanted to go home and rest. She had a pretty bad headache after the 2nd injection. She was advised to take tylenol.
Patient is a 68-year-old female who presented herself to the Emergency Department at the Health System.  She was complaining of some difficulty breathing and abdominal pain and a general feeling of being unwell.  She was noted to have significantly lower blood pressures.  A CT scan of the chest, abdomen, and pelvis revealed a relatively large left lower quadrant intraabdominal abscess with perforation.  There was also findings of free air into the diaphragm and free air tracking along the mediastinum.  The facility did not have any beds available, and so she was transferred to the another facility for further management.  Of note, the patient was admitted to Hospital
have sharp pains in feet; Not feeling good, feels wiped; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (have sharp pains in feet) and MALAISE (Not feeling good, feels wiped) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (have sharp pains in feet) and MALAISE (Not feeling good, feels wiped). At the time of the report, PAIN IN EXTREMITY (have sharp pains in feet) and MALAISE (Not feeling good, feels wiped) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.
"Pt developed a knot and redness at injection site on right leg (larger than a 50 cent piece) that lasted through 2/4/01". "Pt had seizure and was taken by rescue squad to hospital ER on 2/5/01. Fever was 101F and was dx'd with ear infections at ER". Per mom, she is to see PMD on 2/8/01.
RUN DOWN FOR A COUPLE DAYS; FEVER; This spontaneous report received from a consumer via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure no follow up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced run down for a couple days, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever and run down for a couple days was not reported. This report was non-serious.
12 year old female client was given TDAP, Menactra, and HPV . A few minutes after receiving immunizations, client?s lips turned pale, skin was cold, pale and clammy, and client briefly loss consciousness. Client remained seated and did not fall. Mother was with the child. Ammonia inhalant was administered. Client remained pale at this time. Oxygen 2L per minute was given via face mask. Vital signs taken and were as follows: BP=154/134, oxygen saturation=90%, pulse rate =57, respirations=18. Client was lethargic but was able to respond appropriately to questions asked. 911 was called at 11:15 am. Client was continuously monitored by nurses present. 911 responders came in at 11:23. Vital signs were taken by 911 responders and were as follows: BP= 88/58, oxygen saturation=88% on room air, pulse rate=67, respirations=20. Client stated ?I feel very tired?. Skin remained pale, cold and clammy, lips remained pale. Client taken by 911 responders to Hospital at 11:35.
Confusion, fevers and chills for 72 hours. After 6 weeks. Extreme fatigue , both  soles of feet itching  for 4-5 days , goes away , has come back. Usually in th evenings and  and early mornings. Appetite low, have lost several pounds.
Patient presented to the ED and was subsequently hospitalized for dehydration, acute kidney injury, orthostatic hypotension, cellulitis of right foot within 6 weeks of receiving covid vaccination.
Spasms-had 28 episodes until 4:12 pm today; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MUSCLE SPASMS (Spasms-had 28 episodes until 4:12 pm today) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 13-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-May-2021, the patient experienced MUSCLE SPASMS (Spasms-had 28 episodes until 4:12 pm today) (seriousness criterion hospitalization). The patient was hospitalized from 14-May-2021 to 15-May-2021 due to MUSCLE SPASMS. At the time of the report, MUSCLE SPASMS (Spasms-had 28 episodes until 4:12 pm today) outcome was unknown.            No concomitant medication information was provided. Additional information received included that the patient had 28 episodes till now from the first dose vaccination. Treatment information was not provided.  Action taken with mRNA-1273 in response to the drug was not applicable.   This case was linked to MOD-2021-076263 (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, a causal relationship cannot be excluded.  Further information has been requested.
After booster dose patient had low blood pressure and fatigue.; After booster dose patient had low blood pressure and fatigue; This is a spontaneous report from a contactable reporter (Physician) received . A 23-year-old female patient (unknown if pregnant) received bnt162b2 (BNT162B2), administration date an unknown date in Oct2021 (Lot number: unknown) at the age of 23 years as dose 3 (booster), single for COVID-19 immunisation. The patient's relevant medical history was unknown. It was unknown whether the patient received any concomitant medication. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunisation and Covid-19 vaccine (DOSE 2;MANUFACTURER UNKNOWN), for COVID-19 immunisation.  The following information was reported: HYPOTENSION (non-serious) with onset an unknown date in Oct2021, outcome "recovered", described as "Low blood pressure"; FATIGUE (non-serious) with onset an unknown date in Oct2021, outcome "recovered", described as "Fatigue". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of hypotension and fatigue.  Additional information: It was unknown whether the patient had any known allergies. It was unknown if the patient had received any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to vaccination, it was unknown if the patient was diagnosed with COVID-19. Since the vaccination, it was unknown if the patient had been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
103.5 degree F fever, severe chills, body aches, headache, intense pain at injection, nausea, fatigue
Ringing, pain on left ear. Stared mild and progressively started to get worse to a point I could not sleep without medication.
Abdominal/stomach pains; Diarrhea; Spontaneous report received on 09DEC2019.  A nurse reported that a 13-year-old female consumer had abdominal/ stomach pains (PT: Abdominal pain) and diarrhea (PT: Diarrhoea) following immunization with Vivotif. On an unknown date, she had abdominal/ stomach pains and diarrhea that started in the middle of the night after her third dose of Vivotif. Action taken with Vivotif of reported event was vaccine discontinued. She was recovered from the reported events within 12 hours after onset of symptoms   Medical history included celiac disease and prolonged viral syndrome (2016).   Allergies included penicillin allergy (where she would experience rash), egg allergy (where she would experience nausea and vomiting, but she was able to receive the flu vaccine) and allergy to all type of nuts where she would experience anaphylaxis so she had an Epipen (epinephrine). She also had viral induced asthma.  Past medications included Qvar (beclomethasone; prescribed to take as needed) and albuterol (prescribed to take as needed) which she took once for viral induced asthma.  Additionally, the nurse reported that few medications included Wal-Zyr (5 mL per day for allergies), tums, Vitamin D, and multi-vite, were listed on the consumer's list, but she did not know if the consumer was taking these while taking Vivotif.  The reporter considered the events of abdominal/stomach pains and diarrhea were not related to Vivotif.  Company Comment: A consumer had abdominal pain and diarrhea after taking third dose of vivotif and the events resolved within 12 hours without any treatment. The consumer did not take the fourth dose of Vivotif due to the events. Considering the case information and potential of Vivotif to cause abdominal pain and diarrhea, the causality of both the events is assessed as possible with Vivotif.; Sender's Comments: A consumer had abdominal pain and diarrhea after taking third dose of vivotif and the events resolved within 12 hours without any treatment. The consumer did not take the fourth dose of Vivotif due to the events. Considering the case information and potential of Vivotif to cause abdominal pain and diarrhea, the causality of both the events is assessed as possible with Vivotif.
Extreme Fatigue, 101.7°F fever, Body aches, General malaise, Vertigo, Nausea.   All except Vertigo and Nausea disappeared by the morning of the 24th.   Vartigo and Nausea are now diminishing
Anaphylactic reaction, flushing, severe shortness of breath. administered a dose of Epipen Jr. Patient fully recovered after 5 minutes. Was observed for 20 more minutes by Paramedics. Sent home after.
Forty minutes after getting the vaccine I was in the car and I felt like I was having heart palpitations. I then started to itch all over and I noticed that my arms were swelling. My chest started to swell too and my face was huge. My throat was starting to close, and the itching was intense but I could not really feel where I was scratching. I drove straight to the Urgent Care. I was not treated quickly with Benadryl so I took some myself. They advised Hydroxyzine. The swelling started to come back after the Benadryl started to wear off and I took two more. The next day I took more Benadryl and the Hydroxyzine. I still have no feeling in my chest after almost one week. The numb feeling is mostly close to the area of the shot and most of the swelling went down. I did have flu-like symptoms the following day which lasted for three days. I had a fever of 103, muscle aches and some diarrhea.
Rash, joint pain, arthralgia, vasculitis of skin, MCP edema