chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Approximately 2 1/2 hours after injection I started experiencing cramping and abdominal pain with nausea quickly following. At about the 3 hour mark I started vomiting  (several times) and diarrhea followed. The chills then set in with some general achiness and muscle fatique/soreness, I also felt very tired. I did call my PCP who advised that I stay hydrated, watch for rash, eat a bland dinner and if I was not feeling better in the morning to call back.   Today, the day after the injection I have had a sensitive stomach, minor muscle fatigue/soreness but a lot of soreness/pain at the injection site.
Pt. had immunization on 2/17/14 - came into clinic on 2/19/14 with c/o redness to (Rt) arm. Has area of redness - 12cm x 15cm irregular shape - warm to touch. Area was marked and pt. to be re-evaluated 2/20/14.
Following a 2-1/2 month hospitalization requiring ICU acute hypoxemic respiratory failure, hemophagocytic lymphohistiocytosis, and acute kidney injury due to COVID-19, patient had 4 months of gradually improving strength. One month after a 2-dose series of COVID-19 RNA vaccines, patient began to develop stiffness and weakness in his right thigh which gradually spread to his entire body. Presently, patient continues to exhibit muscle stiffness and frequent cramping. Extensive testing yielded a diagnosis of primary myositis with deep perivascular inflammation affecting muscle and intramuscular nerves. Treatment plan includes intravenous immune globulin for 3-9 months along with rituximab and mycophenolate mofetil. Patient has a firm treatment plan in place with appropriate provider follow-up.
Pregnancy; Initial Report Received on 30-May-2023.  This spontaneous report was received from the HEPLISAV-B pregnancy registry.  A healthcare professional reported that a female patient (race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization while pregnant.  No relevant medical history or concomitant medications were reported.  On 27-Apr-2023, the patient received the first dose of HEPLISAV-B (Lot #, expiration date and NDC # not reported).  The patient was 6 months pregnant when she received the first dose.  The patient was at her primary care (PCP) office today (30-May-2023) to receive a second vaccine when she was advised that she received HEPLISAV-B on 27-Apr-2023 in error.   The patient was currently 7 months pregnant.  The patient asked not to be followed up on but said she would consider calling back to learn more about the pregnancy registry.  No additional information was reported.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Patient called pharmacy c/o severe arm pain/stiffness. I recommended ibuprofen and an ice pack. I told patient that is she didn't get better or if it get worse to contact PCP. Patient's arm started to get better, never contacted doctor.
Initial reaction was small area of redness at injection site.  This progressed to area of erythema and induration measuring 6 cm by 6 cm.  There was surrounding erythema but no induration measuring 16 cm by 14 cm.
No fever or rash other than inject site, adenopathy (local inject site area) pain in joints & inflammation of joints & parotitis for 10 days;
Within minutes of receiving an AFLURIA trivalent flu shot, patient describes a metallic taste in her mouth after receiving AFLURIA flu shot.
Waited in vehicle after injection.  At 10 minutes after injection, arm became somewhat tingly down to finger tips. At 15 minutes I felt nauseated.  At 20 minutes the symptoms seemed to plateau  and I drove home and the symptoms mostly subsided, but whole armed seemed cold and tingly.
severe diarrhea; 1JUN92 began 3 wks p/1st shot; diarrhea stopped on 6JUN; got 2nd shot on 8JUN92; diarrhea began again lasted until 28JUN92; MD tested for parasites, etc; all tests were neg;
5 y/o female child received KINRIX (DTaP-IPV) into the left thigh on 4/6/12. Mother noted increased erythema several hours post immunization and the subsequent development of soreness and pain the following day. Mom took child to ED on 4/8/12 for evaluation. Child diagnosed with local reaction from immunization.
Received Pfizer vaccine at 0827 and was instructed by LVN to wait 30 minutes post vaccination for observation.   Patient complains of throat swelling and chest tightness approx 40 minutes post vaccination.   On exam, no lip or throat swelling noted. Denies headaches, shortness of breath, dizziness, rash, itching. Patient speaking in full sentences, respirations even and unlabored. BP 131/83, pulse 82, O2 sat 100%   0925 Benadryl 25mg by mouth given. Patient remained alert and oriented, speaking in full sentences. BP 128/76, pulse 76, O2 sat 99% Patient continues to complain of chest tightness; throat swelling mildly improved per patient. History of asthma- instructed to use albuterol inhaler 2 puffs at 0930.   0935 Transported via wheelchair to UC for further evaluation.
Information has been received from a nurse concerning a 9 week old female with no known drug allergies and no pertinent medical history who on 01-JUN-2011 was vaccinated with the first dose of ROTATEQ (lot # 668964/1200Z) orally. There was no concomitant medication. The patient experienced intussusception following administration of her first dose of ROTATEQ on 08-JUN-2011 (also reported as 2 weeks after vaccination). She was eating poorly, had blood in her stool, and became lethargic. Patient sought medical attention by office visit. Patient was changed to ALIMENTUM formula for possible milk allergy. On 08-JUN-2011 she was diagnosed with intussusception and hospitalized. Ultrasound of abdomen and contrast enema were performed, although, results were not provided. Intussusception was treated with surgery. She recovered and was discharged on 10-JUN-2011. Additional information has been requested.
SYNCOPE WITHIN 5 MINUTES OF VACCINATION, LASTED LESS THAN A MINUTE. PATIENT WAS ABLE TO PROCEED OUT OF THE PHARMACY ON HIS OWN. NO TREATMENT NECESSARY.
Patient received first dose of Pfizer vaccine at 10:00am. AT 10:11 am patient reported feeling like her throat was closing and lightheadedness. Benadryl .5ml administered IM at 10:12am. V/s 123/86, 77, 99%, 37.0, 16. Lungs clear all lobes, no wheezing. At 10:22am  patient reports relief. Instructed to go to ED if symptoms return.
screamed for 6 hrs treated by APAP, cold washcloths, feeding, walking, called PMD stated nothing could be done unless fever or convulsing;
Generalized myalgias. Fever. Malaise. Fatigue.  Note: I did have and recovered from COVID-19 infection in December 2020.
Arm being hot; Arm being hot and swollen; This case was reported by a consumer and described the occurrence of skin warm in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced skin warm and swelling arm. On an unknown date, the outcome of the skin warm and swelling arm were unknown.   It was unknown if the reporter considered the skin warm and swelling arm to be related to Shingles vaccine.  Additional details were provided as follows: The age group was not reported but was selected as per the vaccine indication. The age at vaccination was not reported. The patient asked what could do about his/her arm being hot and swollen after the shingles shot.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 44 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (20May2022) positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Return of Covid symptoms and a positive antigen test seven days after completing Paxlovid course. Were you/Was the patient taking any other medications/products within 2 weeks of starting COVID-19 treatment?: No. Did you/the patient previously receive a COVID-19 Vaccine?: Yes  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Back pain; pain moved to all of their long bones and muscles/been beaten with a bat; myalgia/been beaten with a bat; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Back pain), PAIN (pain moved to all of their long bones and muscles/been beaten with a bat) and MYALGIA (myalgia/been beaten with a bat) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     The patient's past medical history included Cough (believes they had COVID-19 because they suffered having a bad cough back) from 24-Jan-2020 to 15-Feb-2020. Concurrent medical conditions included Migraine. Concomitant products included FENTANYL, MORPHINE and TOPIRAMATE (TOPAMAX) for an unknown indication.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BACK PAIN (Back pain), PAIN (pain moved to all of their long bones and muscles/been beaten with a bat) and MYALGIA (myalgia/been beaten with a bat). At the time of the report, BACK PAIN (Back pain), PAIN (pain moved to all of their long bones and muscles/been beaten with a bat) and MYALGIA (myalgia/been beaten with a bat) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication was reported.  The patient reports about 2 hours after getting the first and second dose they experienced severe myalgia.  The patient described it as "been beaten with a bat,patient explained these symptoms lasted through the first night, was gone the next day, then the pain came back the following day, and finally the next day it all went away.   This case was linked to MOD-2021-294576, MOD-2021-294577 (Patient Link).
?Jansen COVID-19 Vaccine EUA Migraine Headache (horrible) for at least 24 hours. Body aches. Took ibuprofen felt better, drank a lot of water and liquids.
Within the 15 minute observation window post vaccine, the patient experienced 3 waves of a tingling sensation that went away as quickly as they came.  Afterward, she felt "cognitively disconnected and shaky like on caffeine."  She remained in the pharmacy an additional  30 to 45 minutes until effects subsided.
Significant induration, redness, tenderness at injection site (13 cm), fever 102.
At 3 AM on 4/25/21 I felt a twitch begin in my leg. It then started spreading and fairly quickly I was shaking/trembling all over. This lasted at least 30 to 40 minutes, finally at which point I fell asleep. I thought it was just a panic attack, but at around 3:40 PM today, I've felt the same twitching / "off" feeling in my legs, and I've had to walk around a lot to try to stave off a full blown twitching/shaking episode. It also makes my teeth chatter a little bit & it's hard to swallow any water during. I'm not yet concerned enough to go to the doctor, but will if it doesn't go away in the next day or two. I still wanted to report it because I had seen others online potentially having the same event happen a few days after their second dose.
4/30 - 2nd shot administered - Symptoms of fatigue, myalgia, injection site pain, and nausea  started in 30 mins 5/4 - Patient felt much better 5/5 night - Symptoms started back up again. 5/6 - Pharmacy referred patient to consult PCP
I was fine until about 10 hours lately and it cut my air off. I'm on Prednisone right now. I went to ER - they injected me with an injection to get the swelling down so I could breathe. They have me on Prednisone still. I am breathing as long as I stay on the Prednisone. The hospital under dosed me and so I went to the doctor and he increased the amount and I have to be on that a few more days. The Prednisone makes me very jittery but it also keeps the swelling down so that I can breathe. But I'm very tired and normally I'm very energetic and feel really good and healthy. Tiredness is really hitting me today - no energy, whatsoever. I had very little pain in my arm in my shot - subsided very quickly. If I had to guess, I'm guessing that I may have reacted to the Polyglycol that is in the vaccine. I ran no fever. I don't ache - bones and joints don't ache. I just feel very sluggish and lethargic. I have never had this much Prednisone before. I will have another follow visit with doctor when Prednisone is done in about four days if I'm not up to par.
The morning of 1/4/20, redness and swelling at the injection was noted. A circular flat ?lump? at the site is present with mild intermittent itching. No treatment at this time.
Eyelid swelling, swelling treated with IV and oral corticosteroids and oral antihistamine about 24 hours after administration.
4 days post vax experienced blind spot in lt eye, blurred vision, flashing lights went to take nap when awoke had headache went to MD Dx ophthalmic migraine. Continued headache and fatigue for wk. Developed bronchitis 5Jul90. Resolved
Patient is not exhibiting any adverse symptom; Received an extra dose of Vaqta/Indicate at which point in the process the medication error ocurred: Administration; This spontaneous report was received from a medical assistant and refers to an 18-year-old male patient. The patient's concurrent conditions included seasonal allergies and no information was provided regarding the patient's medical history or drug reactions.  On 11-SEP-2008, the patient was vaccinated with the first dose of Hepatitis A Vaccine, Inactivated (VAQTA) for prophylaxis (strength, dose number, anatomical location, route of administration, lot number and expiration date were not reported) and on 17-NOV-2010 received the second dose  (strength, dose number, anatomical location, route of administration, lot number and expiration date were not reported).  On 07-JUL-2021, an administration error occurred, and the patient was vaccinated with an extra dose of Hepatitis A Vaccine, Inactivated (VAQTA) intramuscularly, lot # T033519 with expiration date on 11-DEC-2021. The vaccine was administered by a trained healthcare professional and treatment was not required for the experience and the patient did not exhibit any adverse symptom. The same date the patient was vaccinated with diphtheria vaccine toxoid, pertussis vaccine acellular 5-component, tetanus vaccine toxoid (ADACEL) and hepatitis b vaccine.
Fatigue and weakness Warmth in the area of the shot in the left arm  Warmth in the upper chest area
Headache, Phlebitis, Fever, chills, sore arm, , fatigue. Narrative:  Other Relevant History:
Chills, Fever, Breathing, Weakness, Headache.  This started in afternoon 1 day after receiving vaccine.  Took 2 Tylenol 4 hours later took 2 Advil.  Chills went away.  Had a fever , but this morning it is gone.  I have never had a reaction to any kind of vaccination before exept for a minor sore arm.  If I had a reaction to the first one, should I have a reaction to the second does also?
3-11-21 4:26PM CALLED TO VACCINE STATION.  PARENT STATES PT HAS BEEN HAVING SEIZURES OFF & ON X ARPOX. 20MIN. SEIZURES STARTED BEFORE VACCINATION.  4:40PM PT POST ICTAL; PINK, W/D, RESP REG WITH EASE - NO RESP DISTRESS.  TO EXIT PER W/C TO BE TAKEN HOME PER MOM.  NO SEIZURES AT THIS TIME. 3-12-21 9:30AM MOM STATES PT IS '100% BETTER TODAY'.
11/28/21 SX and obtained a positive COVID-19 test. 11/28/21 admitted to hospital and treated with dexamethasone, Zn and oxygen. Discharged 12/7/21 stable and continued on chronic home O2.
No adverse event; patient received 0.5 ml the Moderna booster as opposed to the bivalent; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (patient received 0.5 ml the Moderna booster as opposed to the bivalent) and NO ADVERSE EVENT (No adverse event) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In December 2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In December 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Oct-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 06-Oct-2022, the patient experienced WRONG PRODUCT ADMINISTERED (patient received 0.5 ml the Moderna booster as opposed to the bivalent). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (patient received 0.5 ml the Moderna booster as opposed to the bivalent) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (patient received 0.5 ml the Moderna booster as opposed to the bivalent).    No concomitant medication information provided.  It was reported that patient had 0.5 ml of a regular Moderna booster.  No treatment information provided.
150-200 red bumps / hives on my body. Very itchy. Mainly my torso but now spread to my legs & arms. Some of these red bumps are getting larger & becoming more like pimples that I could squeeze/pop.
Allergic reaction around the eyes and chest; This case was reported by a physician via sales rep and described the occurrence of allergic reaction in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix (intramuscular) .5 ml. On an unknown date, less than a week after receiving Shingrix, the patient experienced allergic reaction. On an unknown date, the outcome of the allergic reaction was unknown.   It was unknown if the reporter considered the allergic reaction to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient went 2 days after vaccination with shingrix to the doctor with an apparent allergic reaction around the eyes and chest. The reporter agree to follow up with GlaxoSmithKline.
Prior to the first dose of COVID vaccine on 16Mar2021, I had a small mouth sore on the inside upper right of my mouth. I am not prone to mouth sores but had bit my lip in this location.  Following the first vaccine, this mouth sore became larger and painful accompanied by visible lip swelling. Duration of lip swelling was approximately 4 days. Treatment included salt water gargles a few times a day.    Prior to my second vaccine on 08Apr2021, I had no mouth sores. Approximately one day following the immunization, I experienced a small mouth sore on the inside left lower area of my mouth on the inside of my lip. Over the past few days, the sore has gotten larger with associated pain.  This morning (11Apr2021), I awoke to visible swelling in this area.
First night (Saturday, 2/6) - around 7-8pm, became fatigued, lethargic, headache, muscle pain, cough, fever (as expected for second dose); Sunday (2/7) - same symptoms, less severe; Monday (2/8) - no symptoms; Tuesday (2/9) - hard to get up in morning (extreme fatigue), chills, muscle aches, productive cough, headache, dry mouth, ocular sinus pressure, cyanosis (not severe - blue fingernails, blue toenails, feet slightly blue), dizziness, trouble breathing when walking up stairs. Symptoms would come and go throughout day, but were worse in the mornings. Wednesday (2/10) - Present (2/13) - same symptoms as Tuesday (2/9). Symptoms worse in the mornings and after physical exertion (going to school, walking stairs), and at night as well. Symptoms are not severe, but I am concerned that they have lasted a full week. I have been taking Day-Quil severe every 4 hours. I was also on my period, which just ended yesterday (2/12). I believe my period started the day of the vaccine.  I plan on going to a doctor's office, but have been too tired to move from my apartment.
Flu like symptoms; Irritability that he is having trouble controlling which has not stopped; Injection site pain; Headache; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), IRRITABILITY (Irritability that he is having trouble controlling which has not stopped), VACCINATION SITE PAIN (Injection site pain), HEADACHE (Headache) and FATIGUE (Tiredness) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Aug-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), IRRITABILITY (Irritability that he is having trouble controlling which has not stopped), VACCINATION SITE PAIN (Injection site pain), HEADACHE (Headache) and FATIGUE (Tiredness). On 07-Aug-2021, VACCINATION SITE PAIN (Injection site pain) and HEADACHE (Headache) had resolved. At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms), IRRITABILITY (Irritability that he is having trouble controlling which has not stopped) and FATIGUE (Tiredness) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
Around 9:30 pm on 2/4/2021 my right cheek felt numb and was tingly. This persisted through the evening and my right jaw started to feel the same way. My right ear felt like it had to pop. I went to my doctor she stated she didn?t know what was wrong but she could prescribe me a steroid and to take Tylenol or Motrin fir pain. Later that evening I went to emergency and they repeated the same thing; however, I had a high blood pressure at the doctors office 181/91 and then 141/91. At emergency it was 171/80. I left emergency with the same pain and no answers. The following morning I felt better. Around 3:30 my right cheek and jaw started to feel numb with a tingly sensation. My ear was hurting and later on in the evening I had a massive headache and blurred vision. I stayed in bed all day 2/7 and had the same symptoms. As of 2/8 my jaw and ear have massive pain and I have a slight headache. My blood pressure keeps fluctuating and my left cheek area feels tight.
I experienced flu like symptoms for 2 to 3 days, chills, fatigue, headaches, nausea. I then experienced continual outbreaks of Herpes II virus and canker sores that were difficult to treat with Vaclyclovir and a homeopathic remedy of Ranunculus which normally work. I have finally gotten better after almost a month with the Herpes outbreaks and canker sores. It was bad enough that I considered not getting the 2nd shot in the series. I will, but I'm waiting till it's close to the 6 months deadline. I had read a number of years ago that it was advised NOT to receive the Shingles vaccine if you had Herpes II. I asked both my primary care physician and the pharmacist who both said there was no know issue. I did read some blog information by people who had issues but decided I'd try it. I would not necessarily recommend it to people.