chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient tries to drink water, but can't keep anything in her stomach after second dose; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (Patient tries to drink water, but can't keep anything in her stomach after second dose) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced VOMITING (Patient tries to drink water, but can't keep anything in her stomach after second dose). At the time of the report, VOMITING (Patient tries to drink water, but can't keep anything in her stomach after second dose) outcome was unknown. Not Provided          Concomitant medications were not provided. Treatment details were not provided.
pt recvd vax; 1 day later, pt exp inj site rxn characterized by redness & warmth;
woke up in the morning to a droopy lip and the right side of my face didn't function properly.  Went to the hospital and was told i have Bell's Palsy.  Was given anti viral meds and steroids.
COVID 19 Treatment; COVID 19 Treatment; Vaccine brand other=Moderna; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from product quality group. The reporter is the patient.  A 75-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Sep2022 as dose 5 (booster), single (Lot number: GT2524) at the age of 75 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 24Feb2021 as dose 1, single (Lot number: EL8982), in left arm, on 17Mar2021 as dose 2, single (Lot number: EN6201), in left arm and on 09Sep2021 as dose 3 (booster), single (Lot number: FC8184), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 09Apr2022 as dose 4 (booster), single (Lot number: 048L21A), in left arm and on 21May2023 as dose 6 (booster), single (Lot number: AS7185B), in left arm for covid-19 immunisation. The patient's relevant medical history included: "moderate hyperlipidemia" (unspecified if ongoing); "Known allergies: some shellfish" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 09Apr2022, outcome "unknown", described as "Vaccine brand other=Moderna"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19. Additional information: Patient received Paxlovid (Lot number GF7870 & G02988, Pfizer) for Significant symptomatic Covid rebound on 18Jun2023 with from 10Jun2023 for COVID 19 anti viral treatment.; Sender's Comments: Based on the information provided and temporal association, a causal relationship between BNT162b2, and the events covid-19, vaccination failure, Interchange of vaccine products  cannot be excluded.
Eight days after injection a red area appeared near site. Was larger (2in by 1.5 inches approximately) and redder. Slight swelling, firm . Not itchy but sore, irritated. Started blotchy on Sunday (1/23) and was solid ref starting the next morning. Seen by doctor 1/26 and started taking Benadryl. This morning, 1/27 the area is larger. Over all the color has faded to light red with dark red border.
Patient received 2 immunizations, influenza in right arm and PREVNAR 13 in left arm on 2/5/19. Patient returned to pharmacy 2/12/19 stating she has had red blotches and warmth in her left arm. Interviewed patient and she told me starting 2/6/19 she had warmth and pain in her left arm which was blotchy, felt lightheaded, bilateral joint pain in wrists and ankles. Patient stated all symptoms resolved within the following day except her left arm warmth/discomfort and blotches. Pharmacy manager and myself examined left arm and observed the red blotches, no signs of infection were visible.
Headache, tiredness, non-productive cough, scratchy sore throat, fever, nausea, abdominal pain, vomiting.  Started suddenly day after vaccination.  Symptoms reported to doctor.
Patient had previously had a single dose of Pfizer vaccine, this was not disclosed to the pharmacist.
This spontaneous report as received from a healthcare worker refers to a female patient newborn patient. On the day the patient was born, 20-FEB-2013, she was vaccinated with her first dose of RECOMBIVAX HB (lot number not provided) 5 mcg/0.5 ml intramuscularly. On 22-FEB-2013, the second dose of RECOMBIVAX HB was administered. No adverse effect was reported. Medical attention was not sought. Additional information has been requested.
About 2.5 inches of erythema/edema at shot site. Tender lasted about 48 hours. Started right after shot. Resolved on its own without treatment.
Headache, Myalgia, Diarrhea, fatigue, exhaustion Narrative:  plans to phone PCP for headache issue if it does not pass
Information has been received from a school nurse concerning a female who was vaccinated with a dose of varicella virus vaccine live on an unspecified date. Subsequently, the patient developed a breakthrough case of chickenpox and herpes zoster as well. The patient was seen by a physician, the zoster was diagnosed by the physician. There was no outcome information given. At the time of this report there were no further details available. It was noted that the chickenpox stemmed from one wild type case. No product quality complaint was involved. Additional information has been requested.
Have had a clear mammogram for past several years and this year I have had to have a Diagnostic mammogram - the results were: Overall Assessment: BI-RADS Category 3: Probably Benign.  This means that I have a lymphoid that is swollen and will now need to be monitored.   Which now I have to have a follow-up mammogram in 6 months.
Sweats, collapse, vertigo, memory loss, loss of vision, uncontrollable cough, weak muscles
Information has been received from a registered nurse (R.N.) concerning a child in elementary school (who is between grades 3-5) who was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). It was reported that an outbreak of chickenpox began in an elementary school in November 2005. "Recently", "since November 2005", the child developed chickenpox and sought unspecified medical attention. No outcome was reported. No product quality complaint was involved.
Rash/hives two hours after receiving vaccine, moderate severity, wrists, arms, chest, neck. Tx with BENADRYL 50 mg po.
Vaccine administered in R bicep ~6-6:15 pm 10/11/16. Hives/itching/heat down at elbow around 7pm. Noticed pain/swelling/soreness radiating from area of injection, difficulty moving/lifting R arm increasing over the next few hours. Applied ice around 10pm and helped reduce heat/swelling slightly.  Woke up due to pain overnight. massaged arm and used natural oils to help loosen muscle. Slight fever. Chest tightened some. Took hot shower 10/12/16 5am - was able to lift arm enough to dress and come to work. Out of breath walking up hill to work every day. Arm is still swollen and painful as of 11AM 10/11/16. Took small dose of Benedryl (1/2 teaspoon) with no reduction of swelling. Took 1 aleve and fever has gone down. Will be visiting the doctor later today.
A week later my arm became itchy, red, and swollen in the same spot the shot taken place.
Double Vision, Went to ER for a possible TIA.  ER wanted to do an Echo Cardiogram, but I had that done the next week.  Cat scan and MRI of the head were performed.  Blood tests were run.  Overnight in the hospital where they put me on a Statin and advised to use a low dose aspirin.  Saw my doctor 9/3/22, who ordered an Echo Cardiogram for 9/22.  This revealed a leaky left valve.  Stain and aspirin exacerbated unrelated rectal bleeding, leading to blood loss and a hematologist consult.
large lower extremity deep venous thrombosis and small pulmonary embolus; outcome: responded well to anti-coagulants, with decreased pain, swelling and improved oxygenation
No adverse effects - vaccine was two months expired and had not been quarantined from refrigerator stock appropriately, so was administered during a high-volume day
I was sweaty and had a headache. I ran a low-grade fever and fatigued. The third day I felt better. I tested positive on February 27, 2023, for COVID-19. I spoke with doctor and got Paxlovid.
had a fever; unable to sleep; felt uncomfortable; tired; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (unable to sleep), FEELING ABNORMAL (felt uncomfortable), FATIGUE (tired) and PYREXIA (had a fever) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025J02A and 028L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Jan-2021, the patient experienced INSOMNIA (unable to sleep), FEELING ABNORMAL (felt uncomfortable) and FATIGUE (tired). On an unknown date, the patient experienced PYREXIA (had a fever). At the time of the report, INSOMNIA (unable to sleep), FEELING ABNORMAL (felt uncomfortable), FATIGUE (tired) and PYREXIA (had a fever) outcome was unknown.            No concomitant medications were provided. Caller took treatments.   This case was linked to MOD-2021-313006 (Patient Link).
Left deltoid with redness, swelling to area.  No fever.  Area painful.  Treatment warm/cold compress, Tylenol or Motrin as needed.  If swelling increasing return to clinic.
pt recvd vax; pt exp pain in arm 1 hr following vax; pt devel blotches on arm & chest, & hives all over upper body;
Swollen lymph node in neck above right clavicle. Woke on 4/7 to bean shaped swelling which is tender. Waiting to see if it goes away within a day or two.
rash on inside of upper arm (left) measuring approx 4 inches wide by 8 inches long same arm where vaccine was administered
Client vaccinated for Covid with Pfizer vaccines on 7/13 and 8/3/2021.  Symptoms started on 12/3 - nasal congestion, fever, headache, myalgia, sore throat, loss of taste and smell.  Breakthrough Covid case.
Soreness at injection site Began with tiredness and low grade fever at 12 noon 3/24/21 (took Tylenol) later in afternoon began with feeling like on a boat (like seasick), nausea occasionally, mild headache by evening of 3/24/21 mild chills intermittently Tiredness lasted a couple days Mild feeling  like on a boat lasted for almost a week  - came on more strongly in the evenings and dissipated as the week went on
Extreme pain in arm, nausea, exhaustion, cold sweat. The cold sweat and nausea were gone by the next day. The arm pain was gone two days after the shot. I had taken Excedrin after the shot when the pain developed.
Stiffness joints; Vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of JOINT STIFFNESS (Stiffness joints) and VACCINATION SITE PAIN (Vaccination site pain) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Pneumonia in 2004, Anxiety in 2006, Depression in 2006, Fatigue in 2006, Hearing loss in 2010, Joint pain in 2010, Eye inflammation in 2018, Eye pain in 2018, Dry eyes, Dry mouth, Abstains from alcohol, Tobacco abuse, Epstein Barr virus positive mucocutaneous ulcer, Foot surgery in 1984, Knee surgery NOS in 1988, Ligament operation in 1988, Appendectomy in 1992, Caesarean section in 1998, Surgery in 2014 and Uterine ablation in 2014. Concurrent medical conditions included Psoriasis, Psoriatic arthritis, Pain in ankle, Pain in elbow, Shoulder pain and Pain in extremity.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced JOINT STIFFNESS (Stiffness joints) and VACCINATION SITE PAIN (Vaccination site pain). In March 2021, VACCINATION SITE PAIN (Vaccination site pain) had resolved. In April 2021, JOINT STIFFNESS (Stiffness joints) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant product use was not provided by the reporter. Treatment information was not provided.   This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in   This case was linked to MOD-2021-112558 (Patient Link).
Onset of joint pain particularly in hands and left shoulder, fatigue lasting 2 weeks. Joint pain still present.
Expired Ipol was administered to a patient/ no adverse event; Initial information regarding an unsolicited valid non-serious case was received on 19-Apr-2021 from a physician via Medical Information (Reference number- 00567285) and transmitted to Sanofi on 19-Apr-2021  This case involves a 4 year-old female patient who was vaccinated with 0.5 mL (once) expired dose of IPV (VERO) [IPOL] (batch number R1B251M; Strength- standard and expiry date 13-Mar-2021) via an intramuscular route at the right arm on 15-Apr-2021 for prophylactic vaccination (expired product administered). Medical Assistant wanted to know how soon they can revaccinate.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant therapy was given.   It was a case of actual medication error due to expired vaccine used (latency was on same day).  At the time of report, no adverse event reported.  Result of assessment was not reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
I had a metal taste in my mouth. I did not feel well. I was nauseous. When I came home, I was running a fever. I had a sore arm and my legs hurt. I did not feel good the next few days. Then I had a seizure on that Thursday or Friday. My husband called the ambulance and I went to the emergency room. I've had on and off seizures ever since.
Pfizer-BioNTech COVID-19 Vaccine EUA Woke up 12/21 feeling feverish, fatigued, and myalgia, as well as injection site soreness, got worse in the afternoon, peaked around 6pm but started to improve in the evening. Completely gone the following morning 12/22. No treatment taken
This spontaneous report was received from a nurse regarding multiple unspecified patients of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date, the patients were vaccinated with improperly stored VAQTA, 25/0.5 (unknown Units), lot # L007559, expiration date- 01-JUN-2017, lot # L001627, expiration date- 11-NOV-2015. No concomitant medication was reported. No adverse event was reported. The outcome of the event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Moderna COVID?19 Vaccine EUA?  Diffuse scattered urticarial rash after first dose received on 01/2021 associate it with  sore throat   , face , lip , eye  lid  swelling , recurrent episodes affecting daily activities   symptoms getting worse with each episode Afraid of having anaphylactic shock Been in doctor office multiple times, saw an allergist specialist as well . Received form allergist Xolair 2 injection , I'm taking Allegra and Benadryl every day , got 5 days treatment  RX for predniSONE 40 MG Tablet. On 05/28/2021 I felt my throat  was closing up , couldn't swallow  but I was able to breath , happened again on 06/02/201 same episode with swelling face and eye lid and sore throat as well .
Redness; Swelling; Muscle pain; Itchiness on the vaccination site; My arm has been itchy; Bump on the vaccination site; This is a spontaneous report from a Sponsored Program Support and contactable consumer (Patient) or other non-HCP, who reported for herself.  A 75-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number was not reported (Consumer stated, "I am not sure, I cant read the writing, does it start with the PW0151)  via an unspecified route of administration, administered in Arm Right on 20Apr2021 (at the age of 75-years-old) as DOSE 1, SINGLE dose for COVID-19 immunization. The patient relevant medical history included high blood pressure from an unspecified date. Concomitant medications included Lisinopril 5mg taken from an unspecified date and for an unspecified indication. Consumer stated, "No one prescribed it, I scheduled the shot myself. On an unspecified date, the patient experienced redness, swelling, muscle pain, Itchiness on the vaccination site; My arm has been itchy and bump on the vaccination site. Her concern was, she mentioned that she got her first dose six days ago and after that she is experiencing redness, swelling and muscle pain and they are still there. Also, she was now also experiencing itchiness on the vaccination site and also a bump on the vaccination site. Consumer stated, "I have lots of common side effects that were listed in the sheet that I got when I took the first covid-19 vaccine last Tuesday. So, my arm has been itchy and I am not sure, is that something that comes with it, is that a common side effect or not. Today, a little while ago, I noticed that on the site there is a little bump but it is going down since I have been on the phone. So, I was wondering and asking if that was considered as injection site swelling or is that something different. It was my first one." (manufacturer not clarified, hence is this a Pfizer product tab left unchecked). Consumer stated, "They have improved a little like I said the bump went down but it appeared just today morning and improved. About treatment consumer stated, "No, I didn't know what to do. Consumer further stated, "I just wanted to know whether that was something considered swelling like was that something in the list of side effects or was this something I should worry about or not". The due date for the second shot was on 11Ma2021. The investigation assessment was not provided. The clinical outcome of events was recovering.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
A FEW DAYS OF ILLNESS AND THROBBING RED ARM. BETTER NOW.  BLISTERS AND FLU LIKE SXS.  STILL RED ARM AND SWOLLEN.
7 days after the shot I had my first ever herpes outbreak (I was tested 20 years ago & told it was in my system).  My doctor called it an ?atypical outbreak? because there are only 2 small lesions that look like blisters.  No pain, just a little discomfort. Dr said to get a sample of discharge if there is any. She also thought it might be a staff infection?   I?ve been put on:  valacyclovir 1gram 2x/day for 5 days Gabapentin 100mg 3x/day Mupirocin ointment 2% 3x/day
Vaccine administered 11/27/12 started to feel ill 11/28 with fever T 100, chills, HA. Seemed to subside 11/29 however achy joints especially knees. Advised to try Ibuprofen.
Patient who received an expired dose of Menveo; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 17-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA268A, expiry date 31st March 2021) for prophylaxis.   On 2nd April 2021, the patient received Menveo. On 2nd April 2021, unknown after receiving Menveo, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were provided as follows: The reporter was a medical assistant. Reporter informed patient was administered with the expired Menveo vaccine on 02nd April 2021. Vaccine was expired on 31st March 2021. Reporter consented to follow up.
Pt's left thigh had redness on injection site. Redness started a day later after vaccination.
12 hrs after vaccination pt reports that her lip and tongue were tingling and her arm was sore. She called her Md who told her to take Diphenhydramine 25mg. Symptoms resolved after taking.
pt was admitted to hospital with diarrhea and cough; dx with acute anemia, suspected blood loss, melena; O2 supplementation; positive for COVID as well; given dexamethasone, remdesivir, Actemra; dc'd to hospice facility (Care Center); per death certificate, pt died in hospice with cause of death being COVID 19
Information has been received from a nurse practitioner concerning a 21 year old female patient with no pertinent medical history and no drug reactions or allergies, who on 26-APR-2011 was vaccinated with the first dose of GARDASIL (Lot number not reported). Concomitant therapy included NUVARING. The nurse practitioner reported that on 26-APR-2011, after administration of the vaccine, the patient experienced labial swelling. No lab diagnostics studies were performed. Vaseline applied locally was given as a treatment for the experience. On 27-APR-2011 the patient recovered from labial swelling. The patient sought medical attention by calling the nurse practitioner. Additional information has been requested.
client has red area approximately 2-3 inches in diameter over injection site arm. Area is slightly warm and some slight swelling is present.  RN, recommended to patient to monitor site closely, use ice and Tylenol/Ibuprofen as needed and consult with primary healthcare provider or other healthcare provider if no improvement.
This spontaneous report as received from a medical assistant (M.A.) refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 27-OCT-2015, the patient was vaccinated with the third dose of improperly stored ROTATEQ oral liquid (lot # L008574, expiration date 22-NOV-2016) (dose unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
localized severe erythema & induration treated w/Duricef as poss cellulitis;
Patient had a reaction immediately after the JJ vaccine. Patient passed out for 10-15seconds, her body stiffened up, she felt hot and then cold and started sweating excessively. Patients eyes closed briefly and then opened. Patient then became conscious and was unware what had happened.  Patient is not on any medication and had not eaten all morning. After administering the vaccine a small amount of blood came out. I gave her a cotton ball to apply on the area and to hold. After 20-30 seconds she said she felt faint and hot all of a sudden. Her body then went limp and her eyes began to close. Her body then stiffened up for a few seconds. After shouting her name a few times she regained consciousness and was able to talk. she didn't realize what had happened. Her body was fine again but she had urinated during the episode.  Upon speaking to the patient I learnt that she was nervous about the vaccination and she had felt dizzy in the past when giving blood. I observed the patient over the next 45 minutes. Her speech was fine, she was still a little light headed. She was in her seat for 40 minutes, then I asked her to stand and to move a little to see how she was. She was able to walk a bit but then sat down as she still felt light headed. She than sipped on water and continued talking and seemed to get some energy back.