chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The day of my 1st vaccine, about 10 min after I was in the waiting room and I started feeling "weird" in my whole body and lightheaded. I got some juice. Then I started to get hot and was sweating, my whole face and neck were flushed; I also felt mild burning sensation on the R lower lung area. They took me in back and gave me more juice and water and put ice packs on me. It took 30+ minutes to feel better. They called a team to come do my vitals and my HR was in the 100s and they said my eyes were dilated. On my way home I had a weird throbbing pain in my L upper chest just above my boob. When I  got home I had chills/felt freezing for a few hours and was fatigued. The next day (Sun) I had moderate joint pain, fatigue, and was very achy; my chest felt tight and I needed my inhaler and some tramadol. On Mon I felt better and went back to work, but then Tues I was achy again and my coworker said I looked pale; I took some tramadol and felt better, just tired. On wed I was having pains in my neck, shoulder, down my arm L arm, and down my scapula- the arm I had the injection. Throughout the day the pain was throbbing and ended up a 7/10 and edema in my neck/shoulder/axillary occurred; I couldnt carry anything heavy and was guarding that arm.  Tramadol didn't help the pain and I eventually took 600mg  ibuprofen and made a telemedicine visit w/ my MD for the next day. After 3 days the pain was subsiding but the edema took ~ 1 week- it subsided the weekend before my next vaccine.  The day of my 2nd dose I did ok after the vaccine at 4pm. While they were injecting it I felt burning down my arm. I felt lightheaded and "weird" afterwards and warm, but no eye dilation or flushing. 3 hours after the vaccine at 7pm I felt tired and a little achy and slept from 7-9pm. At 9pm I woke up very achy, I had 1 itchy hive that popped up on my R inner forearm.  The next day I had joint pain in every joint and very achy and fatigued. The joint pain subsided on day 2 after the vaccine but I was very achy and fatigued for a good 72 hrs. Vaccine was wed and saturday the pain in my neck returned and the edema came back and was a little worse than before, and the area where the edema was, was painful to touch. It started subsiding ~ a week after the vaccine, but a little bit is still currently here- but no pain to touch. My allergist has been following up w/ me this whole time.
the vaccine expired on yesterday and the nurse administered the vaccine (Daptacel) to a patient by mistake; Initial information received on 17-May-2019 regarding an unsolicited valid non-serious case received from a physician by phone.  This case involves a patient of an unknown demographics who was vaccinated with an expired dose of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (expiration date: 16-May-2019, batch number, dose, dose in series, route and site of administration were not reported) on 17-May-2019 (reported as today).  The patient's past medical history, medical treatment(s), vaccination(s), family history and concomitant medications were not provided.   It was a case of actual medication error due to expired vaccine used.  It was unknown if any adverse event occurred or not following the vaccination.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.   Information on the batch number was requested.  Documents held by the sender: none.
was given 0.5ml of the covid vaccine  had fever and nausea for 2 days
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 01-MAR-2018, the patient was vaccinated with improperly stored dose of VARIVAX, lot # reported as N014485, expiration date reported as 10-MAY-2019, subcutaneous for prophylaxis. The vaccine underwent a temperature excursion of 26 degrees Celsius for 9 hours and 33 minutes. There was no previous temperature excursion. Data logger was involved. No adverse effects were reported. Lot number N014485 is an invalid lot number for varicella virus vaccine live (oka/merck).
shingles/persistent strain of herpes zoster; vaccine did not prevent shinges as intended; Information was received from a lawyer regarding a case in litigation concerning a patient, age , gender, and medical history not provided.  On an unknown date,  the patient was inoculated with zoster vaccine live (ZOSTAVAX) for routine health maintenance and the prevention of shingles.  The vaccine did not prevent shingles but rather caused the patient to contract a persistent strain of herpes zoster accompanied by pain.  As a result the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages.
Patient's arm was red, raised and warm at injection site. Patient also reported "heat flares" on side of her torso.
24 hours after immunization sudden temp to 105 and febrile seizure.  asymptomatic today 12 hours later.
Headache, Myalgia, Arthralgia, Diarrhea, fatigue, chills Narrative:
ARTHRITIC ONSET TO LEFT HAND OF INJECTED ARM. TRIGGER FINGER ONSET TO PINKY FINGER. WEAKNESS OF LEFT HAND. AS OF 8/13/2015 CONDITIONS HAVE NOT IMPROVED.
That night, I was drenched in sweat yet I felt chills at the same time. I had severe headaches and vertigo by the next morning, nausea, and debilitating joint pain. By day 3, I continued experiencing headaches and spontaneous vertigo. I have been extremely tired and can sleep for hours.  Day 4, I was feeling much better. I went out that night, and after only 2 drinks, the vertigo came back so badly, I wasn't able to drive home. For the following days till today, I am still experiencing terrible headaches that will not even lessen with medication, spontaneous vertigo although they don't last too long any more, and I am extremely tired all the time.
stiff/painful neck that started 4 days post-vaccine. "Arthritis of the spine ? took Topamax for a while until she found out she was allergic to it. Takes gabapentin now; with diclofenac. Counseled to take Tylenol every 8 hours on schedule and apply cold packs. Patient was taking ibuprofen prn; advised to discontinue. If event becomes acute: present to ER. If event gets gradually worse: see primary doctor.
The patient was seen in the Urgent Care Dept for a rash at the injection site. The patient still had the rash 4 months after the injection, but much less severe. No treatment was received.
The patient stated she developed a rash which spread over her entire body in one weeks time. This started 24 hours after the vaccine was given.
Streptococcus Group A rapid antigen test results were positive; sore throat; left ear otalgia; This case was reported by a pharmacist via call center representative and described the occurrence of bacterial infection due to streptococcus, group a in a 44-year-old female patient who received HBV (Engerix B) (batch number 39TZ2, expiry date unknown) for prophylaxis.   On 24th February 2022, the patient received the 1st dose of Engerix B. On 28th February 2022, 4 days after receiving Engerix B, the patient experienced bacterial infection due to streptococcus, group a (serious criteria GSK medically significant), sore throat and otalgia. On an unknown date, the outcome of the bacterial infection due to streptococcus, group a, sore throat and otalgia were not recovered/not resolved.   It was unknown if the reporter considered the bacterial infection due to streptococcus, group a, sore throat and otalgia to be related to Engerix B.  Additional details were provided as follows: The case was reported by pharmacist for herself. The patient received a dose of Engerix B in left deltoid and started experiencing sore throat and left ear otalgia. On 3rd March 2022, the patient consulted with a health care provider and Streptococcus Group A rapid antigen test results were positive and was prescribed a 10 day course of antibiotics. The symptoms were reported as ongoing at the moment of the report.  The reporter consented to follow-up.
On 1/24 pt's reports area swollen and sore, on 1/29 was draining pus, blood and yellow clear drainage. area remains swollen about size of golf ball 1/29. Pt was treated with Amox. Pt was to return in 2-3 days if warm, red or tender.
This spontaneous case was reported by a health care professional and describes the occurrence of VACCINATION SITE PRURITUS (injection site has a Bumpy rash and itchy.), VACCINATION SITE RASH (injection site has a Bumpy rash and itc), INJECTION SITE PAIN (Tender) and VACCINATION SITE SWELLING (injection site has a Bumpy rash and itchy) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     Concomitant products included THYROID (ARMOUR THYROID) for an unknown indication.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced INJECTION SITE PAIN (Tender) and VACCINATION SITE SWELLING (injection site has a Bumpy rash and itchy). On 23-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (injection site has a Bumpy rash and itchy.) and VACCINATION SITE RASH (injection site has a Bumpy rash and itc). The patient was treated with HYDROCORTISONE at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. On 18-Jan-2021, INJECTION SITE PAIN (Tender) had resolved. At the time of the report, VACCINATION SITE PRURITUS (injection site has a Bumpy rash and itchy.), VACCINATION SITE RASH (injection site has a Bumpy rash and itc) and VACCINATION SITE SWELLING (injection site has a Bumpy rash and itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
There was confusion related to the new names of Pfizer and Moderna and despite Spikevax ready to give, I was talking with the patient about getting the newest COVID vaccine. I asked when she recieved the last dose and she said last year. I asked if she had received a dose this year and she said no. I asked if she wanted one. She said yes and I prepared a Comirnaty and injected both into the left deltoid one inch apart. After realizing what had happened about an hour later, I called her and discussed the situation stating that I would report the incident. I discussed that my quick research showed that the most common side effects were increase local reactions. I discussed with her that if she experience any more severe reactions to contact me or emergency services immediately. I requested that she follow up with me tomorrow, 10/19/23. I will reach out if I don't hear from her.
My first menstrual cycle after the shot (03/12)2021); I had the worst cramps ever ( I never cramp) my flow was super heavy, I was going through pads and tampons at least every two hours.  The second menstrual 04/14/2021)  cycle I had a heavier than usual flow, not as heavy as the March cycle, but no cramping.  The first flow was so unusual and the cramps were so bad that I contemplated going to the emergency room.  While searching google I read an article that said unusual menstrual cycles was on of the side affects of J&J Covid Vaccines
I started having a horrible sore throat, fatigue, fever, malaise. I took a home COVID-19 test that came back positive. I called my insurance COVID-19 hotline, to have a virtual health appointment. I elected to not take any medication for COVID-19. It did take three weeks for me to not test positive for the virus. This past week I had flu and cold symptoms, I started having rattling in my chest. I went to an Urgent Care where they did a chest X-ray, I was diagnosed with pneumonia. I was prescribed Doxycycline to help rid my body of the infection.
Patient had severe anxiety over receiving the vaccine. After administration she felt like she was going to pass out, however, did not. Administered cool compress and took blood pressure. She felt better after 10 minutes and was able to leave on her own
Received PPV-23 on 10/31/13. 11-2-13 induration, pain, redness at site. Approximately 11-4/5-13 developed myalgia, fatigue. 11-9-13 generalized itching.
pt recvd vax; pt was having continuous crying episodes; pt taken to MD who said to administer DT instead of DTP for further immunizations; pt put on apnea monitor 2 wks after vax; pt under care of neurologist for possible seizure disorder;
Information has been received from a Pharm. D. Concerning a pt who on 06/13/2001 was vaccinated with a dose of varicella vaccine. The Pharm. D. reported that on 06/21/2001, 5 to 10 eruptions appeared on the pt. The pt sought unspecified medical attention. In follow-up, the Pharm. D. reported that he had been consulted about the pt who had been immunized with varicella vaccine and "had a few pox lesions appear." He stated, "The child was fine but the twist in the case was the child's mother who was pregnant." The pt's mother did not think she had been exposed to varicella previously. The Pharm. D. stated, "Everything turned out fine. there was no adverse events." No further info is available.
Swelling, redness and pain at the site of injection, was treated in the Urgent care twice for drainage. Pt then went to ER when the fluid reaccumulated, and required I&D in the OR. On oral antibiotics presently and receiving wound care at home with packing.
The patient is a 85 y.o. male with a history of AS, HTN, hx of Granulomatous disease who presented to the Hospital 2/11/23 with worsening SOB and generalized weakness in the setting of COVID-19. Hospital course complicated by Submassive saddle PE and was transferred to another hospital 2/12/23 and admitted to the ICU.   consulted to assume medical management out of the ICU.    1. Acute Hypoxic Respiratory Failure: In setting of submassive PE and COVID-19. Not on O2 at baseline. Admit CXR with hazy left opacities. Admit CT PA with ground glass opacities consistent with COVID-19 and pulmonary embolism as below. Weaned from BiPAP to  HHFNC to now 3L nasal cannula only with exertion. Requiring 3 L with exertion at time of discharge  2. COVID-19: Presented as above. Symptom onset 1 week PTA with sinus congestion, tested positive on 2/11/23, +vaccinated. CXR 2/11/23 with hazy left opacities. CT PA 2/11/23 with groundglass opacities in bilateral lungs. Continued decadron with stop date 2/20/23. Did not get remdesivir due to AKI. Symptoms improving. Isolation ends 2/21/23.  3. Acute Submassive PE with core pulmonale:  in setting of COVID-19 infection.  Admit CT PA with large saddle embolus and groundglass opacities consistent with COVID-19 infection. Duplex ultrasounds 2/11/23: residual DVTs in left distal femoral, popliteal, and tibial veins; low chance of embolization.  S/p bilateral pulmonary artery mechanical thrombectomy 2/12/2023 (Dr., cardiology). Continued eliquis with plan for 1 year.  4. Transaminitis: asymptomatic. Alk phos elevated, AST and ALT downtrending. Tbili 2.5. Dbili 2.1, downtrending. RUQ U/S 2/14/23 with sludge, which clinically would fit with cholestasis. LFTs improving: T. Bili 1.6, D. Bili 1.1, ALP 300, AST 100, ALT 141 at time of discharge  5.  Anemia: Baseline Hgb ~13-14, Hgb 12.4 in setting above on 2/13/23, stable. No evidence of further acute blood loss. Hemoglobin stable at 12.6 at time of discharge  6. AKI: Baseline Cr. ~1.2. Cr 1.5 peak, potentially pre-renal in setting of acute illness and decreased PO intake. Acute kidney injury resolved, creatinine 1.0 at time of discharge
pt recv vax 6NOV94 & 14NOV94 exp gen rash & 2 days later lost appetite; MD reported pt devel gen morbilliform erythematous rash, compatible w/viral rash; also devel fever of 100-101 x 2 days;
gave a patient an IPOL on accident instead of Rotovirus(oral)/ no symptoms; Initial information received on 13-Jun-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 2 months old male patient who received vaccine IPV (VERO) [IPOL] instead of ROTAVIRUS VACCINE.  The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, HEPATITIS B VACCINE RHBSAG (YEAST), PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID (PEDIARIX) for Immunisation; PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for Immunisation; and HIB VACCINE CONJ (TET TOX) (ACT HIB) for Immunisation.  On 13-Jun-2019, the patient received a dose of suspect IPV (VERO) lot NIG511M , expiry date 02Aug-2019, via left vastus lateralis instead of suspect ROTAVIRUS VACCINE not produced by Sanofi Pasteur lot number not reported via oral route.  It was an actual medication error due to wrong vaccine administered.  It was reported that patient was given IPOL on accident instead of Rotovirus (oral).  The patient did not experience any adverse reaction after the injection.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the 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.  List of documents held by sender: none.
Received 2nd dose at 3 weeks not 4 weeks, called cdc. informed pt to get another shot after 28 days, pt refused.  Informed pt to call pharmacy if notice any adverse reactions  and given vaers website to report.  previous pharmacist wrote the follow up date wrong at 3 weeks, and pt went off on that.  did not process through insurance
minor fatiguue; fever; Dizzy; This case was reported by a other health professional and described the occurrence of dizziness in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd March 2022, the patient received the 1st dose of Shingrix. On 23rd March 2022, 1 days after receiving Shingrix, the patient experienced dizziness. On an unknown date, the patient experienced fatigue and fever. On an unknown date, the outcome of the dizziness, fatigue and fever were recovered/resolved.   It was unknown if the reporter considered the dizziness, fatigue and fever to be related to Shingrix.  GSK Receipt Date: 05-JUN-2022 Reporter's Comment: The patient got Shingrix and the following day was dizzy.  The patient had expected minor fatigue and fever which he/she did experience.  All symptoms were dissipated by the third day. The patient decided to not get the recommended Shingrix booster because the dizziness could be dangerous and also, because he/she could not find any evidence why the booster was necessary. Less than 3 months after vaccination, the patient had expected minor fatigue and fever which he/she did experience.  The reporter asked that, what made GlaxoSmithKline think that a single Shingrix was not adequate if you never did a study on a single dose. The reporter further asked that, why did the FDA (Food and Drug Administration) approve two doses when the manufacturer supplied no data on the efficacy of a single dose.
When the patient wake on 11/13/19 there was swelling under his left eye and his feet were swollen and there was redness and swelling at the injection site.The swelling in his feet went down that day but eye and arm remained swollen. On the morning of 11/14/2019 there was swelling under his right eye. As of today 11/15/2019 there was still swelling under both eyes and arm was swollen about 2 inches around the injection site.
This spontaneous report was received from a nurse referring to a 12 month old patient. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 29-JAN-2019, the patient was vaccinated with 1 dose of VARIVAX lot # R018143, expiring on 25-JUN-2020 for prophylaxis (dose, dose number, route of administration and site of injection were not reported). On the same day, the patient received a dose of PROQUAD lot # R018779, expiring on 29-DEC-2019 for prophylaxis (dose, dose number, route of administration and site of injection were not reported). The patient experienced no adverse event. The outcome of inappropriate schedule of product administration was unknown.
Patient sweated profusely for the two nights following vaccination, but no other symptoms developed until the second day.  Initially a lump was noticed to the upper right of injection site as severe tenderness and pain were experienced.  Site is warm to the touch and surrounded by raised flesh-toned hives.  Sudden diarrhea was experienced approximately four hours later and again later that night.  Increased irritability and emotionality (tears) were noticed.
10-15 pruritic erythematous papules, clinically consistent with mild varicella, over thighs, groin, buttocks, penis, scrotum.
This spontaneous report as received from a nurse refers to a 13 years old female patient with no pertinent medical history. The patient was vaccinated subcutaneously with a 0.5 ml dose of (Lot # 0414AE; exp date 27-FEB-2014) VARIVAX on 03-JUL-2012. No other co-suspects were reported. There was no concomitant medication. On an unknown date the patient experienced an injection site reaction after being administered the vaccine. The patient sought unspecified medical attention. Treatment was provided by observing the patient since the vaccine. The patient does annual check ups. At the time of the report the patient was recovering. The relatedness for injection site reaction is unknown for VARIVAX. A lot check was requested by the nurse. This is one of several reports received from the same source. Additional information has been requested.
This case was reported by a nurse and described a subject (age and gender unknown) who did not respond to immunization to Engerix-B. On unspecified dates, the subject received Engerix-B. On an unspecified date before 12 May 2006, a hepatitis B surface antibody titer was negative after the third dose of Engerix-B was received. No adverse events were reported.
Left breast generalized tenderness, warmth and mild swelling with focal area of induration to inferior breast tissue.  Warmth, tenderness and generalized swelling resolved after 5 days.  Induration, ? mass persisted 1 week later prompting diagnostic work-up in clinic with imaging ordered
I had what felt like a sinus infection, sore throat, stuffy nose, body aches and fatigue.
her husband has underlying medical conditions; and got COVID before he got the vaccine; and had heart problems after the infection.; This is a spontaneous report from a contactable consumer (patient's wife). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included underlying medical conditions and got COVID before he got the vaccine. The patient's concomitant medications were not reported. It was reported that the patient had underlying medical conditions; and got COVID before he got the vaccine; and had heart problems after the infection. Outcome of the event was unknown.  Information on Lot/Batch number has been requested.
I experienced a breakthrough case of COVID-19 with coughing, sore throat, body aches, ear infection and fever.