chrisvoncsefalvay/vaers-outcomes huggingface dataset:
When I received the injection, I had a metallic taste in my mouth, felt a little dizzy, had a cold sweat, and a funny feeling in my throat. This lasted only a couple of minutes. On around March 25th, I noticed a round rash around the injection site. I still have the rash as of April 1, 2021.
Arm soreness, chills, lethargy, and very low grade fever for one day. Took 2 Tylenol twice, 8 hours apart.
Sixteen hours after my second Moderna vaccination I experienced full body aches, dizziness, nausea, chills and a raspy throat.
This spontaneous report as received from a nurse practitioner refers to a 6 year old male patient. The patient was a healthy and active boy. His relevant past drug history was unknown. On 20-JUL-2010, the patient was vaccinated with the first dose of (Merck) VARIVAX (dose and route unspecified) and on 12-OCT-2015, the patient was inadvertently vaccinated with a full adult dose of ZOSTAVAX (lot # reported as L017138 exp date 13-AUG-2015) (route not reported) instead of being given his second dose of (Merck) VARIVAX. There was no concomitant medications. It was unknown if there was any relevant lab work. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
This spontaneous report was received from a 74 year old male consumer with penicillin allergy and sulfa allergy and no pertinent medical history, on an unknown day, approximately in 2010, 3 years ago was vaccinated with a dose of PNEUMOVAX23, intramuscular (lot number and expiration date were not provided). No other co-suspects were reported. No concomitant medications were reported. The consumer reported that on an unknown date. 6 months to a year later, he developed pneumonia. He was seen in a urgent care clinic and was given prednisone (manufacturer unknown) and azithromycin (manufacturer unknown) and was not admitted to the hospital. On an unknown date, the pneumonia resolved. Additional information is not expected.
Lump 2" in diameter & protruding 1/2 " for three weeks.Lump was red,sore, and hot to the touch for several days;also accompanied by muscle aches.
pt states about 5 minutes after taking the covid vax she started swelling on the left inside of her throat and then she noticed the swelling was moving up towards her face around her eyes and ears then back down towards her mouth.  Vax administrator checked her vitals.  Her BP 133/78 which is high for her. Her O2 level was good.  About 20 minutes later she started feeling light headed and noticed some swelling in the right side of her throat and also experienced some discomfort on the right side of her body and had some chest tightening.  She started having SOB and could feel her tongue swelling.  Her blood pressure started going up.  She was given 50cc Benadryl.  Pt was transported by wheelchair to ER.  Her BP 160/88, pulse was 79 and respiration was 18.  Temp was 97.1.  She had a normal EKG, normal Chest X-ray normal blood work.  She was administered a steroid shot and given an IV.  She was monitored and released to FU w/ PCP and advised not to take 2nd dose.  Pt is waiting for her doctor to receive ER records to schedule FU appt.  Pt still has some sensation on the left side of her face.
Patient reported throat feeling tight, light headed. Patient didn't eat anything this morning. 11:41 V15, 116/71, P59, o2 94, T 34.9. Patient was given water. 11:59 patient stated feeling much better.
A sore arm; Migraine; Slept most; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 30 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 24Apr2021 (Lot number: EW0153) at the age of 30 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "A sore arm"; MIGRAINE (non-serious), outcome "unknown", described as "Migraine"; SOMNOLENCE (non-serious), outcome "unknown", described as "Slept most".  Additional Information:  After receiving her second dose she began to experience the "normal" side effects on Saturday evening into Sunday. She states that after her first dose of the vaccine she experienced a sore arm, a migraine and slept most of the day. She did not experienced any sort of chest tightness after her first dose. She would like to know if there is any information regarding chest tightness as a side effect for the Pfizer COVID-19 vaccine  No follow-up attempts are possible. No further information is expected.
Starting approximately 8 hours after vaccination, I developed a low grade (100 degrees) fever and headache.  Muscle and joint aches, and pain in left arm muscles.  24 hours after vaccination I sustained a fever of 102 degrees for approximately 12 hours, treated with ibuprofen.  Fever would reduce to 100 degrees, but rebound to 102 repeatedly throughout day.  Headache was severe and sharp, similar to migraine.  48 hours after vaccination, fever remained low grade between 99 and 100 degrees for another 24 hours.  Injection site became red and warm to the touch, headache and body aches subsided.  72 hours after vaccination, injection site developed rash across band of upper left arm, which was very warm to the touch and began to itch.  This was treated with Benadryl.  96 hours after vaccination, no fever, headache, body aches.  Area around injection site now pinkish instead or red, warmer to touch than surrounding skin, but no longer inflamed, and no itching.
Dx: Chicken pox - Papules and vesicles in different stages, wide spread, afebrile, itching. Tx: Zovirax (Acyclovir)
left upper thigh erythema, edema ( lump and bruise )  and pain, extending to the midthigh about 10 cm .
Moderna vaccine administration to a 17 year old; A spontaneous report was received from a pharmacist concerning a 17-year-old female patient who received Moderna's COVID-19 Vaccine (mRNA-1273)  vaccine given to a 17-year-old patient.    The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On 14 Jan 2021 the patient received their first of two planned doses of mRNA-1273 (Lot 025J20-2A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.   The reporter reported the vaccine was given to 17-year-old. No treatment information was provided.   Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, vaccine given to a 17-year-old, was considered resolved on 14 Jan 2021.; Reporter's Comments: This case concerns a 17-year-old female patient who received their first of two planned doses of mRNA-1273 (t 025J20-2A), reporting Product administered to patient of inappropriate age.
Expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 49-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 10-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Reporter stated that the vaccine was stored in in freezer, and they take out one to two vials and place in fridge each day as needed.  No concomitant medications were reported. No treatment medications were reported.
This Non valid spontaneous report was received from a registered nurse and refers to an unspecified number of unspecified patients of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On dates on or after 21-SEP-2017, the patients were vaccinated with improperly stored dose of PEDVAXHIB for prophylaxis, lot# N000238 with expiration date of 25-OCT-2019, lot# N003701 with expiration date of 01-NOV-2019, lot# N008079 with expiration date of 02-DEC-2019, lot# N012920 with expiration date of 07-FEB-2020 (strength, dose, route and frequency were not reported); or with improperly stored dose of RECOMBIVAX HB for prophylaxis, lot# N020613 with expiration date of 05-MAY-2020, lot# N002202 with expiration date of 04-NOV-2019, lot# N011851 with expiration date of 19-DEC-2019; or with improperly stored dose of ROTATEQ)orally, for prophylaxis, lot# N000175 with expiration date of 20-SEP-2018, lot# N005618 with expiration date of 04-OCT-2018, lot# N005078 with expiration date of 22-NOV-2018; or with improperly stored dose of VAQTA for prophylaxis, reported lot# M019924 with expiration date of 02-SEP-2018, lot# N008823 with expiration date of 26-MAY-2018. No adverse effects were reported. It was stated that the vaccines underwent a temperature excursion of 32°F (degrees Fahrenheit) to 35°F for 40 minutes; No previous temperature excursion was done. The call was because of a "data logger". This is a non-valid case due to lack of patient identifier. Follow up information was received from the registered nurse 30-APR-2018. The nurse stated the temperature excursion was stable and they had two refrigerators that held the related vaccines. The nurse was not able to provide patients' names or initials, or ages, but was able to provide number of patients, gender information, and vaccination dates. This report referred to three male patients vaccinated with improperly stored VAQTA (lot# N019924 with expiration date 02-SEP-2018) on 29-SEP-2017. Upon receipt of follow-up information it was determined that this case is now valid because patient identifier was received. This is one of several reports received form the same reporter (link reports: 1710USA004069, 1805USA001661, 1805USA004617, 1805USA004618, 1805USA004590, 1805USA004591, 1805USA004592, 1805USA004593, 1805USA004674, 1805USA004675, 1805USA004676, 1805USA004677, 1805USA004678, 1805USA004679, 1805USA004680, 1805USA004681, 1805USA004682, 1805USA004683, 1805USA004967, 1805USA004968, 1805USA004969, 1805USA004970, 1805USA004971, 1805USA004972, 1805USA004973, 1805USA004974, 1805USA004975, 1805USA004977, 1805USA004978, 1805USA004979, 1805USA004980, 1805USA004981, 1805USA004982).
A Medical Assistant administered the Moderna Covid Vaccine (Lot #003C21A, Expiration Date 10-17-2021) after the 12 hours that was supposed to be administered. The vial was always at the refrigerator, but it was used after the recommended time. The Moderna Covid Vaccine vial was originally at a temperature of -3.2 degrees Fahrenheit. On 8-5-2021 the vial was placed on the refrigerator at a temperature approximately of 41.0 degrees Fahrenheit, and the vial was at that temperature for 24 hrs, when the vaccine was administered. The vial was opened on 8-5-2021 at 9:20 am, and by protocol, the open vial was not supposed to be used after 3:20 pm of the same day. On 8-6-2021, the same vial was used by the Medical Assistant, to vaccinate the patients She thought that the vial was already prepared for the day and the expiration time was 3:20 pm, but she didn't notice that the vial was from the day before (8-5-2021). The vaccination protocol was followed, the patient was observed after vaccination, and the patient didn?t have an adverse reaction. This incident was reported to the Medical Director, and the Vaccine Coordinator. Dr recommended to call the patient that received the vaccine to inform the incident. The patient also will be called for three days to evaluate her health condition. Vaccine Coordinator called the Moderna Medical Staff and report the event with a Case #MOD21127564. The Medical Staff recommendations will be presented the next 7 days.  The MA called the patient to explain the situation about the use of the vaccine after the time recommended. She communicated with the patient on 8-6-2021, patient understood the explanation and will wait for her call the next three days to evaluate any health complaint. The patient was called today, and she informed that she feels well.
One day after being vaccinated the pt developed a 1 cm-1.5 cm area of induration at the site of the Prevnar injection. She also developed a streak of erythema that extended from the area of induration.
Patient was administered vaccine that was expired. It was unknown that the vaccine expired on 10/03/2021 rather than the frozen storage expiration date of 11/01/2021.
Immunization was given after BUD of 12-8-22. Moderna manufacturer was notified and case # was assigned. The Lot of AS7166B was tested and found per Moderna the vaccine DID have the necessary activity to protect against the SARS-CoV-2 virus at the time of administration. Patient and patient's PCP notified.
My periods cycle has changed and it arrived 2 weeks in advance. I checked with a few neighbors and a lot of females complaining same side effects. Change in mensural cycle. This is not good, i hope this side effect is temporary and the vaccination will not play with our hormonal system. Very sacred to go for the second shot.
Serious rash; began on inside LH arm, then progressed to RH Anterior and posterior leg, distal to knee. Progressed to Right leg, back, shoulders, and scalp.  Estimated surface area 30%
Probable viral URI/sinusitis. Possible delayed reaction to immunizations. Follow up information received 04/21/2003 states: left axillary pain, lymphadenitis, etiology unknown.
Information has been received from a 69 year old female patient with no medical history, who on 09-NOV-2007 was vaccinated with a dose of ZOSTAVAX.  On approximately 25-NOV-2007 the patient experienced a blotchy rash at injection site and on different parts of her body.  She spoke with her doctor's physician assistant who told her that the one at the injection site was an injection site reaction and the rest were a viral type rash.  She did not say if it was shingles or if it was related to the virus in the vaccine.  No product quality complaint was involved.  No other information was provided.  Additional information has been requested.
This spontaneous report as received from a pharmacist refers to a 66 year old female patient with sulfa allergy and allergic to SYMBICORT and no other pertinent medical history. On 19-MAY-2014 the patient was vaccinated with ZOSTAVAX lot # J011341, expiring on 13-DEC-2014, 0.65 ml, subcutaneous prescribed by physician. Concomitant therapies included fluoxetine, atorvastatin, furosemide (manufacturer unspecified), magnesium citrate, tramadol, gabapentin, amlodipine, buspirone hydrochloride, trazodone hydrochloride and pantoprazole. The day after receiving ZOSTAVAX, on 20-MAY-2014, the patient developed itchiness over her entire body, a red discolored skin mark at the site of injection which was raised and hard underneath like an egg, constant headache, and swollen throat glands. No treatment was given for the adverse events. No lab diagnostic tests were performed. The itchiness had since subsided however the other symptoms were still present; the patient said the induration had gone done and it was not as bad as it was the day after. The pharmacist instructed the patient to seek medical advice with her physician. The causal relationship was not reported. Additional information has been requested.
pt devel hives over trunk, arms & legs 72hrs p/vax;hives appear, resolve then reappear;pt depressed;MD reported 1wk p/vax gen pruritic rash;dx papular vesicular dermatitis;poss Grover's disease
A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on Mar2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced tinnitus in both ears within 15 minutes or so after 1st dose (going on 4 weeks now). Patient had odd sensations in the top and back of our head. Outcome of tinnitus in both ears was not resolved. Outcome of other events was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
8/3/04: awakened with severe joint pain of all extremities. 8/4/04: seen in emergency department and treated with IV steroids and Phenergen. Discharged with Benadryl q4hours. CDC notified by ER.
This spontaneous report was received from a pharmacist concerning a 69 year old male patient. on 11-OCT-2011, when the patient was 67 years old, the patient was vaccinated with a dose of VARIVAX (dose, route and lot # not reported). No other co-suspect therapy was reported. Concomitant medications were not provided. The pharmacist stated that a physician's office had administered a vaccine, unknown if the vaccine was VARIVAX or ZOSTAVAX. Patient would have been indicated for ZOSTAVAX not VARIVAX. At the time of the report, patient's outcome was unknown. Additional information has been requested.
After 5 mins of getting the vaccine, pt had a syncope and/or seizure episode.  Pt's eyes started to roll back and was only showing the white.  His hands were flinching into fist and pt was unresponsive.  This lasted about 20-30 secs.  We called ED and got the operator on the phone.  When we started to give the operator information, pt starts waking up.  Pt's mom didn't want the ambulance to come since pt is now awake so we told the operator everything is fine now and hung up.  Pt's forehead was sweaty and facial color was very pale.  We gave pt some water to drink and asked pt to continue to sit there and relax.  Pt has no idea of what happened he said he just remember one moment talking to his mom and the next moment she was holding him up.  Pt sat there for a total of about 1 hour and he said he was fine so they left.  We informed mom and pt to please go the UC or ER for follow up but they declined.  They said they will have him rest and hopefully things will be OK soon.  I checked his Blood pressure x 2 and both times they were good at around 128/87.  Gave mom my pharmacy business card to call with any further questions or concerns
I came home with COVID; I came home with COVID; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from product quality group. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Sep2022 as dose number unknown (booster), single (Lot number: GH9694) for covid-19 immunisation; BNT162b2 (BNT162B2), on 14Apr2022 as dose number unknown (booster), single (Lot number: FK9894) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 19Sep2022, outcome "not recovered" and all described as "I came home with COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (24Sep2022) Positive. The patient is a teacher. The patient received the Omicron booster on 07Sep2022. Students returned and on 19Sep2022, the patient came home with COVID. The patient had been wearing a mask at school and at stores. The patient's symptoms were extensive. The patient is still testing a strong positive on Saturday 24Sep2022 and experiencing symptoms. The booster before the Omicron was (Pfizer FK9894) on 14Apr2022. The patient has hypertension so he/she have always looked to avoid COVID.   Follow-up attempts are completed. No further information is expected.
I became symptomatic on March 31. I had this overall yucky feeling. It was a feeling of overall malaise, fatigue and sore throat. I tested negative for 2 days prior to me testing positive on the 3rd day. I called my doctor to see if I could get antivirals but he was not helpful. I called all over to try to get a prescriptions for antivirals but was unsuccessful. I called my doctor back and got a telehealth appointment. The telehealth person prescribed the medication. I had developed a sore throat and I kept getting wreaker. I had some muscle and joint discomfort. I begin to take the antivirals that Tuesday. I stayed sick a lot longer than I think I would, had I gotten the antivirals sooner. I was prescribed PAXLOVID, taking 3 tablets twice a day for 5 days. It took me about a month to feel better. I contracted the chicken pox right as I was scheduled to get my fourth vaccine. My recovery was slow. I had to take 2 rounds of prednisone to get over the chicken pox. For 2 months afterwards, I was having health issues.
Pain at injection site starting on day of vaccination, gradually spreading into shoulder, followed by pain in other joints. Most significantly has pain & swelling of joints of hands. Also c/o recurrent subjective fevers. At 3 wks post-vacc had positive labs for rheumatoid arthritis. Currently symptomatic, undergoing work-up & Tx for RA. Has been given Prednisone without significant change in Sx, other meds contraindicated b/c pt is breastfeeding.
Site was bruised where the injection was and whelps above & below injection site that felt like a bruise. It lasted 1 week & 5 days.
Severe Headache, Constant Pain in the left arm, large bruise at the injection site. Insomnia, chills, dizziness, diarrhea, nausea.
Pt received vaccination and waited 15 minutes at store.  When she returned home, she noticed that her sleeve was wet with blood.  Additional bandaging and pressure did not stop the bleeding.  After consulting with pharmacy, she sought medical help. Agency was able to get the bleeding stopped and instructed pt to not use the arm for the rest of the day.  She was also instructed to check with her PCP the next day.  Pt reports that she has been having a lot of bruising lately.
This is in follow-up to report(s) previously submitted on 8/14/2008. Information has been received from a registered nurse concerning a 15 week old patient who will receive their first dose of ROTATEQ vaccine live (human-bovine) on 30-JUL-2008. At the time of the report, the patient's status was unknown. There was no product quality complaint involved. This is one of several reports from the same source. Additional information has been requested.
Symptom free for about ten hours, then onset of chills, severe joint pain, muscle pain and weakness, severe neck pain, severe headache, nausea. Symptoms rapidly increase until peaking at about 16 hours post vaccine (vaccine at 10 am - worst symptoms at about 2 am). Slow return to functioning state at about 29 hours post vaccine but lingering moderate muscle/joint pain and headache.
redness/swelling to right deltoid, fever (unsure how high body just feels warm) since vaccination but worsening.   on exam erythematous, edematous and warm to touch approximately 3 inches in diameter surround IM injection site.  Diagnoses as cellulitis.  Treatment with keflex orally and resolved without complications.
Patient complains of pain and tenderness near injection site @ left deltoid, she also has decreased ROM in abduction of left arm.  MD gave diagnosis of questionable bursitis and ordered patient to start Ibuprofen 400-800 mg every 8 hours and advises use of heat or ice.
About 8.5 hrs after vaccination, the infant began to run a fever despite being given infant Tylenol Temperature was 103.5 rectally. Lasted for 48 hrs. The infant was also listless and reacted as if in pain when injection site is touched-left side.
Intense flu symptoms, severe body pains, headache, confusion at night, hallucinations at night. Severe pain in injection site. Faintness