chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Cold sore (herpes labialis); This is a spontaneous report from a non-contactable physician (Patient). A 43-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EK9231), via an unspecified route of administration on 08Jan2021 20:30 (08:30 PM) at single dose  on the right arm for COVID-19 immunization. Patient is not pregnant. Medical history included allergies with mango. No other medical history. There were no concomitant medications (reported as "Other medications in two weeks: No"). No other vaccines in four weeks. The patient was not diagnosed with COVID-19 prior vaccination. The patient received the first dose on 17Dec2020 03:00 PM  (lot number: EH9899) on the right arm. The patient experienced cold sore (herpes labialis) on 11Jan2021 20:00 (reported as "08:00 PM"). No treatment was received for the event. Outcome of the event was recovered in Jan2021. Patient was not tested for COVID-19 since the vaccination.  No follow-up attempts are possible. No further information is expected.
fever; reaction; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever) and ADVERSE REACTION (reaction) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     The patient's past medical history included No adverse event.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (fever) and ADVERSE REACTION (reaction). At the time of the report, PYREXIA (fever) and ADVERSE REACTION (reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-031890, MOD-2021-032177 (Patient Link).
Afebrile, vomiting & fussy (unable to keep anything down), p/midnite the evening of immun (9-10 hrs p/immun) bruise @ site of DTP; MD feels had virus;
This spontaneous report as received from a nurse practitioner refers to a female patient of unknown age. The patient's concurrent conditions included pectoralis excavatum. On 01-NOV-2015, the patient was vaccinated with an expired dose of PNEUMOVAX 23 lot # K006681, expiration date 21-OCT-2015 (route and site of administration not reported). On the same day, she concomitantly received an unspecified influenza virus vaccine. Later on 01-NOV-2015, after the vaccines had been administered, the patient become woozy. She used cold compresses and laid down for 15 minutes. The outcome of becoming woozy was reported as recovered/resolved on 01-NOV-2015. The reported did not assess the causal relationship between the event "become woozy" and vaccination with PNEUMOVAX 23. Additional information has been requested.
Pain, tingling, burning in arm that radiates down. Started 2 days after shot. Feels hot. Pt called MD and MD said this happens after flu shot, should heal. Pt did not recall RPh placing needle to high or low in arm.
This was the patients second dose of Moderna, she informed our staff there was an allergic reaction the first time stating her PMD instructed her to take Benadryl prior and hold her BP meds. She was given Benadryl 25mg in site and received the vaccine a few minutes after. She then was watched out in observation where she began to shiver, became clamy and would respond but eyes closed and would not open them. Vitals were taken BP 189/147, HR 87, O2 97 room air. Oxygen was applied for comfort, she stated her throat was not closing up like it did with first dose. Staff from her company then decided to call 911 where LAFD took over, she was then released home as she refused any care from them.
On 05/09/2021- I was overcome with doziness and muscle ache. Over the summer the symptoms got worse, and I would have muscle aches a lot and foggy brain and the fatigue became worse and worse too.  The symptoms gradually became worse. 09/29/ 2021 I saw the doctor and got blood work done. 10/16/2021-I had more blood work, diagnosed me with fibromyalgia. I am not sure in any way this is related to the vaccine. Maybe just coincided. Maybe something that was triggered around the same time as the vaccine.
This spontaneous report as received from a registered nurse refers to a patient of unknown age. On 04-MAR-2011 the patient was vaccinated with the first dose of GARDASIL, the second dose on 12-DEC-2012, and the third dose on 19-FEB-2013. No lot # was reported. No adverse effect reported. Additional information has been requested.
1st shot:   My right arm only went numb multiple times for 3 days after shot, was numb from shoulder to hand.  Started having short dizzy spells.  Have episodes where I have a hard time focusing on my surroundings.  Ended up with diarrhea for a couple of days.  My hair started falling out.  2nd shot:  By that night I was sick.  I had uncontrollable cold chills, couldn't focus, wanted to throw up, ABD pain.  By morning I had no energy, could hardly walk, was dizzy and unsteady on my feet, I couldn't focus, my vision was blurry.   I had 102 fever for 2 days followed by 2 days of diarrhea.   My whole body ached, especially up my spine into my head.  Felt like someone was trying to crack my head open.  My hair is still falling out in handfuls daily.  I fear I will be bald soon.   It's 6 days after my second dose and I have headaches on a off. Right now my head is killing me.  It's the same headache, I feel it up my spine and into my head.   I randomly have dizzy/near syncopal episodes.  I still have episodes of blurry vision and having hard time focusing on my surrounds.
This spontaneous report as received from a physician refers to a 4 month old patient. On 28-AUG-2017, the patient was vaccinated with PEDVAXHIB (dose, route of administration, lot # and expiration date were not reported) for prophylaxis. On 28-AUG-2017, the patient experienced incorrect product storage. Sender's Comments: US-009507513-1708USA013219.
On the day of vaccination in the evening Lightheaded, pain in all joints, body ache and vomiting twice.  Fever101.  Next day shaking hands on and off.  As of today still on and off hands shaking, lightheadedness and joints pain
Started fever along with a non itchy rash the day after the shot, along with diarrhea. The rash worsened.
Seizure event, approx 20 min. Pt had 1 seizure episode prior to Fluvirin and was taken to the ER and found  to have a UTI and fever. After Fluvirin was given approx 20 min later mother reported child had 1 seizure and was taken to hospital and again found to have a UTI and fever that started developing. Currently this child is being worked up for seizure disorder unrelated to Fluvirin event.
No additional adverse events; Caller is medical assistant reporting administered doses of improperly stored vaccines; This spontaneous report has been received from a medical assistant concerning to a patient of unknown age and gender. The patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications were not reported.  On an unknown date, a temperature excursion occurred for measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), in which the vaccine was at the following temperatures: 8.8 degrees Celsius for 1 hour and 27 minutes, 8.5 degrees Celsius for 6 hours and 39 minutes, 8.8 degrees Celsius for 8 hours and 45 minutes, 10.7 degrees Celsius for 11 hours and 42 minutes, 9.83 degrees Celsius for 18 hours and 48 minutes, 9.5 degrees Celsius for 14 hours and 10 minutes and 9 degrees Celsius for 9 hours and 24 minutes. Also a temperature excursion occurred for varicella virus vaccine live (oka/merck) (VARIVAX), which was at a temperature of -13.1 degrees Celsius for 18 minutes and -11.9 degrees Celsius for 21 minutes (both temperatures were also reported as "-14 to -10 degrees Celsius"). No previous temperature excursions were reported for any of the vaccines.  On 30-JUN-2022, the patient was vaccinated with 1 dose of one dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinant human albumin (rHA) (M-M-R II)  lot # U006485, expiration date 26-FEB-2023 (dose, route of administration and anatomical location were not provided) for prophylaxis and 1 dose of varicella virus vaccine live (oka/merck) (VARIVAX)  lot # U002400, expiration date 22-JAN-2023 (dose, route of administration and anatomical location were not provided) for prophylaxis (product error). No additional events were reported (no adverse event).  This is one of multiple reports from the same reporter.
Fever, inflammation, shooting pains, insomnia, severe bloating and abdominal cramping and sharp pains. Violent vomiting and diarrhea. So many symptoms. Shooting in all my joints. Loss of fine motor skills, cognitive impairment, tightness in chest, hard to breathe, swollen throat, stiff neck, couldn?t walk. Post COVID multi system inflammatory syndrome.
Information has been received from a physician in the form of pediatric medical records which were received and reviewed concerning an approximately 3 month old normal female infant with a history of upper respiratory tract infection and constipation and with thrush and positional plagiocephaly (WAES # 0708USA01526), who on 09-MAY-2008 was vaccinated with PEDVAXHIB and PEDIARIX and PREVNAR.  On 09-MAY-2008 the infant was noted to have age appropriate growth and development weighted: 12 pounds, Height:  24 inches, and (FOC):  41.4.  Physical exam revealed positional plagiocephaly (infant was encouraged to look towards left) and constipation.  Reinforced safe sleep practices, supervised (tummy time) were recommended.  Also 1 ounce of prune juice added to 1 or 2 bottles of formula per day was recommended.  In June 2008, the approximately 3 month old infant with age appropriate growth and development weighted 15 pounds and 1 ounce.  Height:  25, 5 inches and FOC: 43.0  Physical exams were normal.  Ocassional constipation was noted.  Reinforced safe sleep practices supervised were  recommended (tummy time).  On 19-JUN-2008, mild eczema-like rash was noted on left cheek treated with EUCERIN.  On 15-JUL-2008 the approximately 4 months and a half old infant was vaccinated with PEDIARIX, PEDVAXHIB, PREVNAR.  Weight 16 pounds.  Height:  26.25 inches and FOC: 44.4  Physical and development exams were normal.  No further information is available.
On 1/8/13 infant received vaccines. Shortly after mom noticed hives across arms & trunk. Went to ER & was treated with BENADRYL & TYLENOL. Symptoms resolved. F/U with MD, and she presents here today for 6mo vaccines with note from MD. To Whom it May Concern: This is to notify you that patient was seen in ER after her 2nd set of immunization for hives. As she was given injections of 5 different immunizations, it's best to give next set on individual injections at different days and DTaP to be administered last.
2 episodes of severe nausea and vomiting. 1st episode: day 2. 2nd episode: days 5-6
12/23@9:35am EST- Caller stated on12/22/20  at midnight he felt fever 103.0, chills, muscle soreness and aching, nausea and extreme fatigue. Caller called Primary and  was told to take Tylenol 1gr.  Benadryl and naproxen for headache and body aches. Rash covered  arms , neck and thighs and patika on elbow and armpit. This morning rash is still prominent, eyes are swollen and urine is bright red.  Caller is  awaiting primary to call back.
large rash on arm; This case was reported by a nurse via sales rep and described the occurrence of rash in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were reported as follows: The age at he vaccination was not reported. The patient received dose of Shingrix and experienced large rash on arm. No further information was available. The reporter consented to follow up.
pt recv vax 15MAY96 & 21MAY96 pt exp cold-like sx & fever of 101 & rash on chest, buttocks, & penile area;
Red bump rash with blister head present 03/29/02. 7 pox rash.
Patient reported severe pain in injected deltoid which radiates throughout the arm beginning soon after injection and to this date 2/6/19. She mentioned she will be going to see her physician soon regarding this.
Increased seizure activity, encephalopathic EEG. 12/9/2009 MR and DC summary for 11/17-12/3/2009, patient with c/o's URI sx x 5 days including cough, episodes of being less responsive and staring spells with increased frequency of seizure activity, tx'd with IV ABX for pneumonia,  Tamiflu, LP done,  on 11/19/2009 patient's condition changed with mental status changes and increased respiratory efforts, to PICU, intubated x 8 days DC Dx pneumonia
left facial droop and left upper extremity weakness, vomiting, intermittently lethargic,
Severe pain in left arm, hard to lift, aches all the time. No swelling or redness pain seems to be coming from within the arm shoots up into shoulder at times. Can still use it but aches most when resting have not visited dr yet but will make appt at first contributed it to just the shot but not after 10 days.
Low estrogen; can't concentrate/can't focus; has anxiety; can't sleep; Depressed; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): MOD21-160615 (Moderna), MOD21-160642 (Moderna).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BLOOD OESTROGEN DECREASED (non-serious), outcome "unknown", described as "Low estrogen"; DISTURBANCE IN ATTENTION (non-serious), outcome "unknown", described as "can't concentrate/can't focus"; ANXIETY (non-serious), outcome "unknown", described as "has anxiety"; INSOMNIA (non-serious), outcome "unknown", described as "can't sleep"; DEPRESSION (non-serious), outcome "unknown", described as "Depressed". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Call received from patient who believed that she relieved the Moderna vaccine, stating that since  receiving her 2nd dose in April, she has low estrogen, cannot sleep, cannot focus, depressed, has anxiety and cannot concentrate. She was tested and test proves that she has low estrogen. She went  on to state that she is aware of 10 people who experienced the similar reactions. 5 of which are (Withheld) 5 and she is (Withheld) and did not mention the nationality of the other 5. Upon request of date of vaccination and LOT number/EXP Date for the Moderna vaccine, patient realized that she called the wrong number because she received both doses of the Pfizer vaccine. Age was not captured.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER_INC-202101533632
No additional AEs; an expired dose of RECOMBIVAX HB was administered to a patient.; This spontaneous report was received from a healthcare professional (HCP) referring to a patient of unknown age and gender. Information of the patient's medical history, concurrent condition and concomitant therapy was not reported.  On 26-JAN-2023, the patient was administrated with an dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) intramuscular injection (frequency: once, expiration date: 25-JAN-2023, strength, lot#, route and anatomical location were not reported) for prophylaxis (expired product administered). The hepatitis b vaccine (recombinant) (RECOMBIVAX HB) had no prior temperature excursion (TE). There were no additional adverse events (AEs).
This spontaneous non valid report, was received from a Respiratory Therapist referring to a Multiple unspecified patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions or concomitant therapies was provided. On an unknown date, the patients were vaccinated with an improperly stored dose of PNEUMOVAX 23 lot # N019838, expiration date on 16-FEB-2019 (strength, dose number and route were not provided) for prophylaxis. No adverse events reported. The case was reported due to digital data logger, with a temperature of -0.4 °C during 2 hours, no previous temperature excursion.
back pain is gone; This is a spontaneous report from a contactable consumer (patient). This patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose on an unspecified date for COVID-19 immunisation. Medical history included back pain. Concomitant medication was not reported. Patient just got the Pfizer vaccine yesterday and now the back pain was gone. Patient had had back pain for the past year only thing that changed was yesterday taking that shot. Patient asked if this was a temporary symptom or would no longer have back pain. The outcome of event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
The patient was at the clinic to receive her second dose of the Serogroup B meningococcal (Bexsero). She had previously received her first dose at the clinic pharmacy on 7/20/2021. At her visit on 8/19/2021 the patient received a dose of 0.5ml Menactra in error administered by CMA.  No adverse reactions noted. The patient and her mother were both informed of administration error.  The incident was immediately reported to the Clinical Coordinator, the Chief Operations Officer and the Pharmacy Director.  The Pharmacy Director contacted company,  and was told the following: They have data that demonstrates safety (no adverse effects when Bexsero and Menveo (Menactra's substitute that company manufactures). You are able to simultaneously administer the 2 vaccines, just at separate sites. The patient will, however, need to complete the series to obtain full protection. These recommendations have been approved by the agency, according to company.
Small amount of booster vaccine leaked, patient expressed concern per pharmacist judgement, patient received full dose of vaccine in body, no need to revaccinate, assured patient of received full dose.
Mucus in throat; Catching a cold; Congested; Nose running; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of SECRETION DISCHARGE (Mucus in throat), NASOPHARYNGITIS (Catching a cold), NASAL CONGESTION (Congested), RHINORRHOEA (Nose running) and PAIN IN EXTREMITY (Sore arm) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Aug-2021, the patient experienced SECRETION DISCHARGE (Mucus in throat), NASOPHARYNGITIS (Catching a cold), NASAL CONGESTION (Congested), RHINORRHOEA (Nose running) and PAIN IN EXTREMITY (Sore arm). The patient was treated with PARACETAMOL (TYLENOL) for Myalgia, at an unspecified dose and frequency. At the time of the report, SECRETION DISCHARGE (Mucus in throat) had not resolved and NASOPHARYNGITIS (Catching a cold), NASAL CONGESTION (Congested), RHINORRHOEA (Nose running) and PAIN IN EXTREMITY (Sore arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided Treatment information include throat lozenges and drinks tea with honey.
9-7-10 presented with history of dizziness x 2-3 days able to attend school. Cheerleading practice and visiting with friends, sore throat, fever and fatigue. Also normal neurological exam with exaggerated dramatic ataxic no alt when observed, normal gait when unaware of observation and symptoms of anxiety previously but unconcerned about current problems. Headache and ataxic become more severe taken to ER. Admitted.
Patient received Zostavax vaccine at approximately 10:30 am on 7/18/08. Administered in L upper arm. That evening at 7pm began to have Right back patient. By next morning pain increase and later in day developed rash beneath Right breast. Following day this rash spread toward back. On 7/21/08 patient diagnosed with Herpes Zoster of right T 8-9 dermatome.
The last Saturday in June, I was at the home of a client who had just returned from a trip. The husband was sick and he stayed out of the home while I was there all day although he had not been tested for COVID-19. My sinuses began to become irritated worse and worse and I noticed that I had a runny nose which isn't common for my normal sinus issues. I used some nasal spray which helped a lot because I had been congested and my ears were stuffy and I had a wet productive cough. I was also noticing some fatigue at that time and my husband started to feel unwell as well. I took an at home COVID-19 test which was positive. I called my doctor as soon as I tested positive. They did not advise the anti viral medication at that time and just suggested that I continue to monitor my symptoms and get back in touch if my symptoms worsened. My symptoms lasted around 5 days at most and now I feel better than I did before I contracted COVID-19 with the exception of some fatigue.
Chills, fatigue, nausea, injection site pain, body aches lasting for 24 hours.  Late period, menstrual type cramps, spotting and bloating. Been going on for a week now.
1 day after administration of vaccine, patient called pharmacy and told RPh on duty her site of injection was very painful, red and swollen down to (L) elbow. Patient is a retired nurse and suspected cellulitis; a phone call was made to patient 7 days later and symptoms did subside after applying warm compresses. No other medical intervention was necessary.
Left arm swollen, red, warm and hard at site of EIPV.  Recommended MD visit on Monday, shot given on Friday 10/17/2003.
PT HAD NEAR-SYNCOPAL EPISODE. PT WAS LIGHTHEADED, DIZZY, BUT DID NOT FAINT OR LOSE CONSCIOUSNESS.
hives all over my body, became allergic to cow milk, eggs. wheat, soreness and redness of the vaccinated  area
REceived Pfizer vaccine on 03/02/21, 3/30/21 and 10/26/21. COVID positive and presented to ER on 1/12/22. was admitted on 01/12/2022 for COVID-19 pneumonia and decompensated CHF.  Patient was treated with remdesivir and dexamethasone therapy per COVID-19 treatment protocol Empiric antibiotic therapy with ceftriaxone and azithromycin was also offered. There was a suspicion for a GI bleed given blood streaked stools; her anticoagulation therapy was put on hold and H&H monitored and currently stable. Protonix was also given for GI prophylaxis. The patient improved clinically and was ultimately discharged back to a nursing home residence. She will follow up with the PCP within 1 week. Discharged on 1/19/22
Urticaria, throat swelling and tachycardia requiring treatment with BENADRYL, SOLUMEDROL and epinephrine. Transferred to ER; monitored; discharged to home.
Patient had received a vaccine that had been in the refrigerator longer than 6 hours. Vaccine was punctured at 3:35pm on 6/15/21. It was given to the patient on 6/16/21 at 3:15PM. Patient does not have any adverse events at this time.
Localized urticaria, pruritis around immunization site occurring within 48 hours of injections.
Patient reports that as of 11/23/2022 at site of MPV vaccine it is indurated, swollen, bruised.
Immunization reaction left deltoid 3x4cm induration, cool compresses Tylenol prn Keflex.
Narrative: Patient COVID positive despite 2 doses of COVID vaccine. Patient admitted for acute hypoxic respiratory failure.
Dry, rough, red patches Initially started at injection sites on both right and left thighs. They were mentioned at the following visit and mentioned eczema. After the 2 dose of injections in both thighs, the dry, red patches are all over both legs and 3 on the face.