chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient had gunk in her eyes real bad the morning of the 10th.  She had a fever of 104.9 when we took her to the emergency room where they gave her Tylenol.  She also tested positive for the rsv virus.  They prescribed ibuprofen and Tylenol.  We tried to control her fever for the next three days and we took her to the family doctor.  Where she was diagnosed with an ear infection and pink eye.  She was prescribed amoxycillin and eye drops.  Two days later she was drastically worse and we took her to the emergency room where they flew her to hospital.  There she was put in the pediatric icu.  She tested positive for the adeno virus.  She was paralyzed and put into a coma.  Two weeks later she was upgraded and released the next day because she was doing good and that she came down with the chicken pox.   Shes currently at home with the chicken pox.  One of the vaccines.  She just got was the varicella.  6/8/09 Received hospital medical records of 5/16-5/29/2009. FINAL DX: respiratory failure secondary to adenovirus; RSV bronchiolitis; secondary bacterial pneumonia. Records reveal patient experienced progressively worsening respiratory distress w/O2 sats 80's.  Seen in outlying ER & transferred to higher level of care.  Temp in ER 104.4.  Tx w/steroids, epi, intubation, PICU, pressor support, TPN,PRBCs.   Developed clot in right femoral secondary to line.  Developed papular rash which became varicella suspected to be from vaccine.  Improved, extubated, diet advanced & tx w/valium/methadone wean. ICD9 Codes:   6/15/09 Received vaccine & PCP medical records of 5/8-5/14/2009. On 5/8 pt noted to have clear nasal discharge, marked speech delay.  Received DTaP, IPV & Varicella, no MMR.  RTC 5/14 w/URI, fever, eye discharge, croupy cough, nasal congestion, decreased appetite, decreased fluid intake x 5 days.  Dx w/RSV bronchiolitis, otitis media & conjunctivitis.  Tx w/antibiotics.    6/29/09 ICD-9 codes received:  4800, 46619   6/17/10 Follow up: She has breathing problems since her hospital stay. She weezes constantly. Has also been treated for asthma.
Headache, Fever, NauseaVomiting, feels "off balance, like I've been drinking: Narrative:
I started getting symptoms of tiredness and no fever but like spiking a fever. I took Tylenol. I took an at home COVID-19 test that was positive. I contacted my doctor and was prescribed Paxlovid. My symptoms were mild. My symptoms lasted for 5 days and I was mostly tired and felt fatigue.
PATIENT FELT LIGHTHEADED AND BP WAS ELEVATED.  THE PHARMACIST INSTRUCTED THE PATIENT TO PUT HER HEAD BETWEEN HER KNEES WHICH SHE DID.  BP WAS 174/90 WITH A PULSE OF 74 IN THE LEFT ARM.  THE PATIENT DRANK SOME WATER AND A BP CHECK FIVE MINUTES LATER WAS 150/80 IN THE RIGHT ARM.  THE PATIENT WAS SITTING UPRIGHT & CONVERSING IN A NORMAL MANNER.  A THIRD BP CHECK WAS 120/90 & THE PATIENT DECIDED TO GO HOME.  THE PHARMACIST WALKED HER TO HER CAR & SHE STATED SHE FELT WELL ENOUGH TO DRIVE.  30 MIN LATER THE PT RETURNED TO THE PHARMACY & SAID SHE WAS HAVING TROUBLE SWALLOWING & HER BP WAS ELEVATED.  THE PHARMACIST DID NOT OBSERVE ANY TROUBLE WITH THE PATIENT'S BREATHING & THE PT WAS ABLE TO DRINK WATER.  THE PHARMACIST RECOMMENDED THE PT CALL HER PHYSICIAN, BUT HE WAS NOT IN THE OFFICE ON FRIDAY.  THE PHARMACIST THEN RECOMMENDED THE PT GO TO THE HOSPITAL IF SHE WAS HAVING DIFFICULTY BREATHING (WHICH THE PT SAID SHE WAS ALTHOUGH SHE DID NOT APPEAR TO BE).  THE INJECTION SITE LOOKED NORMAL, NO UNUSUAL REDNESS OR SWELLING.  THE PT STATED SHE WOULD GO HOME & TAKE BENADRYL AND AGAIN THE PHARMACIST WALKED HER TO HER CAR, THE PT WALKED WITH NO DIFFICULTY OR APPARENT SOB.  THE PHARMACIST CALLED THE PATIENT 20 MINUTES LATER-THE PATIENT SAID SHE HAD TAKEN BENADRYL AND USED HER COMBIVENT INHALER (THE PT HAD NOT MENTIONED THAT SHE USED MEDICATIONS FOR COPD/ASTHMA) & THAT SHE FELT BETTER.  A FOLLOW UP PHONE CALL AT 5:44 PM WAS NOT ANSWERED.
redness on the injection site arm; swelling on the injection site arm; a reaction that hurts to the touch on the injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (redness on the injection site arm), VACCINATION SITE SWELLING (swelling on the injection site arm) and VACCINATION SITE PAIN (a reaction that hurts to the touch on the injection site arm) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.  On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (redness on the injection site arm), VACCINATION SITE SWELLING (swelling on the injection site arm) and VACCINATION SITE PAIN (a reaction that hurts to the touch on the injection site arm). At the time of the report, VACCINATION SITE ERYTHEMA (redness on the injection site arm), VACCINATION SITE SWELLING (swelling on the injection site arm) and VACCINATION SITE PAIN (a reaction that hurts to the touch on the injection site arm) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.  Concomitant product use was not provided by the reporter. No treatment information was provided.
After day 1 my arm developed a half dollar sized red circle which was warm to the touch - circle continued to get larger a little bit each day and was itchy but resolved and cleared up by 1/10/21 - on 1/13/21, the redness returned and the itching returned and spread drastically over my upper arm and was swollen and hot to the touch.  I went to my PCP and she determined that I had cellulitis due to bacterial skin infection over the injection site.  Another doctor was brought in that confirmed the diagnosis.  i was given a 7 day prescription of Bactrim and the arm started to clear up within 2 days of starting the antibiotic.
Head ache, muscle ache/joint, fatigue, chills, loose stools , pain injection site
On 24Nov2009, this 44 year old female patient received 0.5mL of pneumococcal vaccine, intramuscularly, in her left arm. The patient&#8217;s relevant medical history includes no previous allergic reaction to the pneumococcal vaccine. On 26Nov2009, a lump developed at injection site. The lump was sore to touch and it was hard to move the left arm for a few days after the lump developed per the patient&#8217;s report.  On 09Dec2009, the lump is approximately 3.5cm x 2cm; no redness and no streaking; the lump is slightly warm and tender to touch. The patient was viewed by a doctor. It was recommended that the patient use ice and call if swelling becomes worse or redness develops. It is unknown if the patient continues pneumococcal vaccine and it is unknown if she continues to experience a lump at the injection site.
Shingrix administered subcutaneously; This case was reported by a pharmacist via call center representative and described the occurrence of intramuscular formulation administered by other route in a 55-year-old female patient who received Herpes zoster (Shingrix) (batch number 2J5BF, expiry date 6th October 2023) for prophylaxis.   On 24th October 2022, the patient received Shingrix (subcutaneous). On 24th October 2022, unknown after receiving Shingrix, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the intramuscular formulation administered by other route was unknown.   Additional Information: GSK Receipt Date: 04-NOV-2022 Reporter's Comment: Pharmacist called to report Shingrix was administered subcutaneous on the triceps to a patient. The reporter did consent to follow up via email Additional Supportive Information: The patient received Shingrix subcutaneously, which led to intramuscular formulation administered by other route.
Swelling arm; Vaccination site pain; A spontaneous report was received from a consumer concerning a 85-years-old patient who received Moderna's COVID-19 vaccine (mRNA-1273) and developed pain in her arm and soreness.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 22 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 032L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 22 Jan 2021, the patient experienced the event(s) pain in her arm. soreness.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), pain in her arm, soreness was unknown.
hospitalized for 5 days, extreme vertigo, unable to walk or sit up, extreme nystagmus, unable to open my eyes for 3-4 days, unable to focus, vomiting, diarrhea, menstrual bleeding, light and noise sensitivity, hallucinations, extreme ear, head, and neck pain, brain fog, confusion, loss of time, released from the hospital with the use of a walker, unable to drive for 6 weeks, unable to work for 6 weeks
I tested positive for COVID-19 on March 13, 2023. My symptoms were fever, chills, runny nose and I was prescribed Paxlovid for my symptoms.
Vaccine site redness, itching and pain extending from top of shoulder down to just below the elbow joint.
Approximately 2 weeks after the first COVID vaccine she developed shortness of breath that was much more significant than she had previously. This was the first time she had expressed this symptom to me as being something she was concerned about and difficult for her to manage (we have spoken almost daily for many years). Within 24 hours of the second dose of the mRNA vaccine, they called an ambulance to get her and she was taken to the hospital and diagnosed with bacterial pneumonia.   The doctors said it was unrelated, but I found a study with a different vaccine (LAIV) that also seemed to increase the incidence of bacterial pneumonia. They hypothesized through diverting the immune system. So while I don't think the vaccine gave her the bacteria, I do think it may have caused her immune system to be temporarily compromised allowing the bacteria to grow out of control. I feel this is important to report to look for these types of patterns as perhaps it can help others avoid the death spiral that happened to my mother. There were also intervening events between her hospitalization and her death including two successful surgeries (one for a broken hip and another to put in stents in her leg). So to summarize, the first vaccine was within about 2 weeks of the onset of her breathing problems. Within 24 hours of the second vaccine she was hospitalized and diagnosed with bacterial pneumonia. As she was battling bacterial pneumonia in the hospital she broke her hip and was found to have reduced peripheral circulation and had 2 surgeries to correct those. They were successful according to the surgeons, however she died within a week or so of the surgeries.  She had other comorbidities as well which I'm sure predisposed her such as diabetes, hypertension and cancer for many years.
No additional AE; Medical assistant reporting that a dose of PNEUMOVAX23 with a labeled expiry of 6/22/2022 was inadvertently administered to a patient on 11/14/2022. Caller reports no temperature excursion involved. No additional information provided. No additional A; This spontaneous report was received from a medical assistant and referred to a 58-year-old male patient. Pertinent medical history, concomitant medications and drug reactions/allergies were not reported.  On 14-NOV-2022, the patient was inadvertently administered with a labeled expiry of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, 0,5 milliliters (lot number: T034630 and expiration date: 22-JUN-2022) for prophylaxis (strength and route of administration were not provided). No temperature excursion was involved. No additional information provided. No additional adverse event was reported at the reporting time.
complaint of feeling throat tightness and lip smacking.  She states she is history of anxiety and think she is having a anxiety attack.  She has no rash.  No lip swelling.  No tongue swelling.  Patient was not hypoxic.  She is able to speak with a stutter.
One week after taking the first dose of the Moderna vaccine, I developed a welt on my left arm just below the vaccination site. The welt was about the side of a lemon or egg, red and itchy. After two days, the welt went away completely.
pt recv vax & woke up from nap crying;grandma reported pt appeared to make jerking, movements of head & arms then went limp & turned blue/purple;rescue squad was called & pt was evaluated by squad & taken to hosp;sz, hot to touch;t100
I was too weary. I was not thirsty or hungry and I became very cloud because I'm hyper-glasitic that lasted for two weeks
Patient received a first dose Moderna Covid vaccine at a Pharmacy on January 13, 2021 accompanied by her parents. When the family returned to receive their Moderna vaccine second doses the facility refused to administer second dose Moderna vaccine to the patient as she was underage according to the Moderna guidelines. Parents were told that the pharmacy would be in touch to facilitate resolution and subsequently they were never contacted by anyone from the pharmacy according to the mother. The patient's pediatrician, was able to facilitate the patient receiving her second dose  Moderna vaccine through a vaccination clinic at the hospital. The patient was given her second dose of Moderna vaccine as an off label use and according to CDC guidelines on July 23 at 5:30pm and was monitored for 15 minutes without incident. The mother filed a complaint with the pharmacy customer service about this situation of her daughter being delayed receiving her second dose Moderna shot.
Breakthrough case of COVID-19; I had two to three days of neck pain followed by back and knee pain. Wherever I have metal in my body hurt very bad. I then had a scratchy throat 48 hours before I took the test, then for the next 4 days after being tested positive, I had extreme body aches and extreme fatigue. I have basically recovered but just am still extremely tired and fatigue. I did take the PAXLOVID as well.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 10-AUG-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot # J001694, expiration date 08-MAY-2014, dose, frequency, route and indication not reported). The vaccine was stored improperly at temperatures up to 21F from 01-JUL-2013 to 08-OCT-2013. On 08-OCT-2013, the vaccine was discarded. No adverse effects were reported. It was unspecified if the patient had sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Pneumococcal vaccine given in deltoid IM. Next day arm swollen, hot, red from shoulder to elbow. Pain with movement.
Warm to the touch; Red itchy, and warm to the touch; Experienced red itchy, and warm to the touch; A spontaneous report was received from a Consumer concerning a 33-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events red (Injection site erythema) itchy (Injection site pruritus) and warm to the touch (Injection site warmth).  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 5 Jan 2021, approximately 13 days prior to the onset of the events the patient received dose of mRNA-1273 (Batch Number: 026L20A) in the left arm for prophylaxis of COVID-19 infection.  On 13 Jan 2021, the patient experienced the events red (Injection site erythema) itchy (Injection site pruritus) and warm to the touch (Injection site warmth).  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, red (Injection site erythema) itchy (Injection site pruritus) and warm to the touch (Injection site warmth) is considered recovering (symptoms have subsided).; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.
Extreme pain in arm where injection was placed; Numbness in hands; Tingling sharp pain throughout entire arm and under arm; Tingling sharp pain throughout entire arm and under arm; Weakness in arm that injection was placed.; This is a spontaneous report from a contactable Other HCP (patient). This 31-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: unknown), via intramuscular route of administration, on 07Jan2021 at 11:00 AM as a single dose in the right arm for COVID-19 immunization at hospital facility. Relevant medical history was none. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included fluoxetine hydrochloride (PROZAC), lamotrigine (LAMICTAL). The patient previously received the first dose of BNT162B2 (lot number/expiration date: unknown) on unknown date via unknown route of administration for COVID-19 immunization. It was unknown if the patient receive any other vaccines within 4 weeks prior to the COVID vaccine. On 07Jan2021 at 08:00 PM, after the second dose, the patient experienced extreme pain in arm where injection was placed, numbness in hands, tingling sharp pain throughout entire arm and under arm and weakness in arm that injection was placed. No treatment was received for the events extreme pain in arm where injection was placed, numbness in hands, tingling sharp pain throughout entire arm and under arm and weakness in arm that injection was placed. The outcome of the events extreme pain in arm where injection was placed, numbness in hands, tingling sharp pain throughout entire arm and under arm and weakness in arm that injection was placed was unknown. The patient was not pregnant at the time of vaccination. Since the vaccination, the patient had not been tested for COVID-19.     The lot number for the vaccine, BNT162B2 dose 1, was not provided and will be requested during follow up.
Mother found child in crib not breathing. Called an ambulance, but unable to resuscitate. COD as per death certificate -- cystic encephalomalacia
No known adverse health events associated with this vaccine administration.  VAERS report is being filed in order to follow CDC Interim Clinical Considerations for Use of COVID-19 Vaccines, which states that this administration error (unauthorized age group) should be reported
No additional AEs; product was quarantined in freezer awaiting instructions for return/ Improperly stored vaccine that experienced shipping temperature excursion on 8/31/22 was administered to patient on 9/19/22.; PROQUAD shipment, which was received late on 8/31/22 past must receive by date 8/30/22, late shipment; This spontaneous report was received from a clinic director/ office manager referring to a 4 years old male patient. The patient's concomitant medication, pertinent medical history and drug reactions/ allergies were not reported.  The measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) shipment, which was received late on 31-AUG-2022 past must receive by date 30-AUG-2022 (product distribution issue). The late shipment had already been reported the agency. The improperly stored vaccine that experienced shipping temperature excursion on 31-AUG-2022.  The product was quarantined in freezer awaiting instructions for return. But on 19-SEP-2022, the vaccine measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) (lot # W019626, 19-DEC-2023; 0.5 milliliter, once; strength and route were not reported) was accidentally administered to the patient for prophylaxis (product storage error). No additional AEs (no adverse event).
10/29 Chills, fever, body aches. 10/30/13 Chills, fever, body aches, slight headache, general malaise, frequent micturition during night.
pt recv vax 3APR97 began fever 4APR97 Friday noc 103 ax fever lasted 3 days;rash devel 2 days p/vax on abd, arms & legs;mom states looked blotchy;no itching;unable to feel rash had runny nose;
Nausea, diarrhea, headache, dizziness, chills, sore throat, body aches, fever, sweating,  stomach cramping.
Pain in arm of injection site immediately after injection and intensifying over the next day Severe back and neck pain with headache 5 hours after injection carrying over into the next day Nausea 7 hours after injection carrying over into next day Chills turning to Fever/Sweating  9 hours after injection resolved the next day
This spontaneous report was received from a registered pharmacist refers to a 89 years old female patient with no pertinent medical history and allergy to tetracycline who on 11-SEP-2012, was vaccinated subcutaneously with a 0.65 ml dose of ZOSTAVAX (lot number 0365AE, Exp. Date: 23-MAR-2013). No other co-suspects were reported. No concomitant medications were reported. The pharmacist reported that on 14-SEP-2012, the patient developed injection site red spots, rash and itching. It was also noted that the patient stated of a possible rash around her wrist, as well. No treatment was given for the experience. No lab diagnostics studies were performed. At the time of the report, the patient had not recovered. The patient sought medical attention by contacted the pharmacist. The relatedness for patient developed injection site red spots, rash and itching and possible rash around her wrist was unknown for ZOSTAVAX. Additional information is not expected.
Pt describes fever of 102 degrees and chills 1st day after injection. Day 2 awoke with 5 inch circle that was 4 inches above site. C/O red/hot area with 20 sm circles within the larger area. Generalized malaise, abd cramping, diarrhea.
Pt exp hives, itching on stomach - spread to back, arms, thighs, face scalp.
There was temperature excursion from freezer; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (There was temperature excursion from freezer) in a 69-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 08-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (There was temperature excursion from freezer). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (There was temperature excursion from freezer) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were provided  On 01-Oct-2021, There was temperature excursion from  freezer.   It was stated 10 Number of vials/doses were impacted. Storage condition at the time of the excursion was frozen and Minimum temperatures reached 4.2 degrees F and maximum was 5.7 degreed F and Excursion duration was 6 minutes.  No treatment medications were provided.