chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Recv'd flu shot on 10/13/99.Afterwards, pt exp difficulty walking. 11'27/99, pt's husband had to support her going up & down stairs. Pt was examined on 11/29 & admitted to hosp.Pt's alertness, walking,gait,speech, & short time memory were affected. Discharge summary received states principal dx as ventriculo-peritoneal shunt malfunction with a secondary dx of pelvic mass (coincidentally discovered). Performed distal revision of vp shunt.
Her bones are sore; She was very sick /was sick for about 2 weekand; Now she has a deep cough; Tired; This spontaneous case was reported by a consumer and describes the occurrence of BONE PAIN (Her bones are sore), ILLNESS (She was very sick /was sick for about 2 weekand), COUGH (Now she has a deep cough) and FATIGUE (Tired) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025A21A and 031M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced BONE PAIN (Her bones are sore), ILLNESS (She was very sick /was sick for about 2 weekand), COUGH (Now she has a deep cough) and FATIGUE (Tired). At the time of the report, BONE PAIN (Her bones are sore), ILLNESS (She was very sick /was sick for about 2 weekand), COUGH (Now she has a deep cough) and FATIGUE (Tired) had not resolved.      Patient is still experiencing symptoms No concomitant medications were provided. No treatment medications were provided   Most recent FOLLOW-UP information incorporated above includes: On 09-Nov-2021: Follow up received contains Non significant information.
Patient's left deltoid burning, very red in color from area of injection to elbow and warm to touch.
About 24 hrs post vaccination patient had edema, localized redness, heat, and affected area was hard to the touch.  Patient also had cellulitis.  A heating pad was applied to the area and vancomycin 1.9 gm load, 1.5 gm q24hr was started. 5/13/08-records received for DOS 3/15-3/19/08-DC DX: Coronary artery disease with myocardial ischemia. Congestive heart failure with left ventricular systolic dysfunction, ejection fraction of 39%. Paroxysmal atrial fibrillation. Cellulitis of left deltoid area. Acute renal failure. presented to ED with witnessed syncope. C/O light-headednes, generalized weakness, diarrhea, macular rash on legs.
This case was reported by a physician via call center representative and described the occurrence of erythema in a male patient who received SHINGRIX for prophylaxis. On 25th October 2018, the patient received the 2nd dose of SHINGRIX. In October 2018, less than a week after receiving SHINGRIX, the patient experienced erythema, eye red, eye swelling, facial swelling, swelling, burning in eyes and burning sensation. On an unknown date, the outcome of the erythema, eye red, eye swelling, facial swelling, swelling, burning in eyes and burning sensation were unknown. It was unknown if the reporter considered the erythema, eye red, eye swelling, facial swelling, swelling, burning in eyes and burning sensation to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The physician reported that the patient received a dose of SHINGRIX on left arm. On the day of reporting (26th October 2018), the patient presented to the office with redness, burning and swelling on right side of his head, face, eye and cheeks. The physician was not able to discuss the events as she had the patient in the office. She was seeking information on this being possible side effect of vaccine as it was not noted in the prescribing information as burning feeling on head, face eye and cheeks. It was attempted to transfer to MIS (medical information system), but caller was not able to hold, so disconnected. MIS number was not provided.
Information has been received from a health professional concerning an approximately 29 year old male with pcn allergy who in 1995 or 1996 was vaccinated with a first and second dose of varicella vaccine. There was no illness at the time of vaccination. Post-vaccination, in approximately 1995, the pt had titers drawn and he was non-immune. The pt was re-tested in December 2001 and again, the titers showed he was not immune. No further info is available.
Information has been received from a medical assistant referring to an 8 week old male patient. No relevant medical history or concurrent conditions were reported. On 30-JUN-2015, the patient was inadvertently vaccinated with improperly stored ROTATEQ (lot # K014826, expiration date 28-MAY-2016; dose was not reported) orally. No adverse effects were reported. This is one of several reports received from the same reporter. Original report is MARRS#1507USA011322. Additional information has been requested.
A few hours after receiving the vaccine I began experiencing extreme flu like symptoms: nausea, vomiting, body aches, fever, shaking uncontrollably.  This continued throughout the entire night and I had recovered by the following day.
TENIVAC had an excursion at temperature -1.07C for 2 days and 13 hours with no adverse event; TENIVAC administered after an excursion with no adverse event; Initial information received on 07-Apr-2023 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case is linked to case 2023SA111504.  This case involves a 23 years old female patient to whom diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult [Tenivac] was administered after an excursion at temperature -1.07c for 2 days and 13 hours with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was reported that on an unknown date the tenivac had an excursion at temperature -1.07c for 2 days and 13 hours with no adverse event (product storage error) (unknown latency). The refrigerator door was left open and excursion occurred due to a human error.  On 22-Feb-2023, the patient was administered unknown dose of suspect diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult, suspension for injection, (lot LU7189AA; strength and expiry date not reported) via unknown route in unknown administration site for Immunization after an excursion with no adverse event (poor quality product administered) (latency; on same day).  Action taken : not applicable.  Outcome : Unknown.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. 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.
Patient admitted on 10/03/22 with "not detected" COVID test for a fever and abdominal pain with frequent history of UTI's and upcoming need for ureter stent exchange. Patient received COVID booster on 10/05/22.  On 10/07/22 he had routine COVID testing completed due to need for admission testing at a skilled nursing facility.  The 10/07/22 test resulted "detected" for COVID.  No hypoxia or respiratory issues during stay.  Was treated for issues with urinary tract.  Provider d/c note:  "86 yo male with PMHx of dementia , DM2, and nephrolithiasis here with fever and abdominal pain. He is unsure of how long he has had this pain, history is given by daughter at bedside. He has had abdominal pain for the past several months, follows at local Urology for his kidney stones, he is s/p stent exchange 4 weeks ago with subsequent UTI. Daughter states that he began to have a fever with increased confusion, overall weakness with loss of appetite and 1 episode of emesis last night. Daughter states that patient does not articulate pain, but that she can tell when he has increased abdominal pain when he begins to pant, which he has been doing intermittently. Patient was seen treated for anti fungals for fungal infection that he had with fluconazole. It was also determined that the patient had a renal stone and it had to be removed. The stent and the stone was not removed due to cloudy urine and possible infection and the procedure was delayed for when the urine is cleared. Patient was started on antibiotics as well after the urine cultures were positive with bacteria. The patient was send to local care facility in stable condition with the plan to continue antibiotics and antifungal until he meets with ID specialist and with Urology specialist".
strong metallic taste (3 days) resulting in severe nausea (3 days), swollen blood vessels in head, legs, chest (3days), lightheadnesss lying down/dizziness standing and moving (3 days), joint pain in left hip, knees and toes (3days), swelling and pain in left arm (4days), hot flashes (1 day)  Treatment: ice chips, gatorade ice chips for nausea, ice packs for swelling, Tylenol for pain  I had moderate Covid in January 2021.
Vaccine given at 10am. He worked all day, home at 11pm. He said the pain from the shot in his arm had traveled to his neck.At around 11:45 pm he got out of bed and became FREEZING, started shaking, teeth chattering, fever of 101. I gave him Tylenol pm to halt the fever. He was up all night shaking, teeth chattering, burning with fever. This morning the fever is 100. He had Covid over Thanksgiving which started the same way. He went to the ER with Covid and could not get out of bed for ten days.  No additional medical treatment at this time
total knee replacement; This non-serious case was reported by a consumer and described the occurrence of knee replacement in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30-JAN-2023, the patient received the 1st dose of Shingrix. On 17-MAY-2023, 107 days after receiving Shingrix, the patient experienced knee replacement (Verbatim: total knee replacement). The outcome of the knee replacement was not reported.   It was unknown if the reporter considered the knee replacement to be related to Shingrix.     It was unknown if the company considered the knee replacement to be related to Shingrix.   Additional Information: GSK receipt date: 08-Jul-2023 The patient had 1st dose of Shingrix and had total knee replacement. The patient wanted to know if there any contraindications with a total knee replacement 8 weeks post operation. The reporter was requested for follow up.
10 hours after receiving flu vaccine, noted a severe throat pain and noted tingling to (L) arm earlier in the evening. Awoke today with a red rash to the injected arm, spreading from deltoid to hand. The client reports the sore throat has persisted. Denies Respiratory distress. Sore throat continues this afternoon; redness to arm is gone.
covid-19; covid-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 28-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Apr2022 as dose 2, single (Batch/Lot number: unknown) at the age of 28 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 15Sep2021 as dose 1, single (Batch/Lot number: unknown), in left arm and on 21Apr2022 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Latex" (unspecified if ongoing), notes: Known allergies: Latex; "interchange of vaccine products" (unspecified if ongoing). Concomitant medication(s) included: LEXAPRO, start date: 01Oct2018; VYVANSE, start date: 01Jun2019. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Results, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Information has been received from a pharmacist concerning a female who on 15-AUG-2007 was vaccinated with a dose of Gardasil (lot# 657005/0314U). On 15-AUG-2007, after the vaccination, the patient felt faint and nauseous. At the time of the report, the outcome was unknown. Additional information has been requested.
In order of onset?  Lip Tingling (20 min after vaccination) Facial flushing (20 min after vaccination) Swelling of throat/uvula (30 min after vaccination )  Throat irritation (60 min after vaccination) Symptom relief after 2 antihistamine tablets 50mg (Benadryl)
Sore arm, nausea, vomiting, diarrhea, body aches, chills, low grade fever, headache.
Woke up with Chills, Dizziness, Ringing Ears, 156 pulse, 200/90- BP, Metallic Taste, Belly Pain, Knees & Hips hard to move. Short of Breath.
Abdominal pain, arthralgia, myalgia, HA, fever, chest pain, SOB, cough, symptoms x 14 days, now hospitalized.
Sore arm; Dizziness; Diarrhea; Weakness; Fast heart; Chills; vomiting; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), DIZZINESS (Dizziness), DIARRHOEA (Diarrhea), ASTHENIA (Weakness) and HEART RATE INCREASED (Fast heart) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (no historical condition was reported).    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), DIZZINESS (Dizziness), DIARRHOEA (Diarrhea), ASTHENIA (Weakness), HEART RATE INCREASED (Fast heart), CHILLS (Chills) and VOMITING (vomiting). At the time of the report, PAIN IN EXTREMITY (Sore arm), DIZZINESS (Dizziness), DIARRHOEA (Diarrhea), ASTHENIA (Weakness), HEART RATE INCREASED (Fast heart), CHILLS (Chills) and VOMITING (vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Patient called 8/4/19 to complain of redness, swelling, pain at the injection site, and lethargy beginning  8/2/19.
Pain and swelling in left armpit and that lasted for 3 days; Pain and swelling in left armpit and that lasted for 3 days; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 15Apr2021 at 12:15 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. Other medical history was reported as none. The patient had no known allergies to food, medications, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included paracetamol (TYLENOL), naproxen sodium (ALEVE), omeprazole (MANUFACTURER UNKNOWN) and alprazolam (MANUFACTURER UNKNOWN); all from unknown dates for unknown indications and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 25Mar2021 at 12:15 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient reported that with the first vaccine the patient had no side effects at all. On 16Apr2021 at around 19:00, the following night after second vaccine, the patient experienced pain and swelling in left armpit and that lasted for 3 days. That was the only side effect. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events pain and swelling in left armpit was resolved on 19Apr2021, after the duration of 3 days.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Case number PHHY2012US051991 is an initial literature report received on 12 Jun 2012. Authors searched VAERS for reports of adverse events (AEs) in pregnant women who received INFLUENZA from 01 Jul 1999 through 30 Jun 2009. This case refers to a pregnant female patient (age not specified). She was vaccinated with INFLUENZA (manufacturer and batch number: unknown) at an unknown gestational age, on an unspecified date between 01 Jul 1999 through 30 Jun 2009. On an unspecified date after vaccination she experienced viral meningitis. The outcome of pregnancy was not reported. The causality was not reported. Authors stated that the VAERS system does not allow for active follow-up of adverse events among pregnant women; thus, pregnancy outcome data are not available for women who had an adverse pregnancy event. Authors concluded that no unusual patterns of pregnancy complications or fetal outcomes were observed in the VAERS reports of pregnant women after the administration of INFLUENZA vaccine.
1/30/30 - 2nd dose - bruising , sore arm (like a tetanus shot) and redness at injection site.  Injection was done at 9:34 AM.  Around 10:30 PM started with headache.  1/31/20 - Woke up at 7:00 AM with fever (100.3), aches, major headache, overly tired and chills.  Slept most of the day.  I alternated Tylenol and Ibuprofen.  Around 6:30 PM the fever was gone and the chills had dissipated.  2/1/20 - Woke up at 6:00 AM a little sluggish but 90% better.  Arm is still sore.  Headache, chills, fever and feeling tired are gone.  Still a little achy.
shingles; Information has been received from a lawyer regarding a case in litigation concerning a patient of unknown age and gender. No information was received regarding the patient's past medical history, concurrent conditions, and concomitant medication.  On or about 29-DEC-2014, the patient was inoculated with a dose of zoster vaccine live (ZOSTAVAX) (lot number, dosage and route of administration not provided), at a pharmacy as recommended for the long-term prevention of shingles and zoster-related conditions.  Subsequently, on an unspecified date, the patient was treated by providers for the following injuries resulting from patient' vaccine use: herpes zoster and postherpetic neuralgia. The outcome of herpes zoster and postherpetic neuralgia was unknown.  The reporter considered herpes zoster and post herpetic neuralgia to be related to Zoster Vaccine Live(ZOSTAVAX).
Admitted to Hospital on 8/5/2021 for cough/dizzy/fall/SOB and sepsis.  COVID-19 test was positive upon admission.  RT-PCR was performed.  Hospital reported that he was not admitted to the ICU, did not require mechanical ventilation and did not expire from the illness.
She stated having reactions to a Pneumonia vaccine in the past.; 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 female patient received pneumococcal 13-val conj vac (dipht CRM197 protein) (PNEUMOCOCCAL 13-VAL CONJ VAC (DIPHT CRM197 PROTEIN)), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ALLERGY TO CHEMICALS (non-serious), outcome "unknown", described as "She stated having reactions to a Pneumonia vaccine in the past.". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Flu like symptoms, extreme fatigue, headache, body aches, neck/shoulder pain.
No known adverse effects; a patient received a dose of VARIVAX and a dose of PROQUAD; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's past medical history, concurrent conditions, drug reactions/ allergies and concomitant medications were not reported. On 05-MAY-2020, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) lot number S017240 and expiry date 01-DEC-2020 and varicella virus vaccine live (oka/merck) (VARIVAX) lot number S010296 and expiry date 03-APR-2021 (strength, exact dose, anatomical location were not reported for both the suspects) for prophylaxis (inappropriate schedule of product administration). The outcome of inappropriate schedule of product administration was unknown. No known adverse effects were reported. No product quality complaint (PQC) was reported.
4x3 cm left delta ... Mother states that patient complained once or twice about the pain after administration. Swelling and pain started one day after administration. Mother gave patient ibuprofen for pain, which helped, and applied Neosporin to the area of concern. Mother states that patient possibly scratched the area of administration as it caused redness, which is why Neosporin was applied, and a scab formed. Swelling and pain was gone after 2-3 days of administration. During that time, area was sensitive to touch and there was a possible bruise?
Pt got her COVID vaccine waited her 15 mins for observation went out to her car felt flushed face a little red and felt a slight tingling in her lip.  Pt came back into the office , we put her in room 15 for observation pt was given 1000mg tylenol evaluated by Dr.  advised to stay for further monitoring and observation.  Pt was observed no other adverse reactions   she has had anaphylaxis with compazine in the past , she does not have any other allergies at this time.  Pt takes metoprolol no other medications at this time.  she has COPD or asthma she does not know definitively .
self limited facial rash--resolved after 1 hour with no medication. no oral, respiratory or GI involvement
Chest pain; Dehydration; Elevated troponin; Encephalopathy, metabolic; Hypernatremia; Troponin I above reference range; Uremia; Weak; Weakness
Chest pains just over 12 hours later. Went to ER, but left ama when pain subsided. Squeezing sensation in chest and arm was numb at time of event.
Patient says the evening of his vaccine, he was unable to move his arm at all. He went to the MD was given a steroid shot. Pt was able to move arm, but still can't move part 90° at the shoulder. Still having pain.
When entering the vaccine dose information into the EMR, an alert popped up stating the patient had already completed their series.  This was then the patients 3rd dose.
pt recvd MMR vax on 19JAN88 & 4MAR91; pt was seen by MD on 9MAR91 w/congestion, t102, koplik's spots; chest was clear & pt did not have a rash; dx w/poss rubeolla; also exp fever, rash, cough & chest congestion;