chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Increased temperature 103-104 degrees on day 6 after 2nd MMR, relieved with Tylenol and Ibuprofen.  Patient recovering and temperature normal on 01/25/2006.
Presented to hospital on 11/7 following a fall. Noted to have large left pleural effusion, concerning for chylothorax. Had thoracentesis for fluid removal and thoracic duct embolization. Noted to have + COVID test on 11/9. Treated with Decadron and remdesivir.  ICU after episode of bradycardia and unresponsiveness during which he was intubated and chest tube was placed.  Improved and was extubated and returned to a regular hospital floor.  Unable to recover fully and on 12/4 had increased respiratory distress resulting in intubation.  Transferred to ICU and family requested comfort care. Extubated and passed.
Information has been received from a registered nurse regarding a patient of an unknown age and gender. On 18 OCT-2012, the patient was vaccinated with an out of temperature range dose of ZOSTAVAX (Lot # 0468AE, exp date 04-APR-2013) (dose and route administration were not provided). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
Patient recieved injections 2/12/21 and 3/15/21. Had Juvaderm injections in 4/2021. Developed facial swelling, allergic reaction
8 days after vaccination site became inflamed. Red, hot to touch, sore, itchy, swollen.
Initial report received on 20 April 2012 from the Investigator participating in post-marketing study under the reference number M5A16. A case of pertussis in a 12-month-old female subject was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received 3 doses of PENTACEL; lot number C3800AA received on 27 May 2011, lot number C3871AA received on 24 August 2011 and lot number C3912AA received on 06 October 2011 (routes and sites of administration not reported). The subject developed a paroxysmal cough with whoop on 27 March 2012, approximately five months after the last dose. The subject also experienced sleep disturbance and apnea. Laboratory testing included positive PCR on 27 March 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 28 March 2012 for five days. The subject was not hospitalized. At the time of final contact on 18 April 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 22 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Fever; chills; sweats; Site injection pain; general malaise; This is a spontaneous report from a contactable consumer (patient) via Pfizer Sales Representative. A 73-year-old male patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration from 22Jan2021 08:00 at single dose for COVID-19 immunisation. Medical history included blood pressure abnormal. Concomitant medication included benazepril as blood pressure medication. Patient experienced site injection pain and general malaise on Saturday 23Jan2021. Fever of 101.2 F and chills and sweats on Sunday 24Jan2021. Fever managed with ibuprofen. Fever resolved on 25Jan2021 - temp back to 98.8 F. Outcome of fever was resolved. Outcome of other events was unknown.  Information on the lot/batch number has been requested.
This prospective pregnancy case was reported by a pharmacist and described the occurrence of amniotic fluid leakage in a 21-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline) while pregnant. On 21 January 2012 the pregnant subject received a dose of BOOSTRIX at 0.5 ml. The subject experienced vaccine exposure during pregnancy. It was reported that the subject had not used contraception. Her date of last menstrual period was not reported and her estimated date of delivery was March 2012. Ultrasounds performed on unspecified dates revealed no defects. In January 2012, less than one week after vaccination with BOOSTRIX (prior to or on 23 January 2012), the subject experienced amniotic fluid leakage and was hospitalized. At the time of reporting the outcome of the event was unspecified. The pharmacist considered the event was unrelated to vaccination with BOOSTRIX. The pregnancy was ongoing, however, it was reported that "they" planned to deliver the baby early due to the leaking.
Hives - 4 right forearm within 30 mins 1 left forearm. Given BENADRYL 25mg stat, then rslvd. No more hives.
pt recv vax 20JAN99 & 22JAN99 pt died of SIDS;pt recv first dose 18DEC98;
This is a spontaneous report from a contactable consumer (patient) via medical information team. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: en0158) via an unspecified route of administration on 13Apr2021 as single dose for COVID-19 immunization. Medical history was not reported. Concomitant medication included ongoing gabapentin daily for back. Patient received first vaccine dose and in the first day she experienced nausea and some chest tightness on 13Apr2021. These symptoms went away but she also reported having soreness to her arm at the injection site and under her armpit in Apr2021. She couldn't lift the arm, it hurt to lift it so she put an ice pack on it because it was really swollen. The pain was under her armpit and on the top of her arm right where the vaccine was given. It was still swollen but a little better this morning reporting that she is putting ice on it, rubbing alcohol on it, massaging it. She asked if this was a swollen lymph node and if that is a sign that the shot is working. The outcome of events nausea and some chest tightness was recovered in Apr2021; for other events was unknown.  No follow-up attempts are possible. No further information is expected.
Dtap vaccine given instead of Tdap vaccine recommended for age. No adverse reactions. Per guidelines, no need to re-vaccinate.
Bad / metallic taste for a few hours after taking a dose; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (Bad / metallic taste for a few hours after taking a dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066F21A) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment.    Previously administered products included for Product used for unknown indication: Pfizer / BioNTech (Dose Number: 2 Batch/Lot No: EW0153 Location of injection: Arm Left) on 07-Apr-2021 and Pfizer / BioNTech (Dose Number: 1 Batch/Lot No: EP7534 Location of injection: Arm Left) on 17-Mar-2022. Past adverse reactions to the above products included No adverse event with Pfizer / BioNTech and Pfizer / BioNTech. Concurrent medical conditions included Allergy (No product reported).   On 18-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On 25-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DYSGEUSIA (Bad / metallic taste for a few hours after taking a dose). At the time of the report, DYSGEUSIA (Bad / metallic taste for a few hours after taking a dose) outcome was unknown.            No concomitant medications were reported.  Patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment. Device Date was reported as 27-May-2022  No treatment medications were reported.
right armpit swelling not red or hard but painful and definitely swollen I did have the usual muscular aches in the right arm and body on 12/2 night and mildly tender right arm 12/3
Patient came in for vaccines: Menactra, Gardasil and Varicella. Doctor ordered them correctly.   Patient received: Zostavax instead of the Varicella.  Staff member gave it in error.  The Menactra and Gardasil were correctly given.
This case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too short in a 78-year-old male patient who received Herpes zoster (Shingrix) (batch number 3B55B, expiry date 18th December 2022) for prophylaxis. Concomitant products included Herpes zoster (Shingrix).  On 30th November 2021, the patient received the 2nd dose of Shingrix. On 30th November 2021, unknown after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the patient experienced accidental overdose. On an unknown date, the outcome of the drug dose administration interval too short and accidental overdose were unknown. Additional details were reported as follows: The nurse reported that patient received his 1st dose of Shingrix on 30th November 2021 and accidentally received a 2nd dose about 30 minutes later, which led to drug dose administration interval too short and accidental overdose. No symptoms reported. The reporter consented to follow up.
Arm discomfort; pain on the neck; Pain on cheeks; pain in shoulder of left arm; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (Arm discomfort), NECK PAIN (pain on the neck), FACIAL PAIN (Pain on cheeks) and ARTHRALGIA (pain in shoulder of left arm) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis, Diabetes, Hypertension and High cholesterol.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LIMB DISCOMFORT (Arm discomfort), NECK PAIN (pain on the neck), FACIAL PAIN (Pain on cheeks) and ARTHRALGIA (pain in shoulder of left arm). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, LIMB DISCOMFORT (Arm discomfort), NECK PAIN (pain on the neck), FACIAL PAIN (Pain on cheeks) and ARTHRALGIA (pain in shoulder of left arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications included diabetes medicine,cholesterol medicine, blood pressure medicine.
Woke in the morning in pain in the left arm, neck to finger tips. I felt like I had a pull noodle. The was a large swelling the soft ball left in the armpit and the armpit.
On post vaccination day 6 the patient developed erythema, swelling and induration of ca. 8cm at the around the injection site and a pruritic rash of the anterior cervical area and upper thorax. On post vaccination day 7 the swelling, erythema, and induration of the injection site had expanded to 10 cm, the rash of the cervical area somewhat resolved but a mild pruritic rash of the face had developed.
Terrible Itching under left armpit, then underarm, arm swelled , turned bright red and  arm itched, hand swelled;   moved to right underarm, itching, turned bright red and swelled; torso swelled, turned red, looked like a sun burn; finally neck and face turned red, swelled.  Took on 12.5lbs of fluids.  Physician prescribed steroids', Claritin and Benadryl; Swelling was gradual over a three week period.  Just completed steriod  treatment  and had Physician follow-up,  body fluid down, still a little on left side and toroso
FEVER; CAN'T HOLD FOOD DOWN; DROWSY; CONFUSION; LOSS OF APPETITE; FEELING BAD; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: L-1802072, and batch number: L-1802072 expiry: UNKNOWN) .5 ml, administered on 10-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced can't hold food down. On MAR-2021, the subject experienced drowsy. On MAR-2021, the subject experienced confusion. On MAR-2021, the subject experienced loss of appetite. On MAR-2021, the subject experienced feeling bad. On 12-MAR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 103 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, can't hold food down, drowsy, confusion, loss of appetite and feeling bad was not reported. This report was non-serious.
p/vax pt noted pain in lt foot in the joint between the great toe & the ball of the foot;pt did not seek medical attention & as of 6/9/99 the pain persists;
1015AM pt began w/profuse sneezing, puffy watery eyes & diff breathing;tx epi;
Local site irritation, at first slightly red, then turned more red.  Swollen and sore to the touch. Larger than a silver dollar.
Pt called today, 12/29/99. She woke during the night with the injection site itching. She has a rash & it is warm. After consulting w/health dept was instrucked to see MD.
DTap given approx. 2:30pm on 03/12/2002. On 03/13/2002 am right arm was swollen from injection site to elbow. Area was red, warm to touch. Child had slight fever. Contacted the doctor and Benadrly was given. Parent took child to ER child given Benadryl injection. Arm still swollen on 03/14/2002. Parent took the child to the pediatrician on 03/14/2002. On 03/15/2002 swelling subsiding today but still taking Benadryl.
Reportedly on 8/16/00, the pt developed redness and swelling of the right thigh. The pt's mother contacted the physician's office and was instructed to watch the site and check for fever and treat as needed. Follow up received 09/22/2000 states no further information is anticipated for this report. The case is closed.
swelling of the gland; This is a spontaneous report from a contactable consumer (patient's husband). A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date the patient experienced a side effect after getting the vaccine which was swelling of the gland. The outcome of swelling of the gland was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
This is a Pfizer BOOSTER TO (J&J VACCINE)-  Severe headache, intense muscle and joint pain, widespread intense pain, nerve and arthritis pain exacerbated to very high levels. Nothing would help the pain. No fever, no nausea or vomiting,
severe headache severe fatigue severe loss of appetite (did not eat anything for 3 days) nausea (2 days) and vomiting (1 day) mild pain at site of injection
Headache; tiredness; chills without fever; Soreness at injection site; This is a spontaneous report from a contactable consumer or other non hcp.  A 40-years-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 18Feb2021 09:15 (Batch/Lot Number: EL3247) as dose 2, single dose for covid-19 immunisation.  Medical history included covid-19 from Nov2020. There were no concomitant medications. The patient had not known allergies. The patient did not receive any other vaccine in four weeks. Prior to vaccination patient was not diagnosed with COVID. Post vaccination patient did not test for COVID On 18Feb2021 18:00 the patient experienced, Headache, tiredness, and chills without fever, Soreness at injection site with outcome of recovered. No treatment was received.  Follow-up (26Feb2021): This is a follow-up spontaneous report received in response to the mail trail sent regarding the confirmation of Pfizer receipt date (PRD). reported information included.  No follow-up attempts are possible. No further information is expected.
I had low-grade fever for over a week.  I had serve cough that I could not get rid of.  On Aug 31st, I tested positive for COVID-19.
07/29/2005 - Informed by patient's wife on 07/27/2005 that patient started to seem like he was going to pass out at 04:30PM and that he was nauseated.  Patient's blood pressure was 180/100 at 04:30PM with pulse of 50.  States his normal blood pressure is 135/78 and normal heart rate is 62.  He states his respiratory rate was closest to 18.  States he had to take a deep breath ever 1-2 minutes (he called it shortness of breath) although denied hoarseness or wheezing or any other respiratory difficulties.  Reported decreased appetite with nausea and no emesis.  Reports dizziness and weakness and when he developed tightness in his chest at 9PM he went to the ER where he received nitro tabs and the pain went away, per his report.  States his temperature was 96 orally at 04:30pm and eventually went up to 97 before going to the ER.  He lost about 20 pounds lately through calorie reduction and noticed he had gone from 208-213 in the few days prior to Hepatitis B Booster 1 which was given on 07/27/2005 at 08:00AM.  On 07/27/2005 at 03:00AM he awoke to void, and woke up 2 more times that night and voided, per his estimation.  Wife states patient was also sensitive to sound on evening of 07/27/2005.  Patient reports his blood pressure and pulse were improving.
Numbness and tingling immediately in face and fingers.  Could not swallow.  Dizzy, off balance.  Flushing.  Pulse in 70s and BP was 150/86.  Transferred to the ED.
1 bout of Violent diarrhea that occurred on 4/9/21 or 4/10/21- passed out on the bed after the episode, exhausted.  Nausea followed the diarrhea. Comes and goes. Still happening. Experienced heart palpitations at night on 4/12/2021, never experienced before. Got EKG the next day- normal. Back ache began on 4/15/21 to 4/16/21. Not experienced this before. The ache comes and goes. Fatigue and weakness in the whole body. Comes and goes. Better after food.
pt recvd flu vax 25OCT93 & 27OCT93 exp redness & pain @ the inject site w/a 3.5cm area of burning which was hot to the touch; pt was seen by MD & given Keflex & APAP;
Three days after the second vaccination I woke up with very bad tinnitus. I tried to ignore it, but a few days after that the pressure in my ears hurt so bad that I had to go to an urgent care. I thought that I might have an ear infection. She looked in my ears and saw fluid in one ear, but said that they didn't look infected. This was almost 2 weeks ago. The ringing in my ears is non-stop and louder than ever since then.
fluzone HD was given to a 2 year old patient, no AE; fluzone HD was given to a 2 year old patient, no AE; Initial information received on 22-Oct-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 2 years old patient who experienced a dose of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (lot number, expiry date, route and site of administration were not reported) on an unknown date.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error due to inappropriate age at vaccine administration and overdose.  At the time of reporting, no adverse event not reported.  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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on batch number is requested.
In the week following the vaccination the patient had symptoms of diarrhea and stomach pain which she related to the virus known to be in the region.  On the above noted date (today) she woke to a whole body rash with a heaver concentration on the arms, neck and chest. Patient referred to her PCP for follow-up with recommendation to have CBC and consult and referral with MD if necessary
Information has been received from a physician via a company representative concerning a patient of unknown age and gender. No relevant medical conditions were reported. On an unknown date, the patient was vaccinated with the second dose of GARDASIL intramuscularly (strength, dose, lot# and expiration date not reported) one year later than the first dose (inappropriate schedule of vaccine administration). No adverse effects were reported. Additional information is not expected since the reporting physician did not want to be contacted.
FATIGUE, SORE THROAT, VERTIGO/DIZZINESS, HEADACHE.   RESTED, DRANK FLUIDS, TOOK TYLENOL FOR 24 HOURS AFTER ONSET OF SYMPTOMS.   SYMPTOMS STARTED WITH FATIGUE AND SORE THROAT AROUND 9PM ON 11/21 (DATE OF VACCINE) AND I WOKE UP ON 11/22 WITH VERTIGO/DIZZINESS/HEADACHE AND THOUGHT I WOULD FAINT IF I TRIED TO GET OUT OF BED. SYMPTOMS RESOLVED BY THE TIME I WOKE UP ON 11/23
Struggle to maintain mental focus, intermittent but uncontrollable shaking/ body tremors,  high blood pressure, rapid heart rate that remains high even through rest and sleep, feeling of disassociation/ disconnection from what's happening around me, waves of burning sensation on skin surface mostly on face, upper back, arms, and chest, intense feelings of pins and needles in scalp, face, hands and feet, extreme fatigue
The day after face was reddened like she was hot, but was not. This continued a couple of days. Then on day 4 after shot she developed a slightly itchy red, raised bumpy rash on her chest.
just got a new kidney; This spontaneous case was reported by a consumer and describes the occurrence of RENAL DISORDER (just got a new kidney) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.   In August 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RENAL DISORDER (just got a new kidney). The patient was treated with Surgery (Kidney transplant) for Renal disorder. At the time of the report, RENAL DISORDER (just got a new kidney) outcome was unknown.            The  concomitant medications on use were not provided.  Patient received first two doses and a booster dose in August. Patient was not sure that if they received full or half dose. The nurse told patient they have second Moderna booster doses available.   Most recent FOLLOW-UP information incorporated above includes: On 07-Feb-2022: Follow-up information included no new information.
1/30/08 - 2/27/08 seen for constipation.  Diagnosis: Intussusception 12 d. post vaccine.  5/27/08-clinic records for DOS 1/15/08-C/O stuffy nose, cough. Clinic note 2/27/08-C/O constipation only 4 BMs since 1/24/08, soft pudding like forceful flatulence. Fussy. Uncomfortable. PE: Tight anal sphincter some gas after removing finger.