chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This initial spontaneous report was received on 06-OCT-2017 from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Medical history, concurrent conditions, and concomitant medications were not provided. On or about 16-APR-2008, at a physician's office, the patient was inoculated with ZOSTAVAX as recommended for routine adult health maintenance and for the prevention of shingles (dose, route of administration, site of administration and lot # were not provided). The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about (no date reported), the patient was treated at a health center/facility for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, or shingles. The patient has been prescribed valacyclovir (VALTREX) for management of her painful condition. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was not resolved. The lawyer felt the events were related to ZOSTAVAX. Additional information has been requested.
This spontaneous report was received from a back office lead and refers to a 41 year old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 24-APR-2016, the patient was vaccinated with an improperly stored dose of M-M-R II lot # L005291, expiration date: 11-FEB-2017, 0.5 ml, intramuscularly, in right deltoid (dose number was not provided). There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Non-Stop Crying, Highly Agitated, Not Able to Soothe, Pushes Away when I am usually the only one who can calm. The day he received vaccination he took a short nap after his appointment and cried pretty much non-stop from around 1:00 pm until we laid him down for bed at 9:30 pm; he only calmed down long enough to eat his dinner. Today, the day after being vaccinated, he seemed fine until around 9:30 am then cried on and off until his nap, around 12:00 pm. Then he was hysterically non-stop crying from 6:00 pm until 9:30 pm and counting. He was laid down for bed at 8:30, but he keeps cycling from sleeping to crying, which he does not usually do.
lips became numb; throat started to sound very scratchy and itchy; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in the right arm on 22Jan2021 at 16:15 (at the age of 52-years-old) as a single dose for COVID-19 immunization. Medical history included asthma, hypertension, morbid obesity, anemia, arthritis, allergic to fish (shell & fin) and all nuts. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported, but it was reported that the patient took other medications within 2 weeks of the vaccination. The patient did not receive any other vaccines within 4 weeks of the vaccination. On 22Jan2021, at 16:15 (also reported as after 15 minutes), the patient's lips became numb and the throat started to sound very scratchy and itchy. This resulted in a doctor or other healthcare professional visit. Treatment for the events included the patient taking her own diphenhydramine (BENADRYL), epinephrine (EPIPEN) and albuterol. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of lips became numb and the throat started to sound very scratchy and itchy was resolved with sequel on Jan2021.   Information on the batch/lot number has been requested.
1315 pt c/o H/A,dizziness and nausea V/S BP 170/120 p 100. Pt refused medication, pt refused EMS. Pt states this happened with first covid vaccine and she has white coat syndrome. 1325 V/S BP 186/109 p86 pt states she states she just wants to go home, pt educated on blood pressure and advised if s/s worsen to go to ED.  Pt agrees. 1330 V/S BP 187/109 p 84. Pt again refuses treatment or EMS. Pt leaves floor ambulatory with family.
Had vaccine at approximately 3:30pm on 10/31, noticed symptoms at 8:30pm: swollen lips, and at 7:00am on 11/01 woke up with hives around neck, and lips still swollen.  Hives lasted until about 9:30am.  Treated with over the counter cortisone cream in am.  No PO meds except iron supplement, and "metro lotion" for treament of rosacea - only on face.  Have had injectable flu shots the last three years with no problem.
This is a not serious case from a consumer involving sore throat and cough. The reporter causality is not reported. This case qualifies for accelerated reporting. This pt is a 43 year old female who received her first dose of FluMist on 01Nov04. She reports that by the afternoon on 01Nov04 she began feeling weird and light headed, with a low grade fever. the following morning 02Nov04 she felt congested. On 12Nov04 she experienced a low grade fever and lethargy. She reports that from 13Nov04 through 16Nov04 she had a runny nose, sore throat, coughing, throat congestion, as well as the fact that she was sleeping only two to three hours a night due to her symptoms. She started antibiotic therapy on 17No04. She lost her voice for approx 5 days from 11Nov04 until 16Nov04 but now her voice had returned and she is improving overall. No further information is available for this case. Feb 5, 2009 Additional information: Patient date of birth; Product Lot Number; Physician's Information;
Patient requested second dose of Moderna, first dose administered by a different pharmacy on 1/6/2022 (despite his age of 17). Staff decided to continue his Moderna series and administered the second Moderna dose on 3/10/2022.
Welp on (L) arm, red, itches, "aches" about the size of a quarter, but bruised right after she got it.
Patient has been fully vaccinated and contracted covid-19. She was vaccinated with Pfizer BioNTech on 1/4/21 lot EJ1685 and 1/25/21 lot EJ1686. On 3/10/21 she tested positive for COVID-19. Sample was sent to the lab test and was detected as variant B117. Her husband and 4 kids who live with her were not vaccinated and had covid.
no aditional AE; freezer underwent an excursion and they did not realize the excursion until later/temperature excursion for VARIVAX and PROQUAD/ VARIVAX and PROQUAD may have been administered to multiple patients; This spontaneous report has been received from a nurse, concerning a 4-year-old male patient. The patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies, and concomitant medications were not provided.  On 15-MAY-2023, the reporter's freezer underwent a temperature excursion; in which varicella virus vaccine live (oka/merck) (VARIVAX) and measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (rHA) were stored. On that same day, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # W035466 and W017567 with following expiration dates 06-MAY-2024 and 29-NOV-2023, 0.5 milliliter for prophylaxis (dose number and route of administration were not provided).  Other suspect therapies included varicella virus vaccine live (oka/merck) (VARIVAX) lot # U039723 and W031812   with following expirations dates 15-DEC-2023 and 05-OCT-2024, 0.5 milliliter for prophylaxis (dose number and route of administration were not provided) (product storage error and no adverse event).; Sender's Comments:  US-009507513-2306USA004082: US-009507513-2306USA004086: US-009507513-2306USA004087: US-009507513-2306USA004088: US-009507513-2306USA004089: US-009507513-2306USA004085: US-009507513-2305USA007959: US-009507513-2306USA004084: US-009507513-2306USA004083:
Muscular pain in the upper and mostly lower arm muscles of the left arm which is the arm that received the vaccine shot. Symptoms have continued to date, waxing and waning over this period. Do not recall straining or otherwise injuring left arm muscles.
prolonged muscle soreness in left arm/muscle soreness; disruption of menstrual cycle/delay in cycle start; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 25Mar2021 08:30 (Lot number: ER8737) at the age of 33 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "known allergies:Sulfa" (unspecified if ongoing), notes: known allergies:Sulfa. Concomitant medication(s) included: CLARITIN [LORATADINE]; ALEVE; OLLY WOMENS MULTIVITAMIN. The following information was reported: MYALGIA (non-serious) with onset 2021, outcome "recovered" (2021), described as "prolonged muscle soreness in left arm/muscle soreness"; MENSTRUAL DISORDER (non-serious) with onset 2021, outcome "recovered" (2021), described as "disruption of menstrual cycle/delay in cycle start". Therapeutic measures were not taken as a result of myalgia, menstrual disorder.  Additional Information: The patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any treatment for the events.  No follow-up attempts are possible. No further information is expected.
Body aches and weakness; Body aches and weakness; Really fatigued; Sore arm; Chills; This is a spontaneous report from a contactable consumer (patient). This 25-years-old female patient (no pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EH9899) on 23Dec2020 02:15 PM on Right arm for COVID-19 immunization. Medical history and concomitant drug were not reported. Past drug was known allergies with pethidine hydrochloride (DEMEROL). No other vaccine in four weeks, no other medications in two weeks. It was reported that patient experienced really fatigued, sore arm, chills and slight body aches and weakness (all reported as non-serious) on 23Dec2020 08:00 PM with outcome was Recovered in an unspecific date in Dec2020. No treatment. No COVID prior vaccination. No COVID tested post vaccination. Prior to vaccination no diagnosed with COVID-19.  No follow-up attempts are possible. No further information expected.
I experienced a loss of breast milk production.  Before the vaccine my production was 16 oz a day, after the vaccine my production wasn't over 7 oz. When I went back for the booster on 12/23/2021 I lost the remainder of my breast milk production.  Was not able to express any breast milk after the booster.  I also have a hard lump at the injection site that has not gone away.
Onset of swelling in neck. Reported via phone that he has 2 lumps that began yesterday. He also said he started experiencing an allergic rash on his back. Advised to seek medical care.
swelling; pain; redness; This case was reported by a consumer via call center representative and described the occurrence of extensive swelling of vaccinated limb in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced extensive swelling of vaccinated limb, pain in arm and erythema of extremities. On an unknown date, the outcome of the extensive swelling of vaccinated limb, pain in arm and erythema of extremities were unknown.   It was unknown if the reporter considered the extensive swelling of vaccinated limb, pain in arm and erythema of extremities to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient had pain, swelling and redness of the injected arm from elbow to shoulder. No additional information was available. The reporter did not consent to follow up. This case has been linked with case US2019230500 and US2019230505, reported by the same reporter.
Date and time the vial was initially stored in the refrigerator on 25Feb2022 and date administered on 06 Apr 2022; Dose administered after 30-day Use by Date or after manufacturer date of expiry; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Date and time the vial was initially stored in the refrigerator on 25Feb2022 and date administered on 06 Apr 2022) and EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use by Date or after manufacturer date of expiry) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Ceftin allergy), Drug allergy (Losartan allergy), Drug allergy (Potassium allergy) and Hepatitis C. Concomitant products included VARENICLINE TARTRATE (CHANTIX), COLECALCIFEROL (VIT D3), METHIMAZOLE, AMLODIPINE and PRAVASTATIN SODIUM for an unknown indication.    On 06-Apr-2022 at 9:32 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2022 at 9:32 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use by Date or after manufacturer date of expiry). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Date and time the vial was initially stored in the refrigerator on 25Feb2022 and date administered on 06 Apr 2022). At the time of the report, PRODUCT STORAGE ERROR (Date and time the vial was initially stored in the refrigerator on 25Feb2022 and date administered on 06 Apr 2022) and EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use by Date or after manufacturer date of expiry) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, COVID-19: not tested covid positive within last month (Negative) not tested Covid positive within last month.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient had not tested positive for COVID  within last month. The expiration date was 25-Mar-2022. Date and time the vial was initially stored in the refrigerator on 25-Feb-2022. Vial didn't undergo any temperature excursions. It was reported that the patient did not experienced any side effects yet. No treatment medication information provided
Patient experienced loss of hearing, & complete loss of vision within 5 minutes of receiving shot. Lasted for about 15 min for vision, hearing returned a bit later. Patient's mom called ambulance, hearing & vision returned before ambulance arrived. Reported to immunization RPh 9/30/10, but nothing was documented or filed. Patient said vision started getting darker & darker until everything was black. Hearing loss was not complete, but it was quite severe. Patient was driving home from the pharmacy at the time of hearing & vision loss. Patient did not take the ambulance to any facility nor did she follow up with her physician about the issue. She did call the pharmacy an reported to the immunization pharmacist that she had experienced this & he told her not to worry about it, that nobody has had problems with the vaccine this year.
pt recvd vax; 8aug95 broke out in an unlocalized rash;
Subsequent to receiving vax, the pt experienced a seizure. As of 01/09/2001, no further information was available.  The reporter declined to provide additional information and declined to grant permission for follow-up investigation.
Severe pain in arm and shoulder, particularly in underside muscle of arm that was administered shot. Neither Ibuprofen nor Naproxen are helping, arm is barely usable and sometimes causes disruption and difficulty performing tasks in daily life.
pt recvd vax; fever of 105; grand mal sz p/ a period of irritability; mom states child had diff walking prior to sz; to hosp;
Mild headache; Nausea; mild aches throughout most of my body; This is a spontaneous report from a non-contactable consumer (patient).   A 30-year-old male patient received BNT162B2 (PFIZER-BIOTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EL3247) via an unspecified route of administration, administered in Arm Left on 19Feb2021 14:00 (at the age of 30 years old) as dose 2, single for COVID-19 immunisation. The patient's medical history reported as none and concomitant medications were not reported. No known allergies. The patient previously received BNT162B2 (Batch/Lot number: EL3247) administered in arm left on 29Jan2021 14:00 (at the age of 30 years old) as dose 1, single for COVID-19 immunisation. On 20Feb2021 08:00, the patient experienced mild headache, nausea, and mild aches throughout most of body, no fever (as reported). The facility type vaccine was reported as other. Patient had no other vaccine in four weeks. Patient had no COVID prior vaccination and not COVID tested post vaccination. . There was no treatment for adverse events. The outcome of the events was recovering.   No follow-up attempts are possible. No further information is expected.
In the evening on the day of the vaccine and the following day my arm was sore and then my entire body.  Body was so sore that I had to take med to sleep.  It is early Friday morning now and I have been so tired and hurting that I have slept most of the week (4 days).   I don't often take immunizations as they kick in my rheumatic/psoriatic arthritis so badly and I hurt so badly and can't do anything. I was hoping that this immunization would be different as it's action is supposed to be different.  I am still planning on getting the second shot as it is so important:especially due to my age and other conditions.
At 15:10 providers were alerted to situation by wife.  Pt. had loss of consciousness.  Pt was pale, cool, diaphoretic.  He was rousable to stimulation.  Pt has HR of 48, O2 of 80, He had respirations of 8 with his head lolling on his shoulder, and his mouth open and deep breaths.  A&O was 2  times person and place.  With prompting from the paramedic on scene he was able to rouse himself.  Upon second assessment at 15:19 he stated he had blurry vision, and  was  A&O x4.   BP was 130/90, O2 90, HR 96.  Paramedics were called to scene where they were able to asses BS at 113.  Hx from wife Pt diagnosed in 1996 with Diabetes II.  He is chronically untreated, and has not seen any MD since 2006.  Pt. does not use a BS test kit, and will not check his own sugar.  He goes by a "feeling" which he uses to tell him when to eat or not.  Per wife pt often appears pale, cool, and diaphoretic.  They recommended pt be transported by ambulance to ED to be assessed by physician.  Pt. refused and signed out AMA.  Paramedics departed scene without pt. 15:40.  Paramedics  recommended pt stay and be monitored for 15 minutes.  Pt.departed scene at 1550.  Pt. departed scene AMA.  All providers on scene recommended pt. see a specialist for his chronically untreated diabetes.
Skin Rash, itch,inching, haves 12/20/2020 Skin rash, itching, haves 12/26/2020
Administrator attempted to give shot and had a problem saying, "Something's wrong."  Gave another shot in same arm (Lot#33CG3). Arm was sore as expected for a day or so, but then did not get better. Arm pain continues currently and is impeding use of right arm and sleep.
local rxn @ site of inj extending mid arm, swelling, warm w/good capillary recoil;minimal tenderness;pt described numbness @ fingertip;
This is a spontaneous report from a contactable physician via Pfizer Colleague. An infant patient of an unspecified gender received three doses of PREVNAR 13, all on an unspecified date at single dose. The patient medical history and concomitant medications were not reported. Although the patient received 3 doses of vaccine, there was no response as titers were 0. The outcome of the event was unknown. The physician asked about process for revaccinating. Follow-up (19Jul2013): Follow-up attempts completed. No further information expected.
SHOT ON FRIDAY. SWEATING, CHILLS THE FOLLOWING DAY.  NAUSEA AND VOMITING, BAD STOMACH CRAMPS 3 DAYS LATER ON MONDAY
Patient presented to clinic for booster dose of Moderna vaccine. Patient successfully vaccinated. Post waiting period patient reports itchiness, numbness and swelling in her tongue and upper lip. Rapid Response activated. Patient denies difficulty breathing, respiratory distress or any other symptoms. Patient is otherwise stable and oriented to person, place, and time. Provider Dr notified and assessment complete. 1:30 vitals 124/80 HR 63. 02 98%. Patient reports that she can feel her tongue. Vitals at 1:37pm. BP 147/90 HR 62. 02 98% (elevated by reading most likely due to patient talking and moving during this reading). Vitals at 1:52pm 125/80. HR 60. 02 95%. Temp 97.9. Patient reports resolution of itchiness stating "I just feel a little itchy on my back and no where else". Patients resolution of symptoms is reassuring. Hx: Patient experienced same symptoms after her 1 dose of Moderna vaccine in January. Per patient symptoms lasted 3 days. 2nd dose in Feb no adverse symptoms, Booster dose today symptomatic. Patient is stable at this time.  Walking, talking, and laughed with RN. Ok for discharge at this time per provider. Patient released to her son who will take her home and monitor. Patient excused for X2 days from work due to return 12/22/2021. Son and patient advised If itchiness/swelling persist patient can take OTC Benadryl. If symptoms worsen or patient develops difficulty breathing or respiratory distress to head straight to the ER. Son and patient verbalized understanding. No other questions or concerns.
On 9/28/2021 mild headache at 3:30pm, balance wobbly, extreme headache, muscle aches all over body at 7:30pm;, and fever at 11pm. On 9/29/2021 extreme body aches, 102 fever all night, hot flashes, night sweats then chills, and very cold. Bad headache and balance wobbly. Did not sleep much since my body ached so bad, even my toe nails hurt.  On 9/30/2021 morning felt 95% better with just a touch of wobbly balance and light headedness, but continued to improve throughout the day.  The night of 9/30 I had a horrible nightmare about losing my grandson. Hardly ever do I have nightmares.
This case was reported by a healthcare professional and described the occurrence of vaccine exposure during pregnancy in a 15-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline) while pregnant. Concurrent medications included Prenatal vitamins. On 18 November 2008 at 10:15 the subject received a dose of BOOSTRIX at 0.5 ml in the left arm. This was considered to be a case of vaccine exposure during pregnancy. The subjects due date was reported as 20 March 2009. No adverse events were reported. Follow-up information was received on 22 December 2008, via healthcare professional who reported the subject possesses the sickle cell trait. She also received an Influenza vaccine on 05 November 2008. The subject's last menstrual period occurred on 13 June 2008. Follow-up received on 26 May 2009: On 06 March 2009, the subject gave birth to a healthy male neonate of 38 weeks gestation via normal vaginal delivery. The neonate had weight of 3280 grams and Apgar score of 8 at 1 minute and 9 at 5 minutes. Follow-up information was received on 10 August 2009 from the reporting nurse midwife. Date of birth of the baby was reported as 07 March 2009. The fetal/neonatal status was reported as normal. The infant was reported to be healthy. The method of delivery was spontaneous vaginal. Chorioamnionitis was reported. Please see A0758632B for the baby case.
pain at injection site Narrative: day 2 to day 3 after first dose had pain at injection site
I received the Moderna vaccine and had no problems until 01/03/2021, (6 days post injection).  All of a sudden I started itching constantly at the injection site and now it is swollen, red and itching.