chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Maternal exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) in a 36-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     The patient's past medical history included Alcohol use. Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) from 06-Jan-2021 to an unknown date and VITAMIN D NOS from 06-Jan-2021 to an unknown date for an unknown indication.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 19-Aug-2020 and the estimated date of delivery was 04-Jun-2021. On 24-Mar-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirty-first week of the pregnancy. The vaginal delivery occurred on 01-Jun-2021, which was reported as Full-term. For neonate 1, the birth weight was 3500 grams (7lbs 11oz). The outcome was reported as Delivered NOS. length of the baby (male) was 50 cm. On 24-Mar-2021, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Sep-2020, Pregnancy test: positive (Positive) Positive. On 15-Feb-2021, Ultrasound scan: normal (normal) Normal. On 17-Mar-2021, Glucose tolerance test normal: normal (normal) normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Previous pregnancy end date was 30 Jan 2018 and outcome was live birth. On 03 Mar 2021, Chorionic villus sampling (CVS) was performed and results were normal.   This case was linked to MOD-2021-266107 (Parent-Child Link).   See case MOD-2021-266107 for details regarding the child case.  Most recent FOLLOW-UP information incorporated above includes: On 23-Jul-2021: Follow up received contains- Pregnancy outcome update
This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. Information about medical history or concurrent conditions was not provided. On 17-JUL-2014 the patient was vaccinated with an incorrect stored dose of GARDASIL 0.5 ml, intramuscular injection (frequency, lot number and expiration date were not provided), which had underwent a temperature excursion. Concomitant medications were not reported. No adverse effect was reported and there was no product quality complaint involved. This is one of several reports received from the same source. Additional information has been requested.
Developed hives covering neck and torso; This is a spontaneous report from a contactable consumer, the patient. A 64-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EWO150) via an unspecified route of administration in the left arm on 05Apr2021 at 12:45 (at the age of 64-years-old), as a single dose for COVID-19 immunisation. Medical history was reported as none. Concomitant medications included second dose of varicella zoster vaccine (MANUFACTURER UNKNOWN) in the left arm for immunisation on 22Mar2021 and simvastatin (MANUFACTURER UNKNOWN), fexofenadine hydrochloride (ALLEGRA), vitamin d nos (VITAMIN D), zinc (MANUFACTURER UNKNOWN) and ascorbic acid (VITAMIN C); all for unspecified indication from unknown date.  Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient had no allergies to medications, food and other products. On 11Apr2021 at 12:00, the patient developed hives covering neck and torso five days following COVID vaccine. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of event, which included treatment with prednisone. The clinical outcome of the event developed hives covering neck and torso was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
This is an initial spontaneous report by a contactable consumer. This female consumer reported for her currently 19 month old son who received PREVNAR 13 intramuscular injection on an unknown site on an unknown date. Relevant medical history was none. Relevant concomitant medications were none. Vaccines given on the same day were unknown. Vaccines taken within the last four weeks were unknown. In 2011 after PREVNAR 13 vaccine the patient had an allergic reaction and hives all over the body. Relevant lab data was unknown. At the time of the report he had recovered from the events on an unknown date. Follow-up (18MAY2012) Follow-up attempts completed. No further information expected.
Got dose 2 on 04/16/2021 and had soreness at the injection site for several days, Not much else initially - Headache and fatigue on day 1&2 and a few sparse and self resolving episodes of ringing in ears in the weeks that followed and the occasional light headache or itching sensation at the site of the injection.  Woke up on 05/16/2021 with persistent high pitched tinnitus have seen an urgent care doc and ENT and Audiologist since all to no avail or relief. The condition persists and may be permanent at this point they don't know.
On 8/25 patient (26 weeks pregnant) developed sudden premature rupture of membrane.  Patient was admitted to hospital and underwent emergent C section on 9/6, delivering a baby at 28 weeks.  Patient had at least 2 prior pregnancy and delivery and she said her baby was always term.  She developed chorioamnionitis and septic shock, requiring ICU admission.  Patient was discharged to home on 9/11.
Was playing golf after received VARIVAX- at 11:45 am-started breaking out in hives -> face-was getting worse- eyes. Watery etc- Did not eat anything new- Severe allergy to bee stings, peanuts and eggs gave 50 mg BENADRYL @ 4:11 pm. Carries Epi Pen
Muscle aches. Intense at night, then lessening and continuing for 24+ hours Fever Chills  Aches Diarrhea Nausea Fatigue Loss of appetite Chest pain for 5 min following day
Information regarding Prevnar (pneumococcal 7 valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a consumer regarding a 6 month old male patient who experienced difficulty sleeping and upset stomach. At 6 months of age, the patient received a dose on 26-SEP-2003. The patient also received a dose of haemophilus b vaccine (manufacturer unknown), a dose of DPT (manufacturer unknown) (diptheria and tetanus toxoids and pertussis) and a dose of Hepatitis B Vaccine (manufacturer unknown) on 26-SEP-20003.  The patient experienced sleeping difficulty (insomnia) and upset stomach (dyspepsia) on 26-SEP-2003. See related case: HQWYE975502OCT03 (adverse event, non-expedited). No additional information was available at the time of this report.
pt recv vax  & would not bear weight on rt leg;there were no local changes;pt in pain;pt irritability from DTP;
Cold Sores on lips within 24 hours of vaccination, generalized arthralgia, elevated temperature, general ill feeling 3-4 days post vaccination, raised rash on right shoulder 7 days post vaccination.
Nausea-stomach upset, with inclination to vomit-very severe diarrhea for a week. I took Promethazine  for nausea, Imodium AD for one week until the nausea and diarrhea stopped.
pt recv vax & pt exp sx of muscle weakness, tingling & diff walking;sx lasted about 1wk w/no lasting effects;
Seven hours after receiving the shot, I started to have severe chills. This carried on for about three hours. During the night, I started to have a fever. The highest I measured the fever was at 101.  Into the next day, the fever lingered and I was sore. I had a headache that had extreme sinus pressure by my temples. Into the second day  and there are no signs of a fever or chills, but there is a light headache.
Client got Pfizer COVID vaccine at 1405, started feeling light headed, dizzy, and sweaty with a rapid pulse at around 1410. Client was unresponsive and out of it like he passed out for a few seconds and came out of it and was coherent and responsive again. Client was safe, with three EMTs and lead nurse alongside him. Vital signs taken at 1414, BP 138/88, O2 99%, and P 80. Client started feeling better, no longer sweaty or dizzy at around 1415. Client informed healthcare staff that he had not eaten or had any water since 0800. Vital signs taken again 1425, BP 140/90, O2 100%, and P 72. Client was stabilized and ambulated out of the facility and driven home by his mother at 1430.
Dizziness, Headache, Myalgia, Arthralgia, Fever, Rash, UrticariaPruritus, Diarrhea, NauseaVomiting warm sensation all over, Narrative:  Advised employee to call PMD especially if symptoms progress. Given ice pack, placed in left arm.  Other Relevant History:
Itching, redness, pain, and swelling at the injection site, loss of appetite, body aches, chills
Pt broke out in large whelps on back of legs, arms, back, buttocks as well as injection site---pt took Benadryl but did not help. Went to ER on 9/19/15 pt received prednisone and vistaril which helped.
45 minutes after injection the left side of my face became numb to half of my tongue  BP was higher than normal 177/97! Numbness lasted about 45 minutes!  BP was back to normal the next morning! 2/9/2021
Within hours I got a very sore throat, swollen glands in my throat and my tongue turned white with a crack down the middle that was bright red.  It got worse through the next day, stayed the same, and then began to dissipate.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Shakiness-Mild
Rash on her face got really bad; Whole face swelling; Redness on her whole face after the second dose; Itching on her whole face after the second dose; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (Whole face swelling), ERYTHEMA (Redness on her whole face after the second dose), PRURITUS (Itching on her whole face after the second dose) and RASH (Rash on her face got really bad) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Allergic to Benadryl).   On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Mar-2021, the patient experienced SWELLING FACE (Whole face swelling), ERYTHEMA (Redness on her whole face after the second dose) and PRURITUS (Itching on her whole face after the second dose). On 20-Mar-2021, the patient experienced RASH (Rash on her face got really bad). At the time of the report, SWELLING FACE (Whole face swelling), ERYTHEMA (Redness on her whole face after the second dose), PRURITUS (Itching on her whole face after the second dose) and RASH (Rash on her face got really bad) outcome was unknown.            This case was linked to MOD-2021-056203 (Patient Link).
Pt was given Pentacel and unfortunately, it was found later to have been an expired dose. After contacting the state, it was recommended the vaccine be re-administered. Mom was made aware at the time of the visit. We will re-administer when a dose is available.
she knows 3 other people with the same symptoms/ all over body pain; shoulders were really painful; hardly lift arms up; legs were like lost mobility; inflammation; This is a spontaneous report from a contactable consumer, reporting same events under the same suspect product for 4 patients. This is second of the 4 reports. A patient of an unknown age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, lot number: not provided, expiry date: not provided), via an unknown route of administration on an unknown date as dose number unknown, single for COVID-19 immunization. The patient's medical history and concomitant medication were not reported. Reporter stated that she knew 3 other people (patient) with the same symptom, all over body pain, shoulders were really painful, hardly lift arms up, legs were like lost mobility and inflammation on an unspecified date. The clinical outcome for events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101182532 same reporter/drug/event, different patient
missed the second dose of the Moderna COVID-19 vaccine; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue) and PRODUCT DOSE OMISSION ISSUE (missed the second dose of the Moderna COVID-19 vaccine) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced FATIGUE (fatigue). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (missed the second dose of the Moderna COVID-19 vaccine). At the time of the report, FATIGUE (fatigue) and PRODUCT DOSE OMISSION ISSUE (missed the second dose of the Moderna COVID-19 vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient missed the second dose vaccine. The patient reported those symptoms seemed to gone away and did not take any medication to try alleviate the symptom.  The patient had  second dose scheduled on 18 jun2021.   Concomitant medications were not provided. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jun-2021: Follow-up information received on 15/Jun/2021: processed with initial report, reporter's email address added.
This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. It was reported that, on 30-MAY-2017, the patient was vaccinated with an improperly stored dose of GARDASIL 9 "single dose", intramuscularly, lot # M035486 with expiration date of 05-JUN-2019, for prophylaxis (anatomical location and frequency were not reported). No adverse effects were reported. It was stated that the vaccine underwent a temperature excursion of 32 to 35 degrees Fahrenheit for 12 hours 29 minutes (supported). No previous temperature excursion was performed. The call was because of a "data logger". Additional information is not expected because there is no consent to contact the reporter.
Diarrhea, "very bad" headache (similar to a migraine headache), aching, feeling very cold.
8/2/2022 Started around 5 PM with crankiness and crying .  Then fever to 101 F temporal.  Then had very large watery foul-smelling diarrhea; no blood.  He vomited the 9 PM feed and all other feeds after that.  He tolerated sips of water.  Urine became concentrated. 8/3/2022 at  10 AM had another smaller watery foul-smelling diarrhea; no blood.   Tolerated oral Pedialyte 8/3/2022 at 11:55 AM.
Received vaccine 3PM.  3AM woke with raging Tinnitus.  I have had Tinnitus for many year but this spike is overwhelming and extremely loud.  There are no treatments.  May not return for second shot if Tinnitus does not calm down.  Will not risk Tinnitus spike with second shot as this could be permanent damage.
About 24 hours after the injection, I had a 102 fever, headache, extreme fatigue, chills and pain with swelling at the injection site. Most symptoms lasted about a day and a half, but the pain at the injection site lasted about 3 days.
at 6 am this morning I felt that the muscle on my left arm on the injection site is twitching and it continues to twitch off and on up to the time I am writing this note at 2:20 pm
Pt reported that arm (left) was sore the evening of vaccine, woke up in the morning, arm at site of vaccine was warm, red, and severely swollen. Pt went to clinic; received diphenhydramine injection and Prednisone taper.
Immediate arm pain that got worse by the hour - extreme pain peaking at 12 hours post injection in which I couldn't even move my arm.  Pain was excruciating -like no other vaccine injection pain I've ever experienced.   24 hours of flu like symptoms, followed by a severe headache for 7 days.
not received 2nd dose yet; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 31st October 2022).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: not received 2nd dose yet). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 29-JUN-2023 The reporter reported that patient got 1st dose of Shingrix on 31st October 2022 and never got the 2nd dose which led to incomplete course of vaccination. The reporter wanted to know if the patient needed to be revaccinated. The reporter consented to follow up via phone or fax.
This individual called and stated she received this first Pfizer vaccine at the facility where she worked. About two months after receiving this vaccine she noticed tingling in her left hand, feels like it fell asleep. She received her second Pfizer vaccine in her right arm on 1/12/21, same lot number and again in about two months stated she starting having tingling in her right hand as well. She also has swollen lymph nodes in right arm pit. Currently both hands feel tingly and occasional feel like they have fallen asleep. Denies any other lingering side effects. States at the time of vaccination she had a tender arm(s) after injection and then nothing  until the tingling showed about two months after each injection.
After the first Covid 19 vaccine, caller reports the tired feeling lasted a few days; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 84-year-old patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 06Mar2021 (Lot number: EN6202, Expiration Date: 30Jun2021) at the age of 84 years as dose 1, single for covid-19 immunization.   Relevant medical history included: "high blood pressure" (ongoing), notes: Verbatim: high blood pressure. Concomitant medication(s) included: AMLODIPINE taken for blood pressure measurement.  The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "After the first Covid 19 vaccine, caller reports the tired feeling lasted a few days".  Additional information: No investigation assessment was done. Caller realized there may be a connection between the Covid 19 vaccine and having higher than normal blood pressure. Caller felt tired the next day after the Covid 19 vaccine and it lasted 6 days or so. With the tiredness she also had high blood pressure. Caller had an Amron blood pressure machine at home. No emergency room visit was required. Prior Vaccinations (within 4 weeks) If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s) were reported as none.  regarding Amlodipine on 08Apr2021 at 12:36:11 PM. Call went to voicemail, no message left. ININ: 2013720874. Second attempt made at 12:40:35 PM and was answered but no voice contact made. ININ: 2013721044. Description of complaint: NOT THE SUSPECT PRODUCT. Amlodipine provided as her blood pressure medication and caller stated it didn't help much, didn't bring the numbers down much, when asked for treatment for the increase in blood pressure after getting the COVID vaccine. Stated during the call this is her only medication. Outbound call made in QR in an attempt to obtain Lot for the PC regarding Amlodipine on 08Apr2021 at 12:36:11 PM. Call went to voicemail, no message left. ININ: 2013720874. Second attempt made at 12:40:35 PM and was answered but no voice contact made. ININ: 2013721044.  Product strength and count size dispensed: 2.5 once a day Additional lot numbers: not available
COVID - 19 Moderna Vaccine was given at age 16.  No adverse events noted.  Boost dose given on 4/22/21.  Parent aware.
Allergic reaction, approx 8 hrs post vaccine; This is a spontaneous report from a contactable consumer. A 24-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 19Mar2021 (Batch/Lot Number: EN6207) as 1st dose, single, at the age of 24-years-old for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. The patient experienced allergic reaction, approximately 8 hours post vaccine on Mar2021. The event resulted in emergency room/department or urgent care visit. Benadryl was given as treatment. Prior to vaccination, was the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the event was recovered. The event was reported as non-serious.
This spontaneous report as received from a pharmacist referring to a 17 year old female patient. Patient's concurrent conditions and medical history were not provided. On 31-DEC-2008, the patient was vaccinated with the first dose of GARDASIL (dose, lot #, expiration date and route were not reported). Three months later on 03-APR-2009, second dose of GARDASIL (dose, lot #, expiration date and route were not reported), and the third dose of GARDASIL (dose, lot #, expiration date and route were not reported) was administered on 01-JUN-2009, two months after. The patient had not reported or demonstrated an adverse experience, subsequently the vaccine administration. It was unknown if the patient sought medical attention. Additional information has been requested.
Mother of patient called clinic on 6/13 to report patient was experiencing congestion and rash
48 hrs after receiving COVID Booster and Seasonal Flu Vaccine in left deltoid, pt develop painful swollen left arm, rash on palms of hands, sore throat and lip swelling. Blister covering vaccination site developed the following day.
No additional AE details.; Inbound call from HBP who stated PNEUMOVAX 23 was inadvertently administered after a non-supported temp excursion. No additional AE details or PQC. Names of vaccines involved (including lot/exp) PNEUMOVAX 23 U022819 01/14/2023; This spontaneous report was received from an office manager referring to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies or concomitant therapies was provided.   On 11-APR-2022, the patient was inadvertently administered pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (lot #U022819, expiration date: 14-JAN-2023, strength, dose and route of administration were not provided) for prophylaxis after a non-supported temperature excursion (Incorrect product storage).   The vaccine involved was stored at 7 degrees Fahrenheit (F) for 96 hours. There was no previous temperature excursion reported. No additional adverse event.