chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Ciprofloxacin allergy).    On 31-Jan-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-Dec-2020 and the estimated date of delivery was 29-Sep-2021. On 31-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  sixth week of the pregnancy. The vaginal delivery occurred on 30-Sep-2021, which was reported as Full-term. For neonate 1, the birth weight was 3000 grams (6lbs 10oz) with an APGAR score of 9 at 5 minutes. The outcome was reported as Delivered NOS. Fetus/infant details, week of gestation 40, weight 3 Kg, length 48 cm, head circumference unknown, APGAR score at 1 min unknown and APGAR score at 5 min was 9. The patient was treated with MULTIVITAMINS [VITAMINS NOS] at an unspecified dose and frequency. On 31-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Jan-2021, Pregnancy test: positive (Positive) Positive.     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.   No concomitant medications reported.  CC: This case concerns a 37-year-old, female patient with no relevant medical history, who experienced the non-serious unexpected event of Maternal exposure during pregnancy. The patient received the first dose of vaccine at 6 weeks of gestation. The patient did not have any issues during pregnancy, had vaginal delivery full term and neonate had good APGAR scores. The benefit-risk relationship of Spikevax in not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 12-Oct-2021: Significant Follow-up received on 12-Oct-2021 includes reporter details, patient details and pregnancy information.; Sender's Comments: This case concerns a 37-year-old, female patient with no relevant medical history, who experienced the non-serious unexpected event of Maternal exposure during pregnancy. The patient received the first dose of vaccine at 6 weeks of gestation. The patient did not have any issues during pregnancy, had vaginal delivery full term and neonate had good APGAR scores. The benefit-risk relationship of Spikevax in not affected by this report.
Taken to ER about 11pm due to sx of 102 temp, listless, very warm skin, very red rash starting at abd and spreading to entire body. Mom states "pimple like not hives." Given Benadryl injection discharged after 5hrs with fading rash and gone in am. ER phys noted some wheezing.
This spontaneous report was received from a nurse practitioner via medical records and refers to an 18 year old male patient. On 24-AUG-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (lot # M011117, expiration date: 07-DEC-2017; dose and route were not provided). The vaccine underwent a temperature excursion of 29.7 degrees Fahrenheit for 5 hours, which was detected by a data logger. There was also previous temperature excursion, but more details were not available. No adverse effects were reported. All available medical records will be provided upon request. This is one of several reports received from the same source. Additional information is not expected as all follow up information was received. Sender's Comments: US-009507513-1609USA007391: US-009507513-1610USA002333: US-009507513-1610USA002334: US-009507513-1612USA003507: US-009507513-1612USA003508: US-009507513-1612USA003509.
persistent unconsolable crying in the evening p/shot this lasted for about 4hrs off & on;also had a t100;exp sz like episodes of throwing arms, legs & head;then became very sleepy p/crying episodes, couldn't be aroused
Diagnosed with Shingles on 3/20. Symptoms started 3/14. Treated with Valacyclovir.
This spontaneous report as received from a medical assistant refers to a male patient of unknown age. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 02-AUG-2016, the patient was vaccinated with his first dose of improperly stored VARIVAX lot # L046884, expiration date 23-NOV-2017, 0.5 ml, subcutaneous. There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 23.9 degrees Fahrenheit for 1 hour and 25 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.
Hands Hurt; Swollen Hands/Arms itching, swollen, and red; hives are under his chest, groin, and all over now, but not on his face; itching on his hands like crazy, like he wanted to take his skin off; Arms itching, swollen, and red; This is a spontaneous report from a contactable consumer. A 51-years-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Lot Number and expiry date was not reported) via an unspecified route of administration on 23Apr2021 as a single dose for covid-19 immunisation. Medical history included ongoing splenectomy which was continuing. The patient's concomitant medications were not reported. Historical vaccine included BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection) on 02APR2021 for covid-19 immunisation. On 29Apr2021 20:00 patient experienced swollen hands with, hives are under his chest, groin, and all over now, but not on his face, itching on his hands like crazy, like he wanted to take his skin off, hands hurt, arms itching, swollen, and red, arms itching, swollen, and red, arms itching, swollen, and red. Therapeutic measures were taken(Benadryl three times a day) as a result of swollen hands, hives are under his chest, groin, and all over now, but not on his face, itching on his hands like crazy, like he wanted to take his skin off, hands hurt, arms itching, swollen, and red, arms itching, swollen, and red , arms itching, swollen, and red. Patient did not visited emergency room/physician office due to events. Outcome of the events was recovering.    Information on the lot/batch number has been requested.   Follow-up (21Jun2021): Follow-up attempts completed. No further information expected.
This spontaneous report as received from a pharmacist refers to a 61 year old male patient. The patient had no any pertinent medical history, concurrent conditions and no known drug reactions/allergies. On 06-APR-2015, the patient was vaccinated with a dose of ZOSTAVAX, 0.65 ml subcutaneously, lot # K018173 and expiry date in January 2016. Co-suspect therapies or concomitant medications were not provided. It was reported that on 09-APR-2015, the patient's wife contacted the pharmacist and stated that patient complained of swelling and pain at injection site. The pharmacist stated that no treatment was given to patient up to this point. The wife was considering contacting the physician. No laboratory diagnostic test was performed. At the time of the report, the patient had not recovered from adverse events. The relatedness between the vaccine and the events were not provided. Additional information has been requested.
now have shingles/ dealing with shingles right now; Suspected vaccination failure/ now have shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. In JUL-2023, less than 2 years after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure/ now have shingles) (serious criteria GSK medically significant). On an unknown date, the patient experienced shingles (Verbatim: now have shingles/ dealing with shingles right now). The outcome of the vaccination failure was unknown and the outcome of the shingles was not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 23-JUL-2023 The case was received from the patient via interactive digital media. The patient have had the shots one year ago and was dealing with shingles right now. The patient stated that they told him that they only help 50 percent (only 50 percent works from the shots) . The patient stated good luck. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting.
04/19/2021 at 8:00am woke up with a very bad headache. Temperature of 101.2. Sat in dark room with ice bag on head and use of tylenol. Drank soda and sat quietly. 04/20/2021 7:30 am. Headache gone with fever. Left arm is now very swollen. Hot to touch. Itchy. Achy. And about a 4? wide rash band on my left arm near crease/ elbow. 4-29/2021 rash is still slightly visible but fading. No heat emitting from it.
This case was reported by a consumer via call center representative and described the occurrence of joint pain in a 59-year-old male patient who received SHINGRIX. Concurrent medical conditions included ophthalmic herpes simplex. Concomitant products included VALTREX. On 30th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 30th April 2018, less than a day after receiving SHINGRIX, the patient experienced joint pain, general body pain, pain in arm, malaise and fatigue. On an unknown date, the outcome of the joint pain was not recovered/not resolved and the outcome of the general body pain, pain in arm, malaise and fatigue were unknown. The reporter considered the joint pain, general body pain, pain in arm, malaise and fatigue to be related to SHINGRIX. Additional details were provided as follows: The patient reported that later that evening of vaccination he experienced the events. The patient had limited contact information for health care professional at the time of reporting.
Headache & Myalgia Narrative:  2/3 upon waking arm soreness, fatigue,  headache and aching joints.
1 wk p/immun - fever 101, rash for 1 wk;
15 minutes after vaccination, started to have SOB, numbness on legs and extremities-- > sent to ED for evaluation.  She c/o funny feeling in her mouth and tingling in her arms and legs after vaccination.  She felt short of breath initially, but not at ED.  No rash.  No swelling that she is aware of.  She just doesn't feel right.  States she feels "jittery" and shaky. Received 2 L NS and epi 0.3mg IM x1 and diphenhydramine 25mg IV x-- > symptoms improved. Observed for 4 more hrs in ED.   Discharged home on Epi pen.
Circular redness a bit larger than a quarter size, noticeable hard lump under skin, area warm and tender to the touch
Patient is a 76 y.o. non-smoker with a history of hypertension, hyperlipidemia, and GERD that presents to hospital complaining of fevers and cough.  She reports she was diagnosed with COVID 19 about 8/1/21 and she has had progressively worsening symptoms.  She states she is unsure how high her temperature was at home.  She denies shortness of breath, headache, dizziness, nausea, vomiting, and loss of taste and smell.  She called her PCP yesterday to report her worsening symptoms and was sent to the ED for further evaluation.  She required 6L supplemental oxygen on arrival to the ED.  Work up in the ED revealed Na 130, K+ 3.2, lactate 2.1, and procal 0.30.  A chest x-ray showed cardiomegaly and vascular congestion.  Patient with acute respiratory distress and hypoxemia secondary to COVID-19 pneumonia.  Treating with oxygen, twice daily dexamethasone, and remdesivir.
Mother of patient states that she does not remember exactly when symptom began but that it was during November before Thanksgiving, 2006.  Patient c/o upper right arm twitching/jerking.  It is an occasional twitch/jerk and usually occurs in the evening.  Mother states the movements are so noticeable, that patient has experienced embarrassment in front of friends.  She has taken him to a neurologist who wanted her to investigate immunization side effects, especially referring to thimerosal.  These movements have not stopped yet.  I have not personally observed this happening.  He has received no treatment to date.  The patient received first series of vaccines on 10-18-06 including Hep B, Varicella, Menactra.  He received second series on 11-29-06 including Tdap, Hep B and Varicella.
Pt vaccinated with FLU developed persistent muscle aches, weakness at inject site. Lasting 2 months now - no other hx of injury of other arthritic/rheumatic symptoms.
Chronic lymphocytic leukemia; Autoimmune hemolytic anemia; Coughing; Feeling sick all over/Malaise; Sneezing; Runny nose; Pain and swelling in her left elbow; Pain and swelling in her left elbow; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 75 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 07Jun2021 (Lot number: EW0202) at the age of 75 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. Family Medical History was None. There were no concomitant medications. Vaccination history included: Bnt162b2 (1st dose, Lot: EW0167, Location: Left arm), administration date: 17May2021, when the patient was 75 years old, for COVID-19 immunization. The following information was reported: CHRONIC LYMPHOCYTIC LEUKAEMIA (medically significant) with onset Nov2021, outcome "not recovered", described as "Chronic lymphocytic leukemia"; AUTOIMMUNE HAEMOLYTIC ANAEMIA (medically significant) with onset Nov2021, outcome "not recovered", described as "Autoimmune hemolytic anemia"; COUGH (non-serious) with onset Jul2021, outcome "not recovered", described as "Coughing"; MALAISE (non-serious) with onset Jul2021, outcome "not recovered", described as "Feeling sick all over/Malaise"; SNEEZING (non-serious) with onset Jul2021, outcome "not recovered", described as "Sneezing"; RHINORRHOEA (non-serious) with onset Jul2021, outcome "not recovered", described as "Runny nose"; ARTHRALGIA (non-serious), JOINT SWELLING (non-serious) all with onset Jul2021, outcome "not recovered" and all described as "Pain and swelling in her left elbow". The events "chronic lymphocytic leukemia", "autoimmune hemolytic anemia", "pain and swelling in her left elbow" and "pain and swelling in her left elbow" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: coagulation test: (2021) negative; blood test: (2021) unknown result; (Oct2021) unknown result; x-ray: (2021) unknown result. Therapeutic measures were taken as a result of chronic lymphocytic leukaemia, autoimmune haemolytic anaemia, cough, malaise, sneezing, rhinorrhoea, arthralgia, joint swelling. In Jul2021, she coughing and was feeling really sick all over, was sneezing and had a runny nose. She didn't have a fever; she just had malaise for 6-7 days. Then the following week she had 3 days with the same symptoms. After all that, she ended up going to the doctor for pain and swelling that showed up overnight in her left elbow. She was then sent to a Hematology/Oncology doctor in Oct2021 and diagnosed in Nov2021 with Chronic lymphocytic leukemia and autoimmune hemolytic anemia. On 01Dec2021, she went to MD withheld and is now being treated. States that she is not saying that the vaccines had anything to do with all this, but she wants to report this to Pfizer because of how quickly her health deteriorated after her 2nd vaccine.
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and unknown gender. The patient pertinent medical history was not reported. On 18-JUL-2013, the patient was vaccinated with VARIVAX (Merck) (dose strength and route was not reported) (lot # H018796 and expiry date: 24-OCT-2014) which was improperly stored. Primary reporter was reporting excursion of 6 F since 01-JUN-2013 (confirmed date) affecting VARIVAX (Merck), nurse also reported that products were not stored in an overall average support range of -58 degree F and 5 degree F. No adverse effects reported. No product quality complaint (PQC) was reported for VARIVAX (Merck). This is one of the several reports from the same reporter. Additional information has been requested.
Dizziness; This is a spontaneous report from a contactable consumer (patient).  A 73-year-old male consumer received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 21Jan2021at a single dose in left upper arm for Covid-19 immunisation at the age of 73-year-old. Lot number was EL9262. Medical history and concomitant medications were none. On 26Jan2021, the patient experienced Dizziness, it started in the morning, when he got out of bed, the first time he woke was at 5 AM and right at the time of report it was going on 11 AM and he was taking it easy, sitting back and relaxing, he fell asleep. The patient did not recover from the event.
Systemic: Allergic: Rash Generalized-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium
bad taste in throat within 2 hours. started with low grade fever within 5 hours. Fever spikes up to 103 degrees, body shakes, body shivers, painful skin, terrible headache and fatigue.  after 4 days the fever went away and the headache stayed with added dizziness and nausea.  7 days later still struggling with headache, dizziness.  Low grade fever here and there.
ACUTE DVT OF RIGHT TIBIAL VEIN ACUTE DVT OF LEFT TIBIAL VEIN CHRONIC HYPOXEMIC RESPIRATORY FAILURE HYPOXIA
Headache: 7 days and counting Body ache  7 days and counting Joint pain  7 days and counting Fatigue  7 days and counting
Vaccine given 11/1/10 -> seen at office on 11/3/10 with red, swollen, warm, painful (L) deltoid and with fever 101.6 oral, patient placed on KEFLEX 500mg 1 tab 2x day for 10 days.
STROKE, LEFT-SIDED WEAKNESS, 1030PM 4/26/2021.
Left arm deltoid tenderness, swelling, no redness with some left hand swelling requiring pt to remove ring from 4th digit. 25 mg PO BENADRYL and ice to L arm.
This spontaneous report as received from a nurse and refers to a patient of unknown age and gender. There was no information about patient's concomitant medications, pertinent medical history, drug reactions and allergies provided. On 28-JUL-2015, the patient was vaccinated with an improperly stored GARDASIL 9 (lot# K026246, expiration date 28-JAN-2017, dose, route and site of administration were not reported). The vaccine was exposed to temperatures outside of the recommended range. No adverse experiences were reported. This is one of several reports received from the same reporter. Additional information has been requested.
The patient was admitted two days after the COVID vaccine with weakness, hearing loss, and fatigue. This was thought to be due to progression of his multiple myeloma on workup, and he was started on chemotherapy with Daratumumab, Carfilzomib, and dexamethasone. He was discharged on 5/10.
pt recv vax 17FEB97 & on 28FEB97 pt devel less than 50 lesions described by the pt mom as red bumps;It was reported that on the day of the vax pt had hypercarotenemia & tinea corpus & was treated w/Lotrimin;
feel hotness on the injection site; it was itchy and pinkish; it was itchy and pinkish; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (feel hotness on the injection site), VACCINATION SITE PRURITUS (it was itchy and pinkish) and VACCINATION SITE ERYTHEMA (it was itchy and pinkish) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 010M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced VACCINATION SITE WARMTH (feel hotness on the injection site), VACCINATION SITE PRURITUS (it was itchy and pinkish) and VACCINATION SITE ERYTHEMA (it was itchy and pinkish). At the time of the report, VACCINATION SITE WARMTH (feel hotness on the injection site), VACCINATION SITE PRURITUS (it was itchy and pinkish) and VACCINATION SITE ERYTHEMA (it was itchy and pinkish) outcome was unknown.      No concomitant medications were provided. No treatment was reported for the events.
Hearing loss in the right ear 3 days after vaccination.  This was confirmed by an audiologist.
Nurse Practitioner opened a new vial an didn't diluent vial prior too administering to the patient.  Patient recieved 0.2 mL of undiluted COVID Pfizer Vaccine.
a female patient. I have received all 4 doses of Moderna vaccine on the following dates: January 8, 2021 (Lot: 025620A), February 2, 2021 (Lot: 012M0A), November 6, 2021 (Lot: 037F21A), and May 18, 2022 (Lot: 056A22A). I am writing to Moderna to bring to your attention a potential problem with the side effects of your Covid-19 vaccine. The issue I want to raise is related to a possible side effect of the vaccine that I am personally experiencing.  After the first dose, I developed a burning pain in the back of my thighs, especially on the left side, which gradually also presented on the right. After multiple electromyogram studies, lumbar myelogram test, magnetic resonance imaging, and tomographies, various neurosurgeons issued similar diagnoses of spondylolisthesis conditions and incipient nerve compression. However, the doctors agree that the exams reveal that the conditions visualized in the spine, which typically cause pain in the lower back due to nerve compression problems in the column, are not the ones I currently present with pain in the back of my thighs. And they agree that neurosurgery would not eliminate the symptoms I have been experiencing since 2021. To this day, I still do not know the cause of my symptoms and leg pains. Given this situation, I would like to consult with you at Moderna if you have had any reports from anyone who has reported any side effects of the vaccine, similar to what I am experiencing with muscle pains in the back of my thighs. In case someone has reported similar symptoms, I would like to know if you have identified those symptoms as side effects caused by the Moderna vaccine. If that is the case, I would like to know if you have identified and applied any solution to this problem. I would also appreciate it if you could investigate this matter further and take necessary actions to address any potential risks associated with the side effects of your vaccine. Thank you in advance for your kind attention to this matter and your prompt response.
Information has been received from a physician concerning a 65 year old female with a history of myalgia who on 30-MAR-2007 in the afternoon was vaccinated with a second dose of Pneumovax 23. (Her first dose of Pneumovax 23 was reportedly several years ago). On 30-MAR-2007, in the evening, the patient had pain in her arms, legs and back. She visited the rheumatologist was diagnosed with polymyalgia rheumatica. Subsequently, the patient recovered from polymyalgia rheumatica on an unspecified date. Additional information has been requested.