chrisvoncsefalvay/vaers-outcomes huggingface dataset:
19 weeks pregnant female received Adacel/ no AE; they were not supposed to give the vaccine to the patient until she was 27 weeks pregnant/no AE; Initial information regarding an unsolicited valid non serious case was received from a nurse via Medical Information (Reference number- 00704218) and transmitted to Sanofi on 30-Jul-2021.  This case involves a 15-year-old pregnant female patient who was exposed to vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] at her 19 weeks of pregnancy she was not supposed to give this vaccine until she was 27 weeks pregnant (exposure during pregnancy and inappropriate schedule of product administration).  Data regarding this pregnancy were received prospectively. The gestation period at onset 19 weeks. The date of last menstrual period was reported as March 2021. The estimated due date was not reported. The patient's past vaccination(s) included TETANUS TOXOID in 2019. The patient's medical history, past medical treatment(s), concomitant medications and family history were not provided. The patient had unknown previous pregnancy.  On 29-Jul-2021, the patient received a first dose of 0.5 ml of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot U6621BA, expiry date: 31-Mar-2022) a via an unknown route in unknown administration site for prophylactic vaccination.  It was a case of exposure during pregnancy (latency same day).  It was actual medication error case due to inappropriate schedule of vaccine administered (latency same day).  It was reported that, "the vaccine was given to a patient who is 19 weeks pregnant, and they realized that they were not supposed to give the vaccine to the patient until she was 27 weeks pregnant. Caller would like to know if there is anything they need to tell the patient or if there are any adverse effects".  Additionally, at time of reporting, the outcome of the pregnancy is unknown.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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.
Onset of whole body maculopapular rash with some areas of confluence and papa measure 2-13 mm in size. One large patch 34 cm on post (L) arm
he is not feeling  "100% fine"; her husband is experiencing sometimes dizziness; This is a spontaneous report from a contactable consumer. This consumer reported similar events for two patients (herself and husband). This is the second of reports. A 42-year-old male patient received BNT162B2 (COVID-19 VACCINE; Lot number and expiry date not reported), via an unspecified route of administration on an unspecified date as 1st dose, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter stated that her husband received the same COVID-19 vaccine as her and he is not feeling "100% fine", he feels dizzy as well. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : Same reporter/drug/events, different Patient
When I woke up the morning after getting the second dose, I felt fairly lethargic and it took me a while to get going, more so than usual even though I'm not a morning person. I had a light headache, which I'd put at about a 3 on a 1-10 scale, but after being at work for a few hours it increased to about a 5. I left early, around 1pm, and slept again from about 3pm to 8pm. The headache eased up after this nap, but was still there in the background. The next morning (this morning, 1/29), the headache was nearly entirely gone.
inner ear disorder; debilitating; extreme dizziness; nausea; vomiting; stomach discomfort; slight weakness; This is a spontaneous report from a contactable consumer. A 69-years-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EN5318), via an unspecified route of administration, administered in Arm Left on 25Jan2021 13:30 (at the age of 49-years-old) at a single dose for COVID-19 immunization. Medical history included blood pressure, cholesterol and seasonal allergies. Blood pressure and cholesterol controlled by meds. Other medical history included drug hypersensitivity. The patient was known allergies to Codeine, Erythromycin, Septra, Sulfa drugs, Vicodin, Medrol. The patient's concomitant medications were not reported.. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient experienced inner ear disorder, very debilitating, extreme dizziness, nausea, vomiting on 27Jan2021 at 08:30 AM. The patient had inner ear problems before, 5 or 6 in my lifetime. She was still experiencing some stomach discomfort and a slight weakness. She had no idea if her inner ear problems this week are related to the vaccine or not. The outcome of events were recovering.
One of her thighs had LARGER than golf ball-sized lumps where the injection sites were.    She couldn't walk for a day or two, then could only limp for a couple of weeks. Even though I tried to massage it after a couple of days when she would let me touch it, the lump did not go down until about a month or more.  Could this mean that her body put a protective bubble around the immunizations like when sometimes an appendix bursts and the poison is encapsulated by a protective covering.  And so then maybe the immunizations weren't as effective in her????  ALSO,COULD THis LUMP ALSO BE SCARRING HER MUSCLES??   She seems to be easily allergic to stuff---skin rashes especially....is this related and could this affect her immunity?  It happened in  both of her thighs 5 months later and I just reported that too.  but it didn't happen with the hep b or varicella she just recieved in 8/9/05 and it didn't happen before this  time...
mom brought pt in redness, swelling, warmth @ inj site;sent to MD office exam;no other s/s noted-no temp;MD dx was inflammation of lt leg;apply cool packs & use Ibuprofen as needed;
Rash, hives at inj. site, (R) cheek and post shoulder left.
On the morning after my second shot, I was extremely week, shaky and exhausted. This lasted for 24 hours. I was so week I could not walk from my room to the bathroom without assistance.
This spontaneous report as received from a physician via company representative refers to a female patient of unknown age. In approximately June 2013 (about a month ago) the patient was vaccinated with the second dose of GARDASIL (lot # unspecified) for prophylaxis. On an unknown date the patient experienced unspecified joint pain after vaccination. The physician reported that the patient would not receive the third dose of GARDASIL. The outcome of unspecified joint pain was unknown. Unspecified laboratory tests were performed. The patient had sought medical attention via calling the physician. Additional information has been requested.
within first 24 hours lots of wheezing and difficulty breathing, headache. In 3rd & 4th day morning nausea along with terrible headaches. Taken inhalers for wheezing and better by 3rd day. I've been taking Extra Strength Tylenol and Musinex to relieve headaches but still have them.
PT STATES SHE HAS HAD SEVERE JOINT PAIN ON HER LEFT SIDE FROM HEAD TO TOE.  SHE HAS SEEN A DR FOR THIS AND HAS ANOTHER APPT ON 10/4 FOR FURTHER TREATMENT
Facial drooping and paralysis started 8/5/21. Pt went to ER the following day (8/6/21) and was diagnosed with Bell's Palsy. Given steroid and valacyclovir. At time of report on 8/20/21, it has not completely resolved. We only were told because we called to remind him of his second dose appointment that would be this coming Monday. I (pharmacist) contacted Moderna to report. He has chosen not to get the second dose.
Enlarged area at injection site on (R) deltoid. Warm to touch. C/O extended days of pain.
BLOOD CLOTS/ 3 OR 4 WOMEN THAT DIED FROM BLOOD CLOTS; This spontaneous report received from a patient via a company representative via a social media post concerned 3 or 4 female patients of unspecified age, race and ethnic origin. No past medical history or concurrent conditions were reported. These patients received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, Expiry: Unknown) dose, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot number. No concomitant medications were reported. On an unspecified date, the reporter stated that "I really Hope you do not get the J and J there have been 3 or 4 Women that Died from Blood Clots". On an unspecified date, the patients died from blood clots. It was unknown if autopsy was performed. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death). This case, from the same reporter is linked to 20211125101.; Sender's Comments: V0: 20211124990-covid-19 vaccine ad26.cov2.s -blood clots/ 3 or 4 women that died from blood clots. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: BLOOD CLOTS
Patient had dose #2 of COVID vaccine on 1/29/2021.   Patient developed symptoms of COVID on 3/23/2021 with fever, chills, ache, cough, loss of taste/smell, and nasal congestion.  Positive COVID test.
syncope, diaphoresis, bradycardia.  Evaluated by EMS-Cleared
15MAY91 pt vax;  exp malaise, lightheadedness, local inject site tenderness, mild h/a, & gen weakness w/in 30 min.
On the clinic day, the vaccine was transported out from the pharmacy to the facility without a digital data logger. The packing used for transport was refrigerated packaging tote to maintain a temperature of 36 F - 46 F.  However, that is not approved by State  for COVID-19 vaccine transportation. The total time (from when vaccine left the pharmacy to the clinic completion) was less than 6 hours. There were no adverse events.
3/12: mild dizziness/lightheadedness started about 45 minutes after shot and continued intermittently through evening 3/13: moderate arm soreness at injection site in morning progressed to severe arm pain in evening.  Diarrhea in afternoon.  Mild fever (99.7) in evening along with general malaise, headache, nausea and night sweats. 3/14: Fever resolved by morning. Arm soreness reduced to moderate. Mild headache and malaise. Slight dizziness in evening. 3/15: Mild to moderate arm pain. intermittent mild dizziness in evening upon laying down. 3/16: Mild Arm pain. Ringing/fullness in ears in afternoon. Intermittent mild dizziness in evening upon laying down.  3/17: Arm pain resolved. New and unusual symptom emerged. In the afternoon, I felt a sneeze coming on and a strong urge to sneeze. However, right before the sneeze came the sneeze reflex suddenly halted. I could not sneeze and felt uncomfortable pressure in sinus area. This same phenomenon happened another 5-6 times while in bed trying to fall asleep. Slight intermittent dizziness while trying to fall asleep. 3/18: All other symptoms resolved except for halted sneeze reflex and sinus pressure. Experienced another episode this morning where I felt like I needed to sneeze but could not. I have not successfully sneezed since yesterday morning.
Swelling, redness, soreness at injection site. Upper arm soreness. Headache. Itching all over body.
patient received FLUZONE QIV NP from 14OCT2021 to 15OCT2021 that expired on 30JUN2021 with no AE; Initial information was received on 15-Oct-2021 regarding an unsolicited valid non-serious case from a nurse via regulatory authority (under reference: ).  This case is linked to cases 2021SA344107, 2021SA344343, 2021SA344898, 2021SA345067, 2021SA345099, 2021SA345086, 2021SA345249, 2021SA345617,2021SA345624,2021SA345823,2021SA345419,2021SA345587(same reporter).    This case involves a 10-year-old male patient who received INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] on 14oct2021 that expired on 30-Jun-2021 (expired product administered).  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On 14-Oct-2021, the patient received a first dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (0.5mL, once, total, lot UT7108MA, expiry date: 30-Jun-2021) via intramuscular route in the left deltoid for prophylactic vaccination.  It was an actual case of medication error due to expired vaccine used (latency: same day).  It was reported "Nurse practitioner states that 12 patients have received FLUZONE QIV NP vaccines in her practice from 14OCT2021 to 15OCT2021 that expired on 30JUN2021. Caller asked how to proceed in this situation. Caller asked if there were any differences between the 2020 FLUZONE QIV NP vaccine and the 2021 FLUZONE QIV NP vaccine. See inquiries associated with this contact for additional patient information. This information is regarding the seventh of 12 patients that received expired FLUZONE QIV NP."  At time of reporting, no adverse event was 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 the 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.
Booster shot - Caused severe appetite loss, resulting in fatigue, stomach ulcer, low blood pressure, and stroke.
Patient received Covid vaccine (Moderna Lot number 028A21A - short dated expiration) on 4/7/2021.  Patient came down with an earache on Saturday 4/17/2021.  On Sunday 4/18/2021 patient had mouth droopiness and went to the ER.  She was then diagnosed with Bells Palsy at that time
This spontaneous report as received from a pharmacist refers to a newborn female patient of unknown age. On 12-NOV-2012 at 15:21, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
9 days after receiving the first dose of the MODERNA vaccine, my right arm presented a rash in the area of the vaccine, which has an approximate circumference of 3 cm, it presented itching, pain, a hot and red sensation. I also had a mark, resembling a "bite" and feels like a small button.
Pt came in for 5 year cpx 05/20/02. It was thought at the time he may have chickenpox so vaccine deferred til 06/11/02. On 06/12/02 child was seen in ER presenting with swelling, redness, warmth and pain with ROM. Dx with cellulitis/dose of IV antibiotics and prescribed oral Anti followed up in our office 06/13/02.
I have been experiencing heat induced hives for the first time in my life of 67 years.Because of severe itching associated with hives causing me to loose sleep,I had to obtain prescription for Hydroxyzine from my PCP. This adverse event occurred about the same time as I received the 4 th dose (second booster) of the Pfizer vaccine.I am not sure the adverse event is related to the vaccine but I thought that because it is so unusual  for me that I should report this.This symptom did not show after any of the previous 3 Pfizer Covid shots.
10/5/11 Arm swollen at flu injection site/Rt arm, swollen at injection site & redness below area Flu vaccine given 10/4/11.
Mom brings in daughter to clinic appointment at 11:45 am. Pt. receives her Hepatitis A vaccine to left deltoid at approximately 12 pm with no problems, only crying. Mom then takes daughter into next clinic room for a finger stick lead test. Mom exits building with child at approximately 12:12 pm. At approximately 12:15 pm, Mom returns to office with a pale limp child in her arms. Mom reports to this nurse that child "threw up and passed out in the car. EMS called, child assessed and vital signs monitored. Child aroused with verbal/tactile stimuli.
Itchy rash appeared on left side of the collar bone,  face, back and face.
Red, hot, ITCHY, raised rash day of vaccination that resolved, but the area remained sore to the touch and bruised looking. On Wednesday 2/24/21, the rash returned with a red ring around the injection site it and was very itchy.  It also seemed to spread to the left shoulder/scapula a red circle that was sore and also down toward the arm pit was sore.  Today, 3/15, the injection site still has a bruised looking area, the shoulder and arm pit area remain sore, but not as much. It is also no longer itchy.
Head , neck sinus, Whole body flu like muscle pain lasting ten days. High fever on tenth day.  Unbearable pain. Took covid test was negative. Daily nausea and farting all day.
she had planned procedure and her kidney stone; Headache; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4321702-00.  A 65 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 21Mar2021 (Batch/Lot number: unknown) at the age of 64 years as dose 1, single and intramuscular, administration date 30Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) for psoriasis. Relevant medical history included: "stage 3 colon cancer", start date: 2009 (unspecified if ongoing); "kidney stone" (unspecified if ongoing), notes: her kidney stone was removed which was three cm in size. The patient's concomitant medications were not reported. The following information was reported: NEPHROLITHIASIS (medically significant), outcome "recovered", described as "she had planned procedure and her kidney stone"; HEADACHE (non-serious), outcome "recovered", described as "Headache". The patient underwent the following laboratory tests and procedures: investigation: (2009) stage 3 colon cancer. The action taken for adalimumab was unknown. Clinical Course: It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Causality for Humira (Adalimumab): The reporter's causality for the event(s) kidney stone and headache was not provided. Agencies opinion is that there is no reasonable possibility that the events of kidney stone and headache are related to Humira (Adalimumab).  Causality for Pfizer BioNTech covid-19 vaccine: The reporter's causality for the event kidney stone was not reported and reporter's causality for the event headache was possible.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on possibility of high recurrence rate, the event of present episode of kidney stone could be more likely be related to patient's underlying relevant medical history of kidney stone, hence considered unrelated to BNT162B2 as per company assessment. Based on known drug safety profile, the event Headache assessed as related to BNT162B2.
Patient received COVID Bivalent booster on 10/25/2022 in left deltoid. Noted pain in arm and armpit the same night. Yesterday felt swelling and increased pain in the left shoulder and arm pit. She took Tylenol and Ibuprofen with fair to moderate relief. Today the swelling has increased to the size of a baseball in her left arm pit and is extremely painful. No relief with OTC pain reliever. Has been taking mostly Tylenol today because she has no Ibuprofen. Patient denies rash, fever, swelling of mouth, lips eyes, tongue or throat. Is having no difficulty breathing or swallowing.  Recommended patient be seen right away. States she cannot leave work but will go when she is off. I highly recommended she leave as soon as possible . Patient verbalized understanding.
evaluation and management of her symptoms by colorectal surgery and her liver transplant team. Notably, patient also reported cold symptoms and tested positive for COVID-19.
Received vaccine at 4pm.  Woke at 1:30 on 1/23 with headache .  At 4pm aches settled in.  At 9am fever of 101 started along with Hyper skin sensitivity and eye sensitivity and chills.  Aches turned into actual pain in my thighs and calves. It literally felt like I was hit with a baseball bat in my thighs.   Fever kept climbing all day to 103.9 at 3pm. Even though I was alternating Advil and Tylenol. During afternoon and evening I had extreme dizziness. Fever, chills, fatigue, hypersensitive skin and to sunlight with my eyes have persisted for another 24 hours. I am now snd 65 hours post vaccine and I?m still running fever 100-102. With fatigue and body aches.
Patient may have received an undiluted dose of Pfizer pediatric.  Fatigue reported last night and tonight 12/16/21.
8:00 am - noticed weakness during exercise session, but not severe;   4:00 pm sudden onset of extreme exhaustion and joint aches;   5:00 pm sudden onset of chills, increased aches, headache, temp. of 100;  treated with Ibuprophen and Tylenol (alternately);  next day, 8:00 am, arm swollen and sore, temp normal, chills gone (in fact periods of feeling hot during night), headache about the same, aches decreased;    4:00 pm.  Chills and temp of 100 return, increased headache, sudden congestion of nasal passages, increased weakness;  continuing to take Ibuprofen and Tylenol, along with occassional nasal spray.
Hives; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 19-Jan-2021 and was forwarded to Moderna on 19-Jan-2021.    This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to nuts (hives). Concomitant products included VITAMINS NOS for an unknown indication.    On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jan-2021, the patient experienced URTICARIA (Hives). On 05-Jan-2021, URTICARIA (Hives) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product included birth control.  Treatment medication included Benadryl.   Most recent FOLLOW-UP information incorporated above includes: On 19-Jan-2021: No specific follow-up information recorded.
Starting on the day of the injection Extreme continuous  pain from the site  ,affecting shoulder,  down my arm  affecting my elbow joint , so painful was difficult bending and using arm from sept. 17th. until today only because the Orthopedic Dr. Prescribe a  6 day  treatment of IC METHYLPREDISOLONE 4 MG. DOSEPK which seems to have quieted it down. I have 2 days more to take so I will wait to see if its completely gone. I have tried other treatments  Naproxen,. Lidocain patches , advil and nothing touched it.
I was exposed to COVID-19 4 days before feeling bad, but I never tested positive. I had a headache, sore throat, cough, and fatigue. I still have a cough.