chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a registered nurse refers to a 4 month old patient. The patient's concurrent conditions, medical history and drug allergies were not reported. On 20-DEC-2016, the patient was vaccinated with improperly stored ROTATEQ, oral, (dose not reported) from lot # M007311 (expiry date: unspecified) for prophylaxis. Concomitant medications were not reported. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information is not expected as all correspondence has been received. Follow-up information indicated that suspect product with the lot# M007311 had not actually involved in the previously reported temperature excursion. Therefore, case # 1612USA012662 is being deleted from our files on generic rotavirus vaccine, live, oral, pentavalent. Sender's Comments: US-009507513-1610USA008140: US-009507513-1610USA014705: US-009507513-1610USA014706.
Neck aching; Lethargic; Head aching; Tired; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP6955) via an unspecified route of administration in the right arm on 23Mar2021 at 10:00 (at the age of 53-years-old) as a single dose for COVID 19 immunisation. Medical history reported as none. The patient did not have any allergies to food, medications, or other products. The patient did not receive any other medications within two weeks of vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3247) via an unspecified route of administration in the right arm on 01Mar2021 at 10:00 (at the age of 53-years-old) as a single dose for COVID 19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient had not been diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 24Mar2021, the patient experienced neck and head aching, patient was tired and lethargic. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive treatment for the reported events. The clinical outcome of the event neck pain, headache, tiredness and lethargic was not resolved at the time of reporting.   No follow-up attempts are needed. No further information is expected.
11/05/22 presents for "cardiac arrest" "hypoxia in the setting of preceding respiratory distress/recent COVID". PMHx of "ESRD on HD MWF, T2DM, HTN"
This spontaneous report was received from a pharmacist and a control nurse via a company representative and refers to a 70 years old non-pregnant female patient. The patient's pertinent medical history, and concurrent conditions were not reported. The patient's historical drugs included PREVNAR 13, more than a year ago. Concomitant therapies included acetazolamide, aspirin(manufacturer unknown), vitamin b complex, calcium, naproxen(NAPROSYN), turmeric, ascorbic acid, vitamin e and vitamin d. On 09-JAN-2018 (also reported as 19-JAN-2018), the patient was vaccinated with PNEUMOVAX 23 (dose and route of administration were not reported, lot # N019348 and expiration date: 08-FEB-2019) for routine vaccination. On 11-JAN-2018 (reported as 48 hours post vaccination with PNEUMOVAX 23), the patient experienced a problem with cellulitis; the signs were reported as redness, swelling, pain and heat with what was termed "like a bacterial infection". The patient sought medical attention by a physician office visit on the same date but, it was unknown if laboratory diagnostic tests were performed. As treatment for the event, the patient received cephalexin (KEFLEX) and doxycycline. At the time of this report, the patient was recovering from the event cellulitis.  The reporting nurse request a lot check to determine contamination and offered to send a sample if it would help with the investigation. The nurse stated that the vaccine was quarantined. Additionally, the clinic had many sites but the reactions only occurred in one site. The causality between cellulitis and PNEUMOVAX 23 was not reported. Upon internal review, cellulitis was considered medically significant.  This is one of three reports from the same reporter.; Sender's Comments: US-009507513-1801USA007997: US-009507513-1801USA007902:
Developed rash, high fever 104F, blisters in mouth, hands. Nausea, vomiting, diarrhea X 10 days, began 4 days after vax. Developed nausea, vomiting, high fever 104F, fine generalized red  rash head to toe again.
After administration of the vaccine, the patient was found to be pregnant; no adverse event; This spontaneous pregnancy report was received from a medical assistant referring to an 18 year old female patient.    The patient had no pertinent medical history or drug reactions/allergies.  Concomitant therapies included ibuprofen and loratadine.   On 10-FEB-2021, the patient went to the medical center for birth control management, and it was noticed that she was due for the  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) vaccine. The medical assistant administered the dose of with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) pre-filled syringe, lot # 1621929, expiring on 06-DEC-2021, intramuscularly.  Then a pregnancy test was taken and the patient was found to be pregnant.  The last menstrual period and estimated due date were unknown.  The pregnacy was ongoing at the time of reporting.  No additional adverse event or product quality issues were reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1621929; expirationdate: 06-DEC-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
Rheumatoid arthritis flare up; Pain in arm; This is a solicited report based on the information received by Pfizer from AbbVie Inc. (MFR Control No. 21K-163-4065072-00) from a non-contactable female consumer (patient) reported for herself.  A 66-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 intramuscular on 09Mar2021 (Batch/Lot number was not reported) as single dose (at the age of 66 years old) for COVID-19 immunisation; adalimumab (HUMIRA), subcutaneous from an unspecified date (Batch/Lot number was not reported) and ongoing, at Citrate Free for rheumatoid arthritis. The patient medical history and concomitant medications were not reported. Previously the patient received the first dose intramuscular of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE on 12Feb2021 for COVID-19 immunisation On an unspecified date in 2021, the patient experienced rheumatoid arthritis flare up (medically significant), pain in arm. The outcome of the events was unknown. The action taken in response to the events for adalimumab was not applicable.  The reporter's causality for the event(s) of rheumatoid arthritis flare up with Humira (ADALIMUMAB) was a reasonable possibility. The reporter's causality for the event(s) of sore arm with Humira (ADALIMUMAB) was no reasonable possibility.  The reporter's assessment of the causal relationship of the events with the BNT162B2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: The events Rheumatoid arthritis and Pain in extremity are assessed as possibly related to the suspect drug BNT162B2 based on causal association but consider also possible contributory effects from patient's medical history and/or concomitant medications.The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Headache, chills, fever, muscle aches beginning 11 hours after vaccine received.
Fatigue; Disorientation; Epistaxis; This is a spontaneous report from non-contactable consumer. A 70-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Dose 1 on Jan2021 and Dose 2 on Feb2021, both via an unspecified route of administration as single dose for COVID-19 immunisation. Medical history included trigeminal neuralgia and multiple sclerosis. Concomitant medications included certain medications like pregabalin (LYRICA), baclofen, oxcarbazepine (TRILEPTAL), glatiramer acetate (COPAXONE), all for trigeminal neuralgia. The reporter said that they got their Pfizer Cocvid-19 Vaccine in Jan2021 for the first dose, and the end of Feb2021. He had a unique problem that kept reoccurring. She asked if anyone had ever reported extreme epistaxis after the receiving the Covid vaccine. She said that it was profuse. She said that he had no reaction to the shot, but a little fatigue and disorientation. His first episode was on 12Mar2021. He had never had a nose bleed in his life before that. She said that it was like turning on a faucet and he had to go to the ER. They could not stop it after 30 minutes. It was like projecting out of both nostrils. It was all over his face, clothes, and all over the towel on his face. She said that they kept him in the ER from 2300 until 0600 the next day. She said that he had had at least 4-5 incidences since then. She said that it happened in Apr2021, 3 times in May2021, and 3 rimes in Jun2021. The patient had been to the EENT and they scoped his nose and throat. They could see the bleeding and treated him with antibiotics and they still can't figure out where it was coming from. They didn't know. He had an MRI and no tumors, and nothing was shown. It was just a blood thing. The last episode he had was 22Jun2021. She said that she had her vaccine at the same time and had no side effects. Outcome of the event was recovered on 22Jun2021, of the events fatigue and disorientation was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
PT was found unresponsive in the back of his vehicle. Last know alive when he spoke to mother regarding receiving the vaccination in the morning/early afternoon.  ACLS resuscitative efforts performed. Not successful. NO recent health complaints known
After I received my flu shot on 10/4/22, I experienced chills that evening and the following day noticed a large red, hot and raised area that was very tender approximately almost a hand width distal to the site of the injection. The redness and significant tenderness has persisted throughout the week, but fading slowly. I have never had any reaction like this to the annual flu shot, so this was unusual.
Patient complained of new onset palpitations 3 days after the 2nd dose of vaccine.  Has had intermittent episodes of palpitations since then.   Also, has a history of GAD, so unsure if related to vaccine vs GAD.
Patient presented and was admitted through the ED for palpitations and chest pain.   In the ER patient notes blood pressure was noted to be elevated. D-dimer was 1509, CTA chest ruled out PE. Patient was observed for two days and was discharged in stable condition.
On 10-21-05 pm developed the following Sx fever, chills, sweating. From elbow to mid rt arm red and tender, denies swelling. Developed rash waist, under arms, breast, eyes and cheek. Denied any sob or wheeze at anytime. 10/26/05 Sx improving afebrile rash.
A non-serious spontaneous report of gave 1/2 dose of H1N1 was received from a consumer concerning a 22-year-old female. On 27-Oct-2009 the patient received 1/2 dose (0.1 ml) of H1N1, Intranasal in a single nostril. The other half dose was discarded by the person administering the vaccine. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.
When I went to the bathroom it was all blood, my bowel movement; diarrhea; fatigue, it was horrible; horrible headache; real bad chest pains; sore throat; This spontaneous case was reported by a consumer and describes the occurrence of HAEMATOCHEZIA (When I went to the bathroom it was all blood, my bowel movement) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in July 2020. Concurrent medical conditions included Diabetes. Concomitant products included SEMAGLUTIDE (OZEMPIC), INSULIN GLARGINE (TOUJEO) and INSULIN LISPRO (HUMALOG) for an unknown indication.    On 24-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-May-2021, the patient experienced CHEST PAIN (real bad chest pains), OROPHARYNGEAL PAIN (sore throat), FATIGUE (fatigue, it was horrible) and HEADACHE (horrible headache). On 25-May-2021, the patient experienced DIARRHOEA (diarrhea). On 26-May-2021, the patient experienced HAEMATOCHEZIA (When I went to the bathroom it was all blood, my bowel movement) (seriousness criterion medically significant). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at an unspecified dose and frequency. On 24-May-2021, CHEST PAIN (real bad chest pains) had resolved. On 25-May-2021, OROPHARYNGEAL PAIN (sore throat) had resolved. At the time of the report, HAEMATOCHEZIA (When I went to the bathroom it was all blood, my bowel movement), DIARRHOEA (diarrhea), FATIGUE (fatigue, it was horrible) and HEADACHE (horrible headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient's concomitant drug included beta-blocker (unknown).  Company comment Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
pt recv vax;exp pins&needles,local swelling,and warmth at inject site;exp flashing,electrical shocks on lt arm,& "clubbing" of fingers;exp intermittent numbness on skin&top of lt foot;
Around 1 am on 2/4/2021 I felt, headache, nauseas, body aches, I couldn't move because my whole body was painful, I felt very sick. It lasted for 4 days I didn't get out of bed until the end of 3rd day.
headache all night; swelling with bubbling around the wrist; This is a spontaneous report from Pfizer Sponsored  program. A contactable consumer (patient) reported a female patient of unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route single dose for COVID-19 immunization on 31Mar2021. Medical history and concomitant medication were not reported. On 31Mar2021, the patient developed a swelling with bubbling around the wrist. she stated that she was prone to hives. The swelling only lasted about 5 minutes. She had a headache all night. Outcome of the event headache was unknown; outcome of the other event was resolved on 31Mar2021.  No follow-up attempts are needed. No further information is expected.
morning after injection given, area around sight and 2 inch in diameter red, irritated s/ swollen, itches
slight dizziness several times during the day.  I went to play tennis after the shot so roughly 10am  During the round I got dizzy.  didn't note the time.  Then again after tennis I went to the hairdresser, appt at 1pm.  At the end getting up from the chair I was dizzy but less so than earlier in the day.  That would have been approx 1:40pm.
Patient received her second dose of the COVID-19 vaccine from Moderna. Patient tolerated the first dose well, but her second dose on 02/12/2021 caused some adverse reactions. She experienced injection site pain, itching along her upper arm, fatigue, a low-grade fever, and facial flushing that lasted about 4 days with only mild relief from OTC ibuprofen. Recommended OTC acetaminophen to the patient and to report to her PCP for follow-up.
Had a fever, chills, brain fog and lethargy. Took home COVID-19 test and was positive. Rested and felt better 5 days later. Started having dizzy spells and lasting brain fog.
Patient called 48 hours after Shingles vaccination complaining of pain from elbow down of the arm where the vaccination occurred. Patient did report minimal swelling with no redness around the injection site.
This spontaneous report as received from a consumer refers to a 49 years old female patient. The patient medical history included shingles. The patient was vaccinated with 1 ZOSTAVAX on SEP-2012. No other co-suspects were reported. No concomitant medications were reported. On 28-SEP-2012 the patient experienced inappropriate schedule. No treatment information was reported. The outcome of inappropriate schedule is unknown. The relatedness for inappropriate schedule is unknown for ZOSTAVAX. No further information was provided.
About 45 minutes after the shot into my left arm on Sat., 07102021 my upper left arm started to become extremely painful. Within moments, I started to feel an intermittent severe pain over my right eye.  I also felt very tired. The next day, Sunday, I could not lift my left arm up due to the pain in the upper arm; I still had above-the-eye pain intermittently over my right eye; and I was extremely tired. By evening the right half of my right eye had become very red. On Monday, after difficulty sleeping due to pain in left arm, the pain began to subside in my arm and over my eye. On Tuesday, right eye still red in outer half, determined I had Pink Eye, which apparently can be caused by the COVID virus. Second COVID shot received on Monday, August 9, 2021 about 9 AM and didn't seem to cause problems like before. On Tuesday, August 10, 2021, however, woke up about 3 AM with body stiffness and aching; pain in head, including skull, jawbones, and cheekbones; VERY tired. While standing at bathroom sink about 5 minutes later, suddenly started to feel sick to my stomach so I sat down on the toilet, from which I fell onto the floor and hit my head against the tub because I passed out. When I came to, I was too weak to get up and my husband was calling emergency services. They arrived in about 15 minutes and checked my vital signs, which were okay. I eventually was able to get up and return to bed and I slept most of next day. I believe this was a second adverse reaction to the Moderna vaccine I'd received less than 24 hours earlier
A patient received only the Dtap and polio portion of the vaccine, no AE; Initial information regarding an unsolicited valid non-serious case was received from other healthcare professional via Medical Information (Reference number- 00524890) and transmitted to Sanofi on 18-Mar-2021.  This case involves a four-month-old female patient who received only the dtap and polio portion of a 0.5 mL dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] [lot UJ319AA and expiry date: 04-Jun-2021) via an intramuscular route in the right thigh for prophylactic vaccination on 16-Mar-2021 (product preparation issue).  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included ROTAVIRUS VACCINE and PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for prophylactic vaccination.  This was a case of actual medication error case due to inappropriate reconstitution technique (latency same day).  At the 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 holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
DERMA WART WENT AWAY; This spontaneous report received from a patient via a company representative concerned a 62 year old of unspecified sex. The patient's height, and weight were not reported. The patient's past medical history included: derma wart, and other pre-existing medical conditions included: The patient had used different unspecified topical creams over many years. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced derma wart went away. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of derma wart went away was not reported. This report was non-serious.
This spontaneous report as received from a registered nurse refers to a 9 weeks old male patient with no drug allergy. The patient's medical history included hyperbilirubinemia at birth, nurse stated child was 38 weeks plus 5 days gestation, no pertinent medical history. The patient was vaccinated with the first dose of live, oral ROTATEQ (lot# reported as 0182AE; expired date: 16-SEP-2013) 0.2 ml orally on 11-SEP-2012 with no concomitant medications. No other co-suspects were reported. The mother of child brought the baby in for a 4 month well check up on 19-NOV-2012("yesterday"). Nurse stated mother reported one day after getting live, oral ROTATEQ on 12-SEP-2012, her child had 1 diaper that had watery diarrhea and some streaks of blood in it. The second diaper after that also had diarrhea but only some specks of blood in it. Child recovered. No treatment was given. No lab tests were performed. Additional information has been requested.
Per the patient, states that a few hours after vaccine began to get hives on different areas of her body (counted about 8 in total). States there are no hives at area of administration. Has treated with BENADRYL with some relief. No reports of any anyphylaxis. Patient also states she has received vaccine in previous years with no reaction. I recommended also reaching out to her doctor so they are aware of possible allergic reaction.
Presented to clinic with c/o redness, irritation, swelling and pain in left upper arm at injection site.  Referred to Dr.  Seen by Dr. on 7/15/08.
I had nausea  all day, heart rate over 120, pelvic & back pain, chills, normal temp of 98.6. Throughout the day my heart rate was at 125 even at sitting . My blood sugars were completely normal.