chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Approximately 20 min after leaving the office Mom came back and reported 'flushed'  appearance and hives.  Given dose of Benadryl in the office and observed for following 30 min.  During that time frame, noticed lips began to swell slightly and had purplish appearance.  Vital signs stable.  No respiratory distress initially but began to sound congested and slight audible wheeze.  Given Epinephrine 30 min after Benadryl dose and EMS called to office.  Within 5 minutes of giving epi, pt. back to baseline.  Color and swelling improved, and mild congestion remaining.  Transported to local ER via EMS in stable condition.
This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 70-year-old female patient who received SHINGRIX (batch number LT533, expiry date 11th October 2020) for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was recovered/resolved. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were reported as follows: The health care professional reported that, the patient developed shingles after vaccination with SHINGRIX.
Raised blood pressure of  168/94, 170/89, and 158/82 4-6 hours after injection even after taking regular medication.
Immediately after administration, client stated that she felt strange with tingling sensation along left side of body. Blood pressure elevated at 5 and 15 min after injection. Client left clinic on own to go to urgent care and was directed to Emergency Room at medical ctr. Tingling in tongue still present on 10/21/15.
Pt recv vax on 10/27/98; on 10/28/98 pt exp swollen, red, hot, achy arm x 2 day
I received 2 of the 3 HEPATITIS B Vaccines after the first mild achiness after the 2nd my Rt leg & arm went numb - vision disturbances. Can't see well stumbling gait chest pain. Neuro changes, can't feel feet and hands at times. Very weak, SOB, tired all of the time memory shot. Vision comes & goes Alzheimers & Guillain Barre like symptoms for 1 year now, can't work! Within 2 weeks of shot. I was G.I bleeding & had a nose bleed that continues & had to be cauterized 2 times by on ENT. With no current insurance, kids in college & no job I went to ENT to avoid an Epistaxis Balloon & exorbitant high charges & we did the cauterize after. I am still getting occasional nose bleed but I have some continued bleeding & clotting problem since the swelling in Rt arm & leg with pain & just blew it off thinking it would go away but now I think it activated something & that it was actually clots in both limbs. I have color changes pain & swelling still in these 2 limbs that continues to this day. Fingers blue limbs mottled foot pads go dusky especially on Rt foot & in Rt hand. I had & still have a speaking defect expressive aphasia for speaking at times with slurred speech. I have a gait defect Rt sided weakness & if you throw a light switch off I veer drastically to the Rt side & crash into walls fall onto floor or off step porch etc. Basically cannot tell if I am upright in the dark. Vision "greys" out. Very scary.
Information has been received from a registered nurse concerning a 21 year old female with asthma and no drug reactions/allergies who on 17-MAY-2007 was vaccinated with Gardasil (lot # 657736/0389U) 0.5 mL IM in the left arm. Concomitant therapy included fluticasone propionate (+) salmeterol xinafoate (ADVAIR). On 17-MAY-2007 the patient developed injection site swelling immediately after vaccination with Gardasil. For the following two weeks she had a bruise at the site. Medical attention was sought. At the time of reporting the patient had recovered. No further information is available. Additional information has been requested.
Information has been received through a Merck pregnancy registry from a 27 year old female with penicillin allergy and no pertinent medical history who on 20-AUG-2007 was vaccinated with a single dose of GARDASIL.  There was no concomitant medication.  She became pregnant in September 2007.  A pregnancy test was performed (result not provided).  Her LMP was 08-SEP-2007.  Expected date of delivery was 14-JUN-2008.  The patient did not have any adverse symptoms as a result of receiving GARDASIL.  She did not have any additional doses of GARDASIL.  On 11-JUN-2008 the patient gave birth to a baby girl.  The child had been diagnosed with congenital cataracts in both eyes.  Unspecified medical attention was sought.  Additional information has been requested.
Starting about 2 weeks after receiving the vaccine, I developed vertigo and my PCP contributed it to the vaccine. I went to see an ENT the day before the 2nd dose and he said it was not related to the vaccine. I got the 2nd dose on 04/21/2021 and the symptoms got worse. The vertigo got worse and, after speaking over the phone with my eye doctor. I was referred to a very specialized ENT. I was able to get in to see them on 05/05/2021 and he had noticed others with vestibular issues after the vaccine. So, he had me do two tests. I did the first test, which came back normal and, by the time I got ready to do the 2nd test, the symptoms had subsided.
Chills, tightness and burning sensation in chest, lethargy appeared 48 hours after vaccine.
Fatigue.  Leg pain.  Leg fatigue.  Slight pain like muscle pain.
This spontaneous report was received from a registered nurse refers to a multiple unspecified patient's of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not provided. On an multiple unspecified dates, the multiple unspecified patient's were vaccinated with improperly stored doses of M-M-R II (lot, expiry date and dosage regimen was unknown) for a year. No adverse effects reported. No product quality complaint was filed. This is one of several reports received from the same reporter. Additional information has been requested.
Information has been received from a registered nurse concerning a 15 year old female patient who on an unspecified date was vaccinated with a first dose of GARDASIL (dose, route and Lot # not reported) and "6 months ago" on approximately 30-SEP-20110 was vaccinated with a second dose of GARDASIL (dose, route and lot# not reported). The nurse stated that "6 months ago" on approximately 30-SEP-2010, the patient fainted one hour after receiving her second GARDASIL dose. The nurse also stated that the patient did not have a reaction after her first GARDASIL. The nurse reported that there was no treatment necessary, nor provided thus the patient was fine. The patient sought medical attention by an office visit. Additional information has been requested.
10/11/2022 I started feeling like I was getting a cold, I had fever, sore throat, low grade fever and body aches 10 days. 10/13/2022 I tested positive for COVID-19 10/14/2022 I was seen at the medical practice and was prescribed a 5 day course of Paxlovid and OTC TYLENOL for fever and body aches. Symptoms lasted in total 10 days. I did have a lingering cough for about 4 weeks but I am feeling much better now.
Information has been received from a Doctor of Pharmacy concerning a 12 month old patient who on 24-OCT-2007 was vaccinated with a dose of PNEUMOVAX 23. The PharmD reported that there was a lack of clarity with request from the nurse regarding what needed. The nurse stated they needed a pneumococcal vaccine, but did not state the age of the patient. Therefore, the incorrect vaccine was administered to the patient. No problems were reported. The corrective action at the site was to ask the age of the patient who would need the vaccine. Additional information has been requested.
Arm soreness; Believe has 101 temperature feels hot; Chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm soreness), PYREXIA (Believe has 101 temperature feels hot), CHILLS (Chills) and HEADACHE (Headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm soreness), PYREXIA (Believe has 101 temperature feels hot), CHILLS (Chills) and HEADACHE (Headache). At the time of the report, PAIN IN EXTREMITY (Arm soreness), PYREXIA (Believe has 101 temperature feels hot), CHILLS (Chills) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101 (Inconclusive) 101.         Concomitant product use was not provided by the reporter. Treatment included cold pak.   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Follow-up information received on 11-May-2021 contains non-significant information.
Pfizer BioNTech COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer Vaccines on 1/20/2021 and 2/17/2021. Patient presented to ED on 10/14 with c/o general malaise, abdominal pain with a cough and fever that had been ongoing for 4 days. CXR revealed diffuse bilateral lung infiltrates concerning for PNA. Upon arrival to the ED, pt tested positive for COVID-19. Patient started on BiPAP and subsequently intubated on 10/18. CRRT started on 10/20 and requiring vasopressor support. Patient treated with Remdesivir, methylpred, and tocilizumab. Patient family requested palliative care and transitioned to comfort care on 11/3. Patient expired 11/3.
Started with bilateral proximal leg weakness, went to the LUE and LLE sensory symptoms and fasciculations which then decreased and went to the right side of the body with waxing and waning cramping of RUE and RLE.
Vertigo; Dizziness; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (Vertigo) and DIZZINESS (Dizziness) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     Concurrent medical conditions included Vertigo (had an incident of vertigo last year).    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced VERTIGO (Vertigo) and DIZZINESS (Dizziness). At the time of the report, VERTIGO (Vertigo) and DIZZINESS (Dizziness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were provided. No treatment information was provided. Patient  had the symptoms while moving from  laying down to an upright position or simply turning head while in bed.
patient received Menactra wich was excursed at low temperature and was not suitable for use/no AE; patient received Menactra wich was excursed at low temperature and was not suitable for use/no AE; Initial information received on 04-Feb-2020 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case is linked to cases 2020SA032086 and 2020SA032093 (same reporter).  This case involves a patient of unknown demographics who received vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot U6594AA, expiry date: 03-Feb-2021 via unknown route in unknown administration site) on 03-Feb-2020 which was excursed at low temperature and was not suitable for use (Poor quality product administered, Product storage error).  The patient medical history, medical treatment(s), vaccination(s), concomitant therapy and family history were not provided.   It was of actual medication error due to incorrect product storage (Product storage error) and Poor quality vaccine administered (Poor quality product administered).  It was reported that patient did not experience any adverse event.  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 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.
Patient was given 2nd dose of series too early; administered 14 days after 1st dose.
patient has symptoms of shigles on the other arm 1 week after getting the 2nd dose. (rash and soreness on the right arm)
Shot given at 11:00 AM as standard well visit. At dinner time (6:30PM) child complained of belly ache and was not Interested in eating. This is highly unusual as he normally has a strong appetite.  Woke up in middle of night (3:00 AM) with fever 102.7 and had headache, stomach pains and swollen hot arm. Asked for a drink of Water and had the chills for about an hour. At 4:00 AM started heaving and vomiting for 15-20 minutes. Afterwards still had headache and sore arm but fever went down and stomach was better. Went to sleep until 7AM. Woke up with sore arm and fever was gone.
3OCT91 pt recvd Engerix-B & on 10OCT91 pt devel hives; as of 14OCT91 hives reported to be still inc;
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2014, the patient was inoculated with ZOSTAVAX as recommended for routine adult health maintenance and for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 01-SEP-2015, the patient was treated at urgent care for a persistent and severe vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
a drastic change in my health/experienced health related issues; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), in Jul2021 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: GENERAL PHYSICAL HEALTH DETERIORATION (non-serious), outcome "unknown", described as "a drastic change in my health/experienced health related issues". Additional information: Since Jul2021, the patient noticed a drastic change in health. The patient experienced health related issues that the patient knew were directly connected to the vaccine.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received. Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300045087 Same patient, Same reporter, Same product, Different dose, Same event;
I woke up at 11:30 pm with severe intestinal cramping.  I have IBS so I used what normally worked - heat and a dicyclomine capsule.  It got worse and worse to the point my whole body was shaking.  I felt nauseous and thought I might throw up from the pain (I didn't).  At 1:00 am I took a 5mg Oxycodone pill.  I got a little relieft at about 1:45 am.  The spasms started coming in waves.  At 3:15 am I took another dicyclomine and again used the heating pad.  At about 4:30 am, I was able to fall asleep.  This is absolutely the worst spasming I have ever had.
Severe body aches Fever 102.4 Chills Massive Migraine Sweats Fatigue Weak
This case was reported by a pharmacist and described the occurrence of elevated white blood cell count in a 68-year-old male subject who was vaccinated with FLULAVAL (GlaxoSmithKline). Concurrent medical conditions included Crohn's disease. Concurrent medications included MESALAMINE, loratadine, omeprazole, prednisone, terazosin, clonazepam, gabapentin, multivitamin, simethicone, propranolol and loperamide. On 16 October 2008 the subject received a dose of FLULAVAL at 0.5 ml. On 16 October 2008, less than one day after vaccination with FLULAVAL, the subject experienced elevated white blood cell count and fever. The subject was already hospitalized and ready to be discharged when the flu vaccine was administered. The subject's hospital stay was extended because of the fever and elevated white blood cell count. The pharmacist considered the events were disabling, life threatening and clinically significant (or requiring intervention). The subject was treated with antibiotic. At the time of reporting the subject's elevated white blood cell count was improved and the fever was resolved. In the reporter's opinion, the elevated white blood cell count was probably related to treatment with FLULAVAL. The relationship of the fever to FLULAVAL was unknown. The reporting pharmacist did state that in hindsight, they probably should have not started the antibiotic therapy and his extended stay could be related to that and not the actual flu vaccine.
arm has been incredibly sore and painful; having troubles lifting his arm above his head.; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm has been incredibly sore and painful) and LIMB DISCOMFORT (having troubles lifting his arm above his head.) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm has been incredibly sore and painful) and LIMB DISCOMFORT (having troubles lifting his arm above his head.). The patient was treated with PARACETAMOL (TYLENOL) for Paracetamol, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (arm has been incredibly sore and painful) and LIMB DISCOMFORT (having troubles lifting his arm above his head.) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant products were reported.
This spontaneous report was received from two physicians referring to sever unspecified male patients of unknown age. The patients' concurrent conditions, medical history and concomitant therapies were not reported. Approximately in October 2018, reported as within the last 6 months, the patients had finger sticks at their doctor visits in order to check their cholesterol levels. The same patients then were vaccinated with a dose of GARDASIL 9 (dose, frequency, route, lot# and expiration date were not reported) for prophylaxis at the same office visit. The same patients fainted (syncope) after receiving dose of GARDASIL 9. The patients sought medical attention in the doctor's office. The outcome of the event was unknown. The action taken with the suspect vaccine was not applicable. The causality between the event and the suspect vaccine was not reported by the reporter. Upon internal review, event of  fainted (syncope) was considered as medically significant. This is one of two reports received from the same reporter; Sender's Comments: US-009507513-1904USA013128.
Feeling tired/fatigue; Shortness of breath; blood pressure remained slightly elevated.; This is a spontaneous report from a contactable pharmacist. A 77-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via intramuscular route of administration in the arm right on 17Mar2021 (at the age of 77-year-old) as a single dose for COVID-19 immunisation. Medical history included hypertension (resolved hypertension), AFib (atrial fibrillation), hyperlipidemia, milk allergy, peanut allergy, food allergy (beans) and allergy to beef product. Concomitant medications included atorvastatin (MANUFACTURER UNKNOWN) and carvedilol (MANUFACTURER UNKNOWN); both for an unknown indication and 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 did not receive any other vaccines within four weeks prior to the vaccination. On 17Mar2021, the patient experienced feeling tired /fatigue and shortness of breath. Patient was hypertensive. The patient denied dizziness and chest pain. The patient was offered oxygen supplementation but refused and stated that he felt okay. All symptoms resolved except fatigue and blood pressure remained slightly elevated. On 17Mar2021, the patient underwent blood pressure and the result was blood pressure remained slightly elevated. 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 any treatment for the reported event. The clinical outcome of the event shortness of breath was resolved on an unknown date and of the events blood pressure remained slightly elevated /fatigue and feeling tired was not resolved.  No follow-up attempts are needed. No further information is expected.
Patient experienced generalized weakness, nasal congestion and decreased appetite on 4/14/21 and was tested for COVID-19 infection. Symptoms worsened and patient presented to emergency department. Patient was admitted to hospital for treatment of COVID-19 pneumonia.
Case number PHEH2015US026906 is an initial spontaneous report received from a nurse on 22 Dec 2015. This report refers to a 49 years old female patient. Medical history was not reported. Concomitant medication was not reported. The patient was vaccinated with FLUVIRIN (batch number: 1514501, expiry date: May 2016) into left deltoid on 14 Oct 2015. It was reported that FLUVIRIN administered to the patient had a temperature excursion of 34 degrees. The nurse stated that, the reason was unknown for the  refrigerator to be out of temperature range. There was no any further problem since the temperature excursion problem. No further information was provided. No adverse reaction was experienced by the patient following the maladministration. Follow up report received from nurse on 26 Jan 2016: Updated reporters comments.