chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient received the diluent of the DTaP/IPVof pentacel, no AE; Initial information received on 24-Sep-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to case 2019SA268491 (same reporter).  This case involves a 4 months old female patient who received 0.5 ml dose of diluent DTaP/IPV of vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot UJ101AAA and expiry date: 19Sep2020) via intramuscular route in the right thigh. This patient received the diluent of the DTaP/IPV which was the second dose of a DTaP and a IPV for this patient  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13); and ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) for Immunisation.  It was an actual medication error due to inappropriate reconstitution technique.  At the time of reporting the patient had no 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.  List of documents held by sender: none.
A 16 year old female patient developed a "local reaction of redness of 25 x 20 mm" on the same day after she received a sub-cutaneous injection in the left arm of Menactra on 09/21/2005. The patient went to the student health centre for evaluation. At the time of the report, it was unknown if the patient recovered.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77-year-old patient received BNT162b2 (BNT162B2), on 11May2022 as dose 4 (booster), single (Lot number: FM9992), in left arm for covid-19 immunisation. The patient's relevant medical history included: "left knee replacement" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Anatomical location: Right arm), for COVID-19 immunization; Bnt162b2 (DOSE 2, SINGLE, Anatomical location: Right arm), for COVID-19 immunization; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE, Anatomical location: Right arm), for COVID-19 immunization. The following information was reported: HYPOAESTHESIA (non-serious) with onset 11May2022, outcome "unknown", described as "all of sudden patient arm was like it had no feeling"; PAIN (non-serious) with onset 11May2022, outcome "unknown", described as "could not control it almost, it was very, not in pain, not pain but throbbing pain but it was like pin sticking all in"; SENSORY LOSS (non-serious) with onset 11May2022, outcome "recovered", described as "my arm it was like it had no feeling"; ARTHRALGIA (non-serious) with onset May2022, outcome "not recovered", described as "elbow was still painful"; PAIN IN EXTREMITY (non-serious) with onset 2022, outcome "unknown", described as "I have feeling in my arm, yes. But it is just painful"; SLEEP DISORDER DUE TO A GENERAL MEDICAL CONDITION (non-serious) with onset 2022, outcome "unknown", described as "hip hurts and patient cannot sleep on that side over there"; MUSCULOSKELETAL DISCOMFORT (non-serious) with onset 2022, outcome "not recovered", described as "my shoulder still bothers me"; JOINT RANGE OF MOTION DECREASED (non-serious) with onset 2022, outcome "unknown", described as "patient cannot straighten it out but staying on it to straighten it all the time and cannot straighten it out and it was straight at that time".  The patient was not neglecting the fact that, had left knee replacement. But the patient does not see why that should have anything to do with last booster shot. The first 3 did not bothered.  No follow-up attempts are possible. No further information is expected.
I started off with a deep chest cough. I had never had a fever, my temp fluctuates between 97 and 99 degrees. I have diarrhea on top of my other problem of diarrhea. I don't have a shortness breath but a heaviness of breath. The cough has lessened everyday. I was taking Mucinex with the pills for the first 3 days but stopped that yesterday because the cough wasn't severe enough. The first 3 days I had headaches that came and now have gone. I have a terrible taste in my mouth and had been drinking warm water with honey for 3 days, now have graduated to adding tea bags and now am able to get down regular water. I had a dull back pain near my rib cage and that's  come along. I was given paxlovid.
dose given after vials stored in dry ice box ran out of batteries.temperature therefore unable to be monitored, thus deemed compromised by Agency.
Hurting legs; Back pain; Fever/ low grade fever everyday; Chills; Fatigue; Periods of significant pain / lot of burning pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Periods of significant pain / lot of burning pain), PAIN IN EXTREMITY (Hurting legs), BACK PAIN (Back pain), PYREXIA (Fever/ low grade fever everyday) and CHILLS (Chills) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Back disorder NOS (Patient reported to have pre-existing back problem).   On 13-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, the patient experienced PAIN (Periods of significant pain / lot of burning pain), PYREXIA (Fever/ low grade fever everyday), CHILLS (Chills) and FATIGUE (Fatigue). On an unknown date, the patient experienced PAIN IN EXTREMITY (Hurting legs) and BACK PAIN (Back pain). The patient was treated with PREDNISONE for Pain burning, at a dose of UNK dosage form; PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency and DULOXETINE at a dose of 20 mg. At the time of the report, PAIN (Periods of significant pain / lot of burning pain), PAIN IN EXTREMITY (Hurting legs), BACK PAIN (Back pain), PYREXIA (Fever/ low grade fever everyday), CHILLS (Chills) and FATIGUE (Fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Mar-2021, Body temperature: 102 (High) Reported as 102 Fahrenheit.. On 15-Mar-2021, Body temperature: 100 (High) Reported as 100 Fahrenheit.. On an unknown date, Blood test: inconclusive (Inconclusive) 7 rounds of blood work up was performed and results were not reported.. On an unknown date, SARS-CoV-2 test: negative (Negative) Tested negative.         No concomitant medications were reported. Initially the patient was prescribed with 4 mg of Duloxetine, but later physician increased to 20mg.  The patient noticed fever going up during the day, down during evening but had fever for every single day without fail for last three months. The patient reported that she can't receive vaccine on right side as the region was affected in past for infusion and mentioned that her physician had all the records of tests and results that were performed even the historical records. She had been evaluated by physician, infectious specialist, immunologist but body had no clue of events. The reporter mentioned that the doctors had even researched all the available literature to diagnose the cause of getting low grade fever on daily basis and these were affecting her work.  Action taken with mRNA-1273 in response to the events were not applicable.   This case was linked to MOD-2021-216565 (Patient Link).
Given varicella vaccine 10/14/99 and on 5/16/02 woke up with varicella covering arms, legs face, trunk
I am a MD student who got the first dose of the moderna vaccine on 1/4/2021. I had no immediate reaction other than arm soreness. A couple weeks after my first vaccine, I had a reaction when drinking miralax. Within ~5 minutes of having a few sips of a 17g solution, I had throat tingling/tightening, sense of impending doom, cough, dyspnea, nausea, fecal urgency, and intense chills with shivering. I stopped drinking the solution and my symptoms eventually resolved on their own (the chills and nausea took the longest, about 1.5 hours) - I didn't even think to take benadryl because it wasn't clear to me at the time if I was really having an allergic reaction (no hives, no vomiting - but in retrospect I'm concerned). I've had miralax in the past without any issues. I've never had a vaccine adverse reaction. I have no history of atopy.
A few hours after the vaccination, the patient became very nauseous and vomited. During the night she had a high fever and was sweating. He arm was very swollen and she had limited movement.
Throat began to feel like it was closing/difficulty swallowing, numbing on left side of tongue and jaw and left side of nose. Bad headache.  At 5:53pm still feeling numbness on tongue and roof of mouth, but otherwise symptoms of subsided.  Called doctor, Took 2 Benedryl (25 mg capsules).
Headache, Myalgia,  chills Narrative: Per nursing report: "took 2nd dose vaccine on 8-25-21. States on Thursday morning [8/26] woke up and felt like she had been in a terrible car accident. States entire body was aching and had a terrible headache along with constant chills. States missed Thursday [8/26] and Friday [8/27] due to the side effect of the vaccine."
No additional AE information provided.; temperature excursion; This spontaneous report was received from a physician, referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent condition, drug reactions/allergies and concomitant medication was not provided.  On 19-MAR-2022, the patient was vaccinated with improper stored varicella virus vaccine live (oka/merck) (VARIVAX) (0.5 ml, lot #U015689, expiration date: 18-MAY-2023, strength, and route of administration were not provided) for prophylaxis. The vaccine administered experienced temperature excursions of -14 Degree Celsius to -10 Degree Celsius with average of -14.5 Degree Celsius for 5 minutes (product storage error). No additional adverse event information provided.  This is one of two cases from same reporter.; Sender's Comments:  US-009507513-2204USA006500:
Injection site erythema narrower than 1 inch; injection site wheal - information has been received from a licensed practical nurse concerning a 12 month old caucasian male patient who on 03- Aug 2000 at 1:30 pm. was vaccinated subcutaneously in the right thigh with a first dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation) (635125/0400k).  Concomitant vaccinations that same day included a first dose of varicella virus vaccine live (msd) (lot #632613/1857J) administered subcutaneously via the left thigh.  The patient developed a large wheal at the injection site that when treatec with ice resolved within 30 minutes.  The reporter stated concern regarding the lot of the vaccine.  It was reported that 3 other patients (waes 00382071 through 00082073 ) had a similar experience following exposure to measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation).  Follow up information from the licensed practical nurse indicated that on 03 Aug 2000 the patient developed redness at the injection site 2 cm in diameter.  It was reported that subequently the patient recovered.  No further information is expected.
Patient called complaining about injection site being swollen and red. Area was size of baseball. Area was where ZOSTAVAX injection was given. Using ice and ibuprofen to help w/swelling.
It began with  severe chills and a low grade fever.  The following morning, my fever increased and the highest level noted was 101.8.  I had a loss of appetite, nausea, and no energy.  My fever lasted for approximately 30 hours before subsiding.  I alternated Tylenol and Alieve during my time with fever.  On Sunday, February 7, I began having mouth sores and fever blister on my lips.  For this, I used Lysine, both tablet and lip ointment.
Cellulitis with erythema, warmth, induration and pain. Fevers. Total body aches with HA.
After moderate swelling at the left arm injection site (within 24 hrs.), my underarm began to swell and became very painful. The lymph node (assumption) at my left arm pit stayed swollen for the next 24 hours while I maintained a moderate fever (99/100) with flu like symptoms with lethargy. Within 48 hrs. after injection I could feel an unusual sourness in my left arm extending from the inside of my arm near the injection site to the inside of my wrist (nerve ?). Today 10/16, the symptoms appear to be mitigating, but still very present and annoyingly painful at times.
At this time patient is not experiencing any side effects/symptoms. No additional AE details available. No additional AE reported; Inbound call from nurse who reports 4th dose of GARDASIL 9 has been administered to a patient. Product was administered 1/9/2023. At this time patient is not experiencing any side effects/symptoms. No additional AE details available. No additional AE; This spontaneous report was received from a nurse and refers to a female patient of unspecified age. Her concomitant medications, pertinent medical history, concurrent conditions, drug reactions or allergies were not reported.  On 09-JAN-2023, the patient was vaccinated with 4th dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (strength, dose, lot #, expiry date, and route of administration were not provided) for prophylaxis (Extra dose administered). It was reported the patient was not experiencing any side effects or symptoms. No additional adverse event details were available.
COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included mRNA-1273 (Spikevax) for COVID-19 prophylaxis.    No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) outcome was unknown.            No concomitant medicine was reported. It was reported that the patient got 2nd booster dose as well after the all 3 doses. No treatment medicine was reported.   Reporter did not allow further contact
Narrative: Patient reports slight arm pain at injection pain.  Other Relevant Hx: Symptoms:  & slight arm pain at injection site Treatment:
Multiple vesicles in various stages of development; rash present for ~6 days. Rash is pruritic. Treatment: atavax syrup 3/4 tsp every 6 hours PRN itching.
Received vaccine in L deltoid. Report swollen lymph nodes in L axilla, then R axilla about 4 days ago. Now swollen nodes in neck, starting to feel "sick". Rash on face also.
Diagnosed with Varicella 11-8-07; received Varivax 9-29-99.
Took the vaccine around 11:00 a.m. - around 10:00 p.m. lymph node under right arm got really large and was extremely painful. The lymph node under the left arm got really big too but not as big as the one under the right arm. I did get chills and felt like I had a slight fever. But what I really want to report is, I HAD HEART PALPITATIONS ALMOST ALL NIGHT - BUT HEART WAS RACING FAST AND THUMBING HARD...I DRUNK A LOT OF WATER THAT NIGHT - LIKE THE LADY TOLD ME TO DO. BUT THE PALPITATIONS WENT ON FOR ALMOST HALF THE NIGHT. SINCE I'VE HAD THE BOOSTER - ANY STRESS TO THE BODY - I HAVE PALPITATIONS WHICH I DIDN'T HAVE BEFORE.  In the past, I would only get palpitations if drinking alcohol sometimes and I had stopped drinking . Before the booster, i had not had a glass of wine for a year.  I DID NOT GET THESE PALPITATIONS FROM THE FIRST AND SECOND VACCINES - ONLY WITH THE BOOSTER AND NOW ANY SLIGHT STRESS TO THE BODY - I GET PALPITATIONS - FOR EXAMPLE, A STRING OF MY HAIRS WAS BEING PULLED FROM A BRAID AND I STARTING GETTING PALPITATIONS UNTIL I WAS ABLE TO FIND A WAY TO LOOSEN IT ---- THAT HAD NEVER HAPPENED BEFORE.
I had my second Shingrix shot and had many of the side effects. Muscle pain, feeling tired or weak, headache; shivering, upset stomach for two full days after the shot and two more days to get back to myself.
Approximately 1 month after the second dose of the COVID-19 vaccine, Shingles developed on top of patient's head and developed into the eyes. Two trips to Urgent Care  were required to diagnose and treat the symptoms of Shingles.
Information regarding PREVNAR 13 was received from a consumer regarding a 9-month-old female patient who experienced crying after receiving the injection, accidental overdose and receiving vaccine by mistake - dose was supposed to be given to another child. The patient received the first dose on 03-Aug-2010. The patient experienced crying after receiving the injection, accidental overdose and receiving vaccine by mistake - dose was supposed to be given to another child on 03-Aug-2010. The patient had previously received 3 doses of PREVNAR. Outcome was unknown. No additional information was available at the time of this report.
Patient was given nasal H1N1. Patient is 50 years old and should not have received the nasal H1N1. On 12/10/2009 pateint denies any problems at this time.
Felt sleepy almost immediately after napped for a few hours then was fine. My arm started to feel sore around the midnight and my lower back began hurting. Then around 3am I began getting the chills, my body was in so much pain like achy, a headache, and I could barely move my arm. It?s been over 24 hours after the shot I still have chills, body aches, headache, lower back area hurts really bad, and my right arm is still really sore.
Tooth pain in upper jaw; All upper molar teeth were uncomfortable with pressure and extra sensitivity; All upper molar teeth were uncomfortable with pressure and extra sensitivity; This is a spontaneous report from a non-contactable consumer, the patient. A 36-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE: Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 16May2021 at 11:15 (at the age of 36-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history. Concomitant medications were not reported. The patient had no known allergies to medications, food or other products. 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 17May2021 at 16:30, the patient experienced tooth pain in upper jaw, all upper molar teeth were uncomfortable with pressure and extra sensitivity. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events of tooth ache, tooth discomfort and sensitivity of teeth was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
neck pain that is shooting down the arm; muscle ache, muscle pain; Headache; fatigue; weakness; Arm Pain; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weakness), NECK PAIN (neck pain that is shooting down the arm), PAIN IN EXTREMITY (Arm Pain), MYALGIA (muscle ache, muscle pain) and HEADACHE (Headache) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included CARBAMAZEPINE, GABAPENTIN, LAMOTRIGINE, METOPROLOL, HYDROXYCARBAMIDE (HYDROXYUREA) and CALCIUM for an unknown indication.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm Pain). On 03-Mar-2021, the patient experienced ASTHENIA (weakness), HEADACHE (Headache) and FATIGUE (fatigue). On an unknown date, the patient experienced NECK PAIN (neck pain that is shooting down the arm) and MYALGIA (muscle ache, muscle pain). On 05-Feb-2021, PAIN IN EXTREMITY (Arm Pain) had resolved. On 04-Mar-2021, ASTHENIA (weakness) and HEADACHE (Headache) had resolved. At the time of the report, NECK PAIN (neck pain that is shooting down the arm), MYALGIA (muscle ache, muscle pain) and FATIGUE (fatigue) had resolved.            Treatment information was also not reported. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Not applicable) was Not applicable.   This case was linked to MOD-2021-272911 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 03-Aug-2021: significant FU- AE outcome updated to resolved.
developed a headached. Headache got worse. Took frovatriptan. Did not get better. Dizzines, upset stomach, progressed to vomiting x 3 episode Vomiting occured only on Sat.  Dizzines persisted Sunday, Monday, Tues (present day). Got better, not as dizzy but still feel a little bit dizzy and light headed.
Patient returned 3 days after DPT and IPV were administered at right upper leg with a large hot, itchy patch that was erythematous and swollen.
Initially, all I felt was extreme pain in my left arm. I was advised by the medical staff that my reaction was normal.  During the middle of the night, my left arm felt as if it was burning. It woke me up out of my sleep. From the injection site down mid-elbow, my arm was filled with hives & welts and it was extremely itchy. The arm also felt as if it was on fire.  I applied some Benadryl ointment on my arm and tried to go back to sleep. When I got up, both of my legs felt extremely numb. I felt as if I was walking on air. I attempted to walk around and fell in the street because I was not able to feel my legs. The numbness remained for the balance of the day.  I stayed in bed because I injured myself quite a bit. Every time I tried to move around, I felt as if I was walking on air and was not in a position to stabilize myself. This numbness feeling did not subside until Sunday evening, as well as the issue with my arm.
On April 7, my husband received the J&J COVID vaccination. On April 17, he started to feel ill and developed severe abdomen and back pain, which were not normal symptoms of his other health conditions. He ate very little on that date (and that was the last food he had). At 3:30 a.m. on Monday, April 19, I took him to the ER because of severe pain. They gave him multiple tests, including CT scan, labs, EKG, ultrasound, and others. He was admitted to the hospital, and multiple other tests were performed during his stay. During his stay, his sodium and other electrolyte levels dropped to dangerously low levels, he experienced major swelling, his pain persisted, his swallowing ability diminished, he didn't eat, and his heart consistently ran at a high rate. He was transferred home (with comfort care/hospice) on Tuesday, April 27, and died on Wednesday, April 28, at about 9:30 p.m.