chrisvoncsefalvay/vaers-outcomes huggingface dataset:
second dose for pre-exposure was not available for administration with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from other health professional via The Agency (Reference number- 00351800) and transmitted to Sanofi on 09-Nov-2020.  This case involves a male patient who did not received second dose of RABIES (HDC) VACCINE [IMOVAX RABIES] for pre-exposure as it was not available for administration with no adverse event, (lot number not reported, expiry date not reported) via an unknown route in an unknown administration site for prophylactic vaccination, on an 9-Nov-2020 (product dose omission issue). The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  This was an actual medication error case due to missed dose (latency same day).  No lab test was reported. Action taken was not applicable. Corrective treatment was not reported. The outcome of the event was not applicable. 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.  There will be no information on the batch number for this case.
A nurse reported that a male child received Cholera vaccine, USP along with Typhoid and DTAP vaccines in 1985, at 9 months of age. According to the nurse, the child's parents allege that he developed mental retardation as a result of Cholera vaccine, USP administration. Mental retardation is considered "Medically Important". No further information was available at the date of this report. The reporter indicated that the child received DTAP vaccine in 1985; however, Wyeth Lederle did not manufacture DTAP vaccine in 1985. F/U states on 10/16/01, it was found that the primary suspect was inadvertently listed as Cholera Vaccine (Lederle). This report is being resubmitted with the primary suspect now listed as Cholera Vaccine, USP (Wyeth).
Patient is complaining that her arm is till sore from the 24th and that she does not have full range of motion of her arm.
Friday morning 10 hours of temp, as high as 101.2. Went to bed and got up at 4:15 am woke up with nausea , got up one more time around 4:30 to go to the bathroom and woke up on the bathroom floor. Had passed out.  Went to on Monday and was told that she had a concussion.
Approximately 3- 5 minutes after felt strange mild sensation as if pins and needles was moving throughout my body from the injection site. I also started to breathe differently. Couldn't tell if my heart rate changed or not.   At about 5 minutes, I started to feel light-headed and nauseous as if I just had blood taken or an IV in my, likely a drop in blood pressure. I was reading a book, put it down on my lap as I couldn't focus on reading and considering to get help. At that moment, I passed out, hunched over in my chair staring at the floor.   This moment likely lasted for about 1 minute, but felt like 20. I was in a dream like state and at one point had a series of images and/or memories flash by in a sequence. Then, I felt like I was half asleep but couldn't tell what I was staring at but knew that I had to "wake up".   Then , I was surrounded by people who helped me up. At this moment I felt very weak and tired and was sweating profusely. My right hand felt very weak.   About 10 minutes later, I started feeling better. I was given water which seemed to help. I would have waves of mild nausea come and go that eventually subsided. I also felt random cramping around my stomach/lower chest area and lower right side rib cage area.   At about 15 -20 minutes felt confident to walk to the bathroom and throughout the store. Eventually, I felt confident to drive safely home.  At the time of writing this (approx 2 hours later), I'm feeling random sensations/feelings of itchyness throughout my body. No sign of hives.
Pt had prevnar, Hemaph Aventis in the rt and lt leg. 3 hours after recieving them could not move legs. Cries when moved. Rash broke out 3-4 days after vaccine. No site induration.
Developed red raised rash on both upper extremities. (fine petechial rash) The injection site became red and swollen and painful.
Arm is hot; Back hurts; Neck hurts; This spontaneous case was reported by a pharmacist and describes the occurrence of FEELING HOT (Arm is hot), BACK PAIN (Back hurts) and NECK PAIN (Neck hurts) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2022, the patient experienced FEELING HOT (Arm is hot), BACK PAIN (Back hurts) and NECK PAIN (Neck hurts). At the time of the report, FEELING HOT (Arm is hot), BACK PAIN (Back hurts) and NECK PAIN (Neck hurts) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided.   Reporter did not allow further contact
9.5 x 9.5 cm erythema (R) thigh at injection site.
Cold Hands & Feet two weeks after flu shot, then numbing of hands and feet from elbows down and knees down. numb spot on back. feet are still numb as of this date, but improving.  Lost weight as I could not eat. first Doctor I went to said I had GERD and gave me the purple pill, but could not tell me why my feet and hands were numb. Internal med Doctor took Blood test, Xrays, Cat scan, MRI and referred me to a neurologist and I had a Spinal Tap on March 12,2003 and was told I had GBS, which still lingers today. No more flu shots!!!!!!!!! Medical records state decreased reflexes,abnormal gait. msv
Vaccination site pain; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE PAIN (Vaccination site pain) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, the patient experienced VACCINATION SITE PAIN (Vaccination site pain). At the time of the report, VACCINATION SITE PAIN (Vaccination site pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  No treatment information was provided.
Chest is really heavy; Oxygen saturation level is going down to 93. It oscillates between 93-96% and it is normally higher; Slept most of the day; Tired; Felt groggy; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Felt groggy), FATIGUE (Tired), CHEST DISCOMFORT (Chest is really heavy), OXYGEN SATURATION INCREASED (Oxygen saturation level is going down to 93. It oscillates between 93-96% and it is normally higher) and HYPERSOMNIA (Slept most of the day) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, the patient experienced SOMNOLENCE (Felt groggy), FATIGUE (Tired) and HYPERSOMNIA (Slept most of the day). On 24-Apr-2021, the patient experienced CHEST DISCOMFORT (Chest is really heavy). On an unknown date, the patient experienced OXYGEN SATURATION INCREASED (Oxygen saturation level is going down to 93. It oscillates between 93-96% and it is normally higher). At the time of the report, SOMNOLENCE (Felt groggy), FATIGUE (Tired), CHEST DISCOMFORT (Chest is really heavy) and HYPERSOMNIA (Slept most of the day) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Persistent muscle pain in deltoid started day of vaccine. Pain slightly alleviated with movement/use. Severity of pain varies.
Patient received her second Shingrix shot in the series. She has reported to the pharmacy she still has arm pain.  She has made her physician aware, and he will monitor in another few weeks.  It is extremely sore in the evening and is still sore to sleep on the left arm muscle.
Pt exp a local rxn, consisting of warmth & swelling, @ the inject site p/recvd Typhoid vax;
Fatigue during exercise, after meals, during and after sleep. This random effect started a few months post deployment. Sleep disorders and digestion disorders were also seen. Acid reflux, allergies, cold and flu-like symptoms, asthma, blood pressure high, depression, gastritis, insomnia, numbness and tingling fingers, sinusitis,  10/16/06 Records reviewed.  Records received are for 2006 only.  MSW screening positive for depression 5/06.  6/06 PCP note indicates patient has HTN, upper back pain, insomnia, anxiety & reddish skin rash in elbows with mild scaling for a few months.
A non-serious spontaneous report of "we administered expired FLUMIST" was received from a health professional concerning a 36-month-old male patient. Neither medical history nor concomitant medications have been reported. The product expired on 20-Feb-2010. The patient received the expired FLUMIST on 22-Feb-2010. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age. Additional information was received on 08-Jun-2011 and incorporated into the narrative: The patient did not have any late occurring adverse events.
Client called to report she was sore and didn't feel well the night of vaccine 04-16-21, then at 2:30 AM she woke up and felt like her skin was on fire with stabbing pains on right side of head, felt sciatic pains down her left leg, stabbing pains top of legs esp on left and into feet.  Felt hot but no temperature.  Family wanted to take her into ER, but she refused.  Stated all the next day she was in bed, stabbing pains had stopped.  On Monday she reports all her muscles hurt and ache, is very tired.  Taking aleve and tramadol.  RN (I) her to report this to her local physician.
Pt. in tent 23 at 2:05 pm at observation line.  Complained of light headed and increased blood pressure.  Paramedics assessed pt.  They monitored her until her symptoms subsided.  Pt. was released.  Husband drove her home.
The day after the vaccine was given she abruptly developed fever, chills, photophobia, rash and general feeling of being significantly ill.  The illness lasted 6 hours and abruptly stopped. This is being reported by the physician who saw her for the adverse reaction on 4/19/2006.
woke up my eye burned like somebody touch me, was color blue like someone hit me. only right side; woke up my eye burned like somebody touch me, was color blue like someone hit me. only right side; This is a spontaneous report from a non-contactable consumer (patient).  A 59-years-old female patient received the first dose bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on an unspecified date (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for covid-19 immunisation. The patient medical history and  concomitant medications were not reported.  On an unspecified date the caller reported I woke up and  my eye burned like somebody touch me, was color blue like someone hit me. Only right side. I got my injection in the left arm. Consumer inquired What happens in the second vaccine?  Can it be worse after the second? Is there any record of this happening on the inside. (bruising, blood clotting) ? The clinical outcome of the events was unknown.  No follow-up attempts are possible. No further information expected.
cellulitis at injection site. Diagnosed on 1/13.  Bleeding and swelling and soreness immediately.  Very sore arm and bruise got darker and darker.  Started to feel better then began to get itchy on 1/11. Knot formed. Swollen raised. 1/13 raised. Red. Hot to touch. Low grade fever. Redness spread throughout the day. Grew approximately 4 inches around in size by 9pm at night.
PATIENT WAS GIVEN THE PEDIATRIC FORMULATION OF THE HEPATITIS B VACCINE INSTEAD OF THE ADULT FORMULATION OF THE ABOVE MENTIONED VACCINE
ADVERSE EVENTS: 12:30-12:35- "DIFFICULTY BREATHING, COUGHING". HX OF ASTHMA.  TREATMENTS: ALBUTEROL TREATMENT, DEXAMETHASONE ADMINISTERED. TRANSFERRED TO HOSPITAL
Bell's Palsy - left eye began watering on Thursday, left side of mouth does not move when I smile, went to doctor on Friday (today) and he diagnosed me with Bell's Palsy.
headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 26 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 14Apr2021 10:30 (Batch/Lot number: EW0162) at the age of 26 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset 14Apr2021 13:30, outcome "not recovered", described as "headache".  Additional information: There was no History of all previous immunization with the Pfizer vaccine considered as suspect, no additional Vaccines administered on Same Date of the Pfizer Suspect. Prior Vaccinations (within 4 weeks) was reported as none.  No follow-up attempts are possible. No further information is expected.
Soreness left arm at injection site- 12 hours after injection, Ibuprofen taken, resolved 36 hours after injection Low-grade fever 99.9, at 2 am, approximately 14 hours after injection, Ibuprofen taken, resolved 24 hours after injection Chills- at 2 am, approximately 14 hours after injection, Ibuprofen taken, resolved 24 hours after injection Body aches- at 2 am, approximately 14 hours after injection, ibuprofen taken, resolved 24 hours after injection Tiredness - Began approximately 12 hours after injection, lasted  approximately 32 hours after injection
Information has been received from a pharmacist via a field representative referring to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX, subcutaneously (one time injection, dose and lot number not provided). On an unknown date, the patient was diagnosed with shingles after receiving the ZOSTAVAX vaccine. The outcome of shingles was unknown. Additional information has been requested.
Severe midsternal chest pain, arching of back, throat pain, hyperventilation with dilation of pupils and period of unresponsiveness lasting 30-60 seconds, and recurring every 10-15 minutes for approximately 6 hours.
Dry cough; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Dry cough) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, the patient experienced COUGH (Dry cough). At the time of the report, COUGH (Dry cough) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.  For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments.   Reporter did not allow further contact
No reaction to Moderna dose 1.  However, a few days after Moderna dose 2,  had sudden involuntary clenching of jaw, causing biting of tongue or cheek. This happened several times a day, sometimes causing bleeding. Frequency has been going down, starting about 2 months after the shot. It has stopped happening about a month back.
Starting  five days after receiving the second dose she developed hives across her body which she was able to manage at home using Aveeno lotion and oral Benadryl. She reports that the hives will appear intermittently and go away. This was not a problem that she had before receiving the vaccine.
Severe ringing in both ears still to This day my ENT has tried different Medications and nothing has worked  also now I get vertigo
Pt experienced n,v, diffuse abd pain, flushing, chills, muscle aches, h/a, & "hot cheeks", diarrhea & felt weak following 2nd dose Recombivax HB; Vaccinated w 1st dose w/no side effects;
1hr p/vax arm numb & swollen @ site (half dollar size); 7JUL arm sore but felt OK; 9JUL 3AM all body numb, shivering & sweating, muscle spasms of arm & legs, joint hurt; did not take temp;APAP given; arm still aches, very tired; joint pain
WITHIN 2 HOURS, had symptoms of meningitis -- she had a 102 fever, severe headache, weakness, heart racing, diarrhea, throwing up & very sore (not stiff) neck and was very white. Went to pediatrician -- told she had viral infection.  Next day she was even worse, went back to pedicatrician -- told shot wasn't live and that she couldn't have meningitis.
My lymph node inside my armpit was tender and swollen for about 13 days. I missed my cycle the month of vaccine. I had a lot of muscle soreness and fatigue at the site of injection. My mobility was very limited. The fatigue lasted for about 12 days and then the next month, I did get my cycle, but it lasted for 14 days. My cycle went back to normal until this month (August) and then I missed my cycle again.
Woke up to an extremely heavy flow, extremely light viscosity period that lasted three hours. Note that my normal period is EXTREMELY regular, almost to the hour, and was not due for another 10 days. My normal period is very light flow, heavy viscosity. The amount of blood was almost impressive. This was followed by extreme cold and extreme hunger, with an occasional hot flash, and a lot of dizziness accompanied by some heart fluttering. All of this subsided almost entirely by 3:00 p.m., and later in the evening the heart fluttering and dizziness picked up again. It relaxed for a while then around 10:00 p.m. my heart and my left arm and back (below shoulder blade) got very, very tight. I would vacillate between tightness in my chest and extreme heart pounding - I could feel my heart beat through my whole body. When I went to bed around 11:00 p.m. my heart was pounding out of my chest and it was hard to sleep because my arm and back/under shoulder blade/underarm hurt.
Swollen, red 4-6 inch area on left arm. It was hot to the touch. About 4-5 inches below the injection site. Lasted about 18 hours.
Couldn't sleep; Was sick all night; headache; Fever; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Couldn't sleep), ILLNESS (Was sick all night), HEADACHE (headache) and PYREXIA (Fever) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     No medical history reported.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced INSOMNIA (Couldn't sleep), ILLNESS (Was sick all night), HEADACHE (headache) and PYREXIA (Fever). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. At the time of the report, INSOMNIA (Couldn't sleep), ILLNESS (Was sick all night) and HEADACHE (headache) outcome was unknown and PYREXIA (Fever) had not resolved. Not Provided    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No relevant concomitant medications were reported.
Pulmonary Embolism, in hospital from 4/15 to 4/18, Eliquis DVT Treat 30D, apixaban oral tablets, famotidine chewable tablet, tramadol tablets
100 degree temperature at 4:00 pm.  Had fever since morning. Swollen, tender, painful lump that extends from top left shoulder to top of left collarbone.  Itchy, feverish, swollen rash at  Varicella injection site. Body aches.
PREVNAR 13 injected in right thigh.  Redness that continued to darken.  Swelling half inch above skin that hardened the following 24 hrs.  The red welt and hard swelling spanned over four inches away from actual injection site.  Fever of 100.2  Intense pain on that leg.  This is compared to a different vaccine on the other leg that left only a tiny little dot @ injection site.  Large bruising and lump still across thigh, two days later.  Still watching leg/mood/etc.
30 days after my second shot. I am experiencing chills, fever, headaches, joint pain, sweating, a week of fatigue, dizziness and fainting.  48 hours of chill fever headaches joint pain. 24 hours of dizziness and fainting.
Dizziness & HYPOtension Narrative: Pt reported feeling dizzy and faint about 10 min post vaccination. Pt was noticeably diaphoretic. Vital sign machine was unable to take BP initially, but next readings came back low 90s/60s. Pt was observed for additional 15 minutes and felt better so was released.
Fever up to 102.9 Chills Nausea and vomiting  Earache Headache Backache  For
Information has been received from a physician concerning a 9 year old male patient who on 21-AUG-2008 was vaccinated with a second dose of VARIVAX (Merck) (lot # 660499/0132X). On 09-SEP-2008 the patient was seen in the physician's office with the complaint of chicken pox. The patient's sister also developed chicken pox after vaccination with VARIVAX (Merck) (WAES# 0809USA02381). Additional information has been requested. This is one of several reports from the same source.
Flu vaccine, further information about dosage and type unavailable. Severe lower intestinal cramping and diarreah, sudden onset 5.5 hours after vaccine. Profuse sweating and low body temperature (95.5 degrees) for approx 2 to 3 hours after onset. Extreme weakness, fatigue, dizziness, and mental fog. Temperature returned to normal by midnight. Diarreah continues as of time of submitting this form, as does weakness. Cramping has subsided and mental clarity has returned, but still a general feeling of extreme fatique and general body aches. No side effects such as swelling of lips or impaired breathing. No treatment at this time except for fluids, rest, tylenol.  Have regularly had flu shot with same provider with no reactions of note, except for some localized pain at site of injection.