chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pregnancy; Initial Report Received 29-Mar-2023  Spontaneous report received from a patient calling the Pregnancy Registry on behalf of a female friend who received HEPLISAV-B for hepatitis B immunization.    Medical history and concomitant medications were not reported.   On an unknown date, one week prior to 29-Mar-2023, the patient reportedly was vaccinated with HEPLISAV-B.  On 28-Mar-2023, the patient found out she was pregnant.    No additional information was reported.    Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
None at time of injection.  Adverse events later in life- neurologist seen for migraines and diagnosis of small fiber neuropathy. Dr. seen for IBS.
On 9/24/09 patient received FLUZONE vaccine. 10/5/09 - Had fever and tiredness (T 99). 10/6/09 - decrease in appetite, no v/o. Had stomach ache. 10/7/09 foot pain/swelling bottom of feet. 10/8/09 rash - 10/9/09  - rash around ankles, writs. 10/12/09 diagnosed with henoch - schonlein - purpura -  and lower extremities. Labs increased WBC / increased ESR / to be formed for 6 months. As advised by Nephrology.
diabetic & sugar levels were very high since shot; diabetic & sugar levels were very high since shot; Nose bleeds; Severe headaches; Nausea; Exhaustion; Irritability; Depression worsened; white "bumps" near eyes; Chills; Extreme agitation; Back feels twisted keeping her from sleep; Back feels twisted keeping her from sleep; Loss of appetite; itching in both feet 1st week; Nose running constantly; can't stand light in her eyes; This is a spontaneous report from a contactable consumer (patient). A 62-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the left arm on 01Apr2021 14:45 (Batch/Lot Number: ER8737) as dose 1, single (at the age of 62-years-old) for COVID-19 immunisation. Medical history included chronic kidney disease stage II, carpal tunnel syndrome, degenerative arthritis, high cholesterol, high blood pressure (BP), agoraphobia, anxiety, depression, Hashimoto's disease and diabetes. The patient has unspecified concomitant medications (reported as "many to list"). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took morphine and lisinopril and experienced allergies: anaphylaxis. She has 3 pages of adverse reactions to meds (unspecified). On 02Apr2021 at 15:00 the patient started to have the adverse events. The patient was still having severe headaches, nausea, exhaustion, irritability, anxiety, depression worsened, nose bleeds, white "bumps" near eyes, chills, diabetic & sugar levels were very high since shot. Extreme agitation. Back feels twisted keeping her from sleep. Loss of appetite. The patient would not be taking second dose. 12 days later she still felt the same. She was extremely cautious and had not left home except for labs for three times since the virus began. Nose running constantly, had itching in both feet 1st week. Headache was unbearable and she can't stand light in her eyes. The patient no longer had nosebleeds after 6 days. The patient added that were minor but definitely not the norm. No treatment was received for the adverse events. The patient recovered from the nosebleeds after 6 days (08Apr2021). The patient recovered from itching in both feet 1st week in Apr2021. The patient has not recovered from the remaining events.
low temperature (97) , pain and swelling of facial skin, eyes and sinuses, body aches and fatigue.
RECEIVED A FULL VIAL OF THE VACCINE; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced received a full vial of the vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of received a full vial of the vaccine was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comments not required as per standard procedure as the case is assessed non serious.
I got the first Covid shot on April 13, 2021.  The next day in the afternoon I noticed that the right side of my face was sort of sagging and I has having a hard time drinking without it spilling out of the right side of my mouth.  I called my doctor, but it was around 4:30 PM, 4/14/21.  The next morning I got a call back from her office around 10:30 AM, 4/15/21 and told them what was happening, I had Bell's Palsy  about 20 years ago and this seemed to be the same thing.  She had me go to the ER just to be sure I wasn't having a stroke.  I got to the hospital around noon and they saw me right away. the physician who saw me and diagnosed Bell's Palsy.  I got two prescriptions, one for Prednisone and one for Acyclovir.  I seemed to shake off the numbness in about 4 or 5 days.  I saw my own Dr. on 5/3/21 for ER followup.
5 Minutes after giving patient Vaccines the patient started to vomit, dizzy, and was a little coherent for like 10 minutes
Booster dose of Moderna bivalent were given after the 12 hrs; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Booster dose of Moderna bivalent were given after the 12 hrs) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7173B) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Booster dose of Moderna bivalent were given after the 12 hrs) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Booster dose of Moderna bivalent were given after the 12 hrs) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Booster dose of Moderna bivalent were given after the 12 hrs).    No concomitant medication was reported.  No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-719313 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-719313:Same reporter
This case was reported by a consumer via call center representative and described the occurrence of tremor in a 71-year-old female patient who received SHINGRIX for prophylaxis. In June 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In June 2018, less than a day after receiving SHINGRIX, the patient experienced tremor, headache, fever, cold sweat and influenza-like symptoms. On an unknown date, the outcome of the tremor, headache, fever, cold sweat and influenza-like symptoms were recovered/resolved. It was unknown if the reporter considered the tremor, headache, fever, cold sweat and influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The patient received the dose of SHINGRIX in left arm. The patient planned to continue follow-up with her physician on an unknown date. The patient had denied permission to contact their physician.
sx started around MN woke up several times-itching; had rash, hives, swollen hands & feet; achy joints/muscles; 14MAR94 red rash, some joints, dec strength; lump @ side as neck; red;
Feel dizzy; Feel weak; had pain; body temperature was 102°F.; had a reaction and said it was like having covid-19 all over again; Also mentioned that could not move legs,; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (had a reaction and said it was like having covid-19 all over again), MOBILITY DECREASED (Also mentioned that could not move legs,), DIZZINESS (Feel dizzy), ASTHENIA (Feel weak) and PAIN (had pain) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included GABAPENTIN, METOPROLOL and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Feb-2021, the patient experienced COVID-19 (had a reaction and said it was like having covid-19 all over again), MOBILITY DECREASED (Also mentioned that could not move legs,), PAIN (had pain) and PYREXIA (body temperature was 102°F.). On 08-Feb-2021, the patient experienced DIZZINESS (Feel dizzy) and ASTHENIA (Feel weak). At the time of the report, COVID-19 (had a reaction and said it was like having covid-19 all over again), MOBILITY DECREASED (Also mentioned that could not move legs,), DIZZINESS (Feel dizzy), ASTHENIA (Feel weak), PAIN (had pain) and PYREXIA (body temperature was 102°F.) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Feb-2021, Body temperature: 102°f °F High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Treatment information  provided
I got my first shot at 3:54 Sept. 17th 2021 (today) & only about a minute after i started having pain in the left side of my chest. I was a little light headed about 5-10 minutes after the shot. But by the time the 15 minutes were up symptoms seemed to have subsided a little bit, so i thought it would just go away & be fine. So i didnt bother the staff with this. But the pain didnt go away until later in the evening. From the time the pain started to late evening the pain slowly worked its way down the left side of my rib cage to my low stomach. My stomach started hurting with some nausea the same evening, with some minor shortness of breath but that seems to be getting better by 9pm.
On May 13, 2008 (24 days post vaccincations) child had what his mother described as "flu symtoms"-cough, slight fever, headache.  He seemed to get better after a few days, and then on May 20, 2008, he had a worsening headache, complained of dizziness, and was "clumsy and confused" according to mom. He also had a few episodes of panicking, and "talking out of his head".  Mom also reported fever and some vomiting. The child was taken to Medical Center Emergency Room on May 21, 2008, then transferred to Hospital Emergency Room to be admitted to the Pediatric Unit.  Child is currently a patient at Medical Center Pediatric ICU.  Dx: Acute Disseminated Encephalomyelitis  06/23/2008  Partial MR received for DOS 5/22-7/25/2008 with DX:  Acute Disseminating Encephalomyelitis. Patient initially presented to local hospital with 1 week hx of flu-like sx of cough, fever, and headache. Seemed better for 2 days but then developed worsening h/s, dizziness, clumsiness and confusion. Parent reported some vomiting, panic episodes and disorientation. Transferred to current facility for eval and tx.  Given high dose steroids, plasmapheresis and IVIG without improvement. Intubated 2' to a lung puncture during an IJ insertion attempt, resulting in pneumothorax and chest tube insertion. Developed seizure-like spells. NG tube placed for nutrition. Posturing noted on 6/3/08 exam. Unable to follow commands. Spoke in nonsensical language. Developed agitation tx'd with meds, Candida and Saprophyticus UTIs. Improvement noted in July and pt able to ambulate with assistance. Getting speech, OT, and PT. Discharged to rehab facility.
04/20/2021 developed rash on body. Symptoms off and on.  05/31/2021 patient developed worsening rash 06/02/2021 patient evaluated. Admitted to hospital for ITP.  06/14/2021 patient re-admitted for ITP
chills; fever; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 04-Jun-2021 and was forwarded to Moderna on 04-Jun-2021.    Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills) and PYREXIA (fever) in a 32-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No medical history was provided by the reporter.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CHILLS (chills) and PYREXIA (fever). At the time of the report, CHILLS (chills) and PYREXIA (fever) outcome was unknown.            Concomitant and treatment medication was not provided.
Patient was given an undiluted  0.3 mL Pediatric Pfizer vaccination.  Patient reported pain at injection site at time of vaccination; pain remained 24 hours later.
FLUMIST received 12/27/08. On 12/30/2008 began experiencing itching of nose, 101 f temperature; aching of neck and back. Dad contacted PMD who did rapid flu swab which was positive. Dad called CDC and was told to rep out it to local health dept.
received a dose of menactra at 4 months and 3 days old(with no reported adverse event); Initial information received on 02-Aug-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 4 months 3 days  old female patient who  received a dose of menactra with no reported adverse event while receiving vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].  The patient's past medical history, medical treatment(s), and family history were not provided. Concomitant medications included ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) for Immunisation; and PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for Immunisation.  On 02-Aug-2022, the patient received a dose number 1  of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE( lot U7273BB and expiration date: 24-Apr-2023) at a dose of 0.5ml via intramuscular route in the left thigh for immunization.  On 02-Aug-2022 (latency: same day) , the patient received a dose of menactra with no reported adverse event (product administered to patient of inappropriate age) following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE.  Action taken :not applicable  It was not reported if the patient received a corrective treatment for the event (received a dose of menactra at 4 months and 3 days old(with no reported adverse event)).  Outcome: unknown   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. 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.
12 hours after vaccine I had body aches, rapid heart rate and a headache for 3  to 4 days after vaccine
High fever, shivers, body aches, muscle aches,joint Aches, dehydration Worse than the first shot. I could not stand or walk. I continued to have issues for about a week.  All previous issues like ear infections and mouth sores flared up.
03/25/2023 COVID-19 positive. Symptoms; sore throat, coughing, fever, body aches. 03/26/2023 contacted Physician and was prescribed a 5-day course of Paxlovid.
Paralysis of R leg secondary to demyelination lesion in L frontal lobes.  ADEM vs. early multiple sclerosis.  5/7/2008 MR received for DOS 1/08-12/2008 with Final DX: ADEM vs MS.   Pt presented to ER with R lower extremity weakness.  5 days prior to admission pt c/o h/a and sore throat which resolved. Two days later pt had several episodes of falling,the R calf felt heavy, and pt began dragging the R foot while walking.  PE (+) for decreased reflexes of the R ankle and bilateral patellar.  Decresed strength on R. Tx with prednisone taper. 3/31/2008 F/U Neurosurgery visit of 1/18/2008 received.  Pt doing well in f/u for stereotactic biopsy of a parietal mass which was noted to be a demyelinating disease on bx. Pt still has some weakness of the R lower extremities (toes and with dorsiflexion) and with tandem heel-toe walking.  otherwise exam WNL. 02/06/2010 Still some weakness in right leg.
Pain and stiffness at the injection site. Over the next two days became difficult to raise my arm over my head.  The pain and stiffness worsened over time, and my arm still hurts two days later.
This spontaneous report as received from a medical assistant refers to multiple patients of unknown demographics. On an unknown date in 2013 the patient was vaccinated with GARDASIL. The medical assistant reported that, multiple unspecified patients were administered with GARDASIL that was exposed to unspecified temperature excursions from January 2013 to the present. No adverse effects were reported. This case is linked to 1401USA000054, 1401USA000055, 1401USA000056 (same reporter). Additional information has been requested.
anxiety; They felt soreness in the arm and sleepiness after the first dose of the Pfizer COVID-19 vaccine; mental problem; so sick; They felt soreness in the arm and sleepiness after the first dose of the Pfizer COVID-19 vaccine; This is a spontaneous report from a contactable consumer. A 40-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 22Mar2021 (Batch/Lot Number: EP6955) as SINGLE DOSE for covid-19 immunisation.   Medical history included bipolar from an unknown date and unknown if ongoing, depression from an unknown date and unknown if ongoing.     The patient's concomitant medications were not reported. On 22Mar2021, the patient experienced sleepiness. On an unspecified date, the patient experienced anxiety, they felt soreness in the arm and sleepiness after the first dose of the Pfizer COVID-19 vaccine, mental problem, so sick. She had really serious problem, had to leave work and go to the hospital and get treated for anxiety in the emergency room.  Causing her anxiety to go crazy. After taking the Vistaril yesterday it calmed the girlfriend down. Outcome of events anxiety, felt soreness in the arm, mental problem, so sick was unknown. Outcome of Sleepiness was recovered in 2021.   No follow-up attempts are needed. No further information is expected.
Information has been received from a consumer concerning her approximately 12 month old son with a history of intussusception and appendix removed and no drug reactions or allergies who on approximately 11-SEP-2005 was vaccinated with a dose of MMR II (Lot #, expire date and route not reported). There was no concomitant medication. Consumer stated that when her son was around 12 months old after receiving MMR II in approximately 11-SEP-2005, her son experienced rash and itching. Consumer mentioned she noticed a lot more reactions to many types of food with rash and itching after receiving MMR II. Consumer added that on an unspecified date, an allergy test was ordered by physician and her son was found to be allergic to egg white. Consumer also reported that her son's nose was always stuffy. On an unspecified date, antibody levels for measles were measured and showed low antibody levels and physician ordered a booster shot with receiving MMR II. Consumer said creams were given as treatment. At the time of the report, the outcome of the patient was unknown. Follow up information received from the physician on 27-JAN-2011, she stated that she did not have any contact from the patient's parents for 10 days after immunizing the patient. The reason they contacted her because the whole family had strep on an unspecified date, outcome was not reported. Follow up information was received from the physician, who stated that the patient never had intussusception, he had is appendix removed laparoscopically, and he had the appendix removed before MMR II. Additional information is not expected.
Rash at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Rash at injection site) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced VACCINATION SITE RASH (Rash at injection site). At the time of the report, VACCINATION SITE RASH (Rash at injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
At a vaccine event on Jan. 22, 2022 a 65 year old male received a booster dose of Moderna. The individual informed staff that he received the full course of the Sinopharm vaccine primary series, with his last dose in August 2021. Although it has been at least 5 months since his primary series, we are reporting this as an adverse event because the current CDC recommendation for booster dose for individuals who have completed a primary series WHO authorized COVID-19 vaccines would be to receive a dose of the Pfizer COVID-19 vaccine.  The individual tolerated the Moderna booster dose, was monitored for at least 15 minutes after receipt of the dose, and no adverse events were reported and the individual was noted to be in stable condition after leaving the event.
It started out with flu like symptoms and severe joint pain on Friday afternoon. While those symptoms went away like they had in all prior vaccines my left side (I receive vaccine on left side) continued to have severe pain. It felt like I pulled a muscle in my neck, shoulder, arm and side on the left. The pain is still persistent but slowly becoming less. This was with me taking Tylenol consistently and doing warm compresses and taking warm showers for relief.
Since my third Pfizer shot, I have issues with my left arm. I have a limited range of motion, some pain and weakness. When I got my fourth shot, I told this nurse about this experience and she asked me to report it through this site.
pt became woozy & fell to ground, bumping head a few min p/vax;pt c/o feeling heavy, tingling of hands, no SOB, no rash, no loss of consciousness;amb took pt to hosp;
15 minutes after vaccination, I began to feel nauseous , headache and tired. This lasted about 3 days and also very painful injection site (much more than with influenza vaccine). I felt much better on the 4th day but on the 5th day began having chills, dizziness, ongoing severe headache , dizziness and lethargy, this lasted 5 more days. Total 9 days. I had a teleheAlth visit and was tested for covid, influenza and RSV, all were negative. Oddly enough, the next day , after both the first and second doses, I developed a style in my left eye