chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a healthcare worker referring to an unspecified number of patients of unknown age and gender. On unknown dates, the patients were received totally 40 doses of improperly stored ROTATEQ orally (lot number and dose were unknown). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Day 2, On 03-05-2021 I experienced a lemon size red raised welch on my right arm. Day3, 03-06-2021: my welch got bigger in size, triangular in size and it was the size of my palm including fingers. I also experienced GI issues, bad gas in my stomach and it was more like an inflammatory reaction in my body after my second dose vaccine.  Let me also say that after a 6 year of rheumatoid arthritis, I know have a huge flare up and because of increase pain and peripheral neuropathy, I talked to my PCP about my symptoms. My rheumatoid factor is 33 and because of this reading, I have been referred to a rheumatologist. My TSH was fine and after the second vaccine my TSH decreased which indicates hypothyroidism and it decreased by 450%. My normal is 199. It went to 3.3 and in three weeks it went down to .6. I have had a tough time since the vaccine, and I have to take a Xanax ever so often. I am suffering from hypothyroidism, and I am suffering from rheumatoid arthritis which was in remission the past 6 years. Also, about two months ago, I had a cat bite, where I had one little puncture and ended up with cellulitis and had to be on IV and antibiotics. They gave me a tetanus shot which I had a reaction to, and I relate my symptoms to the inflammation I have had since receiving my second dose vaccine.
Information has been received from a physician concerning a "15 year old" female who on an unspecified date was vaccinated intramuscularly with a 0.5 mL second dose of GARDASIL vaccine (yeast) (lot # not reported). Subsequently the patient fainted after receiving the second dose of GARDASIL vaccine (yeast). The patient sought unspecified medical attention. The physician reported that the patient recovered "the same day as the adverse experience". Additional information has been requested. This is in follow-up to freport(s) previously submitted on 7/14/2008. Information has been received from a physician concerning a 15 year old female who on 10-JUN-2008 was vaccinated itramuscularly with a 0.5 ml second dose of GARDASIL (lo #659693/1048U). Subsequently the patient fainted for less than 30 seconds after receiving the second dose of GARDASIL  on 10-JUN-2008. The patient had no seizures and received spontaneously on the same day. The patient felt weak, lighteded and dizzy. She lied doen for 15-10 minutes and felt better so was discharged home, The patient sought unspecified medical attention. Additional information has been requested.
MODERNAMONOVALENT BOOSTER DOSE WAS ADMINISTERED INSTEAD OF THE MODERNA BIVALENT BOOSTER DOSE
12 hrs post immunization greater than T 102 marked swelling of L deltoid and bright up then extends from top L shoulder to mid fumur with marked induration. Better ? several days-blister formed and sup turned this am. ? On 9/25/03 presented on 9/25/03.
Fear of needles, lightheaded. BPs 149/91 (pulse 74), 138/89 (pulse 73). O2 sats 98%-100%. Given juice, water, and crackers.
Intense chills/shivering; Feeling chilly and achy; Feeling chilly and achy; Temperature which was elevated; Mild fever; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration in the left arm on 01Apr2021 at 13:15 (at the age of 34-year-old) as a single dose for COVID-19 immunisation. Medical history of the patient was reported as none. The patient had no known allergies. The patient's concomitant medications included levothyroxine (MANUFACTURER UNKNOWN) 125 mcg once daily and diphenhydramine (MANUFACTURER UNKNOWN) for an unknown indications started from an unknown dates. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration in the left arm on 11Mar2021 at 13:15 as a single dose for COVID-19 immunisation. 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 02Apr2021 in the morning at 03:00, the patient woke up feeling chilly and achy. The patient took his temperature which was elevated at 99.9 F. The patient spent the rest of the day with aches throughout his body and a mild fever. The highest the fever got to was 100.5 F. The patient thought, he was feeling better in the evening, but at 22:00 when the patient walked around he had intense chills/shivering. However, by the time he woke up on the next day 03Apr2021, the patient basically felt totally fine. The events did not result in doctor or other healthcare professional office/clinic visit/ emergency visit. Therapeutic measures were not taken as a result of adverse events. The clinical outcome of the events chilliness, aches, temperature elevation, fever and shivering was resolved on an unknown date in Apr2021.   No follow-up attempts are needed. No further information is expected.
Felt specially dizzied; Space out/ Spacie; Not filling 100 percent/ Feeling crappy; Feel fatigue since getting their third shot  for two days, and still on going but in  on and off; Second dose on 29March2021 and the third shoot on 16Aug2021; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Felt specially dizzied), FEELING ABNORMAL (Space out/ Spacie), MALAISE (Not filling 100 percent/ Feeling crappy), FATIGUE (Feel fatigue since getting their third shot  for two days, and still on going but in  on and off) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose on 29March2021 and the third shoot on 16Aug2021) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011d21a, 028a21a and 027a21a) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included ADALIMUMAB (HUMIRA) for an unknown indication.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Aug-2021, the patient experienced FATIGUE (Feel fatigue since getting their third shot  for two days, and still on going but in  on and off) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose on 29March2021 and the third shoot on 16Aug2021). On 28-Aug-2021, the patient experienced DIZZINESS (Felt specially dizzied), FEELING ABNORMAL (Space out/ Spacie) and MALAISE (Not filling 100 percent/ Feeling crappy). On 16-Aug-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose on 29March2021 and the third shoot on 16Aug2021) had resolved. At the time of the report, DIZZINESS (Felt specially dizzied), FEELING ABNORMAL (Space out/ Spacie), MALAISE (Not filling 100 percent/ Feeling crappy) and FATIGUE (Feel fatigue since getting their third shot  for two days, and still on going but in  on and off) had not resolved.            The patient stated that the concomitant medication Humira had a side effect of lowering the immune system.  Treatment information was not provided.  The patient felt fatigue since getting third shot for two days which was still on going but in on and off.   This case was linked to MOD-2021-300555 (Patient Link).   Reporter did not allow further contact
Right arm showed signs of discomfort a few weeks after the flu vaccine. Mostly aching & I noticed a gradual loss of ability to reach areas I had previously without pain.  I was being treated on Jan 11, 2023 in ER Dept for a Kidney Infection and Kidney stone when I was given an injection of Toradol for pain in my right arm. This is the same arm I the flu vaccine. The instant the needle went into my arm I had the most excruciating pain that made me double over and grab my arm. I felt the sting of the Toradol which I knew was normal. But not the horrible pain that stayed with me  for hours. Since the. I have had more pain that travels all the way down my arm, my arm aches all night long, I have lessened mobility and am unable to reach areas I was before. Today I saw my Dr. who gave me a cream to use for pain. He also gave me a list of excerises to  try to help to increase mobility.  He believes it was a combination of both the flu vaccine and the Toradol shot that has me in so much pain.
This case was found during archiving activities and has not previously been entered into the global safety database. The case was processed using procedural documents and current labelling documents. This spontaneous report was received from a health professional and concerns a 46 year old female subject; Local case ID: 9414. The subject's weight and medical history were not reported. The subject received VIVOTIF (typhoid vaccine oral ty21a) (capsule, hard, oral, batch 132053B) administered on an unspecified date for prophylactic vaccination. Concomitant medications were not reported. On 24-SEP-1994 (interval period from vaccination to onset of reported event was 6-12 hours) the subject developed diarrhea. On 26-SEP-1994 (interval period from vaccination to onset of reported events was 6- 2 days) the subject experienced stomach cramps, breasts sore and kidney sore. The action taken with typhoid vaccine oral ty21a was unknown. The subject's outcome was unknown for kidney sore, diarrhea, stomach cramps and breasts sore. The reporter considered the events of diarrhea, stomach cramps to be definitely related and kidneys sore and breasts sore to be unrelated to typhoid vaccine oral ty21a. This report was serious (medically significant).
pt had flu vax accidentally squirt in lt eye & exp a lot of burning;pt was instructed to flush eye,& p/15 mins of flushing the eye was still burning;the eye burning finally resolved;however,pt c/o eye dryness,attributed water irrigation
Received pneumodical vac sub q right arm. Pt reports swelling, redness, pain started 10/16/03 PM. Today arm red from elbow up arm, very warm to touch, swollen around elbow area.
Headache; Muscle spasms in calf and finger; Deep bilateral muscle pain/discomfort/stiffness in lower back and thighs; Peroneal nerve and tendon damage; Paresthesia; Hypoesthesia.
Very swollen lymph nodes in neck and near clavicle, on injection-side of body. Ice packs have been helping to reduce pressure and discomfort.
bad reaction after both doses; arm was pain; head was pain; felt like all her inside organs were painful; Could not use the arm; Pain and sore in the muscle; two legs had pain and sore; had like period cramps; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (bad reaction after both doses), PAIN IN EXTREMITY (arm was pain), HEADACHE (head was pain), PAIN (felt like all her inside organs were painful) and MOVEMENT DISORDER (Could not use the arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    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, the patient experienced VACCINATION COMPLICATION (bad reaction after both doses), PAIN IN EXTREMITY (arm was pain), HEADACHE (head was pain), PAIN (felt like all her inside organs were painful), MOVEMENT DISORDER (Could not use the arm), MYALGIA (Pain and sore in the muscle), PAIN IN EXTREMITY (two legs had pain and sore) and MUSCLE SPASMS (had like period cramps). At the time of the report, VACCINATION COMPLICATION (bad reaction after both doses), PAIN IN EXTREMITY (arm was pain), HEADACHE (head was pain), PAIN (felt like all her inside organs were painful), MOVEMENT DISORDER (Could not use the arm), MYALGIA (Pain and sore in the muscle), PAIN IN EXTREMITY (two legs had pain and sore) and MUSCLE SPASMS (had like period cramps) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: increased (High) Heart rate increased.         No concomitant medication information were provided. No treatment information were provided.   This case was linked to MOD-2021-326800 (Patient Link).
Patient came to the Pharmacy and  asked for her second Pfizer Vaccine.  She filled out the covid-19 vaccine administration administration form and answered that she received her first dose of Pfizer vaccine. She stated it was late and she received her first Pfizer vaccine on 4-19-21. She lost her Vaccine card. She was given the Pfizer vaccine.  When writing up a new vaccine card for patient, it was noted that her first dose was the  Moderna vaccine and not the Pfizer vaccine.
Injection site bruise.; Injection site swelling; Injection site redness; This is a spontaneous report from a non-contactable consumer, the patient. An 84-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6204) via an unspecified route of administration on 22Mar2021 (at the age of 84-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 22Mar2021, the patient experienced injection site swelling and site redness, followed by a bruise. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events injection site swelling and site redness, followed by a bruise. The clinical outcome of the events Injection site bruise, injection site swelling and injection site redness were resolving at the time of this report.   No follow-up attempts are possible. No further information is expected.
This case was reported by a physician via sales rep and described the occurrence of injection site muscle reaction in an unspecified number of patients who received BEXSERO. On an unknown date, the patient received BEXSERO (intramuscular) .5 ml. On an unknown date, immediately after receiving BEXSERO, the patient experienced injection site muscle reaction. On an unknown date, the outcome of the injection site muscle reaction was unknown. It was unknown if the reporter considered the injection site muscle reaction to be related to BEXSERO. Additional details were reported as follows: The age at vaccination of the patients was not reported, it could be between 16 to 23 years of age. The physician stated that every time she inserted the needle into the arm of the patients and began to administer the vaccine, she noticed the muscle twitches.
This case was reported by a nurse via sales rep and described the occurrence of injection site rash in a 4-year-old male patient who received DTPa-IPV (Kinrix) (batch number 7P5J5, expiry date 30th September 2022) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Kinrix (intradermal) and Kinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced injection site rash and intramuscular formulation administered by other route. On an unknown date, the outcome of the injection site rash and intramuscular formulation administered by other route were unknown.   It was unknown if the reporter considered the injection site rash to be related to Kinrix and Kinrix Pre-Filled Syringe Device.  This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: The age at vaccination was not reported. The nurse on duty who reported that the Kinrix vaccine might have been administered inappropriately to the patient. The vaccine was administered into his leg but which leg was unknown. It was reported that the nurse might have used a needle that was too small therefore given the vaccine intradermally rather than intramuscularly, which led to intramuscular formulation administered by other route. The patient to whom the vaccine was administered experienced the bullseye rash at the site of administration. The time of onset of the rash or if it had resolve, could not be provided by the reporter. THe voice mail had been left for the medical provider to get additional information on the scenario. The date of vaccine administration, exact site of administration, dose, exact route given, when did the symptoms started, had they resolved unknown. The reporter did not consent to follow up.
This spontaneous report received from a physician refers to a 3 year old child (patient). On 12-MAR-2014 the patient was inadvertently vaccinated with a dose of GARDASIL, approximately 0.2 ml, subcutaneous injection. The physician had informed that ice was placed at the injection site to prevent spreading. The patient had sought medical attention by being in the doctor's office. Additional information has been requested.
Hair loss; Hives; Fever; Chills; Headache; Muscle ache; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 05-Mar-2021 and was forwarded to Moderna on 05-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of (Hair loss), (Hives), (Fever), CHILLS (Chills) and HEADACHE (Headache) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for an unknown indication.    No Medical History information was reported.   On 21-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (unknown route) at an unspecified dose. On 21-Feb-2021, the patient experienced  (Hair loss),  (Hives), (Fever), CHILLS (Chills), HEADACHE (Headache) and  (Muscle ache). The patient was treated with CORTICOSTEROID NOS at an unspecified dose and frequency and PREDNISONE at an unspecified dose and frequency. At the time of the report, ALOPECIA (Hair loss),  (Hives),  (Fever), CHILLS (Chills), HEADACHE (Headache) and MYALGIA (Muscle ache) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Myeloma; This spontaneous case was reported by a consumer and describes the occurrence of PLASMA CELL MYELOMA (Myeloma) 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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PLASMA CELL MYELOMA (Myeloma) (seriousness criterion medically significant). At the time of the report, PLASMA CELL MYELOMA (Myeloma) outcome was unknown.            No concomitant medications were reported.  On an unknown date, blood tests were conducted and antibody count was reported as 236236 (units and antibody type not specified).  No treatment medications were reported.    Reporter did not allow further contact; Sender's Comments: Very limited information regarding the event has been provided at this time.  Further information was requested.
Localized erythema within 24 hrs; possible cellulitis -> given antibiotics.
About 16 days after the 2nd shot, I began feeling very tired, fatigued, nauseous, and had a headache.  About 18 days after the shot, I still had the same symptoms but also developed a red rash on my left upper bac, left arm, and left shin.  The rash was painful and burned.  When touched, I could feel the pain shoot through my nerves.  I was seen by the PA referenced above, who treated it as shingles, but diagnosed it as a plant based reaction, as he could not be sure it was shingles.  I was prescribed Mupirocin and valACYclovir HCI.  I still had the fatigue and nausea for several days after starting the medication.  Despite receiving my 2 shingles vaccinations in September and December of 2020, it appears the Pfizer vaccine may have triggered a mild case of shingles.
After directly receiving the shot, I was very achey and weak. Exactly a week after I received my vaccine, I developed a UTI. This is unusual since I have not had one since I was young. I am unable to complete daily tasks without being extremely exhausted and my body hurting. I struggle walking for long periods of time.
Patients mother states client woke up on morning of 3/29/06 with a rash on her face. Clients mother states rash looks like hives, and patient has c/o itching and hotness on face. Rash appears only on patients face. No other symptoms. Instructed to take Benadryl.
pt had a positive COVID test on 8/20/21 from Fast Pace Health in Kodak, TN; per death certificate information, pt died at home with the cause being COVID 19; there are no other records on this patient
Around 6-7:30 pm on the 19th of June, my wife told me that my eye was started to turn red.  I tried at first to put allergy drops in it.  The next morning I had yellow discharge coming from my eye.  I went to the doctor on Sunday and they did not know what it was, they ruled out conjunctivitis.  They did prescribed me a medication to use.  About two days after of using the medication I felt like it was not needed anymore.  About a few days after that the redness went away until it was completely gone.