chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician referring to multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant medication were not reported. On unknown dates, the patients were vaccinated with improperly stored ROTATEQ (lot # L046318 with expiration date 28-SEP-2017, lot# M007125 with expiration date 06-OCT-2017, lot# M002252 with expiration date 28-FEB-2017, dose not reported) orally for prophylaxis. The vaccines had been stored under the temperature of 34 Fahrenheit degrees for 72 hours and 35 Fahrenheit degrees for 72 hours. A data logger was used to log the temperatures. No adverse effects were reported. Follow-up information was received on 07-DEC-2016, indicating that all telephone attempts to obtain follow-up information have been unsuccessful. No additional information was available. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1610USA005661: US-009507513-1610USA005662: US-009507513-1610USA005663: MERCK 1610USA005022:Mfr number.
C/O L arm pain post flu shot. C/O decreased ROM and "catch." Tried Motrin and Medrol dose pack without relief. Referred to neurologist. Ordered Vioxx, Neurontin, MRI and PT. Thinks shot was given "too high."
terrible arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558).  A 64 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "terrible arm". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a pharmacist referring to a patient of unknown age and gender. The patient's concurrent condition included left elbow pain and unspecified joint pain. On 22-APR-2016 the patient was vaccinated with a dose of ZOSTAVAX (lot # L033311, expiration date: 01-DEC-2016, dose and router were unknown). In April 2016, the patient developed a red raised bump at the injection site after receiving ZOSTAVAX. It also reported that the left elbow pain and unspecified joint pain increased after vaccination. The outcome of the events was unknown. The causality was not reported. Additional information has been requested.
Extremely dizzy; Rashes on left arm injection site; Nauseated; A spontaneous report was received from a consumer, concerning herself, a 55-years-old female patient, who received Moderna's COVID-19 Vaccine and experienced rashes on left arm injection site, extremely dizzy and nauseated.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On 28-Dec-2020, approximately 9 days prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (lot number unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 05-Jan-2020 (tuesday), patient developed rashes on left arm of injection site. Additionally, felt extremely dizzy and nauseated, due to which she was unable to go to work on 06-Jan-2021 (Wednesday), hence, underwent Covid rapid test, which showed negative. Treatment information was not provided.   Action taken with mRNA-1273 in response to the events were not provided.   The outcome of the events, rashes on the injection site, extremely dizzy and nauseated were not reported.; Reporter's Comments: A spontaneous report concerns a 55-years-old female patient, who received experienced rashes on left arm injection site, extremely dizzy and nauseated. The events occurred 9 days after the administration of the first dose of the mRNA-1273 vaccine (Lot #: unknown, expiration date-unknown). No treatment was reported, and outcome is unknown. Based on the information provided, which includes the site of vaccine administration and a temporal association with the administration of mRNA-1273 vaccine, a causal association cannot be excluded. The event of injection site rash and nausea is consistent with the known safety profile of mRNA-1273 vaccine.
Current ongoing symptoms in order of severity include: lethargy/brain fog (daily since), thick mucus buildup (nose and back of throat throughout the day), regular headaches, depression, loose stool,  eye redness, and tonsil stones (couched up daily).  Events/symptoms after vaccine: tonic-clonic seizure (twice admitted to Hospital last event on 5/31/2021), petite-mal seizure (not admitted to hospital but noted by others in household), severe pounding headache (on and off in middle and back of cranium)
Hives around eye several hours afterwards. The next day redness, swelling at injection site.
p/recv vax pt exp nausea & 18 days later pt exp chills, fever, abd pain, joint pain & loose stool continuing 2 days later.
COVID breakthrough. Symptoms began on 12/31/21. Presented to ED on 1/3/21 with cough and chills.
Felt sleepy the day after the first dose; This is a spontaneous report from a non-contactable consumer. A 50-year-old non-pregnant female patient received unknown dose of  BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 31Mar2021 (at the age of 50-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. It was unknown whether the patient received any vaccination within four weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient not been tested for COVID-19. On 01Apr2021 the patient experienced  sleepy the day after the first dose. The patient did not receive any treatment for 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 event felt sleepy was recovered on unknown date in Apr2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
I have swollen joints (knees).  It is hard to walk because of the inflammation.  These have been going on since the beginning of December. I went to my doctor about this.  They drew fluid out of the knee.
Patient was given vaccine. Approximately 5-7 minutes after patient's eyes rolled back. Upper body began to jerk. Called 911.
Pt. developed acute arm pain at the site of injection & the following day spread to both arms & legs; diffuse muscle pain throughout developed over 1 week period. Pt had Rheumatology consult to & Normal serology confirm.  7/21/09 Medical records received DOS 5/1/09 to 6/08/09. Assessment: Muscle pains with chronic pain and fatigue. Reaction to vaccination with Varicella or Menactra. Patient presents with left arm pain. Myalgia and arthralgia. Pain in muscles, aching in knees, ankles, wrists, and elbows. Ultracet made her very confused. Trigger point tenderness. Pain management clinic dx: pain amplification syndrome.  9/1/09 Consultant Pain Clinic records received DOS 6/5/09 to 7/10/09. Assessment: Pain Disorder Associated with Both Psychological Factors and a General Medical Condition. Pain and redness at injection site. Pain later extended to entire left arm. In the following weeks pain extended to left leg, right leg, right arm. Pain is throbbing and constantly moves between extremities. Back pain, tense muscles, multiple joint soreness. Stress at school. Acute distress, crying. Exhausted. Shortness of breath, dizziness, paresthesia 4 extremities. Acupuncture. Massage. Poor sleep.  9/10/09 Rheumatology consult records received DOS 5/20/09. Assessment: Juvenile Fibromyalgia. Patient c/o injection pain, redness and numbness along left arm. Pain spread throughout body. Numbness resolved in 2 days. 1 day of severe headaches. Energy decreased. Difficulty falling asleep. Dizziness. Distress, crying.
Left shoulder pain, rotator cuff tendinitis, doctor called it shoulder injury resulting from vaccine administration. Pain lasted for weeks until a doctor was consulted. With steroid injection and regular physical therapy and exercise, injury has calmed down. At three months, pain is still noticeable in certain shoulder positions, but has reduced significantly.
Red swollen rash at site of injection presenting one day post administration of second COVID vaccine. The site is warm to the touch and feels like a firm lump under the skin.
This spontaneous report as received from a pharmacist (or pharmacy technician - it was not confirmed) via company representative refers to a female patient of unknown age and unknown medical history. The husband reporting on his wife to the pharmacist, on an unknown date the patient was vaccinated with ZOSTAVAX, (0.65 ml in one shot; subcutaneously) (lot number, exp. date not reported). On an unknown date reported as shortly after receiving ZOSTAVAX the patient had developed an infection in her heart and died from the infection in her heart shortly after having development of infection on an unknown date. It was reported that the patient may had been immunodeficient because her husband stated that she was not the healthiest prior to receiving ZOSTAVAX and that she might also have developed a rash after receiving ZOSTAVAX but neither the presence of immunodeficiency or the development a rash had been confirmed. The outcome of the heart infection was fatal. The cause of death was heart infection. The patient's husband was adamant that ZOSTAVAX caused the infection in the patient's heart. No legal issues was suspected at this time. Additional information has been requested.
Information has been received from healthcare worker concerning an unspecified number of patients of unknown age and gender. The patients' concomitant medication, pertinent medical history and drug reactions/allergies were not reported. On unknown dates, the patients received unspecified improperly stored doses of PROQUAD (Merck) (strength, frequency and route unknown, Lot# L024124, Exp. date 30-DEC-2016 and therapy type rHA). The vaccines were expose to 30.9F for 11 hours 50 minutes at first excursion; and then expose to 9 F for 3 hours. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Pt had fever, and then progressed to complex febrile seizure lasting approximately 45 minutes.  Required Valium 10mg IV and Fos-phenytoin 240mg IV and Ibuprofen 120mg PO x1.
About 5 minutes after injection SC in left arm, a large red "hivey" area appeared at the site of the injection.  No shortness  of breath or other breathing problems occurred.  Pt was immediately examined by MD and given 2 tsp Benadryl and kept in office for 20 minutes to watch.
Vial had undergone temperature excursion/Off-site clinics were being conducted and the staff was not monitoring vaccine temperatures correctly; vaccine administered to an underage recipient; Off-site clinics were being conducted and the staff was not monitoring vaccine temperatures correctly; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vial had undergone temperature excursion/Off-site clinics were being conducted and the staff was not monitoring vaccine temperatures correctly), PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (vaccine administered to an underage recipient) and POOR QUALITY PRODUCT ADMINISTERED (Off-site clinics were being conducted and the staff was not monitoring vaccine temperatures correctly) in a 15-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Jun-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Jun-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (vaccine administered to an underage recipient) and POOR QUALITY PRODUCT ADMINISTERED (Off-site clinics were being conducted and the staff was not monitoring vaccine temperatures correctly). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vial had undergone temperature excursion/Off-site clinics were being conducted and the staff was not monitoring vaccine temperatures correctly). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vial had undergone temperature excursion/Off-site clinics were being conducted and the staff was not monitoring vaccine temperatures correctly), PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (vaccine administered to an underage recipient) and POOR QUALITY PRODUCT ADMINISTERED (Off-site clinics were being conducted and the staff was not monitoring vaccine temperatures correctly) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications details was not reported by the reporter. Treatment details was not reported by the reporter.  Vial had undergone temperature excursion at the time of refrigerated storage condition. In each of the clinics, the temperature excursion was as long as 4 hours in length.
About 36 hours after my vaccine, the injection site swelled considerably (nearly baseball sized) and was bright red.  However, since swelling is expected and it resolved in two days, I wasn't terribly concerned. On Day 8, however, I woke up to a considerable amount of itching, redness and swelling (ping pong sized). Throughout the day and into the next, the swelling expanded across the entire width of my bicep, approaching the size of a softball. Sensations ranged from itching to burning (the area was hot to the touch) and pain. The paperwork I received with my vaccine indicated symptoms should resolve within seven days of vaccination and to report any prolonged or worsening symptoms. I don't have a PCP/GP, however, so I didn't have a physician to contact. I considered going to an immediate care clinic for evaluation but was afraid of potential COVID exposure and decided to wait a couple more days to see if things improved. I'm now 11 days after my vaccine and 3 days after symptoms began and can report that the swelling does seem to be flattening out, though it is certainly still there (as is the rash). Since it is certainly better today than it was yesterday, I am hopeful things will continue to improve. All the same, I thought it was worth reporting since it began 8 days after my vaccination. I know of dozens of people who have gotten the vaccine, but only one other person who had a similar reaction. In which case, it felt like an anomaly worth reporting. I can provide photos from the past three days, if needed.
Dizziness, 1:30 pm, lasted 12hrs. Headache, 1:30 pm, lasted 12hrs. Tingling tongue, 1:30 pm, ongoing. Tingling roof of mouth, 1:30 pm, ongoing. Tingling lips, 1:30 pm, ongoing.
noticed red spots in it; she was nervous; It is not swollen but the redness is about the size of a tennis ball and warm to touch; her left arm was also warm to the touch, and had swelling like the size of a tennis ball; redness on her arm where she got the shot; This is a spontaneous report from a contactable consumer (Patient). A 57-year-old female patient received bnt162b2 (PFIZER COVID-19 VACCINE, Solution for injection, Batch/Lot number EN6705 was reported, Expiry: unknown), via an unspecified route of administration into arm left on 23Mar2021;9:00 as DOSE 2, SINGLE for covid-19 immunization (at the age of 57-Years-old). The patient medical history included heart issues and concomitant medications were not reported. The patient previously took bnt162b2 (PFIZER COVID-19 VACCINE, Solution for injection, Batch/Lot number EN6198 was reported), via an intramuscular route of administration on an unspecified date on left arm as DOSE 1, SINGLE for covid-19 immunization. On 28Mar2021, the patient had experienced redness on her arm where she got the shot and on 29Mar2021, the patient had experienced her left arm was warm to the touch and she had swelling like the size of a tennis ball on her left arm. On 30Mar2021 the patient had experienced noticed red spots in it and she was nervous. Further explained that there were red dots, or big red spots, in the swelled area on her left arm, redness on her arm where she got the shot, it was reported that she called her family doctor, and her doctor said to put a warm cloth on her left arm and wait a week to see if her left arm got better. She said she was nervous and didn't want to wait a week to see what would happen, so she called Pfizer. Therapeutic measures were taken for the AE and treatment included with Tylenol, clarified as generic Equate brand Acetaminophen 500mg.The clinical outcome of redness on her arm where she got the shot, her left arm was warm to the touch, and she had swelling like the size of a tennis ball on her left arm were not recovered and unknown for she was nervous.  No follow-up attempts are needed. No further information is expected.
The flu shot, did not feel right, from the start.  It was much more painful than usual. It persisted to be sore and stiff at the injection site, and continues to be at the time of this writing. Also, the same pharmacist that gave me the shot; also, gave one of her co workers a shot a few days later.  And she reported to me to have the same problems, with stiffness and soreness.  And it continues to be a problem for her at the time of this writing.  However, it is too early to know if I will need to seek medical treatment or if any permanent problems will result from this adverse event.  As it has only been 18 days.  I have received the flu shot for 15 years, without having any kinds of problems.  I believe this pharmacist gave the shot in an incorrect manner.  The shot was given with the full size needle, and it covered four strains of the flu.  And it was the only vaccine I received that day and within 4 weeks before or after said flu shot.  I would never let this person give me another shot again!  I would go else where.
The patient stated that he was due for the second dose of Moderna and signed a consent form. However, when entering the second dose in system, the first dose was given 2/1/22, which means that it had not been 28 days between the first and second dose given. No adverse effects has been observed after the mistake was found.
left Lower jaw and neck Numb, Pain in shoulder (not at inection site), headache
Rash with itching and heat appeared at injection site over 1 week after being administered. Reported  by email on  website to my doctor, on 2/4/21 who also reported it to allergy and dermatology departments. Was told to ice 3 times a day and take antihistamines 2 times a day. Image sent to doctor through website.
No adverse event; Doses of Moderna Covid-19 bivalent were administered BUD to total of 17 recipients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses of Moderna Covid-19 bivalent were administered BUD to total of 17 recipients) and NO ADVERSE EVENT (No adverse event) in a 15-month-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 215K22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 06-Feb-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 06-Feb-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses of Moderna Covid-19 bivalent were administered BUD to total of 17 recipients). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses of Moderna Covid-19 bivalent were administered BUD to total of 17 recipients) 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Doses of Moderna Covid-19 bivalent were administered BUD to total of 17 recipients).    Concomitant medications were not reported.  This case was created for patient 8 out of 17 patients. Treatment medications were not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-713254 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 28-Feb-2023: Live significant follow-up received contains Patient demographics updated On 28-Feb-2023: Follow-up received contains no new information On 28-Feb-2023: Follow-up received contains no new information; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-713254:Patient 1 out 17 patients
21NOV 3AM woke up w/severe rt leg pain (above ankle), numbness rt hip to rt knee; put on bedrest x 17 days; hospitalized 7DEC93 x 3 days; tenderness in groin, pubic area rt hip; strength is gradually coming back;
Both contracted covid virus after vaccine; Both contracted covid virus after vaccine; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported similar events for 2 patients. This is 2nd of 2 reports. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1st via an unspecified route of administration on 13Jan2021 at single dose for Covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient and his wife had 1st dose of covid vaccine on 13Jan2021. Both contracted covid virus after vaccine. Supposed to get 2nd dose 03Feb2021. They were in quarantine. Wondering if and when they should get 2nd dose of vaccine. The patient experienced both contracted covid virus after vaccine on an unspecified date. Outcome of the event was unknown.  Information about lot/batch number has been requested.; Sender's Comments: Linked Report(s) :different patient, same event and drug
Menstrual cycle abnormal; This spontaneous case was reported by a consumer and describes the occurrence of MENSTRUAL DISORDER (Menstrual cycle abnormal) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, the patient experienced MENSTRUAL DISORDER (Menstrual cycle abnormal). At the time of the report, MENSTRUAL DISORDER (Menstrual cycle abnormal) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Ultrasound scan: normal (normal) Normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       no treatment medications were reported. No concomitant medications were reported.  lab data - Patient had a biopsy done to test the lining of the uterus wand is awaiting results
Severe headache, chills, temperature, sore and swelled arm at injection site, very sore in left arm lymph nodes, achy muscles and joints, nausea.  Rested, Ibuprofen every 4 hours, fever broke at midnight.  Today, no chills, temperature or headache.  Very weak, arm still sore and swollen, and muscles and joints still achy.  Rest.
Patient is vaccinated with a second booster dose and his current age is 47 years. As of today (April 18, 2022) the CDC has not authorized second booster vaccinations for patients under 50 years of age.