chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a health professional refers to unspecified number of patients of unknown demographics. No concurrent condition, medical history or allergy/drug reactions were reported. The health professional reported that on an unspecified date, unspecified patients received doses of improperly stored GARDASIL injection (strength, dose, route and lot number or batch number unspecified). No concomitant medications were reported. No adverse effects were reported. The outcome of the event was unknown. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
lacy slapped look;hives on upper arms;swollen, red cheeks; parents gave DPH;
FEVER, JOINT PAIN, HEADACHE,  REDNESS AND SWELLING  AT THE INJECTION SITE.   ON MONDAY 3/29 INJECTION SITE IS STILL SWOLLEN, RED AND HOT TO THE TOUCH.  THE DIAMETER OF THE INFLAMED  INJECTION SITE IS 3.5 INCHES.
2 weeks post flu immunization, patient reported pain from shoulder to wrist on left arm. He said the pain began soon after the immunization was administered but he thought it would go away. 2 weeks later the pain has not subsided. This writer explained that it is hard to say if the flu shot caused this pain in his arm but understood why he would think the pain is related to the administration of his flu shot. Suggested he consult with his primary healthcare provider.
Fatigue and mild severe pain in the right armpit. A little pain at the injection site. Been feeling the armpit pain since the morning after the vaccine.
3/3/21 Day 0: no issues 3/4/21 Day 1: soreness at injection site 3/5/21 Day 2: soreness at injection site , feverish, chills, fatigue, headache, stomach upset 3/6/21 Day 3: soreness at injection site , feverish, chills, fatigue 3/7/21 Day 4: no symptoms  3/8/21 Day 5: dizziness
Severe headache, neck pain, numbness, tingling in arms and hands, confusion, significant change in mental status, seizure like activity, fainting.
My daughter had intense sweating and felt like she was going to pass out. This started a few minutes after receiving the vaccine.  The reaction after the shot only lasted for roughly 5 minutes, but her clothing was completely soaked from sweat. After 5 minutes, it passed and she felt much better. Medical personnel gave her water and had her sit another 30 minutes. She seemed fine after that, but they told to report the reaction.
chest pain and tightness on left side, Left shoulder hurts(not at injection site), around pectoral muscle.  The feeling is identical to the same thing happening to me after the first dose so I am sure it was the vaccine that is the cause.
Left side of face and left arm went numb within 5 minutes of receiving vaccine.  It went away after approximately 13 hours.   A headache began shortly after and has not went away despite taking excedrin migraine over the course of 5 days.
Headache, Myalgia, Arthralgia, Fever, "brain fog" Narrative:  Phone call with PCP and sent for  laboratory testing. all results were negative.
Crying for about 3 hours, didn't want to be touched. Soft spot on head was hard.
acute fever of 102.0 F,  shortness of breath, arm pain and local swelling, required emergency room visit.
Received the Pfizer shot first at clinic. After this shot (his booster), he became very tired. His moods were immediately different, too. He became more moody and temperament/demeanor was different, overall. Everything seemed to get worse over a 24 hour timeframe- from the time he received this injection.  * When he had past injections of the same Pfizer COVID 19 shot, his moods were like this, too. However, we did not think to report the events.  He also tried to get the Flu shot, and they said no (due to no appointments). So he went to another facility, and received his Flu shot, the same day, too (I didn?t know how to document that on the previous page).
Within 12 hr of vax, several pt at this facility devel inject site, with redness, tenderness & induration.
High grade fever of 101.9F elevating to 103.1F Hasn?t broken after 1000mg of acetaminophen 1 hour later This is occurring roughly 16 hours after 2nd dose
Chest pain, heart palpitations/fluttering, waking from sleep gasping for air paired with palpitations and chest pain, fatigue, shortness of breath, wheezing, mental confusion/fogginess, painful/debilitating headaches
Pt's mom reported that the pt had itchy hands w/ first vaccine dose.  NO indication of reaction to subsequent doses
Reported 6/9-vaccines given on 4/14/05 with golf ball sized lump w/redness and swelling at injection site. :Fever of 103.8 axillary x 24 hours, vomiting x 3 days. Lump subsided in 1 1/2 wks. mom suspects Hep A, as the lump occurred RUT "right at injection site".
Few minutes after injection - unusual taste in the mouth and sense of palpitation About 8 hours after - rash on the back of both hands, not itchy, lacy faint rash rapidly spreading limited to the hands, associated with tingling and paresthesia on both palms.
Pt received second dose of Moderna vaccine on 4/13/2021. Pt lips and face started swelling on 4/14/21 in the evening. Pt present to clinic on 4/15/21 at 1130 with lip and face swelling. Pt denied issues with breathing , just had swelling of the face and lips. She did not take any medication to hep with swelling.
On 8/17/05 patient presented to the ER with complaints of L arm swelling and L arm pain following his smallpox vaccination that occurred at approximately 3pm that day. Patient reported to ER MD that approximately 1-2 hours after his vaccination he started developing some discomfort and approximately 8 hours later he noted significant discomfort and slight swelling of the L hand. Exam noted no changes in the smallpox vaccination site. Swelling noted to the dorsal aspect of the hand, significant enough to cause wedding band to be quite tight, this was removed with some soap. Circulation, motion and sensation were completely intact. The axilla was without nodes. Given Toradol 60mg IM and started on Ibuprofen. Quarters x 24 hours and to follow up at the TMC the following day.
FLU LIKE SYMPTOMS/FEVER/CHILLS/HEADACHE; CHOLESTEROL LOW; This spontaneous report received from a patient concerned a 53 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: tumor in neck/ benign lipoma on the neck, non smoker, alcohol user, nuts allergy, and low density lipoprotein was high, and other pre-existing medical conditions included: Codeine allergy manifestated by face, tounge and feet swelling. Nut allergy was manifestated by anaphylactic reaction, tingling sensation on lips and tounge and scratchy throat. The patient was previously treated with prednisone for drug used for unknown indication; and experienced drug allergy when treated with codeine for drug used for unknown indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1808978 expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. Non-company suspect drugs included: upadacitinib (form of admin unknown, oral, batch number was not reported) 15 mg, 1 time every 1 day, from APR-2021 for moderate to severe rheumatoid arthritis. Concomitant medications included rosuvastatin calcium for high density lipoprotein, and epinephrine for rheumatoid arthritis. On 2021, the patient experienced cholesterol low. Laboratory data included: Cholesterol (NR: not provided) low. On 01-APR-2021, the patient experienced flu like symptoms/fever/chills/headache. Laboratory data (dates unspecified) included: Low density lipoprotein (NR: not provided) high. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and dose of upadacitinib was not changed. The patient recovered from flu like symptoms/fever/chills/headache on 02-APR-2021, and had not recovered from cholesterol low. This report was non-serious.
THE PATIENT RECEIVED VACCINE. DISCUSSED SIDE EFFECTS AND APPOINTMENT FOR DOSE 2. EVERYTHING WAS FINE, PATIENT DIDN'T HAVE ANY OTHER QUESTIONS/CONCERNS. I SAID I WILL CHECK ON HIM IN A FEW MINUTES. WITHIN MAYBE 1-2 MINUTES, HIS WIFE CAME TO THE COUNTER AND SAID HE IS OUT, PASSED OUT.  I WENT TO CHECK ON HIM. YELLED TO MY TECH TO CALL 911. PATIENT WAS SLUMPED OVER IN THE CHAIR. HE WAS BREATHING AND HAD A PULSE, BUT NOT AWAKE. TRIED TO AROUSE HIM BE CALLING HIS NAME AND SHAKING HIS ARM TO WAKE HIM. HIS WIFE THEN WAS TAPPING THE SIDE OF HIS FACE TO WAKE HIM UP. SKIN WAS GRAY IN COLOR. SHE STATED HE IS GOING TO VOMIT AS HE WAKES UP AND NEEDED A GARBAGE CAN. I WENT TO GRAB CAN FROM PHARMACY AND RETURNED. SHE PUT CAN IN BETWEEN HIS LEGS AS HE CAME TO AND IMMEDIATELY STARTED TO VOMIT. HE WAS AWAKE BUT OUT OF SORTS.  AT THAT TIME THE EMT ARRIVED AND WENT TO WORK. PATIENT BP WAS LOW AND THEY STARTED IV FLUIDS. THE PATIENT WAS ABLE TO SPEAK TO EMT AND ANSWER THEIR QUESTIONS. THEY PREPPED HIM FOR TRANSPORT TO THE EMERGENCY DEPT FOR FURTHER EVALUATION. BY THE TIME THE PATIENT WAS BEING TRANSPORTED, HIS BP WAS BACK UP CLOSE TO NORMAL.  I SPOKE TO BOTH THE PATIENT AND HIS WIFE AROUND 5PM THAT DAY. THEY WERE LEAVING THE HOSPITAL AT THAT TIME. THE PATIENT WAS FEELING MUCH BETTER. HIS BP WAS BACK TO NORMAL, HIS COLOR WAS BACK, AND HIS VOICE WAS STRONG. THEY BOTH PLAN ON RETURNING FOR THE COVID 19 DOSE #2.
SYMPTOMS -injection site seemed to be quite higher on the arm than in the past -injection site very painful -severe pain deep in tissue and shoulder area -some numbness -limited range of motion -the normal pain experienced in the 24 hours follows the procedure has persisted for two weeks  I am currently under the care of my primary physician for possible Bursitis.
mild facial swelling, especially around mouth.  I had general aching at my hips and knees, fatigue
shoulder pain; This case was reported by a other health professional via call center representative and described the occurrence of shoulder pain in a 47-year-old female patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2020-2021 season) (batch number G2RX7, expiry date unknown) for prophylaxis.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 26th October 2020, the patient received FluLaval Tetra 2020-2021 season and Flulaval Tetra Pre-Filled Syringe Device. In November 2020, an unknown time after receiving FluLaval Tetra 2020-2021 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced shoulder pain. On an unknown date, the outcome of the shoulder pain was unknown.   It was unknown if the reporter considered the shoulder pain to be related to FluLaval Tetra 2020-2021 season and Flulaval Tetra 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 reporter was physician's assistant. It was reported that the patient experienced shoulder pain 5 weeks after receiving FluLaval vaccine. The reporter did not consented to follow up.
Pt stood up about 1 min after vaccine and felt like he couldn?t see.  Pt also reported that he was really weak and could barely stand.  Pt had a syncopal event w/ associated flushing/sweating and dizziness. Vitals: 110/70, 83, 20, 100%, 96F -- > 90/57, 65, 19, 100% 96F Pt was taken to sick bay and vitals WNL and pt's feet were elevated.  Pt was given apple juice and a snack.  Pt felt better. Pt's parents reported that the pt was currently amoxicillin and was advised to drink plenty of water and eat prior to vaccine and to f/u w/ PCP if s/s continue.  Pt left in stable condition after 30mins wait at 12:10.
Reporter indicated that 5 employees have not converted; some employees recvd 2 courses (6 doses) of Engerix-B; some employees recvd 1 course (3 doses) of Engerix-B & 1 course of Recombivax-HB (3 doses);
7:30 pm Client noticed a painful lump at injection site with heat. Client iced 30 min on and off for approx. 3 hours without relief. Client c/o pain all night and disrupted sleep. next morning client c/o all over body aches and joint pain. IBU 800 mg Q6hours on following day with minor relief. Troubled sleep 09/14/2019 with pain. 09/15/2019 entire Lt. arm was hurting more than the rest of her body. IBU taken with no relief. 09/15/19 client slept better. 09/16/2019 full body aches were gone, but left arm still experiencing pain. Pain did not subside until 09/16/2019 in the evening. 09/17/2019 injection site still sore, warm, and swollen.
back is achy; Injection site pain; Body achy; body feels like after you have a workout; Muscles are sore; My close coworker who works with me in the same company cubicle as me when we document, tested positive for COVID; This is a spontaneous report from a contactable other health professional (patient). A female patient (Age: 35; unit unknown) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EH9899), via an unspecified route of administration on 21Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received COVID vaccine on 21Dec2020 and experienced side effect of the vaccine. Stated 'achy feeling. The patient's abdomen and trunk like after a workout.' She move suddenly her back was achy. She had injection site pain. Consumer stated, her close coworker who worked with her in the same company cubicle as she, tested positive for COVID and he had been having symptoms since Saturday. And she was body achy at the time of this report, like she kind of feel like, her body felt like after she had a workout and her muscles are sore. So, she did not know what to do because she do not know if this body achiness is a symptom of COVID or a symptom of the vaccine. And if she went get tested, whether she will show like a positive because she had the vaccine. The outcome of events was unknown.
Headache, chills, fever. Rash and knot at the point of injection, heat and pain radiating up into my neck and into my hand.
Fever; Chills; Lots of night sweats; Nausea; Feels like been run over the train; Weakness; Low appetite; This is a spontaneous report from a contactable consumer (Patient, reported for herself).  A 76-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, Lot Number: Unknown), via unspecified route of administration, on 03Sep2021 (at the age of 76-year-old) as a dose 2, single for COVID-19 immunization. The patient medical history included lung cancer, emphysema, COPD, osteoporosis, aneurysm and blood pressure high. Patient reported that Lot number looks like an AN0187. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: Unknown) as a dose 1, single for COVID-19 immunization. The patient also reported that she had 3 IV bags of immunotherapy in the year like it was in 2017 and that bags killed her. Patient had 33 reactions (three treatments ended up in ER with it) from that on 3 IV bags of Immunotherapy and she had to stop it. The concomitant medication of the patient included nivolumab (OPDIVO), verapamil (VERAPAMIL), lisinopril (LISINOPRIL), lorazepam (LORAZEPAM) and meloxicam (MELOXICAM). Patient stated that she took verapamil as it was the blood pressure medicine, lisinopril 20mg, once a day, lorazepam 1mg, about she stated it was 8 hours, but she does not take it at all. Patient took occasionally meloxicam 15 mg, but it was not an ongoing thing and don't take to thin the blood. Patient don't need no thin blood with the aneurysm. Patient stated that lisinopril causes her to cough and took it for years. Patient took it for 15-18 years. Patient stated that she took two shots and it never bothers her other vaccine prior to 4 weeks of COVID vaccine. Patient wants to take the shot but not this year. On an unspecified the patient had some reaction to this second shot. Patient started of having in less than 24 hours after she had taken the shot fever, Chills, lots of night sweats and nausea and feel like been run over the train. Patient reported that three weeks back she had the first actually the couple of days over. Patient had it about 03:15 or something like that or 03:30 before that time the next day, she don't know maybe around 2'O clock 3'O clock the next day, Patient was sick and wanted to know how long this step was going to last, this fever and weakness and last night she had night sweats and have low appetite. The patient underwent lab tests and procedures for fever. Patient received the treatment of Tylenol. Outcome for all the reported events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Pt. reports on 7/24/2010, he noted pain in left upper chest, (L) nipple and (L) upper back. Pain was severe enough to require Ibuprofen. On 7/26/10, pt noted rash at (L)  upper chest and (L) upper back. Presents to clinic today, 7/28/10 due to concerns that he is experiencing vaccine related side effects. Patient referred to doctor for evaluation of rash and pain.
Localized reaction, pt had red inflamed area where shot occurred that was warm to the touch. Pt came back on 9/6 and reaction was much better. Pt was followed up with the next day and reaction had improved.
Closed left hip fracture; underwent a surgical repair. ED visit and hospital admission within 6 weeks of receiving the COVID vaccine.
first shot he had slight reactions; slept for a fewhours; his joints hurt a little bit; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (first shot he had slight reactions), INSOMNIA (slept for a fewhours) and ARTHRALGIA (his joints hurt a little bit) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Chronic lymphocytic leukemia.   On 19-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE REACTION (first shot he had slight reactions), INSOMNIA (slept for a fewhours) and ARTHRALGIA (his joints hurt a little bit). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, ADVERSE REACTION (first shot he had slight reactions), INSOMNIA (slept for a fewhours) and ARTHRALGIA (his joints hurt a little bit) outcome was unknown.            No concomitant medications were provided.  He did not have reactions for the second dose.   Reporter did not allow further contact
Vaccine coordinator entering shots. The shot log says Dtap. It matches the TDAP lot number though. Verified it was Tdap that was given to patient. This occurred Friday, May 7, 2021.
Legal report of a male patient who experienced mercury poisoning coincident with Certiva. Between Mar 2001 and Jul 2002, the patient received Certiva vaccination for immunization. On an unreported date, the patient experienced mercury poisoning, which led to toxic neurological effects. Pertinent laboratory test, diagnostic procedure, medical history or concomitant medication information was not provided. The patient was a child. The event of mercury poisoning was considered medically significant (OMIC).
We received the following literature report on 15 JUN 2009. 15 children between 6 and 59 months of age were vaccinated for the first time with an influenza vaccine (batch no. and manufacturer unknown) at the start of each influenza season (defined from 01 NOV to 30 APR) from 1999-2000 through 2006/2007. The children received a total of two doses (fully vaccinated). Vaccine effectiveness among fully vaccinated children as compared with unvaccinated children was 86% (95% confidence interval: 29-97%) for medically attended, laboratory-confirmed influenza illness. Vaccine effectiveness for the partially vaccinated group was 73% (95% confidence interval: 3-93%) as compared with the unvaccinated group. This case refers to one child (for other children, please refer to reference cases MA2009-1692, MA2009-1708 to MA2009-1710 and MA2009-1712 to MA2009-1721. Laboratory-confirmed influenza illness was reported (date?).  Request was sent on 22 JUN 2009, no follow-up information received.
I noticed excessive hair shedding. I don't have any hereditary reason for it. I have probably lost 50 percent of volume of my hair. My hairdresser said that it was not normal to lose that much hair. I went and saw my PCP, Dr, and she ordered thyroid, hormone and vitamin B12 tests. They all came back normal. After that I called my dermatologist and they set me up with a PA that handles hair issues. She requested a CBC, a CMP, vitamin D-25 and also and iron test. All of those tests came back normal. She said that I have Telogen effluvium, which is stress related hair loss. Both doctors have said that they are seeing more cases of patients that have had the virus.
Felt some lower back/hip pain, very sore injection site, chills, sweats (no fever though), slight dizziness, very tired.  Took tylenol in the evening to help get sleep, woke up in the middle of the night with bad chills/then feeling very warm. More tylenol. Woke up in the morning and felt better, arm is still a little sore but I can move it a lot more, feels like a very bad bruise at this point.
Throat felt enclosed; redness on neck; difficulty breathing; hives on chest, arm, and head; nausea; diarrhea; fever; This is a spontaneous report from a contactable consumer reported for herself. A 30-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: FC3182; Expiration date was not reported), dose 1 via an unspecified route of administration, administered in Arm Right on 17Sep2021 16:00 (at the age of 30-years-old) as DOSE 1, SINGLE for covid-19 immunisation at Pharmacy or Drug Store. Patient was not pregnant at the time of vaccination. The patient medical history was not reported. Concomitant medication(s) included zinc (ZINC); vitamin c [ascorbic acid] (VITAMIN C); fish oil (FISH OIL); folic acid (FOLIC ACID) taken for an unspecified indication, start and stop date were not reported. Patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced throat felt enclosed, redness on neck, difficulty breathing, hives on chest, arm, and head, nausea, diarrhea, fever on 18Sep2021 10:30. Therapeutic measures were taken as a result of the events. AE (adverse event) resulted in doctor or other healthcare professional office/clinic visit. Patient received treatment for AE. AE treatment included nausea medication. There was no prolonged hospitalization. The events were not serious and seriousness criteria included none. Clinical outcome of events was not recovered.  Follow-up attempts are completed. No further information is expected.
Client reported discomfort at site of the injection. Upon observing area, noted that the skin was red, warm, and had about 30mm of hardened area underneath the skin. Client reports no s/s of anapylaxis.